sirolimus and Coronary-Disease

This review article aims to summarize the findings of the most relevant research that compared the use of paclitaxel vs. "limus" based drug eluting stent (DES) in diabetic patients and to define the current state of knowledge with new stent technologies in this patient population.. Since drug eluting stents (DES) were introduced, it has been of great interest to establish whether paclitaxel or sirolimus eluting stents have the same safety and efficacy features for patients with coronary artery disease. The answer to this question is particularly relevant for diabetic patients. Several randomized trials, registry-based studies, and meta-analyses have assessed the performance of these different DES in diabetic patients. The most recently published data favors limus over paclitaxel DES in diabetic patients, but most of these studies compared first vs. second generation DES with the inherent caveats of comparing different platforms, alloys, and drug delivery vehicles. In this literature review, we found that there is robust evidence favoring the use of DES over bare metal stents in diabetic patients with coronary artery disease. We also found that the current state of knowledge is that the everolimus eluting stents have better safety and efficacy than paclitaxel eluting stents in diabetic patients and hence should be the preferred choice. New revascularization strategies including bio-absorbable scaffolds, polymer free stents, and bio-degradable polymers are being studied in diabetic patients with encouraging results.

Topics: Coronary Disease; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Treatment Outcome

To evaluate the efficacy and safety of currently used drug eluting stents compared with each other and compared with bare metal stents in patients with diabetes.. Mixed treatment comparison meta-analysis.. PubMed, Embase, and CENTRAL were searched for randomised clinical trials, until April 2012, of four durable polymer drug eluting stents (sirolimus eluting stents, paclitaxel eluting stents, everolimus eluting stents, and zotarolimus eluting stents) compared with each other or with bare metal stents for the treatment of de novo coronary lesions and enrolling at least 50 patients with diabetes.. Efficacy (target vessel revascularisation) and safety (death, myocardial infarction, stent thrombosis).. From 42 trials with 22,844 patient years of follow-up, when compared with bare metal stents (reference rate ratio 1) all of the currently used drug eluting stents were associated with a significant reduction in target vessel revascularisation (37% to 69%), though the efficacy varied with the type of stent (everolimus eluting stents~sirolimus eluting stents>paclitaxel eluting stents~zotarolimus eluting stent>bare metal stents). There was about an 87% probability that everolimus eluting stents were the most efficacious compared with all others, though there were limited usable data for the zotarolimus eluting Resolute stent in patients with diabetes. Moreover, there was no increased risk of any safety outcome (including very late stent thrombosis) with any drug eluting stents compared with bare metal stents. There was about a 62% probability that the everolimus eluting stent was the safest stent for the outcome of "any" stent thrombosis.. Among patients with diabetes treated with coronary stents all currently available drug eluting stents were efficacious without compromising safety compared with bare metal stents. There were relative differences among the drug eluting stents, such that the everolimus eluting stent was the most efficacious and safe.

Topics: Angioplasty, Balloon, Coronary; Bayes Theorem; Coronary Disease; Diabetes Complications; Drug-Eluting Stents; Follow-Up Studies; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

Evidence supporting the use of drug-eluting stents (DES) in saphenous vein graft (SVG) disease is uncertain. Previous studies have suggested that DES might reduce the re-intervention rate in SVG disease, with conflicting data on mortality. Thus, a meta-analysis was performed to compare outcomes of DES vs. bare metal stent (BMS) in SVG disease.. Medline and Web databases were searched for studies comparing DES and BMS for SVG disease, reporting rates of overall mortality, target vessel revascularization (TVR) and myocardial infarction (MI) with a follow-up of ≥6 months. The meta-analysis included 23 studies (7,090 patients). Compared with BMS, DES-treated patients had lower rates of TVR (odds ratio (OR), 0.53; confidence interval (CI), 0.39-0.72; P<0.0001) and overall mortality (OR, 0.63; CI, 0.40-0.99; P=0.05), but similar rates of MI (OR, 0.92; CI, 0.64-1.33; P=0.7). Subgroup analysis highlighted differences between non-randomized studies, in which DES improved mortality rates, and randomized trials, in which benefit from DES was not evident. Meta-regression analysis showed that DES were more effective in the presence of older grafts and type 2 diabetes.. The present meta-analysis showed that, in SVG disease, DES significantly reduced TVR, but did not provide clear benefits on mortality and MI, with an opposite direction of results in mortality observed from randomized and observational data.

Topics: Aged; Aged, 80 and over; Angioplasty; Bias; Clinical Trials as Topic; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Postoperative Complications; Randomized Controlled Trials as Topic; Regression Analysis; Saphenous Vein; Sirolimus; Stents; Treatment Outcome

Topics: Coronary Disease; Drug-Eluting Stents; Equipment Design; Humans; Sirolimus

Topics: Coronary Disease; Drug-Eluting Stents; Equipment Design; Humans; Sirolimus

Topics: Coronary Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Sirolimus

Topics: Coronary Disease; Drug-Eluting Stents; Everolimus; Humans; Sirolimus

Topics: Coronary Disease; Drug-Eluting Stents; Humans; Sirolimus

Smaller coronary arteries are less able to accommodate late loss after percutaneous coronary interventions than larger arteries. The first-generation drug-eluting stents have been shown to have better control of neo-intimal hyperplasia and lower late lumen loss compared with bare-metal stents. However, the reported rates of binary restenosis are still unsatisfactory and small target vessel interventions remain challenging. Recently, a study using a subset of the SPIRIT III trial has demonstrated that the everolimus-eluting stent lowered late lumen loss, rates of binary restenosis and target lesion revascularization compared with the paclitaxel-eluting stent. In this article, we review previous studies evaluating small-vessel interventions and focus on the everolimus-eluting stent in this clinical entity.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Sirolimus

Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher) and paclitaxel-eluting stents (Taxus), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor) and everolimus-eluting stents (Xience V), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.

Topics: Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Sirolimus

Implantation of drug-eluting stents has emerged as the predominant percutaneous revascularization strategy in diabetic patients, despite limited outcomes data. Accordingly, our aim was to conduct a meta-analysis to assess the benefit and safety profile of drug-eluting stents in diabetic patients.. We included randomized trials comparing either the paclitaxel- or sirolimus-eluting stent with a bare-metal stent or with each other in diabetic patients during a follow-up of at least 6 months.. A total of 16 studies were identified, which included 2951 diabetic patients who were followed up for 6 to 12 months. Target lesion revascularization was less frequently performed in patients who received drug-eluting stents compared with bare-metal stents (risk ratio [RR] 0.35, 95% CI 0.27-0.46, P < .0001). Similar reductions were noted in the incidence of major adverse cardiovascular events (RR 0.42, 95% CI 0.31-0.56, P < .0001), in-segment restenosis (RR 0.31, 95% CI 0.25-0.40, P < .0001), and non-Q-wave myocardial infarction (RR 0.57, 95% CI 0.32-0.99, P = .046). Event rates were similar for Q-wave myocardial infarction (RR 0.72, 95% CI 0.25-2.07, P = .54), death (RR 0.64, 95% CI 0.32-1.28, P = .20), and stent thrombosis (RR 0.41, 95% CI 0.13-1.27, P = .12).. In conclusion, diabetic patients who receive drug-eluting stents have a significantly lower incidence of target lesion revascularization, in-segment restenosis and myocardial infarction at 6 to 12 months, compared with bare-metal stents. The rates of mortality and stent thrombosis are similar.

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coronary Disease; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Treatment Outcome

Definitions of stent thrombosis that have been used in clinical trials of drug-eluting stents have been restrictive and have not been used in a uniform manner.. We applied a hierarchical classification of stent thrombosis set by the Academic Research Consortium (ARC) across randomized trials involving 878 patients treated with sirolimus-eluting stents, 1400 treated with paclitaxel-eluting stents, and 2267 treated with bare-metal stents. We then pooled 4 years of follow-up data. All events were adjudicated by an independent clinical-events committee.. The cumulative incidence of stent thrombosis according to the original protocol definitions was 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P=0.20; 95% confidence interval [CI], -0.4 to 1.5) and 1.3% in the paclitaxel-stent group versus 0.8% in the bare-metal-stent group (P=0.24; 95% CI, -0.3 to 1.4). The incidence of definite or probable stent thrombosis as defined by the ARC was 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal-stent group (P=0.70; 95% CI, -1.5 to 1.0) and 1.8% in the paclitaxel-stent group versus 1.4% in the bare-metal-stent group (P=0.52; 95% CI, -0.7 to 1.4). The incidence of definite or probable events occurring 1 to 4 years after implantation was 0.9% in the sirolimus-stent group versus 0.4% in the bare-metal-stent group and 0.9% in the paclitaxel-stent group versus 0.6% in the bare-metal-stent group.. The incidence of stent thrombosis did not differ significantly between patients with drug-eluting stents and those with bare-metal stents in randomized clinical trials, although the power to detect small differences in rates was limited.

Topics: Angioplasty, Balloon, Coronary; Brachytherapy; Combined Modality Therapy; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Prosthesis Design; Prosthesis Failure; Randomized Controlled Trials as Topic; Sirolimus; Stents

The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established.. We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.. The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.. The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Drug Delivery Systems; Follow-Up Studies; Humans; Immunosuppressive Agents; Myocardial Infarction; Prosthesis Design; Prosthesis Failure; Randomized Controlled Trials as Topic; Regression Analysis; Risk; Sirolimus; Stents; Survival Analysis

The safety of drug-eluting stents has been called into question by recent reports of increased stent thrombosis, myocardial infarction, and death. Such studies have been inconclusive because of their insufficient size, the use of historical controls, a limited duration of follow-up, and a lack of access to original source data.. We performed a pooled analysis of data from four double-blind trials in which 1748 patients were randomly assigned to receive either sirolimus-eluting stents or bare-metal stents and five double-blind trials in which 3513 patients were randomly assigned to receive either paclitaxel-eluting stents or bare-metal stents; we then analyzed the major clinical end points of the trials.. The 4-year rates of stent thrombosis were 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P=0.20) and 1.3% in the paclitaxel-stent group versus 0.9% in the bare-metal-stent group (P=0.30). However, after 1 year, there were five episodes of stent thrombosis in patients with sirolimus-eluting stents versus none in patients with bare-metal stents (P=0.025) and nine episodes in patients with paclitaxel-eluting stents versus two in patients with bare-metal stents (P=0.028). The 4-year rates of target-lesion revascularization were markedly reduced in both the sirolimus-stent group and the paclitaxel-stent group, as compared with the bare-metal-stent groups. The rates of death or myocardial infarction did not differ significantly between the groups with drug-eluting stents and those with bare-metal stents.. Stent thrombosis after 1 year was more common with both sirolimus-eluting stents and paclitaxel-eluting stents than with bare-metal stents. Both drug-eluting stents were associated with a marked reduction in target-lesion revascularization. There were no significant differences in the cumulative rates of death or myocardial infarction at 4 years.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Prosthesis Failure; Randomized Controlled Trials as Topic; Sirolimus; Stents

Although randomized studies have shown a beneficial effect of drug-eluting stents in reducing the risk of repeated revascularization, these trials were underpowered to compare rates of death and myocardial infarction. The long-term safety of drug-eluting stents has been questioned recently.. We performed a pooled analysis of 1748 patients in four randomized trials evaluating the safety of sirolimus-eluting stents as compared with bare-metal stents. Patient-level data were obtained and analyzed by independent statisticians at two academic institutions. The primary safety end point was survival at 4 years. We tested for heterogeneities in treatment effect in patient subgroups.. The survival rate at 4 years was 93.3% in the sirolimus-stent group, as compared with 94.6% in the bare-metal-stent group (hazard ratio for death, 1.24; 95% confidence interval [CI], 0.84 to 1.83; P=0.28). In the 428 patients with diabetes, a significant difference in the survival rate was observed in favor of the bare-metal-stent group over the sirolimus-stent group (95.6% vs. 87.8%; hazard ratio for death in the sirolimus-stent group, 2.9; 95% CI, 1.38 to 6.10; P=0.008). The lower survival rate among patients with diabetes who were treated with sirolimus-eluting stents was due to increased numbers of deaths from both cardiovascular and noncardiovascular causes. No difference in survival rate was detected among the patients without diabetes. Rates of myocardial infarction and stent thrombosis were similar in the two groups.. In a pooled analysis of data from four trials comparing sirolimus-eluting stents and bare-metal stents, no significant differences were found between the two treatments in rates of death, myocardial infarction, or stent thrombosis. (ClinicalTrials.gov numbers, NCT00233805 [ClinicalTrials.gov] , NCT00381420 [ClinicalTrials.gov] , NCT00232765 [ClinicalTrials.gov] , and NCT00235144 [ClinicalTrials.gov].)

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Thrombosis; Diabetes Complications; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Randomized Controlled Trials as Topic; Sirolimus; Stents; Survival Rate

Topics: Angioplasty, Balloon, Coronary; Atherectomy; Coronary Disease; Female; Humans; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Sirolimus; Stents; Thrombosis

Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with bare-metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents.. We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with bare-metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18,023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation.. Mortality was similar in the three groups: hazard ratios (HR) were 1.00 (95% credibility interval 0.82-1.25) for sirolimus-eluting versus bare-metal stents, 1.03 (0.84-1.22) for paclitaxel-eluting versus bare-metal stents, and 0.96 (0.83-1.24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0.81, 95% credibility interval 0.66-0.97, p=0.030 vs bare-metal stents; 0.83, 0.71-1.00, p=0.045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2.11, 95% credibility interval 1.19-4.23, p=0.017 vs bare-metal stents; 1.85, 1.02-3.85, p=0.041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with bare-metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0.70, 0.56-0.84; p=0.0021).. The risks of mortality associated with drug-eluting and bare-metal stents are similar. Sirolimus-eluting stents seem to be clinically better than bare-metal and paclitaxel-eluting stents.

Topics: Anti-Bacterial Agents; Coronary Disease; Female; Follow-Up Studies; Humans; Male; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Drug Implants; Humans; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Saphenous Vein; Sirolimus; Stents; Treatment Outcome

Early studies of a cobalt-based alloy stent coated with the novel antiproliferative agent zotarolimus and a phosphorylcholine polymer have demonstrated significant reductions in angiographic restenosis and target vessel revascularization compared with bare metal stents. However, the generalizability of the angiographic outcomes and clinical benefit of zotarolimus-eluting stents (ZESs) to a more real-world patient population is undetermined. Clinical and angiographic outcomes in 1,317 patients treated with the ZES in the first 4 trials of the Endeavor ZES (Medtronic Vascular, Santa Rosa, CA) clinical trials program were pooled for systematic analysis. Protocol-specified follow-up angiography was performed at 8 or 12 months for a subset of 750 of these patients, and clinical follow-up was performed at 9 months after the index procedures in all patients. Diabetes mellitus was present in 22.5% of patients, the mean reference vessel diameter was 2.73 mm, and the mean lesion length was 14.59 mm. At 8 months (12 months for ENDEAVOR I), mean +/- SD in-stent late luminal loss was 0.61 +/- 0.49 mm. In-stent late luminal loss was greatest in larger caliber (>2.9 mm) vessels (0.65 +/- 0.49 mm) and longer (>16.3 mm) lesions (0.70 +/- 0.52 mm) but did not statistically vary according to diabetic status. At 9 months, overall rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) were 4.9% and 7.7%, respectively. The rate of TLR at 12 months was not significantly different relative to diabetes and lesion length >16.3 mm (7.2% and 7.7%, respectively), although TLR was significantly more common when reference vessel diameter was <2.5 mm (8.5%; p = 0.013). At 24 months, overall rates of TLR and MACE were 6.5% and 9.9%, respectively. The overall 24-month rate of stent thrombosis was 0.3%, with no events occurring >14 days after the procedure. Despite varied clinical and angiographic characteristics, treatment with the ZES is associated with consistently low rates of TLR and overall major adverse events, including stent thrombosis. Although these findings indicate the efficacy and safety of the ZES over the time course of the first 4 ENDEAVOR clinical trials, additional ongoing study with more open patient inclusion criteria (including long lesions, small vessels, bifurcations, etc) will be important for discerning whether comparable clinical outcomes can be extended to lesion subsets of higher complexity.

Topics: Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Sirolimus; Survival Rate

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Drug Administration Routes; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Cost-Benefit Analysis; Drug Delivery Systems; Follow-Up Studies; Humans; Immunosuppressive Agents; Meta-Analysis as Topic; Mortality; Myocardial Infarction; Odds Ratio; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents; Time Factors

Cypher (sirolimus-eluting stent) and Taxus (paclitaxel-eluting stent) have been approved for use in percutaneous coronary intervention. Both of the stents have shown superiority over bare metal stents in reducing major adverse cardiac events, restenosis rates and target vessel revascularisation. Results of clinical trials with head-to-head comparison of Taxus and Cypher stents in patients with obstructive coronary artery diseases have recently been reported. This review compares the performance of Cypher and Taxus stents as noted in observational studies and clinical trials in various types of coronary artery lesions.

Topics: Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Combined Modality Therapy; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Diabetes Complications; Drug Implants; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

Drug-eluting stents are commonly used for percutaneous coronary intervention. Despite excellent clinical efficacy, the association between drug-eluting stents and the risk for late thrombosis remains imprecisely defined.. We performed a meta-analysis on 14 contemporary clinical trials that randomized 6675 patients to drug-eluting stents (paclitaxel or sirolimus) compared with bare metal stents. Eight of these trials have reported more than a year of clinical follow-up.. The incidence of very late thrombosis (>1 year after the index procedure) was 5.0 events per 1000 drug-eluting stent patients, with no events in bare metal stent patients (risk ratio [RR]=5.02, 95% confidence interval [CI], 1.29 to 19.52, P=.02). Among sirolimus trials, the incidence of very late thrombosis was 3.6 events per 1000 sirolimus stent patients, with no events in bare metal stent patients (RR=3.99, 95% CI, .45 to 35.62, P=.22). The median time of late sirolimus stent thrombosis was 15.5 months, whereas with bare metal stents it was 4 months. Among paclitaxel trials, the incidence of very late thrombosis was 5.9 events per 1000 paclitaxel stent patients, with no events in bare metal stent patients (RR=5.72, 95% CI, 1.08 to 32.45, P=.049). The median time of late paclitaxel stent thrombosis was 18 months, whereas it was 3.5 months in bare metal stent patients.. Although the incidence of very late stent thrombosis more than 1 year after coronary revascularization is low, drug-eluting stents appear to increase the risk for late thrombosis. Although more of this risk was seen with paclitaxel stents, it remains possible that sirolimus stents similarly increase the risk for late thrombosis compared with bare metal stents.

Topics: Coronary Disease; Drug Delivery Systems; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors

Topics: Antineoplastic Agents, Phytogenic; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Equipment Design; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

We performed a meta-analysis of 10 randomized trials of 5,066 patients with 6 to 12 months of follow-up. The summary risk differences excluded any major differences between the 2 types of stents for death (0.12%, 95% confidence interval [CI] -0.34% to 0.58%, p = 0.60) and overall myocardial infarction (0.04%, 95% CI -0.72% to 0.81%, p = 0.91). There was a modest increase in the risk of Q-wave myocardial infarction with drug-eluting stents (0.36%, 95% CI -0.04% to 0.77%, p = 0.080) but no difference in non-Q-wave myocardial infarction (-0.26%, 95% CI -0.95% to 0.43%, p = 0.47). The trend for increased risk of Q-wave myocardial infarction was seen for paclitaxel and sirolimus stents (risk differences 0.28% and 0.58%, respectively). Drug-eluting stents also had a nonsignificant trend for higher risk of thrombosis (0.29%, 95% CI -0.08% to 0.66%, p = 0.13). We conclude that sirolimus- and paclitaxel-eluting stents are equivalent to bare-metal stents in terms of mortality and overall myocardial infarction risk for the first year of follow-up; the meta-analysis excludes with considerable confidence the presence of large, clinically relevant differences for these outcomes.

Topics: Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Disease; Drug Implants; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents

Drug-eluting stents (DES) have been recently investigated, with favorable data for many devices, but comparative data are lacking. We thus performed an adjusted indirect comparison metaanalysis of DES.. Randomized trials comparing DES vs. bare-metal stents (BMS) were systematically searched, and random effect odds ratios (OR) were computed for target lesion revascularization (TLR) and binary in-stent restenosis rate (BRR) at 6-12 months. We then generated interaction OR for the comparison of different DES.. We pooled data from 17 studies (allocating 3048 patients to BMS and 3392 to nine different DES). Indirect head-to-head comparison of sirolimus-eluting Cypher (N=1007) vs. polymeric paclitaxel-eluting Taxus (N=959) showed nonsignificant differences in TLR [OR=0.8 (0.5-1.4), p=0.45] but significant reductions in BRR favoring Cypher [OR=0.3 (0.1-0.6), p<0.001]. Everolimus-eluting stents appeared noninferior to Cypher or Taxus (p>0.50 for both TLR and BRR). Actinomycin-, mycophenolate-, and apolymeric paclitaxel-eluting stents (PES) all proved significantly worse than Cypher or Taxus for TLR or BRR.. Notwithstanding its inherent limitations, the present metaanalysis confirms the effectiveness of both Cypher and Taxus, supports the promising role of everolimus-eluting stents, and suggests the significant inferiority of most other devices. These post hoc findings, albeit intriguing, await prospective confirmation.

Topics: Coronary Disease; Everolimus; Humans; Immunosuppressive Agents; Odds Ratio; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Stents

Local stent-based drug delivery (drug-eluting stent - DES) is a new technology aimed to prevent the development of neointimal hyperplasia and restenosis following percutaneous coronary interventions. A number of DESs have been developed using different carrier stents, different kind of coatings, and different drugs. However, to date only two polymer-coated DESs (the Cypher sirolimus-eluting stent from Cordis, Johnson & Johnson, Miami Lake, FL, USA; and the Taxus paclitaxel-eluting stent, Boston Scientific, Natick, MA, USA) have become commercially available after a number of randomized trials showed their ability to reduce late luminal loss, binary restenosis and the need for repeat revascularization when compared to bare metal stents. This review describes the general concept of DES and summarizes the results of the principal clinical trials on DESs, both approved for clinical use or under development. For the marketed stents, we also report the results of the first clinical evaluations in real life and a few insights into the most controversial issues.

Topics: Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Female; Humans; Male; Paclitaxel; Prognosis; Radiography; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Sirolimus; Stents; Treatment Outcome

We conducted a meta-analysis on 6 studies in 2,963 patients who had coronary artery disease and received a sirolimus-eluting stent or a bare metal stent for revascularization. Compared with bare metal stents, sirolimus-eluting stents did not appear to increase the risk for thrombosis up to 13.5 months after coronary intervention (risk ratio 0.49, 95% confidence interval 0.22 to 1.12, p = 0.09).

Topics: Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Disease; Coronary Stenosis; Coronary Thrombosis; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Postoperative Complications; Radiography; Randomized Controlled Trials as Topic; Registries; Retrospective Studies; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

Diabetes mellitus has reached epidemic proportions worldwide. Patients with diabetes are at increased risk for acute coronary syndromes, and these syndromes lead to frequent morbidity and cardiovascular mortality. Emerging adjunctive pharmacological strategies coupled with the drug-eluting stent platform have resulted in improved adverse event rates for this high-risk group. This review will concentrate on the historical data associated with acute coronary syndromes in diabetes mellitus, focusing on revascularisation, drug-eluting stents and antiplatelet therapies.

Topics: Acute Disease; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Diabetes Complications; Humans; Paclitaxel; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Purinergic P2 Receptor Antagonists; Randomized Controlled Trials as Topic; Sirolimus; Stents; Syndrome

Drug eluting stent is a new technology aimed to prevent the development of neointimal hyperplasia and restenosis following percutaneous coronary intervention. This review describes the direction for their use at the present time and the future of their utilization with the summary of the principals clinicals trials.

Topics: Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents; Tubulin Modulators

Convincing end point data demonstrating the anatomic and clinical superiority of stent placement compared with balloon angioplasty together with significant improvement in stenting technique and poststent management have resulted in an explosion in stenting procedures and the emergence of more than 40 stent types with disparate designs and material composition in clinical use. Structural nuances in design, composition, and coating of different stent models, however, have been shown to have a major influence on the risk of stent thrombosis, the degree of vessel wall injury, and subsequent intimal proliferation in the experimental model. There is now substantial amount of evidence to indicate that the same relationship between stent structural characteristics and vessel wall outcome holds true in humans. This article provides an up-to-date overview of the clinical impact of stent construction and design, including the clinical performance of drug-eluting stents.

Topics: Biocompatible Materials; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Humans; Paclitaxel; Prosthesis Design; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Drug Delivery Systems; Estradiol; Everolimus; Humans; Paclitaxel; Sirolimus; Stents; Tacrolimus

Drug-eluting stents have been developed to prevent in-stent restenosis following percutaneous coronary revascularization. In a number of randomized trials, polymer-coated sirolimus- and paclitaxel-eluting stents have been proven to markedly reduce the incidence of angiographic restenosis and repeat revascularization when compared to bare metal stents. Effectiveness of sirolimus-eluting stents in the prevention of restenosis has been confirmed in many subsets of patients and lesions not included in randomized trials, such as in-stent restenosis, chronic total occlusion, acute myocardial infarction, and others. Very promising data in the real world are emerging for utilization of paclitaxel-eluting stents as well. Other drug-eluting stents gave less brilliant results or even true failures, whilst a number of new drugs and stent platforms are under clinical or preclinical evaluation. In this review we describe the main clinical trials on drug-eluting stents, and the most recent informations derived from observational studies and registries. Moreover, preliminary results on new drug-eluting stents are summarized.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Disease; Coronary Restenosis; Drug Therapy, Combination; Humans; Immunosuppressive Agents; Paclitaxel; Polymers; Randomized Controlled Trials as Topic; Sirolimus; Stents

Coronary artery disease is the largest killer of men and women in the United States and costs the health care system billions of dollars annually. Several advances in both mechanical and pharmacologic treatment of coronary artery disease have occurred in recent decades. Mechanically, percutaneous coronary intervention is commonly used to treat coronary atherosclerosis. This approach has dramatically reduced both morbidity and mortality for patients with different levels of severity of coronary artery disease. However, percutaneous coronary intervention is limited by restenosis, which is an increase in growth of the intimal layer of the vessel wall. Despite the introduction of intracoronary stents and the addition of systemic pharmacotherapy, restenosis still affects a significant number of patients. The new technology of drug-eluting stents combines mechanical and pharmacologic approaches to prevent restenosis. Various types of these stents exist in different stages of development; several have been shown to prevent or reduce intimal growth after stent deployment. An understanding of how this combined mechanical and pharmacologic approach reduces restenosis requires consideration of complex issues in pathophysiology and pharmacology.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents; Brachytherapy; Clinical Trials as Topic; Coronary Disease; Coronary Restenosis; Female; Humans; Male; Paclitaxel; Sirolimus; Stents

Drug-eluting stenting is part of the evolution of interventional cardiology that started with Gruentzig's introduction of balloon angioplasty in 1977. Numerous advances in interventional cardiology technique have occurred since that time, and drug-eluting stents hold promise for reducing the restenosis rate but as yet have not been shown to influence survival or freedom from myocardial infarction. The ability of stents to influence these hard end points will be tested against the most difficult patient subset for interventional cardiology: persons with diabetes mellitus and multivessel disease. As more data are accumulated, prudent selective use of drug-eluting stenting seems most appropriate.

Topics: Angioplasty, Balloon, Coronary; Anti-Infective Agents; Brachytherapy; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Follow-Up Studies; Humans; Immunosuppressive Agents; Meta-Analysis as Topic; Multicenter Studies as Topic; Paclitaxel; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Stents; Time Factors

Coronary revascularization procedures are associated with less favourable outcomes in diabetic patients as compared to non-diabetic individuals. Especially, percutaneous coronary angioplasty (PTCA) is associated with a high level of restenosis and recurrent cardiac morbidity and mortality. In diabetic patients, PTCA should ideally be combined with stents. Bare-metal stents reduce by almost half the risk of restenosis, but this favourable effect decreases with the vessel calibre, a common finding in diabetic patients. Drug-eluting stents containing pharmacological agents that can reduce the risk of restenosis (sirolimus, paclitaxel) provide better angiographic results, including in small coronary arteries, and this effect has been shown to be accompanied by significant reduction of both morbidity and mortality. Such preliminary results obtained in the general population (including around 20% of diabetic subjects) deserve further confirmation in a large clinical trial specifically devoted to diabetic patients. Drug-eluting stents may represent a major advance in the management of diabetic patients with coronary heart disease in the near future.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Diabetes Complications; Drug Delivery Systems; Humans; Paclitaxel; Platelet Aggregation Inhibitors; Sirolimus; Stents

The cellular action of rapamycin (sirolimus), a natural fermentation product produced by Streptomyces hygroscopicus, is mediated by binding to the FK506 binding protein. By inhibiting a kinase known as the target of rapamycin, it restricts the proliferation of smooth-muscle cells by blocking cell-cycle progression at the G1/S transition. The finding that rapamycin possesses both anti-proliferative and antimigratory activity suggests that it could contribute to the control of arterial re-narrowing after percutaneous intervention and control the vascular manifestations of chronic rejection in transplanted hearts. The first clinical trials of implantation of rapamycin- coated stents in obstructive coronary artery lesions have been reported and, in selected patient groups, it appears that the restenosis process has been abolished. Studies are underway to establish the benefits of rapamycin-coated stents in day-to-day interventional practice, including small vessels, long lesions and patients with multivessel disease. With the addition of novel antiplatelet agents and delivery systems, it is possible that the two major limitations of percutaneous coronary intervention - restenosis and stent thrombosis - will be overcome. Cardiac graft loss due to intimal hyperplasia and accelerated atherosclerosis remains the major limitation to long-term survival following cardiac transplantation. Animal studies of rapamycin have suggested that this process can be reduced or abolished. Human studies of the efficacy of rapamycin in preventing both acute rejection and allograft arterial disease are in progress. Concerns regarding toxicity, carcinogenicity, delayed healing and endothelialization remain. As with any new agent or technology, we must remain vigilant to late adverse side-effects.

Topics: Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Graft Rejection; Humans; Immunosuppressive Agents; Sirolimus; Stents; Transplantation Immunology

Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Humans; ortho-Aminobenzoates; Paclitaxel; Probucol; Radiotherapy; Sirolimus; Stents; Trapidil

For interventional cardiologists restenosis has represented the main limit for the successful long-term treatment of coronary artery disease. The past 2 years witnessed the extraordinary results of drug-eluting stents (DES), putting this technique at the center stage. The safety and efficacy of sirolimus and paclitaxel-eluting stents have been proved in large prospective, multicenter, randomized trials (RAVEL, SIRIUS, TAXUS II). It is possible that the introduction of DES will lead to substantial changes in the therapeutic and/or the economic strategies of the treatment of ischemic coronary artery disease (increase in the complexity of patients treated, reduction in surgical indications, growing costs). Realizing the potential value of this technology will require the successful management of more complex coronary situations (for lesions and patients characteristics). Many extreme situations are still unexplored, although for some of them studies are currently in progress or already being planned.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Costs and Cost Analysis; Humans; Immunosuppressive Agents; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents

This study evaluated the early outcomes of patients with acute coronary syndromes (ACS) treated with sirolimus-eluting stents (SES).. The safety of SES implantation in patients with a high risk for early thrombotic complications is currently unknown.. Sirolimus-eluting stents have been utilized as the device of choice for all percutaneous procedures in our institution, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. After four months of enrollment, 198 patients with ACS had been treated exclusively with SES (64% of those treated in the period) and were compared with a control group composed of 301 consecutive patients treated with bare stents in the same time period immediately before this study. The incidence of major adverse cardiac events (MACE) during the first month was evaluated (death, nonfatal myocardial infarction [MI], or re-intervention).. Compared with control patients, patients treated with SES had more primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01). The 30-day MACE rate was similar between both groups (SES 6.1% vs. control patients 6.6%; p = 0.8), with most complications occurring during the first week. Stent thrombosis occurred in 0.5% of SES patients and in 1.7% of control patients (p = 0.4). In multivariate analysis, SES utilization did not influence the incidence of MACE (odds ratio 1.0 [95% confidence interval: 0.4 to 2.2]; p = 0.97).. Sirolimus-eluting stent implantation for patients with ACS is safe, with early outcomes comparable with bare metal stents.

Topics: Acute Disease; Aged; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Combined Modality Therapy; Coronary Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Multivariate Analysis; Netherlands; Postoperative Complications; Predictive Value of Tests; Risk Factors; Sirolimus; Stents; Syndrome; Time Factors; Treatment Outcome

Since the advent of percutaneous coronary intervention (PCI) for stenosing coronary disease, restenosis has remained a clinical problem. Despite the emergence and evolution of coronary stents, the rate of restenosis following PCI is still 10-20%, and above 50% in high risk subgroups. With increased understanding of the pathophysiology of this process, a number of potential therapeutic targets have been identified, allowing the development of novel therapies against restenosis, which can now be delivered locally using stent platforms. Some of the reported clinical trial data utilizing drug-eluting stents (DES) have produced such profound reductions in clinical and angiographic restenosis that we have been tempted to believe we are on the brink of eradicating this process completely. As the initial excitement subsides, however, there is a need to decide whether these tools will remain effective in real-world interventional practice. In this article we review the pathophysiology of the restenotic process, and the biological targets of the DES therapies currently available in clinical practice. We attempt to define clinical target populations for DES therapy, and assess the impact on outcomes thus far. We consider the advantages that newly emergent stent coatings might offer, and whether targeting specific patient subgroups with unique antiproliferative agents may provide the best chance of limiting restenosis in high risk subgroups. Finally, we consider future strategies to prevent restenosis, with a movement away from the antiproliferative approach, and toward accelerating endothelialization.

Topics: Antibiotics, Antineoplastic; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Forecasting; Humans; Immunosuppressive Agents; Paclitaxel; Risk Factors; Sirolimus; Stents

Nowadays stent placement has replaced balloon angioplasty as the most commonly performed percutaneous coronary interventional procedure, mainly because of its better acute and chronic outcome. As a result, in-stent restenosis (ISR) has become a widespread problem. The incidence of ISR varies from 10% to 50% and depends on the absence or presence of several risk factors, such as small vessel size, longer lesions, and diabetes. Intravascular ultrasound studies have demonstrated that ISR is mainly caused by neointimal proliferation; consequently, this pathologic process has become the target of many preventive and therapeutic approaches. This article provides an overview of such management strategies, highlighting the rather disappointing experiences with mechanical and systemic drug therapies; the relative merits and disadvantages of intracoronary radiation; and the exciting yet realistic promise, embodied by the recent advancements in drug-eluting stent technology, of potentially eradicating ISR in the near future.

Topics: Angioplasty, Balloon, Coronary; Animals; Brachytherapy; Cell Cycle; Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Gene Transfer Techniques; Humans; Paclitaxel; Sirolimus; Stents

Sirolimus (rapamycin), a macrolide antibiotic with known potent immunosuppressive properties, acts in the first phase (G1) of the cell cycle, blocking its further progression to the phase of DNA synthesis (S). In experimental models, rapamycin is effective in inhibiting smooth muscle cell proliferation and migration after vessel wall injury with balloon angioplasty. These results lead to the clinical application of sirolimus-eluting stents in 45 patients in Sao Paulo and Rotterdam (FIM Registry) and 238 patients in a randomized, European multicenter trial (RAVEL). These trials showed, by angiography and intravascular ultrasound, almost complete abolition of in-stent late hyperplasia up to one year after the procedure. In this review, we describe the experimental and clinical results of sirolimus-eluting stents including our experience of 26 stents implanted in 17 patients. In elective de novo lesions has shown remarkably clear lumens at follow-up angiography and intravascular ultrasound within the stented segments were observed with no lesion progression at the stent margins or thrombosis after a 2 month regimen of aspirin, and ticlopodine or clopidogrel. New large-scale ongoing clinical trials will investigate the efficacy of sirolimus-eluting stents in lesions that are traditionally associated with high restenosis rates after stent implantation, such as long lesions, bifurcations and instent restenosis.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Animals; Aspirin; Clopidogrel; Coronary Angiography; Coronary Disease; Coronary Restenosis; Disease Models, Animal; Drug Delivery Systems; Follow-Up Studies; Humans; Immunosuppressive Agents; Injections, Intramuscular; Multicenter Studies as Topic; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Rats; Sirolimus; Stents; Swine; Thrombosis; Ticlopidine; Time Factors; Ultrasonography, Interventional

Topics: Coronary Disease; Cyclosporine; Heart Transplantation; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Immunosuppression Therapy; Immunosuppressive Agents; Isoxazoles; Leflunomide; Mycophenolic Acid; Polyenes; Postoperative Complications; Sirolimus; Tacrolimus

We performed a multicenter, randomized controlled trial to determine the noninferiority of a novel biodegradable polymer drug-eluting stent (BP-DES), the EXCEL 2 stent, to the first-generation BP-DES, the EXCEL stent.. The second-generation BP-DES (EXCEL 2) was noninferior to the first-generation BP-DES (EXCEL) for the primary endpoint of in-stent LL at 9 months. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02057978.

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Endpoint Determination; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Patient Safety; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding.. This study analyzed 2-year outcomes to determine whether these benefits are maintained.. In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization.. At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, anemia, raised plasma creatinine, and planned long-term anticoagulation. Correlates of the primary safety endpoint were age, anemia, congestive heart failure, multivessel disease, number of stents implanted, and use of a BMS rather than a DCS.. Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Thrombosis; Death; Double-Blind Method; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Risk; Sirolimus; Statistics as Topic; Stents; Survival Rate

We performed a randomised controlled open-label non-inferiority trial to compare angiographic outcomes between the ultra-thin strut, biodegradable hybrid polymer Orsiro sirolimus-eluting stent (O-SES) and the durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES).. A total of 372 patients planned to undergo percutaneous coronary revascularisation were randomly assigned 2:1 to treatment with O-SES or R-ZES (250 and 122 patients, respectively). O-SES was non-inferior to R-ZES for the primary endpoint, in-stent late lumen loss at nine months (median 0.06 mm [interquartile range, -0.09 to 0.24 mm] versus 0.12 mm [-0.07 to 0.32 mm]; p for non-inferiority <0.001; p for superiority=0.205). Percent diameter stenosis was significantly lower in the O-SES group than in the R-ZES group (15.0 [10.0 to 20.0] versus 20.0 [13.3 to 26.0]; p=0.002). Target lesion failure occurred in 2.4% and 3.3% of the O-SES and R-ZES groups, respectively (p=0.621). Subgroup analyses showed consistently similar outcomes between the two groups in terms of the primary endpoint, except for the diabetic subgroup.. O-SES was non-inferior to R-ZES in terms of in-stent late loss at nine months. Angiographic restenosis and clinical adverse events were low in both groups. This study confirms the good safety and efficacy profiles of both contemporary coronary stents.

Topics: Adult; Aged; Aged, 80 and over; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome

Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES).. EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoints. There was no difference in cardiac death and definite/probable stent thrombosis between the two groups; however, there was a trend towards reduction in myocardial infarction and repeat revascularisation in the NES group at five-year follow-up.. At five-year follow-up, the incidence of device- and patient-oriented events was significantly lower in the NES group. Further studies, adequately powered for clinical outcomes, are warranted.

Topics: Adult; Aged; Coronary Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Macrolides; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus

It is widely known that drug-eluting stents (DES) induce coronary vasomotion abnormalities. We have previously demonstrated that chronic treatment with long-acting nifedipine suppresses coronary hyperconstricting responses induced by the first-generation DES (e.g. sirolimus- and pacritaxel-eluting stents) through inhibition of vascular inflammation in pigs. To examine whether this is also the case with the second-generation DES (everolimus-eluting stents, EES) in humans, the most widely used DES in the world, we conducted a prospective, randomized, multicentre trial, termed as the NOVEL Study.. We evaluated 100 patients with stable angina pectoris who underwent scheduled implantation of EES in the left coronary arteries. They were randomly assigned to receive either conventional treatments alone or additionally long-acting nifedipine (10-60 mg/day) (n = 50 each). After 8-10 months, 37 patients in the control and 38 in the nifedipine group were examined for coronary vasoreactivity to intracoronary acetylcholine (ACh) by quantitative coronary angiography after 48-h withdrawal of nifedipine. Coronary vasoconstricting responses to ACh were significantly enhanced at the distal edge of EES compared with non-stented vessel (P = 0.0001) and were significantly suppressed in the nifedipine group compared with the control group (P = 0.0044). Furthermore, the inflammatory profiles were also improved only in the nifedipine group, which evaluated by serum levels of high-sensitivity CRP (P = 0.0001) and adiponectin (P = 0.0039).. These results indicate that DES-induced coronary vasomotion abnormalities still remain an important clinical issue even with the second-generation DES, for which long-acting nifedipine exerts beneficial effects associated with its anti-inflammatory effects.. This study is registered at the UMIN Clinical Trial Registry (UMIN-CTR; ID=UMIN000015147).

Topics: Coronary Disease; Drug-Eluting Stents; Everolimus; Humans; Nifedipine; Prospective Studies; Sirolimus; Treatment Outcome

In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers.. The large-scale, investigator-initiated, multicentre, assessor and patient blinded, three-arm, randomised, BIO-RESORT non-inferiority trial was done at four clinical sites in the Netherlands. All-comer patients were aged 18 years or older, capable of providing informed consent, and required a percutaneous coronary intervention with drug-eluting stent implantation according to clinical guidelines or the operators' judgment. Exclusion criteria were: participation in another randomised drug or device study before reaching the primary endpoint of that study; planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months; known intolerance to components of the investigational product or medication required; uncertainty about the adherence to follow-up procedures or an assumed life expectancy of less than 1 year; or known pregnancy. Web-based computer-generated allocation sequences randomly assigned patients (1:1:1) to treatment with very thin strut biodegradable polymer everolimus-eluting or sirolimus-eluting stents (which differ substantially in type, amount, distribution, and resorption speed of their respective coating), or thin strut durable polymer zotarolimus-eluting stents. The primary endpoint was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularisation) at 12 months of follow up with a very thin strut biodegradable polymer of either everolimus-eluting or sirolimus-eluting stents, compared with durable polymer zotarolimus-eluting stents, analysed by intention to treat (non-inferiority margin 3·5%). This trial was registered with ClinicalTrials.gov, number NCT01674803.. From Dec 21, 2012, to Aug 24, 2015, 3514 patients were enrolled and analysed, of whom 2449 (70%) had acute coronary syndromes, which included 1073 (31%) ST-elevation myocardial infarctions. 12 month follow-up of 3490 (99%) patients (three lost to follow-up; 21 withdrawals) was available. The primary endpoint was met by 55 (5%) of 1172 patients assigned to everolimus-eluting stents, 55 (5%) of 1169 assigned to sirolimus-eluting stents and 63 (5%) of 1173 assigned to zotarolimus-eluting stents. Non-inferiority of the everolimus-eluting stents and sirolimus-eluting stents compared with zotarolimus-eluting stents was confirmed (both -0·7% absolute risk difference, 95% CI -2·4 to 1·1; upper limit of one sided 95% CI 0·8%, p. At 12 month follow-up, both very thin strut drug-eluting stents with dissimilar biodegradable polymer coatings (eluting either everolimus or sirolimus) were non-inferior to the durable polymer stent (eluting zotarolimus) in treating allcomers with a high proportion of patients with acute coronary syndromes. The absence of a loss of 1 year safety and efficacy with the use of these two biodegradable polymer-coated stents is a prerequisite before assessing their potential longer-term benefits.. Biotronik, Boston Scientific, and Medtronic.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Anti-Bacterial Agents; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome

To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents (ZES) versus Xience V everolimus-eluting stents (EES).. Nowadays, many complex patients with coronary disease are treated with percutaneous coronary interventions, using drug-eluting stents (DES).. We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial, treated with second-generation Resolute ZES or Xience V EES. Complex patients had at least one of the following characteristics: renal insufficiency (creatinine ≥ 140 µmol/l); ejection fraction < 30%; acute myocardial infarction (MI) within previous 72 hrs; >1 lesion/vessel; >2 vessels treated; lesion length > 27 mm; bifurcation; saphenous vein graft lesion; arterial bypass graft lesion; in-stent restenosis; unprotected left main lesion; lesion with thrombus; or lesion with total occlusion. Target vessel failure (TVF), the primary composite endpoint of the trial, was defined as cardiac death, target vessel-related MI, or target vessel revascularization.. Among the 1,033 complex patients, 529 (51%) were treated with Resolute ZES and 504 (49%) with Xience V EES. Patient- and procedure-related characteristics were similar between DES groups. After 2-year follow-up, outcome was also similar between DES groups. TVF occurred in 12.1% of patients treated with Resolute ZES and 12.3% of patients treated with Xience V EES. In addition, DES groups did not differ significantly in cardiac death, MI, or target vessel revascularization-the individual components of TVF.. Complex patients treated with Resolute ZES and Xience V EES showed similar safety and efficacy during 2-year follow-up. © 2014 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The second-generation drug-eluting stents (DES) have shown superiority in many studies relating to safety and efficacy when compared with the first-generation DES. However, it is unclear whether there are differences in efficacy and safety among the second-generation DES after long-term follow-up.. This multicenter, prospective, randomized, open-labeled trial will directly compare the efficacy and safety among the patients treated with either everolimus-eluting stent (EES), zotarolimus-eluting stent with biolinx polymer (ZES-R), or biolimus-eluting stent (BES) with minimal exclusion criteria. The primary end point is a patient-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel and clinically indicated target lesion revascularization at 24-month clinical follow-up post-index procedure. With the hypothesis that "BES is non-inferior to EES" or "BES is non-inferior to ZES-R" in primary end point, approximately 2,600 patients will be assigned to one of the types of stents using a web-based randomization system.. The CHOICE trial will directly compare the efficacy and safety of EES, ZES-R, and BES in everyday clinical practice for long-term follow-up.

Topics: Adult; Algorithms; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Myocardial Infarction; Prosthesis Design; Sirolimus

The angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate. We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents.. Patient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the 2 drug-eluting stents (ISAR-TEST) clinical trial and the LIPSIA Yukon clinical trial (randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus) were pooled. The angiographic (primary) endpoint was in-stent late lumen loss at 6 months to 9 months. The clinical (secondary) endpoints were death or myocardial infarction, cardiac death or myocardial infarction, target lesion revascularization, and myocardial infarction.. A total of 686 patients (polymer-free sirolimus-eluting stents, n=345 vs polymer-based paclitaxel-eluting stents, n=341) and 751 lesions (polymer-free sirolimus-eluting stents, n=383 vs polymer-based paclitaxel-eluting stents, n=368) were included in the study. Control angiography (606 lesions, 80.6%) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents (0.53 [0.59] mm vs 0.46 [0.57] mm; P=.15). Median follow-up was 34.8 months. Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0.49-2.80; P=.71), cardiac death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0.72-1.89; P=.50), target lesion revascularization (relative risk=0.98; 95% confidence interval, 0.65-1.47; P=.93), and myocardial infarction (relative risk=1.79; 95% confidence interval, 0.85-3.76; P=.12).. In this pooled analysis, polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy.

Topics: Aged; Antineoplastic Agents, Phytogenic; Coronary Disease; Drug-Eluting Stents; Endpoint Determination; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Treatment Outcome

Even in the drug-eluting stent era, adverse cardiac events, including restenosis after percutaneous coronary intervention (PCI), have been more frequently seen in patients on hemodialysis (HD) than in non-HD patients. The objective of this study was to compare the sirolimus-eluting stent (SES) and everolimus-eluting stent (EES) for prevention of adverse cardiac events, including restenosis, in HD patients.. A total of 100 consecutive patients on HD who underwent PCI were enrolled and randomly assigned to receive SES or EES. Although there was no difference between the 2 groups in baseline patient and lesion characteristics, the angiographic restenosis rate at 8-month follow-up was 21.2% in the SES group and 8.7% in the EES group (P = 0.041). Significant differences were also seen in % diameter stenosis (%DS), minimal lumen diameter, and late lumen loss at 8-month follow-up (P = 0.0024, P = 0.0040, and P = 0.033, respectively). During the 1-year follow-up, major adverse cardiac events occurred in 11 (22.0%) patients in the SES group and in 5 (10.0%) patients in the EES group (P = 0.10).. The use of EES was as safe as that of SES. Moreover, EES significantly prevented restenosis in patients on maintenance HD compared with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Renal Dialysis; Sirolimus; Treatment Outcome

Positive peri-stent vascular remodeling (PPVR) after drug-eluting stent (DES) implantation is an important mechanism of late-acquired stent malapposition (LASM).. A total of 226 patients (sirolimus-eluting stent [SES], n=105; paclitaxel-eluting stent [PES], n=121) from the Poststent Optimal Stent Expansion Trial who underwent a post-intervention and 9-month follow-up intravascular ultrasound were followed clinically for 5 years. PPVR was arbitrarily defined as a >10% increase in the external elastic membrane volume index at follow-up. PPVR and LASM occurred more frequently with SESs than with PESs. The 5-year rate of major adverse cardiac events was lower with SES than with PES (10.7% vs. 23.2%, P=0.002). The late and very late stent thrombosis (ST) rate was similar between the 2 DES types, but it was higher in patients with PPVR than in those without PPVR (8.8% vs. 1.3%, P=0.009) regardless of the DES type. Early discontinuation (<1 year) of dual antiplatelet therapy (DAPT; hazard ratio [HR], 24.14; 95% confidence interval [CI]: 4.90-118.87; P<0.001), PPVR (HR, 14.94; 95%CI: 1.85-120.46; P=0.011), LASM (HR, 8.01; 95%CI: 1.93-33.16; P=0.004), and stent length (HR, 1.14; 95%CI: 0.98-1.32 per mm; P=0.078) were associated with increased risk of late and very late ST.. PPVR and LASM development after DES implantation, along with early discontinuation of DAPT and longer stent length, are important risk factors of late and very late ST.

Topics: Aged; Coronary Disease; Drug-Eluting Stents; Elasticity; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Sirolimus; Thrombosis; Ultrasonography

Pivotal studies on drug-eluting stents have excluded hemodialysis (HD) patients. No quantitative coronary angiography (QCA) analysis has been reported.. The OUtcome of Cypher stent in Hemodialysis patients (OUCH) Study is a prospective non-randomized single-arm registry designed to assess the results of sirolimus-eluting stents in HD patients, with follow-up QCA in an independent core laboratory. The primary endpoint was the occurrence of target-vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 1 year. A total of 117 patients were enrolled. The TVF rate was 24.9% (2.6% cardiac death, 1.4% MI, 23.9% TVR), and stent thrombosis was documented in 1 patient (0.9%). Coronary calcification was a predictor of TVF. Late lumen loss (LLL) averaged 0.69±0.93mm. The histogram of LLL showed that a total of 76% of lesions were distributed the same normally as that in normal renal function (average LLL 0.20±0.29mm), but 24% of lesions were outliers (average LLL 2.07±0.62mm).. This report describes different clinical and QCA results in HD patients as higher TVF rate, different predictive factors, and different histogram of LLL compared with normal renal function. The different histogram of LLL was the existence of many outliers with the same average and the same deviation, suggesting the loss of sirolimus had an effect on a significant number of HD patients.

Topics: Aged; Coronary Disease; Death; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Kidney Function Tests; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Renal Dialysis; Sirolimus; Time Factors; Vascular Calcification

The Sparrow stent system (Biosensors International) consists of a self-expanding, ultra-thin nitinol stent mounted within a 0.014″ guidewire designed for small or tortuous coronary lesions. We compared the intravascular ultrasound (IVUS) findings between the novel self-expanding sirolimus-eluting stent (Sparrow-SES) and a conventional balloon-expandable sirolimus-eluting stent (Cypher-SES) in patients with small coronary disease.. We examined 14 lesions treated with the Sparrow-SES from CARE II, compared with 22 small vessel lesions treated with Cypher-SES. IVUS examination was performed post-procedure and 8 months later. Volumetric data were standardized by length as volume index (VI; mm³/mm).. While baseline stent VI trended smaller in Sparrow-SES, follow-up stent VI became similar between the 2 groups due to a significant increase of stent VI in self-expanding Sparrow-SES during the follow-up period. At 8 months, Sparrow-SES showed greater neointima than Cypher-SES (0.8 ± 0.6 mm³/mm vs 0.2 ± 0.2 mm³/mm; P<.001). However, the decrease in lumen VI was only 0.3 ± 0.7 mm³/mm in Sparrow-SES, as compared to 0.1 ± 0.3 mm³/mm in Cypher-SES (P=.259), since the late loss due to neointimal hyperplasia was partly counterbalanced by the chronic stent expansion in Sparrow-SES.. While 8-month follow-up of Sparrow-SES revealed greater amounts of neointimal hyperplasia compared with conventional Cypher-SES, chronic stent expansion preserved the lumen by increasing stent volume. This novel, guidewire-based, self-expanding stent system designed to be delivered through complex anatomies may be useful to treat patients with small-caliber coronary lesions by offering sufficient lumen preservation at follow-up.

Topics: Aged; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Equipment Design; Female; Follow-Up Studies; Humans; Hyperplasia; Male; Middle Aged; Neointima; Prospective Studies; Retrospective Studies; Single-Blind Method; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

Women treated with the XIENCE V have improved 1-year clinical outcomes compared to women treated with TAXUS; whether benefits in women are sustained at 3 years is unknown. Three-year follow-up of the SPIRIT III trial revealed improved clinical outcomes of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent. One thousand two patients with coronary artery lesions ≤28 mm in length in 2.5- to 3.75-mm diameter vessels were prospectively randomized to receive XIENCE V or TAXUS stents. A post hoc gender subset analysis was performed. Six hundred sixty-nine patients (30% women) received XIENCE V and 332 patients (34% women) received TAXUS. In the overall population, women had higher 3-year rates of major adverse cardiac events (16.0% vs 10.0%, p = 0.01) and target lesion revascularization (10.2% vs 5.3%, p = 0.008) compared to men. In women, those with XIENCE V continued to have lower major adverse cardiac event rates than those with TAXUS at 2 years (9.5% vs 18.3%, p = 0.03) and 3 years (12.2% vs 22.6%, p = 0.03). Although 1-year target vessel failure rates were similar, at 2- and 3-year follow-up women treated with XIENCE V had approximately 40% relative decreases in target vessel failure rates compared to those treated with TAXUS (12.7% vs 22.0%, p = 0.05; 16.0% vs 26.4%, p = 0.03, respectively). Stent thrombosis and bleeding complication rates were similar between treatment arms in the gender subgroups through 3 years. In conclusion, women in the SPIRIT III trial have sustained clinical benefits from XIENCE V implantation compared to TAXUS without increases in long-term complications.

Topics: Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Sex Factors; Single-Blind Method; Sirolimus; Treatment Outcome; Tubulin Modulators; Women

The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner.. EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined.. This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee.. Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38).. EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Prosthesis Failure; Sirolimus

In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery disease who were receiving routine clinical care with no direct follow-up.. We did a single-blind, all-comer superiority trial in adult patients with chronic stable coronary artery disease or acute coronary syndromes, and at least one target lesion. Patients were treated at one of five percutaneous coronary intervention centres between January, 2006, and August, 2007. Computer-generated block randomisation and a telephone allocation service were used to randomly assign patients to receive the zotarolimus-eluting or the sirolimus-eluting stent. Data for follow-up were obtained from national Danish administrative and health-care registries. The primary endpoint was a composite of major adverse cardiac events within 9 months: cardiac death, myocardial infarction, and target vessel revascularisation. Intention-to-treat analyses were done at 9-month and 18-month follow-up. This trial is registered with ClinicalTrials.gov, number NCT00660478.. 1162 patients (1619 lesions) were assigned to receive the zotarolimus-eluting stent, and 1170 patients (1611 lesions) to receive the sirolimus-eluting stent. 67 patients (72 lesions) had stent failure, and six patients were lost to follow-up. All randomly assigned patients were included in analyses at 9-month follow-up; 2200 patients (94%) had completed 18-month follow-up by the time of our assessment. At 9 months, the primary endpoint had occurred in a higher proportion of patients treated with the zotarolimus-eluting stent than in those treated with the sirolimus-eluting stent (72 [6%] vs 34 [3%]; HR 2.15, 95% CI 1.43-3.23; p=0.0002). At 18-month follow-up, this difference was sustained (113 [10%] vs 53 [5%]; 2.19, 1.58-3.04; p<0.0001). For patients receiving the zotarolimus-eluting stent and those receiving the sirolimus-eluting stent, all cause-mortality was similar at 9-month follow-up (25 [2%] vs 18 [2%]; 1.40, 0.76-2.56; p=0.28), but was significantly different at 18-month follow-up (51 [4%] vs 32 [3%]; 1.61, 1.03-2.50; p=0.035).. The sirolimus-eluting stent is superior to the zotarolimus-eluting stent for patients receiving routine clinical care.. Cordis and Medtronic.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Retreatment; Single-Blind Method; Sirolimus; Thrombosis; Treatment Outcome

The sirolimus-eluting stent has demonstrated the least amount of late lumen loss among previously released drug-eluting stents, but its safety and efficacy has not been compared head-to-head with the everolimus-eluting stent.. The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non-inferiority design, power calculations estimated a needed enrolment of 2,678 patients. The primary endpoint is a composite of cardiac death, myocardial infarction, and stent thrombosis or target vessel revascularization after 9 months. Data on clinical events and mortality for all randomized patients will be obtained from national databases at 9 months. No clinical follow-up examination is scheduled.. The SORT OUT IV trial will directly compare clinically relevant differences in efficacy and safety in two drug-eluting stents: a first-generation sirolimus-eluting stent versus a second-generation everolimus-eluting stent. The study makes use of clinical endpoints routinely collected in computerized healthcare registries, allowing complete follow-up of a large, well-defined population without scheduled angiographic examinations.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; Immunosuppressive Agents; Research Design; Sample Size; Sirolimus

New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration.. In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months.. At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/-SD) of in-stent stenosis (21.65+/-14.42% for zotarolimus vs. 19.76+/-14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27+/-0.43 mm in the zotarolimus-stent group versus 0.19+/-0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events.. At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.)

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Retreatment; Sirolimus; Treatment Failure

A potentially adverse vascular response to overlapping drug eluting stents (DES) has been suggested in current research.. To evaluate the impact of baseline disease severity at the site of stent overlap.. This is a substudy of ODESSA, a prospective, randomised controlled trial designed to evaluate healing of overlapping stents. 71/77 patients with a total of 86 overlapping stents were studied: 25 sirolimus, 24 paclitaxel, 26 zotarolimus-eluting stents; and 11 bare metal stents (BMS). Patients were categorised into high-grade stenosis (HGS, ≥ 70% diameter stenosis) and low-grade stenosis (LGS, <70%) at the site of stent overlap. Angiography and intravascular ultrasound were performed after stent deployment and repeated at 6 months, together with additional optical coherence tomography. Images were analysed by an independent core laboratory. End points were binary restenosis, percentage neointimal hyperplasia (%NIH), mean lumen and stent areas and degree of strut coverage/apposition at overlapping stents at 6 months. Stent overlaps occurred in 49 HGS and 37 LGS. Restenosis was found in 5/6 HGS versus 0/5 LGS treated with overlapping BMS (p=0.01) and 4/43 HGS versus 0/32 LGS treated with overlapping DES. There was a trend towards higher %NIH at BMS overlap in HGS versus LGS (p=0.07). DES overlaps had lower lumen and stent areas and similar %NIH in HGS versus LGS. Any uncovered or malapposed struts occurred more often in overlapping DES at LGS than at HGS (59.4% vs 32.6%, p=0.03).. Overlapping DES in normal-appearing coronary segments showed a higher incidence of uncovered or malapposed struts, while restenosis occurred exclusively in overlapping stents at HGS. These findings should be considered when deploying overlapping stents.

Topics: Aged; Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Radiography; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome; Tubulin Modulators; Ultrasonography, Interventional

Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether this increase in risk was also seen with second-generation drug-eluting stents.. We randomly assigned 2314 patients needing stents that were 3.0 mm or more in diameter to receive sirolimus-eluting, everolimus-eluting, or bare-metal stents. The primary end point was the composite of death from cardiac causes or nonfatal myocardial infarction at 2 years. Late events (occurring during months 7 to 24) and target-vessel revascularization were the main secondary end points.. The rates of the primary end point were 2.6% among patients receiving sirolimus-eluting stents, 3.2% among those receiving everolimus-eluting stents, and 4.8% among those receiving bare-metal stents, with no significant differences between patients receiving either drug-eluting stent and those receiving bare-metal stents. There were also no significant between-group differences in the rate of late events or in the rate of death, myocardial infarction, or stent thrombosis. Rates of target-vessel revascularization for reasons unrelated to myocardial infarction were 3.7% among patients receiving sirolimus-eluting stents, 3.1% among those receiving everolimus-eluting stents, and 8.9% among those receiving bare-metal stents. The rate of target-vessel revascularization was significantly reduced among patients receiving either drug-eluting stent, as compared with a bare-metal stent, with no significant difference between the two types of drug-eluting stents.. In patients requiring stenting of large coronary arteries, no significant differences were found among sirolimus-eluting, everolimus-eluting, and bare-metal stents with respect to the rate of death or myocardial infarction. With the two drug-eluting stents, similar reductions in rates of target-vessel revascularization were seen. (Funded by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research; Current Controlled Trials number, ISRCTN72444640.).

Topics: Aged; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Revascularization; Prospective Studies; Retreatment; Sirolimus; Stents

To investigate the effects of coronary stenting with rapamycin-eluting stents on parameters of cell immunity.. 26 patients (group 1) with stable coronary heart disease and angiographically proved coronary stenosis underwent stenting with rapamycin-eluting stents. The control group (group 2) consisted of 6 patients: 4 patients underwent diagnostic coronaroangiography, I patient got a bare metal stent and in 1 patient angioplasty was unsuccessful. Blood samples were obtained before and 1 month after the intervention. The quantity of activated (CD4+CD25low+) and regulatory (CD4+CD25high+) T cells was measured by direct immunofluorescence and flow cytometry. Plasma concentration of IL-10 was determined by ELISA.. In group 1 the percentages of CD4+CD25high+ regulatory T-cells increased significantly one month after stenting, while in group 2 no difference in regulatory T-cell levels before and after the intervention was observed. No changes in total number of leukocytes, relative levels of lymphocytes, CD4+ T-cells, activated CD4+CD25+low T-cells and IL-10 plasma concentration before and after the procedure were detected in both groups.. Rapamycin-eluting stent implantation is associated with a significant increase of circulating CD4+CD25high+ regulatory T-cell level.

Topics: Antibiotics, Antineoplastic; Blood Cell Count; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Interleukin-10; Male; Middle Aged; Sirolimus; T-Lymphocytes, Regulatory

We describe the rationale and design for the 'PercutAneous INTervention with biodegradable-polymer based paclitaxel-eluting or sirolimus-eluting versus bare stents for de novo coronary lesions - PAINT trial'.. To evaluate two novel formulations of paclitaxel-eluting stent and the sirolimus-eluting stent against a stent with the same metallic structure but without polymer coating or drug elution.. The PAINT is a multicenter 3-arm randomized trial, conducted in Brazilian tertiary institutions, which included 275 patients allocated for the InfinniumR paclitaxel-eluting stent, the SupralimusR sirolimus-eluting stent or the Milennium MatrixR bare metal stent in a 2:2:1 ratio. Patients had de novo coronary lesions in native vessels with a diameter between 2.5 and 3.5 mm, amenable for treatment with a single stent of 29 mm or less in length. The primary objective was to compare the in-stent late loss at 9 months of both paclitaxel- and sirolimus-eluting versus the late loss of control bare metal stents. Important secondary objectives included the comparison in outcomes between sirolimus and paclitaxel stents, as well as the analysis of the incidence of major adverse cardiac events.. The PAINT trial had a unique design that allowed for the evaluation of the safety and efficacy profiles of two novel drug-eluting stent formulations, with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). As the drug-eluting stents differed by the drug, but were identical otherwise, the trial also allowed the comparison of the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).

Topics: Absorbable Implants; Adolescent; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Epidemiologic Methods; Humans; Paclitaxel; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome; Young Adult

Drug-eluting stent failures were associated with various clinical factors. However, the clinical impact of stent deployment technique was unknown. This study was designed to evaluate the frequency and impact of suboptimal percutaneous coronary intervention on long-term outcomes of 1,557 patients treated with sirolimus-eluting stents (SESs) in 41 US hospitals. All steps of the interventional procedure were scrutinized by an independent core laboratory to determine the occurrence of geographic miss (GM). GM included longitudinal (LGM; injured or diseased segment not covered by SES) or axial GM (balloon-artery size ratio <0.9 or >1.3) mismatches. Patients with and without GM were stratified (GM vs no-GM group). Patients, investigators, and the independent clinical event adjudication committee were blind to study group assignments. The primary end point was 1-year target-vessel revascularization (TVR) rate. Incidences and predictors of GM and safety outcomes were secondary end points. GM occurred in 943 patients (66.5%): 47.6% had LGM, 35.2% had axial GM, and 16.5% had both. One-year TVR rates were 5.1% in the GM group versus 2.5% in the no-GM group (p=0.025). TVR was 6.1% in the LGM versus 2.6% in the no-LGM subgroups (p=0.001). The association of GM with 1-year TVR was independent of clinical or anatomic factors (hazard ratio 2.0, 95% confidence interval 1.0 to 4.02, p=0.05). There was a 3-fold increase in myocardial infarction rates associated with GM (2.4% vs 0.8%; p=0.04). In conclusion, GM occurred frequently during SES implantation and was associated with increased risk of TVR and myocardial infarction at 1 year. These results emphasized the need for improvement in contemporary percutaneous coronary intervention practices and technologies.

Topics: Aged; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Electrocardiography; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Myocardial Revascularization; Prospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome

A novel stent platform eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with a sirolimus-eluting stent (with durable polymer).. We undertook a multicentre, assessor-blind, non-inferiority study in ten European centres. 1707 patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes were centrally randomised by a computer-generated allocation sequence to treatment with either biolimus-eluting (n=857) or sirolimus-eluting (n=850) stents. The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months. Analysis was by intention to treat. 427 patients were randomly allocated to angiographic follow-up, with in-stent percentage diameter stenosis as principal outcome measure at 9 months. The trial is registered with ClinicalTrials.gov, number NCT00389220.. We analysed all randomised patients. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents for the primary endpoint at 9 months (79 [9%] patients vs 89 [11%], rate ratio 0.88 [95% CI 0.64-1.19], p for non-inferiority=0.003, p for superiority=0.39). Frequency of cardiac death (14 [1.6%] vs 21 [2.5%], p for superiority=0.22), myocardial infarction (49 [5.7%] vs 39 [4.6%], p=0.30), and clinically-indicated target vessel revascularisation (38 [4.4%] vs 47 [5.5%], p=0.29) were similar for both stent types. 168 (79%) patients in the biolimus-eluting group and 167 (78%) in the sirolimus-eluting group had data for angiographic follow-up available. Biolimus-eluting stents were non-inferior to sirolimus-eluting stents in in-stent percentage diameter stenosis (20.9%vs 23.3%, difference -2.2% [95% CI -6.0 to 1.6], p for non-inferiority=0.001, p for superiority=0.26).. Our results suggest that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes.. Biosensors Europe SA, Switzerland.

Topics: Absorbable Implants; Aged; Biocompatible Materials; Chronic Disease; Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Materials Testing; Metals; Middle Aged; Polymers; Sirolimus; Thrombosis; Treatment Outcome

We evaluated the pharmacokinetics of the eluted everolimus by assessing systemic drug release and distribution of everolimus-eluting stents.. Drugs eluted by a coronary stent might cause adverse events such as tumors, infections, or noncardiac death. The systemic exposure of the drugs is unknown because there are only limited data about pharmacokinetics of drug-eluting stents in humans.. Venous blood samples in a subset of 39 patients were drawn just before implantation of the first stent (baseline, 0-minute time point) and at 10 and 30 minutes and 1, 2, 4, 6, 12, 24, 36, 48, 72, 168, and 720 hours (30 days) after completion of implantation of the last stent. Whole blood concentrations of everolimus were determined using a sensitive validated high-performance liquid chromatography mass spectrometry/mass spectrometry method.. The total dose of everolimus received by the patients ranged from 53 to 588 microg. The last time point up to which whole blood concentrations could be quantified ranged per patient from 4 to 720 hours after implantation of the last stent. Across all dose levels, individual T(max) values ranged from 0.13 and 2.17 hours; individual C(max) ranged from 0.14 to 2.79 ng/mL.. This study confirms the limited exposure to the systemic circulation of the eluted drug with the use of the XIENCE V Everolimus-Eluting Coronary Stent System (Abbott Vascular, Santa Clara, CA). Therefore, a systemic cause of adverse events is unlikely.

Topics: Aged; Angioplasty, Balloon, Coronary; Area Under Curve; Chromatography, High Pressure Liquid; Coronary Disease; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Half-Life; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus

There have been recent concerns regarding the long-term safety of the first generation of drug-eluting stents, which utilised a permanent polymer coating for drug delivery. SERIES I is a prospective, non-randomised, first-in-man open label study with the biodegradable polymer-based Supralimus sirolimus eluting stent (Sahajanand Medical Technologies Pvt. Ltd, India) for the treatment of patients with coronary artery lesions.. One hundred patients were treated with 126 Supralimus stents (mean lesion length 10.5 +/- 4.3 mm, mean reference vessel diameter 2.66 +/- 0.62 mm). The pre-specified primary endpoint was angiographic binary in-stent restenosis at six months. Secondary endpoints were device-orientated major adverse clinical events (MACE; defined as a composite of cardiac death, nonfatal myocardial infarction [Q-wave and Non-Q wave], or clinically-justified target vessel revascularisation) at 30 days, nine months and 30 months. Angiographic follow-up in a pre-specified subgroup of 60 patients at six months showed binary angiographic restenosis rates of 0% (in-stent) and 1.7% (in-segment). The in-stent late loss was 0.09 +/- 0.37 mm. MACE rates were 0% after one month, 6% at 9-month follow-up and 7% after 30 months follow-up.. The biodegradable-polymer-based sirolimus-eluting stent (Supralimus) is effective in inhibiting neointimal hyperplasia.

Topics: Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Disease-Free Survival; Drug-Eluting Stents; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Polymers; Prospective Studies; Sirolimus; Treatment Outcome

The aim of this study was to examine the impact of overlapping bare-metal stent (BMS) and three different formulations of drug-eluting stent (DES) on intimal hyperplasia (IH) response of patients with diabetes mellitus (DM).. Forty-nine DM patients treated with overlapping BMS (19 lesions), sirolimus-eluting stent (SES 12 lesions), paclitaxel-eluting stent (PES 8 lesions) or tacrolimus-eluting stent (TES 10 lesions) were studied. Baseline and 9-month follow-up volumetric intravascular vascular ultrasound (IVUS) and quantitative coronary angiography (QCA) analysis were performed in the entire stented segment and in the overlapped (OL) and non-overlapped (non-OL) subsegments. Clinical outcomes were evaluated at 1-year follow-up.. Post-procedure (PO-) QCA measurements were similar in all stent groups, and between OL and non-OL subsegments in each individual type of stents. Percent IH was lower in SES and PES vs. BMS (p < 0.05). Percent IH was significantly greater in OL subsegment compared with non-OL subsegment in BMS (p < 0.05), but not in all type of DES groups. SES showed significantly less %IH compared with PES and TES in OL and non-OL subsegments. Vessel area at the OL remained unchanged from PO to FU in all type of DES and BMS groups. There were no aneurysm formation and no stent thrombosis up to 1-year follow-up.. Overlapping BMS is associated with enhanced IH response in diabetic patients, whereas overlapping DES, particularly SES and PES, appear effective to inhibit IH without detectable late vascular adverse effects.

Topics: Analysis of Variance; Coronary Angiography; Coronary Disease; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Hyperplasia; Imaging, Three-Dimensional; Male; Paclitaxel; Prospective Studies; Sirolimus; Stents; Tacrolimus; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

It is still controversial whether sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) are equally effective in patients with diabetes. In these patients, multiple individual variables may be responsible for neointimal hyperplasia, thus making difficult the comparison of the two drug-eluting stents (DES).. We designed a prospective, randomized study to compare the efficacy in prevention of restenosis of SES and PES, both implanted in the same diabetic patient with multiple de novo coronary artery lesions undergoing elective percutaneous coronary intervention. We enrolled 60 patients with diabetes with at least two significant de novo angiographic stenoses in different coronary segments. The primary end point was in-stent late luminal loss (LLL) at 8-month angiographic follow-up.. A total of 120 lesions were successfully treated with the randomly assigned DES (SES, n = 60; PES, n = 60). In-stent LLL was lower in the SES than in the PES group (0.26 +/- 0.4 vs. 0.50 +/- 0.6 mm; P = 0.01). Coronary lesions treated with SES presented a reduced in-stent LLL in 40 (68%) patients, while PES resulted in a lower in-stent LLL in 19 (32%) patients (P = 0.0002). At multivariable analysis, the type of DES implanted was the only independent predictor of in-stent LLL (odds ratio 2.3 [95% CI 1.1-5.0]; P = 0.03).. SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis.

Topics: Aged; Anti-Bacterial Agents; Antineoplastic Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus

A fully bioabsorbable drug-eluting coronary stent that scaffolds the vessel wall when needed and then disappears once the acute recoil and constrictive remodelling processes have subsided has theoretical advantages. The bioasorbable everolimus-eluting stent (BVS) has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. We assessed the feasibility and safety of this BVS stent.. In this prospective, open-label study we enrolled 30 patients who had either stable, unstable, or silent ischaemia and a single de-novo lesion that was suitable for treatment with a single 3.0 x 12 mm or 3.0 x 18 mm stent. Patients were enrolled from four academic hospitals in Auckland, Rotterdam, Krakow, and Skejby. The composite endpoint was cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation. Angiographic endpoints were available for 26 patients and intravascular-ultrasound endpoints for 24 patients. Clinical endpoints were assessed in all 30 patients at 6 and 12 months. In a subset of 13 patients, optical coherence tomography was undertaken at baseline and follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00300131.. Procedural success was 100% (30/30 patients), and device success 94% (29/31 attempts at implantation of the stent). At 1 year, the rate of major adverse cardiac events was 3.3%, with only one patient having a non-Q wave myocardial infarction and no target lesion revascularisations. No late stent thromboses were recorded. At 6-month follow-up, the angiographic in-stent late loss was 0.44 (0.35) mm and was mainly due to a mild reduction of the stent area (-11.8%) as measured by intravascular ultrasound. The neointimal area was small (0.30 [SD 0.44] mm2), with a minimal area obstruction of 5.5%.. This study shows the feasibility of implantation of the bioabsorbable everolimus-eluting stent, with an acceptable in-stent late loss, minimal intrastent neointimal hyperplasia, and a low stent area obstruction.. Abbott Vascular.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Safety; Sirolimus; Ultrasonography

The differential safety and efficacy profiles of sirolimus-eluting stents when implanted in patients with multivessel coronary artery disease who have increased body mass indexes (BMIs) compared with those with normal BMIs are largely unknown. This study evaluated the impact of BMI on 1-year outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents as part of the Arterial Revascularization Therapies Study Part II (ARTS II). From February to November 2003, 607 patients were included at 45 centers; 176 patients had normal BMIs (<25 kg/m(2)), 289 were overweight (> or =25 and < or =30 kg/m(2)), and 142 were obese (>30 kg/m(2)). At 30 days, the cumulative incidence of the primary combined end point of death, myocardial infarction, cerebrovascular accident, and repeat revascularization (major adverse cardiac and cerebrovascular events) was 3.4% in the group with normal BMIs, 3.1% in overweight patients, and 2.8% in obese patients (p = 0.76). At 1 year, the cumulative incidence of major adverse cardiac and cerebrovascular events was 10.8%, 11.8%, and 7.0% in the normal BMI, overweight, and obese groups, respectively (p = 0.31). In conclusion, BMI had no impact on 1-year clinical outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents in ARTS II.

Topics: Adult; Aged; Aged, 80 and over; Body Mass Index; Coated Materials, Biocompatible; Coronary Disease; Europe; Female; Follow-Up Studies; Hospital Mortality; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Revascularization; Obesity; Retrospective Studies; Risk Factors; Sirolimus; Stents; Stroke; Survival Rate; Time Factors; Treatment Outcome; United States

Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions.. Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited data of the long-term outcome of patients with complex coronary artery lesions.. We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted.. At 3 years, major adverse cardiac events had occurred in 20 patients (12%) in the SES group and in 59 patients (38%) in the BMS group (p < 0.001). Four versus 2 patients suffered a cardiac death (p = NS), and 5 versus 1 died of a noncardiac disease (p = NS) in the SES versus the BMS group. Six patients in the SES group versus 15 patients in the BMS group suffered a myocardial infarction (p < 0.05) during the 3-year observation period, and target lesion revascularization was performed in 8 patients (4.9%) versus 53 patients (33.8%), respectively (p < 0.001); of these, 4 in the SES versus 7 in the BMS group were performed between 1 and 3 years after the index treatment (p = NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (p = NS); very late stent thrombosis was observed in 4 versus 1 patient.. A continued benefit was observed up to 3 years after implantation of SES in patients with complex coronary artery lesions. The rate of late adverse events was similar in the 2 groups, and stent thromboses occurred rarely after 1 year. (Sirolimus Eluting Stents in Complex Coronary Lesions [SCANDSTENT]; NCT00151658)

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Fibrinolytic Agents; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Sirolimus; Stents; Treatment Outcome

Drug-eluting stents have been shown to reduce restenosis in many types of lesions. The purpose of this article is to assess the efficacy of sirolimus- and paclitaxel-eluting stents in patients with bifurcation lesions.. Between June 2003 and October 2004, 205 patients were enrolled in a prospective randomized trial; 103 patients were assigned to sirolimus stents and 102 patients to paclitaxel stents. All patients were treated by provisional T-stenting.. There were no differences between groups in terms of age, risk factors, clinical condition, location of the bifurcation lesion, or other technical factors. Angiographic data and immediate results were also similar in both groups. Three patients developed inhospital non-Q-wave acute myocardial infarction (2 from the sirolimus group and 1 from the paclitaxel group). Follow-up angiography was obtained in 109 patients (53%). In the sirolimus group, 5 patients developed restenosis (9%): 1 at the main vessel, 2 at the side branch, and 2 in both branches. In contrast, 16 patients from the paclitaxel group had restenosis (29%): 6 at the main vessel, 5 at the side branch, and 5 in both branches. Target lesion revascularization at 24 +/- 5 months post stenting occurred in 4 patients from the sirolimus group (4%) and in 13 from the paclitaxel group (13%) (P < .05). Late loss at the main vessel in the sirolimus group patients was 0.31 +/- 0.59 versus 0.60 +/- 0.77 mm in patients from the paclitaxel group (P < .05).. Patients with bifurcation lesions treated by sirolimus showed significantly lower rates of late loss, restenosis and target lesion revascularization than patients treated with paclitaxel-eluting stents.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Creatine Kinase; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Stents; Troponin I; Ultrasonography, Interventional

To evaluate the short and long-term outcomes between stenting with sirolimus eluting stent (SES) and spot stenting with small vessel stent (SVS) for treatment of small vessels with long lesions.. 306 coronary heart disease patients in need of stenting in small vessel (diameter < 3.0 mm) with long lesions (> 20 mm) were divided into 2 groups: SES group (n = 93, receiving 157 CYPHER stents) and SVS group (n = 113, receiving spot stenting tactics). The clinical characteristics, success rate of procedure, rate of in-stent restenosis, target lesion revasculation (TLR), and major adverse cardiac events (MACE) were recorded after 6-month follow-up.. The baseline clinical and angiographic characteristics were similar between these two groups. Two CYPHER stents failed to pass the tortuous and calcified lesions in the SES group; DRIVER stents were used instead and succeeded in the passing. The rates of in-stent restenosis, TLR, and MACE of the SES group were 4.0%, 2.2%, and 3.2% respectively, all significantly, lower than those of the SVS group (26.5%, 10.6%, and 13.3% respectively, all P < 0.05).. In treatment of small vessel with long lesions, the rates of in-stent restenosis, TLR, and MACE are all much lower in the SES group than in the SVS group. Spot stenting with SVS may be feasible for small vessels with long and tortuous lesions, especially for those in which SES fails to pass through.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

The Syntax score (SXscore) was recently developed as a comprehensive angiographic scoring system aiming to assist in patient selection and risk stratification of patients with extensive coronary artery disease undergoing contemporary revascularization. A validation of this angiographic classification scheme is lacking. We assessed its predictive value in patients who underwent percutaneous intervention (PCI) for 3-vessel disease and explored its performance in comparison with the modified lesion classification system of the American Heart Association/American College of Cardiology. The SXscore, applied to 1,292 lesions in 306 patients who underwent PCI for 3-vessel disease in the Arterial Revascularization Therapies Study Part II, was 4 to 54.5, and after a median of 370 days (range 274 to 400) predicted the rate of major adverse cardiac and cerebrovascular events (hazard ratio 1.08/U increase, 95% confidence interval 1.05 to 1.11, p <0.0001), with patients in the highest SXscore tertile having a significantly higher event rate (27.9%) than patients in the lowest tertile (8.7%, hazard ratio 3.5, 95% confidence interval 1.7 to 7.4, p = 0.001). By multivariable analyses, SXscore independently predicted outcome with an almost fourfold adjusted increase in the risk of major adverse cardiac and cerebrovascular events in patients with high versus low values based on the discrimination level provided by classification and regression tree analysis. Compared with the modified lesion classification scheme of the American Heart Association/American College of Cardiology, SXscore showed a greater discrimination ability (c-index 0.58 +/- 0.08 vs 0.67 +/- 0.08, respectively, p <0.001) and a better goodness of fit with the Hosmer-Lemeshow statistic. In conclusion, the SXscore is a promising tool to risk stratify outcome in patients with extensive coronary artery disease undergoing contemporary PCI.

Topics: Aged; Angioplasty, Balloon, Coronary; Brain Ischemia; Coronary Angiography; Coronary Disease; Female; Fibrinolytic Agents; Follow-Up Studies; Forecasting; Humans; Ischemic Attack, Transient; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Risk Assessment; Sirolimus; Stents; Stroke; Survival Rate; Treatment Outcome

Stent thrombosis has been regarded as a severe complication of PCI therapy, therefore, analyzing the causes of thrombosis after implantation of drug-eluting stents (DES) is necessary.. This is a single center study with no limitation of entry criteria for using DES in patients with coronary heart disease (CHD). From Dec. 2001 to Dec. 2005, 3345 consecutive patients underwent implantation with Cypher stents (eluted with sirolimus: 2165 patients, 2362 lesions, 2695 stents) or TAXUS stents (eluted with paclitaxel: 1180 patients, 1453 lesions, 1725 stents) in our hospital. 10-month follow-up was completed in 2296 patients (1455 patients with 1632 lesions using 1773 Cypher stents & 841 patients with 1032 lesions used 1182 TAXUS stents). All patients were treated with aspirin plus clopidogrel at least 9 months after PCI procedure.. Among 3345 patients, 9 patients had acute stent thrombosis (0.27%): 7 in the sirolimus group, 2 in the paclitaxel group (0.32% vs 0.17%, P = 0.637), 7 patients had subacute stent thrombosis (0.21%): 5 in the sirolimus group and 2 in the paclitaxel group (0.23% vs 0.17%, P = 0.526) and 13 patients had late stent thrombosis (0.57%): 5 in the sirolimus group and 8 in the paclitaxel group (0.34% vs 0.95%, P = 0.114) Among the 29 patients with DES thrombosis. 8 patients (26.7%) presented as sudden death, 13 nonfatal MI and 8 unstable angina. Stent thrombosis was demonstrated by angiography in 21 patients (72.4%). The causes of acute and subacute DES thrombosis were related to suboptimal stenting in 8 patients including 7 patients with bifurcation lesions or to uncovered injury segment of the diffuse lesions in five patients. The causes for late thrombosis were discontinuation of antiplatelet drugs in four cases and related to poor left ventricular function in 6 cases with history of old myocardial infarction.. Our study showed that suboptimal stenting, especially for bifurcation lesions and uncovered injury segment of diffuse lesions were the main causes of acute and subacute stent thrombosis. Left ventricular disfunction and premature discontinuation of antiplatelet therapy were the main reasons of late thrombosis.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Thrombosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Sirolimus; Stents; Taxoids

To describe a novel modification of the T-stenting technique and to report the bench test as well as the first clinical results obtained.. The best technique to treat bifurcated coronary lesions has not been defined.. This novel modification of the T-stenting technique is based, after stenting of the main vessel (MV) and kissing balloon, on the intentional minimal protrusion of the side-branch (SB) stent within the MV. Final kissing balloon is performed using the balloon kept uninflated into the MV before SB stenting. The technique was tested in vitro and applied in two independent series of patients undergoing elective drug-eluting stent implantation on one bifurcated lesion. Bifurcated lesions were classified according to the Medina classification. Patients' outcome up to 9 month was prospectively assessed.. The bench test showed perfect coverage of the bifurcation with minimal stent's struts overlap at the proximal part of SB ostium and a small, single layer stent struts, neo-carina not affecting the MV patency. Seventy-three complex patients (67% of Medina 1,1,1 lesions; 44% of unprotected distal left main lesions) were treated with sirolimus-, paclitaxel-, or zotarolimus-eluting stents using the TAP technique. Procedural success was achieved in all cases and the clinical outcome up to 9 month was characterized by a low rate of clinically-driven target vessel revascularization (6.8%).. The TAP-stenting is a modification of the T-stenting technique which allows full coverage of bifurcated lesions and facilitates final kissing balloon. The first clinical experience suggests that this technique may be practical, thus calling for further evaluations of the technique.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Disease; Female; Humans; Italy; Korea; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Radiography, Interventional; Severity of Illness Index; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Primary intracoronary drug-eluting stent placement after the successful crossing of total coronary occlusions decreases restenosis rate at long-term follow-up compared with bare-metal stent implantation. The PRISON II trial was the first randomized study to show the safety and efficacy of sirolimus-eluting stents in patients with totally occluded native coronary arteries. The sirolimus-eluting stent is superior to the bare-metal stent in treating patients with total coronary occlusions, with significant reduction in angiographic binary in-stent and in-segment restenosis resulting in significantly reduced need for target lesion and target vessel revascularization. Whether sirolimus-eluting stents are superior to other drug-eluting stents in total coronary occlusions is unknown. In this prospective, randomized trial, sirolimus-eluting stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of total coronary occlusions. A total of 300 patients will be followed for up to 5 years with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point will be in-segment late luminal loss at 8 months angiographic follow-up.

Topics: Coronary Disease; Drug Delivery Systems; Humans; Prospective Studies; Single-Blind Method; Sirolimus; Stents

The Endeavor zotarolimus-eluting stent (ZES; Medtronic Vascular, Santa Rosa, CA) has been found to provide event-free clinical outcomes to 2 years for the treatment of symptomatic CAD by suppressing neointimal proliferation of the target lesion. The clinical outcomes of patients treated with the Endeavor ZES were evaluated at 4 years after implantation. One hundred consecutive patients with symptomatic ischemic heart disease due to de novo stenotic lesions of native coronary arteries were treated with the Endeavor ZES at 8 centers according to a standardized procedure. At 4 years, 3 patients were lost to follow-up analysis. The incidence of major adverse cardiac events (MACE; defined as death, myocardial infarction, emergent cardiac surgery, or repeat revascularization of the target lesion) was 2% at 4 months, 2% at 1 year, 3% at 2 years, 6.1% at 3 years, and 7.2% at 4 years. The difference in these rates was due to 4 deaths caused by cancer (metastatic melanoma, metastatic adenocarcinoma, small-cell cancer of the bladder, and lung carcinoma). From 2-4 years, there was an additional reported case of target lesion revascularization (TLR). A single case of stent thrombosis occurred at 10 days after the index procedure but no cases occurred thereafter. The treatment of patients with symptomatic CAD due to de novo lesions in native coronary arteries with the Endeavor ZES has sustained clinical benefits to 4 years, with very low rates of MACE and TLR.

Topics: Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Coronary Artery Bypass; Coronary Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus; Treatment Outcome

The clinical and angiographic factors that predict clinically driven target lesion revascularization (TLR) in patients treated with the zotarolimus-eluting stent (ZES) are not known. Accordingly, the differences between ZES-treated patients who required TLR and ZES-treated patients who did not require TLR were examined in 1,306 patients enrolled in 4 pivotal trials of the Endeavor ZES (Medtronic Vascular, Santa Rosa, CA) for the treatment of symptomatic native coronary artery disease. TLR was performed in 64 patients (4.9%) by 9 months, with most cases (89.1%) occurring after 30 days. ZES-treated patients who required TLR had a greater incidence of 2- or 3-vessel disease (p <0.01), more stents implanted (p = 0.05), and lower device (p = 0.04) and procedure (p <0.01) success rates than ZES-treated patients who did not require TLR. The stents implanted in ZES-treated patients who later required TLR were also longer (p = 0.02) and smaller in diameter (p <0.01). Most angiographic outcomes at 8 months (12 months for ZES-treated patients in ENDEAVOR I) were worse for ZES-treated patients who later required TLR. At 9 months, 10.9% of the ZES-treated patients who required TLR had had myocardial infarctions, compared with 2.2% who did not require TLR (p = 0.001). Multivariate analysis identified older age (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.00-1.06), male sex (OR, 1.79; 95% CI, 0.88-3.65), and longer lesion length (OR, 1.03; 95% CI, 0.99-1.07) as risk factors for TLR after ZES implantation (with a C statistic of 0.61, suggesting a modest discriminatory value). These data provide insight into the clinical and angiographic factors that predict TLR at 9 months in ZES-treated patients, making possible the focused surveillance of selected ZES-treated patients who might be at greater risk of TLR.

Topics: Anti-Bacterial Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Registries; Sirolimus

The results of 2 randomized controlled trials of the Endeavor zotarolimus-eluting stent (ZES; Medtronic Vascular, Santa Rosa, CA) were recently reported: ENDEAVOR II, in which the Endeavor stent was compared with the Driver bare metal stent (BMS; Medtronic Vascular), and ENDEAVOR III, in which the Endeavor stent was compared with the first-generation Cypher sirolimus-eluting stent (SES; Cordis Corporation, Miami Lakes, FL). To examine in detail the vascular responses to the Endeavor stent, serial intravascular ultrasound (IVUS) analyses were performed in subsets of patients in the 2 trials at baseline and 8-month follow-up. The investigators report results for various IVUS parameters and compare those with published results for the first-generation SES and paclitaxel-eluting stent (PES). The ZES demonstrated significantly improved effectiveness and equivalent safety compared with the BMS in ENDEAVOR II. Although the ZES seems to be slightly less effective at inhibiting intimal hyperplasia than the SES and PES, early results are indicative of an acceptable safety profile. This finding may be due in part to the relatively complete and uniform neointimal coverage associated with the ZES.

Topics: Anti-Bacterial Agents; Coronary Disease; Double-Blind Method; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hyperplasia; Male; Middle Aged; Sirolimus; Tunica Intima; Ultrasonography

The E-Five is a prospective, nonrandomized, multicenter global registry of patients receiving the Endeavor zotarolimus-eluting stent (ZES; Medtronic Vascular, Santa Rosa, CA) for the treatment of coronary artery stenosis. All consecutive procedures were included in the registry, without any specific anatomic or clinical exclusion criteria. Since October 2005, 8,318 patients have been enrolled in the E-Five Registry at 188 hospitals in Europe, South America, Australia, New Zealand, and Asia, and 10,343 lesions have been treated. The primary end point is the rate of major adverse cardiac events (MACE) at 1 year. Of the lesions treated, 60.3% were American College of Cardiology (ACC) and American Heart Association (AHA) type B2 or C lesions, and 16.5% were bifurcation stenoses. The average lesion length was 18.50 +/- 10.60 mm, and 50.6% of the lesions were > or =16 mm long. Clinical data have been analyzed for 1,989 of the patients (23.9%) receiving the Endeavor ZES in this registry, with 30-day clinical outcomes available for 1,985 of these 1,989 patients (99.8%). The acute procedure success rate in these patients was 98.6%, comparable with procedure success rates observed in previous Endeavor ZES clinical trials. The 30-day rate of MACE in these patients was just 1.7%, comparable with 30-day rates of MACE observed in previous ENDEAVOR clinical trials. In an early analysis of a subgroup of patients enrolled in the E-Five Registry, the Endeavor ZES demonstrated encouraging acute and 30-day outcomes in a real-world population of patients who underwent single-vessel or multivessel percutaneous coronary intervention.

Topics: Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Coronary Artery Bypass; Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Registries; Sirolimus; Treatment Outcome

Our aim was to determine whether drug-eluting stents are good value for money in long-term, everyday practice.. We did an 18-month cost-effectiveness analysis of the Basel Stent KostenEffektivitäts Trial (BASKET), which randomised 826 patients 2:1 to drug-eluting stents (n=545) or to bare-metal stents (281). We used non-parametric bootstrap techniques to determine incremental cost-effectiveness ratios (ICERs) of drug-eluting versus bare-metal stents, to compare low-risk (> or =3.0 mm stents in native vessels; n=558, 68%) and high-risk patients (<3.0 mm stents/bypass graft stenting; n=268, 32%), and to do sensitivity analyses by altering costs and event rates in the whole study sample and in predefined subgroups. Quality-adjusted life-years (QALYs) were assessed by EQ-5D questionnaire (available in 703/826 patients).. Overall costs were higher for patients with drug-eluting stents than in those with bare-metal stents (11,808 euros [SD 400] per patient with drug-eluting stents and 10,450 euros [592] per patient with bare-metal stents, mean difference 1358 euros [717], p<0.0001), due to higher stent costs. We calculated an ICER of 64,732 euros to prevent one major adverse cardiac event, and of 40,467 euros per QALY gained. Stent costs, number of events, and QALYs affected ICERs most, but unrealistic alterations would have been required to achieve acceptable cost-effectiveness. In low-risk patients, the probability of drug-eluting stents achieving an arbitrary ICER of 10,000 euros or less to prevent one major adverse cardiac event was 0.016; by contrast, it was 0.874 in high-risk patients.. If used in all patients, drug-eluting stents are not good value for money, even if prices were substantially reduced. Drug-eluting stents are cost effective in patients needing small vessel or bypass graft stenting, but not in those who require large native vessel stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Coronary Disease; Cost-Benefit Analysis; Female; Humans; Male; Middle Aged; Paclitaxel; Quality-Adjusted Life Years; Risk Factors; Sirolimus; Stents

We investigated the potential of conversion to sirolimus (SRL) as a primary immunosuppressant in attenuating cardiac allograft vasculopathy progression.. Twenty-nine cardiac transplant recipients were converted to SRL 3.8+/-3.4 years after transplantation with complete calcineurin inhibitor (CNI) withdrawal. Secondary immunosuppressants (azathioprine or mycophenolate) and steroids remained unchanged. Forty patients (controls) 4.8+/-4.0 years from transplantation were maintained on CNIs. Three-dimensional intravascular ultrasound studies were performed at baseline and 12.1+/-2.6 months later. Mean plaque (media and intima) volume (PV) and plaque index (PI) (PV/vessel volume percent) increased significantly in the CNI group (1.28+/-2.86 mm(3)/mm, P=0.004; and 6+/-8%, P=0.0001) but not in the SRL group (0.1+/-1.13 mm(3)/mm, P=0.63; and 0.1+/-8%, P=0.94). In patients enrolled within 2 years after transplantation, the increases in PV (0.06+/-1.06 versus 1.77+/-1.65 mm(3)/mm; P=0.0081) and PI (0+/-9% versus 10+/-8%; P=0.0145) were smaller in the SRL group (n=11) than in the CNI (n=12) group. In patients enrolled >/=2 years after transplantation, the increase in PI was less in the SRL group compared with the CNI group (0.1+/-6.5% versus 5+/-8%; P=0.033), but changes in PV did not differ significantly. Treatment with azathioprine or mycophenolate did not affect PV or PI in either the SRL group (PV: 0.22+/-0.66 versus 0.05+/-1.45 mm(3)/mm, P=0.46; PI: 1.5+/-6% versus -1.6+/-8.5%, P=0.29) or the CNI group (PV: 1.42+/-1.39 versus 1.06+/-2.28 mm(3)/mm, P=0.49; PI: 7.8+/-8.7% versus 4.8+/-7.3%, P=0.23).. Substituting CNI with SRL as primary immunosuppression attenuates cardiac allograft vasculopathy progression.

Topics: Adrenal Cortex Hormones; Adult; Aged; Azathioprine; Coronary Disease; Female; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Mycophenolic Acid; Sirolimus; Transplantation, Homologous

Both the proliferation signal inhibitor everolimus (1.5 mg/day) and mycophenolate mofetil (MMF) (3 g/day) have shown superior efficacy versus azathioprine in de novo heart transplantation. The cost-effectiveness of everolimus and MMF versus azathioprine was assessed to 6 months posttransplantation.. The evaluation was performed from the German health insurance payer perspective. The composite efficacy endpoint in the everolimus trial was death, graft loss/retransplantation, biopsy-proven acute rejection (BPAR) grade>or=3A, rejection with hemodynamic compromise, and loss to follow-up. The composite endpoint in the MMF trial included only death, retransplantation, and BPAR with hemodynamic compromise. To mimic the everolimus endpoint, an estimated number of patients with BPAR>or=3A was added to the MMF trial results, using two mapping scenarios.. The incremental 6-month cost versus azathioprine was euro2535 for everolimus and euro3007 for MMF. The absolute reduction in efficacy failure versus azathioprine was 10.4% for everolimus and 9.8% and 10.1% for MMF, respectively, using scenarios 1 and 2. The incremental cost per efficacy failure avoided (ie, the incremental cost versus azathioprine divided by the reduction in efficacy failure) was euro24,457 for everolimus, and euro30,628 and euro29,912 for MMF in scenarios 1 and 2.. This analysis, based on findings from two clinical trials, suggested that everolimus was more cost-effective than MMF versus azathioprine in the first 6 months after heart transplantation. Data from a head-to-head trial are required to confirm these results.

Topics: Acute Disease; Adult; Azathioprine; Belgium; Cardiomyopathy, Dilated; Coronary Disease; Cost of Illness; Double-Blind Method; Everolimus; Female; Graft Rejection; Heart Transplantation; Hemodynamics; Humans; Immunosuppressive Agents; Male; Middle Aged; Mycophenolic Acid; Sirolimus; Survival Analysis; Treatment Failure

This study was conducted to assess the systemic drug release and distribution of sirolimus-eluting stents. Early results with sirolimus-eluting stents have demonstrated a favorable outcome for reducing restenosis post coronary intervention. However, the clinical systemic pharmacokinetics of sirolimus released from these stents has not been investigated. Sirolimus-eluting stents (150-178 mcg/18 mm stent) were implanted in 19 patients with coronary artery disease using standard techniques. Blood samples were obtained at multiple times to determine the kinetics of sirolimus release and elimination. Non-compartmental analysis showed that the maximum blood concentration of sirolimus occurred between 3 and 4 hr after implantation, with a peak concentration of 0.57 +/- 0.12 ng/mL (mean +/- SD) and 1.05 +/- 0.39 ng/mL in patients receiving one or two stents, respectively. Terminal-phase elimination half-life was independent of the number of stents and averaged at 213 hr, a value longer than that seen in patients following oral dosing. The apparent clearance was 1.46 +/- 0.45 L/hr with an apparent volume of distribution in the terminal phase of 407 +/- 111 L (data for both stent doses pooled). Minimal measurable blood levels were detectable at 7 days. Peak whole blood level following sirolimus stent implantation in humans is proportional to the number of stents implanted. The prolonged terminal half-life may reflect kinetics of blood clearance combined with continued drug elution and secondary local tissue release.

Topics: Adult; Aged; Aged, 80 and over; Coronary Disease; Female; Graft Occlusion, Vascular; Half-Life; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus; Stents

The purpose of the SCANDSTENT study was to evaluate the use of sirolimus-eluting stents (SES) in complex coronary lesions.. The use of SES improves angiographic and clinical outcomes compared with bare-metal stents (BMS) in simple coronary artery lesions, but there is limited evidence of their safety and efficacy when implanted in complex lesions.. We randomly assigned 322 patients with symptomatic complex coronary artery disease to receive either SES or BMS. The lesions were occluded (36%), bifurcational (34%), ostial (22%), or angulated (8%) in morphology. The primary end point was the difference in minimal lumen diameter six months after stent implantation.. The patients were well matched in terms of demographic and angiographic baseline characteristics; 18% had diabetes. The reference vessel diameter was 2.86 mm in mean, and the lesion length 18.0 mm. At follow-up, patients who received SES had a minimal lumen diameter of 2.48 mm compared with 1.65 mm in those who received BMS (p < 0.001), a diameter stenosis of 19.3% versus 43.8% (p < 0.001), and 2.0% versus 31.9% developed restenosis (p < 0.001). The rate of major adverse cardiac events was 4.3% with SES versus 29.3% with BMS (p < 0.001), and stent thrombosis was observed in 0.6% in the SES group versus 3.1% in the BMS group (p = 0.15).. The use of SES markedly reduced restenosis and the occurrence of major adverse cardiac events in patients with complex coronary artery lesions without increasing the risk of stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Vessels; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents

We sought to investigate the effects of 2 different coronary drug-eluting stents on the distribution of central or effector memory T cells circulating in the coronary sinus of patients with coronary artery disease who underwent percutaneous coronary revascularization. We randomly assigned 43 patients (mean age 65.4 +/- 4.3 years; 34 men) presenting with stable coronary disease and angiographically proved stenosis of the left anterior descending artery to treatment with sirolimus- or paclitaxel-eluting stents. Heparinized blood samples were obtained from the coronary sinus before and 20 minutes after stent implantation. Analysis of surface phenotype was performed by 4-color flow cytometry, and data are expressed as the percentage of positive cells. The percentages of CD8+ and CD4+ effector memory T cells, as defined by the CD3+CD45RO+CD27- phenotype, were significantly reduced in patients who received a sirolimus-eluting stent compared with the basal values. Conversely, the percentages of CD8+, but not CD4+, central memory T cells (CD3+CD45RO+CD27+) were increased in the same treatment group after the revascularization procedure. No changes in the percentages of memory T-cell populations in the paclitaxel-eluting stent group were observed. These findings show that sirolimus-eluting stents rapidly induced a redistribution of memory T lymphocytes, with a significant decrease of proinflammatory effector memory T cells circulating within the coronary sinus.

Topics: Aged; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Coronary Disease; Female; Flow Cytometry; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; T-Lymphocyte Subsets

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Cost-Benefit Analysis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Paclitaxel; Probability; Prosthesis Design; Risk Assessment; Sensitivity and Specificity; Sirolimus; Stents; Survival Rate; Treatment Outcome

To Compare the efficacy and safety of Rapamycin (Cypher) and Paclitaxel (TAXUS) eluting stents for multi-vessel coronary diseases.. From June 2003 to December 2004, a total of 416 patients with multi-vessel coronary diseases were randomly treated with Rapamycin (n = 210) and Paclitaxel (n = 206) eluting stents. Patients with left main lesion, acute myocardial infarction, revascularization were not included. Acute and long-term outcomes were compared between the two groups.. Baseline clinical characteristics, including risk factors of coronary heart disease, coronary lesion type, heart function, rates of success and complication of percutaneous coronary intervention procedure in the two groups were comparable. Number of stents implanted was not significantly different between the two groups (3.24 +/- 1.25 vs 3.19 +/- 1.38, P > 0.05). Mean follow-up duration was (19.5 +/- 8.9) months. Follow-up rate (96.2 vs 95.1%), angina pectoris reoccurrence (4.0 vs 6.1%), restenosis (7.1 vs 9.6%), major adverse cardiac event (6.4 vs 8.8%) and event free survival (93.1 vs 91.3%) during follow-up were not significantly different between the two groups. Subacute stent thrombosis rate tended to be higher in Paclitaxel eluting stent group compared with Rapamycin eluting stent group (1.0% vs 0.5%, P > 0.05). At 6 to 9 months angiographic follow-up, the in-stent minimal lumen diameter (MLD) and the in-segment MLD were similar between the two groups.. Satisfactory acute and long term outcomes for patients with multi-vessel coronary disease were achieved by both Cypher and TAXUS stent implantation and the safety and efficacy of the two kinds of stents were comparable.

Topics: Angioplasty, Balloon, Coronary; Constriction, Pathologic; Coronary Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Paclitaxel; Sirolimus; Treatment Outcome

A predefined intravascular ultrasound (IVUS) substudy was performed to evaluate the vascular effects of sirolimus-eluting stent (SES) versus bare-metal stent (BMS).. The Diabetes and Sirolimus-Eluting Stent (DIABETES) trial is a prospective, multicenter, randomized, controlled trial aimed at demonstrating the efficacy of the SES compared with BMS in diabetic patients.. Serial intravascular ultrasound analyses were performed in 140 lesions (SES = 75; BMS = 65) immediately after stent implantation and at nine-month follow-up. Vessel, luminal, and stent mean areas and volumes were evaluated at both edges and within the stented segment. Qualitative assessment of residual dissections and stent apposition were also performed.. Baseline clinical and angiographic characteristics were similar between groups. At 9 months, in-stent neointimal hyperplasia (NIH) mean area and volume were significantly reduced in the SES group (median NIH area 0.01 mm2 [0.0 to 0.1] vs. 2.0 mm2 [1.0 to 2.9] and median NIH volume 0.11 mm3 [0 to 2.1] vs. 35.3 mm3 [16.6 to 62.6]; both p < 0.0001). In the SES group, stent edges evidenced significant increase in lumen dimensions mainly due to significant increase in vessel volume, whereas those of the BMS group presented vessel shrinkage leading to significant lumen reduction. Late acquired incomplete stent apposition was observed in 11 lesions (14.7%) in the SES group and 0 in the BMS group (p = 0.001). At one year, no stent thromboses occurred in malapposed stents.. The SES implantation effectively inhibits NIH in diabetic patients. The antirestenotic effect of SES is also appreciated at the stent edges. Late acquired stent malapposition is a frequent phenomenon in diabetic patients treated with SES.

Topics: Aged; Coronary Angiography; Coronary Disease; Diabetic Angiopathies; Equipment Design; Female; Follow-Up Studies; Humans; Hyperplasia; Imaging, Three-Dimensional; Male; Metals; Middle Aged; Sirolimus; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months.. Patients (n = 1197) treated for single coronary artery stenosis were enrolled in a prospective, randomized, double-blind study and randomly assigned to receive the Endeavor zotarolimus-eluting phosphorylcholine polymer-coated stent (n = 598) or the same bare metal stent but without the drug or the polymer coating (n = 599). The 2 groups were well matched in baseline characteristics. Diabetes was present in 20.1% of patients; the mean reference vessel diameter was 2.75 mm; and the mean lesion length was 14.2 mm. The primary end point of target vessel failure at 9 months was reduced from 15.1% with the bare metal stent to 7.9% with the Endeavor (P = 0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (P = 0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (P = 0.0001). The rate of stent thrombosis was 0.5% with the Endeavor, which was not significantly different from 1.2% with the bare metal stent. In 531 patients submitted to angiographic follow-up, late loss was reduced from 1.03 +/- 0.58 to 0.61 +/- 0.46 (P < 0.001) in stent and from 0.72 +/- 0.61 to 0.36 +/- 0.46 (P < 0.001) in segment. The rate of in-segment restenosis was reduced from 35.0% to 13.2% with Endeavor (P < 0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malapposition by intravascular ultrasound imaging. Differences in clinical outcome were maintained at 12 and 24 months (P < 0.0001).. Compared with bare metal stents, the Endeavor stent is safe and reduces the rates of clinical and angiographic restenosis at 9, 12, and 24 months.

Topics: Aged; Anti-Bacterial Agents; Capsules; Cardiac Catheterization; Coronary Angiography; Coronary Disease; Double-Blind Method; Equipment Design; Female; Humans; Male; Middle Aged; Sirolimus; Stents

Sirolimus-eluting stent implantation improves the outcome in simple coronary artery lesions compared with bare metal stents, but there is limited evidence of their safety and efficacy when implanted in complex lesions like coronary bifurcations.. SCANDSTENT was a randomized controlled study comparing implantation of sirolimus-eluting stents with bare-metal stents in patients with complex coronary artery disease. This substudy evaluates the angiographic and clinical outcome of 126 patients with lesions located in a coronary bifurcation.. The baseline characteristics of the patients were comparable: 15% had diabetes, and 1.7 stents were implanted per lesion. At follow-up, the minimum lumen diameter of the main branch was 2.35 mm in patients who received sirolimus-eluting stents compared with 1.68 mm in those who received bare-metal stents, and that of the side branch was 1.70 versus 1.19 mm (both P < .001). The late lumen loss in the main branch was 0.12 mm in the sirolimus-eluting stent group versus 0.99 mm in the bare-metal stent group and 0.03 versus 0.56 mm in the side branch (both P < .001). Thus, sirolimus-eluting stents reduced the restenosis rate from 28.3% to 4.9% in the main branch and from 43.4% to 14.8% in the side branches (both P < .001). Major adverse cardiac events occurred in 9% with sirolimus-eluting stents versus 28% with bare-metal stents (P = .01), and stent thrombosis was observed in 0% versus 9% (P = .02).. Sirolimus-eluting stent implantation improves both the angiographic and clinical outcomes considerably compared with that of bare-metal stents in patients with stenoses located in coronary bifurcations.

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Vessels; Drug Delivery Systems; Equipment Design; Female; Humans; Incidence; Male; Metals; Middle Aged; Sirolimus; Stents; Thrombosis; Treatment Outcome

To compare the effect of sirolimus-eluting stents to paclitaxel-eluting stents in complex and diffuse coronary lesions.. 138 consecutive patients with complex and diffuse coronary lesions were enrolled from April 2004 to August 2005; they were implanted with more than 25 mm long sirolimus-eluting stents or paclitaxel-eluting stents. Unsuccessful cases were excluded. All patients received medical treatment according to guideline. Aspirin 300 mg and clopidogrel 75 mg once daily were continually administered for 6 months after the procedure. The patients were followed up after 6 months.. The study population consisted of 138 patients, including 124 men and 14 women. There were 129 (87.8%) C ACC/AHA type lesions. The average reference vessel diameter was (2.91 +/- 0.43) mm. The average lesion length was (36.36 +/- 12.27) mm. The average stent length per lesion was (40.25 +/- 12.79) mm. There was no difference of patient and lesion baseline characteristics between the groups of sirolimus-eluting and paclitaxel-eluting stents. At the end of follow up, in-stent restenosis rate (5.9% vs 17.7%, P = 0.023) and in-segment restenosis rate (9.4% vs 21.0%, P = 0.048) in the group of sirolimus-eluting stents were less than that in the group of paclitaxel-eluting stents. The difference was also seen in in-stent late luminal loss [(0.26 +/- 0.46) mm vs (0.60 +/- 0.66) mm, P = 0.001)] and in-segment late lumens loss [(0.16 +/- 0.52) mm vs (0.45 +/- 0.65) mm, P = 0.003)]. There was no difference between the sirolimus-eluting stents group and paclitaxel-eluting stents group in the incidence of target lesion revascularization (7.1% vs 12.9%, P = 0.223).. In patients with complex and diffuse coronary lesions, the use of the sirolimus-eluting stent was associated with a decrease in the extent of late luminal loss, as compared with use of paclitaxel-eluting stents, suggesting that sirolimus-eluting stent might be more suitable to be used in small vessel.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; Treatment Outcome

We prospectively studied the inflammatory response to coronary stenting (calculated as the difference between the highest postprocedural C-reactive protein [CRP] and baseline CRP levels [DeltaCRP]) and restenosis in 301 patients who received a sirolimus-eluting stent (n = 149) or a bare stent (n = 152) in the setting of a randomized trial. Median values of DeltaCRP were 3.1 mg/L in the sirolimus-eluting stent group and 3.0 mg/L in the bare stent group (p = 0.71). In the sirolimus-eluting group, restenotic rates were 9.7% in the subgroup with DeltaCRP higher than the median and 11.5% in the subgroup with DeltaCRP no higher than the median (p = 0.37). In the bare stent group, restenotic rates were 28.6% in the subgroup with DeltaCRP higher than the median and 15.4% in the subgroup with DeltaCRP no higher than the median (p = 0.04).

Topics: Aged; Angioplasty, Balloon, Coronary; C-Reactive Protein; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Humans; Immunosuppressive Agents; Male; Prospective Studies; Sirolimus; Stents; Treatment Outcome

To analyse the impact of sirolimus-eluting stents (SES) on long-term outcomes in patients with coronary artery disease (CAD) and diabetes.. Among 1004 patients with CAD undergone percutaneous coronary intervention (PCI), 84 diabetic and 250 non-diabetic patients received SES, 168 diabetic and 502 non-diabetic patients had bare metal stent (BMS) implantation. Baseline clinical characteristics, interventional procedures (coronary angiography and PCI), occurrence of major adverse cardiac events (MACE), and MACE-free survival rates at one year during follow-up were compared.. During follow-up (average 16.2 months), patients (with and without diabetes mellitus) who received SES had similar occurrence of MACE (4.8% vs. 3.6%, P = 0.744) and MACE-free survival rates at one year (95.0% vs. 96.7%, P = 0.602). However those received BMS had a higher occurrence of MACE in diabetes mellitus than that in non-diabetic patients (31.0% vs. 21.7%, P = 0.015). MACE-free survival rate at one year was lower in diabetic patients with BMS than that in non-diabetic patients with BMS (74.2% vs. 86.8%, P = 0.001).. Implantation of sirolimus-eluting stents may reduce the major adverse cardiac events and the frequency of repeat intervention in patients with diabetes mellitus.

Topics: Coronary Disease; Diabetic Angiopathies; Female; Humans; Male; Retrospective Studies; Sirolimus; Stents

Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents.. We conducted a randomized, controlled, single-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents in 1012 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (death from cardiac causes, myocardial infarction, and ischemia-driven revascularization of the target lesion) by nine months. Follow-up angiography was completed in 540 of 1012 patients (53.4 percent).. The two groups had similar baseline clinical and angiographic characteristics. The rate of major adverse cardiac events at nine months was 6.2 percent in the sirolimus-stent group and 10.8 percent in the paclitaxel-stent group (hazard ratio, 0.56; 95 percent confidence interval, 0.36 to 0.86; P=0.009). The difference was driven by a lower rate of target-lesion revascularization in the sirolimus-stent group than in the paclitaxel-stent group (4.8 percent vs. 8.3 percent; hazard ratio, 0.56; 95 percent confidence interval, 0.34 to 0.93; P=0.03). Rates of death from cardiac causes were 0.6 percent in the sirolimus-stent group and 1.6 percent in the paclitaxel-stent group (P=0.15); the rates of myocardial infarction were 2.8 percent and 3.5 percent, respectively (P=0.49); and the rates of angiographic restenosis were 6.6 percent and 11.7 percent, respectively (P=0.02).. As compared with paclitaxel-eluting stents, the use of sirolimus-eluting stents results in fewer major adverse cardiac events, primarily by decreasing the rates of clinical and angiographic restenosis.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Single-Blind Method; Sirolimus; Stents; Survival Analysis

Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis. It is not known whether there are differences in the effectiveness of currently approved drug-eluting stents in the high-risk subgroup of patients with diabetes mellitus.. We enrolled 250 patients with diabetes and coronary artery disease: 125 were randomly assigned to receive paclitaxel-eluting stents, and 125 to receive sirolimus-eluting stents. The primary end point was in-segment late luminal loss. Secondary end points were angiographic restenosis (defined as in-segment stenosis of at least 50 percent at follow-up angiography) and the need for revascularization of the target lesion during a nine-month follow-up period. The study was designed to show noninferiority of the paclitaxel stent as compared with the sirolimus stent, defined as a difference in the extent of in-segment late luminal loss of no more than 0.16 mm.. The extent of in-segment late luminal loss was 0.24 mm (95 percent confidence interval, 0.09 to 0.39) greater in the paclitaxel-stent group than in the sirolimus-stent group (P=0.002). In-segment restenosis was identified on follow-up angiography in 16.5 percent of the patients in the paclitaxel-stent group and 6.9 percent of the patients in the sirolimus-stent group (P=0.03). Target-lesion revascularization was performed in 12.0 percent of the patients in the paclitaxel-stent group and 6.4 percent of the patients in the sirolimus-stent group (P=0.13).. In patients with diabetes mellitus and coronary artery disease, use of the sirolimus-eluting stent is associated with a decrease in the extent of late luminal loss, as compared with use of the paclitaxel-eluting stent, suggesting a reduced risk of restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetes Complications; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Regression Analysis; Sirolimus; Stents; Survival Analysis

A pharmacokinetic (PK) study was conducted to evaluate sirolimus-eluting stents (SES) in Japanese people, representing the first clinical trial of the use of drug-eluting stents in Japan.. The PK study was conducted in 20 patients with 30 lesions treated with sirolimus-coated BX Velocity stents. All lesions were treated with a single SES (3 x 18 mm). Angiographic follow-up was performed at 8 months after SES implantation, and the clinical outcomes were evaluated at 1 year in all cases. All procedures were successful, and all patients were discharged without any adverse cardiac events. The total restenosis rate was 10% (3 lesions) and target vessel revascularization was performed in those 3 cases (15%). Restenoses occurred at the proximal and distal stent margins. Intravascular ultrasound examination of restenosis cases revealed abundant plaque burden at the stent edges even though the luminal area was preserved.. The sirolimus-eluting BX Velocity stent is safe and useful for Japanese patients with coronary artery disease. However, restenosis at proximal stent edge seems to be a problem.

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Restenosis; Humans; Immunosuppressive Agents; Japan; Middle Aged; Sirolimus; Stents

Recent human trials with rapamycin-eluting stents have shown very low restenosis rates. However, the high costs of these devices preclude their use in routine angioplasty, especially when considering multiple stenting. We evaluated whether orally administered rapamycin inhibits in-stent neointimal growth in patients with unstable angina.. We enrolled 15 patients successfully treated with the implantation of a single stent in a single de novo lesion in native coronary arteries. Correct stent expansion and apposition were corroborated with intravascular ultrasound scanning in all patients. Patients received aspirin, clopidogrel, and atorvastatin for 6 months. Rapamycin was administered in a loading dose of 5 mg, followed by 2 mg/day for 4 weeks.. The reference diameter was 3.4 +/- 0.4 mm, lesion length was 11.2 +/- 2 mm, lesion type B1 was 36%, and lesion type B2 was 64%. After the procedure, in-stent minimal lumen diameter and diameter stenosis (DS) were 3.3 +/- 0.4 mm and 0.3% +/- 7.5%, respectively. At 10 days, plasma levels of rapamycin were 7.95 +/- 2.6 ng/mL. At 6 months, angiographic determinations demonstrated an in-stent minimal lumen diameter of 2 +/- 1 mm, an in-stent DS of 41.3% +/- 28.0%, and an in-stent late loss of 1.4 +/- 1.1 mm. Binary restenosis (>50% DS) was present in 6 of 15 patients (40%). Target lesion revascularization (coronary artery bypass grafting) was performed in 2 of 15 patients (13.3%). There were no serious adverse events during the 6-month period of follow-up, but 1 patient had severe heartburn caused by esophagitis, and another patient had herpes zoster at the end of the protocol.. Oral rapamycin was well tolerated, but did not suppress in-stent neointimal growth in this small group of patients.

Topics: Administration, Oral; Angina, Unstable; Angioplasty, Balloon, Coronary; Combined Modality Therapy; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Vessels; Humans; Immunosuppressive Agents; Pilot Projects; Sirolimus; Stents; Tunica Intima

Rapamycin-eluting stents (RES) have been shown to reduce restenosis in many types of lesions. However, the ideal strategy for the treatment of coronary bifurcated lesions has not been established to date. This randomized study compares 2 strategies for the RES treatment of bifurcation lesions: a simple approach (stenting the main vessel and balloon dilatation for the side branch [SB]) versus a complex approach (stents for both vessels).. To compare both strategies, a randomized study was conducted in 91 patients with true coronary bifurcation lesions. All patients received an RES at the main vessel, covering the SB. Patients from group A (n = 47) were assigned to balloon dilation of the involved SB (simple strategy); patients in group B (n = 44) were randomized to receive a second stent at the SB origin (complex strategy). There were no differences between groups regarding baseline clinical and angiographic data.. Major adverse cardiac events occurred in 3 patients from group A (2 non-Q-wave myocardial infarctions and 1 target lesion revascularization). Six-month angiographic reevaluation was obtained in 80 patients (88%). Restenosis of the main vessel was observed in 1 (2%) patient from group A and in 4 (10%) from group B. Restenosis of the SB appeared in 2 (5%) patients from group A and in 6 (15%) from group B.. Both strategies are effective in reducing the restenosis rate, with no differences in terms of clinical outcome. Elective SB stenting seems to provide no advantages over the simpler stent jail followed by SB balloon dilation.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Vessels; Cross-Over Studies; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

Despite the growing use of drug-eluting stents, restenosis remains to occur especially in high risk subgroups like patients with diffuse in-stent restenosis. This observation is supporting the search for new and potentially even more effective drug eluting stent systems. Everolimus has been used in conjunction with a new bioabsorbable polymer and gave promising results in initial clinical studies. In FUTURE I, a single-center, single-blinded randomized safety and feasibility study enrolling 15 patients with bare metal stents and 27 patients with everolimus-coated stents, 30-day MACE rate was 0% in both groups. In-stent late loss at six months was 0.83 mm in the control group and 0.10 mm in the everolimus group (p < 0.0001). In FUTURE II, a randomized multi-center study, a total of 64 patients were enrolled confirming safety and feasibility. After 6 months late loss was 0.85 mm in the control group and 0.12 mm in the everolimus group (p < 0.001).

Topics: Coronary Disease; Coronary Restenosis; Everolimus; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Sirolimus; Stents

FIM STUDY: We investigated the 2-year safety and efficacy of sirolimus-eluting stents. Thirty patients had a single 18-mm sirolimus-eluting coronary stent implanted. Twenty-eight patients underwent angiographic and intravascular ultrasound follow-up at 2 years. No death occurred during the study period. No patient developed in-stent restenosis. One patient had a 52% in-lesion stenosis that required repeated revascularization and another patient underwent target vessel revascularization. Neointimal hyperplasia volume was minimal at 2 years in both groups. This study demonstrates the 2-year safety and efficacy of sirolimus-eluting stenting. The slow release formulation showed slight superiority over the fast-release formulation in preventing late lumen loss, which was minimal in both groups.. This-study was a randomized, double-blind study that included 238 patients at 19 medical centers (15 in Europe, 3 in Brazil, and 1 in Mexico). Patients were eligible for the study if they were between 18 and 85 years of age, and had been given a diagnosis of stable or unstable angina or silent ischemia. Additional eligibility criteria were presence of a single primary target lesion in a native coronary artery that was 2.5 to 3.5 mm in diameter and that could be covered by an 18-mm stent stenosis of 51% to 99% of the luminal diameter and a flow rate of grade 1 or higher according to the Thrombolysis in Myocardial Infarction.. One hundred twenty patients were randomly assigned to receive the sirolimus-eluting stent, and 118 were assigned to receive the standard stent. At 6 months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01 +/- 0.33 mm) than in the standard-stent group (0.80 +/- 0.53 mm, P <.001). None of the patients in the sirolimus-stent group, as compared with 26.6% of those in the standard-stent group, had restenosis of >/=50% of the luminal diameter (P <.001). There were no episodes of stent thrombosis. During a follow-up period of up to 1 year, the overall rate of major cardiac events was 5.8% in the sirolimus-stent group and 28.8% in the standard-stent group (P <.001). The difference was due entirely to the higher rate of revascularization of the target vessel in the standard-stent group.. Patients with angina who received sirolimus-eluting stents for the treatment of single, primary lesions in native coronary arteries had no angiographic evidence of late luminal loss or in-stent restenosis at 6 months, no episodes of thrombosis, and a very low rate of cardiac events at 1 year.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Vessels; Female; Follow-Up Studies; Humans; Hypertension; Immunosuppressive Agents; Male; Middle Aged; Risk Factors; Sirolimus; Smoking; Stents; Time Factors; Treatment Outcome

We show the key results of our 4-year experience with sirolimus in kidney transplant patients and in nontransplanted patients undergoing coronary angioplasty.. Recipients of one-haplotype living-related kidney allografts were randomized to receive sirolimus (2 mg/d, n = 35) or azathioprine (2 mg/kg per day, n = 35). Recipients of fully mismatched living kidney allografts (n = 55) received sirolimus (2 mg/day). High-risk recipients of black ethnicity (n = 68) were randomized to target whole-blood trough sirolimus concentrations between 8 and 12 ng/mL or 15 to 20 ng/mL. All kidney transplant patients received cyclosporine and prednisone. Sirolimus/cyclosporine pharmacokinetic studies were performed in 40 patients receiving 2 mg (n = 20) or 5 mg (n = 20) of sirolimus 7 days after transplantation. In the coronary intervention study, 12 patients at high risk for in-stent restenosis received sirolimus for 28 days after angioplasty.. The incidence of biopsy-confirmed acute rejection was 11.4% in recipients of one-haplotype living-related kidney allografts, 16.4% in recipients of fully mismatched living kidney allografts, and 15% (8 to 12 ng/mL) and 4% (15 to 20 ng/mL) in high-risk recipients of black ethnicity. Cyclosporine exposure was higher after morning administration compared to evening administration. There were poor correlations between sirolimus and cyclosporine exposures. The 4-month follow-up angiography revealed no restenosis (stenosis diameter > 50%), a late loss of 0.56 +/- 0.40 mm, and a loss index of 0.33 +/- 0.30. The follow-up 3D-intravascular ultrasound restudy showed an in-stent relative volumetric obstruction of 9.9 +/- 5.5%. Sirolimus in highly effective in preventing kidney allograft acute rejection and in-stent coronary restenosis.

Topics: Adult; Angioplasty, Balloon, Coronary; Azathioprine; Black People; Cadaver; Coronary Disease; Cyclosporine; Family; Female; Graft Rejection; Histocompatibility Testing; Humans; Immunosuppressive Agents; Incidence; Kidney Transplantation; Living Donors; Male; Risk Assessment; Safety; Sirolimus; Tissue Donors; Transplantation, Homologous

Everolimus, a novel proliferation inhibitor and immunosuppressive agent, may suppress cardiac-allograft vasculopathy. We conducted a randomized, double-blind, clinical trial comparing everolimus with azathioprine in recipients of a first heart transplant.. A total of 634 patients were randomly assigned to receive 1.5 mg of everolimus per day (209 patients), 3.0 mg of everolimus per day (211 patients), or 1.0 to 3.0 mg of azathioprine per kilogram of body weight per day (214 patients), in combination with cyclosporine, corticosteroids, and statins. The primary efficacy end point was a composite of death, graft loss or retransplantation, loss to follow-up, biopsy-proved acute rejection of grade 3A, or rejection with hemodynamic compromise.. At six months, the percentage of patients who had reached the primary efficacy end point was significantly smaller in the group given 3.0 mg of everolimus (27.0 percent, P<0.001) and the group given 1.5 mg of everolimus (36.4 percent, P=0.03) than in the azathioprine group (46.7 percent). Intravascular ultrasonography showed that the average increase in maximal intimal thickness 12 months after transplantation was significantly smaller in the two everolimus groups than in the azathioprine group. The incidence of vasculopathy was also significantly lower in the 1.5-mg group (35.7 percent, P=0.045) and the 3.0-mg group (30.4 percent, P=0.01) than in the azathioprine group (52.8 percent). The rates of cytomegalovirus infection were significantly lower in the 1.5-mg group (7.7 percent, P<0.001) and the 3.0-mg group (7.6 percent, P<0.001) than in the azathioprine group (21.5 percent). Rates of bacterial infection were significantly higher in the 3.0-mg group than in the azathioprine group. Serum creatinine levels were also significantly higher in the two everolimus groups than in the azathioprine group.. Everolimus was more efficacious than azathioprine in reducing the severity and incidence of cardiac-allograft vasculopathy, suggesting that everolimus therapy may alleviate this serious problem.

Topics: Adult; Aged; Azathioprine; Coronary Disease; Coronary Vessels; Cyclosporine; Cytomegalovirus Infections; Double-Blind Method; Drug Therapy, Combination; Everolimus; Female; Graft Rejection; Heart Transplantation; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Immunosuppressive Agents; Lipids; Male; Middle Aged; Reoperation; Sirolimus; Transplantation, Homologous; Tunica Intima; Ultrasonography, Interventional

This report describes the effects of sirolimus on plasma lipids, and uses the Framingham risk model to assess the clinical importance of these effects. Lipid data from two large controlled studies of 1295 renal transplant patients were analyzed retrospectively. Sirolimus 2 mg/day and 5 mg/day were compared with placebo or azathioprine, and administered concomitantly with steroids and cyclosporine over 12 months. Hypercholesterolemia and hypertriglyceridemia occurred in all treatment groups and were maximal at 2-3 months. The sirolimus groups evidenced higher lipid levels than the controls, but the elevations diminished over time. At 1 year, the patients given sirolimus 2 mg/day had a mean cholesterol level 17 mg/dL greater and a mean triglyceride level 59 mg/dL greater than the controls. Among the patients given sirolimus 5 mg/day, mean cholesterol was 30 mg/dL greater and mean triglycerides were 103 mg/dL greater than the controls. Treatment with statins and fibrates was effective in reducing cholesterol and triglyceride levels, respectively, in the sirolimus-treated patients. The Framingham risk model predicted that the 17 mg/dL elevation in cholesterol would increase the incidence of coronary heart disease (CHD) by 1.5 new cases per 1000 persons per year and CHD death by 0.7 events per 1000 persons per year. Lipid elevations observed in the sirolimus-treated patients were manageable, improved over time, and responded to lipid-lowering therapy. Based on the Framingham risk model, the CHD risks associated with these cholesterol elevations are small compared with the baseline risks of the transplant population.

Topics: Cholesterol; Coronary Disease; Humans; Hyperlipidemias; Hypolipidemic Agents; Immunosuppressive Agents; Kidney Transplantation; Lipid Metabolism; Risk Assessment; Sirolimus; Triglycerides

The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris.. We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months.. At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group.. As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.

Topics: Coronary Disease; Coronary Restenosis; Coronary Vessels; Delayed-Action Preparations; Double-Blind Method; Female; Humans; Hyperplasia; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents. The aim of the present investigation was to determine whether these results are sustained over a period of 1 year.. Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo, Brazil (n=30, 15 fast release [group I, GI] and 15 slow release [GII]) and Rotterdam, The Netherlands (15 slow release, GIII). Angiographic and volumetric intravascular ultrasound (IVUS) follow-up was obtained at 4 and 12 months (GI and GII) and 6 months (GIII). In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups (at 12 months, GI and GII; at 6 months, GIII). Follow-up in-lesion minimal lumen diameter was 2.28 mm (GIII), 2.32 mm (GI), and 2.48 mm (GII). No patient approached the >/=50% diameter stenosis at 1 year by angiography or IVUS assessment, and no edge restenosis was observed. Neointimal hyperplasia, as detected by IVUS, was virtually absent at 6 months (2+/-5% obstruction volume, GIII) and at 12 months (GI=2+/-5% and GII=2+/-3%).. This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation.

Topics: Blood Vessel Prosthesis Implantation; Brazil; Cohort Studies; Coronary Angiography; Coronary Disease; Delayed-Action Preparations; Drug Implants; Endosonography; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Netherlands; Sirolimus; Stents; Survival Rate; Treatment Outcome; Tunica Intima; Vascular Patency

A recent thinner strut drug-eluting stent might facilitate early strut coverage after its placement. We aimed to investigate early vascular healing responses after the placement of an ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) compared to those with a durable-polymer everolimus-eluting stent (DP-EES) using optical coherence tomography (OCT) imaging.This study included 40 patients with chronic coronary syndrome (CCS) who underwent OCT-guided percutaneous coronary intervention (PCI). Twenty patients each received either BP-SES or DP-EES implantation. OCT was performed immediately after stent placement (baseline) and at 1-month follow-up.At one month, the percentage of uncovered struts reduced significantly in both the BP-SES (80.9 ± 10.3% to 2.9 ± 1.7%; P < 0.001) and DP-EES (81.9 ± 13.0% to 5.7 ± 1.8%; P < 0.001) groups, and the percentage was lower in the BP-SES group than in the DP-EES group (P < 0.001). In the BP-SES group, the percentage of malapposed struts also decreased significantly at 1 month (4.9 ± 3.7% to 2.6 ± 3.0%; P = 0.025), which was comparable to that of the DP-EES group (2.5 ± 2.2%; P = 0.860). The optimal cut-off value of the distance between the strut and vessel surface immediately after the placement to predict resolved malapposed struts was ≤ 160 μm for BP-SES and ≤ 190 μm for DP-EES.Compared to DP-EES, ultrathin-strut BP-SES demonstrated favorable vascular responses at one month, with a lower rate of uncovered struts and a comparable rate of malapposed struts.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Antineoplastic Agents; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; Tomography, Optical Coherence

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Follow-Up Studies; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis; Treatment Outcome

Topics: Adult; Antiphospholipid Syndrome; Coronary Disease; Humans; Male; Microcirculation; Signal Transduction; Sirolimus; TOR Serine-Threonine Kinases

Traditional coronary drug-eluting stents (DES) are made from metal and are coated with a permanent polymer film containing an anti-proliferative drug. Subsequent to stent deployment in a diseased coronary artery, the drug releases into the artery wall and helps prevent restenosis by inhibiting the proliferation of smooth muscle cells. Although this technology has proven to be remarkably successful, there are ongoing concerns that the presence of a polymer in the artery can lead to deleterious medical complications, such as late stent thrombosis. Polymer-free DES may help overcome such shortcomings. However, the absence of a rate-controlling polymer layer makes optimisation of the drug release profile a particular challenge. The use of microporous stent surfaces to modulate the drug release rate is an approach that has recently shown particularly promising clinical results. In this study, we develop a mathematical model to describe drug release from such stents. In particular, we develop a mathematical model to describe drug release from microporous surfaces. The model predicts a two-stage release profile, with a relatively rapid initial release of most of the drug, followed by a slower release of the remaining drug. In the model, the slow release phase is accounted for by an adsorption/desorption mechanism close to the stent surface. The theoretical predictions are compared with experimental release data obtained in our laboratory, and good agreement is found. The valuable insights provided by our model will serve as a useful guide for designing the enhanced polymer-free stents of the future.

Topics: Antibiotics, Antineoplastic; Coronary Disease; Coronary Restenosis; Drug Liberation; Drug-Eluting Stents; Humans; Microscopy, Atomic Force; Models, Biological; Percutaneous Coronary Intervention; Porosity; Sirolimus; Surface Properties

The objectives of this study are to assess the healing score (HS) and neointimal thickness of the Xinsorb scaffold, and explore the relationships between the implanted patterns, neointimal thickness, and HS. The Xinsorb bioresorbable sirolimus-eluting scaffold is the first domestically designed and fabricated bioresorbable scaffold in China. The 6-month follow-up found it to be safe and effective in the treatment of single de novo coronary lesions. The Xinsorb scaffolds were implanted in 30 patients with symptomatic ischemic coronary disease. A 6-month follow-up was performed in a subset of 19 patients; the HS and neointimal thickness were evaluated by optical coherence tomography. Struts were classified as ApposedCovered, ApposedUncovered, MalapposedCovered, MalapposedUncovered, jailing and presence of intraluminal masses. The implanted pressure, implanted duration, and post-expansion pressure were recorded during the operation. We evaluated the relationship between the HS or neointimal thickness and the implanted pressure, holding time, and post-expansion pressure. The device and procedure success rates were both 100%. No major adverse cardiac or scaffold-thrombus related events occurred. At 6 months, 12,295 struts were analyzed to determine the HS (6.23) and neointimal thickness (0.1021 ± 0.05718 mm) in the Xinsorb scaffolds. There was a strong negative relationship between the HS and the implantation duration (Pearson r = - 0.518, p = 0.023). A significant negative relationship also existed between the HS and post-dilatation (Pearson r = - 0.631, p = 0.004). The Xinsorb scaffold HS appears negative correlated with the implanted duration and post-dilatation. We will further evaluate the HS of randomized controlled trial of the Xissorb scaffold.

Topics: Absorbable Implants; Adult; Aged; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prospective Studies; Severity of Illness Index; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence

Whether arterial repair following implantation of drug-eluting stents (DES) of the second generation differs among stent types remains unknown. We examined 41 DES placed in 28 patients (age 72 ± 7 years, male 89%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed 4 ± 1 months after stent implantation. Patients were divided into two groups based on the DES types: 22 cobalt-chrome everolimus-eluting stents (CoCr-EES) in 13 patients and 19 slow-release zotarolimus-eluting stents (R-ZES) in 15 patients. Neointimal coverage (NIC) was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of thrombus was also investigated. Distribution of dominant NIC grade (CoCr-EES: grade 0, 9%; grade 1, 77%; grade 2, 9%; grade 3, 5%; R-ZES: grade 0, 16%; grade 1: 47%; grade 2, 37%; grade 3, 0%, P = 0.38) and heterogeneity of NIC (P = 0.43) were similar between CoCr-EES and R-ZES groups. Existence of thrombus was not significantly different in CoCr-EES and R-ZES (18 versus 42%, P = 0.17). Arterial repair occurred without significant differences between CoCr-EES and R-ZES 4 months after implantation.

Topics: Aged; Angina, Stable; Angioscopy; Chromium Alloys; Coronary Angiography; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Sirolimus; Wound Healing

A 62-year-old male underwent three percutaneous coronary interventions involving four bare metal stents and six Cypher sirolimus-eluting stents within 1 month. At the latest coronary angiographic examination, all of the Cypher stents, but none of the bare metal stents, exhibited peri-stent contrast staining. Moreover, these findings had progressively worsened over time, especially for lesions where two stents came into contact or stent fracture had occurred. It is rare for Cypher stent implantation to result in progressive peri-stent contrast staining, but patients who are treated with these stents should be carefully followed-up, including for stent thrombosis.

Topics: Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Contrast Media; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus

To investigate the impact of lesion angle on the incidence and distribution of acute vessel wall injuries and incomplete stent apposition (ISA) following second-generation drug-eluting stent (DES) implantation using optical coherence tomography (OCT). Several ex vivo studies demonstrated that angled arterial walls are exposed to imbalanced mechanical stress from deployed stents.. We included 243 lesions treated with a single DES (148 everolimus-eluting stent and 95 zotarolimus-eluting stent). Angled lesions were defined as lesions with angle ≥45° on an angiogram (n = 58). The vessel wall injuries and ISA were evaluated by OCT. The results were compared with non-angled lesions (<45°, n = 185). The incidence of instent dissection, thrombus, and ISA was significantly higher in the angled group than in the non-angled group (84.5 vs. 63.2%, P < 0.01; 55.2 vs. 35.1%, P < 0.01; 75.9 vs. 44.9%, P < 0.001, respectively). In the angled group, the normalized tissue protrusion volume around the centre of angle (6.59 ± 6.81, mm(3) × 10(2)) was higher than in the distal sub-segment (2.21 ± 2.87, mm3 × 10(2), P < 0.001), in the proximal sub-segment (4.14 ± 5.34, mm3 × 10(2), P = 0.02), and in the non-angled group (3.30 ± 2.81, mm3 × 10(2), P < 0.001). The incidence of major adverse cardiac events within 12 months was similar between the groups.. Angled coronary lesions had a higher incidence rate of OCT-detected vessel wall injuries and ISA compared with non-angled lesions following second-generation DES implantation. Further studies are needed to understand the long-term clinical significance of these findings.

Topics: Adult; Coronary Angiography; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Male; Percutaneous Coronary Intervention; Registries; Sirolimus; Stress, Mechanical; Tomography, Optical Coherence; Vascular System Injuries

This study aimed to examine clinical efficacy, safety, and intermediate clinical outcomes with everolimus-eluting stents (EESs) in patients with transplant coronary artery disease (TCAD).. TCAD is a major cause of mortality in patients following orthotopic heart transplantation (OHT). Systemic everolimus in OHT patients has been shown to reduce TCAD. The safety and efficacy of an EES, the Xience V, have not been evaluated in this population.. Patients post-OHT with hemodynamically significant CAD who underwent percutaneous coronary intervention (PCI) with EES were included. Participants were maintained on dual antiplatelet therapy for 1-year post-PCI. We examined procedural success, in-hospital and 1-year mortality, stent thrombosis, angiographic restenosis, and myocardial infarction rates. All patients had follow-up angiography 1-year after PCI. Target vessel revascularization (TVR), target lesion revascularization (TLR), in-segment restenosis, target vessel failure (TVF), and lumen late loss were noted.. PCI was performed in 34 de novo lesions in 21 patients, and 40 EES were placed. Procedural success rate was 100%. Average stent was 16.5 ± 5.1 mm long and 3.0 ± 0.6 mm in diameter. All patients had angiographic follow-up (409 ± 201 days). There was no stent thrombosis, deaths, or myocardial infarctions during follow-up. Two patients had focal in-stent restenosis. TLR rate was 5.9% (2/34), and TVR rate was 11.1% (3/27). Quantitative coronary angiography (QCA) showed stenosis diameter to be 19.98 ± 17.57%.. Use of an EES is associated with a low incidence of TVR and TLR in patients with TCAD. Further studies are needed to determine whether PCI with EES changes long-term outcomes.

Topics: Allografts; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Postoperative Complications; Retrospective Studies; Sirolimus; Treatment Outcome

The optimal medication therapies are recommended in patients with coronary artery disease even after the coronary revascularization. However, the information of optimal medical therapy in dialysis population is scant. We assessed the efficacy of statin on the clinical outcomes after Sirolimus-eluting stent (SES) implantation in patients with and without dialysis.. We analyzed date from 843 consecutive patients who successfully treated with SES in our institution between August 2004 and November 2006. Among patients, 96 patients (11.4%) were undergoing dialysis. In non-dialysis patients, 405 patients (54%) were treated with statin at hospital discharge. In dialysis patients, only 16 patients (17%) were treated with statin. In non-dialysis patients, mortality rate was significantly lower in patients treated with statin than those without statin (4.4% vs. 13.9%, p<0.0001). While in dialysis patients, mortality rate was similar between patients treated with and without statin (56.3% vs. 57.6%, p=0.86). After adjusting for confounders, the hazard ratios for mortality were 0.39 (95% confidence interval (CI), 0.14-0.99; p=0.047) in non-dialysis patients and 1.79 (95% CI, 0.39-7.86; 0.45) for dialysis patients. The interaction probability between statin use and dialysis for mortality was 0.016.. The use of statin may have beneficial effect on reducing mortality rate in patients after SES implantation in non-dialysis patients. However, such favorable effect was not observed in dialysis population.

Topics: Aged; Biomarkers; Cause of Death; Comorbidity; Coronary Disease; Drug-Eluting Stents; Dyslipidemias; Female; Follow-Up Studies; Heart Failure; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Kaplan-Meier Estimate; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Revascularization; Proportional Hazards Models; Renal Dialysis; Retrospective Studies; Sirolimus; Treatment Outcome

The consequences of acute strut malapposition in everolimus-eluting stents (EES) are unknown. This study investigated the impact of strut-vessel (S-V) distance and plaque type underneath acute strut malapposition on the mid-term vessel response in EES. Twenty-nine patients (35 EES) underwent optical coherence tomography (OCT) immediately after percutaneous coronary intervention and at 8-month follow-up. S-V distance and plaque type (lipid, calcified, or fibrous) underneath acute strut malapposition were evaluated. Follow-up OCT classified acute strut malapposition as persistent or resolved. The S-V cutoff value for predicting resolved strut malapposition and the incidence of intra-stent thrombi were determined. Among 569 cases of acute strut malapposition, involving 29,168 struts, 139 (24.4 %) were persistent. Mean S-V distance was significantly longer in persistent than in resolved strut malapposition (600 ± 294 vs. 231 ± 95 μm; P < 0.0001). S-V distance ≤380 μm was the best cutoff value for predicting resolved strut malapposition (sensitivity 93.5 %, specificity 69.8 %, area under curve 0.878). Acute strut malapposition with S-V distance ≤380 μm remained persistent more frequently over lipid/calcified than over fibrous plaques (lipid: 13.4 %, calcified: 18.2 %, fibrous: 4.2 %; lipid vs. fibrous, P = 0.001; calcified vs. fibrous, P = 0.02). Intra-stent thrombi were more frequent in stents with ≥1 persistent strut malapposition than in those without [4/11 stents (36.3 %) vs. 0/24 (0 %); P = 0.006]. Lipid and calcified plaque, together with S-V distance, affect the resolution of acute strut malapposition in EES. Persistent strut malapposition is associated with the presence of thrombi at follow-up, which could be the substrate for late stent thrombosis.

Topics: Aged; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Postoperative Complications; Prosthesis Failure; Sensitivity and Specificity; Sirolimus; Tomography, Optical Coherence

Previous intravascular ultrasound studies have shown that echolucent neointimal hyperplasia occasionally appears after bare-metal stent (BMS) or sirolimus-eluting stent (SES) implantation. Optical coherence tomography (OCT) studies have also demonstrated that paclitaxel-eluting stent (PES) restenosis exhibited similar images showing low signal intensity areas (LSIA) surrounding stent struts and three-layer appearance (TLA). The aim of the present study was to investigate the clinical significance of LSIA on OCT images in various types of stents. Fifty nine consecutive patients who underwent scheduled follow-up coronary angiography and OCT were enrolled. There was no significant difference in the prevalence of LSIA among the 3 stent groups (BMS 30%, SES 19%, PES 28%, P = 0.70). LSIA thickness was larger in the PES group than in the other stent groups (BMS 0.51 ± 0.21 mm, SES 0.35 ± 0.06 mm, PES 0.87 ± 0.19 mm, P < 0.01). The ratio of LSIA thickness to the neointimal thickness was also larger in PES compared with other stents (BMS 53 ± 9 %, SES 57 ± 8 %, PES 77 ± 5 %, P < 0.01). Also, LSIA thickness in patients with in-stent restenosis (ISR) was significantly larger than in those without ISR (0.37 ± 0.37 mm versus 0.12 ± 0.26 mm, P = 0.048). Our results suggest that LSIA might be involved in excessive neointimal formation, and that the healing response after PES implantation might be different from BMS or SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Humans; Hyperplasia; Immunosuppressive Agents; Japan; Male; Middle Aged; Neointima; Outcome Assessment, Health Care; Paclitaxel; Postoperative Complications; Prospective Studies; Sirolimus; Stents; Tomography, Optical Coherence; Tubulin Modulators

To clarify the impact of off-label use of drug-eluting stent (DES) on 5-year outcomes.. Studies on the outcomes of on- vs. off-label use of DES have been limited by the duration of observation.. We analyzed 1937 patients from a multicenter registry that includes 95% of patients with 5-year follow-up data. We defined 10 variables as off-label indications according to the manufacturer's instructions for use, and 1665 of 1937 patients (86.0%) met the criteria for at least 1 off-label indication.. At 5 years, there were no differences in the rates of death, myocardial infarction (MI), and stent thrombosis between off-label and on-label use. The frequency of major adverse cardiac events (MACE), target lesion revascularization (TLR), non-TL but target vessel revascularization (TVR), and target vessel failure were higher in the off-label only during the first year. Among the off-label, having 2 indications was associated with TVR hazard ratio (HR) 1.62; 95% confidence interval (95%CI), 1.09-2.36 and TLR (HR, 1.90; 95%CI, 1.30-2.85). Moreover, having ≥3 off-label indications increased the risk of MACE (HR, 1.70; 95% CI, 1.23-2.40) compared with on-label use. Thrombosis rates increased with the number of off-label indications; it was 0.32% with 1, 0.69% with 2, and 3.54% with ≥3 off-label indications (p<0.001). This trend was also seen with other outcomes, except for non-TL TVR. Patients with ≥3 off-label indications had a remarkably different clinical course.. Off-label use did not increase rates of death and MI as compared with on-label use, but the number of off-label indications influenced outcomes at 5 years.

Topics: Aged; Coronary Disease; Databases, Factual; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Patient Selection; Product Surveillance, Postmarketing; Registries; Risk; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This study aimed to compare the safety and efficacy of everolimus-eluting stents (EES) to first-generation drug-eluting stents (DES) in multivessel disease (MVD).. Second-generation EES have demonstrated superiority over first-generation DES for single-vessel disease, although the merits of EES in MVD are less established.. A cohort of 1,285 patients (3,124 lesions) with ≥ 2 diseased vessels were treated with either first-generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non-fatal myocardial infarction, were compared at 1 year.. Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first-generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38-0.87]; P = 0.009; 95% confidence interval).. The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first-generation DES. Randomized trials comparing new-generation DES to coronary artery bypass grafting surgery are warranted.

Topics: Aged; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Sirolimus; Treatment Outcome

Topics: Antineoplastic Agents, Phytogenic; Coronary Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Paclitaxel; Sirolimus

Whether endothelial dysfunction after sirolimus-eluting stent (SES) implantation is persistent has not been fully evaluated. Endothelial function was evaluated in 152 lesions that underwent follow-up coronary angiography after SES implantation. Lesions were classified into 2 groups according to the duration between SES implantation and follow-up: ≤12 months (n = 95) and >12 months (n = 57). Changes in coronary diameter in response to 10(-8) mol/L (-2.4% ± 6.3% vs -4.9% ± 3.8%, P < .01) and 10(-7) mol/L acetylcholine (Ach; -4.6% ± 7.6% vs -10.7% ± 9.1%, P < .001) in segment proximal to SES were significantly attenuated in the >12-month group than in the ≤12-month group. There were less changes in coronary diameter in response to 10(-8) mol/L (-2.3% ± 4.6% vs -6.9% ± 5.0%, P < .001) and 10(-7) mol/L Ach (-6.5% ± 11.4% vs -16.8% ± 10.5%, P < .001) in segment distal to SES in the >12-month group. Endothelial dysfunction may diminish long after SES implantation.

Topics: Aged; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Endothelium, Vascular; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Pilot Projects; Sirolimus

It is unknown whether the use of intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention can attenuate the stent length effect on clinical outcomes. The aim of the present study was to determine the differential prognostic effect of IVUS according to the implanted stent length. We enrolled 3,244 consecutive patients from the Interventional Cardiology Research In-cooperation Society-Drug-Eluting Stents (IRIS-DES) registry who had undergone single or overlapping stent implantation. The primary end point was major adverse cardiac events (MACE; a composite of death, myocardial infarction, and target vessel revascularization). The study population was divided by the tertiles of implanted stent length and IVUS usage. IVUS use was at the discretion of the operator. After adjusting for significant covariates, the stent length was significantly associated with the risk of MACE in the no-IVUS group (hazard ratio 1.13, 95% confidence interval 1.01 to 1.28, p = 0.042) but not in the IVUS group (hazard ratio 1.08, 95% confidence interval 0.97 to 1.20, p = 0.16). In addition, in patients with an implanted stent length of ≤22 mm (n = 998), the risk of MACE was not significantly different between the IVUS group and the no-IVUS group (hazard ratio 1.06, 95% confidence interval 0.50 to 2.28, p = 0.88). In contrast, in patients with a longer implanted stent length, the risk of MACE was significantly lower in the IVUS group than in the no-IVUS group (hazard ratio 0.47, 95% confidence interval 0.24 to 0.92, p = 0.027 for 23 to 32 mm, n = 1,109; hazard ratio 0.57, 95% confidence interval 0.33 to 0.98, p = 0.042 for ≥33 mm, n = 1,137). In conclusion, IVUS usage can attenuate the detrimental effect of the increase in the implanted stent length, supporting IVUS usage, particularly during percutaneous coronary intervention with long stent implantation.

Topics: Analysis of Variance; Chi-Square Distribution; Comorbidity; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prognosis; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Sirolimus; Ultrasonography, Interventional

Off-pump coronary artery bypass surgery and sirolimus-eluting stent placement have been widely used for the treatment of coronary artery disease. The goal of this study was to compare long-term outcomes after off-pump coronary artery bypass surgery or sirolimus-eluting stent placement in diabetic patients with multivessel disease.. This observational study enrolled 350 off-pump coronary artery bypass patients and 143 sirolimus-eluting stent patients receiving care at our institution between 2000 and 2007. All patients had diabetes and multivessel disease including proximal left anterior descending or left main coronary artery. The choice of revascularization (percutaneous coronary intervention versus coronary artery bypass surgery) was left to the physician's discretion rather than randomization. Cox proportional-hazard analyses, adjusting baseline risk factors and propensity score, which predicted the probability of receiving off-pump coronary artery bypass, were conducted to evaluate outcomes, including all-cause mortality, cardiac death, target vessel revascularization, and major adverse cardiac and cerebrovascular events.. During the follow-up (2.6±1.6 years) period, there was no difference between off-pump coronary artery bypass and sirolimus-eluting stent placement in all-cause mortality or cardiac death. However, the incidences of acute coronary syndrome, target vessel revascularization, and major adverse cardiac and cerebrovascular events were markedly lower in the patients undergoing off-pump coronary artery bypass than in those receiving sirolimus-eluting stent placement.. Off-pump coronary artery bypass is superior to sirolimus-eluting stent placement in terms of acute coronary syndrome, target vessel revascularization, and major adverse cardiac and cerebrovascular events in diabetic patients with multivessel coronary artery disease.

Topics: Aged; Coronary Artery Bypass, Off-Pump; Coronary Disease; Diabetes Complications; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Proportional Hazards Models; Sirolimus; Treatment Outcome

Peri-stent contrast staining (PSS) is an abnormal angiographic finding following drug-eluting stent implantation which suggests the presence of a space outside the stent struts. PSS has been reported to be associated with very late stent thrombosis (VLST). The aims of this study were to compare the occurrence rate of late acquired PSS between sirolimus-eluting stent (SES) and everolimus-eluting stent (EES) implantation, and to identify clinical characteristics associated with PSS. The percutaneous coronary intervention (PCI) database of our hospital was queried to identify patients meeting the following criteria: (i) patients who received SES or EES in de novo coronary artery lesions; and (ii) patients who had angiographic follow-up between 3 and 15 months after stent implantation. There were 221 patients with 249 lesions treated with SES, and 173 patients with 212 lesions treated with EES. The occurrence of PSS was evaluated and compared between SES and EES implantation on a patient and lesion basis. The occurrence rate of late acquired PSS with EES was lower than that with SES. (On a patient basis; 1.2% versus 4.5%, P = 0.045, on a lesion basis; 0.9% versus 4.0%, P = 0.043). Among the clinical characteristics, chronic total occlusion (CTO) lesions were associated with PSS. The occurrence of late acquired PSS in EES was lower than that in SES. In conclusion, the occurrence rate of late acquired PSS with EES was lower than that with SES, however, it remains to be determined whether this difference translates to the difference in the rate of VLST.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Everolimus; Extravasation of Diagnostic and Therapeutic Materials; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Risk Factors; Sirolimus; Stents

Almost all data on drug-eluting stents (DES) fracture have been derived from initial platform of first-generation DES such as Cypher Bx® (CBX) and Taxus Express®. However, incidence and clinical impact of fracture of newer DES platforms (including Cypher Select®, Taxus® Liberté™, Endeavor®, and Xience™ V) that have been used widely in current clinical practice have not yet been studied.. We analyzed data of 1518 lesions treated with the newer DES platforms in patients who underwent follow-up coronary angiography and compared the results with those of 622 lesions treated with the CBX. The group of newer DES platforms showed significantly lower incidence of stent fracture (SF) than the CBX group (1.25% vs. 5.8%, p<0.001). Binary restenosis (42.1% vs. 6.6%, p<0.001) and target lesion revascularization (TLR) (47.3% vs. 6.2%, p<0.001) related to SF in the newer DES platforms' group were significantly higher than those not related to SF. Notably, SF-related binary restenosis (42.1% vs. 36.1%, p=0.52) and TLR (47.3% vs. 41.6%, p=0.2) were similar between the newer DES platforms' group and the CBX group. On multivariable logistic regression analysis, lesion angulation>45° (odds ratio [OR]: 7.6; 95% confidence interval [CI]: 2.2-26.31), RCA stenting (OR: 5.14; 95% CI: 1.62-16.3) and total stent length (OR: 1.18; 95% CI: 1.03-1.33) were identified as independent predictors for fracture of the newer DES platforms, while closed-cell design stent (Cypher Select®) was not.. Although implantation of the newer DES platforms might reduce the occurrence of SF compared with the CBX, SF-related binary restenosis and TLR remain similarly high. And to predict SF in the newer DES platforms' era, lesion characteristics on index procedure are more important than implanted stent design.

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prosthesis Design; Prosthesis Failure; Sirolimus

Although percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) is associated with worse clinical outcomes, the efficacy of drug-eluting stents (DES) in Japanese patients and differences in effectiveness between different DES types remain unknown.. Five-hundred and sixty-two consecutive patients (183 with DM, 379 without DM) with 676 lesions were treated with sirolimus-eluting stents (SES, n=531; 160 DM group, 371 non-DM group) or paclitaxel-eluting stents (PES, n=145; 64 and 81, respectively). We assessed the initial and 8-month follow-up clinical and angiographic outcomes.. There were no significant differences in clinical and lesion characteristics, although the pre-minimum luminal diameter was smaller in the DM group (p=0.016). The risk of major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, congestive heart failure, or recurrent angina pectoris, was higher in the DM group compared with the non-DM group (17.4% vs 9.5%, p=0.007). Among diabetic patients, although SES reduced late loss by 0.45 mm (p<0.001) and the binary restenosis rate by 66.4% (7.4% vs 22.0%, p<0.001) compared with PES at 8 months, it did not reduce target lesion revascularization or MACE, as in the non-DM group.. Diabetic patients have worse mid-term prognosis than non-diabetic patients undergoing PCI with DES. Although the superiority of SES in terms of late loss or restenosis may not play a clinically meaningful role in the treatment of diabetic patients, this phenomenon was independent of the presence of diabetes.

Topics: Aged; Aged, 80 and over; Asian People; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetes Complications; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prognosis; Retrospective Studies; Sirolimus; Treatment Outcome

Extensive application of stents coated with a medicinal antiproliferative agent in clinical practice significantly improved late results of endovascular treatment of patients with various forms of coronary heart disease (CHD). The largest clinical experience is gained with the use of sirolimus- and paclitaxel-coated stents (Cypher, J&J; Cordis, and Taxus, Boston Scientific). However recent publications suggest a rather high frequency of late thrombosis after implantation of such stents. The aim of this work was to estimate their efficacy and safety during the 6-8 month follow-up in 712 patients with various forms of CHD to whom 910 sirolimus- and paclitaxel-coated stents were implanted. The immediate positive angiographic result was documented in 98.8% of the cases in group 1 (n=514, 667 Cypher stents) and 96,7% in group 2 (n=198, 243 Taxus stents). Acute thrombosis was documented in 1 patient of each group (p > 0.5). The frequency of restenosis was 2.9 and 3.1% in groups 1 and 2 respectively (p > 0.5). Late thrombosis within 1 year after implantation occurred in 0.4 and 1% of the patients respectively (p > 0.5). Late thrombosis is supposed to be due to a variety of factors, viz. withdrawal of antithrombotic therapy, incomplete stent opening, the use of non-absorbable polymer; suppression of epithelization, etc. All patients undergoing steent implantation are in need of antiaggregation therapy with acetylsalicylic acid and clopidogrel till the cause of late thrombosis is clarified.

Topics: Adult; Cell Proliferation; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Endovascular Procedures; Follow-Up Studies; Humans; Paclitaxel; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty; Clinical Trials as Topic; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Meta-Analysis as Topic; Paclitaxel; Postoperative Complications; Randomized Controlled Trials as Topic; Saphenous Vein; Sirolimus; Stents; Treatment Outcome

Topics: Coronary Disease; Data Interpretation, Statistical; Drug-Eluting Stents; Heart Diseases; Humans; Sirolimus; Stents

Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.. The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.. Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21 ± 0.40) mm in-segment and (0.23 ± 0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.. The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656)

Topics: Aged; Angioplasty, Balloon, Coronary; Asian People; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Treatment Outcome

We report a late thrombosis of sirolimus-eluting stent 6 months after implantation of a drug-eluting stent. A 70-year-old man (52 kg, 148 cm) was diagnosed as acute cauda equina syndrome, and spinal surgery was scheduled. One week before the operation, the patient's aspirin and clopidogrel regimen was replaced with heparin injection, which was then discontinued 8 hours before the operation. The operation was completed uneventfully. The patient complained of severe chest pain 1 hour after the end of operation. Coronary angiography demonstrated stent thrombosis. PCI (removal of the thrombosis and plain old balloon angioplasty) was performed, and incomplete stent apposition was diagnosed with coronary angiography.

Topics: Aged; Coronary Disease; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Male; Perioperative Period; Polyradiculopathy; Sirolimus; Thrombosis; Time Factors

Although not a definitive treatment, percutaneous coronary intervention offers a palliative benefit to patients with cardiac allograft vasculopathy. Given the superior outcomes with drug-eluting stents (DESs) over bare metal stents (BMSs) in native coronary artery disease, similar improvements might be expected in transplant patients; however, the results have been mixed. Consecutive cardiac transplantation recipients at a single center receiving a stent for de novo cardiac allograft vasculopathy from 1997 to 2009 were retrospectively analyzed according to receipt of a DES versus a BMS. The angiographic and clinical outcomes were subsequently evaluated at 1 year. The baseline clinical and procedural characteristics were similar among those receiving DESs (n = 18) and BMSs (n = 16). Quantitative coronary angiography revealed no difference in the reference diameter, lesion length, or pre-/postprocedural minimal luminal diameter. At the 12-month angiographic follow-up visit, the mean lumen loss was significantly lower in the DES group than in the BMS group (0.19 ± 0.73 mm vs 0.76 ± 0.97 mm, p = 0.02). The DES group also had a lower rate of in-stent restenosis (12.5% vs 33%, p = 0.18), as well as a significantly lower rate of target lesion revascularization (0% vs 19%, p = 0.03). At 1 year, DESs were associated with a lower composite rate of cardiac death and nonfatal myocardial infarction (12% vs 38%, p = 0.04). In conclusion, DESs are safe and effective in the suppression of neointimal hyperplasia after percutaneous coronary intervention for cardiac allograft vasculopathy, resulting in significantly lower rates of late lumen loss and target lesion revascularization, as well as a reduced combined rate of cardiac death and nonfatal myocardial infarction.

Topics: Aspirin; Chi-Square Distribution; Clopidogrel; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Metals; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Retrospective Studies; Risk Factors; Sirolimus; Stents; Ticlopidine; Transplantation, Homologous; Treatment Outcome; Tubulin Modulators

Topics: Aged; Clinical Protocols; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Italy; Male; Middle Aged; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Performing percutaneous coronary intervention (PCI) to multiple coronary lesions during the same procedure has potential economic and social advantages. However comprehensive outcome data of real world practice in a large population is limited. We aimed to compare short- and long-term outcomes between patients with multivessel coronary artery disease who either underwent single- or multivessel PCI within the e-SELECT registry.. The e-SELECT registry combines data collected at 320 medical centres in 56 countries where patients received CYPHER Select® or CYPHER Select® Plus sirolimus-eluting stent (SES). Rates of myocardial infarction and major adverse cardiac event (MACE) (defined as any death, myocardial infarction or target lesion revascularisation) were compared between patients undergoing single-vessel versus multivessel PCI. A total of 15,147 patients who satisfied the inclusion criteria were included in the e-SELECT registry. Two thousand two hundred and seventy-eight (2,278) subjects (15%) underwent multivessel PCI and 12,869 (85%) had single-vessel PCI. The mean age was higher in the multivessel PCI group (63 vs. 62 years, p<0.001) and there was a higher prevalence of diabetes mellitus (32.4 vs. 30.0%, p=0.02). Lesions were more complex in the single-PCI group while pre- and post-dilatation were less common in the multivessel PCI group. Myocardial infarction within the first 30 days post PCI was more common in the multivessel PCI group (1.9 vs. 0.8%, p<0.001) and most of the infarctions were periprocedural (1.3 vs. 0.6%, p=0.001). Mortality and myocardial infarction at one-year were higher in the multivessel PCI group resulting in a significantly higher MACE (6.1 vs. 4.6%, p=0.005).. Overall procedural and one year outcomes were excellent for both single- and multivessel procedures. However despite lower lesion complexity, performing multivessel PCI was associated with higher rates of periprocedural myocardial infarction and MACE when compared to single-vessel PCI in the e-SELECT registry.

Topics: Aged; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Registries; Sirolimus; Treatment Outcome

It is said that the chronic outcomes of the two-stent technique for bifurcation lesions are inferior to that of cross-over single stenting. However, there are many cases where true bifurcations are difficult to treat by single stenting and, in particular, strategies for bifurcation lesions that are not left main trunk (LMT) bifurcations are still not clear.. This study aims to compare the usefulness of crush stenting with that of cross-over single stenting using the sirolimus-eluting stent (SES) on bifurcation lesions with the exclusion of LMT bifurcations.. Subjects were 92 consecutive patients (100 lesions) who underwent cross-over single stenting or crush stenting using SES for bifurcation lesions with the exclusion of LMT bifurcations. The patients were divided into 33 patients with 34 lesions, in whom the stent was implanted in the main vessel alone with the kissing balloon technique performed for the main vessel and side branch (Single-stenting group; S group), and 59 patients with 66 lesions, in whom the stent was implanted through crush stenting (Crush-stenting group; C group). The two groups were compared for target lesion revascularization (TLR) and major adverse cardiac events (MACE).. There were no differences for TLR, with this conducted in the main vessel in 5.9% of S group and 4.5% of C group. There was no difference between the groups in MACE with 9.1% in S group and 8.5% in C group. No significant difference was seen in MACE-free survival rate in the chronic phase with 93.9% for S group and 94.9% for C group (P=NS).. No differences in chronic clinical outcomes were revealed in a comparison between cross-over single stenting and crush stenting. Good clinical outcomes were achieved by both cross-over single stenting and crush stenting in the treatment of non-left main bifurcation lesions.

Topics: Aged; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Sirolimus; Treatment Outcome

The purpose of this study was to assess the long-term risks and benefits of drug-eluting stents (DESs) compared with bare-metal stents (BMSs) for treatment of coronary bifurcation lesions.. Our registry comprised 1,038 patients treated for coronary bifurcation lesion according to the provisional T-stenting strategy who were followed up for 3 years.. Target lesion revascularization rates were 24.3% for BMSs (n = 337), 15.6% for sirolimus-eluting stents (SESs, n = 422), and 17.3% for paclitaxel-eluting stents (PESs, n = 279) (P = .003 BMSs vs DESs, P = .54 SESs vs PESs). The respective incidences were 11.4%, 9.5%, and 14.8% (P = .65, P = .13) for death and myocardial infarction and 9.9%, 6.5%, and 10.6% (P = .72, P = .19) for death. Propensity score adjusted hazard ratios (95% CI) for DESs versus BMSs were 0.49 (0.35-0.68, P < .001) for target lesion revascularization, 0.94 (0.64-1.40, P = .078) for death and myocardial infarction, and 0.85 (0.55-1.32, P = .47) for death. We did not find any significant differences between SESs and PESs, except for an increased risk of death after PESs compared with SESs (but not BMSs) in the subgroup receiving a side-branch stent (adjusted hazard ratio 2.45, 95% CI 1.05-5.73, P = .035).. Compared with BMSs, both PESs and SESs substantially reduced the long-term need for repeated revascularization but did not increase the risk of death and myocardial infarction.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Mortality; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

We compare real-world, extended target vessel revascularization (TVR)-free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) following an index drug-eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES-supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in-hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan-Meier and Cox's proportional hazard survival methods were performed. TVR-free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan-Meier survival curves did not significantly differ (adjusted hazard ratio -1.39 [95% CI 0.99-1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3-97.6] vs. 95.7% for PES [95% CI 94.1-96.9]) and two (95.0%[95% CI 93.0-96.4] for SES vs. 93.7% for PES [95% CI 91.6-95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7-97.3) and 95.3% for PES (95% CI 93.7-96.5). SES and PES drug-eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Inpatients; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Prospective Studies; Registries; Sirolimus; Treatment Outcome

Transplanted heart coronary artery disease (TxCAD) may occur in a significant proportion of patients following cardiac transplantation. Drug-eluting stents (DES) have been successfully used in patients with CAD, but their efficacy in TxCAD patients has not been well established.. To compare long-term results of intracoronary implantation of DES and BMS in patients suffering from TxCAD.. We performed a retrospective analysis of all intracoronary stent implantations for TxCAD with at least one control coronary angiography performed during follow-up. We identified 28 DES (all sirolimus-eluting stents, SES) and 28 BMS implantations in 23 patients. The mean follow-up time was 410+/-58 days after DES, and 572+/-434 days after BMS implantation (p=0.004). We compared the occurrence of in-stent restenosis (ISR) in DES and BMS, and survival of patients in the context of risk factors that were identified for each stent implantation separately.. There were 2 (7%) ISR revealed in DES patients (mean time from PCI to restenosis 492+/-58 days) vs. 17 (61%) ISR in BMS patients (mean time from PCI to restenosis 475+/-345 days) (p<0.001). There were 3 (18%) deaths in patients with DES, 4 (31%) in patients with BMS, and 1 (14%) in a patient with DES and BMS (NS). The risk factor profile was comparable, except for higher age at the time of transplantation (46+/-7 vs. 41+/-6 years, p=0.011) and stent implantation (54+/-7 vs. 49+/-6 years, p<0.001) for DES.. Favourable long-term results of DES compared with BMS implantation for TxCAD suggest the preferential use of DES in heart transplant recipients.

Topics: Adult; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Heart Failure; Heart Transplantation; Humans; Male; Middle Aged; Recurrence; Retrospective Studies; Risk Factors; Sirolimus; Stents; Survival Rate

The zotarolimus-eluting stent (ZES) has been documented as significantly reducing restenosis and target lesion revascularization (TLR) requirement compared to bare metal stents (BMS).. In this single-centered, prospective study we sought to evaluate the short- and medium-term outcomes of ZES placement in bifurcated coronary artery lesions. Between August 2006 and December 2007, 107 consecutive patients (110 bifurcations) were recruited to have ZES placement in the lesion. The provisional T stenting (PTS) technique was used in 96.3%. Angiographic success was 100% in main vessel (MV) cases and 97.2% in that of side branch (SB).. With a mean follow-up of 12.4 +/- 1.77 (mean +/- SD) months there were four deaths, three from cardiac cause (2.85%). There were 18 patients (19 bifurcations) requiring TLR (17.59%) for clinical reasons. The only predictor of TLR was the use diameter of ZES

Topics: Adult; Aged; Aged, 80 and over; Cardiac Catheterization; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Equipment Design; Female; Follow-Up Studies; Humans; Inpatients; Male; Middle Aged; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome

Previously the polymer-free sirolimus-eluting YUKON-Choice stent (A) has demonstrated noninferiority compared to the polymer-based paclitaxel-eluting TAXUS stent (B). To test for long-term equivalency in unselected real-world coronary lesions of various complexities, we retrospectively compared both stents.. A total of 410 patients with symptomatic coronary artery disease (CAD) were treated with stent A (n = 205) or stent B (n = 205). Baseline clinical characteristics, lesion location, and length and the number of stents implanted per lesion were equally distributed. Clinical follow-up with assessment of major adverse cardiac events (MACE) and noncardiac deaths was obtained at 9 and 12 months.. Nominal stent diameter and nominal length of the stented segment were without differences between the groups. The incidence of MACE after 12 months was significantly higher in group A (35.1%) compared to group B (16.6%, P = .001). This was mainly due to increased rates of target-lesion revascularizations in group A (13.7%) vs group B (4.4%, P = .005). No significant differences in target-vessel revascularizations and non-target-vessel revascularizations were observed. In group B, 1 stent thrombosis was documented (0.5%) vs none in group A (P > .05); in each group 1 myocardial infarction (MI), but no cardiac deaths occurred; 3 noncardiac deaths in group A (1.5%) vs 7 in group B (3.4%) were observed (P = .3).. In contrast to our previous findings indicating no differences in MACE between patients treated with the polymer-free sirolimus-eluting YUKON-Choice stent and the polymer-based paclitaxel-eluting TAXUS stent at 6 months, we herewith show that 12 months after percutaneous coronary intervention (PCI) of real-world coronary lesions the YUKON stent appears to be inferior due to increased target-lesion revascularization (TLR) rates as a consequence of delayed restenosis.

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Paclitaxel; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Outcome; Tubulin Modulators

Coating of stents has been shown to minimize the interactions between platelets, stent surface and vascular response following stent implantation. The aim of our study was to compare the tacrolimus-eluting carbon-coated JANUS(®) stent with sirolimus-eluting CYPHER(®) stent for the prevention of symptom-driven clinical end points in a real world clinical setting.. This prospective registry with a follow-up period of 24 months was conducted in 90 consecutive patients undergoing coronary artery stenting receiving CYPHER(®) (n = 48) or JANUS(®) (n = 42) stents. The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction and target vessel revascularisation, and the secondary end point was clinically driven in-stent restenosis.. The primary combined endpoint occurred in 38% of patients (n = 16) in the JANUS(®) group compared to 10% (n = 5) in the CYPHER(®) group. The relative risk increase of the composite end point was therefore 63% higher in patients receiving JANUS(®) stents compared to the CYPHER(®) stents (crude HR = 1.63, 95% CI = 1.17-2.28, p = 0.004; adjusted HR = 1.79, CI = 1.26-2.55, p = 0.001). Interestingly, 75% of events in the JANUS(®) group occurred during the first 6 months after stent implantation. Similarly, the rate of clinically driven in-stent restenosis was higher in patients receiving JANUS(®) stent (n = 10, 2%) compared to the CYPHER(®) stent (n = 2, 4%). Concordantly, the relative risk for clinically driven in-stent restenosis was 81% higher in the JANUS(®) group compared to the CYPHER(®) group (crude HR = 1.81, 95% CI = 1.08-3.02, p = 0.02; adjusted HR = 2.24, CI = 1.26-3.96, p = 0.006).. The use of tacrolimus-eluting carbon coated JANUS(®) stent was associated with worse clinical outcome compared to the sirolimus-eluting CYPHER(®) stent in clinical routine use.

Topics: Aged; Angioplasty, Balloon, Coronary; Carbon; Cardiovascular Diseases; Coronary Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Registries; Sirolimus; Tacrolimus; Treatment Outcome

Topics: Aspirin; Clopidogrel; Coronary Disease; Coronary Thrombosis; Drug-Eluting Stents; Humans; Paclitaxel; Platelet Aggregation Inhibitors; Polymers; Sirolimus; Ticlopidine

Patients with metabolic syndrome (MetS) are at increased risk of cardiovascular events. The long-term effectiveness of sirolimus-eluting stents (SES) in patients with MetS and in diabetic patients is not well defined.. 563 consecutive patients with 629 de novo coronary lesions (< 50 mm lesion length, reference diameter < 3.5 mm) successfully treated with SES were enrolled in the study and followed for 41 +/- 17 months. Bifurcation and left main lesions were excluded. Patients were categorized into three groups: 1) no MetS and no diabetes; 2) MetS and no diabetes; and 3) diabetes. MetS was defined as the presence of > or = 3 of the following criteria: obesity, hypertension, hypertriglyceridemia, low high-density lipoprotein cholesterol, elevated fasting glucose.. 284 patients (51%) with 318 lesions had neither MetS nor diabetes, 148 patients (26%) with 163 lesions had MetS without diabetes and 131 patients (23%) with 148 lesions had diabetes. Baseline angiographic parameters were comparable between the three groups. Clinically driven target lesion revascularization rates for controls, MetS and diabetics were 7.7%, 5.4% and 14.5%, respectively (p = 0.041). Mortality rates for the three groups were 4.2%, 10.1% and 15.3%, respectively (p = 0.042). There were also significant differences in stent thrombosis (ST) rates with 0.3% in controls, 0.6% in MetS and 6.1% in diabetics (p = 0.037). Annual mortality and ST rates for controls, patients with MetS and diabetic patients were 1.2%, 3.0% and 5.6% (p = 0.037) and 0.2%, 0.3% and 2.7% (p = 0.039), respectively. Late loss in-lesion was 0.19 +/- 0.59 mm in controls, 0.17 +/- 0.44 mm in patients with MetS/no diabetes and 0.46 +/- 0.81 mm in diabetics (p < 0.001).. During long-term follow up after implantation of SES in de novo coronary lesions, MetS without diabetes does not result in an increase in target lesion revascularization or ST rates compared with control patients. However, patients with MetS have a higher follow-up mortality rate compared to control patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Thrombosis; Diabetes Complications; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Longitudinal Studies; Male; Metabolic Syndrome; Middle Aged; Prognosis; Sirolimus; Survival Rate; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Prognosis; Sirolimus

Drug-eluting stents have been effective in randomized controlled trials, but their safety and efficacy in patients with insulin-dependent diabetes has not been well studied. Baseline clinical and angiographic characteristics and in-hospital and follow-up events were recorded for enrolled patients. From October 2005 and October 2006, 581 patients with insulin-dependent diabetes and 1,078 with non-insulin-dependent diabetes treated with sirolimus- and paclitaxel-eluting stents were enrolled at 98 sites. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events, as well as target vessel revascularization was used as the primary end point. Multiple logistic regression analysis was used to adjust for confounding parameters. Baseline clinical characteristics were more severe in patients with insulin-dependent diabetes, whereas descriptive characteristics were not unique. At 1-year follow-up, the comparison between the 2 groups revealed significantly higher rates of overall death (7.4% vs 4.6%, p <0.05), target vessel revascularization (15.1% vs 10.4%, p <0.05), and overall stent thrombosis (6.5% vs 4.1%, p <0.05) for insulin-dependent patients, while rates of major adverse cardiac and cerebrovascular events were not significantly different (12.8% vs 9.9%, p = 0.09). These results persisted even after risk adjustment for heterogenous baseline characteristics of the 2 groups. In conclusion, the data generated from the German Drug-Eluting Stent (DES.DE) registry revealed that even with drug-eluting stents, the annual risk for death, target vessel revascularization, and thrombotic events remains higher in patients with insulin-dependent diabetes compared to those with non-insulin-dependent diabetes.

Topics: Aged; Coronary Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Female; Germany; Humans; Hypoglycemic Agents; Immunosuppressive Agents; Insulin; Logistic Models; Male; Paclitaxel; Prospective Studies; Registries; Sirolimus; Survival Rate; Treatment Outcome; Tubulin Modulators

Patients with diabetic retinopathy (DR) have an increased risk of death from coronary heart disease and myocardial infarction. The purpose of this study was to compare the outcomes of revascularization strategies (sirolimus-eluting stent [SES] and coronary artery bypass surgery [CABG]) in patients with DR according to the stage of retinopathy: non-proliferative retinopathy (NPDR) and proliferative retinopathy (PDR).. From April 2004 until February 2007, 627 patients including 51 NPDR and 62 PDR patients underwent SES implantation. For each retinopathy group, a historical comparison group at the same stages of retinopathy undergoing CABG was selected. Cardiac events were defined as a composite of cardiac death, myocardial infarction, and repeat revascularization.. The average follow-up from the time of the initial revascularization was 27.7 ± 8.5 months for NPDR-SES patients, 69.6 ± 36.6 months for NPDR-CABG patients, 26.4 ± 9.7 months for PDR-SES patients, and 68.3 ± 44.2 months for PDR-CABG patients; and Kaplan-Meier estimates of the percentages of events at 24 months were 47.0%, 22.8%, 28.5%, and 26.0%. Kaplan-Meier curves for cardiac events differed significantly between the SES group and the CABG group in NPDR patients (p = 0.04), whereas the curves did not differ significantly between the two groups of PDR patients. The adjusted hazard ratio of SES implantation for cardiac events in the entire group of DR patients was 1.75 (95% confidence interval [CI] 1.02-3.00, p = 0.04).. SES implantation is not a suitable method of revascularization in DR patients, especially in NPDR patients. CABG may become the first-choice revascularization technique for these patients.

Topics: Aged; Coronary Artery Bypass; Coronary Disease; Diabetic Retinopathy; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Myocardial Infarction; Sirolimus; Treatment Outcome

Transplant allograft vasculopathy (TAV) was a leading cause of death in cardiac transplant recipients after the first year of transplantation. Whether drug-eluting stents (DESs) performed better than bare-metal stents (BMSs) for the treatment of patients with discrete epicardial stenosis was unknown. The aim was to determine the safety and efficacy of DESs compared with BMSs in the treatment of patients with TAV. Outcomes of 32 patients sequentially treated using DESs for TAV were retrospectively reviewed and compared with a historic cohort of 35 patients treated sequentially with BMSs for TAV. Patients treated with DESs were also compared with age- and gender-matched cardiac transplant controls to determine differences in survival. After adjustment for baseline risk factors, there was no difference in 1-year survival between patients treated with DESs or BMSs for TAV. Restenosis rates at 1 year were 49% in lesions treated using BMSs and 19% in those treated using DESs. Compared with an age- and gender-matched control group of cardiac transplant patients who did not have discrete obstructive epicardial TAV, patients who required treatment with DESs for epicardial obstructive disease had significantly worse survival. In conclusion, treatment of patients with TAV with DESs did not seem to alter the natural deleterious history of this disease process.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Heart Transplantation; Humans; Male; Middle Aged; Sirolimus; Survival Rate

This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS).. Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death.. A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding.. The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups.. During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Sirolimus; Stents; Thrombosis

Drug-eluting metallic coronary stents predispose to late stent thrombosis, prevent late lumen vessel enlargement, hinder surgical revascularisation, and impair imaging with multislice CT. We assessed the safety of the bioabsorbable everolimus-eluting stent (BVS).. 30 patients with a single de-novo coronary artery lesion were followed up for 2 years clinically and with multiple imaging methods: multislice CT, angiography, intravascular ultrasound, derived morphology parameters (virtual histology, palpography, and echogenicity), and optical coherence tomography (OCT).. Clinical data were obtained from 29 of 30 patients. At 2 years, the device was safe with no cardiac deaths, ischaemia-driven target lesion revascularisations, or stent thromboses recorded, and only one myocardial infarction (non-Q wave). 18-month multislice CT (assessed in 25 patients) showed a mean diameter stenosis of 19% (SD 9). At 2-year angiography, the in-stent late loss of 0.48 mm (SD 0.28) and the diameter stenosis of 27% (11) did not differ from the findings at 6 months. The luminal area enlargement on OCT and intravascular ultrasound between 6 months and 2 years was due to a decrease in plaque size without change in vessel size. At 2 years, 34.5% of strut locations presented no discernible features by OCT, confirming decreases in echogenicity and in radiofrequency backscattering; the remaining apparent struts were fully apposed. Additionally, vasomotion occurred at the stented site and adjacent coronary artery in response to vasoactive agents.. At 2 years after implantation the stent was bioabsorbed, had vasomotion restored and restenosis prevented, and was clinically safe, suggesting freedom from late thrombosis. Late luminal enlargement due to plaque reduction without vessel remodelling needs confirmation.

Topics: Absorbable Implants; Clinical Trials as Topic; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Multicenter Studies as Topic; Sirolimus; Treatment Outcome; Ultrasonography

Coronary heart disease is mainly caused by atherosclerosis, which is a multifactorial and systemic disease. Lipid metabolism disorder and chronic inflammation are two well accepted mechanisms leading to atherosclerosis. The key initiating process in athrogenesis is lipid retention in subendothelium. Inflammatory activity plays an important role in the whole pathogenesis of atherosclerosis. Recent investigations have demonstrated that rapamycin reduces lipid retention by increasing adipose-tissue lipase activity and decreasing lipoprotein lipase activity. Rapamycin also reduce intracellular lipid accumulation in smooth muscle cells and macrophages. Since rapamycin is a definite immunosuppressive agent, and inflammatory process has been involved in atherosclerosis, the compound would have effect on the progression of atherosclerosis through reducing inflammatory activity. Moreover, rapamycin would protect plaque from rupture by selectively clearing macrophages without affecting vascular smooth muscle cells. Even some in vivo studies demonstrate that rapamycin can notably inhibit the development of atherosclerosis. Rapamycin, especially its analog, everolimus, is a non-toxic, well-tolerated drug suitable for long term use. Clinical experiments demonstrate that everolimus can reduce graft vasculopathy in heart transplant patients. Therefore, we propose that everolimus administered systemically is a promising medical therapy to attenuate atherosclerosis and prevent further adverse events. In addition, rapamycin is a selective and effective mammalian target of rapamycin (mTOR) inhibitor. mTOR acts as a hub for cell metabolism, cell growth and cell survival. Based on previous evidences, we hypotheses that mTOR signaling pathway could play a significant role in the pathogenesis of atherosclerosis.

Topics: Coronary Disease; Everolimus; Humans; Immunosuppressive Agents; Protein Kinases; Signal Transduction; Sirolimus; TOR Serine-Threonine Kinases

Since the introduction of drug-eluting stents, the optimum revascularization strategy in diabetic patients with multivessel coronary disease has remained controversial.. This study used multivariate logistic regression analysis and propensity score matching to compare results in 270 consecutive diabetic patients (2000-2004) with multivessel disease (> or =2 vessels with a >70% de novo stenosis involving the proximal left anterior descending coronary artery) who underwent either coronary artery bypass grafting (CABG; n=142) or implantation of a drug-eluting stent (DES; i.e. rapamycin or paclitaxel; n=128). The following clinical outcomes (i.e. major adverse cardiac or cerebrovascular events [MACCEs]) were assessed: death, nonfatal myocardial infarction (MI), stroke and repeat revascularization at 2 years.. Patients who received DESs were older (67.5+/-7 years vs. 65.3+/-8 years; P=.05) and more often had a previous MI (49.2% vs. 28.2%; P< .01), but no more often had a depressed left ventricular ejection fraction < or =45% (32.4% vs. 28.1%). Coronary anatomy was more complex in surgical patients (SYNTAX score, 25.9+/-7 vs. 18.5+/-6; P< .001) and the quality of revascularization was better (i.e. anatomically complete revascularization: 52.8% vs. 28.1%; P< .01). The incidence of MACCEs was 18.7% in the CABG group and 21.8% in the DES group (adjusted odds ratio [OR] = 0.93; 95% confidence interval [CI], 0.47-1.86). The composite endpoint of death, MI or stroke occurred in 15.8% undergoing CABG and 12.9% receiving a DES (adjusted OR = 1.19; 95% CI, 0.72-1.88). There was less need for revascularization in CABG patients (4.3% vs. 12.1%; adjusted OR = 0.42; 95% CI, 0.16-1.14; P=.09).. In an unselected population of diabetic patients with multivessel coronary disease, the principle advantage of CABG was the reduced need for revascularization. There was no difference in the rate of death, MI or stroke.

Topics: Aged; Antineoplastic Agents, Phytogenic; Cohort Studies; Coronary Artery Bypass; Coronary Disease; Diabetic Angiopathies; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Logistic Models; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Retrospective Studies; Sirolimus; Treatment Outcome

Small studies have indicated that drug-drug interactions and such clinical characteristics as diabetes mellitus may increase residual platelet reactivity in patients on clopidogrel therapy. The independent contribution of these variables to high residual platelet reactivity (HRPR) is not well studied. Residual platelet reactivity was assessed using the VerifyNow P2Y12 assay (Accumetrics Inc., San Diego, California) in 377 patients with stable coronary artery disease on maintenance clopidogrel therapy. HRPR was defined using a threshold previously shown to predict adverse clinical outcomes. Residual platelet reactivity was significantly higher in women (220 +/- 82 vs 200 +/- 77 P2Y12 reaction units [PRU]; p = 0.041), non-Caucasians (229 +/- 79 vs 202 +/- 78 PRU; p = 0.047), patients with diabetes mellitus (220 +/- 73 vs 196 +/- 80 PRU; p = 0.005), and those treated with nitrates (233 +/- 70 vs 200 +/- 80 PRU; p = 0.018) or proton-pump inhibitors (218 +/- 79 vs 198 +/- 78 PRU; p = 0.02), whereas residual platelet reactivity was significantly lower in active smokers (168 +/- 82 vs 208 +/- 77 PRU; p = 0.006). Independent predictors of HRPR were female gender (odds ratio [OR] 1.91, 95% confidence interval [CI] 1.14 to 3.19, p = 0.014), non-Caucasian ethnicity (OR 3.05, 95% CI 1.49 to 6.28, p = 0.002), use of proton-pump inhibitors (OR 1.64, 95% CI 1.03 to 2.59, p = 0.035), and active smoking (OR 0.37, 95% CI 0.14 to 0.94, p = 0.037). HRPR was associated with increased 6-month mortality rates (3.0% vs 0%; p = 0.016). In conclusion, our findings support the hypothesis that clopidogrel nonresponsiveness is primarily the result of genetic mechanisms and factors that may influence activity of the cytochrome P-450 system.

Topics: Aged; Blood Platelets; Chi-Square Distribution; Clopidogrel; Coronary Disease; Drug Interactions; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Platelet Aggregation; Platelet Aggregation Inhibitors; Platelet Function Tests; Predictive Value of Tests; Sirolimus; Ticlopidine; Treatment Outcome

Five-year clinical follow-up has been scheduled per protocol by the 4 Cypher (Cordis/Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) versus bare-metal stent (BMS) randomized trials.. A delayed arterial healing response after drug-eluting stent implantation has raised concerns about the long-term safety of drug-eluting stents.. In a pooled analysis of 4 randomized trials, 1,748 patients were assigned to receive either an SES (n = 878) or BMS (n = 870).. At 5 years, there was no significant difference in the rate of death, myocardial infarction (MI), or the composite of death/MI between the 2 groups (15.1% in the SES group vs. 13.6% in the BMS group; p = 0.36). The 5-year incidence of stent thrombosis by the Academic Research Consortium definition did not differ between SES and BMS (definite/probable stent thrombosis, 2.1% vs. 2.0%; p = 0.99). The incidence of very late stent thrombosis was also similar between the SES and BMS groups (1.4% vs. 0.7%; p = 0.22). The annualized rates of definite/probable stent thrombosis after 1 year were 0.4% for SES and 0.2% for BMS. The 5-year incidence of target vessel revascularization was significantly lower in the SES group (15.2% vs. 30.1%; p < 0.0001).. In this patient-level pooled analysis, overall use of SES compared with BMS demonstrated persistent superior efficacy at 5 years in terms of a reduction in target vessel revascularization, without an increase in rates of death, MI, or stent thrombosis. (The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study, NCT00233805; The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions, NCT00381420; Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions [SIRIUS], NCT00232765; The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions, NCT00235144).

Topics: Aged; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Multicenter Studies as Topic; Myocardial Infarction; Myocardial Revascularization; Randomized Controlled Trials as Topic; Sirolimus; Stents; Thrombosis; Treatment Outcome

Trifurcation lesions, which are mostly observed in distal left main (LM), represent a technical challenge for interventional cardiologists. We sought to determine the feasibility and long-term clinical outcome of drug eluting stent (DES) implantation in patients with LM coronary trifurcation lesions.. All patients with clinically significant de novo LM trifurcation lesions, who refused coronary artery bypass surgery and were considered eligible for percutaneous coronary intervention (PCI), were consecutively enrolled in this study from November 2005 to February 2007. Eleven patients (65+/-9 years, 91% men) met all the inclusion criteria and underwent LM trifurcation stenting with DES. Angiographic success was 100%. Clinical follow-up in all patients and angiographic follow-up in 91% of patients was available at 32+/-7 and 8+/-2 months, respectively. The primary endpoint, defined as the composite of cardiac death or acute myocardial infarction, occurred in one patient (9%). No cases of stent thrombosis were recorded. Three patients (27%), experienced a clinically-driven target lesion revascularisation (TLR).. PCI with DES implantation in patients with LM trifurcation seems feasible and safe, with acceptable TLR rates. Large scale multicentre registries are warranted to reliably address clinical outcome of this subset of patients.

Topics: Aged; Angioplasty; Coronary Angiography; Coronary Disease; Coronary Vessels; Drug-Eluting Stents; Equipment Design; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Tubulin Modulators

After novel findings from genomewide association studies that sequence variation on chromosome 9p21.3 is a genetic factor for coronary heart disease, we investigated whether this locus influenced the clinical and angiographic outcomes after implantation of drug-eluting stents in coronary arteries.. Recently, genomewide association studies have identified a locus on chromosome 9 (approximately 100 kb in band p21.3) as the strongest genetic factor for coronary heart disease.. We studied the rs7865618, rs1537378, rs1333040, and rs1333049 polymorphisms located on chromosome 9p21.3 in a cohort of 2,028 patients who were treated with percutaneous coronary intervention and implantation of sirolimus- or paclitaxel-eluting stents. Records of 3-year adverse clinical outcomes were obtained from all stented patients. Follow-up angiography at 6 to 8 months after stenting was performed in 1,683 patients (83%).. The polymorphisms were not significantly related with clinical outcomes at 3 years, including death (p >or= 0.18), myocardial infarction (p >or= 0.19), repeat revascularization (p >or= 0.08), and the composite end point of adverse events (death, myocardial infarction, repeat revascularization) (p >or= 0.34). No association of the polymorphisms was found with angiographic measures at follow-up, including minimal lumen diameter (p >or= 0.51), diameter stenosis (p >or= 0.31), late lumen loss (p >or= 0.05), and binary restenosis (p >or= 0.31).. Specific polymorphisms in the chromosome 9p21.3 region that were shown to be associated with coronary heart disease in genomewide analyses were not related to the clinical and angiographic outcomes after the placement of drug-eluting stents in coronary arteries.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromosomes, Human, Pair 9; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Gene Frequency; Genetic Predisposition to Disease; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Phenotype; Polymorphism, Single Nucleotide; Proportional Hazards Models; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Usefulness and efficacy of intravascular ultrasound (IVUS) for the implantation of sirolimus-eluting stent (SES) is controversial. We investigated the primary and mid-term results of SES deployment with angiographic guidance comparing with IVUS guidance, retrospectively.. SESs were deployed in 480 de novo lesions of 459 patients (341 lesions treated without IVUS and 139 lesions treated using IVUS); 368 lesions underwent follow-up coronary angiography. Late luminal loss, in-stent restenosis (ISR) rate and target lesion revascularization (TLR) rate were not significantly different between the non-IVUS group and the IVUS group. There was no acute thrombosis or other major adverse cardiac events except for TLR in both groups. Multivariate logistic regression analysis showed that SES implantation without IVUS was not an independent risk factor for restenosis. On the other hand, in one case, target-vessel revascularization was difficult because of the mal-apposition of the SES previously implanted without IVUS.. For lesions for which stent size and endpoint are decided from angiographic information alone, angio-guided SES implantation is safe and provides a good mid-term outcome that is comparable to the IVUS-guided SES stent deployment., while IVUS may be helpful to decide stent size for complex lesions and reduce possible complications.

Topics: Aged; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Sirolimus; Ultrasonography, Interventional

We report an autopsy case showing medial necrosis at the segment of sirolimus-eluting stent implantation. These findings indicate that cytotoxic effects of sirolimus can induce late-acquired incomplete stent apposition and/or aneurysmal changes after stenting in human coronary arteries.

Topics: Aged; Autopsy; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Necrosis; Sirolimus; Tunica Intima

RESTEM, a prospective multicenter registry collecting all percutaneous coronary interventions made over 20 months and monitored up to 2 years, had been performed to assess, in the real world, the impact of sirolimus-eluting stents (SES) versus bare metal stents (BMS) on patients' outcomes.. The registry includes 5524 consecutive patients treated with BMS (72%), SES (15%), BMS+SES (4%) or other techniques (9%). The combination of death, acute myocardial infarction, unstable angina and revascularization had been chosen as primary endpoint.. The 2-year adjusted results confirm a significant advantage of SES in target vessel revascularization (8.3 vs 13.7%, odds ratio [OR] 0.66), a benefit for overall revascularizations (18.3 vs 25.6%, OR 0.76) without reducing mortality, other clinical events and primary endpoint, therefore denying the benefit on primary endpoint observed at 12 months (18.5 vs 25.0%, OR 0.68 at 1 year and 25.8 vs 32.4%, OR 0.84 at 2 years).. RESTEM results confirm the SES capacity to reduce target vessel revascularization without decreasing other clinical events, suggest that this advantage is limited to the first 6 months after percutaneous coronary intervention, and show no evidence of excess of deaths, acute myocardial infarction and late thrombosis following SES implantation described in recent meta-analyses.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Data Interpretation, Statistical; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Multicenter Studies as Topic; Multivariate Analysis; Myocardial Infarction; Prospective Studies; Registries; Sirolimus; Time Factors; Treatment Outcome

Multiple studies comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease have been performed. Despite these comparisons, it remains uncertain whether a differential in long-term efficacy and safety exists. Unselected patients treated exclusively with 1 drug-eluting stent type were enrolled in the Registry Experience at the Washington Hospital Center with Drug-Eluting Stents. There were 2,099 patients (3,766 lesions) treated with SES and 1,079 patients (1,850 lesions) treated with PES. Patients were followed at 30 days, 1 year, and 2 years for the clinical endpoints of death, myocardial infarction, target vessel revascularization, and definite and definite/probable stent thrombosis. Patients in the SES group had more dyslipidemia, history of congestive heart failure, and ostial lesions; patients treated with PES had more previous coronary artery bypass surgery, unstable angina, and type C lesions. At 2 years, unadjusted major adverse cardiac events (MACE) (22.6% vs 21.1%, p = 0.3) and target vessel revascularization (13.3% vs 11.2%, p = 0.1) were comparable. The incidence of definite stent thrombosis was higher in the SES group (1.8% vs 0.9%, p = 0.05) driven by early events. Similar results were seen after adjustment for baseline differences: MACE (hazard ratio 1.1, 95% confidence interval [CI] 0.9 to 1.3, p = 0.5), definite stent thrombosis (hazard ratio 2.3, 95% CI 1.0 to 5.2, p = 0.05), and target vessel revascularization (hazard ratio 1.1, 95% CI 0.9 to 1.4, p = 0.4). The incidence and rate of late stent thrombosis (>30 days) were similar (0.7% vs 0.5%, p = 0.4 and 0.24%/year, both groups, respectively). In conclusion, no major differential in long-term safety or efficacy was detected between SES and PES; both stent types were efficacious in reducing revascularization but were limited by a small continual increase in late stent thrombosis.

Topics: Aged; Coronary Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Paclitaxel; Sirolimus; Treatment Outcome

Patterns of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation and outcomes after treatment have not been studied systematically in all comers. We compared patterns of ISR and outcomes of repeated percutaneous coronary intervention in consecutive patients with DES-ISR. A total of 137 patients with 182 lesions underwent repeated percutaneous coronary intervention for DES-ISR at Columbia University Medical Center from August 2004 to April 2006. DES-ISR was treated with repeated DES placement in 84% of patients and balloon angioplasty in 16%. There was 1 stent thrombosis at 30 days, and at 1 year, major adverse cardiac events occurred in 10% of patients, driven primarily by an 8% rate of target-lesion revascularization. After exclusion of 12 patients with multiple ISR lesions, data were further analyzed from 125 patients with 152 DES-ISR lesions, of which 118 were originally treated with sirolimus-eluting stents and 34 were treated with paclitaxel-eluting stents (PES-ISR). Baseline features were well matched between the 2 groups, except that patients with PES-ISR were older. A focal pattern of ISR was observed in 69.5% of patients overall. However, patients originally treated with a PES had a significantly higher frequency of diffuse-intrastent ISR in comparison with sirolimus-eluting stent ISR (30.3% vs 13.6%, p = 0.03). In conclusion, the pattern of ISR in most DES-ISR in this unselected patient population was focal, with higher rates of diffuse intrastent restenosis seen with PES-ISR. Treatment with either repeated DES implantation or balloon angioplasty for DES-ISR was safe and associated with low overall rates of target-lesion revascularization and major adverse cardiac events at 1 year.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Sirolimus

Although previous studies have documented persistent clinical benefit of sirolimus-eluting stents (SES)in reducing the need for target vessel revascularization without an increase in myocardial infarction (MI) or mortality, the long-term safety and efficacy of CYPHER stent use in routine clinical practice, including off-label stent implantation, remains uncertain.. We compared long-term clinical outcomes in 2,550 patients treated with one or more SES with 1,022 patients treated with one or more bare metal or heparin-coated stents (BMS). The study groups included 1,058 SES patients (41.5%) and 488 BMS patients (47.7%) with off-label indications. A propensity-score method was utilized to adjust for differences in baseline characteristics. Patients were followed for up to five years for the occurrence of all-cause mortality, MI and repeat target vessel revascularization.. Compared to BMS patients, SES patients demonstrated significantly improved event-free survival with respect to all-cause mortality (RR, 1.39; 95% CI, 1.07 to 1.80, P = 0.014) and repeat target vessel revascularization (RR, 2.72; 95% CI, 1.99 to 3.73, P < 0.001), with no significant difference in the incidence of cumulative MI. A landmark analysis, examining composite adverse events occurring six months after stent implantation in the two study groups, demonstrated no increased late hazard associated with SES use (relative risk, 1.08; 95% CI, 0.80 to 1.46).. Use of SES in routine clinical practice, including off-label indications, is associated with improved long-term mortality, reduced need for repeat target vessel revascularization and no increase in MI compared to BMS.

Topics: Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Aged; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Myocardial Revascularization; Sirolimus; Time Factors; Treatment Outcome

The aim of the study was to compare the outcomes of sirolimus-eluting (SES) and paclitaxel-eluting (PES) stent implantation in coronary bifurcations treated with either a 1-stent or 2-stent strategy.. The study used a retrospective cohort analysis of consecutive de novo bifurcations, excluding left main, treated with SES or PES between April 2003 and June 2005.. We identified 170 bifurcations in 161 patients treated with SES and 119 bifurcations in 112 patients treated with PES. During a median follow-up of 1,061 days (interquartile range 814-1,314), 43 patients (26.7%) in the SES group and 28 (25.0%) in the PES group had a major adverse cardiac event (P = .78). The angiographic restenosis rate per bifurcation was 20.9% and 25.9%, respectively (P = .41). There was no difference overall in the occurrence of target lesion revascularization (TLR) per bifurcation, 22 with SES (12.9%) and 18 with PES (15.1%), P = .61. The TLR rate was similar for SES and PES in bifurcations treated with 1 stent (6.7% vs 11.4%, P = .40) and in bifurcations treated with both branch stenting (20.0% vs 20.4%, P =1.0).. In this cohort, the long-term clinical outcomes appear similar overall between SES and PES in the treatment of coronary bifurcations irrespective of whether a 1-stent or 2-stent strategy was used.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Treatment Outcome

The side effects of proliferation signal inhibitors (PSIs) have been characterized as a class. However, it would be convenient to assess them according to the molecule.. To assess prospectively the tolerance of PSIs among heart transplant (HT) patients.. We studied 56 HT patients who sequentially received PSIs to either withdraw (77%) or reduce the dosage of a calcineurin inhibitor; 42 received everolimus (EVE) and 14 sirolimus (SRL). We analyzed the demographic variables, side effects, and need to withdraw the drug during a median follow-up period of 365 days.. No differences between groups were observed upon analysis of the clinical and demographic variables when the treatment was changed owing to renal dysfunction (67%) or tumor (32%). No difference between groups was observed over the follow-up period (P = .28). Infection was the most common side effect, 28.6%: EVE, 14.3% versus SRL, 71.4% (P < .0001). Edema occurred in 26.8% of patients: EVE, 14.3% versus SRL, 64.3% (P = .001); diarrhea in 5.4% of patients: EVE, 2.4% versus SRL, 14.3% (P = .15). Treatment was withdrawn in 23.2% of the patients due to intolerance: EVE, 11.9% versus SRL, 57.1% (P < .0001). EVE showed significantly better survival without edema or infections or used for drug withdrawal upon Kaplan-Meier analysis, (P = .01; P = .0005; P = .0097). Only SRL use was shown to be an independent predictor of side effects.. Edema and infections are the main problems caused by PSIs. EVE may display a better tolerance profile than SRL.

Topics: Adult; Calcineurin Inhibitors; Cardiomyopathy, Dilated; Coronary Disease; Disease-Free Survival; Dose-Response Relationship, Drug; Drug Tolerance; Edema; Everolimus; Female; Follow-Up Studies; Heart Transplantation; Humans; Immunosuppressive Agents; Infections; Male; Middle Aged; Regression Analysis; Retrospective Studies; Sirolimus

To compare the long-term effects of the China-made sirolimus-eluting stent (Firebird) and the imported paclitaxel-eluting stent (Taxus).. From April 2004 to April 2005, 314 consecutive patients underwent implantation of Firebird (n=88, F Group), aged (57.9 +/- 10.5), or Taxus (n=226, T group), aged (57.2 +/- 10.2). Then the patients were followed up in ward or out-patients department 1, 3, and 6 months after implantation and 1, 2, and 3 years after implantation by phone. Seven months after implantation coronary angiographic follow-up was performed.. The baseline type B2 + C lesion rate of T Group was 85.5%, significantly higher than that of F Group (75.5%; P = 0.026). The percent diameter stenosis of T Group was 70.1% +/- 15.2%, significantly higher than that of F Group (64.4% +/- 14.5%; P = 0.026). The balloon pre-dilation rate of T Group was 88.2%, significantly higher than that of F Group (70.9%, P = 0.000). The stent length ofT Group was (21.5 +/- 7.84) mm, significantly longer than that of F Group [(18.6 +/- 4.51) mm, P = 0.035]. The major adverse cardiac event (MACE) rate of T Group was 21.7%, significantly higher than that of F Group (8.0%, P = 0.05), the target vessel revascularization rate of T Group was 16.4%, ignificantly higher than that of F Group (6.8%, = 0.028), However, there were not significant differences in the rates of cardiac death and fatal myocardial infarction between these two groups (0% vs 1.8%, P = 0.580 and 1.1% vs. 3.5%, P = 0.45 respectively). There was no significant differences in the total, early, late, and very late stent thrombosis between these 2 groups (1.1% vs. 3.5%., P = 0.453, 1.1% vs. 0.9%, P = 0.580, and: 0% vs. 1.3%, P = 0.562, and 0% vs. 1.3%; P = 0.562). Angiography indicated that the in-stent and in-segment restenosis rates of T Group were both significantly lower than those of F Group (0% vs21.0.%; P 0.002, and 0% vs 24.0.% ; P =0.001 ). The in-stent and in-segment late loss levels of T Group were significantly smaller than those of F Group [(0.11 +/- 0.07) mm vs. (0.53 +/- 0.38)mm; P = 0.000, and (0.05 +/- 0.03) mm vs. (0.38 +/- 0.19) mm; P = 0.000].. Firebird stent is more effective and safer than Taxus stent, especially is superior in the restenosis-reducing effect.

Topics: Aged; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Immunosuppressive Agents; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Time Factors; Tubulin Modulators

Sirolimus-eluting stents (SES) prevent restenosis and repeat percutaneous coronary intervention (PCI), but safety data in unselected patients are limited, especially for intermediate-term follow-up.. All patients undergoing SES implantation at 4 Italian centers were enrolled into a dedicated database. Baseline, procedural, and outcome data at discharge and at follow-up were abstracted. Outcomes of interest were the occurrence of major adverse cerebrocardiovascular events (MACCE) at 6 months, as well as long-term event-free survival and multivariable event predictors.. One thousand four hundred twenty-four patients were enrolled (2,915 lesions, treated with 3,305 stents). Specifically, 1,074 (75.4%) subjects had multivessel disease, 399 (28.1%) had diabetes, 89 (6.3%) had ST-elevation myocardial infarction, and 44 (3.1%) underwent unprotected left main intervention. At 6 months, MACCE had occurred in 121 (9.0%) patients. After a median of 48.7 months (first-third quartile 41.8-55.3), MACCE-free survival was 69.2%+/-2.6%, with definite stent thrombosis occurring acutely in 6 (0.4%), subacutely in 11 (0.8%), after 30 days in 12 (0.8%), and cumulatively in 28 (2.0%). Major multivariable outcome predictors were diabetes (target lesion revascularization [TLR], MACCE), ejection fraction (TLR, MACCE), and maximal balloon length (TLR).. This large cohort of unselected patients supports the overall safety of unrestricted percutaneous SES implantation, as shown by the low rates of stent thrombosis. Event attrition remains, however, high at long-term follow-up, driven mainly by target vessel revascularization, with diabetes and ejection fraction as the most important prognostic factors.

Topics: Coronary Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prognosis; Prosthesis Implantation; Retrospective Studies; Sirolimus

Recently, concerns were raised about the relative long-term safety and efficacy of drug-eluting stents (DES) in saphenous vein bypass grafts (SVG). Our objective was to assess the 4-year relative safety and efficacy of the unrestricted use of drug-eluting stents (DES) as compared to bare metal stents (BMS) in saphenous vein bypass grafts (SVG).. Between April 16, 2002 and December 2005 a total of 122 consecutive patients were treated with either sirolimus- or paclitaxel-eluting stents for saphenous vein graft disease. These patients were compared with 128 consecutive patients treated with BMS in the immediate preceding period (January 1, 2000 to April 2002).. At 4-years the cumulative survival rate in the DES group was 77.5% versus 73.0% in the BMS group (adjusted HR 1.09; 95% CI 0.63-1.90, Logrank p=0.65). The cumulative survival free of major adverse cardiac events (MACE: death, myocardial infarction and target vessel revascularisation) was 61.5% vs. 46.8% in the DES and BMS groups respectively (adjusted HR 0.77, 95% CI; 0.51-1.16) due to a higher event free survival of clinically driven target vessel revascularisation in the DES group as compared to the BMS group (81.6% vs. 69.0%; adjusted HR 0.53; 95% CI 0.27-1.05).. In the present study, the use of DES for SVG PCI was associated a similar safety profile and there was a trend towards lower rates of TVR and MACE at four years as compared to BMS.

Topics: Aged; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel; Saphenous Vein; Sirolimus; Treatment Outcome

Accelerated atherosclerosis is a major risk for long-term survivors receiving hemodialysis (HD), with coronary events being the leading cause of mortality.. A total of 88 consecutive patients on HD (121 lesions) who underwent percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) were compared with 78 patients on HD (95 lesions) who received bare metal stents (BMS) in the preceding 1 year. The primary endpoint was angiographic restenosis defined as > or =50% diameter stenosis at 6-8 months follow-up after PCI. The angiographic restenosis rate at follow-up was 22.2% in the SES group and 24.4% in the BMS group. No difference was detected in the restenosis rate between the 2 groups (p=0.73). When including both HD and non-HD patients, the independent predictors for restenosis after SES implantation were treatment with HD (hazard ratio (HR) 3.12; 95% confidence interval (CI) 1.23-7.95; p=0.016), incidence of hyperlipidemia (HR 3.93; 95%CI 1.12-13.7; p=0.032), coronary calcification (HR 2.78; 95%CI 1.12-6.91; p=0.027), and implantation of multi-stents (HR 4.14; 95%CI 1.70-10.1; p=0.0017).. Even if treated with SES, patients with end-stage renal failure on HD are at high risk of restenosis after PCI.

Topics: Aged; Calcinosis; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Hyperlipidemias; Japan; Kidney Failure, Chronic; Male; Middle Aged; Recurrence; Renal Dialysis; Sirolimus; Stents

This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world.. From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure.. Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%).. Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Registries; Sicily; Sirolimus

Calcified coronary lesions carry the risk of suboptimal stent expansion, subsequently leading to restenosis. The effectiveness of sirolimus-eluting stents (SES) for the treatment of calcified lesion has not been fully investigated. In the present study, therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified coronary lesions.. A total of 333 consecutive patients with 453 lesions were enrolled in this study. They were divided into two groups according to whether the lesion treated with SES was calcified or not; no calcification group (n = 264) and calcification group (n = 189). Lesions treated with SES were subjected to quantitative coronary angiography (QCA) immediately and 8 months following stenting.. Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. Angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups; in-stent restenosis: 3.8% vs 4.2%; P = 0.081; in-segment restenosis: 8.7% vs 10.6%, P = 0.503. The target lesion revascularization (TLR) was also not significantly different between the two groups; 4.9% vs 6.9%, P = 0.378. In addition, the in-stent late loss was similar in both groups; (0.16 +/- 0.40) mm vs (0.17 +/- 0.33) mm, P > 0.05. Meantime, overall thrombosis rates were also similar in both groups; 1.6% vs 1.6%, P > 0.05.. Although calcified coronary lesion was hard to stent, successful percutaneous coronary intervention with SES stenting for calcified lesions was conferred by the similar favorable results that were seen when comparing non-calcified and calcified coronary lesions.

Topics: Adult; Aged; Calcinosis; Coronary Angiography; Coronary Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus

The efficacy and safety of drug-eluting stent (DES) implantation for unprotected left main coronary artery (LMCA) disease remain to be established in different clinical settings.. Elective DES implantation for unprotected LMCA stenosis was performed in 220 patients at the Fu Wai Hospital, China, from April 2003 to February 2006. Data derived from the latter group were compared with those derived from 224 patients treated with bare-metal stents (BMSs) before March 2003 in a Chinese registry of unprotected LMCA stenting.. Compared with the historical BMS control group, the DES group had more multivessel disease and underwent more bifurcation stenting. The inhospital major adverse cardiac events were significantly higher in the DES than in the BMS recipients (4.1% vs 0.9%, P = .030) because of more complex lesions and procedures in the DES group. During the 15-month mean follow-up period, cumulative cardiac death (0.5% vs 4.9%, P = .004), target-vessel revascularization (5.9% vs 11.6%, P = .034), and major adverse cardiac event (9.5% vs 16.5%, P = .029) rates were significantly lower in the DES than in the BMS group. There was no significant difference in clinical efficacy between sirolimus- and paclitaxel-eluting stents. Angiographic follow-up was performed in 46.4% of DES and 45.7% of BMS recipients, respectively; and the binary restenosis rate was significantly lower in the DES versus the BMS control group (16.7% vs 31.4%, P = .014).. Based on this comparison with a historical control, DES implantation for unprotected LMCA appears safe in selected patients and might be more effective in preventing major adverse cardiac events compared with BMS implantation over a mean follow-up period of 15 months.

Topics: Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; China; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Metals; Middle Aged; Myocardial Revascularization; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional

This study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice.. The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications.. We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring.. Of 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality.. The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Registries; Sirolimus; Stroke Volume

Insulin-treated diabetic patients undergoing drug-eluting stent implantation are prone to high rates of adverse cardiac events. The efficacy of the sirolimus- (SES) and paclitaxel-eluting stent (PES) in this population was analyzed. Registry data for 434 consecutive patients with insulin-treated diabetes who underwent SES or PES implantation were analyzed. The end point, major adverse cardiac events (MACEs) at 1 year, was high for patients with SESs and PESs (20.6% vs 20.2%; p=0.91). Cox regression and propensity analysis were used to compare outcomes. The adjusted hazard ratio (HR) for MACEs according to stent type (Cox model) was 1.0 (95% confidence interval [CI] 0.64 to 1.76, p=0.82). The propensity score-adjusted (C statistic=0.66) HR was 0.95 (95% CI 0.56 to 1.61, p=0.84). Stent thrombosis rates were relatively high at 2.0% for SESs and 1.5% for PESs (p=0.49). The propensity score-adjusted HR for stent thrombosis was 2.7 (95% CI 0.31 to 23.6, p=0.37). In conclusion, SESs and PESs are similarly efficacious in insulin-treated diabetic patients. The high MACE and stent thrombosis rates are of concern. Additional studies in this group of patients are required to determine the optimal mode of revascularization and minimize the overall stent thrombosis rate.

Topics: Blood Vessel Prosthesis Implantation; Chi-Square Distribution; Coronary Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Insulin; Logistic Models; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Registries; Retrospective Studies; Sirolimus; Treatment Outcome

Anxiety is an often overlooked risk factor in coronary artery disease (CAD). Hence, little is known about predictors of unremitting chronic anxiety in CAD patients. We examined whether the distressed personality (type-D) predicts chronic anxiety post percutaneous coronary intervention (PCI).. Unselected patients (n=167) treated with PCI using sirolimus-eluting or bare metal stents as part of the RESEARCH registry, who were anxious 6 months post-PCI, qualified for inclusion. Patients completed the Hospital Anxiety and Depression Scale at 6 and 12 months and the Type-D Scale (DS14) 6 months post-PCI.. Of 167 patients anxious at 6 months, 108 (65%) were still anxious 12 months post-PCI. Significant univariable predictors of chronic anxiety were type-D personality (OR: 3.17; 95% CI: 1.64-6.14) and sirolimus-eluting stent implantation (OR: 0.51; 95% CI: 0.27-0.98), with sirolimus-eluting stent showing a protective effect. In multivariable analyses, type-D personality (OR: 3.31; 95% CI: 1.59-6.87) and sirolimus-eluting stent implantation (OR: 0.44; 95% CI: 0.21-0.92) remained significant independent predictors of chronic anxiety adjusting for depressive symptoms at 6 months, demographic and clinical risk factors.. All psychological measures were based on self-report, and we had no information on cardiac rehabilitation or use of pharmacotherapy; however our sample represented patients seen in daily clinical practice.. These findings suggest that type-D personality is a risk factor and sirolimus-eluting stent implantation a protective factor for the occurrence of chronic anxiety. The protective effect of sirolimus-eluting stents in relation to anxiety warrants replication in future studies.

Topics: Aged; Angioplasty, Balloon, Coronary; Anxiety; Chronic Disease; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Disease; Depression; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Personality Inventory; Sirolimus; Stents; Type A Personality

Predictors of cardiac events and restenosis after sirolimus-eluting stent (SES) implantation in small coronary arteries were evaluated.. Although SES implantation has markedly reduced the risk of restenosis, small vessel disease remains a major cause of SES failure.. We prospectively investigated the factors predictive of cardiac events and restenosis in 1,092 consecutive patients who received SES implantation for 1,269 lesions in small coronary arteries (< or = 2.8 mm). Follow-up angiography at 6 months was performed in 751 patients with 889 lesions (follow-up rate 70.3%).. Restenosis (diameter stenosis > or = 50%) was angiographically documented in 65 patients with 77 lesions (8.7%): 55 focal (71.4%), 8 diffuse (10.4%), 2 diffuse proliferative (2.6%), and 12 total (15.6%). Lesion length, stent length, reference artery size, and in-stent restenotic lesions were univariate predictors of restenosis. By multivariate analysis, lesion length (OR 1.04; 95% CI 1.02-1.05; P < 0.001) and in-stent restenotic lesions (OR 3.38; 95% CI 1.80-6.35; P < 0.001) were significant independent predictors of restenosis. During follow-up (23.2 +/- 7.9 months), there were 17 deaths (5 cardiac and 12 noncardiac), 5 nonfatal Q-wave myocardial infarctions, and 42 target lesion revascularizations. The cumulative probability of survival without major adverse cardiac events (MACE) was (96.6 +/- 0.6)% at 1 year and (95.1 +/- 0.7)% at 2 years. In multivariate analysis, lesion length (HR 1.04; 95% CI 1.01-1.07; P = 0.004) and in-stent restenotic lesions (HR 3.29; 95% CI 1.58-6.86; P = 0.001) were independently related to MACE.. SES implantation in small coronary arteries is safe and effective, with lesion length having a major impact on restenosis and MACE.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Follow-Up Studies; Humans; Male; Middle Aged; Odds Ratio; Predictive Value of Tests; Prospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.

Topics: Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Survival Rate; United States

Overlapping homogenous drug-eluting stents (DESs) may be used instead of overlapping bare metal stents (BMSs) to treat coronary lesions longer than available stents. Yet, no data are available on patients treated with overlapping heterogenous DESs or DESs and BMSs. We prospectively assessed 9-month clinical outcome and 6-month angiographic late loss (evaluated at 5 different lesion segments) in a consecutive series of 40 patients who received overlapping homogenous DESs (sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]), heterogenous DESs (SES + PES), or overlapping DESs and BMSs. In 8 patients (7 with angiographic follow-up) with overlapping heterogenous DESs, no angiographic or clinical adverse event was observed. Moreover, in-segment late loss was similar to that of patients who received homogenous DESs. In 8 patients (7 with angiographic follow-up) with overlapping DESs and BMSs, there was a higher incidence of major adverse events (3 repeat percutaneous coronary interventions and 1 death, 50% adverse event rate) and worse in-segment binary restenosis rate compared with patients treated with homogenous or heterogenous DESs (p = 0.02 and 0.012, respectively). Late lumen loss at the site of stent overlap showed significant differences according to type of overlapped stent (1.00 +/- 0.76 mm in DES-BMS overlap, 0.32 +/- 0.55 mm in PES-PES overlap, 0.13 +/- 0.11 in SES-PES overlap, and 0.08 +/- 0.10 mm in SES-SES overlap, p = 0.005). In conclusion, the present study suggests that overlap of DESs and BMSs should be avoided because the antirestenotic effect of DESs is skewed by contiguous BMS implantation. Overlap between SESs and PESs in this very preliminary report was associated with no specific adverse event.

Topics: Aged; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Metals; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

This retrospective study of prospectively collected data compared coronary artery bypass graft (CABG) surgery to drug-eluting stenting (DES) in diabetic patients with multivessel coronary artery disease (CAD). Prior randomized trials and clinical studies have suggested that CABG may be the preferred revascularization strategy in diabetic patients with multivessel CAD. Data are limited regarding the impact of DES vs. CABG on clinical outcomes.. We included 205 consecutive diabetic patients who underwent either CABG (n=103) or DES (n=102). The primary clinical end points were freedom from major adverse cardiac events (MACE) at 30 days and 1 year.. Baseline characteristics were similar between both groups. At 1 year, the mortality rate was similar in the CABG and DES group (8% vs. 10%, p=0.6) but the MACE rate was lower in the CABG group (12% vs. 27%, p=0.006) due to less repeat revascularization with CABG (3% vs. 20%, p<0.001). Stroke occurred only in the CABG group (4% vs. 0%, p=0.04). Angiographically-documented stent thrombosis after DES occurred in 3%. Presentation with acute myocardial infarction (hazard ratio [HR], 2.26, 95% CI, 1.13 to 4.55) and DES (HR, 2.4, 95% CI, 1.23 to 4.77) were positive independent predictors, whereas therapy with a statin was a negative independent predictor of MACE (HR, 0.40, 95% CI, 0.21 to 0.76).. Bypass surgery was associated with less MACE primarily due to the higher repeat revascularization rate with DES and is therefore superior to DES despite more extensive CAD in CABG patients.

Topics: Aged; Antineoplastic Agents, Phytogenic; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Bypass; Coronary Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome

Recent reports have indicated that there may be an increased risk of late stent thrombosis with the use of drug-eluting stents, as compared with bare-metal stents.. We evaluated 6033 patients treated with drug-eluting stents and 13,738 patients treated with bare-metal stents in 2003 and 2004, using data from the Swedish Coronary Angiography and Angioplasty Registry. The outcome analysis covering a period of up to 3 years was based on 1424 deaths and 2463 myocardial infarctions and was adjusted for differences in baseline characteristics.. The two study groups did not differ significantly in the composite of death and myocardial infarction during 3 years of follow-up. At 6 months, there was a trend toward a lower unadjusted event rate in patients with drug-eluting stents than in those with bare-metal stents, with 13.4 fewer such events per 1000 patients. However, after 6 months, patients with drug-eluting stents had a significantly higher event rate, with 12.7 more events per 1000 patients per year (adjusted relative risk, 1.20; 95% confidence interval [CI], 1.05 to 1.37). At 3 years, mortality was significantly higher in patients with drug-eluting stents (adjusted relative risk, 1.18; 95% CI, 1.04 to 1.35), and from 6 months to 3 years, the adjusted relative risk for death in this group was 1.32 (95% CI, 1.11 to 1.57).. Drug-eluting stents were associated with an increased rate of death, as compared with bare-metal stents. This trend appeared after 6 months, when the risk of death was 0.5 percentage point higher and a composite of death or myocardial infarction was 0.5 to 1.0 percentage point higher per year. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Registries; Risk; Sirolimus; Stents; Sweden

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Thrombosis; Device Approval; Drug Delivery Systems; Humans; Myocardial Infarction; Paclitaxel; Prosthesis Design; Prosthesis Failure; Risk; Sirolimus; Stents; United States; United States Food and Drug Administration

Drug-eluting stents (DESs) are superior to bare metal stents (BMSs) in decreasing restenosis rates across a wide range of patient and lesion subsets. However, widespread utilization of DESs raises concerns with regard to risks of prolonged dual antiplatelet therapy, the potential for late adverse events such as late thrombosis, and cost. Vessel diameter and lesion length have been previously identified as predictors for restenosis for DESs and BMSs. This study compared the clinical outcomes of DESs versus BMSs in large coronary arteries (> or =3.5 mm). A cohort of 233 patients who underwent single-vessel angioplasty with DES implantation in large vessels was compared with 233 propensity-matched patients who received BMSs in vessels with similar reference vessel diameters. Clinical outcomes at 30 days, 6 months, and 1 year were compared between groups. Baseline clinical and procedural characteristics were similar. Target lesion revascularization and target vessel revascularization rates and the incidence of major adverse cardiac events were low and comparable between the 2 groups at all follow-up intervals. At 1 year, the primary outcome occurred in 8.5% of patients with DESs and 7.7% of patients with BMSs (p = 0.80). There were no episodes of subacute stent thrombosis or late thrombosis in either group. In conclusion, implantation of DESs in large coronary arteries confers no additional benefit compared with BMSs, and the 2 approaches are associated with equally favorable clinical outcomes at 1 year.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Disease; Equipment Design; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Survival Rate; Treatment Outcome; Tubulin Modulators

Restenosis after sirolimuseluting stent (SES) implantation has been reported to be usually focal. We report a case of focal in-stent stenosis discovered angiographically 6 months after SES implantation, despite continuation of dual antiplatelet medication. Continuity and uniform distribution of the struts were confirmed by intravascular ultrasound (IVUS). Material from the lesion was extracted and found to be an organized thrombus on histological inspection. This observation suggests that special attention should be paid to focal stenotic lesions, particularly when IVUS shows proper and circular stent expansion, since it might represent an atypical form of late stent thrombosis.

Topics: Aged, 80 and over; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Drug Delivery Systems; Female; Humans; Sirolimus; Stents; Ultrasonography, Interventional

With device improvements, more total occlusions have been crossed with a guidewire and balloon. However, true intraluminal/intrastent passage is not always accessed, which is not apparent on coronary angiography. In this study, using intravascular ultrasound as well as computed tomography, we demonstrated a crushed stent previously implanted outside the sirolimus-eluting stent, which resulted from subintimal (outside the stent) passage of a guidewire.

Topics: Adult; Coronary Angiography; Coronary Disease; Drug Delivery Systems; Equipment Failure; Humans; Male; Retreatment; Sirolimus; Stents; Tomography, X-Ray Computed; Ultrasonography, Interventional

Everolimus (Certican; Novartis Pharma AG, Basel, Switzerland) represents the latest generation of proliferation signal inhibitors (PSIs). Everolimus is indicated for use as an immunosuppressive drug in renal and heart transplantation. This report reflects the recommendations of the second German-Austrian Certican Consensus Conference, held in January 2006, for the clinical use of everolimus.

Topics: Angioedema; Coronary Disease; Drug Interactions; Drug Monitoring; Everolimus; Heart Diseases; Heart Transplantation; Humans; Hypertension; Immunosuppressive Agents; Lipids; Lung Diseases, Interstitial; Renal Insufficiency; Sirolimus; Skin Diseases; Transplantation, Homologous; Wound Healing

Recent sirolimus-eluting stent (SES) studies have suggested higher rates of restenosis in non-left anterior descending (LAD) artery lesions. The aim of this study was to evaluate differential vessel response (LAD versus non-LAD) to SES implantation using serial intravascular ultrasound (IVUS). A total of 94 patients who underwent SES implantation and serial (post-PCI and 8 months) 3-dimensional IVUS were enrolled from our database. Volumetric analysis was performed throughout the stent as well as the adjacent reference segment (up to 5 mm). Volume index (volume/length) was calculated for vessel (VVI), lumen (LVI), and plaque (PVI). Cross-sectional narrowing (CSN) was defined as neointimal area divided by stent area (%). With respect to the in-stent segment, VVI, PVI, and LVI at post-PCI were not significantly different between the LAD (n = 41) and non-LAD (n = 53) lesions. At follow up, however, maximum CSN was significantly greater in the non-LAD lesions (18.3 +/- 15.2% versus 12.2 +/- 10.0%; p = 0.029). At the proximal reference segment, the non-LAD lesions showed a significantly greater LVI decrease than the LAD lesions (p <0.05), primarily due to mild vessel shrinkage observed in the non-LAD lesions. There were no significant differences at the distal reference segment between the LAD and non-LAD lesions. This detailed IVUS analysis suggests that there are minimal differences in the vessel responses following SES implantation. These findings may have potential implications for mechanical and pharmacokinetic properties of next-generation drug-eluting stent technology.

Topics: Aged; Coronary Disease; Coronary Restenosis; Coronary Vessels; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Ultrasonography, Interventional

Studies focusing on short- and mid-term follow up support the beneficial role of sirolimus-eluting stents (SES) in the treatment of in-stent restenosis (ISR), yet no long-term safety and/or efficacy data are available.. Patients with ISR following bare-metal stenting (BMS) and treated with SES were prospectively studied. Baseline, procedural, and in-hospital data were appraised. The primary endpoint was the rate of major cardiovascular events (MACE) at long-term follow up (>9 months). Secondary endpoints were the individual contributors to MACE.. A total of 180 SES were implanted to treat 138 consecutive patients. Procedural success was achieved in all patients without in-hospital death, acute stent thrombosis, stroke, or urgent coronary artery bypass. During follow up, MACE occurred in 5.8% of patients at 6 months, 14.3% at 12 months, and 25% at 24 months. Specifically, all-cause mortality was 1.7% at 6 months, 3.5% at 12 months, and 4.8% at 24 months, for a total of 5 deaths. Target vessel revascularization occurred at 6, 12, and 24 months in 4.2%, 11.2%, and 15.9% of patients, respectively, while target lesion revascularization (TLR) alone accounted for 3.4% at 6 months, 9.6% at 12 months, and 11% at 24 months. Three case of myocardial infarction occurred during follow up (2.2%), without any surgical revascularization or stent thrombosis.. Treatment of ISR with SES appears safe and effective, even if a 10% annual rate of MACE can be expected, with a sizable portion of these due to apparently nontarget lesion events.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Follow-Up Studies; Humans; Immunosuppressive Agents; Prospective Studies; Prosthesis Design; Sirolimus; Stents

The aim of this study was to compare the initial and long-term outcomes of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with calcified lesions without performing rotational atherectomy. The subjects were 79 consecutive lesions (38 in the SES group and 41 in the BMS group) which were confirmed to have superficially calcified lesions by intravascular ultrasound. In all lesions, the stent was implanted after predilatation with a balloon. The patient characteristics were not different between the 2 groups. All procedures were successfully performed in both groups. Vessel area was significantly smaller in the SES group than in the BMS group (11.01 +/- 3.88 mm(2) versus 13.08 +/- 3.49 mm(2), P < 0.005), as was the lumen area (5.41 +/- 2.31mm(2) versus 6.48 +/- 2.04 mm(2), P < 0.005). Minimum stent area was significantly smaller in the SES group than in the BMS group (5.61 +/- 1.54 mm(2) versus 6.69 +/- 1.74 mm(2), P < 0.01). In cases in whom angiographic follow-ups were performed, the late loss was significantly smaller in the SES group than in the BMS group (0.19 +/- 0.49 mm versus 0.76 +/- 0.48 mm, P < 0.001). The restenosis rate was significantly lower in the SES group than in the BMS group (8.8% versus 33.3%, P < 0.05) and the TLR rate tended to be lower in the SES group (7.9% versus 19.5%). Stent thrombosis was not observed in either group. The results suggest that SES are more effective than BMS and can be used safely when treating calcified lesions if predilatation with a balloon is possible.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Calcinosis; Coronary Disease; Equipment Design; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Radiography; Retrospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography

Confirming complete neointimal coverage after implantation of a drug-eluting stent is clinically important because incomplete stent coverage is responsible for late thrombosis and sudden cardiac death. Optical coherence tomography is a high-resolution (approximately 10 microm) imaging technique capable of detecting a thin layer of neointimal hyperplasia (NIH) inside a sirolimus-eluting stent (SES) and stent malapposition. This investigation evaluated stent exposure and malapposition 3 months after SES implantation using optical coherence tomography in a different clinical presentations, such as acute coronary syndrome (ACS) and non-ACS. Motorized optical coherence tomographic pullback (1 mm/s) was performed at 3-month follow-up to examine consecutive implanted 31 SESs in 21 lesions in 21 patients (9 with ACS and 12 with non-ACS). NIH thickness inside each strut and percent NIH area in each cross section were measured. In total, 4,516 struts in 567-mm single-stented segments were analyzed. Overall, NIH thickness and percent NIH area were 29 +/- 41 microm and 10 +/- 4%, respectively. Rates of exposed struts and exposed struts with malapposition were 15% and 6%, respectively. These were more frequent in patients with ACS than in those with non-ACS (18% vs 13%, p <0.0001; 8% vs 5%, p <0.005, respectively). In conclusion, neointimal coverage over a SES at 3-month follow-up is incomplete in ACS and non-ACS. Our study suggests that dual antiplatelet therapy might be continued >3 months after SES implantation.

Topics: Adult; Aged; Aged, 80 and over; Anatomy, Cross-Sectional; Angina, Unstable; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Fibrinolytic Agents; Follow-Up Studies; Foreign-Body Migration; Humans; Male; Middle Aged; Myocardial Infarction; Retrospective Studies; Sirolimus; Stents; Surface Properties; Tomography, Optical Coherence; Tunica Intima

Advanced age independently predicts early and late mortality and major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI). Randomized clinical trials indicate that sirolimus-eluting stent (SES) implantation reduces target lesion revascularization (TLR), but there are limited data on the impact of age on outcomes following SES implantation in patients with coronary artery disease (CAD) in real-world practice.. A total of 333 CAD patients with 453 lesions were enrolled in this study. Subjects were divided into two groups according to age: a young group (< 65 years old, 244 patients with 369 lesions) and elderly group (= 65 years old, 89 patients with 113 lesions). Clinical follow-up and quantitative coronary angiography (QCA) were performed seven months after PCI.. Baseline clinical, demographic, angiographic, and procedural chararcteristics were similar in both groups, except that there were more female patients in the elderly group (21.3% vs 9.8%, P = 0.006). Primary success rate was similar in both groups (96.5% in young group vs 95.7% in elderly group, P > 0.05). During angiographic follow-up at 7 months, binary in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups (4.7% vs 1.8%; 9.7% vs 8.8%, P > 0.05 respectively). Both sub-acute and late thrombosis rates were similar in the two groups (0.3% vs 0.9% and 1.2% vs 0.9%, P > 0.05 respectively). TLR was not significantly different between the two groups (6.5% vs 3.5%; P = 0.246). The rates of bleeding, stroke, angina rehospitalization during the follow-up period were also similar in both groups (P > 0.05 respectively).. Despite a high-risk clinical profile, coronary SES implantation can be safely and effectively performed in elderly patients with a similar procedural success rate, a low complication rate, and excellent 7-month outcomes.

Topics: Adult; Age Factors; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Thrombosis; Drug Delivery Systems; Humans; Paclitaxel; Sirolimus; Stents

The emergence of drug-eluting stents (DES) has dramatically reduced the incidence of in-stent restenosis. This study was conducted to evaluate the safety and efficacy of sirolimus-eluting cobalt-chrome stents (Firebird 2) for treating patients with coronary artery disease.. Sixty-seven patients with de novo or non-stented restenostic coronary lesions were chosen to receive the Firebird 2 stent as the final treatment (Firebird 2 group). Another 49 consecutive patients were implanted with bare cobalt alloyed stents (Driver, Medtronic) within the previous six months and served as historical controls (control group). Baseline clinical characteristics, angiographic features, procedural results, 30-day, 6-month and 12-month clinical follow-up regarding the occurrence of major adverse cardiac events (MACE), as well as the primary endpoint of late lumen loss at 6-month angiographic follow-up were compared between the two groups.. The demographic characteristics were similar between the two groups despite more patients in the Firebird 2 group who underwent previous percutaneous coronary intervention (22.4% vs 8.2%, P = 0.0418) and who had diabetes mellitus (29.9% vs 12.2%, P = 0.0253). In the Firebird 2 group, the mean diameter of the reference vessel was smaller ((2.79 +/- 0.46) mm vs (2.98 +/- 0.49) mm, P = 0.0175) and more stents were implanted for each lesion (1.28 +/- 0.52 vs 1.10 +/- 0.30, P = 0.0060). Other angiographic, procedural results and the device success rate were similar between the two groups. The MACE rate at 30-day and 3-month was the same, but significantly fewer MACE occurred in the Firebird 2 group at 6- and 12-month follow-up (1.5% vs 12.2% at 6 month, P = 0.0168; 1.5% vs 26.5% at 12 month, P < 0.0001). The primary endpoint of late lumen loss at 6-month angiographic follow-up was significantly reduced in the Firebird 2 group (in-stent: (0.05 +/- 0.09) mm vs (0.98 +/- 0.61) mm; in-segment: (0.05 +/- 0.18) mm vs (0.72 +/- 0.59) mm; P < 0.0001) than the control group. One patient in the Firebird 2 group had in-segment restenosis (1.3%) while the rate in the control group (38.1%) was significantly higher, P < 0.0001. Intravascular ultrasound examination was performed in 70.1% of patients in the Firebird 2 group and revealed that the percentage of volumetric obstruction was (1.26 +/- 1.05)%. No stent thrombosis was observed in either group at 12-month follow-up.. The Firebird 2 sirolimus-eluting cobalt alloyed stent is safe and feasible in treating patients with coronary artery disease.

Topics: Aged; Angioplasty, Balloon, Coronary; Cobalt; Coronary Angiography; Coronary Disease; Coronary Thrombosis; Coronary Vessels; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Ultrasonography, Interventional

The safety and efficacy of drug-eluting stents (DES) implantation in unprotected left main (LM) bifurcation lesions has yet to be determined. The aim of the present report was to evaluate the long-term outcome following implantation of DES in unprotected LM bifurcation lesions.. We identified 70 consecutive patients treated with DES in unprotected LM bifurcation lesions from April 2003 to January 2005. Of them, 42 patients were treated with sirolimus-eluting stent (SES) and 28 patients were treated with paclitaxel-eluting stent (PES).. Stents to the left anterior descending and to the circumflex were implanted in 62 patients. During 1-year follow-up, 3 (4.3%) patients died of cardiac causes. One of them had myocardial infarction and adjudicated as possibly due to stent thrombosis. Angiographic follow-up was available in 80% of patients. The per lesion restenosis rate was 13.4% in the entire cohort, of which 10.7% occurred in lesions treated with SES and 16.1% in those treated with PES (P = 0.58). All restenosis was focal and occurred in the lesions treated with a stent with stent size to post-procedural reference vessel diameter ratio < 1.0 (17.6% vs 0, P = 0.04). The per patient target lesion revascularization rate at 1 year was 17.1%. One year survival free from major adverse cardiac events was 77.1%.. Treatment of LM bifurcation lesions using DES is a safe and feasible way with a low one-year mortality. The need for revascularization in 17% of patients demands for improvement.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Sirolimus; Stents

Patients with small coronary lesions are at increased risk for repeat interventions after coronary angioplasty and stenting. The efficacy of drug-eluting stents (DES) has been demonstrated to improve the outcomes of these patients and is a focus of interest. Currently, two platforms of DES are available (sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES)). However, it has less been known that DES, SES vs PES, is superior for the treatment of small coronary lesions.. In this retrospective study, 87 consecutive patients with 151 lesions underwent implantation of coronary SES (n = 68) and PES (n = 83). Quantitative coronary angiography (QCA) was performed at the time of stent implantation and subsequently at 8 months post-stenting. Small vessel disease was defined as lesions in vessels with diameter 2.5 mm measured by QCA. Major adverse cardiac events (MACE) including death, thrombosis, nonfatal myocardial infarction and target lesion revascularization (TLR) were compared between the two groups.. Baseline clinical characteristics and angiographic parameters were similar between the two groups. At clinical and angiographic follow-up, overall thrombosis rates were similar in both groups (0 vs 1.2%, P > 0.05). The TLR and in-segment restenosis were not significantly different (19.1% vs 25.3%; 10.3% vs 10.8%, P = 0.365 and P = 0.913 respectively) between the two groups. The in-stent restenosis rate, however, was significantly higher in the PES group (4.4% vs 21.7%; P = 0.002). Similarly, the late loss was significantly higher in the PES group ((0.140.38) mm vs (0.490.61) mm; P < 0.001).. In this small sample-size, non-randomized study, the data indicated that implantation of SES for the treatment of patients with small coronary lesion showed more favorable results in respect of restenosis compared with PES implantation.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Stents

As the number of recipients of heart transplantation grows over time and they survive longer, more are at risk for developing severe cardiac allograft vasculopathy and allograft dysfunction, which might lead to consideration for retransplantation. Clearly, outcomes following cardiac retransplantation are compromised, and with donor shortage, the selection of candidates must be judicious. Retransplantation appears most appropriate for those patients more than 6 months following original heart transplantation, who have severe cardiac allograft vasculopathy and associated left ventricular dysfunction, or allograft dysfunction and progressive symptoms of heart failure in the absence of acute rejection. Relative contraindications to transplantation (ie, advanced age, comorbidities, psychosocial issues) require thorough assessment when retransplantation is being considered.

Topics: Cardiovascular Diseases; Child; Contraindications; Coronary Disease; Heart Transplantation; Humans; Immunosuppressive Agents; Prognosis; Reoperation; Risk Factors; Sirolimus; Survival Analysis; Time Factors; Transplantation, Homologous; Treatment Outcome

To compare the cost-effectiveness ratios of sirolimus-eluting stents (SES) with bare-metal stents (BMS) under two perspectives: the "supplementary medical system" (health plans and private patients) and the public health (SUS) system.. A decision-analytic model using three different therapeutic strategies for coronary lesions: percutaneous coronary intervention (PCI) with BMS; with SES; or with BMS followed by SES to treat symptomatic restenosis. Study endpoints were one-year event-free survival and life expectancy. Decision trees were constructed using the results of published registries and clinical trials.. One-year restenosis-free survival was 92.7% with SES and 78.8% with BMS. Estimated life expectancy was very similar for all the strategies, ranging from 18.5 to 19 years. Under a nonpublic perspective, the cost difference in the first year between BMS and SES was R$3,816, with an incremental cost-effectiveness ratio of R$27,403 per event avoided in one year. Under the SUS perspective, the cost per event avoided in one year was R$47,529. In the sensitivity analysis, probability of restenosis, risk reduction expected with SES, the price of the stent and cost of treating restenosis were all important predictors. In the Monte Carlo simulation, data per years of life saved showed very high cost-effectiveness ratios.. In the Brazilian model, the cost-effectiveness ratios for SES were elevated. The use of SES was more favorable for patients with high risk of restenosis, as it is associated with elevated costs in restenosis management of and under a nonpublic perspective.

Topics: Angioplasty, Balloon, Coronary; Brazil; Coronary Disease; Coronary Restenosis; Cost-Benefit Analysis; Disease-Free Survival; Drug-Eluting Stents; Health Care Costs; Humans; Immunosuppressive Agents; Sirolimus; Stents; Treatment Outcome

This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients.. A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent.. All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis.. There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61).. In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.

Topics: Aged; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Sirolimus; Stents; Treatment Outcome

To evaluate the short and long-term therapeutic efficacy of drug-eluting stents (Firebird) for the treatment of coronary artery disease.. From Nov. 2003 to Jan. 2005, 501 Firebird stents were implanted in 410 patients with 460 lesions. All patients were administered with aspirin and clopidogrel before and after the procedures. Follow-up was made by telephone or interview, 102 out of 410 patients were followed up by angiography.. The procedure success rate was 99.5%. Stent thrombosis occurred in one patient during the procedure and one sudden death developed 10 hours after the procedure in hospital. The major adverse cardiac event (MACE, including death, acute myocardial infarction and target lesion revascularization) rate during hospitalization was 0.2% (1/410). The MACE rate was 4.3% (16/376) and the stent thrombosis rate was 1.1% (4/376) during clinical follow-up of 376 patients (12.8 +/- 3.2 months). The angiographic restenosis rate in 102 patients with 122 lesions was 9.8% (12/122).. Firebird drug-eluting stent could be used safely and effectively in patient with coronary heart disease.

Topics: Aged; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Retrospective Studies; Sirolimus; Treatment Outcome

We sought to assess the frequency and causes of stent thrombosis in diabetic and nondiabetic patients after implantation of sirolimus-eluting stents.. Safety concerns about late stent thrombosis have been raised, particularly when drug-eluting stents are used in less highly selected patients than in randomized trials.. The EVASTENT study is a matched multicenter cohort registry of 1,731 patients undergoing revascularization exclusively with sirolimus stents; for each diabetic patient included (stratified as single- or multiple-vessel disease), a nondiabetic patient was subsequently included. Patients were treated with aspirin + clopidogrel for at least 3 months and were followed for 465 (range 0 to 1,062) days (1-year follow-up in 98.5%). The primary end point was a composite of stent thrombosis (according to Academic Research Consortium definitions), cardiovascular death, and nonfatal myocardial infarction (major adverse cardiac events [MACE]).. During follow-up, MACE occurred in 78 patients (4.5%), cardiac death in 35 (2.1%), and stent thrombosis in 45 (2.6%): 30 definite, 23 subacute, and 22 late, including 9 at >6 months. In univariate analysis, the 1-year stent thrombosis rate was 1.8 times higher in diabetic than in nondiabetic patients (3.2% vs. 1.7%; log rank p = 0.03), with diabetic patients with multiple-vessel disease experiencing the highest rate and nondiabetic single-vessel disease patients the lowest (4.3% vs. 0.8%; p < 0.001). In multivariate analysis, in addition to the interruption of antithrombotic treatment, independent stent thrombosis predictors were previous stroke, renal failure, lower ejection fraction, calcified lesion, length stented, and insulin-requiring diabetes.. The risk of sirolimus stent thrombosis is higher for multiple-vessel disease diabetic patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Blood Vessel Prosthesis Implantation; Case-Control Studies; Coronary Disease; Diabetic Angiopathies; Disease-Free Survival; Drug Delivery Systems; Female; Humans; Insulin; Male; Middle Aged; Prospective Studies; Registries; Risk Factors; Sirolimus; Stents; Thrombosis; Treatment Outcome

Randomized trials of drug-eluting stents (DES) excluded patients with severe renal insufficiency. We sought to evaluate the impact of baseline renal function on clinical outcomes in recipients of coronary DES.. We retrospectively reviewed our hospital databases to identify consecutive patients who underwent DES implantations between May 2003 and December 2004, subgrouped among 4 ranges of glomerular filtration rate (GFR) between > or = 90 ml per minute and < 30 ml per minute, in 30 ml per minute decrements, and 1 group treated with long-term dialysis. Clinical follow up was obtained at 6 months, 1 year and annually thereafter.. Our study group included 2,758 patients with long-term outcomes recorded over a mean follow up of 706 +/- 273 days. The rates of in-hospital adverse events increased significantly as GFR decreased, though no major adverse event occurred among the dialyzed patients. Actuarial survival analyses up to 2 years revealed significant between-groups differences in rates of major adverse cardiac events (MACE) and death (both p < 0.001), while the differences in target vessel revascularization (TVR) rates did not reach statistical significance (p = 0.069). By Cox regression analysis, a GFR < 60 ml per minute remained a significant predictor of 2-year mortality (p < 0.001) and MACE (p < 0.001), but not TVR (p = 0.839).. In conclusion, low rates of TVR were observed over 2 years in DES recipients with a wide range of renal function. Low rates of TVR were countered by high rates of death and MACE among renally insufficient patients over the long term.

Topics: Aged; Coronary Disease; Drug Delivery Systems; Female; Follow-Up Studies; Glomerular Filtration Rate; Humans; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Predictive Value of Tests; Proportional Hazards Models; Renal Dialysis; Retrospective Studies; Sirolimus; Stents; Survival Analysis; Thrombosis

Acute and long-term results after sirolimus-eluting stent (SES) implantation of proximal left anterior descending coronary artery (LAD) disease were evaluated.. Although SES has been used increasingly for the treatment of LAD disease, data regarding their safety and efficacy in a real-world population are limited.. We investigate the short- and long-term results in 966 patients who underwent SES implantation for stenosis of proximal LAD.. The procedural success rate was 97.6%, and procedural non-Q-wave myocardial infarction (MI) rate was 14.5%. In-hospital major complications occurred in five patients (0.5%), including three deaths and two Q-wave MIs. During follow-up (20.4 +/- 8.9 months), there were 16 deaths (1.7%; 10 cardiac, 6 noncardiac), 2 Q-wave MIs, and 22 target lesion revascularizations (2.3%). Late stent thrombosis occurred in two patients (0.2%), 14 and 23 months after the procedure. The event-free survival rates for cardiac death/Q-wave MI were 98.6% +/- 0.4% at 1 year and 97.8% +/- 0.6% at 2 years. The cumulative probabilities of survival without major adverse cardiac events (MACE) were 96.7% +/- 0.6% at 1 year and 95.4% +/- 0.8% at 2 years. In multivariate analysis, stented length (HR 1.04, 95%CI 1.01-1.07, P = 0.009) and infarct-related artery (HR 5.18, 95%CI 1.09-24.64, P = 0.039) were independently related to cardiac death/Q-wave MI. In addition, stented length (HR 1.04, 95%CI 1.02-1.06, P < 0.001) and left ventricular dysfunction (HR 2.66, 95%CI 1.07-6.63, P = 0.036) were significant independent predictors of MACE.. SES implantation for proximal LAD disease appears safe and effective in a real-world population, and the independent predictors of MACE included stented length and left ventricular dysfunction.

Topics: Adult; Aged; Aged, 80 and over; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Electrocardiography; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Postoperative Complications; Prognosis; Retrospective Studies; Sirolimus; Stents; Time Factors

Incomplete stent apposition (ISA) is frequently observed after sirolimus-eluting stent (SES) implantation. This study investigated the incidence, morphological features, and possible mechanisms of this phenomenon.. Fifty-two lesions in 47 eligible patients were treated with SES and serial intravascular ultrasound (IVUS) assessment at the time of post-intervention and 8-month follow-up. ISA was carefully identified from the IVUS images of these lesions. Specifically, quantitative two dimensional IVUS analysis was performed if the lesions demonstrated ISA, including routine IVUS parameters as well as other measurements related to ISA.. Overall, ISA was observed in 13 lesions (25.0%) at follow-up. Persistent ISA (n = 6, 11.5%), defined as ISA consistently observed both at post-intervention and follow-up, and late-acquired ISA (n = 7, 13.5%)were systematically compared. Eighty-three percent of cases of persistent ISA were located around the stent edges, whereas all cases of late-acquired ISA were in the stent body. In the persistent ISA group, no serial changes were observed in the lumen area or external elastic membrane area (EEMA) from post-intervention to follow-up. However, in the late-acquired ISA group, EEMA and lumen area significantly increased from post-intervention to follow-up (EEMA: 13.4 +/- 3.2 vs 17.6 +/- 3.3 mm2, respectively, p < 0.0001 ; lumen area: 6.7 +/- 1.4 vs 9.2 +/- 1.8 mm2, respectively, p = 0.004). No adverse clinical events were observed in either group.. ISA was frequently observed during and after SES implantation in clinical practice. No clinical disadvantages were observed during 16 month clinical follow-up periods. Positive remodeling may potentially cause late-acquired ISA.

Topics: Aged; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Disease; Coronary Vessels; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prognosis; Prosthesis Failure; Sirolimus; Stents; Ultrasonography, Interventional

Diabetes mellitus is associated with an increased risk of restenosis, stent thrombosis, and death after percutaneous coronary interventions. Little is known about the late outcome of patients with diabetes mellitus who receive drug-eluting stents (DES).. This study includes a prospective database of 2557 consecutive patients with coronary artery disease who underwent DES implantation in native coronary arteries in 2 German hospitals. The primary end points of the study were mortality and clinical restenosis (target lesion revascularization). Secondary end points were binary angiographic restenosis, stent thrombosis, and the composite of death or myocardial infarction.. Within a median follow-up period of 2.3 years, stent thrombosis occurred in 14 patients with diabetes versus 17 patients without diabetes: 3-year Kaplan-Meier estimates of stent thrombosis were 2.2% versus 1.0%, with a relative risk of 2.17 (95% CI 1.09-4.33, P = .027). Binary angiographic restenosis was observed in 87 patients with diabetes and 208 patients without diabetes (15.2% vs 13.5%, P = .32). Target lesion revascularization was needed in 93 patients with diabetes and 219 patients without diabetes (12.8% vs 12.0%, P = .56). There were 93 deaths among diabetic patients versus 118 deaths among nondiabetic patients: 3-year Kaplan-Meier estimates of mortality were 17.3% versus 7.8%, with a relative risk of 2.10 (95% CI 1.61-2.74, P < .001). After adjustment in the multivariable analyses, diabetes remained an independent predictor of 3-year mortality with a hazard ratio of 1.63 (95% CI 1.23-2.17, P < .001), but not of angiographic (P = .92) or clinical restenosis (P = .97).. Although DES attenuate diabetes-associated excess risk of restenosis, risk of death and thrombotic complications remains higher in patients with diabetes than in nondiabetic patients in the DES era.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Diabetic Angiopathies; Follow-Up Studies; Humans; Immunosuppressive Agents; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Risk Factors; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Patients with metabolic syndrome (MS) are at increased risk for cardiovascular events. Although the number of patients with MS requiring coronary revascularization is increasing rapidly, the impact of MS on clinical events and restenosis in patients who undergo stent placement is not well defined. Seven hundred thirty-four consecutive patients with 734 de novo coronary lesions (<50 mm lesion length, reference vessel diameter <3.5 mm) were enrolled in this study. Four hundred thirty-seven patients were treated with bare-metal stents, and 297 patients were treated with sirolimus-eluting stents. Patients with bifurcation lesions, left main lesions, and ST-segment-elevation myocardial infarctions were excluded from the study. Patients were categorized into 3 groups: those with (1) diabetes mellitus (DM), (2) MS without DM, and (3) no MS and no DM. MS was defined according to American Heart Association and National Heart, Lung, and Blood Institute criteria (the presence of > or =3 of the following criteria: obesity, hypertension, hypertriglyceridemia, low high-density lipoprotein cholesterol, and increased fasting glucose). Clinical follow-up was performed for > or =1 year (mean 27.5 +/- 18.1 months). One hundred sixty-four patients (22%) had DM, 180 patients (25%) had MS without DM, and 390 patients (53%) had no MS and no DM. Baseline clinical and angiographic parameters were comparable among the 3 groups, including lesion length and reference vessel diameter. In patients treated with bare-metal stents, the rates of major adverse cardiac events (MACEs) at 12 months were 14% in patients without DM or MS, 18% in those with MS but no DM, and 33% in those with DM (p = 0.046). In patients treated with sirolimus-eluting stents, the MACE rates were 3% in patients without DM or MS, 4% in those with MS, and 13% in those with DM (p = 0.034). DM (odds ratio 2.14, 95% confidence interval 1.48 to 3.07, p <0.001) and bare-metal stent (odds ratio 2.51, 95% confidence interval 1.49 to 4.22, p <0.001) implantation were independent predictors of MACEs during follow-up, whereas MS was not predictive. Similarly, MS was not a predictor of target lesion revascularization. In conclusion, patients with MS did not have an increased risk for target lesion revascularization or a greater MACE rate compared with control patients during a 12 month follow-up period after bare-metal or drug-eluting stent placement. In contrast, DM is associated with significantly increased event rates.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetic Angiopathies; Female; Humans; Immunosuppressive Agents; Male; Metabolic Syndrome; Middle Aged; Retrospective Studies; Sirolimus; Stents

We compared the 1-year outcome of coronary revascularization with sirolimus-eluting stents (SESs) or coronary artery bypass grafting (CABG) for coronary artery disease involving the left anterior descending artery (LAD) in diabetic patients according to their retinal status: no diabetic retinopathy (NDR) and diabetic retinopathy (DR).. Between April 2004 and October 2005, 220 consecutive patients with coronary artery disease involving the LAD underwent implantation of SESs; of these, 25 patients had NDR and 54 had DR. For each group, we included a comparison group of diabetic patients who had undergone CABG and had the same retinal status.. During 1 year after revascularization, five cardiac events (cardiac death, myocardial infarction, and repeat revascularization) were noted in NDR-SES patients, four in NDR-CABG, 24 in DR-SES, and eight in DR-CABG patients. Most cardiac events were repeat revascularizations. Kaplan-Meier estimates of the incidence of cardiac events at 1 year were 21.1%, 11.4%, 44.0%, and 14.0%, respectively. Kaplan-Meier curves for cardiac events in SES patients were different from those of CABG patients for the DR group (p = 0.003), but not NDR groups. After adjustments for the potential confounders, the hazard ratio of cardiac events in DR-SES patients was 2.8 (95% confidence interval, 1.1 to 6.9; p = 0.02).. Compared with SES implantation, CABG is more suitable for revascularization in patients with coronary artery disease involving the LAD and DR.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Diabetic Retinopathy; Female; Humans; Male; Middle Aged; Retrospective Studies; Sirolimus; Stents

The aim of the study was to compare long-term results of intracoronary implantation of drug-eluting stents (DES) and bare metal stents (BMS) in patients suffering from transplant coronary artery disease (TxCAD).. We performed a retrospective analysis of all intracoronary stent implantations for TxCAD among subjects with at least one follow-up coronary angiography. We identified 28 sirolimus-eluting DES (n = 17) patients, 24 BMS (n = 13 patients), and both DES and BMS (n = 7 patients) implantations among 23 recipients. Mean follow-up after DES was 14 months and after BMS implantation, 20 months. We compared the occurrence of in-stent restenosis (ISR), and patient survival in the context of risk factors that were identified separately for each stent type. Significance was assessed using the log-rank, chi(2) and Mann-Whitney U test.. There were 2 (7%) ISR among DES versus 14 (58%) ISR among BMS (P = .0002) patients, with a longer time of freedom from IRS after DES implantation (P = .022). There were three deaths (18%) among DES, four (31%) with BMS, and one (14%) with DES and BMS (P = NS). Left anterior descending artery was the place of DES implantation in 17 (61%) versus 10 (42%) of BMS cases (P = NS). Risk factor profile was comparable except for a higher age at the time of transplantation (46 +/- 7 vs 41 +/- 6 years; P = .011) and stent implantation (54 +/- 7 vs 49 +/- 6 years; P = .0002) for DES.. Favorable long-term results of sirolimus-eluting stents over BMS implanted for TxCAD suggested their preferential use in heart transplant recipients.

Topics: Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Heart Transplantation; Humans; Immunosuppressive Agents; Metals; Retrospective Studies; Sirolimus; Stents; Survival Analysis; Treatment Outcome

The objective of our study is to evaluate the long-term results of coronary angioplasty using active stents in a population of diabetic patients. This is a single-centre study on a consecutive series of 122 diabetic patients (40% of them insulin dependent) who between January 2003 and June 2004 underwent angioplasty with implantation of an active stent (sirolimus Cypher(R) or paclitaxel Taxus(R)) for one or more de novo coronary lesions. The mean age was 66 +/- 10 years and a total of 171 coronary segments were treated. The lesions treated were complex (type B2 + C) in 69% of the cases, with a mean stent length of 21 +/- 15 mm and a mean stent diameter of 2.7 +/- 0.3 mm. Follow-up at two years for 119 patients (3 lost to follow-up) revealed a mortality rate of 4.2%, and a myocardial infarction rate of 7.5%. The rates for revascularisation of the target lesion and the target vessel were 11.4% and 17.8% respectively, with a rate of major cardiac events of 22.5%. During this period, 25.2% of the patients underwent revascularisation of at least one vessel. This study confirms the benefits of using active stents for revascularisation of the target lesion in diabetic patients. However, it serves as a reminder that the progression of coronary atheroma is global, and that the prognosis for these patients depends essentially upon managing risk factors, and particularly on controlling their diabetes.

Topics: Aged; Coronary Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Sirolimus; Survival Analysis; Treatment Outcome

Topics: Adrenal Cortex Hormones; Adult; Aged; Azathioprine; Coronary Disease; Female; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Mycophenolic Acid; Sirolimus; Transplantation, Homologous

Negative emotions have an adverse effect on cardiac prognosis. We investigated whether social inhibition (inhibited self-expression in social interaction) modulates the effect of negative emotions on clinical outcome following percutaneous coronary intervention (PCI).. Eight hundred and seventy-five consecutive patients from the RESEARCH registry (Erasmus Medical Centre, Rotterdam) completed depression, anxiety, negativity (negative emotions in general), and social inhibition scales 6 months following PCI. The endpoint was major adverse cardiac event (MACE-death, myocardial infarction, coronary artery bypass graft (CABG), or PCI) at 9 months following assessment. There were 100 MACE; patients who were high in both negativity and inhibition were at increased risk of MACE (38/254=15%) when compared with high negativity/low inhibition patients (13/136=10%; P=0.018). Depression (P=0.23) or anxiety (P=0.63) did not explain away this moderating effect of inhibition. High negativity/high inhibition (HR=1.92, 95%CI 1.22-3.01, P=0.005) and previous CABG (HR=1.90, 95%CI 1.04-3.47, P=0.038) were independent predictors of MACE. Patients with high negativity but low inhibition were not at increased risk (P=0.76). High negativity/high inhibition also independently predicted death/MI (n=20) as a more specific endpoint (HR=5.85, P=0.001).. The interaction effect of social inhibition and negative emotions, rather than negative emotions per se, predicted poor clinical outcome following PCI. Social inhibition should not be overlooked as a modulating factor.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Emotions; Female; Humans; Immunosuppressive Agents; Inhibition, Psychological; Interpersonal Relations; Male; Middle Aged; Prognosis; Risk Factors; Sirolimus; Stents

Drug-eluting stents (DES) constitute a major breakthrough in restenosis prevention after initial percutaneous coronary intervention (PCI). Target lesion and vessel revascularization rates of <10% at six months follow-up represent a significant medical advance. Many cardiologists consider it reasonable to assume that PCI using DES ought to be considered equivalent, if not superior, to bypass surgery. The argument made is that in previous randomized clinical trials comparing PCI to coronary artery bypass grafting, restenosis was the determining factor favoring surgery, an event that clinical experience suggests is no longer as frequent. In the absence of a definitive clinical trial to support this view, how should the prudent, cutting edge cardiologist evaluate the data and manage their patients?

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Humans; Paclitaxel; Sirolimus; Stents

This study was conducted to reevaluate the significance of angiographic late loss and to assess the agreement between new proposed neointimal volumetric measurements derived from quantitative coronary angiography (QCA) and standard intravascular ultrasound (IVUS)-based parameters. Neointimal volumetric measurements may better estimate the magnitude of neointimal growth after stenting than late loss. In 56 in-stent segments (27, everolimus; 29, bare metal) in the SPIRIT FIRST study, we compared QCA measures with the corresponding IVUS parameters. Two IVUS-late loss models were derived from minimal luminal diameter (MLD) using either a circular model or a so-called projected MLD. QCA-neointimal volume was calculated as follows: stent volume (mean area of the stented segment x stent length) at post procedure - lumen volume (mean area of the stented segment x stent length) at follow-up (the stent length either from nominal stent length or the length measured by QCA). Videodensitometric neointimal volume was also evaluated. Each of the three neointimal volume and percentage volume obstruction by QCA showed significant correlation with the corresponding IVUS parameters (r = 0.557-0.594, P < 0.0001), albeit with a broad range of limits of agreement. Late loss and volumetric measurements by QCA had a broader range of standard deviation than those by IVUS. QCA-volumetric measurements successfully confirmed the efficacy of everolimus-eluting stents over bare metal stents (P < 0.05). Our proposed QCA volumetric measurements may be a practical surrogate for IVUS measurements and a discriminant methodological approach for assessment of treatment effects of drug-eluting stents.

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Everolimus; Female; Humans; Linear Models; Male; Randomized Controlled Trials as Topic; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

We investigated early and mid-term clinical and angiographic outcomes of patients who had de novo ostial left anterior descending coronary artery (LAD) lesions that were treated with drug-eluting stents (DESs) or bare metal stents (BMSs). We identified 43 consecutive patients who underwent percutaneous intervention for isolated de novo ostial LAD lesions with implantation of DESs and compared them with 43 patients who had similar lesions that were treated with BMSs. All stents were successfully implanted. There were no significant differences with respect to major in-hospital complications between the 2 groups. One patient in the BMS group died during hospitalization. Non-Q-wave myocardial infarction occurred in 2 patients (4.7%) in the DES and in 1 patient (2.3%) in the BMS group. At 9-month follow-up, 3 patients (7%) in the DES group and 11 (25.6%) in the BMS group underwent target lesion revascularization (p = 0.038); major adverse cardiac events were less frequent in the DES than in the BMS group (9.3% vs 32.6%, p = 0.015). Angiographic follow-up was available in 82% of patients in the DES group and 75% of those in the BMS group (p = 0.6) and showed lower binary restenotic rates (5.7% vs 31.3%, p = 0.01) and smaller late loss (0.30 +/- 0.81 vs 1.23 +/- 0.93 mm, p = 0.0001) in the DES group. In conclusion, DES implantation in de novo ostial LAD lesions appears safe and effective and is associated with a significant decrease in restenotic rates compared with historical experience with BMSs.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Stents

An intraluminal echolucent tissue, dubbed "black hole," has been identified by intravascular ultrasonography after intracoronary brachytherapy. This study reports the characteristics and incidence of the black hole in patients treated with drug-eluting stent implantation using a sirolimus-eluting stent (SES). We included intravascular ultrasound data from the Compassionate Use of Sirolimus-Eluting Stent (SECURE, n = 61 lesions) registry, a study involving patients in whom previous brachytherapy had failed, and the DIABETES trial (n = 165 lesions), a multicenter, randomized study comparing SES versus bare metal stents in diabetic patients. Intravascular ultrasound follow-up was scheduled at 8 months (SECURE trial, post-brachytherapy population) and 9 months (DIABETES trial). In the SECURE population, a black hole was observed in 10 patients (19.6%). Seven black hole segments had significant intimal hyperplasia (> 10%). A black hole accounted for 27% of total intraluminal tissue. In the DIABETES trial, 2 patients (2.5%) in the SES group and none in the bare metal stent group showed echolucent intimal hyperplasia. In conclusion, a black hole occurred frequently after implantation of a SES in patients in whom intracoronary brachytherapy had previously failed. Black holes were also identified in a nonirradiated population, although the incidence was lower than in the post-brachytherapy patients. Bare metal stents were not associated with this phenomenon.

Topics: Adult; Aged; Aged, 80 and over; Angina Pectoris; Brachytherapy; Coronary Disease; Coronary Vessels; Diabetic Angiopathies; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

Drug-eluting stent (DES) could obviously reduce in-stent restenosis, which has been proved by international multi-center clinical trials. However, the types of the lesions for stenting were highly selected in these trials. Up to now, there has been no large scale study on the effect of DES in treating complex lesions in real world. Although REALITY trial was just reported during American College of Cardiology Congress 2005, the entry criteria for lesions were limited to one or two de novo lesions. This study was conducted to compare the short- and mid-term clinical outcomes between sirolimus-eluting stent (CYPHER stent) and paclitaxel-eluting stent (TAXUS stent) in patients with complex lesion.. This is a retrospective study. From April 2002 to June 2004, a total of 1061 patients were treated with DES in Fu Wai Hospital, of which, 611 patients (642 lesions with 698 CYPHER stents) were in CYPHER group, and 450 patients (534 lesions with 600 TAXUS stents) were in TAXUS group. There was no significant difference in clinical data and lesion types between CYPHER group and TAXUS group.. Success rates of stent implantation were 99.2% and 98.8% in CYPHER and TAXUS stent groups respectively. The major adverse cardiac events (MACE) during in-hospital and 6-8-month follow-up were 0.7% and 2.3% in CYPHER stent group versus 1.3% and 3.2% in TAXUS stent group. There was no significant difference in MACE rate between these two groups. Restenosis rate was a little higher in TAXUS stent group than that in CYPHER stent group (14.0% vs 7.3%), but there was no significant difference. The incidence of acute occlusion of side branch after implanting DES in main vessel was 6.9% in CYPHER group and 11.9% in TAXUS group (P < 0.05).. CYPHER and TAXUS DES were safe and effective in patients with complex lesion. Clinical outcomes of CYPHER stent were better than TAXUS stent in bifurcation lesions. There was an increasing tendency in restenosis rate and late thrombosis in TAXUS group as compared with that of CYPHER group.

Topics: Coronary Disease; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Stents

Topics: Adult; Aged; Coronary Disease; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus; Stents; Thrombosis

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Diseases; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Humans; Radiography; Sirolimus; Stents

This retrospective analysis compared clinical outcomes of patients who underwent stenting with > or =3 sirolimus-eluting stents (SESs) with those who received a single SES. SES (Cypher) implantation for single vessels is proved to be effective and durable, but knowledge regarding the safety and effectiveness of multiple stenting with SESs is currently limited. In total, 929 consecutive patients who received SESs were identified; 63 received > or =3 SESs (multi group) and 866 received 1 SES (single group). The multi group had more non-Q-wave myocardial infarctions (MIs) during the index hospitalization (p = 0.02). At 30-day follow-up, death, Q-wave MI, subacute thrombosis, and major adverse cardiac events were higher in the multi group than in the single group. At 6 months, death, Q-wave MI, target lesion revascularization, and major adverse cardiac events continued to be higher in the multi group. Using multivariate analysis, > or =3 SES implantations, American College of Cardiology/American Heart Association type C lesions, and cardiogenic shock were identified as independent predictors for 6-month major adverse cardiac events. In addition, patients in the multi group had a significantly lower survival rate than patients in the single group (p <0.0001). Patients who required > or =3 SES implantations developed increased periprocedural non-Q-wave MI and worse adverse clinical outcomes at 30 days and 6 months compared with patients who required a single SES implantation. In conclusion, when patients present with multiple coronary lesions, percutaneous coronary intervention with multiple SESs should be undertaken with great caution.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; District of Columbia; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Retrospective Studies; Sirolimus; Stents; Survival Rate; Time Factors; Treatment Outcome; Vascular Resistance

Patients with chronic renal insufficiency (CRI) have higher rates of target vessel revascularization and mortality. The efficacy of sirolimus-eluting stents (SESs) to improve the clinical outcomes of these patients is unknown. We investigated the effect of SESs versus bare metal stents (BMSs) on outcomes of patients with CRI. Among the first 1,522 patients treated with SESs, 76 were identified with CRI and 1,446 without CRI. In-hospital and 1- and 6-month clinical outcomes were compared with 153 patients with CRI who were treated with BMSs. Patients with CRI were older, hypertensive, and diabetic and had more previous myocardial infarctions, revascularizations, and decreased left ventricular function (p <0.001). These patients had more saphenous vein graft lesions, were treated with more debulking devices (p <0.003), and had higher rates of in-hospital complications and mortality (p <0.001) compared with those without CRI. Among patients with CRI, treatment with SESs did not affect clinical outcomes at 1 month and was associated with lower incidences of target vessel revascularization (7.1% vs 22.1%, p = 0.02) at 6 months but did not affect other events, including mortality (16.7% vs 14.7% p = 0.89), compared with BMSs. However, treatment with SESs in patients without CRI was associated with significantly lower rates of major adverse cardiac events at 6 months (p <0.001). In conclusion, percutaneous coronary intervention with SESs in patients with CRI is associated with low rates of repeat revascularization compared with BMSs but has no effect on mortality at 6 months.

Topics: Aged; Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Case-Control Studies; Coronary Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Design; Renal Insufficiency, Chronic; Retrospective Studies; Sirolimus; Stents; Survival Rate; Treatment Outcome

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Stenosis; Humans; Image Processing, Computer-Assisted; Male; Sirolimus; Stents; Tomography, Spiral Computed; Tomography, X-Ray Computed

The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice.. Between April 2002 and September 2005, data were collected on 15,157 patients who underwent implantation of > or =1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7+/-11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18,295 lesions were treated (20,503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade <3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months.. This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

Topics: Aged; Angioplasty, Balloon, Coronary; Aspirin; Cause of Death; Clopidogrel; Comorbidity; Coronary Disease; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Drug Implants; Female; Fibrinolytic Agents; Follow-Up Studies; Humans; Internet; Male; Middle Aged; Myocardial Infarction; Product Surveillance, Postmarketing; Registries; Risk Factors; Sirolimus; Stents; Thrombosis; Ticlopidine; United States

The purpose of this study was to examine the two-year clinical outcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) study.. The SIRIUS study was a double-blinded randomized study which demonstrated that sirolimus-eluting stents (SES) significantly improved angiographic results (at 8 months) and clinical outcomes (at 9 and 12 months) compared with bare-metal stents (BMS).. Patients with de novo native coronary artery lesions randomized to either SES (533 patients) or control BMS (525 patients) were followed for two years.. Between one and two years, there were infrequent additional clinical events that were equally distributed between the sirolimus and control groups. After two years, target lesion revascularization was 5.8% and 21.3% in SES and control patients, respectively (p < 0.001), and major adverse cardiovascular events and target vessel failure rates were 10.1% versus 24.4% and 12.0% versus 26.7%, respectively (p < 0.0001 for both). There were no differences in death, myocardial infarction, and stent thrombosis between the two groups.. Clinical outcomes two years after implantation of SES continue to demonstrate significant reduction in the need for repeat target lesion (and vessel) revascularization compared with BMS without evidence for either disproportionate late restenosis or late stent thrombosis.

Topics: Coronary Angiography; Coronary Disease; Double-Blind Method; Follow-Up Studies; Humans; Incidence; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Sirolimus; Stents; Thrombosis; Treatment Outcome

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Pilot Projects; Registries; Sirolimus; Stents

To evaluate coronary artery atherosclerotic plaque characteristics and changes post coronary stenting by optical coherence tomography (OCT).. OCT images were obtained in 22 diseased coronary vessels after coronary angiography or percutaneous coronary interventions (PCI) in 20 patients and in 23 stents [7 sirolimus-eluting stents (SES) follow up at 4-29 months post stenting and 8 bare mental stents (BMS) at 4-35 months post stenting, 8 stents immediately after PCI].. All 22 vessels and 23 stents OCT images were successfully acquired. Two thromboses, 8 fibrous, 9 lipid-rich and 3 calcium plaques as well as 3 plaque ruptures were visualized by OCT. No significant neointimal proliferation and restenosis were found in SES stents and some struts were not covered with neointima even at 29 months post stenting. Significant neointimal proliferation on surfaces of stent struts were visualized in all 8 BMS stents and restenosis was detected in 3 BMS stents. OCT images obtained immediately after PCI showed that 3 stents were well positioned, tissue prolapse between coronary stent struts occurred in 4 stents and stent dissociation with vessel wall could be seen in 1 stent.. OCT imaging can clearly visualize different types of atherosclerotic plaques. By providing detailed information on plaque characteristics, this technique might help cardiologists in choosing suitable stents and guiding preventive therapy for patients with coronary heart disease.

Topics: Adult; Aged; Coronary Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Radiography; Sirolimus; Stents; Tomography, Optical Coherence

This study sought to investigate whether the anatomical location of the disease carries prognostic implications in patients undergoing drug-eluting stent (DES) implantation for the left main coronary artery (LMCA) stenosis.. Liberal use of DES, compared with a bare metal stent (BMS), has resulted in an improved outcome in patients undergoing LMCA intervention. However, the overall event rate in this subset of patients remains high, and alternative tools to risk-stratify this population beyond conventional surgical risk status would be desirable.. From April 2002 to June 2004, 130 patients received DES as part of the percutaneous intervention for LMCA stenoses in our institution. Distal LMCA disease (DLMD) was present in 94 patients. They were at higher surgical risk and presented with a greater coronary disease extent compared with patients without DLMD.. After a median of 587 days (range 368 to 1,179 days), the cumulative incidence of major adverse cardiac events (MACE) was significantly higher in patients with DLMD at 30% versus 11% in those without DLMD (hazard ratio [HR] 3.42, 95% confidence interval [CI] 1.34 to 9.7; p = 0.007), mainly driven by the different rate of target vessel revascularization (13% and 3%; HR 6, 95% CI 1.2 to 29; p = 0.02). After adjustment for confounders, DLMD (HR 2.79,95% CI 1.17 to 8.9; p = 0.032) and surgical risk status (HR 2.18,95% CI 1.06 to 4.5; p = 0.038) remained independent and complementary predictors of MACE.. Distal LMCA disease carries independent prognostic implications, and it may help in selecting the most appropriate patient subset for LMCA intervention beyond the conventional surgical risk status in the DES era.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Female; Humans; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Predictive Value of Tests; Sirolimus; Stents; Treatment Outcome

Stenting with a sirolimus-eluting stent (SES) dramatically reduces the risk of restenosis compared to bare metal stent (BMS) implantation. However, before SES can be widely adopted in clinical practice, it is essential to conduct an economic evaluation of this effective but expensive device. Our study was undertaken to estimate the three-year cumulative medical costs of stenting using SES compared to BMS. The data on clinical sequelae of stenting using BMS were derived from our previous study, based on data collected from three Japanese hospitals. We estimated that the probability of PTCA required for revascularization would be 0.224 times in SES implantation compared than in BMS implantation based on the SIRIUS study result. The medical costs for procedures were obtained from published articles and were adjusted to the March 2005 level. Our simulation showed the expected three-year cumulative medical cost per patient to be approximately 200,000 yen lower in the SES group(2,233,000 yen ) than in the BMS group (2,431,000 yen ). Sensitivity analyses with different presumptions confirmed that the economic advantage of SES over BMS was quite robust. We concluded that the use of SES would be a cost-saving option as compared with BMS implantation within the context of the Japanese healthcare system.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Health Care Costs; Humans; Metals; Sirolimus; Stents

This study evaluated the clinical and angiographic effectiveness of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation for chronic total occlusion (CTO) lesions.. It has not been known which drug-eluting stent, SES vs. PES, is superior for the treatment of CTO lesions.. This study comprises 107 CTO lesions which were successfully treated with SES implantation and 29 CTO lesions with PES implantation. Six-month angiographic restenosis rates and major adverse cardiac events (MACE) including death, nonfatal myocardial infarction and target lesion revascularization were compared between the two groups.. Baseline clinical characteristics were similar between the two groups. The procedural success rate was 98.1% in the SES group and 100% in the PES group. There was 1 sudden death due to in-hospital acute thrombosis in the PES group. There were no significant differences in baseline angiographic measures between both groups, except larger postprocedural minimal luminal diameter and acute gain in the PES group. At 6-month angiographic follow up, the restenosis rate was significantly higher in the PES group (28.6% vs. 9.4%; p = 0.020). Similarly, the late loss was significantly higher in the PES group (0.8 +/- 0.8 mm vs. 0.4 +/- 0.8 mm; p = 0.025). At one-year follow up, the MACE-free survival rate was significantly higher in the SES group (95.8% vs. 85.8%; p = 0.049).. The implantation of SES in the treatment of CTO lesions showed more favorable results regarding restenosis and clinical outcomes compared with PES implantation.

Topics: Adult; Chronic Disease; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Follow-Up Studies; Heart Diseases; Humans; Inpatients; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Topics: Chronic Disease; Coronary Disease; Humans; Paclitaxel; Sirolimus; Stents

To assess the characteristics and short-term outcome of patients, undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES), in routine clinical practice.. Observational study.. The Aga Khan University Hospital, from 2002 to 2003.. All the patients who underwent PCI with DES at cath lab, AKUH, during the year 2002 and 2003 were included. Data was collected from database and by reviewing clinical records. Follow-up data for a period of 6-9 months was collected from the clinical records and by a telephone interview where required.. A total of 141 patients underwent PCI with DES at AKUH during the year 2002 and 2003. This study was predominantly male dominated (approximately 77%), with a mean age of 55+/-11 years. Thirty-nine percent were diabetics, and 53% were hypertensives. Twelve percent of patients had prior coronary artery bypass graft surgery (CABG) and 17% had prior PCI. Two or more than two lesions were attempted in 55% of patients. Majority (84.4%) of lesions were moderate to high risk category. Six to nine months follow-up was available in 133 (94%) patients. The only death was due to heart failure in the presence of a patent stent. Nearly 8% had clinical angina and 3.8% had myocardial infarction (MI) during follow-up. Target lesion revascularization (TLR) was performed in 4.6%. Major adverse cardiac events (MACE), defined as death, MI, and TLR occurred in 6.8% of patients.. This data shows that DES are being used in a broad variety of clinical settings in routine or real life clinical practice. The outcome is excellent and comparable to randomized trials.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Female; Humans; Male; Middle Aged; Paclitaxel; Registries; Retrospective Studies; Sirolimus; Stents

In patients treated with percutaneous coronary intervention (PCI) in the drug-eluting stent era, we compared women's and men's health status 6 and 12 months post-PCI and investigated whether predictors of poor health status at 12 months are similar for women and men.. Consecutive patients (n=692; 28% women) treated with PCI completed the 36-item Short-Form Health Survey (SF-36) 6 and 12 months post-PCI.. There was a significant improvement in health status over time (P<.001), but women experienced a significantly poorer health status compared with men (P<.001) at 6 and 12 months, adjusting for differences in baseline characteristics and health status at 6 months. Predictors of impaired health status were generally different for women and men. In women, the predominant predictors were previous coronary artery bypass graft (CABG) surgery, renal impairment, and older age; in contrast, in men, older age was associated with better functioning. In women, previous CABG was associated with a 4-15 fold increased risk of impaired health status. Health status at 6 months was a predictor of all SF-36 domains at 12 months in both women and men.. Women reported poorer health status compared with men 6 and 12 months post-PCI, and predictors of impaired health status generally differed for women and men. Further studies examining risk factors for adverse outcomes for women and men separately, which will lead to better risk stratification in research and clinical practice, are warranted.

Topics: Administration, Topical; Aged; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Female; Follow-Up Studies; Health Status; Humans; Immunosuppressive Agents; Male; Middle Aged; Prognosis; Retreatment; Risk Factors; Sex Factors; Sirolimus; Stents; Treatment Outcome

Topics: Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Vessels; Humans; Hyperplasia; Immunosuppressive Agents; Risk Factors; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

This study was performed to compare the safety and efficacy of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) on the outcomes of diabetic patients. Recent data with drug-eluting stents have shown improved clinical outcomes in diabetic patients. This study compared outcomes between the 2 available drug-eluting stents, SESs and PESs. From the prospective drug-eluting stent registries at the investigators' institution, 1,320 consecutive diabetic patients treated with SESs (n=873, 1,293 lesions) and PESs (n=447, 733 lesions) were identified and their in-hospital and 1- and 6-month clinical outcomes compared. Baseline characteristics showed more men, more patients with previous coronary bypass surgery, and smaller ejection fractions in the PES group and more obese patients in the SES group. Procedural characteristics were similar except for more left anterior descending artery and proximal lesions and the greater use of glycoprotein IIb/IIIa inhibitors in the SES group and more type C lesions, direct stenting, and stents per patient in the PES group. In-hospital complications were similar. Clinical follow-up at 1 month was also similar between the 2 groups, including subacute stent thrombosis. At 6 months, the 2 groups had similar mortality (7% vs 7%), myocardial infarctions (18% vs 21%), target lesion revascularization, target vessel revascularization, major adverse cardiac events (11% vs 12%), and late thrombosis (0.3% vs 0%). Subanalysis of insulin-treated diabetic patients showed no significant differences in outcomes in the 2 groups. No significant differences were found between SESs and PESs on Cox regression analysis for hazard ratios. In conclusion, SESs and PESs are associated with similar efficacy and safety with regard to repeat revascularization rates, major adverse cardiac events, and stent thrombosis up to 6 months for the treatment of coronary artery disease in patients with diabetes mellitus regardless of insulin therapy.

Topics: Aged; Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Diabetes Mellitus, Type 1; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Stents; Treatment Outcome

This study sought to analyze the cost of percutaneous coronary interventions with use of sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) in patients at high risk of restenosis.. Recent studies have shown different clinical efficacy with these drug-eluting stents. Whether this difference extends on cost estimates between the 2 stents is not known.. We included 450 patients with diabetes mellitus and in-stent restenosis from 2 randomized studies comparing SES with PES. Assigned costs for the economic evaluation were the initial hospitalization and all subsequent cardiac-related inpatient/outpatient health resources during 9 to 12 months of clinical follow-up. The economic evaluation was performed from the health insurance system's perspective.. There were no differences between the 2 study groups regarding mortality (p = 0.78) and myocardial infarction rates (p = 0.76). Target lesion revascularization was performed in 16 patients (7.1%) in the SES group and in 34 patients (15.1%) in the PES group (p = 0.01). Initial hospital costs were not significantly different between the 2 stents (p = 0.53). The follow-up costs were, however, different: 2,684 +/- 2,072 euros per patient treated with SES and 4,527 +/- 6,466 euros per patient treated with PES (p < 0.001). Total costs also differed at the end of the follow-up: 8,924 +/- 3,077 euros per patient treated with SES and 10,903 +/- 7,205 euros per patient treated with PES (p < 0.001).. In patients at high risk of restenosis, use of SES is associated with lower costs compared with PES. The cost savings are mainly due to the reduced need of repeat revascularization procedures with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Disease; Coronary Restenosis; Cost Savings; Costs and Cost Analysis; Diabetic Angiopathies; Female; Germany; Health Services; Hospital Costs; Hospitalization; Humans; Male; Middle Aged; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus

Randomized trials have shown that implantation of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) reduce the incidence of major adverse cardiac events (MACEs) compared with bare metal stents. We compared the impact of SESs and PESs on clinical outcome in medically treated diabetic patients with multivessel stents. In this study, the in-hospital and 9-month clinical outcomes of 260 consecutive diabetic patients who underwent implantation of SESs (147 patients) or PESs (113 patients) were compared. MACEs were defined as death, nonfatal myocardial infarction, and clinically driven target vessel revascularization. The baseline demographic and angiographic characteristics were well matched. An average of 3.0 +/- 1.3 versus 2.8 +/- 1.2 lesions were treated in the SES and PES groups, respectively (p = 0.34), with a mean stented length per patient of 73 +/- 43 versus 61 +/- 36 mm (p = 0.08). No significant difference was observed between the SES and PES groups for in-hospital (6.1% vs 3.5%, p = 0.34) or 9-month MACE (24.5% vs 19.5%, p = 0.34) rates or for subacute (1.4% vs 0.9%, p = 0.72) or late (0.7% vs 0.9%, p = 0.85) stent thrombosis. Insulin-requiring diabetic patients treated with SESs and PESs also had similar demographic and angiographic characteristics and rates of in-hospital (4.7% vs 7.7%, p = 0.57) and 9-month (28.0% vs 38.4%, p = 0.44) MACEs. Insulin-dependent diabetes was the only independent predictor of MACEs (odds ratio 2.68, 95% confidence interval 1.46 to 4.89, p = 0.001). In conclusion, our results demonstrated a relatively high incidence of MACEs in a diabetic population with multivessel disease, despite treatment with drug-eluting stents. In addition, we could not find any clear advantage of 1 type of stent versus the other.

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Diabetes Mellitus; Female; Follow-Up Studies; Hospital Mortality; Humans; Immunosuppressive Agents; Male; Middle Aged; Odds Ratio; Paclitaxel; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Previous observations in the bare metal stent (BMS) era have demonstrated an association between a high preprocedural C-reactive protein (CRP) level and an increased incidence of death or myocardial infarction after percutaneous coronary intervention (PCI). We hypothesized that PCI with sirolimus-eluting stents (SESs) would result in a smaller increase in CRP compared with BMSs and that a high CRP level before PCI would be associated with a higher incidence of death or myocardial infarction at 12 months, regardless of the type of stent implanted. We analyzed patients who underwent PCI with stenting at the Cleveland Clinic Foundation. Patients who received BMSs and SESs were analyzed separately by categorizing them into low and high CRP groups based on whether their CRP level before PCI was above or below the median for each group. The increase in CRP that occurred with PCI was termed DeltaCRP. In total, 652 patients were included in the analysis. Median DeltaCRP was smaller in the SES group than in the BMS group (1.5 vs 0.7 mg/L, p = 0.009). In the BMS group, patients with a CRP level above the median before PCI had a higher incidence of 12-month death or myocardial infarction compared with patients with a CRP level below the median (11.3% vs 1.6%, p = 0.002). The same relation was present in the SES group, i.e., patients with a higher CRP level had a higher incidence of 12-month death or myocardial infarction compared with patients with a low CRP level (6.3% vs 1.0%, p = 0.005) and a higher 12-month mortality (5.2% vs 0%, p = 0.001). Multivariate logistic regression analysis demonstrated that the CRP level above the median before PCI was associated with a higher 12-month incidence of death or myocardial infarction, independent of the type of stent used, or DeltaCRP. In conclusion, PCI in the SES era causes a smaller increase in CRP compared with the BMS era. A high CRP level before PCI is independently associated with a higher risk of long-term death or myocardial infarction. This finding was present in the BMS and SES groups and highlights the need for aggressive risk-factor modification after PCI.

Topics: Aged; Biomarkers; Blood Vessel Prosthesis Implantation; C-Reactive Protein; Coated Materials, Biocompatible; Coronary Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Ohio; Prognosis; Prospective Studies; Risk Factors; Sirolimus; Stents; Survival Rate; Time Factors

The aim of this research was to evaluate the plaque prolapse (PP) phenomenon after bare-metal (BMS) and drug-eluting stent (DES) implantation in patients with diabetes mellitus using 3-dimensional volumetric intravascular ultrasound (IVUS).. Plaque prolapse has been observed in up to 22% of patients treated with BMS. Diabetic patients have a larger atherothrombotic burden and may be more prone to have PP. However, the incidence of PP and its clinical impact after DES implantation is unknown.. Three-dimensional IVUS was performed after intervention and at 9-month follow-up in 168 patients with diabetes (205 lesions) treated with bare BX Velocity stents ((BX Velocity/Sonic, Cordis, Johnson & Johnson) (BMS, n = 65), sirolimus-eluting stents (Cypher, Cordis) (SES, n = 69), and paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, Massachusetts) (PES, n = 71). Intravascular ultrasound data at the sites of PP were compared with stented segments without PP in each lesion. Outcomes were evaluated at 9- and 12-month follow-up.. There were 42 sites of PP (BMS = 11, SES = 11, PES = 20, p = NS) in 34 stented segments of 205 (16.6%) lesions. Plaque prolapse was more frequent in the right coronary artery and in chronic total occlusion lesions. Post-procedure PP volume was 1.95 mm3 in BMS, 2.96 mm3 in SES, and 4.53 mm3 in PES. At follow-up, tissue volume increased at PP sites in both BMS and PES, but not after SES. Neointimal proliferation was similar between PP and non-PP sites. Stent thrombosis and restenosis rates were similar between PP and non-PP lesions.. The incidence of PP after implantation of new generation tubular stents in patients with diabetes remains high. Drug-eluting stent implantation was not associated with increased risk of PP. Plaque prolapse was not associated with stent thrombosis or increased neointimal proliferation.

Topics: Aged; Chronic Disease; Coronary Disease; Coronary Stenosis; Diabetic Angiopathies; Drug Delivery Systems; Equipment Design; Female; Follow-Up Studies; Humans; Imaging, Three-Dimensional; Male; Metals; Middle Aged; Multicenter Studies as Topic; Paclitaxel; Prolapse; Randomized Controlled Trials as Topic; Risk Assessment; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Serial (baseline and 9-month follow-up) intravascular ultrasound analysis was performed at 5-mm reference segments immediately proximal and distal to the sirolimus-eluting stent (SES) in 33 lesions. Proximal and distal reference segments were divided into 1-mm subsegments. Between postintervention and follow-up intravascular ultrasound studies, there were significant decreases in the lumen and increases in plaque & media areas in the subsegment closest to the distal edge, with no change in external elastic membrane area. There was no significant change in external elastic membrane, lumen, and plaque & media areas within the other subsegments. At the nearest 1-mm subsegment from the proximal and distal edges, baseline plaque & media area was associated with subsequent vessel remodeling. In conclusion, a large amount of plaque at the SES edge may be a risk of negative remodeling at follow-up (stent edge restenosis). It supports the importance of "normal-to-normal" SES deployment.

Topics: Aged; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Vessels; Female; Follow-Up Studies; Humans; Male; Regression Analysis; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Biomarkers; C-Reactive Protein; Coronary Disease; Creatine Kinase, MB Form; Equipment Design; Humans; Immunosuppressive Agents; Myocardial Infarction; Sirolimus; Stents

The DEScover Registry was designed to characterize patients selected for drug-eluting stents (DES) in routine clinical practice and their outcomes in the United States.. From January to June 2005, data were collected on 6906 patients who underwent percutaneous coronary intervention at 140 medical centers. Baseline characteristics and outcomes were compared on the basis of treatment with > or =1 bare-metal (BMS; n=397), sirolimus-eluting (SES; n=3873), or paclitaxel-eluting (PES; n=2636) stent. Clinical characteristics and the types of lesion treated for BMS patients differed substantially from those treated with DES, but minimal differences were noted between DES patients receiving SES or PES. At 1 year, the unadjusted cumulative incidence of death/myocardial infarction was higher in BMS than in DES patients (9.0% versus 5.2%; P=0.002) but similar in SES and PES patients (5.2% versus 5.3%; P=0.64). After adjustment, risk of death/MI was not significantly lower in DES- compared with BMS-treated patients (adjusted hazard ratio, 0.74; 95% confidence interval, 0.52 to 1.07). Although target vessel revascularization occurred less often in DES patients (9.5% versus 6.0%; P=0.007), rates were similar between SES and PES patients (6.3% versus 5.5%; P=0.20). Rates of stent thrombosis were similar among BMS (0.8%), SES (0.5%), and PES (0.8%) patients.. In DEScover, differences in patient selection were observed between BMS and DES patients but not between SES and PES patients. DES use resulted in lower rates of clinically driven repeat revascularization with similar rates of stent thrombosis. These observations confirm the effectiveness and safety of both SES and PES in unselected patients.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Drug Delivery Systems; Equipment Design; Humans; Incidence; Metals; Myocardial Infarction; Paclitaxel; Registries; Retreatment; Risk Assessment; Sirolimus; Stents; Thrombosis; Treatment Outcome

Topics: Adult; Angioplasty, Balloon, Coronary; Cardiomyopathy, Hypertrophic; Combined Modality Therapy; Coronary Disease; Drug Implants; Dyspnea; Ethanol; Heart Septum; Humans; Magnetic Resonance Imaging; Male; Mitral Valve Insufficiency; Physical Exertion; Recurrence; Sclerosing Solutions; Sirolimus; Stents; Tomography, Spiral Computed; Ultrasonography

Studies in Western countries have shown that sirolimus-eluting stents (SES) are clinically effective in the real world, but the detailed serial angiographic analyses are limited to some complex lesions. In addition, the efficacy of SES has not been fully investigated in a Japanese population.. The study population consisted of 249 consecutive unselected patients who underwent percutaneous coronary intervention (PCI) with SES. Clinical and angiographic follow-up were evaluated at 8 months. Clinical follow-up was obtained in all patients and angiographic follow-up was obtained in 228 patients (91.6%) with 272 lesions (91.0%). Major adverse cardiac events were documented in 44 patients (17.7%). There were 2 stent thromboses within 24 h and 11 days after PCI (0.8%). Late lumen loss in the proximal edge, in-stent, and distal edge was 0.06+/-0.44 mm, 0.26+/-0.60 mm, and -0.05+/-0.30 mm, respectively. The rate of angiographic in-segment binary restenosis was 14.0% (proximal edge: 3.3%, in-stent: 10.7%, distal edge: 0.7%). By multivariate analysis, an increased risk of restenosis was significantly associated with hemodialysis, diabetes, lesion length, and impaired left ventricular ejection fraction.. In accordance with previous reports, SES is considered to be feasible, safe and effective based on the results in an unselected Japanese population. ).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Drug Delivery Systems; Female; Humans; Japan; Male; Middle Aged; Multivariate Analysis; Platelet Aggregation Inhibitors; Predictive Value of Tests; Sirolimus; Stents; Ticlopidine; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Anti-Inflammatory Agents; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Humans; Sirolimus; Stents

A 37 year-old female who had suffered from arteritis for 20 years underwent a Bentall operation. Since severe stenosis was observed in her left main coronary artery (LMCA) the following year, a minimally invasive direct coronary artery bypass (MIDCAB) operation was performed. Unfortunately, she again complained of angina about 6 months after the second surgery and coronary angiography (CAG) revealed that her left internal thoracic artery graft was totally occluded. Although a 4.0 x 15 mm S670 stent was placed in her LMCA, the LMCA re-stented every 3 months and she underwent reintervention 8 times. We placed 2 sirolimus-eluting stents for treating the LMCA using the culottes stenting technique. CAG 6 months after the index procedure showed no stenosis at her LMCA. Sirolimus-eluting stents were effective for treating stenosis resulting from arteritis as well as that caused by atherosclerosis.

Topics: Adult; Coronary Angiography; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Coronary Vessels; Female; Humans; Sirolimus; Stents; Takayasu Arteritis

Sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation for the treatment of single coronary lesions has proved to be effective and durable. However, the safety and efficacy of overlapping drug-eluting stents for the treatment of long lesions have not been well established. In total, 114 patients who received overlapping drug-eluting stents were identified, 55 of whom received overlapping SESs and 59 received overlapping PESs. Baseline clinical and angiographic characteristics were balanced. In-hospital complications were similar between the 2 groups. At 30-day and 6-month follow-ups, all clinical outcomes were also similar. In addition, the event-free survival rate was comparable (p = 0.71). Implantation of overlapping drug-eluting stents for the treatment of long, native coronary lesions is feasible and effective. In conclusion, in this observational study, clinical outcomes appeared similar in patients treated with overlapping SES implantation compared with those treated with overlapping PES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Disease-Free Survival; Female; Humans; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; Treatment Outcome

Drug-eluting coronary stents are the most recent "breakthrough" technology in interventional cardiology. Whereas risk factors influencing restenosis and need for target vessel revascularization are well known, risk factors for dying or developing a myocardial infarction (MI) after drug-eluting coronary stent implantation need to be evaluated yet.. We evaluated data from the German Cypher Stent Registry.. From April 2002 to December 2004, 7445 patients at 122 hospitals, who received at least one sirolimus-eluting stent during percutaneous coronary intervention, were included. Complete follow-up at a median of 6.6 months (quartiles 6.1-8.1 months) was available in 6755 patients (91%). Death occurred in 1.8% (120/6755) of patients, nonfatal MI in 2.3% (156/6635), and death or MI in 4.1% (276/6755) of patients. Independent predictors of death or MI were initial presentation with ST-elevation MI or non-ST-elevation MI (OR [odds ratio] 2.21, 95% CI 1.66-2.95, P < .0001), cardiogenic shock (OR 3.05, 95% CI 1.67-5.55, P = .0003), renal insufficiency (OR 1.74, 95% CI 1.24-2.44, P = .0017), reduced left ventricular function (OR 1.74, 95% CI 1.21-2.50, P = .0027), age (per decade) (OR 1.19, 95% CI 1.05-1.36, P = .0058), diabetes mellitus (OR 1.39, 95% CI 1.05-1.84, P = .0183), 3-vessel disease (OR 1.32, 95% CI 0.99-1.77, P = .043), and prior MI (OR 1.35, 95% CI 1.01-1.80, P = .0468), whereas interventional and lesion characteristics showed no significant association.. These results demonstrate that the most powerful predictors of death or MI after sirolimus-eluting stent implantation during percutaneous coronary intervention are presentation with an acute coronary syndrome, impaired left ventricular ejection fraction, and conventional risk factors for coronary heart disease. Interventional and lesion characteristics do not play a major role.

Topics: Acute Disease; Aged; Coronary Disease; Coronary Stenosis; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Registries; Risk Factors; Sirolimus; Stents; Stroke Volume; Syndrome

Sirolimus-eluting stents (SES) can reduce restenosis and reintervention compared with bare metal stents (BMS). However, the safety and efficacy of SES for diffuse long lesions remain unknown. This study compared the efficacy of SES and BMS using the initial and mid-term outcomes of 124 patients with 130 long coronary lesions (SES lengths > or = 30 mm) compared to 141 patients with 146 lesions treated with BMS.. Quantitative coronary arteriography parameters and initial success rate were not significantly different between the two groups. Occurrence of stent thrombosis was not different between the groups (1 case, 0.7% in group SES vs 0 case, 0% in group BMS). Restenosis and major adverse cardiac event rates at 6 months were lower in the SES group than in the BMS group (3.1% vs 34.2%, p < 0.0001, 3.8% vs 31.5%, p < 0.0001).. Initial effects of sirolimus-eluting stents for diffuse long lesions are as useful and as safe as BMS. The mid-term outcomes for SES are superior due to the lower rates of both restenosis and major adverse cardiac event.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Humans; Metals; Middle Aged; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

We sought to assess the impact of direct stenting (DS) using the sirolimus-eluting stent (SES) on angiographic and clinical outcomes.. The SES is superior to bare-metal stents in the treatment of native de novo coronary artery lesions in randomized, controlled trials.. A post hoc analysis was performed on 225 patients (158 men; 62 +/- 11 years old) who received SES in the pooled cohorts of the European and Canadian Sirolimus-Eluting Stent in Coronary Lesions (E-SIRIUS and C-SIRIUS, respectively) trials. Of these patients, 57 (25%) had undergone DS at the investigator's discretion. Lesion predilation preceded SES implantation in the remaining 168 patients.. Patient and lesion characteristics were no different between the two subgroups, except for a lower prevalence of moderate to severe lesion calcification (5% vs. predilation 19%, p=0.017) and a lower baseline diameter stenosis (61.6% vs. predilation 68.1%, p <0.001) in the DS subgroup. At eight months, in-lesion late loss (0.10 vs. 0.19 mm at predilation, p=0.14) and in-lesion binary restenosis (2.0% vs. 6.1% at predilation, p=0.46) tended to be lower after DS. Clinical follow-up at one year revealed non-significantly reduced incidences of target lesion revascularization (1.8% vs. 5.4% at predilation, p=0.46) and major adverse cardiac events (5.3% vs. 8.9% at predilation, p=0.57).. Direct SES deployment performed at the investigator's discretion was as safe and efficacious at mid-term follow-up as stenting preceded by lesion predilation.

Topics: Aged; Clinical Trials as Topic; Coronary Angiography; Coronary Disease; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Multicenter Studies as Topic; Prosthesis Design; Sirolimus; Stents

Patients with diabetes have an increased incidence and severity of ischemic heart disease, which leads to an increased requirement for coronary revascularization. Comparative information regarding mode of revascularization--coronary artery bypass graft surgery surgery (CABG) or percutaneous coronary intervention (PCI)--is limited, mainly confined to a subanalysis of the Bypass Angioplasty Revascularization (BARI) trial, suggesting a mortality benefit of CABG over PCI. No prospective trial has specifically compared these modes of revascularization in patients with diabetes.. The Coronary Artery Revascularisation in Diabetes (CARDia) trial is designed to address the hypothesis that optimal PCI is not inferior to modern CABG as a revascularization strategy for diabetics with multivessel or complex single-vessel coronary disease. The primary end point is a composite of death, nonfatal myocardial infarction, and cerebrovascular accident at 1 year.. A total of 600 patients with diabetes are to be randomized to either PCI or CABG, with few protocol restrictions on operative techniques or use of new technology. This gives a power of 80% to detect non-inferiority of PCI assuming that the PCI 1-year event rate is 9%. A cardiac surgeon and a cardiologist must agree that a patient is suitable for revascularization by either technique prior to recruitment into the study. Twenty-one centers in the United Kingdom and Ireland are recruiting patients. Data on cost effectiveness, quality of life, and neurocognitive function are being collected. Long-term (3-5 year) follow-up data will also be collected.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Diabetes Complications; Humans; Immunosuppressive Agents; Multicenter Studies as Topic; Myocardial Infarction; Randomized Controlled Trials as Topic; Research Design; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Coronary Vessels; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

Sirolimus-eluting stents have recently been shown to reduce the risk of restenosis among patients who undergo percutaneous coronary intervention (PCI). Given that sirolimus-eluting stents cost about 4 times as much as conventional stents, and considering the volume of PCI procedures, the decision to use sirolimus-eluting stents has large economic implications.. We performed an economic evaluation comparing treatment with sirolimus-eluting and conventional stents in patients undergoing PCI and in subgroups based on age and diabetes mellitus status. The probabilities of transition between clinical states and estimates of resource use and health-related quality of life were derived from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) database. Information on effectiveness was based on a meta-analysis of randomized controlled clinical trials (RCTs) comparing sirolimus-eluting and conventional stents.. Cost per quality-adjusted life year (QALY) gained in the baseline analysis was Can58,721 dollars. Sirolimus-eluting stents were more cost-effective in patients with diabetes and in those over 75 years of age, the costs per QALY gained being 44,135 dollars and 40,129 dollars, respectively. The results were sensitive to plausible variations in the cost of stents, the estimate of the effectiveness of sirolimus-eluting stents and the assumption that sirolimus-eluting stents would prevent the need for cardiac catheterizations in the subsequent year when no revascularization procedure was performed to treat restenosis.. The use of sirolimus-eluting stents is associated with a cost per QALY that is similar to or higher than that of other accepted medical forms of therapy and is associated with a significant incremental cost. Sirolimus-eluting stents are more economically attractive for patients who are at higher risk of restenosis or at a high risk of death if a second revascularization procedure were to be required.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Disease; Coronary Restenosis; Cost-Benefit Analysis; Diabetes Complications; Female; Humans; Immunosuppressive Agents; Male; Markov Chains; Middle Aged; Quality-Adjusted Life Years; Risk; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Cost-Benefit Analysis; Humans; Immunosuppressive Agents; Quality-Adjusted Life Years; Sirolimus; Stents

The safety and efficacy of percutaneous coronary intervention in unprotected left main (ULM) coronary arteries are still a matter of debate.. All consecutive patients who had a sirolimus-eluting stent (Cypher, Cordis, Johnson and Johnson Co) or a paclitaxel-eluting stent (Taxus, Boston Scientific) electively implanted in de novo lesions on unprotected left main were analyzed. Patients treated with a drug-eluting stent (DES) were compared with the historical group of consecutive patients treated with bare metal stent (BMS). Eighty-five patients were treated with DES; 64 had BMS implantation. Patients treated with DES had lower ejection fractions (51.1+/-11% versus 57.4+/-13%, P=0.002) and were more often diabetics (21.2% versus 10.9%, P=0.12) with more frequent distal left main involvement (81.2% versus 57.8%, P=0.003). Furthermore, in the DES group, smaller vessels (3.33+/-0.6 versus 3.7+/-0.7 mm, respectively; P=0.0001) with more lesions (2.94+/-1.6 versus 2.25+/-1.3, P=0.004) and vessels (2.03+/-0.69 versus 1.8+/-0.72, P=0.05) were treated with longer stents (24.3+/-12 versus 15.8+/-8.6 mm, P=0.0001). Despite the higher-risk patients and lesion profiles in the DES group, the incidence of major cardiac events at a 6-month clinical follow-up was lower in the DES than in the BMS group (20.0% versus 35.9%, respectively; P=0.039). Moreover, cardiac deaths occurred in 3 DES patients (3.5%), as compared with 6 (9.3%) in the BMS group (P=0.17).. In this early experience with DES in unprotected left main, this procedure appears safe with favorable and improved clinical results as compared with historical control subjects with a BMS. A randomized study comparing surgery appears justified at present.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Coronary Vessels; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Risk Factors; Sirolimus; Stents; Treatment Outcome

We evaluated C-reactive protein increases after implantation of bare metal stents in 200 patients and sirolimus-eluting stents in 100 patients. The magnitude of change in C-reactive protein was comparable between groups. Clinical follow-up showed a relation between the postprocedural C-reactive protein increase and outcome that was significant in the bare metal stent group, which accounted for the most of events, but not in the sirolimus-eluting stent group.

Topics: Aged; Angina, Unstable; C-Reactive Protein; Coronary Disease; Coronary Restenosis; Disease-Free Survival; Female; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Outcome and Process Assessment, Health Care; Prognosis; Sirolimus; Statistics as Topic; Stents; Survival Rate

A large Phase III clinical trial with the novel proliferation signal inhibitor, Certican (everolimus), has shown this agent to be associated with lower rates of acute rejection, cardiac allograft vasculopathy (CAV) and cytomegalovirus (CMV) infection when compared with azathioprine (AZA) at 12 months post-transplant. Given that CAV is the main risk factor for mortality after the first year post-transplant, and that acute rejection and CMV infection play a key role in the development of this disease, the findings suggest that everolimus has an important role as part of the primary immunosuppression of this population. Consideration of the presentation and outcome of patients from Stanford University who were enrolled in the pivotal trial with everolimus in heart transplantation has highlighted the efficacy of everolimus in this setting. Analysis of the angiographic outcome data of these patients demonstrates that the efficacy of everolimus observed in the large, multicenter trial involving heart transplant patients was replicated in the findings of a single center. This finding is important for the interpretation of clinical trial data, offering reassurance that data from large trials are applicable to an individual center. The results from Stanford also reveal an important difference between everolimus and AZA with regard to intimal thickening and the incidence of abnormal left ventricular ejection fraction (LVEF), suggesting that everolimus may improve left ventricular function. Because abnormal LVEF has been associated with greater risk of vascular rejection and allograft vascular disease, use of everolimus could well improve long-term outcomes in heart transplant recipients.

Topics: Adult; Angioplasty, Balloon, Coronary; Azathioprine; Clinical Trials, Phase III as Topic; Coronary Disease; Coronary Vessels; Everolimus; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Mycophenolic Acid; Sirolimus; Transplantation, Homologous; Tunica Intima; Ultrasonography, Interventional

The impact of drug-eluting stent (DES) implantation on the incidence of major adverse cardiovascular events in patients undergoing percutaneous intervention for left main (LM) coronary disease is largely unknown.. From April 2001 to December 2003, 181 patients underwent percutaneous coronary intervention for LM stenosis at our institution. The first cohort consisted of 86 patients (19 protected LM) treated with bare metal stents (pre-DES group); the second cohort comprised 95 patients (15 protected LM) treated exclusively with DES. The 2 cohorts were well balanced for all baseline characteristics. At a median follow-up of 503 days (range, 331 to 873 days), the cumulative incidence of major adverse cardiovascular events was lower in the DES cohort than in patients in the pre-DES group (24% versus 45%, respectively; hazard ratio [HR], 0.52 [95% CI, 0.31 to 0.88]; P=0.01). Total mortality did not differ between cohorts; however, there were significantly lower rates of both myocardial infarction (4% versus 12%, respectively; HR, 0.22 [95% CI, 0.07 to 0.65]; P=0.006) and target vessel revascularization (6% versus 23%, respectively; HR, 0.26 [95% CI, 0.10 to 0.65]; P=0.004) in the DES group. On multivariate analysis, use of DES, Parsonnet classification, troponin elevation at entry, distal LM location, and reference vessel diameter were independent predictors of major adverse cardiovascular events.. When percutaneous coronary intervention is undertaken at LM lesions, routine DES implantation, which reduces the cumulative incidence of myocardial infarction and the need for target vessel revascularization compared with bare metal stents, should currently be the preferred strategy.

Topics: Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug Implants; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Registries; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

The purpose of the present study was to assess coronary vasomotor response to exercise after sirolimus-eluting stent (SES) implantation.. Sirolimus-eluting stents have been shown to markedly reduce the incidence of angiographic and clinical restenosis. However, long-term effects of sirolimus on endothelial function are unknown.. Coronary vasomotion was evaluated with biplane quantitative coronary angiography at rest and during supine bicycle exercise in 25 patients with coronary artery disease. Eleven patients were treated with a bare-metal stent (BMS) (control group) and 14 patients underwent SES implantation (sirolimus group) for de novo coronary artery lesions. Both groups were studied 6 +/- 1 month after the intervention. Minimal luminal diameter; stent diameter; and proximal, distal, and reference vessel diameter were determined.. The reference vessel showed exercise-induced vasodilation (+13 +/- 4%) in both groups. Vasomotion within the stented vessel segments was abolished. In controls, the adjacent segments proximal and distal to the stent showed exercise-induced vasodilation (+15 +/- 3% and +17 +/- 4%, respectively). In contrast, there was exercise-induced vasoconstriction of the proximal and distal vessel segments adjacent to SESs (-12 +/- 4% and -15 +/- 6%, respectively; p < 0.001 vs. corresponding segments of controls). Sublingual nitroglycerin was associated with maximal vasodilation of the proximal and distal vessel segments in both groups.. Implantation of a BMS does not affect physiologic response to exercise proximal and distal to the stent. However, SESs are associated with exercise-induced paradoxic coronary vasoconstriction of the adjacent vessel segments, although vasodilatory response to nitroglycerin is maintained. These observations suggest (drug-induced) endothelial dysfunction as the underlying mechanism.

Topics: Case-Control Studies; Coronary Angiography; Coronary Disease; Coronary Vessels; Endothelium, Vascular; Exercise; Exercise Test; Female; Hemodynamics; Humans; Immunosuppressive Agents; Male; Middle Aged; Nitroglycerin; Sirolimus; Stents; Time Factors; Vasoconstriction; Vasodilator Agents

The efficacy of sirolimus-eluting stents (SES) compared to paclitaxel-eluting stents (PES) remains unknown. We evaluated the clinical outcomes after implantation of 2.25 mm diameter SES and PES.. PES have been used as the stent of choice for all percutaneous coronary interventions as part of the prospective Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) Registry. Ninety consecutive patients received at least one 2.25 mm PES (PES group), and were compared with 107 patients who received at least one 2.25 mm SES as part of the RESEARCH registry. The overall population presented high-risk characteristics commonly excluded from most studies. Populations were well-matched. There were 2 (2.2%) incidents of subacute stent thrombosis in the PES group (in a 2.25 mm stent), and none in the SES group. At one year, the cumulative incidence of major adverse cardiac events was 5.6% in the SES group, and 17.8% in the PES group (p = 0.007). After adjustments for other significant univariate variables, presentation with acute coronary syndrome (ACS) (adjusted OR 5.2 [95% CI 1.8-15.0], p = 0.002) and PES utilization (adjusted OR 3.7 [95% CI 1.3-10.5], p = 0.013) were found to be significant independent predictors of major adverse cardiac events (MACE).. In an unselected population treated for very small vessel disease, SES were associated with better 12-month clinical outcomes and the use of PES was identified as an independent predictor of adverse events.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Randomized Controlled Trials as Topic; Registries; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Prosthesis Design; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Humans; Paclitaxel; Sirolimus; Stents

Sirolimus-eluting stents (SESs) reduce restenosis compared with bare metal stents. Safety issues with drug-eluting stents are particularly important given concerns of possible increased thrombogenicity. Compared with heparin plus glycoprotein IIb/IIIa inhibitors, the direct thrombin inhibitor bivalirudin has been shown to reduce the risk of hemorrhagic complications in patients receiving bare metal stents, with similar efficacy in preventing ischemic complications. The safety and efficacy of percutaneous coronary intervention (PCI) with SESs and bivalirudin anticoagulation have not been prospectively studied. This prospective study performed at 9 United States hospitals evaluated 1,182 patients referred for PCI with SESs in whom the procedural anticoagulant was bivalirudin. Clopidogrel was administered before PCI in 79% of patients, and only 5.3% received procedural glycoprotein IIb/IIIa inhibitors. At 30 days, major adverse cardiac events occurred in 7.1% of patients, including 0.3% mortality, 4.4% myocardial infarction (defined as creatine kinase-MB >3x normal), 1.7% target vessel revascularization, and 0.6% stent thrombosis. Major bleeding occurred in only 0.8% of patients. Thus, use of bivalirudin as the procedural anticoagulant to support SES implantation in a "real world" population of patients undergoing PCI results in low rates of major adverse cardiac events, stent thrombosis, and major bleeding.

Topics: Angioplasty, Balloon, Coronary; Anticoagulants; Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Follow-Up Studies; Hirudins; Hospital Mortality; Humans; Immunosuppressive Agents; Middle Aged; Peptide Fragments; Prospective Studies; Recombinant Proteins; Risk Factors; Safety; Sirolimus; Stents; Treatment Outcome; United States

Patients with diabetes mellitus are at increased risk for repeat interventions and mortality after coronary angioplasty and stenting. The efficacy of sirolimus-eluting stents (SESs) to improve the outcomes of these patients is a focus of interest. In the first 1,407 patients treated with SESs at our institution, 492 were diabetic (insulin dependent diabetes mellitus [IDDM], n = 160 and non-insulin-dependent DM [NIDDM], n = 332). The in-hospital and 1- and 6-month clinical outcomes were compared with those of 915 patients without DM (non-DM). The baseline characteristics were similar, except for more women, obesity, previous myocardial infarction, coronary artery bypass grafting, and renal insufficiency in the DM group (p <0.001). Compared with non-DM patients, DM patients had higher in-hospital (p <0.05) and 1-month mortality (p = 0.02). IDDM patients had more in-hospital renal failure (p = 0.04) and Q-wave myocardial infarctions (1.6% vs 0%, p = 0.04) compared with NIDDM patients, and higher mortality (3.1% vs 0.8%, p = 0.04) and subacute stent thromboses (2.3% vs 0.5%, p = 0.07) than non-DM patients at 30 days. At 6 months, DM patients had a higher incidence of Q-wave myocardial infarction, target lesion revascularization-major adverse cardiac events, and composite of death and Q-wave myocardial infarction than non-DM patients (6.0% vs 2.7%, p = 0.01). Late outcomes between the IDDM and NIDDM groups were similar. Multivariate analysis showed diabetes and acute renal failure as independent predictors of target lesion revascularization-major adverse cardiac events. In conclusion, our data showed that, despite a reduction in repeat revascularization, coronary intervention with SESs in diabetic patients is limited by higher mortality at 1 month and a higher incidence of Q-wave myocardial infarction and target lesion revascularization-major adverse cardiac events at 6 months compared with non-DM patients. Careful surveillance is required in IDDM patients undergoing SES implantation.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Hospital Mortality; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Sirolimus; Stents; Treatment Outcome

Topics: Coronary Disease; Coronary Restenosis; Data Interpretation, Statistical; Diabetes Complications; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

Topics: Coronary Disease; Coronary Restenosis; Diabetes Complications; Humans; Immunosuppressive Agents; Paclitaxel; Research Design; Sirolimus; Stents

Topics: Coronary Angiography; Coronary Disease; Coronary Restenosis; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

Topics: Angiotensin II Type 2 Receptor Blockers; Blood Glucose; Confounding Factors, Epidemiologic; Coronary Disease; Coronary Restenosis; Diabetes Complications; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

Topics: Coronary Disease; Coronary Restenosis; Diabetes Complications; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

To compare the short and long-term clinical outcomes of rapamycin (sirolimus)-eluting stent (DES) (CYPHER stent) and paclitaxel-DES (TAXUS stent) in treatment of coronary heart disease (CHD) patients with complicated lesions.. 611 CHD patients with 642 lesions, were treated with 698 CYPHER stents, and 450 sex, age, clinical data and lesion type-matched patients, with 534 lesions, were treated with 600 TAXUS stents by means of percutaneous coronary intervention. The short and long term outcomes were compared between these 2 groups.. The success rate of stent implantation was 99.2% (606/611) and 98.8% (445/450) in the CYPHER stent and TAXUS stent groups respectfully. The overall rate of major cardiac events, including death, acute myocardial infarction (AMI) target lesion revascularization (TLR), and major adverse cardiac event (MACE), during hospitalization and 6 - 8 month' follow-up were 0.65% and 2.3% in the CYPHER stent group, not significantly different from those of the TAXUS stent group (1.3% and 3.2% respectively). The restenosis rate of the TAXUS stent group was 7.3%, a little higher than that of the CYPHER stent group (14%), but without significant difference.. CYPHER and TAXUS DES are both safe and effective in CHD patients with complicated lesions. There is an increasing tendency of restenosis rate in the TAXUS stent group in comparison with the CYPHER stent.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; Treatment Outcome

To compare the clinical effects of rapamycin-eluting stent implantation and coronary artery bypass grafting (CABG) in treatment of the patients with multi-vessel coronary disease.. From January 2002 to December 2004, 262 patients with multi-vessel coronary disease underwent CABG, and 250 age, clinical characteristics, and characteristics of coronary disease-matched patients chose to receive rapamycin-eluting stent implantation. 6-9 months after the treatment angiography of the coronary artery was conducted. All the patients were followed up for 19 +/- 14 months. The clinical outcomes were compared.. No intra-operative death occurred in the rapamycin-eluting stent implantation group with an operation success rate of 100%, significantly higher than that of the CABG group with 9 intra-operative deaths and an operation success rate of 96.6% (P < 0.01). Three perioperative deaths occurred in the rapamycin-eluting stent implantation with a perioperative death rate of 1.2%, not significantly different from that of the CABG group (1.9% with 5 perioperative deaths). The total death rate during hospitalization of the rapamycin-eluting stent implantation group was 1.2%, significantly lower than that of the CABG group (5.3%, P < 0.05). The rate of in-hospital major adverse cardiac event (MACE) of the rapamycin-eluting stent implantation group was 1.6%, significantly lower than that of the CABG group (5.3%, P < 0.05). There was no significant difference in MACE rate and angina pectoris recurrence during follow-up and event-free survival rate between these 2 groups.. A better treatment for the patients with multi-vessel coronary disease, rapamycin-eluting stent implantation has the clinical effects comparable to those of the CABG.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Disease; Female; Humans; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

Drug-eluting stents are designed to reduce the risk of major adverse cardiac events after percutaneous coronary intervention by inhibiting cellular proliferation and reducing restenosis of the coronary artery. In high-risk lesions, drug-eluting stents may limit restenosis and the need for repeat revascularization. In optimal lesions, they may eliminate restenosis completely. Drug-eluting stents have made percutaneous intervention a safe and definitive treatment for coronary artery disease.

Topics: Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coronary Disease; Coronary Restenosis; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus

Topics: Coronary Disease; Cost Savings; Cost-Benefit Analysis; Drug Costs; Economic Competition; Health Care Costs; Humans; Paclitaxel; Sirolimus; Stents; United States

Cardiovascular medicine is changing rapidly with the development, testing, and introduction of new diagnostic and therapeutic methods. New interventional techniques such as the use of drug-eluting stents have important implications for the care of individual patients and the delivery and economics of health care in general. Drug-eluting stents have been shown to improve outcomes among patients undergoing percutaneous coronary intervention by significantly reducing restenosis rates. Two randomized trials have documented that per 100 patients treated with the sirolimus drug-eluting stent, 12.5 to 13.6 patients avoided the need for subsequent target lesion revascularization, when compared with patients treated with conventional stents. The economic effect of the introduction of these stents, which are projected to be two to three times as expensive as conventional stents, is complex and depends on which segment of health care is considered. These stents will be favorably received by patients, physicians, employers, and society as well as payers. However, hospitals may be adversely affected by having increased procedural costs for the stents, along with fewer procedures for evaluation and treatment of restenosis and probably decreased surgical volumes. Drug-eluting stents are only the first of many new technologic advances that will affect cardiovascular care. These procedures have many features in common, including: 1). replacement of major surgical procedures with less invasive approaches; and 2). redistribution of costs, with a decrease in hospital profits but potentially lower costs of health care delivery for society as a whole.

Topics: Coronary Disease; Delivery of Health Care; Diagnosis-Related Groups; Drug Delivery Systems; Female; Health Care Costs; Hospital Costs; Humans; Immunosuppressive Agents; Insurance, Health, Reimbursement; Male; Medicare; Middle Aged; Multicenter Studies as Topic; Myocardial Revascularization; Randomized Controlled Trials as Topic; Reimbursement Mechanisms; Sirolimus; Stents; United States

Drug-eluting intracoronary stents decrease restenosis and later revascularization. The US Department of Health and Human Services (HHS), recognizing the financial and clinical impact of this technology, recently proposed accelerated reimbursement to hospitals.. A disease state-transition computer model simulated the clinical and economic consequences to hospitals of drug-eluting stents over 5 years. Model parameters combined information from a longitudinal clinical database, a hospital cost-accounting system, and a survey instrument. Simulations were repeated 1000 times for each set of parameters. With 85% of stent procedures shifted to drug-eluting stents in the first year of availability, the mean number of repeat revascularizations dropped by 60.4% at year 5. With no changes in reimbursement policy, a hospital with a catheterization laboratory volume of 3112 patients yearly converted from a 2.01 million dollars (M) annual profit to an 8.10 M dollars loss in the first year (95% CI 8.09 M dollars to 8.12 M dollars) and 8.7 M dollars annual losses in later years. This represented an overall change in cash flow of 55.71 M dollars (95% CI 55.66 M dollars to 55.76 M dollars) away from the hospital over 5 years. The incremental reimbursement proposed by HHS reduced this loss to 4.75 M dollars in the first year and to 5.6 M dollars annually thereafter. In sensitivity analyses, the conversion of patients from bypass surgery to drug-eluting stents was the largest driver of overall cash flow shifts.. Although Medicare has proposed to increase reimbursement to ease the impact of drug-eluting stents on hospitals, this increase will not totally offset the costs.

Topics: Angioplasty, Balloon, Coronary; Computer Simulation; Coronary Disease; Cost-Benefit Analysis; Hospital Costs; Humans; Immunosuppressive Agents; Insurance, Health, Reimbursement; Models, Economic; Sirolimus; Stents

Topics: Blood Vessel Prosthesis Implantation; Catheterization; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Equipment Design; Humans; Immunosuppressive Agents; Myocardial Infarction; Sirolimus; Stents

The purpose of this study was to assess the safety and effectiveness of sirolimus-eluting stent (SES) postdilatation with largely oversized balloons. We evaluated the clinical outcome of 68 consecutive patients enrolled in the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry who underwent percutaneous coronary intervention with SES implantation and further postdilatation with balloons > 1 mm larger than the stent nominal size. Angiographic follow-up was either scheduled for selected subgroups or clinically driven. Overall, 75 lesions were treated. The procedure was successful in 98.5% of the cases. One patient (1.5%) underwent emergency coronary bypass surgery for acute vessel occlusion. During 10.1 +/- 1.7 months of follow-up, three patients (4.5%) died, one (1.5%) had acute myocardial infarction, and four (6%) had target vessel revascularization. At angiographic follow-up, loss index was 0.13 +/- 0.34 and restenosis rate was 7.7%. Although not routinely recommended in every patient, SES postdilatation with largely oversized balloons appears a safe and effective strategy for selected patients.

Topics: Aged; Blood Vessel Prosthesis Implantation; Catheterization; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Coronary Restenosis; Equipment Design; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Netherlands; Platelet Glycoprotein GPIIb-IIIa Complex; Postoperative Complications; Reoperation; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Drugeluting stents (DES) are currently judged to be a "break-through" technology for the prevention of restenosis after percutaneous coronary interventions (PCI). However, experience is limited to randomised controlled clinical trials (RCT) in selected lesions and the currently available DES are more expensive compared to conventional "bare" stents. Therefore, actual clinical practice may be very different to RCT.. We analysed the data of the German Cypher trade mark Registry, a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher trade mark sirolimus-eluting coronary stent, in April 2002.. From April 2002 until March 2003, 1638 procedures at 88 hospitals were included in the German Cypher trade mark Registry. The mean inclusion rate per centre and month remained low (<3 procedures/month and participating hospital) during the whole inclusion period. Most patients presented with stable angina pectoris (45.8%); however, 6.4% of patients were treated for a non-ST elevation myocardial infarction, 10.3% of patients for ST elevation myocardial infarction and 1.7% in cardiogenic shock. In patients without ST elevation myocardial infarction, a de novo stenosis was treated in 68.4% of cases, a restenosis in 4.1%, and an in-stent restenosis in 25.5% of cases. Chronic total occlusions were treated in 6.1% of patients. Predilatation was performed in 68.3% of patients and 1.05 +/- 0.35 Cypher trade mark stents were implanted per patient with a median (quartiles) stent length of 18 (13-21) mm. PCI-related death occurred in 0.1% of patients and a Q-wave myocardial infarction in 1.1%. Urgent re-PCI before hospital discharge was performed in 1.3% and urgent bypass surgery in 0.1% of cases.. The use of the sirolimus-eluting coronary stents in this "real life" registry was found to be safe concerning acute complications. In about one half of the registry patients, the DES was implanted in lesions that were excluded from RCTs.

Topics: Blood Vessel Prosthesis; Comorbidity; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Female; Germany; Humans; Male; Middle Aged; Registries; Sirolimus; Stents

Restenosis has long remained the major limitation of intracoronary stenting, but several randomized trials have recently shown that the use of drug-eluting stents appear to reduce markedly the risk of recurrence following treatment of de novo lesions. To evaluate whether the results of randomized trials can be generalized to routine clinical practice, all patients receiving at least one sirolimus-eluting stent (SES) in two Swiss hospitals were entered into a prospective registry. Only target vessels with a reference diameter > 3.5 mm were excluded. Clinical follow-up was obtained after 6 months. A total of 183 patients were included. The procedural success was 97.8% and the incidence of in-hospital MACE was 2.2%. At 7 +/- 2 months, 95.6% of the patients were event-free, and target lesion revascularization was required in only three patients (1.6%). The excellent medium-term results obtained with the SES in randomized trials can be replicated in routine clinical practice.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Coronary Restenosis; Disease-Free Survival; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Postoperative Complications; Practice Patterns, Physicians'; Prospective Studies; Reoperation; Sirolimus; Stents; Switzerland; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Coronary Restenosis; Humans; Immunosuppressive Agents; Postoperative Complications; Practice Patterns, Physicians'; Sirolimus; Stents

Neointimal proliferation with plaque formation is the principal cause of coronary artery disease. In the neointima, inflammatory cytokines like tumor necrosis factor-alpha (TNF-alpha) are expressed by vascular smooth muscle cells (VSMCs). These cytokines stimulate proliferation and migration of VSMCs, events that are crucial to neointima formation. Stents, liberating rapamycin, have been shown to reduce neointima formation in human coronary arteries. The purpose of this study was to determine if rapamycin could inhibit the production of TNF-alpha by VSMCs. With institutional review board approval, VSMCs were cultured from saphenous vein segments obtained from five patients. Cells were identified as VSMC by immunostaining for smooth muscle alpha-actin. Cells were exposed to bacterial lipopolysaccharide (LPS), LPS plus rapamycin, or LPS plus isoproterenol for 24 hours. Cells with no treatment served as controls. The culture medium was then removed and analyzed for TNF-alpha. Additionally, the effect of treatment on viability was determined by assay of mitochondrial activity. TNF-alpha released into the culture medium is expressed as pg TNF-alpha/mg cell protein. Statistical analysis was by ANOVA. In control cells, TNF-alpha was undetectable in the culture medium. The addition of LPS (10 microg/mL) increased TNF-alpha release to 4312 +/- 705 pg/mg at 24 hours. The addition of 1 ng/mL rapamycin with LPS reduced TNF-alpha production 50 per cent (P < 0.01 vs LPS alone). A similar reduction of TNF-alpha release was seen with 1 microM isoproterenol. LPS, rapamycin, or isoproterenol did not affect cell viability. These data show that rapamycin effectively inhibits the release of TNF-alpha from VSMCs stimulated with inflammatory mediators like LPS. Rapamycin is as effective as agents that raise intracellular cyclic AMP (e.g., isoproterenol). Therefore, a potential mechanism for the effectiveness of rapamycin-releasing stents is reduction of inflammatory cytokine expression by VSMCs.

Topics: Analysis of Variance; Anti-Bacterial Agents; Causality; Cell Division; Cell Movement; Cells, Cultured; Coated Materials, Biocompatible; Coronary Disease; Cyclic AMP; Drug Evaluation, Preclinical; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Inflammation; Isoproterenol; Lipopolysaccharides; Muscle, Smooth, Vascular; Saphenous Vein; Sirolimus; Stents; Tumor Necrosis Factor-alpha; Tunica Intima

Routine stent implantations have significantly improved the results of percutaneous coronary angioplasty. In relation to balloon dilatation, the intervention success is improved, while restenosis as well as recurrence of progressive atherosclerotic disease at the site of previous dilatation are significantly reduced. In complicated interventional procedures such as dilatation of multi-vessels, long lesions, left main lesion, bifurcation lesions, dilatation of small vessels, and lesions in patients with diabetes mellitus in spite of stent implantation, the incidence of restenosis remains high, about 30%-50%. The introduction of drug-eluting stents (DES) such as sirolimus, paclitaxel and dexamethasone in interventional cardiology has brought important improvement with a significantly decreasing incidence of in-stent restenosis. Despite great enthusiasm and very good initial results, it should not be forgotten that the usage of these stents is still experimental, with many questions, especially concerning longterm results and use of DES in complicated interventional procedures.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Humans; Paclitaxel; Sirolimus; Stents

The effectiveness of sirolimus-eluting stent (SES) implantation in patients treated electively for left main (LM) stenoses has not been yet ascertained. The present study reports on the clinical and angiographic outcome of 16 consecutive patients treated electively for de novo stenoses in the LM. The impact of SES implantation on major adverse cardiac events was evaluated. Mean age was 65 +/- 11 years. Unprotected LM was present in nine (56%), and eight patients (50%) received stents extending into both the left anterior descending and circumflex arteries for stenoses of the distal left main bifurcation. In-house mortality and reintervention rate was zero. One patient developed a non-Q-wave myocardial infarction related to the index procedure. At 1-year clinical follow-up, there were no deaths or further myocardial infarctions; one (6%) patient required target lesion revascularization. A total of 12 patients (75%) underwent 6-month angiographic follow-up with a late lumen loss of 0.04 +/- 0.65 mm and one focal restenosis (8% of patients). Elective SES implantation for LM disease was associated with zero mortality and a very low incidence of additional major adverse events at 1 year.

Topics: Aged; Aged, 80 and over; Coronary Angiography; Coronary Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Humans; Immunosuppressive Agents; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Conventional bare stents have been used to treat unprotected left main (LM) coronary artery stenosis. However, restenosis remains the main limitation. Since rapamycin-eluting stents (RES) appear to inhibit neointimal proliferation, their application to this specific site seems promising.. Since May 2002, we have studied a series of 52 patients with LM lesions treated with RES. Forty-seven patients presented with de novo stenoses, and 5 had in-stent restenosis; 19 patients required combined stent treatment for other remote lesions in the coronary tree, 6 of them at the level of proximal right coronary artery. The RES was implanted directly at the LM in 39 patients; 13 others needed predilation. Once deployed, the RES was overexpanded with short balloons adjusted to the LM length in 44 patients. Quantitative coronary angiograms were analyzed in the same view before and immediately after treatment and at follow-up. Patients were followed-up closely and new cardiac catheterization was scheduled at 6-month evaluation or earlier in the presence of symptoms. At follow-up study, quantitative coronary angiography and motorized intravascular ultrasound analyses were performed in 35 (67%) patients.. Primary success was obtained in 50 patients (96%). Two patients (4%) developed a non-Q-wave myocardial infarction. All patients were symptom-free at discharge. After a mean follow-up of 12 +/- 4 months, 50 patients (96%) remain asymptomatic. No late death or acute thrombosis have been recorded. Two patients became symptomatic 2 and 4 months after treatment, respectively. One had restenosis at a remote site, while the other had in-segment restenosis. None of the remaining 33 angiographically evaluated patients developed restenosis at any site. Target lesion revascularization was 1/52 (2%).. Although longer-term follow-up studies are needed, the tailored treatment of coronary lesions located at the LM by overexpanded RES is feasible and safe. Midterm results seem promising, which might help to shift the orientation of patient management from surgical to percutaneous revascularization.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Sirolimus; Stents; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Device Approval; Drug Delivery Systems; Equipment Failure; Humans; Paclitaxel; Prosthesis Design; Sirolimus; Stents; Thrombosis; United States; United States Food and Drug Administration

Percutaneous coronary intervention of bifurcation lesions is associated with lower procedural success rates, and an increased subsequent rate of major adverse cardiac events and restenosis. Currently, an array of stenting possibilities suggests a rational approach to treat various bifurcation lesions with appropriate techniques. This is however seldom the case. The main problems of treating bifurcation lesions remain plaque shift leading to (threatened) side branch occlusion, and either too much or insufficient side branch ostial stent coverage predisposing to impaired side branch access or restenosis, respectively. This paper reviews the available technologies and their relative merits.

Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Disease; Coronary Restenosis; Humans; Immunosuppressive Agents; Sirolimus; Stents

This study evaluates the response of the coronary vessel wall to implantation of the sirolimus-eluting stent (SES), Bx-VELOCITY, by using serial intravascular ultrasound. SESs have a major impact on the inhibition of in-stent neointimal hyperplasia. However, changes in the vessel wall and behind stent struts in animal models and humans have not been evaluated after SES implantation. Thirty-four patients who received a SES (n = 24) or a Bx-VELOCITY bare stent (BS) (n = 10) for single de novo coronary lesions and had serial motorized pullback 3-dimensional intravascular ultrasound were included. Stent, lumen, and vessel volumes were similar in the 2 groups at baseline. At follow-up, significantly larger lumen and lower neointimal hyperplasia volumes (0.7 vs 33 mm(3), p = 0.001) were seen in the SES group compared with the BS group. There was no significant difference between SES and BS in either the vessel volume (+2.4% vs +0.7%, p = NS) or the plaque behind stent volume change (+3.4% vs +2.5%, p = NS) from after the procedure to late follow-up. The stent edges also showed no significant difference between postprocedural and follow-up measurements, either in patients receiving SESs or BSs. No stented or edge segment required redilatation in the SES group, whereas 2 patients underwent repeat percutaneous coronary angioplasty in the BS group. In the SES group, 1 patient (4%) showed late acquired incomplete stent apposition. Thus, the SES is effective in inhibiting neointimal hyperplasia without affecting vessel volume and plaque behind the stent.

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Vessels; Female; Follow-Up Studies; Humans; Hyperplasia; Imaging, Three-Dimensional; Male; Middle Aged; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

CD45RB is a potent immunomodulatory target to achieve long-term allograft survival. We evaluated the in vivo effect of anti-CD45RB monoclonal antibody (mAb) treatment in combination with conventional immunosuppression or costimulatory blockade strategies as a therapeutic modality for future clinical application.. A fully MHC-mismatched vascularized mouse cardiac allograft model was used to test the interactions between anti-CD45RB mAb and conventional immunosuppressive drugs or costimulatory blockade of the CD40/CD154 or B7/CD28 pathway. Chronic rejection was examined histologically for development of chronic allograft vasculopathy.. Cyclosporine significantly abrogated the effect of anti-CD45RB therapy. In contrast, rapamycin acted synergistically with anti-CD45RB mAb in promoting long-term allograft survival. CD154 blockade further enhanced the tolerogenic efficacy of anti-CD45RB mAb. These synergistic effects of combination treatments also prevented the development of chronic allograft vasculopathy.. CD45RB-targeting strategy in combination with the use of rapamycin or costimulatory blockade promotes allograft tolerance and prevents chronic rejection.

Topics: Abatacept; Animals; Antibodies, Monoclonal; B7-1 Antigen; Blood Group Incompatibility; CD28 Antigens; CD40 Ligand; Chronic Disease; Coronary Disease; Cyclosporine; Drug Interactions; Drug Therapy, Combination; Graft Survival; Heart Transplantation; Immunoconjugates; Immunosuppressive Agents; Leukocyte Common Antigens; Mice; Mice, Inbred BALB C; Mice, Inbred C57BL; Sirolimus; Transplantation Tolerance; Transplantation, Homologous

Since the introduction of coronary stents into clinical practice in the late 1980s, the number of stent implantations has increased so rapidly that stents are currently used in over 80 percent of all percutaneous coronary interventions. Although stent implantation was initially limited to large vessels with proximal and discrete lesions, improvements in stent design and implantation technique now allow their deployment in more complex lesions in smaller and diffusely diseased vessels. The overall acceptance of stents by interventional cardiologists can be attributed to favorable acute and longterm results compared to balloon angioplasty alone. Interventionalists have also been quick to embrace the smoother and larger lumen after stenting, in a shorter procedure time and with no additional risk, especially since the risk of stent thrombosis has been overcome by the introduction of dual antiplatelet therapy with Aspirin and Ticlopidine or Clopidogrel. Although restenosis and the need for reinterventions is lower after stenting compared to balloon angioplasty it still remains significant with about 15 percent of all patients returning for an other revascularization procedure. Meanwhile, a completely new generation of stents promises to eliminate the problem of restenosis. Drug-eluting stents, coated with antiproliferative substances have been successfully tested in small randomized trials. The restenosis rates at 6 and 12 months were extremely low ranging between zero and nine percent, with no clinical drawbacks so far. If these results hold up in longer follow up and in real life practice with more complex lesions stented the treatment of symptomatic coronary artery disease will change even more dramatically.

Topics: Angiogenesis Inhibitors; Angioplasty, Balloon, Coronary; Controlled Clinical Trials as Topic; Coronary Disease; Coronary Restenosis; Double-Blind Method; Follow-Up Studies; Humans; Paclitaxel; Prosthesis Design; Reoperation; Risk Factors; Sirolimus; Stents; Time Factors

Topics: Azathioprine; Coronary Disease; Cytomegalovirus Infections; Drug Therapy, Combination; Everolimus; Heart Transplantation; Humans; Immunosuppressive Agents; Sirolimus

Topics: Angioplasty; Coronary Angiography; Coronary Disease; Humans; Immunosuppressive Agents; Radiography, Interventional; Recurrence; Sirolimus; Stents

Topics: Coronary Disease; Coronary Restenosis; Coronary Vessels; Diabetes Complications; Humans; Immunosuppressive Agents; Molecular Probes; Muscle, Smooth, Vascular; Sirolimus; Stents

Topics: Angioplasty, Balloon; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Equipment Design; Health Care Costs; Humans; Immunosuppressive Agents; Metals; Sirolimus; Stents

Coronary stent implantation is the predominant method of percutaneous coronary interventions (PCI). This is to be attributed to the ease of use beside the better short and long term clinical outcome as compared to balloon angioplasty. Nevertheless, improvements in operator skill and stent technology together with better use of adjunctive pharmacological therapy have contributed to the improvement in clinical outcome. However, the main limitation of coronary stenting is still represented by in-stent restenosis (ISR) with an estimated rate of 17-32%. Thus, compared to coronary bypass surgery, the major adverse cardiac events following stent implantation are still higher and mainly represented by the need for re-intervention. The advent of drug eluting stents (DES) has led the experts to predict that with DES there will be little or no difference between PCI and coronary bypass surgery in terms of long-term outcome leading to a further expansion of indications. The clinical trial programs of the 2 available DES for clinical use (sirolimus-eluting stent, SES - Cypher and paclitaxol-eluting stent - Taxus) have been able to demonstrate the safety and clinical efficacy of both. Nevertheless, off-label use in patients on high risk for restenosis confirmed these data. At least for SES as was demonstrated by 2 "real world" registries. Thus, the introduction of DES represents a remarkable evolution for new standards in coronary artery disease treatment and offers hope to those patients considered to be "high risk" such as diabetics, patients with ISR, diffuse disease in whom surgery was previously the only therapeutic option. This paper will discuss the main results of the clinical trial programs of the DES (mentioned above) available for clinical use in the present time and analyze technical and procedural aspects which could affect long term outcome.

Topics: Adult; Aged; Clinical Trials as Topic; Coronary Disease; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Stents

The true 3-dimensional neointimal thickness distribution in sirolimus-eluting stents was investigated in relation to the shear stress distribution, which was obtained from computational fluid dynamics calculations. Small pits were observed between the stent struts in all patients, and a significant inverse relation between neointimal thickness and shear stress was found, indicating that deeper pits were present in the outside curve of the stented segments.

Topics: Blood Flow Velocity; Coronary Angiography; Coronary Circulation; Coronary Disease; Coronary Vessels; Humans; Immunosuppressive Agents; Sirolimus; Stents; Tunica Intima

Topics: Azathioprine; Coronary Disease; Coronary Vessels; Everolimus; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Incidence; Kidney Failure, Chronic; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Biomedical Research; Coronary Disease; Coronary Restenosis; Defibrillators, Implantable; Drug Delivery Systems; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Immunosuppressive Agents; Robotics; Sirolimus; Stents

Drug eluting stents (DES) release drugs that inhibit tissue growth in narrowed coronary arteries in an effort to prevent restenosis, a renarrowing of the artery. Several types of DES are under investigation in clinical trials; however, none are currently approved for use in Canada. Preliminary trial data are encouraging, demonstrating greater lumen diameter and reduced restenosis with DES versus uncoated stents. If DES prove to be more effective than uncoated stents in the treatment and/or prevention of restenosis, this technology may diffuse rapidly. The total health care costs, including the cost of the stents, post-intervention therapy and possible re-intervention costs, will require assessment to determine the ultimate impact of DES.

Topics: Angioplasty, Balloon, Coronary; Canada; Clinical Trials as Topic; Constriction, Pathologic; Coronary Disease; Coronary Vessels; Cost-Benefit Analysis; Drug Approval; Drug Delivery Systems; Europe; European Union; Humans; Paclitaxel; Sirolimus; Stents; Treatment Outcome

Topics: Coronary Disease; Coronary Restenosis; Cost-Benefit Analysis; Delayed-Action Preparations; Humans; Immunosuppressive Agents; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Humans; Immunosuppressive Agents; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Coronary Disease; Coronary Restenosis; Coronary Vessels; Humans; Hyperplasia; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Sirolimus; Stents

Topics: Anti-Bacterial Agents; Coronary Disease; Humans; Immunosuppressive Agents; Prosthesis Design; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents; Coronary Disease; Humans; Immunosuppressive Agents; Recurrence; Sirolimus; Stents

The purpose of this study was to determine the efficacy of stent-based delivery of sirolimus (SRL) alone or in combination with dexamethasone (DEX) to reduce in-stent neointimal hyperplasia. SRL is a potent immunosuppressive agent that inhibits SMC proliferation by blocking cell cycle progression.. Stents were coated with a nonerodable polymer containing 185 microgram SRL, 350 microgram DEX, or 185 microgram SRL and 350 microgram DEX. Polymer biocompatibility studies in the porcine and canine models showed acceptable tissue response at 60 days. Forty-seven stents (metal, n=13; SRL, n=13; DEX, n=13; SRL and DEX, n=8) were implanted in the coronary arteries of 16 pigs. The tissue level of SRL was 97+/-13 ng/artery, with a stent content of 71+/-10 microgram at 3 days. At 7 days, proliferating cell nuclear antigen and retinoblastoma protein expression were reduced 60% and 50%, respectively, by the SRL stents. After 28 days, the mean neointimal area was 2.47+/-1.04 mm(2) for the SRL alone and 2.42+/-1.04 mm(2) for the combination of SRL and DEX compared with the metal (5.06+/-1.88 mm(2), P<0.0001) or DEX-coated stents (4.31+/-3.21 mm(2), P<0.001), resulting in a 50% reduction of percent in-stent stenosis.. Stent-based delivery of SRL via a nonerodable polymer matrix is feasible and effectively reduces in-stent neointimal hyperplasia by inhibiting cellular proliferation.

Topics: Animals; Anti-Bacterial Agents; Biocompatible Materials; Blotting, Western; Chemokine CCL2; Coronary Disease; Coronary Vessels; Dexamethasone; Disease Models, Animal; Dogs; Drug Delivery Systems; Drug Synergism; Female; Hyperplasia; Interleukin-6; Male; Polymers; Proliferating Cell Nuclear Antigen; Retinoblastoma Protein; Sirolimus; Stents; Swine; Tunica Intima

RAD is a potent immunosuppressive agent that has been shown to be effective in preventing acute and chronic allograft rejection in animal models. The HMGCoA reductase inhibitors have been found to reduce the incidence of graft vascular disease (GVD) in heart transplant patients and in animal models. This study was designed to investigate the effects of fluvastatin or pravastatin in a rodent model of GVD produced using low doses of RAD to prevent acute rejection.. Hearts from Fisher 344 rats were heterotopically transplanted to Lewis rat recipients. RAD was administered orally at 0.5 mg/kg per day for days 0 to 14 and then 0.25 mg/kg per day for an additional 85 days to prevent acute rejection but allow for the development of GVD. Pravastatin (20 mg/kg per day) or fluvastatin (2 or 6 mg/kg per day) was added to the RAD treatment. At the end of a 100-day treatment period, the hearts were harvested for morphometric and histopathologic examinations.. Rats treated with fluvastatin, at either dose, had a significant (P< or =0.0239) decrease in coronary arterial intimal thickening (GVD) of approximately 43%. Rats treated with pravastatin had a 22% reduction in GVD that did not reach statistical significance. Treatment with fluvastatin, but not pravastatin, decreased the degree of endomyocardial mononuclear cell infiltration seen with RAD administered alone.. Fluvastatin significantly decreased GVD in a rat model produced using low-dose RAD immunosuppression. To a lesser extent, pravastatin also decreased GVD in this model. These data lend further support for the study of fluvastatin, pravastatin, and other HMG-CoA reductase inhibitors for the prevention of GVD in cardiac transplant patients.

Topics: Animals; Coronary Disease; Dose-Response Relationship, Drug; Drug Therapy, Combination; Endocardium; Everolimus; Fatty Acids, Monounsaturated; Fluvastatin; Heart Transplantation; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Immunosuppressive Agents; Indoles; Male; Monocytes; Myocardium; Pravastatin; Rats; Rats, Inbred F344; Rats, Inbred Lew; Sirolimus

Topics: Blood Vessel Prosthesis Implantation; Coronary Disease; Drug Implants; Graft Occlusion, Vascular; Humans; Randomized Controlled Trials as Topic; Sample Size; Sirolimus; Stents; Treatment Outcome; Vascular Patency

Although percutaneous transluminal coronary angioplasty (PTCA) is a highly effective procedure to reduce the severity of stenotic coronary atherosclerotic disease, its long-term success is significantly limited by the high rate of restenosis. Several cellular and molecular mechanisms have been implicated in the development of restenosis post-PTCA, including vascular smooth muscle cell (VSMC) activation, migration, and proliferation. Recently, our group demonstrated that rapamycin, an immunosuppressant agent with antiproliferative properties, inhibits both rat and human VSMC proliferation and migration in vitro. In the present study, we investigated (1) whether rapamycin administration could reduce neointimal thickening in a porcine model of restenosis post-PTCA and (2) the mechanism by which rapamycin inhibits VSMCs in vivo.. PTCA was performed on a porcine model at a balloon/vessel ratio of 1.7+/-0.2. Coronary arteries were analyzed for neointimal formation 4 weeks after PTCA. Intramuscular administration of rapamycin started 3 days before PTCA at a dose of 0.5 mg/kg and continued for 14 days at a dose of 0.25 mg/kg. Cyclin-dependent kinase inhibitor (CDKI) p27(kip1) protein levels and pRb phosphorylation within the vessel wall were determined by immunoblot analysis. PTCA in the control group was associated with the development of significant luminal stenosis 4 weeks after the coronary intervention. Luminal narrowing was a consequence of significant neointimal formation in the injured areas. Rapamycin administration was associated with a significant inhibition in coronary stenosis (63+/-3.4% versus 36+/-4.5%; P<0.001), resulting in a concomitant increase in luminal area (1.74+/-0.1 mm2 versus 3. 3+/-0.4 mm2; P<0.001) after PTCA. Inhibition of proliferation was associated with markedly increased concentrations of the p27(kip1) levels and inhibition of pRb phosphorylation within the vessel wall.. Rapamycin administration significantly reduced the arterial proliferative response after PTCA in the pig by increasing the level of the CDKI p27(kip1) and inhibition of the pRb phosphorylation within the vessel wall. Therefore, pharmacological interventions that elevate CDKI in the vessel wall and target cyclin-dependent kinase activity may have a therapeutic role in the treatment of restenosis after angioplasty in humans.

Topics: Angioplasty, Balloon, Coronary; Animals; Cell Cycle Proteins; Cell Division; Cell Movement; Coronary Disease; Coronary Vessels; Cyclin-Dependent Kinase Inhibitor p27; Cyclin-Dependent Kinases; Humans; Microtubule-Associated Proteins; Phosphorylation; Rats; Retinoblastoma Protein; Sirolimus; Swine; Tumor Suppressor Proteins; Tunica Intima

Chronic graft vascular disease (CGVD) in cardiac allografts has been defined as a slowly evolving vasculopathy unresponsive to conventional immunosuppression. We compared 4 rodent models of CGVD to evaluate the reproducibility of CGVD in heart allografts. Rapamycin (Rapa) and cyclosporine (CSA) were then used to treat CGVD.. Hearts were harvested and placed heterotopically into allogenic recipients. CGVD scores of PVG allografts from ACI recipients treated with CSA on days 1 through 10 were significantly elevated on day 90 (n=16) compared with other models (immunosuppression used): (1) Lewis to F344 recipients (CSA), (2) Brown Norway to Lewis (FK506), and (3) DA to Wistar-Firth (methylprednisolone, azathioprine, CSA). Although delayed (day 60 to 90) CSA treatment had no effect (n=6), delayed Rapa (3 mg. kg-1. d-1 IP) reversed CGVD in PVG grafts (0.22+/-0.19 on day 90, n=6). ACI isografts showed no evidence of CGVD (n=6) at day 90. Immunohistochemistry of PVG grafts revealed perivascular infiltrates consisting of CD4(+) T cells and limited numbers of macrophages persisting up to day 90. Flow cytometry demonstrated increased levels of anti-donor antibody at day 90, which was significantly inhibited by Rapa treatment.. PVG grafts developed a significant increase in CGVD without evidence of ongoing myocardial rejection. This CGVD appeared to be mediated by both cellular and humoral mechanisms, given CD4(+) perivascular infiltrates and increased levels of anti-donor antibody. The anti-CGVD effectiveness of Rapa during a period in which there was little myocardial cellular infiltrate supports a novel mechanism of effect such as smooth muscle or B-cell inhibition.

Topics: Animals; Antibody Formation; Antibody Specificity; Coronary Disease; Cyclosporine; Drug Evaluation, Preclinical; Flow Cytometry; Graft Rejection; Graft vs Host Disease; Heart Transplantation; Histocompatibility; Histocompatibility Antigens; Immunity, Cellular; Immunoglobulin G; Immunosuppressive Agents; Isoantibodies; Male; Nitric Oxide; Rats; Rats, Inbred ACI; Rats, Inbred F344; Rats, Inbred Lew; Rats, Inbred WF; Reproducibility of Results; Sirolimus; Transplantation, Homologous

Topics: Angioplasty, Balloon, Coronary; Animals; Cell Division; Cell Movement; Coronary Disease; Dose-Response Relationship, Drug; Humans; Immunosuppressive Agents; Molecular Biology; Molecular Probes; Polyenes; Recurrence; Retinoblastoma Protein; Sirolimus; Stents; Urban Health

Cardiac allograft vasculopathy is the major cause of graft loss more than 1 year after transplantation. Daily rapamycin dosing has been shown to inhibit arterial intimal thickening caused by both alloimmune and mechanical injury. The combination of a single preoperative dose of rapamycin with a short (7 day) course of cyclosporine A has been shown to extend cardiac allograft survival, but its effects on the development of cardiac allograft vasculopathy has not been reported.. The ACI (RT1(a)) to Lewis (RT1(1)) heterotopic cardiac allograft model was used to assess the development of cardiac allograft vasculopathy and rejection. Treatment groups included nonimmunosuppressed control, cyclosporine A, cyclosporine A/donor-specific transfusion, and rapamycin/cyclosporine A.. The addition of a single preoperative dose of rapamycin to a short course of cyclosporine A significantly reduced the prevalence of cardiac allograft vasculopathy in small (1.18 +/- 1.4 versus 0.05 +/- 0.3; p = 0.0001), medium (2.05 +/- 1.09 versus 0.26 +/- 0.62; p = 0.0001), and large (2.57 +/- 0.84 versus 1.43 +/- 1.2; p = 0.0008) vessels when compared with that in allografts treated with a single preoperative donor-specific transfusion and the same cyclosporine A schedule. Cardiac allograft vasculopathy did not develop in the nonimmunosuppressed control grafts or the group treated with cyclosporine A alone, because of the short survival times in these groups. In addition, there was a reduction of the rejection score in the rapamycin-treated allografts compared with that in the other treatment groups (4.0 +/- 0.0 versus 3.25 +/- 0.5; p = 0.0006).. These results suggest that a single preoperative dose of rapamycin is efficacious in preventing the development of cardiac allograft vasculopathy, and continued immunosuppression with rapamycin may be unnecessary.

Topics: Animals; Coronary Disease; Coronary Vessels; Cyclosporine; Graft Rejection; Graft Survival; Heart Transplantation; Immunosuppressive Agents; Male; Polyenes; Prevalence; Rats; Rats, Inbred ACI; Rats, Wistar; Sirolimus; Transplantation, Homologous