cardiovascular-agents and zotarolimus

Diabetes mellitus (DM) and cardiovascular diseases often co-exist. Today, percutaneous coronary intervention (PCI) is the preferred revascularization procedure for majority of patients with coronary artery disease. Polymer-free amphilimus-eluting stents (AES) represent a novel elution technology in the current era of drug-eluting stents. In this analysis, we aimed to systematically compare the cardiovascular outcomes which are associated with polymer-free amphilimus-eluting stents (AES) versus the durable polymer zotarolimus-eluting stents (ZES) for the treatment of patients with DM.. Http://www.. gov, EMBASE, Web of Science, MEDLINE, Cochrane database and Google Scholar were searched for publications comparing polymer-free AES versus durable polymer ZES in patients with DM. Selective cardiovascular outcomes were assessed. Statistical analysis was carried out by the latest version of the RevMan software. Risk ratio (RR) with 95% confidence interval (CI) was used to represent the data analysis.. Four studies with a total number of 1795 participants with DM whereby 912 patients were assigned to be revascularized by the polymer-free AES and 883 patients were assigned to be revascularized by the durable polymer ZES were included in this analysis. In patients with DM, at one year, polymer-free AES were associated with significantly lower risk of major adverse cardiac events (MACEs) (RR: 0.69, 95% CI: 0.54-0.88; P = 0.002) and target lesion failure (TLF) (RR: 0.66, 95% CI: 0.48-0.91; P = 0.01) compared to durable polymer ZES. However, there was no significant change in all-cause mortality (RR: 0.79, 95% CI: 0.51-1.22; P = 0.28), cardiac death and the other cardiovascular outcomes. Similar risk of total stent thrombosis (RR: 1.13, 95% CI: 0.60-2.13; P = 0.70), including definite stent thrombosis (RR: 1.12, 95% CI: 0.38-3.31; P = 0.84), probable stent thrombosis (RR: 0.87, 95% CI: 0.37-2.09; P = 0.76), possible stent thrombosis (RR: 1.19, 95% CI: 0.50-2.87; P = 0.69) and late stent thrombosis (RR: 1.00, 95% CI: 0.17-5.72; P = 1.00) as between polymer-free AES and durable polymer ZES in patients with DM.. At 1 year follow-up, polymer-free AES were associated with significantly lower MACEs and TLF compared to durable polymer ZES in these patients with DM, without any increase in mortality, stent thrombosis and other cardiovascular outcomes. However, this analysis is only based on a follow-up time period of one year, therefore, future research should focus on the long term follow-up time period.

Topics: Cardiovascular Agents; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Treatment Outcome

Two thousand fifteen has been a winning year for Drug Eluting Stents (DES). Increase in the number of patients with cardiovascular diseases treated by Percutaneous Coronary Intervention (PCI) has resulted to a high demand for second generation DES. This current analysis aimed to compare the different types of Stent Thrombosis (ST) associated with Zotarolimus Eluting Stents (ZES) versus Everolimus Eluting Stents (EES) at 1 year follow up.. Electronic databases were searched for studies comparing ZES with EES. Different types of ST reported at 1 year follow up were considered as the primary endpoints in this analysis. Odds Ratios (OR) with 95% Confidence Intervals (CIs) were used as the statistical parameters and the pooled analyses were carried out by the RevMan 5 · 3 software.. A total number of 10,512 patients were included in this analysis. No significant difference in any definite ST, acute definite ST, subacute definite ST, and late definite ST were observed between ZES and EES, at 1 year follow up with OR: 1.70, 95% CI: 0.92 - 3.16; P = 0.09, OR: 3.44, 95% CI: 0.82 - 14.43; P = 0.09, OR: 1.13, 95% CI: 0.43 - 2.95; P = 0.80 and OR: 2.39, 95% CI: 0.83 - 6.85; P = 0.11 respectively. Moreover, any definite or probable ST and definite/probable/possible ST were also not significantly different with OR: 1.39, 95% CI: 0.89 - 2.17; P = 0.15 and OR: 1.19, 95% CI: 0.84 - 1.70; P = 0.33 respectively. In addition, any probable ST, acute probable ST, late probable ST and possible ST were also not significantly different at 1 year follow up with OR: 1.11, 95% CI: 0.60 - 2.05; P = 0.75, OR: 0.53, 95% CI: 0.12 - 2.40; P = 0.41, OR: 1.67, 95% CI: 0.35 - 7.86; P = 0.52 and OR: 1.08, 95% CI: 0.64 - 1.82; P = 0.78 respectively.. At 1 year follow up, ZES were not associated with significantly lower or higher definite and probable ST compared to EES. In addition, no significant difference was observed in acute, subacute and late definite or probable ST. However, further trials are recommended to assess the effects of these second-generation DES during the long-term.

Topics: Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Compared with the zotarolimus-eluting stent (ZES), the everolimus-eluting stent (EES) has reduced the risk of stent restenosis and thrombosis as found in a number of randomized-controlled trials (RCTs). However, the benefits have been variable.. We evaluate the long-term effect of EES and ZES on the risk of stent thrombosis and target lesion revascularization in patients receiving PCI. We identified RCTs by a systematic search of MEDLINE, EMBASE, and Cochrane Database.. Five RCTs (9853 patients) were included. Overall, EES significantly reduced the risk of target lesion revascularization [odds ratio (OR), 0.77; 95% confidence interval (CI), 0.62-0.95; P=0.01] compared with ZES therapy. However, there was no difference in the risk of target vessel revascularization (OR, 0.93; 95% CI, 0.78-1.10; P=0.38) and definite/probable stent thrombosis (OR, 0.83; 95% CI, 0.56-1.25; P=0.37) between the two groups. Furthermore, the risk of mortality (OR, 1.04; 95% CI, 0.84-1.27; P=0.73), myocardial infarction (OR, 0.95; 95% CI, 0.74-1.23; P=0.70), and major adverse cardiac event (OR, 0.96; 95% CI, 0.84-1.10; P=0.53) was similar between the two groups.. The new-generation Resolute-ZES and EES have a similar long-term safety and efficacy profile.

Topics: Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The purpose of this study was to investigate the differential clinical outcomes after percutaneous coronary intervention (PCI) for coronary bifurcation lesions with 1- or 2-stenting techniques using first- or second-generation drug-eluting stents (DES).. The 2-stenting technique has been regarded to have worse clinical outcomes than the 1-stenting technique after bifurcation PCI with first-generation DES. However, there has been a paucity of data comparing the 1- and 2-stenting techniques with the use of second-generation DES.. Patient-level pooled analysis was performed with 3,162 patients undergoing PCI using first- or second-generation DES for bifurcation lesions from the "Korean Bifurcation Pooled Cohorts" (COBIS [Coronary Bifurcation Stenting] II, EXCELLENT [Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting], and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]). The 3-year clinical outcomes were compared between 1- and 2-stenting techniques, stratified by the type of DES.. With first-generation DES, rates of target lesion failure (TLF) or patient-oriented composite outcome (POCO) (a composite of all death, any myocardial infarction, any repeat revascularization, and cerebrovascular accidents) at 3 years were significantly higher after the 2-stenting than the 1-stenting technique (TLF 8.6% vs. 17.5%; p < 0.001; POCO 18.1% vs. 28.5%, p < 0.001). With second-generation DES, however, there was no difference between 1- and 2-stenting techniques (TLF 5.4% vs. 5.8%; p = 0.768; POCO 11.2% vs. 12.9%; p = 0.995). The differential effects of 2-stenting technique on the prognosis according to the type of DES were also corroborated with similar results by the inverse probability weighted model. The 2-stenting technique was a significant independent predictor of TLF in first-generation DES (hazard ratio: 2.046; 95% confidence interval: 1.114 to 3.759; p < 0.001), but not in second-generation DES (hazard ratio: 0.667; 95% confidence interval: 0.247 to 1.802; p = 0.425).. Patient-level pooled analysis of 3,162 patients in Korean Bifurcation Pooled Cohorts demonstrated that the 2-stenting technique showed comparable outcomes to 1-stenting technique with second-generation DES, which is different from the results of first-generation DES favoring the 1-stenting technique.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to investigate the relative safety and efficacy of bioabsorbable polymer (BP)-based biolimus-eluting stents (BES) versus durable-polymer (DP)-drug-eluting stents (DES) and bare-metal stents (BMS) by means of a network meta-analysis.. Studies have suggested that BP-BES might reduce the risk of stent thrombosis (ST) and late adverse outcomes compared with first-generation DES. However, the relative safety and efficacy of BP-BES versus newer-generation DES coated with more biocompatible DP have not been investigated in depth.. Randomized controlled trials comparing BP-BES versus currently U.S.-approved DES or BMS were searched through MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted.. Data from 89 trials including 85,490 patients were analyzed. At 1-year follow-up, BP-BES were associated with lower rates of cardiac death/myocardial infarction (MI), MI, and target vessel revascularization (TVR) than BMS and lower rates of TVR than fast-release zotarolimus-eluting stents. The BP-BES had similar rates of cardiac death/MI, MI, and TVR compared with other second-generation DP-DES but higher rates of 1-year ST than cobalt-chromium everolimus-eluting stents (CoCr-EES). The BP-BES were associated with improved late outcomes compared with BMS and paclitaxel-eluting stents, considering the latest follow-up data available, with nonsignificantly different outcomes compared with other DP-DES although higher rates of definite ST compared with CoCr-EES.. In this large-scale network meta-analysis, BP-BES were associated with superior clinical outcomes compared with BMS and first-generation DES and similar rates of cardiac death/MI, MI, and TVR compared with second-generation DP-DES but higher rates of definite ST than CoCr-EES.

Topics: Cardiovascular Agents; Chromium Alloys; Coated Materials, Biocompatible; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Polymers; Randomized Controlled Trials as Topic; Sirolimus; Stents

Over the past decades, there has been significant evolution in coronary stents used in percutaneous coronary intervention. The current novel drug-eluting stents available in the United States represent significant advancements compared to angioplasty, bare-metal stents, and the first generation of drug-eluting stents (DES). The Xience everolimus-eluting stents, Promus everolimus-eluting stents, and Resolute zotarolimus-eluting stents currently demonstrate the optimal balance of safety and efficacy. Endeavor zotarolimus-eluting stents have shorter drug-elution courses, and recent evidence suggests that 3 months of dual antiplatelet therapy appears safe, making Endeavor preferred when early discontinuation of dual antiplatelet therapy is warranted. Despite these advances in stent design, the permanent polymer and metallic stent remain in the vessel wall and may precipitate sustained inflammation, persistent vasomotor dysfunction, and in-stent neo-atherosclerosis. Bioresorbable platforms with biodegradable polymers have been developed to overcome the aforementioned limitations, and the outcomes of ongoing clinical trials are eagerly anticipated to determine if these novel stents will further improve clinical outcomes.

Topics: Absorbable Implants; Animals; Cardiovascular Agents; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Treatment Outcome

The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes.. The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes.. We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years.. The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%).. The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Medtronic RESOLUTE Clinical Trial; NCT00248079; Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; The Medtronic RESOLUTE US Clinical Trial (R-US); NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [R-Int]; NCT00752128; RESOLUTE Japan-The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent [RJ]; NCT00927940).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Device Approval; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States; United States Food and Drug Administration

Exaggerated neointimal hyperplasia is considered as the primary mechanism for increased restenosis in patients with diabetes mellitus (DM) treated with bare-metal stent. However, the vessel response in DM and non-DM treated with different drug-eluting stents (DES) has not been systematically evaluated.. We investigated 3D intravascular ultrasound (postprocedure and 6 to 9 months) in 971 patients (267 with DM and 704 without DM) treated with sirolimus- (n=104), paclitaxel- (n=303), zotarolimus- (n=391), or everolimus- (n=173) eluting stents. Volumetric data were standardized by length as volume index (VI). At postprocedure, lumen VI at the stented segment was significantly smaller in DM than in non-DM, whereas vessel VI was similar between the 2 groups. At follow-up, neointimal obstruction and maximum cross-sectional narrowing (neointimal area/stent area) were not significantly different between the 2 groups with no interaction for the DES type. Consequently, lumen VI was smaller in DM than in non-DM at follow-up. In the reference segments, residual plaque burden at postprocedure was significantly greater in DM than in non-DM, although change in lumen VI was similar between the 2 groups. The arterial responses at the reference segments also showed no interaction for the DES type.. DM and non-DM lesions showed similar vessel response in both in-stent and reference segments regardless of the DES type. In the DES era, the follow-up lumen in DM patients seems to be determined primarily by the smaller lumen at postprocedure rather than exaggerated neointima within the stent or plaque proliferation at the reference segments.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Linear Models; Male; Middle Aged; Multicenter Studies as Topic; Multivariate Analysis; Neointima; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The elevated risk of adverse events following percutaneous coronary intervention in diabetic patients persists with newer-generation DES. The polymer-free amphilimus-eluting stent (PF-AES) possesses characteristics with a potentially enhanced performance in patients with diabetes. Data from the 1-year follow-up period has been previously published. The aim of this subanalysis was to assess long-term performance of two contemporary drug-eluting stents (DES) in a diabetic population.. In the ReCre8 trial, patients were stratified for diabetes and troponin status, and randomized to implantation of a permanent polymer zotarolimus-eluting stent (PP-ZES) or PF-AES. The primary endpoint was target-lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization. Clinical outcomes between discharge and 3 years follow-up were assessed.. A total of 302 patients with diabetes were included in this analysis. After 3 years, TLF occurred in 12.5% of PP-ZES patients versus 10.0% in PF-AES patients (p = 0.46). Similarly, the separate components of TLF were comparable between the two study arms. The secondary composite endpoint of NACE was higher in the PP-ZES arm with 45 cases (29.6%) versus 30 cases (20.0%) in the PF-AES arm (p = 0.036). In the insulin-dependent diabetic population, TLF occurred in 19.1% of PP-ZES patients versus 10.4% of PF-AES patients (p = 0.21). NACE occurred in 40.4% of PP-ZES patients versus 27.1% of PF-AES patients (p = 0.10).. This subanalysis shows that the use of PF-AES results in similar clinical outcomes as compared to PP-ZES, yet some benefits of use of PF-AES in diabetic patients may prevail. Future dedicated trials should confirm these findings.

Topics: Cardiovascular Agents; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Follow-Up Studies; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Treatment Outcome

We compared long-term clinical outcomes between patients treated with Orsiro sirolimus-eluting stent (O-SES) and those treated with durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES).. The ORIENT trial was a randomized controlled noninferiority trial to compare angiographic outcomes between O-SES and R-ZES. We performed a post hoc analysis of 3-year clinical outcomes and included 372 patients who were prospectively enrolled and randomly assigned to O-SES (n = 250) and R-ZES (n = 122) groups in a 2:1 ratio. The primary endpoint was target lesion failure defined as a composite of cardiac death, nonfatal myocardial infarction, and target lesion revascularization. At 3 years, target lesion failure occurred in 4.7% and 7.8% of O-SES and R-ZES groups, respectively (hazard ratio, 0.58; 95% confidence intervals, 0.24-1.41; p = .232 by log-rank test). Secondary endpoints including cardiac death, myocardial infarction, and target lesion revascularization showed no significant differences between the groups. Stent thrombosis occurred in two patients in R-ZES group (0.0% vs. 1.6%, p = .040).. This study confirms long-term safety and efficacy of the two stents. We found a trend for lower target lesion failure with O-SES compared to R-ZES, although statistically insignificant.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Time Factors; Treatment Outcome

There is limited data comparing the Xience everolimus-eluting stent (EES) and the Resolute zotarolimus-eluting stent (ZES) with the BioMatrix biolimus-eluting stent (BES).. This open-label, randomized, noninferiority trial enrolled all-comer patients to be randomly treated with either BES, EES, or ZES in a 1:1:1 ratio in 15 centers across South Korea. The primary end point was a device-oriented composite outcome consisting of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization at 24 months. The BES was compared with the EES and the ZES by intention-to-treat analyses with a noninferiority margin of 3.8%, respectively.. Because of slow recruitment and low event rates, this trial was prematurely terminated after enrollment of 1935 (75%) of the intended 2580 patients. Of the 1911 patients randomized to either EES (n=638), BES (n=634), or ZES (n =639), the rate of device-oriented composite outcome was 3.6%, 2.2%, and 3.9%, respectively, at 24 months (BES versus EES: absolute risk difference -1.4% [upper limit of 1-sided 95% CI: -3.2%];. The BES was noninferior to either the EES or the ZES in all-comer patients for device-oriented composite outcome at the 24-month follow-up. However, caution is advised regarding interpretation of these results due to the premature termination of this study. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01397175.

Topics: Aged; Cardiovascular Agents; Drug-Eluting Stents; Early Termination of Clinical Trials; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Ischemia; Percutaneous Coronary Intervention; Prosthesis Design; Recurrence; Republic of Korea; Risk Factors; Sirolimus; Treatment Outcome

The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis.. The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates.. A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods.. Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]).. At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.

Topics: Aged; Belgium; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Israel; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second-generation Resolute™ zotarolimus-eluting stent (R-ZES) in patients enrolled in the DAPT-STEMI Trial (NCT01459627).. R-ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited.. The Resolute-STEMI is a prespecified prospective register that reports the safety and efficacy of R-ZES in setting of ST-Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all-cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST).. From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R-ZES. At 6 months the PE occurred in 42 (4.2%) patients. All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%.. The present analysis is the largest to date reporting short-term and mid-term clinical outcomes with the R-ZES stent in setting of STEMI. At 30 days and 6-months R-ZES has an outstanding safety and efficacy even in this high-risk category of patients.

Topics: Aged; Cardiovascular Agents; Cause of Death; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Assessment; Risk Factors; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES).. The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.. A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis.. Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (p. Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution technology in the current era of drug-eluting stents. The clinical safety and efficacy of PF-AES as compared with latest-generation permanent-polymer zotarolimus-eluting stents (PP-ZES) have not yet been investigated in a large randomized trial.. In this physician-initiated, prospective, multicenter, randomized, noninferiority trial, an all-comers population requiring percutaneous coronary intervention was enrolled across 3 European sites. Randomization (1:1 ratio) to PP-ZES or PF-AES was performed after stratification for troponin status and diabetes mellitus. In both treatment arms, troponin-positive patients were planned for 12-month dual antiplatelet therapy, whereas troponin-negative patients were planned for 1-month dual antiplatelet therapy. Outcome assessors were blinded to the allocated treatment. The device-oriented primary end point of target-lesion failure was defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization at 12-months as analyzed by modified intention-to-treat (80% power, and a 3.5% noninferiority margin).. In total, 1502 patients were randomized and 1491 treated with the assigned stent and available for follow-up. The primary end point occurred in 42 (5.6%) of the 744 patients receiving PP-ZES versus 46 (6.2%) of the 747 patients receiving PF-AES. PF-AES were clinically noninferior to PP-ZES (risk difference, 0.5%; upper limit 1-sided 95% confidence interval, 2.6%; P. PF-AES were noninferior to PP-ZES regarding target-lesion failure at 12 months. Findings regarding the secondary end point and prespecified subgroups were generally consistent with that of the primary end point.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02328898.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Angina, Unstable; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Amphilimus sirolimus-eluting stents (A-SES) represent a novel elution technology in the current era of drug-eluting stents with promising results in patients with diabetes mellitus. At present no large trial has been designed to evaluate clinical outcomes of A-SES as compared to new-generation drug-eluting stents in unselected patients. Accordingly, we designed this trial to evaluate clinical noninferiority of A-SES as compared with zotarolimus-eluting stents (ZES) in a real-world, all-comers setting.. ReCre8 is a prospective multicenter randomized clinical trial evaluating the clinical outcomes of A-SES as compared with ZES in all-comers requiring percutaneous coronary intervention. Patients are randomized 1:1 to receive either A-SES or ZES. On-site block-randomization is stratified by diabetes mellitus, and troponin status to perform prespecified subanalyses. Patients receive 1-month of dual antiplatelet therapy (DAPT) when troponin-negative, or 12-months of DAPT when troponin-positive. The primary endpoint is target-lesion failure at 1-year follow-up. A total of 1,532 patients will be enrolled to demonstrate clinical noninferiority of A-SES with at least 80% power, a noninferiority margin of 3.5% and a type-I-error of 0.05.. ReCre8 (NCT02328898) is the first randomized multicenter trial with a head-to-head comparison of A-SES as compared with ZES to investigate the clinical safety and efficacy of these new-generation DES in a real-world, all-comers population.

Topics: Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Equivalence Trials as Topic; Humans; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To assess the safety and efficacy of the novel Resolute (R-) Onyx drug-eluting stent (DES).. The R-Onyx DES consists of a composite wire with an outer shell of cobalt chromium alloy and a platinum-iridium inner core to enhance radiopacity, with thinner, swaged struts and modified stent geometry compared with the predicate Resolute DES, resulting in a slightly lower total drug load in most sizes.. This was a prospective, single-arm non-inferiority trial compared with a historical control. Patients with stable angina/ischemia and up to 2 de novo target lesions ≤35 mm long with reference vessel diameter (RVD) of 2.25-4.2 mm were enrolled. The primary endpoint was late lumen loss at 8-month follow-up. Propensity-score adjusted outcomes from the single-arm RESOLUTE-US trial served as the control.. Seventy-five patients (85 lesions) were enrolled. Mean patient age was 66 ± 9 years, 73% were male, and 32% had diabetes. Mean lesion length was 14.28 ± 6.68 mm, mean RVD was 2.57 ± 0.48 mm, and 86% of lesions were class B2/C. In-stent late lumen loss at 8 months was 0.24 ± 0.39 mm with R-Onyx DES compared with 0.36 ± 0.52 mm with Resolute DES (P < 0.001 for noninferiority, P = 0.029 for superiority). At 8 months, clinically driven target lesion revascularization occurred in 3 patients (4.0%) and target lesion failure occurred in 5 patients (6.7%).. In-stent late lumen loss is non-inferior, and appears to be superior, with the thin-strut novel composite wire R-Onyx DES compared with Resolute DES. Continued evolution of stent design can improve angiographic outcomes in complex lesions, even in the current era of next-generation DES.

Topics: Aged; Angina, Stable; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Iridium; Male; Middle Aged; Percutaneous Coronary Intervention; Platinum; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

There are few randomised studies concerning the optimal duration of dual antiplatelet therapy (DAPT) for patients who receive a second-generation drug-eluting stent (DES). This trial aimed to investigate the safety of six-month compared with 12-month DAPT maintenance after second-generation DES implantation.. A prospective, randomised, multicentre trial was performed at 10 medical centres. The 1,368 patients included in the study received a biolimus-eluting stent (BES) or a zotarolimus-eluting stent (ZES). The primary outcome measured was the composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), or ischaemia-driven target lesion revascularisation at the 12-month follow-up. The secondary outcome was the percentage of uncovered struts at six months in 60 patients (30 ZES, 30 BES) using optical coherence tomography (OCT) assessment. Each patient was randomly assigned to six-month (n=684) or 12-month DAPT (n=684). Major adverse cardiac events at 12 months occurred in eight patients (1.2%) in the six-month DAPT group and in four patients (0.6%) in the 12-month DAPT group (risk difference 0.6%; 95% confidence interval [CI]: -0.4-1.6%; p=0.24). The upper 95% CI limit was lower than the pre-specified limit of 4% non-inferiority (p for non-inferiority <0.05). The percentage of uncovered struts was 3.16±4.30% at six months in 60 stents of 60 patients.. After second-generation DES implantation, six-month DAPT was not inferior to 12-month DAPT in terms of MACE occurrence over the 12-month follow-up period. OCT examination revealed favourable stent strut coverage at six months after stent implantation.

Topics: Aged; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).. The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.. In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.. Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; p. At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Durable polymers used in drug-eluting stents are considered a potential cause of hypersensitivity inflammatory response adversely affecting stent healing. Using a sequential follow-up with optical coherence tomography, we compared the differences in healing profiles of 2 drug-eluting stents with a biodegradable or durable polymer.. Sixty patients with multivessel disease were prospectively enrolled to receive both study stents, which were randomly assigned to 2 individual vessels, a Resolute Integrity zotarolimus-eluting stent with a durable BioLinx polymer and a BioMatrix NeoFlex Biolimus A9-eluting stent with a biodegradable polylactic acid polymer. Optical coherence tomography was performed at baseline, then in 5 randomly assigned monthly groups at 2 to 6 months, and at 9 months in all patients. The primary end point was the difference in optical coherence tomography strut coverage at 9 months. Key secondary end points included angiographic late lumen loss and composite major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, and definite or probable stent thrombosis) at 9 months. Resolute Integrity zotarolimus-eluting stent showed significantly better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent at 2 to 6 months (. Despite having a durable polymer, Resolute Integrity zotarolimus-eluting stent exhibited better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent having a biodegradable polymer; both showed similar antiproliferative efficacy. This novel, longitudinal, sequential optical coherence tomography protocol using each patient as own control could achieve conclusive results in small sample size.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01742507.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Hong Kong; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD).. Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established.. In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter ≥2.25 and ≤2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis.. Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 ± 2.0% with the DCB versus 24.1 ± 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority < 0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72).. In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial.. Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI).. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years.. The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients.. Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prevalence; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD).. Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation.. This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure.. A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%.. In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501).

Topics: Aged; Angina, Stable; Angina, Unstable; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; United States

Patients with ST-segment elevation myocardial infarction (STEMI) undergoing drug-eluting stent (DES) implantation are at increased risk of late adverse events, partly explained by an exaggerated inflammatory reaction to durable-polymer stent coatings.. We sought to investigate whether implantation of polymer-free DES would reduce this risk.. In the ISAR-TEST 5 (the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents) trial, patients were randomly allocated to receive a polymer-free sirolimus- and probucol-eluting stent or a new generation durable-polymer zotarolimus-eluting stent. We analyzed late clinical outcomes in the subgroup of patients presenting with STEMI. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction or target lesion revascularization at 5 years.. 311 patients with STEMI were randomized to receive sirolimus- and probucol-eluting stents (n = 215) or zotarolimus-eluting stents (n = 96). At 5 years, there was no difference in the incidence of the primary endpoint in patients treated with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents (18.3% versus 20.1% respectively, hazard ratio = 0.87, 95% CI, 0.50-1.51; P = 0.62). Rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite/probable stent thrombosis was 1.4% versus 1.0% respectively (hazard ratio = 1.35, 95% CI, 0.14-12.94, P = 0.80).. Long-term outcomes of patients with STEMI treated with polymer-free sirolimus- and probucol-eluting stents versus durable-polymer zotarolimus-eluting stents were similar. Stent thrombosis rates were low and comparable in both treatment groups, with no events beyond 12 months.. Registered at ClinicalTrials.gov (Identifier NCT 00598533) © 2016 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Probucol; Proportional Hazards Models; Prosthesis Design; Recurrence; Risk Factors; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients.. Biodegradable-polymer biolimus-eluting stents are superior to first-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking.. The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target lesion revascularization); the individual endpoints of MACE; all-cause mortality; any myocardial infarction; target vessel revascularization; and definite or probable stent thrombosis at 36 months.. From March 2011 to August 2012, 2,999 patients were randomly assigned (1:1) to receive either the zotarolimus-eluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.36). Occurrence of cardiac death (2.7% vs. 3.4%), myocardial infarction not clearly attributable to a non-target lesion (2.7% vs. 2.5%), and target lesion revascularization (5.4% vs. 5.5%) did not differ significantly between the 2 groups. Definite very late stent thrombosis occurred in 6 (0.4%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 10 (0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33).. At 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome, with no significant difference in safety and efficacy outcomes, including stent thrombosis.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Denmark; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Incomplete neointimal coverage and malapposed struts after stenting are associated with increased risk of stent thrombosis. We aimed to evaluate neointimal coverage early after Resolute zotarolimus-eluting stent (R-ZES) implantation using optical coherence tomography (OCT). A total of 20 patients with de novo native coronary lesions with R-ZES were enrolled. Among these patients, 20 stented lesions in 19 patients were evaluated at 1, 2, and 3 months after R-ZES implantation. The strut apposition and neointimal coverage were evaluated by OCT. Neointimal hyperplasia (NIH) thickness and percentage of covered struts and the proportion of incompletely apposed struts were measured at 1-mm intervals. The mean percentages of covered stent struts were over 85 % within 3 months (88.4 ± 6.3 % at 1 month, 95.5 ± 5.5 % at 2 months, 93.6 ± 3.5 % at 3 months). The percentages of incompletely apposed struts were not significantly different among the groups (4.4 ± 4.2 % at 1 month, 1.9 ± 1.9 % at 2 months, 3.1 ± 2.2 % at 3 months, p = 0.51). Mean NIH thickness (38.9 ± 8.1 μm at 1 month, 70.6 ± 18.8 μm at 2 months, 54.1 ± 5.9 at 3 months, p = 0.0016) was thickest in the 2 months group. Most of all OCT findings within 2 months demonstrated neointimal coverage with low signal intensity. The neointimal coverage of ZES-R was over 85 % within 3 months. These data may support shorter requirement of dual antiplatelet therapy duration with R-ZES.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Percutaneous coronary intervention (PCI) in bifurcated lesions with second-generation drug-eluting stents (DES) was associated with increased myocardial infarction (MI) rates. Flexible stent designs that accommodate well to vessel tapering may be of benefit in challenging anatomies such as bifurcated target lesions, but so far data are scarce.. We analyzed the 2-year follow-up data of the DUTCH PEERS (TWENTE II) trial, which randomized 1811 all-comer patients to PCI with newer generation resolute integrity zotarolimus-eluting (Medtronic) or promus element everolimus-eluting stents (Boston Scientific). In bifurcated lesions, provisional stenting was generally performed. Target vessel failure is a composite endpoint, consisting of cardiac death, target vessel MI, or target vessel revascularization.. Patients with at least one bifurcated lesion (n = 465, 25.7 %) versus patients with non-bifurcated target lesions only (n = 1346, 74.3 %) showed similar rates of clinical endpoints including target vessel failure (9.2 versus 7.9 %, p = 0.36) and definite stent thrombosis (0.4 versus 1.0 %, p = 0.38). Target vessel MI was more common in patients with bifurcated lesions (3.4 versus 1.6 %, p = 0.02); but after multivariate analysis with propensity score adjustment, bifurcation treatment was found not to be an independent predictor of target vessel MI (HR 1.40, 95 % CI 0.71-2.76; p = 0.34). Among patients with bifurcated lesions, DES type and side-branch size did not affect outcome, but periprocedural MI occurred more often after two-stent approaches (9.0 versus 2.1 %; p = 0.002).. All-comer patients treated for bifurcated and non-bifurcated target lesions showed similar and low rates of clinical endpoints, suggesting that the DES used are efficacious and safe for treating bifurcated target lesions.

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

To compare the incidence and predictors of target lesion revascularisation (TLR) and non-TLR after percutaneous coronary intervention with drug-eluting stents (DES).. We pooled patient-level data on 6,137 patients (Resolute zotarolimus-eluting stent: 5,016, XIENCE everolimus-eluting stent: 1,121) in the RESOLUTE Global Program. At three years, clinically driven TLR, unplanned non-TLR, and no revascularisation occurred in 186, 618, and 5,333 patients, respectively. On multivariate analysis, predictors of both TLR and non-TLR were pre-procedure diameter stenosis (%) (odds ratio [OR] 1.01, 95% confidence interval [CI] [1.01-1.02], and OR 0.99 [0.99-1.00]), diabetes (OR 1.46 [1.07-1.99], and OR 1.37 [1.15-1.64]), and prior PCI (OR 1.42 [1.01-2.00], and OR 1.41 [1.18-1.68]). Baseline characteristics associated with TLR only were prior coronary artery bypass graft surgery (OR 2.85 [1.91-4.27]), in-stent restenosis (OR 2.35 [1.43-3.83]), age (OR 0.98 per year [0.97-1.00]), hypertension (OR 1.64 [1.10-2.44]), and pre-procedure reference vessel diameter (OR 0.74 per mm [0.55-0.99]). Baseline characteristics associated with non-TLR only were lesion location (left anterior descending vs. all others) (OR 0.70 [0.59-0.83]), and hyperlipidaemia (OR 1.42 [1.15-1.75]).. The cumulative incidence of non-TLR at three years in patients treated with current-generation DES was almost three times higher than TLR.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study evaluated coronary endothelial function after the implantation of sirolimus-eluting stents (SESs), everolimus-eluting stents (EESs), and zotarolimus-eluting stents (ZES) by a different methodology, and also analyzed whether optical coherence tomography (OCT) findings represent endothelial healing after stenting.. It is unclear whether OCT assessment of stent strut coverage represents endothelial healing after drug-eluting stent implantation.. Thirty patients with a left anterior descending artery lesion were randomized 1:1:1 to receive an SES, EES, or ZES. The vascular response was evaluated 6 months after stenting by three methods: the functional response by acetylcholine infusion, the morphological response by OCT, and the biological response by measuring vascular endothelial growth factor (VEGF) levels.. The proportion of uncovered struts by OCT at 6 months was significantly higher in both SES and EES than in ZES. However, the vasomotor response was impaired and the VEGF level of the coronary sinus was significantly lower in SES than in EES and ZES. There were no relationships between the OCT findings and vasomotor response to acetylcholine and VEGF levels in all cohorts.. The vascular response at 6 months was more preserved in ZES and EES than in SES. Our results suggest that the morphological assessment with OCT may not always be used as a surrogate for functional and biological healing response after stenting. © 2015 Wiley Periodicals, Inc.

Topics: Acetylcholine; Aged; Aged, 80 and over; Biomarkers; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Everolimus; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Endothelial Growth Factor A; Vasodilation; Vasodilator Agents; Wound Healing

In percutaneous coronary intervention (PCI) patients new-generation drug-eluting stent (DES) has reduced adverse events in comparison to early-generation DES. The aim of the current study was to investigate the long-term clinical efficacy and safety of new-generation DES versus early-generation DES for PCI of unprotected left main coronary artery (uLMCA) disease.. The patient-level data from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 randomized trials were pooled. The clinical outcomes of PCI patients assigned to new-generation DES (everolimus- or zotarolimus-eluting stent) versus early-generation DES (paclitaxel- or sirolimus-eluting stent) were studied. The primary endpoint was the composite of death, myocardial infarction (MI), target lesion revascularization and stroke (MACCE, major adverse cardiac and cerebrovascular event).. In total, 1257 patients were available. At 3 years, the risk of MACCE was comparable between patients assigned to new-generation DES or early-generation DES (28.2 versus 27.5 %, hazard ratio-HR 1.03, 95 % confidence intervals-CI 0.83-1.26; P = 0.86). Definite/probable stent thrombosis was low and comparable between new-generation DES and early-generation DES (0.8 versus 1.6 %, HR 0.52, 95 % CI 0.18-1.57; P = 0.25); in patients treated with new-generation DES no cases occurred beyond 30 days. Diabetes increased the risk of MACCE in patients treated with new-generation DES but not with early-generation DES (P interaction = 0.004).. At 3-year follow-up, a PCI with new-generation DES for uLMCA disease shows comparable efficacy to early-generation DES. Rates of stent thrombosis were low in both groups. Diabetes significantly impacts the risk of MACCE at 3 years in patients treated with new-generation DES for uLMCA disease. ClinicalTrials.gov Identifiers: NCT00133237; NCT00598637.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Germany; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Stroke; Time Factors; Treatment Outcome

The objective of this study is to assess 3-year clinical outcome of patients with true bifurcation lesions (TBLs) versus non-true bifurcation lesions (non-TBLs) following treatment with second-generation drug-eluting stents (DES). TBLs are characterized by the obstruction of both main vessel and side-branch. Limited data are available on long-term clinical outcome following TBL treatment with newer-generation DES. We performed an explorative sub-study of the randomized TWENTE trial among 287 patients who had bifurcated target lesions with side-branches ≥2.0 mm. Patients were categorized into TBL (Medina classes: 1.1.1; 1.0.1; 0.1.1) versus non-TBL to compare long-term clinical outcome. A total of 116 (40.4 %) patients had TBL, while 171 (59.6 %) had non-TBL only. Target-lesion revascularization rates were similar (3.5 vs. 3.5 %; p = 1.0), and definite-or-probable stent thrombosis rates were low (both <1.0 %). The target-vessel myocardial infarction (MI) rate was 11.3 versus 5.3 % (p = 0.06), mostly driven by (periprocedural) MI ≤48 h from PCI. All-cause mortality and cardiac death rates were 8.7 versus 3.5 % (p = 0.06) and 3.5 versus 1.2 % (p = 0.22), respectively. The 3-year major adverse cardiac event rate for patients with TBL versus non-TBL was 20.0 versus 11.7 % (p = 0.05). At 1-, 2-, and 3-year follow-up, 6.5, 13.0, and 11.0 % of patients reported chest pain at less than or equal moderate physical effort, respectively, without any between-group difference. Patients treated with second-generation DES for TBL had somewhat higher adverse event rates than patients with non-TBL, but dissimilarities did not reach statistical significance. Up to 3-year follow-up, the vast majority of patients of both groups remained free from chest pain.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease.. DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns.. The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization.. Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups.. Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Metals; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this study was to evaluate the late clinical performance of a polymer-free sirolimus- and probucol-eluting stent compared with a new-generation durable polymer-based zotarolimus-eluting stent.. It was previously shown that polymer-free sirolimus- and probucol-eluting stents were noninferior to zotarolimus-eluting stents at 12 months. However, long-term follow-up of these devices is critical to evaluate late comparative efficacy.. In a clinical trial with minimal exclusion criteria, 3,002 patients were randomly assigned to treatment with polymer-free sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization.. At 5 years, there was no difference in the incidence of the primary endpoint between sirolimus- and probucol-eluting stents and zotarolimus-eluting stents (23.8% vs. 24.2%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.84 to 1.15; p = 0.80). The rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite or probable stent thrombosis was low in both groups (1.3% vs. 1.6%, respectively; hazard ratio: 0.86; 95% confidence interval: 0.46 to 1.62; p = 0.64). The rates of any death, myocardial infarction, and revascularization were similar in both groups. Results were consistent across pre-specified subgroups of age, sex, diabetes, and vessel size.. Long-term outcomes of patients treated with polymer-free sirolimus- and probucol-eluting stents compared with a new-generation durable polymer-based zotarolimus-eluting stent were similar. Rates of stent thrombosis were low and comparable in both treatment groups, with few events beyond 12 months. (Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis [ISAR-TEST-5]; NCT00598533).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Probucol; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial.. In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan-Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models.. A total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76-1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63-1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40-1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72-1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41-2.52).. In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent. Trial registration ClinicalTrials.gov NCT00598533. Registered 10 January 2008.

Topics: Aged; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Diabetic Angiopathies; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Probucol; Proportional Hazards Models; Prosthesis Design; Retreatment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We examined long-term outcomes after implantation of the Resolute zotarolimus-eluting stent (R-ZES) in ST-segment elevation acute myocardial infarction (STEMI) patients.. We compared long-term outcomes of STEMI patients undergoing primary angioplasty <12 hours from symptom onset who were randomised to the R-ZES (n=122) or the everolimus-eluting stent (EES, n=158) in the RESOLUTE All Comers Trial after propensity score adjustment. The five-year cumulative incidence of target lesion failure (TLF) was 7.6% versus 10.4% among patients treated with R-ZES versus EES, respectively, (adjusted p=0.304), and comprised clinically driven target lesion revascularisation (TLR, 2.5% versus 2.0%, adjusted p=0.766) and cardiac death/target vessel MI (5.1% versus 9.1%, adjusted p=0.123). The five-year cumulative incidence of stent thrombosis was 0.8% for R-ZES patients versus 1.3% for EES patients (adjusted p=0.868). In the RESOLUTE Global Clinical Trial Program, excluding RESOLUTE All Comers, the three-year cumulative incidence of TLF with R-ZES was 9.8% and comprised 7.0% clinically driven TLR and 4.5% cardiac death/target vessel MI.. Patients with STEMI who received R-ZES had excellent long-term clinical outcomes which were similar to those of patients who received EES.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; ST Elevation Myocardial Infarction; Time; 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

We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions.. Patients were divided into three groups: chronic TO (CTO; n=256), non-chronic TO (n=292), and no occlusion (n=2,941). Clinical and safety outcomes assessed through two years included target lesion failure (TLF: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation) and Academic Research Consortium definite or probable stent thrombosis. The rate of TLF at two years was not significantly different among patients in the CTO (9.1%), TO (9.8%), and no occlusion (10.4%) groups (log-rank p=0.800); neither were the components of TLF. Definite or probable stent thrombosis occurred more frequently in the TO group (2.8% vs. 1.2% in the CTO and 1.1% in the group with no occlusion, p=0.027). There were 10 late and six very late stent thrombosis events.. Apart from a higher rate of stent thrombosis in patients with TO, patients with totally occluded coronary arteries who receive revascularisation with an R-ZES have clinical outcomes comparable to those who receive a similar stent in non-occluded lesions.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We studied coronary vasomotion in patients treated with the Mistent(®) absorbable polymer sirolimus-eluting stent (APSES) and in patients implanted with the Endeavor(®) zotarolimus-eluting stent (ZES).. First generation (1st-gen) drug-eluting stents (DES) induce persistent vasomotor dysfunction in the treated coronary artery. It is unknown whether and to what extent the implantation of an absorbable polymer DES impairs coronary vasomotion.. This sub-study of the DESSOLVE II trial included 19 APSES Mistent(®) and 10 ZES Endeavor(®) patients. Incremental atrial pacing and quantitative coronary angiography were used to assess vasomotion proximal and distal to the stent and in a reference segment at 9 months after implantation. Percent changes in vessel diameter with pacing versus baseline were calculated and compared. Vasomotor response of the APSES group was also compared with changes observed in a historical group of 17 patients implanted with a 1st-gen sirolimus-eluting stent (SES).. Normal vasomotion (vasodilatation) was preserved and of comparable magnitude in the APSES and in the ZES group both proximally (P = 0.34) and distally (P = 0.38) to the stent. This finding was not observed in the 1st-gen SES group showing marked pacing-induced vasoconstriction at both stent edges (P < 0.05 vs. APSES). The results were practically unchanged after excluding patients with absolute changes in vessel diameter <3% between baseline and maximal pacing.. The implantation of an absorbable polymer sirolimus-eluting stent is associated with preserved coronary vasomotion, comparable to that observed after implantation of the Endeavor(®) ZES, and distinct from 1st-gen SES which induce coronary vasomotor dysfunction.

Topics: Absorbable Implants; Aged; Cardiac Pacing, Artificial; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Historically Controlled Study; Humans; Male; Middle Aged; New Zealand; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; Vasoconstriction; Vasodilation

To compare long-term outcome of patients treated for chronic total occlusion (CTO) lesions versus patients treated for non-CTO lesions only.. Percutaneous coronary interventions (PCI) for CTO lesions generally have a higher adverse event risk than PCI for non-CTO lesions. However, long-term outcome data from prospective studies with second-generation drug-eluting stent (DES) use in CTO lesions is scarce.. We analyzed in this substudy of the TWENTE trial the data of 674 patients, who had stable angina and were electively treated with second-generation DES (Resolute zotarolimus-eluting or Xience V everolimus-eluting stents). Main outcome parameter was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR).. Patients with CTO lesions (n = 59, 8.8%) were more often treated for lesions in small vessels (94.9% vs. 63.1%, P < 0.001), long lesions (52.5% vs. 17.7%, P < 0.001) and multiple vessels (42.4% vs. 22.4%, P < 0.001), and were less often males (62.7% vs. 74.6%, P < 0.05) than patients with non-CTO lesions (n = 615, 91.2%). J-CTO scores ≥2 were present in 56% of CTO lesions. Despite significant differences in characteristics of patients, lesions, and interventional procedures, the TLF rate at 3-year follow-up was similar for both groups (13.6% vs. 12.9%, P = 0.89). In addition, a patient-oriented composite endpoint (any death, MI or revascularization) did not differ between groups (18.6% vs. 18.8%, P = 0.97).. Patients treated with second-generation DES for CTO lesions showed at 3-year follow-up an incidence of adverse clinical events that was low and similar to patients with non-CTO lesions only.

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

The aim of this study was to evaluate the extent of neointimal response after the implantation of a second-generation drug-eluting stent, zotarolimus-eluting stent (ZES-ER, Endeavor Resolute) or everolimus-eluting stent (EES, Xience V), using intravascular ultrasound (IVUS) in diabetic patients.. In all, 154 diabetic patients with de-novo coronary lesions were randomized to be implanted with a ZES-ER or EES, and the angiographic follow-up at 9 months combined with a complete IVUS study was available for 96 patients with 101 lesions.. Baseline demographic and lesion parameters were similar in both groups at index percutaneous coronary intervention. On follow-up angiography, in-stent late lumen loss and minimal lumen diameter were not different between the two groups. On IVUS study, neointimal hyperplasia volume [median (interquartile range): ZES-ER vs. EES; 2.25 mm (0.57-6.25) vs. 1.59 mm (0.45-8.37), P=0.615] and in-stent percentage of volume obstruction [median (interquartile range): ZES-ER vs. EES; 1.16% (0.33-3.61) vs. 0.77% (0.29-4.01), P=0.615] showed similar results between the two groups.. In diabetic patients, the second-generation drug-eluting stents, ZES-ER and EES, were comparable in inhibiting neointimal proliferation.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Pilot Projects; Predictive Value of Tests; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts).. For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce.. The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations.. The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel-related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03).. During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

This study sought to compare clinical outcomes and angiographic findings using the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Santa Rosa, California) versus the Taxus Liberte paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in an all-comer Chinese population.. Concerns regarding restenosis risk led to new-generation drug-eluting stents (DES) designed for use in patients with complex clinical or lesion characteristics. In-stent late lumen loss (LLL) is a measure of restenosis risk.. Patients with an indication for treatment with a DES were randomized in a 1:1 ratio to placement of at least 1 R-ZES or PES with minimal exclusions. The primary endpoint was angiographic in-stent LLL at 9 months post-procedure. Clinical endpoints at 12 months are compared between the 2 stents.. A total of 198 patients received a R-ZES, and 202 patients received a PES. Most patients were male; 25.8% and 29.2% of R-ZES and PES patients, respectively, had diabetes. Over 70% of lesions in both cohorts were American College of Cardiology/American Heart Association lesion classification Type B2 and C (B2/C). In-stent LLL was 0.16 ± 0.38 mm for R-ZES and 0.33 ± 0.52 mm for PES at 9 months (p < 0.001; 95% confidence interval [CI]: -0.26 to -0.08). The rates of clinically driven target lesion revascularization were 1.5% for R-ZES and 7.0% for PES (p = 0.011). The rate of target lesion failure was 5.6% for R-ZES and 11% for PES (p = 0.068).. In an all-comers Chinese population, 9-month in-stent LLL was significantly less with R-ZES compared with PES, which was reflected in lower revascularization rates at 12 months for the R-ZES patients. Results are consistent with previous clinical trials of the R-ZES in all-comer populations. (Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China [R-China RCT]; NCT01334268).

Topics: Aged; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions.. Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices.. Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety.. At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES.. These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years.. In the ZOMAXX I trial, 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe, Australia, and New Zealand. The two groups were generally well matched with respect to both clinical and lesional characteristics, including the incidence of diabetes (ZoMaxx 22% vs. Taxus 26%; P = 0.29), reference vessel diameter (ZoMaxx 2.79 ± 0.43 mm vs. Taxus 2.81 ± 0.46 mm; P = 0.65), and lesion length (ZoMaxx 14.9 ± 5.7 mm vs. Taxus 14.6 ± 5.5; P = 0.61). Through 5 years of follow-up, a total of 21 patients had died, six patients had withdrawn, nine had been lost to follow-up, and 13 missed their 5-year visit, leaving a total of 347 patients for analysis (169 ZoMaxx and 178 Taxus). At the 5-year time point, there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization (TLR; ZoMaxx 10.6% vs. Taxus 7.1%; P = 0.29), Q-wave myocardial infarction (ZoMaxx 1.5% vs. Taxus 1.0%; P = 0.99), definite/probable stent thrombosis (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34), and cardiac death (ZoMaxx 3.0% vs. Taxus 1.0%; P = 0.28).. After 5 years, the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance. However, the nominally higher rate of ischemia-driven TLR (10.6 vs. 7.1%) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus. © 2013 Wiley Periodicals, Inc.

Topics: Aged; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; New Zealand; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate late safety and efficacy outcomes among patients enrolled in clinical trials comparing Endeavor zotarolimus-eluting stents (E-ZES) (Medtronic, Inc., Santa Rosa, California) with first-generation drug-eluting stents (DES) and bare-metal stents (BMS).. Despite demonstration of higher angiographic luminal loss and restenosis with E-ZES compared with alternative DES, whether differences in these early angiographic measures translate into more disparate late clinical events is uncertain.. Among 3,616 patients undergoing percutaneous coronary revascularization in 5 registration trials, late safety and efficacy events were compared between E-ZES (n = 2,132) versus sirolimus- or paclitaxel-eluting stents (n = 888) or BMS (n = 596).. Compared with a parallel cohort of patients treated with first-generation DES and BMS, 5-year rates of cardiac death/myocardial infarction (MI) (5.8% vs. 8.8% DES, p = 0.003; vs. 8.4% BMS, p = 0.02) and major adverse cardiac events (16.1% vs. 20.6% DES, p = 0.009; vs. 24.6% BMS, p < 0.001) were significantly lower with E-ZES. The E-ZES was associated with significantly lower target lesion revascularization (TLR) compared with BMS (7.4% vs. 16.3%, p < 0.001) but similar to comparator DES (7.4% vs. 8.1%, p = 0.63). Despite higher TLR in the first year with E-ZES compared with DES, between 1- and 5-year follow-up, rates of cardiac death/MI, TLR, and definite/probable stent thrombosis were significantly lower with E-ZES.. Over 5 years, significant differences in cardiac death/MI and composite endpoints favored treatment with E-ZES over comparator BMS and DES. Rates of clinical restenosis and safety events, including stent thrombosis beyond the first year of revascularization, remain stable with E-ZES, leading to significant differences compared with first-generation DES.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

Everolimus-eluting stents (EES) have shown favorable clinical outcomes. However, there have been no studies evaluating early vascular response after EES implantation. We designed a prospective study to compare the neointimal response between zotarolimus-eluting stents (ZES) and EES at 3 and 12 months using serial optical coherence tomography examinations.. Sixty patients who underwent 3-month and 12-month follow-up optical coherence tomography (36 EES, 24 ZES) were included. Neointimal coverage and malapposition were evaluated using a strut-based analysis at both 3 and 12 months. Neointimal hyperplasia area and thrombus were assessed. ZES showed a higher incidence of covered struts (81.5 vs. 77.1%, P<0.0001) and lower incidence of malapposed struts (1.4 vs. 2.3%, P=0.001) than EES at 3 months. However, at 12 months, EES showed a slightly higher incidence of covered struts (96.4 vs. 93.6%, P<0.0001) and a lower incidence of malapposed struts (0.9 vs. 1.1%, P=0.03) than ZES. Neointimal hyperplasia area was greater in the ZES group than in the EES group at both 3 and 12 months (0.77 vs. 0.49 mm, P=0.03 and 1.50 vs. 0.97 mm, P=0.01, respectively). No significant difference in the incidence of thrombus was observed at both 3 and 12 months.. ZES showed rapid neointimal healing compared with EES at 3 months. However, at 12 months, EES had a slightly better vascular healing profile than ZES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Observer Variation; Odds Ratio; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Reproducibility of Results; Republic of Korea; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM).. Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compared with bare-metal stents. Recent data suggest that the E-ZES is inferior to other DES in this population.. Patient-level data for 601 patients with DM from the ENDEAVOR III and ENDEAVOR IV trials were pooled, of which 337 were treated with E-ZES and 264 were treated with other DES. The primary outcome was target vessel failure (TVF) in the course of 5 years. Outcomes are reported as rates using Kaplan-Meier (KM) survival method and differences between E-ZES and other stent types (sirolimus-eluting stent or paclitaxel-eluting stent) were compared using the log-rank statistic. The independent effect of stent type on TVF was assessed using Cox proportional hazards regression.. Baseline characteristics were similar between the groups. Five-year TVF KM rate estimate was numerically lower for E-ZES, but the difference did not reach statistical significance (20.2 vs. 26.9%, P = 0.065). The 5-year KM rate estimates of major adverse cardiac events (17.7 vs. 26.6%, P = 0.012), death (7.6 vs. 15.0%, P = 0.004), and myocardial infarction (1.3 vs. 5.1%, P = 0.011) were also lower for E-ZES versus other DES.. Patients with DM implanted with E-ZES have favorable long-term outcomes compared to first-generation DES. Long-term performance of DES should be assessed routinely and may differ from initial performance.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus, via controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited. The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease.. The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective, random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio), for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary 12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization and target vessel-related myocardial infarction).. The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease.. Clinicaltrials.gov NCT01826552.

Topics: Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Republic of Korea; Research Design; Sirolimus; Time Factors; Treatment Outcome

To evaluate long-term patterns of luminal changes after implantation of different types of drug-eluting stents (DES), we analyzed the serial angiographic outcomes of patients implanted with zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES), or paclitaxel-eluting stents (PES).. Little is known regarding long-term luminal changes after DES implantation.. As a subgroup analysis of the ZEST trial, we performed complete angiographic evaluation immediately after the procedure and at 9 months and 2 years in 111 patients with 165 lesions (36 patients with ZES, 40 with SES, and 35 with PES).. Baseline clinical, angiographic, and procedural characteristics were similar among the three groups. Quantitative angiographic analysis revealed significant decreases in minimal luminal diameter 9 months after stent implantation in the ZES (from 2.71 ± 0.49 to 2.21 ± 0.42 mm, P < 0.001), SES (from 2.79 ± 0.49 to 2.58 ± 0.57 mm, P < 0.001), and PES (from 2.66 ± 0.45 to 2.19 ± 0.52 mm, P < 0.001) groups. However, significant late improvements with different degree in luminal diameter were observed between 9 months and 2 years in the ZES (from 2.21 ± 0.42 to 2.39 ± 0.58 mm, P = 0.001), SES (from 2.58 ± 0.57 to 2.66 ± 0.60 mm, P = 0.039), and PES (from 2.19 ± 0.52 to 2.43 ± 0.52 mm, P < 0.001) groups.. Serial angiographic follow-up study revealed a biphasic luminal response after DES implantation, characterized by an early progression phase for the first 9 months and a late regression phase from 9 months to 2 years.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Linear Models; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

To evaluate the differential treatment effects of zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES), and paclitaxel-eluting stents (PES) according to diabetic status.. Diabetic patients have a higher risk of ischemic complications after stenting than nondiabetic patients.. Using data from the ZEST randomized trial, comparing ZES with SES and PES, we evaluated relative outcomes among stents in diabetic and nondiabetic patients. The primary outcome was a major adverse cardiac event (MACE), defined as a composite of death, myocardial infarction, or ischemia-driven target-vessel revascularization.. Of the 2,645 patients enrolled in the ZEST trial, 760 (29%) had diabetes mellitus. Baseline clinical and angiographic characteristics were similar in the three stent groups, regardless of diabetic status. In diabetic patients, ZES showed similar rates of MACE as compared to PES (13.8% vs. 15.3%, P = 0.58), but higher rates of MACE than SES (13.8% vs. 7.7%, P = 0.05). In nondiabetic patients, ZES showed similar rates of MACE as compared to SES (10.3% vs. 10.8%, P = 0.72), whereas significantly lower rates of MACE compared to PES (10.3% vs. 15.3%, P = 0.01). In comparing the ZES and SES groups, there was a substantial interaction between diabetic status and stent types on MACE occurrence (Interaction P = 0.07). However, in comparison of ZES and PES, there were no significant interactions between diabetes and stent type on MACE (Interaction P = 0.25).. In diabetic patients, SES showed the lowest rate of MACE compared with ZES and PES. But, in nondiabetic patients, SES and ZES showed significantly lower rates of MACE than PES. ZES shows a diabetes-related interaction on MACE compared with SES, but not with PES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE-a prospective, randomized, comparative DES trial-"real-world" patients were stratified for gender before randomization for Resolute or Xience V stents.. Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically indicated target vessel revascularization) after 1 year was the predefined endpoint.. Among 1,391 patients, 382 (27.5%) women were randomized to Resolute (n = 192) and Xience V (n = 190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9 vs. 8.4%; adjusted odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.41-2.20, P = 0.91) and a patient-oriented composite endpoint (13.0 vs. 12.1%, P = 0.79) did not differ significantly between women in both arms. Women were older than men (P < 0.01) and had more often diabetes mellitus (26.4 vs. 19.8%, P = 0.01) and hypertension (63.6 vs. 52.5%, P < 0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95% CI: 0.73-1.92, P = 0.50).. This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute- and Xience V-treated females.

Topics: Age Factors; Aged; Cardiovascular Agents; Chi-Square Distribution; Comorbidity; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Netherlands; Odds Ratio; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

Limited data are available regarding the direct comparison of angiographic and clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for chronic total occlusion (CTO).. A prospective, randomized, multicenter trial was conducted to evaluate the non-inferiority of a zotarolimus-eluting stent (ZES; Endeavor Sprint®, n=80) to a sirolimus-eluting stent (SES; Cypher®, n=80) in patients with CTO lesion with a reference vessel diameter ≥ 2.5mm. The primary endpoint was in-segment binary restenosis rate at 9-month angiographic follow-up. Key secondary endpoints included target vessel failure (TVF; including cardiac death, myocardial infarction, and target vessel revascularization) and Academic Research Consortium-defined definite/probable stent thrombosis (ST) within 12 months. The ZES was non-inferior to the SES with respect to the primary endpoint, which occurred in 14.1% (95% confidence interval [CI]: 6.0-22.2) and in 13.7% (95%CI: 5.8-21.6) of patients, respectively (non-inferiority margin, 15.0%; P for non-inferiority <0.001). There were no significant between-group differences in the rate of TVF (10.0% vs. 17.5%; P=0.168) nor in the rate of ST (0.0% vs. 1.3%; P=0.316) during the 12-month clinical follow-up.. The effectiveness and safety of ZES are similar to those of SES and therefore it is a good treatment option in patients undergoing PCI for CTO with DESs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.. Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99).. Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Eligibility Determination; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Netherlands; Odds Ratio; Patient Selection; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo stent-based coronary interventions. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and sirolimus-eluting stents (SES) for patients with de novo long coronary lesions.. This randomized, multicenter, prospective trial, called the Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV (LONG-DES IV) trial, compared long R-ZES and SES in 500 patients with long (≥25 mm) native coronary lesions. The primary end point of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The baseline characteristics were not different between R-ZES and SES groups, including lesion lengths (32.4±13.5 mm versus 31.0±13.5 mm, P=0.27). At 9-month angiographic follow-up, the R-ZES was noninferior to the SES with respect to in-segment late luminal loss, the primary study end point (0.14±0.38 mm versus 0.12±0.43 mm, P for noninferiority=0.03, P for superiority=0.68). In addition, in-stent late luminal loss (0.26±0.36 mm versus 0.24±0.42 mm, P=0.78) and the rates of in-segment (5.2% versus 7.2%, P=0.44) and in-stent (4.0% versus 6.0%, P=0.41) binary restenosis were not significantly different between the 2 groups. There were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target-lesion revascularization, and composite outcomes).. For patients with de novo long coronary artery disease, R-ZES implantation showed noninferior angiographic outcomes as compared with SES implantation.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186094.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This was designed to assess the outcomes of side branch (SB) stenosis after implantation of three drug-eluting stents (DES). From 2,645 patients in the ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Trial, 788 patients had 923 bifurcation lesions with SB ≥ 1.5 mm were included. SB was treated in 150 lesions, including 35 (3.8%) receiving SB stenting. Of untreated SB with baseline stenosis < 50%, the incidences of periprocedural SB compromise was similar in the zotarolimus (15.8%), sirolimus (17.2%), and paclitaxel (16.6%) stent groups (P = 0.92). At follow-up angiography, delayed SB compromise occurred in 13.9%, 3.2%, and 9.4% (P = 0.010) of these groups. When classified into four groups (< 50%, 50%-70%, 70%-99%, and 100%), 9.0% of untreated SB were worsened, whereas improvement and stationary were observed in 9.6% and 81.4%. In a multivariable logistic regression model, main branch (MB) stenosis at follow-up (%) was the only independent predictor of SB stenosis worsening (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < 0.001). After MB stenting in bifurcation lesions, a minority of SB appears to worsen. DES with strong anti-restenotic efficacy may help maintain SB patency.

Topics: Acute Disease; Aged; Blood Vessels; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Odds Ratio; Paclitaxel; Predictive Value of Tests; Sirolimus; Thrombosis; Treatment Outcome

This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.. The SXscore can identify patients treated with PCI who are at highest risk of adverse events.. The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscore(LOW) ≤ 9 (n = 698), 9 17 (n = 659).. At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscore(HIGH) tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles.. The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Health Status Indicators; Humans; Israel; Kaplan-Meier Estimate; Linear Models; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES).. Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events.. Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss.. At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015).. Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We designed a randomized trial exploiting optical coherence tomography (OCT) to assess coverage and apposition of overlapping bare-metal stents (BMS) and drug-eluting stents (DES) in human coronary arteries.. Overlapping DES impair healing in animals. Optical coherence tomography allows accurate in vivo assessment of stent strut coverage and apposition.. Seventy-seven patients with long coronary stenoses were randomized to overlapping sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), or BMS. The primary goal of the study was to determine the rate of uncovered/malapposed struts in overlap versus nonoverlap segments, according to stent type, at 6-month follow-up with OCT.. A total of 53,047 struts were analyzed. The rate of uncovered/malapposed struts was 1.5 +/- 3.4% and 0.6 +/- 2.7% in overlap versus nonoverlap BMS (p = NS), respectively, and 4.3 +/- 11% and 3.6 +/- 8% in overlap versus nonoverlap DES (p = NS), respectively. There were no differences in the rates of uncovered/malapposed struts between overlapping BMS and DES, likely due to low frequency of uncovered/malapposed struts in ZES (0.1 +/- 0.4%), which offset the higher rates observed in SES (6.7 +/- 9.6%) and PES (6.7 +/- 16.5%, p < 0.05). Overlap segments showed greater neointimal volume obstruction versus nonoverlap segments in all DES (p < 0.05 for all DES types). Strut-level neointimal thickness at overlap and nonoverlap segments were lowest in SES (0.16 +/- 0.1 mm and 0.12 +/- 0.1 mm, respectively) compared with PES (0.27 +/- 0.1 mm and 0.20 +/- 0.1 mm, respectively), ZES (0.40 +/- 0.16 mm and 0.33 +/- 0.13 mm, respectively), and BMS (0.55 +/- 0.31 mm and 0.53 +/- 0.25 mm, respectively, p < 0.05).. As assessed by OCT the impact of DES on vascular healing was similar at overlapping and nonoverlapping sites. However, strut malapposition, coverage pattern, and neointimal hyperplasia differ significantly according to DES type. (Optical Coherence Tomography for Drug Eluting Stent Safety [ODESSA]; NCT00693030).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Male; Metals; Middle Aged; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Using optical coherence tomography, we assessed the proportion of uncovered struts at 6-month follow-up in zotarolimus-eluting stents (ZES), specifically Endeavor (Medtronic CardioVascular, Santa Rosa, California) stents, and identical bare-metal stents (BMS) implanted in patients with ST-segment elevation myocardial infarction (STEMI).. Sirolimus- and paclitaxel-eluting stents implanted in STEMI have been associated with delayed healing and incomplete strut coverage. ZES are associated with a more complete and uniform strut coverage in stable patients, but whether this holds true also after STEMI is unknown.. Forty-four patients with STEMI who underwent primary PCI were randomized to ZES or BMS (3:1 randomization). Angiographic, intravascular ultrasound, and optical coherence tomography follow-up was conducted at 6 months and clinical follow-up at 1 year. All images were analyzed by an independent core laboratory that was blind to stent assignments.. There were no differences between ZES and BMS in percentage of uncovered struts (median: 0.00% [interquartile range (IQR): 0.00% to 1.78%] vs. 1.98% [IQR: 0.21% to 7.33%], p = 0.13), maximum length of uncovered segments (0.00 [IQR: 0.00 to 1.19] mm vs. 1.38 [IQR: 0.65 to 3.30] mm, p = 0.10), percentage of malapposed struts (0.00% [IQR: 0.00% to 0.23%] vs. 0.15% [IQR: 0.00% to 5.81%], p = 0.16), and maximum length of malapposed segments (0.00 [IQR: 0.00 to 0.67] mm vs. 0.33 [IQR: 0.00 to 2.55] mm, p = 0.20). Neointimal response was similar between ZES and BMS (332 [IQR: 240 to 429] microm vs. 186 [IQR: 136 to 348] microm, p = 0.99) and evenly distributed. No late acquired malapposition was observed in both groups. There were no deaths, myocardial infarction, or stent thromboses at 1 year.. This optical coherence tomography study found no difference in strut coverage and similar vessel response to ZES, when compared with identical BMS, implanted during primary percutaneous coronary intervention in STEMI patients. (Six-Month Coverage and Vessel Wall Response of the Zotarolimus Drug-Eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography [OCTAMI]; NCT00704561).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

The increased frequency of very late (>1 year) stent thrombosis (VLST) has raised concerns with regard to the safety of sirolimus-eluting stents and paclitaxel-eluting stents (PES).. Experimental and preliminary clinical findings with the zotarolimus-eluting stent (ZES) have suggested a favorable safety profile.. The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial is a single-blind randomized ZES versus PES clinical trial in 1,548 patients with de novo native coronary lesions; the primary end point-9-month target vessel failure-was previously reported, annual clinical follow-up is planned for 5 years, and this report describes the 3-year outcomes.. The ZES compared with PES reduced target vessel failure (12.3% vs. 15.9%, hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.58 to 1.00, p = 0.049), myocardial infarctions (MI) (2.1% vs. 4.9%, HR: 0.44, 95% CI: 0.25 to 0.80, p = 0.005), and cardiac death plus MI (3.6% vs. 7.1%, HR: 0.52, 95% CI 0.32 to 0.82, p = 0.004). Although the overall 3-year rate of Academic Research Consortium definite/probable stent thrombosis did not differ significantly (1.1% vs. 1.7%, HR: 0.67, 95% CI 0.28 to 1.64, p = 0.380), VLST (between 1 and 3 years) was significantly reduced in ZES patients (1 event vs. 11 events; 0.1% vs. 1.6%, HR: 0.09, 95% CI: 0.01 to 0.71, p = 0.004). Ischemia-driven target lesion revascularization at 3 years was similar with ZES versus PES (6.5% vs. 6.1%, HR: 1.10, 95% CI: 0.73 to 1.65, p = 0.662).. Three-year follow-up results from the ENDEAVOR IV trial indicate similar antirestenosis efficacy but improved clinical safety associated with ZES compared with PES, due to significantly fewer peri-procedural and remote MIs associated with fewer VLST events. (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00217269).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

To investigate the mechanistic basis underlying antirestenosis and the antiatherogenic effect of pioglitazone in patients with type 2 diabetes mellitus who were undergoing zotarolimus-eluting stent implantation.. Recent studies highlight the beneficial effect of pioglitazone in attenuating neointimal growth after stent implantation. Patients with coronary artery diseases were randomly assigned to pioglitazone (n=47) or placebo (n=47) after stent implantation. Pioglitazone significantly reduced neointimal hyperplasia within the stented lesion and attenuated total plaque burden in the in-segment regions of the stent, as assessed by intravascular ultrasonography at the 8-month follow-up. These changes were preceded by reduced circulating natural killer (NK) cells, diminished interleukin 6 and monocyte chemoattractant protein-1 levels, and downregulation of chemokine receptor 2 at 2 days after stent implantation; and an elevated interleukin 10 level at 10 days after implantation. Furthermore, the proliferation and migration of vascular smooth muscle cells were inhibited in the presence of pioglitazone-treated patient serum, demonstrating that the antiproliferative effects of pioglitazone occurred concurrently with its antiinflammatory action.. Our data present early cellular and immunologic changes by pioglitazone that might have been associated with antirestenotic and antiatherogenic effects in diabetic patients. Inhibiting proinflammatory responses while promoting antiinflammatory circuits, together with an antiproliferative action, may, in part, account for the antirestenotic effect of pioglitazone by altering vascular remodeling processes in the early phase.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Biomarkers; Blood Glucose; Cardiovascular Agents; Cell Movement; Cell Proliferation; Cells, Cultured; Chemokine CCL2; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug-Eluting Stents; Female; Glycated Hemoglobin; Humans; Hyperplasia; Hypoglycemic Agents; Inflammation Mediators; Insulin; Interleukin-6; Killer Cells, Natural; Lipids; Male; Middle Aged; Myocytes, Smooth Muscle; Pioglitazone; Prospective Studies; Prosthesis Design; Receptors, CCR2; Republic of Korea; Single-Blind Method; Sirolimus; Thiazolidinediones; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

The aim of this study was to compare the vessel response between zotarolimus-eluting stents (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound.. The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial was a randomized controlled study of zotarolimus-eluting, phosphorylcholine-coated, cobalt-alloy stents for the treatment of de novo coronary lesions compared with using PES for the same treatment.. Data were obtained from patients with serial (baseline and 8-months follow-up) intravascular ultrasound analysis available (n = 198). Volumetric analysis was performed for vessel, lumen, plaque, stent, and neointima. Cross-sectional narrowing (given as percentage) was defined as neointimal area divided by stent area. Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. Subsegment analysis was performed at every matched 1-mm subsegment throughout the stent.. At follow-up, the ZES group showed significantly greater percentage of neointimal obstruction (16.6 +/- 12.0% vs. 9.9 +/- 8.9%, p < 0.01) and maximum cross-sectional narrowing (31.8 +/- 16.1% vs. 25.2 +/- 14.9%, p < 0.01) with smaller minimum lumen area than the PES group did. However, the incidence of maximum cross-sectional narrowing >50% was similar in the 2 groups. Neointima-free frame ratio was significantly lower in the ZES group. In overall analysis, whereas the PES group showed positive remodeling during follow-up (13.7 +/- 4.2 mm(3)/mm to 14.3 +/- 4.3 mm(3)/mm), the ZES group showed no significant difference (12.7 +/- 3.6 mm(3)/mm to 12.9 +/- 3.5 mm(3)/mm). In subsegment analysis, significant focal positive vessel remodeling was observed in 5% of ZES and 25% of PES cases (p < 0.05).. There were different global and focal vessel responses for ZES and PES. Both drug-eluting stents showed a similar incidence of lesions with severe narrowing despite ZES having a moderate increase in neointimal hyperplasia compared with neointimal hyperplasia in PES. There was a relatively lower neointima-free frame ratio in ZES, suggesting a greater extent of neointimal coverage. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Cobalt; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Paclitaxel; Phosphorylcholine; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; United States

The aim of this study was to examine outcomes related to the use of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) compared with the TAXUS paclitaxel-eluting stent (PES) (Boston Scientific Corp., Natick, Massachusetts) in the 477 patients with diabetes mellitus (DM) enrolled in the randomized ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial.. Percutaneous coronary intervention (PCI) in diabetic patients is associated with increased rates of restenosis-related end points compared with PCI in nondiabetic patients. Although ZES has been associated with similar clinical efficacy compared with PES in the overall trial population of the ENDEAVOR IV trial, whether these results are maintained in the higher-risk restenosis subgroup of patients with DM has not been determined.. Clinical and angiographic outcomes were compared according to randomized treatment assignment to either ZES or PES.. Baseline characteristics were similar among ZES (n = 241) and PES (n = 236) diabetic patients, with slightly longer lesion lengths in PES-treated patients (12.9 mm vs. 14.0 mm, p = 0.041). Among the 86 DM patients assigned to routine angiographic follow-up (18% of the overall DM cohort), in-stent percent diameter stenosis at 8 months was greater among ZES-treated patients (32.9 vs. 21.1, p = 0.023), with a trend toward higher in-stent late loss. One-year clinical outcomes were similar among DM patients treated with either ZES or PES (target vessel failure: 8.6% vs. 10.8%, p = 0.53; target lesion revascularization: 6.9% vs. 5.8%, p = 0.70; target vessel revascularization: 8.6% vs. 9.4%, p = 0.87). There were no significant interactions between DM status and stent type with respect to the outcomes measured, and the relative efficacy/safety of ZES and PES were similar among insulin- and noninsulin-requiring subgroups.. One-year clinical outcomes were similar among DM patients treated with ZES and PES in the ENDEAVOR IV trial. These findings parallel the overall trial results, which demonstrated similar efficacy and safety of ZES and PES for single de novo coronary lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Severity of Illness Index; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The RESOLUTE trial examined the safety and efficacy of a next-generation zotarolimus-eluting coronary stent, Resolute (Medtronic CardioVascular Inc., Santa Rosa, California).. Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases.. The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters > or =2.5 and < or =3.5 mm and lesion length > or =14 and < or =27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction.. The 9-month in-stent late lumen loss was 0.22 +/- 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 +/- 7.83 mm(3), and percent NIH volume obstruction was 3.73 +/- 4.05%.. In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

To evaluate the 5-year clinical outcomes of patients treated with the Endeavor zotarolimus-eluting stent (ZES) in the ENDEAVOR I first-in-human study.. ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries.. Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have > or = 50% stenosis, be < or = 15 mm in length, and located in a vessel with a reference diameter of 3.0-3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation.. The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non-Q-wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%.. Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Massachusetts; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Drug-eluting stents (DESs) are increasingly used for treatment of acute ST-segment elevation myocardial infarction (STEMI), but there are few comparisons of outcomes of various types of DES. We compared the efficacy and safety of zotarolimus-eluting stents (ZESs), sirolimus-eluting stents (SESs), and paclitaxel-eluting stents (PESs) in primary intervention for STEMI. This multicenter, prospectively randomized ZEST-AMI trial included 328 patients at 12 medical centers who were randomly assigned to ZES (n = 108), SES (n = 110), or PES (n = 110) deployment. The primary end point was major adverse cardiac events (death, MI, and ischemia-driven target vessel revascularization) at 12 months. Secondary end points included the individual components of the primary end point, late loss, angiographic restenosis, and stent thrombosis. Baseline clinical and angiographic characteristics were well matched. In-segment late loss (0.28 +/- 0.42 vs 0.46 +/- 0.48 vs 0.47 +/- 0.50 mm, respectively, p = 0.029) and restenosis rate (2.7% vs 15.9% vs 12.3%, respectively, p = 0.027) at 8 months were lowest in the SES group compared to the ZES and PES groups. At 12 months, cumulative incidence rates of primary end points in the ZES, SES, and PES groups were 11.3%, 8.2%, and 8.2%, respectively (p = 0.834). There were 2 acute (in the SES group) and 5 subacute (2 in the SES group and 3 in the PES group) stent thromboses. Incidence of death, recurrent MI, or ischemia-driven target vessel revascularization did not differ among the 3 groups. In conclusion, despite the difference in restenosis rate, the efficacy and safety of the 3 different DESs showed similar, acceptable results in the treatment of STEMI.

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Recurrence; Sirolimus; Ticlopidine

The aim of this study was to evaluate clinical and economic outcomes for subjects receiving zotarolimus-eluting (ZES) (n = 323) versus sirolimus-eluting stents (SES) (n = 113) in the ENDEAVOR III (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) clinical trial.. Although previous clinical trials have evaluated long-term clinical outcome for drug-eluting stents, none considered their economic implications.. We analyzed case report form information with quality-of-life adjustment and Medicare cost weights applied from secondary sources; compared differences in clinical outcomes, quality-adjusted survival, medical resource use, and medical costs; and evaluated cost-effectiveness through 3-year follow-up.. The use of ZES versus SES reduced the 3-year rates/100 subjects of death or myocardial infarction (3.9 vs. 10.8; difference, -6.9; 95% confidence interval [CI]: -13.0 to 0.8; p = 0.028), with no difference in target vessel revascularization rates (17.9 vs. 12.2; difference, 5.7; 95% CI: -3.7 to 15.1; p = 0.23) but greater use of coronary artery bypass graft (CABG) surgery (3.5 vs. 0.0; difference 3.5; 95% CI: 1.3 to 5.7; p = 0.002). After discounting at 3% per annum, total medical costs for ZES versus SES were similar ($23,353 vs. $21,657; difference, $1,696; 95% CI: -$1,089 to $4,482, p = 0.23), and the 3-year cost-effectiveness ratio was $57,002/quality-adjusted life year.. Despite a reduction in death or myocardial infarction and no difference in total revascularizations, medical costs were not decreased due to increased CABG repeat revascularization procedures for subjects receiving ZES versus SES. If future trials observe similar differences, improved safety with no difference in medical costs, the use of ZES versus SES will be a clinically and economically attractive treatment strategy. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Female; Health Care Costs; Humans; Male; Medicare; Middle Aged; Models, Economic; Myocardial Infarction; Prosthesis Design; Quality of Life; Quality-Adjusted Life Years; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome; United States

The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions.. Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials.. The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES.. The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non-Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar.. After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Constriction, Pathologic; Coronary Angiography; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Female; Health Care Costs; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Models, Economic; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Quality of Life; Quality-Adjusted Life Years; Risk Assessment; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The E-Five registry was designed to evaluate the safety and effectiveness of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) for the treatment of coronary artery stenosis across a wide range of patients treated in real-world clinical practice settings.. Early clinical trials with the Endeavor ZES have demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 4 years of follow-up. A clinical registry was designed to complement controlled trial data by examining a large patient population, including high-risk patient subsets.. The E-Five registry is a prospective, nonrandomized, multicenter global registry conducted at 188 centers worldwide. Adult patients (n = 8,314) with coronary artery disease who underwent single-vessel or multivessel percutaneous coronary intervention were enrolled. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months. A secondary analysis stratified patients by standard versus extended-use clinical and lesion characteristics.. Overall 12-month outcome rates were MACE 7.5%; cardiac death 1.7%; myocardial infarction (all) 1.6%; target lesion revascularization 4.5%; and stent thrombosis (Academic Research Consortium definite and probable) 1.1%. The 12-month MACE rates were 4.3% and 8.6% for standard- and extended-use patients, respectively (p < 0.001).. This large, international multicenter registry provides important information regarding the long-term safety and efficacy of the Endeavor ZES across standard and extended-use patients in the real-world setting. Rates of MACE and measures of safety including cardiac death, myocardial infarction, and stent thrombosis were low and consistent with pooled results of clinical trials. (E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent [eFive Registry]; NCT00623441).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Stenosis; Europe; Female; Humans; Israel; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Sirolimus; South America; Thrombosis; Time Factors; Treatment Outcome; United States

We performed this study to investigate the vascular response in early period after zotarolimus-eluting stent (ZES) (Endeavor Sprint, Medtronic CardioVascular, Minneapolis, Minnesota) implantation.. The ZES has different characteristics, with biocompatible polymer and rapid drug-elution, compared with the first-generation drug-eluting stents (DES).. The ENDEAVOR OCT (Evaluation in 3 Months Duration of Neointimal Coverage after Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography) trial is a prospective, single-center study evaluating vascular healing patterns with optical coherence tomography (OCT) at 3 months after stent implantation. A total of 31 ZES in 30 patients underwent serial OCT at immediate post-intervention and 3 months. Neointimal growth and malapposition were analyzed at each stent strut of cross-sectional OCT images with 0.5-mm intervals.. The incidence of malapposition at post-intervention and 3 months was 6.0% and 0.2%, respectively. However, late acquired malapposition was not detected at 3 months. Of 31 stents, 27 stents (87.1%) were covered completely with neointima, but the remaining 4 stents had 2 (0.8%), 4 (0.9%), 4 (1.2%), and 6 (1.4%) uncovered struts. Overall mean percentage of covered stent struts was 99.9 +/- 0.4%. This finding was consistent among groups with acute coronary syndrome and stable angina pectoris (99.9 +/- 0.3% vs. 99.9 +/- 0.4%, p = 0.92). Intracoronary thrombus was documented in 1 stent (3.2%) among 31 stents.. Most of the stent struts were covered with neointima, and late acquired malapposition was not found at 3 months after ZES implantation. Therefore, the current study demonstrated that ZES might have a favorable in vivo vascular response at 3 months after stent implantation. (Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography [ENDEAVOR OCT]; NCT00815139).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

A novel zotarolimus-eluting coronary stent system (ZoMaxx, Abbott Laboratories, Abbott Park, Illinois) was compared with a paclitaxel-eluting coronary stent (Taxus Express2) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. The primary end point was defined as noninferiority of in-segment late lumen loss after 9 months.. The ZoMaxx stent system elutes 10 microg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum.. Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent.. After 9 months, late lumen loss was significantly greater in the ZoMaxx group (in-stent 0.67 +/- 0.57 mm vs. 0.45 +/- 0.48 mm; p < 0.001; in-segment 0.43 +/- 0.60 mm vs. 0.25 +/- 0. 45 mm; p = 0.003), resulting in significantly higher rates of >50% angiographic restenosis (in-stent 12.9% vs. 5.7%; p = 0.03; in-segment 16.5% vs. 6.9%; p = 0.007). The upper bound of the 95% confidence interval on the difference in in-segment late lumen loss between the 2 treatment groups (0.27 mm) exceeded the 0.25 mm value pre-specified for noninferiority. There were no significant differences between ZoMaxx and Taxus-treated groups with respect to target lesion revascularization (8.0% vs. 4.1%; p = 0.14), major adverse cardiac events (12.6% vs. 9.6%; p = 0.43), or stent thrombosis (0.5% in both groups).. After 9 months, the ZoMaxx stent showed less neointimal inhibition than the Taxus stent, as shown by higher in-stent late loss and restenosis by qualitative coronary angiography.

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Logistic Models; Male; Middle Aged; New Zealand; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months.. Patients (n =1,197) 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% to 13.2% with Endeavor (P<0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malposition 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; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Double-Blind Method; Drug Delivery Systems; Equipment Design; Europe; Female; Humans; Israel; Male; Middle Aged; New Zealand; Pacific Islands; Phosphorylcholine; Prospective Studies; Sirolimus; Stents; Treatment Outcome

The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Phosphorylcholine; Prospective Studies; Prosthesis Design; Research Design; Sirolimus; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

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

Onyx Frontier. We hereby review the principal design features of Onyx Frontier, highlighting differences and similarities with other currently available drug-eluting stents. In addition, we focus on the refinements of this newest platform as compared with previous ZES versions, including the attributes yielding its exceptional crossing profile and deliverability. The clinical implications related to both its newest and inherited characteristics will be discussed.. The nuances of the latest Onyx Frontier, together with the continuous refinement previously witnessed throughout the development of ZES, lead to a latest generation device ideal for a diverse spectrum of clinical and anatomical scenarios. In particular, its peculiarities will be of benefit in the settings often offered by a progressively aging population, such as high bleeding risk patients and complex coronary lesions.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Technology; Treatment Outcome

Thinner stent struts might lead to a higher risk of recoil and subsequently a smaller minimal stent area (MSA), which is known to be the strongest predictor of stent failure. We compared procedural performance between an ultrathin-strut biodegradable-polymer sirolimus-eluting stent (BP-SES) and a durable-polymer zotarolimus-eluting stent (DP-ZES) using intracoronary imaging.. A consecutive cohort of patients underwent percutaneous coronary intervention (PCI) with either BP-SES or DP-ZES in a pseudorandomized fashion between July 2018 and October 2019. In the present subanalysis, we included cases in which post-PCI imaging with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was performed. The primary endpoint of the study was MSA. Secondary endpoints included percentage stent expansion and presence of residual edge disease, malapposition, tissue protrusion, submedial edge dissections, or edge hematoma.. A total of 141 treated lesions (78 BP-SES and 63 DP-ZES) in 127 patients were analyzed. Median age was 69.3 years (interquartile range [IQR], 57.3-75.6) and 74.0% of patients were male. All baseline and procedural characteristics were comparable between both groups. Median MSA was 5.80 mm² (IQR, 4.40-7.24) for BP-SES and 6.35 mm² (IQR, 4.76-8.31) for DP-ZES (P=.15). No significant differences in stent expansion, residual edge disease and presence of malapposition, tissue protrusion, submedial edge dissections, or edge hematomas were found. Stent diameter and stent length were found to be independent predictors of MSA.. No significant differences in MSA were found between lesions treated with BP-SES vs DP-ZES. BP-SES and DP-ZES were comparable in terms of procedural performance.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Treatment Outcome

To compare stent recoil (SR) of the thin-strut durable-polymer Zotarolimus-eluting stent (dp-ZES) and the ultrathin-strut bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in chronic total occlusions (CTOs) and to investigate the predictors of high SR in CTOs.. Newer ultrathin drug eluting stent might be associated with lower radial force and higher elastic recoil due to the thinner strut design, possibly impacting on the rate of in-stent restenosis and thrombosis.. Between January 2017 and November 2019, consecutive patients with CTOs undergoing percutaneous coronary intervention were evaluated. Only patients treated with dp-ZES or bp-SES were included and stratified accordingly. Quantitative coronary angiography analysis was used to assess absolute SR, relative SR, absolute focal SR, relative focal SR, high absolute, and high relative focal SR.. A total of 128 lesions (67 treated with dp-ZES and 61 with bp-SES) in 123 patients were analyzed. Between bp-SES and dp-ZES no differences were found in absolute SR (p = .188), relative SR (p = .138), absolute focal SR (p = .069), and relative focal SR (p = .064). High absolute and high relative focal SR occurred more frequently in bp-SES than in dp-ZES (p = .004 and p = .015). Bp-SES was a predictor of high absolute focal SR (Odds ratio [OR] 3.29, 95% confidence interval [CI] 1.50-7.22, p = .003]. High-pressure postdilation and bp-SES were predictors of high relative focal SR (OR 2.22, 95% CI 1.01-4.86, p = .047; OR 2.74, 95% CI 1.24-6.02, p = .012, respectively).. Both stents showed an overall low SR. However, ultra-thin strut bp-SES was a predictor of high absolute and high relative focal SR.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

Reports of long-term outcomes of patients treated with drug-eluting stents in total coronary occlusions are limited. We analysed clinical outcomes of patients treated with the zotarolimus-eluting Resolute stent (R-ZES) implanted in coronary total occlusions versus non-occluded lesions.. Patients treated with R-ZES and included in four trials (RESOLUTE All Comers, RESOLUTE International, RESOLUTE China RCT, and RESOLUTE China Registry) were pooled and divided into three groups - patients with chronic total occlusions (CTO), patients with total occlusions that had occurred recently (rec-TO), and patients without total occlusions (non-TO). Clinical outcomes at five years were analysed. Of 5,487 patients treated with R-ZES in these trials, 8.0% had CTOs, 8.5% rec-TOs and 83.5% non-TOs. Patients had a mean age of 62.8 years, approximately 25% were female and 30% were diabetics. TLF was similar in the three groups at five years (TLF was 13.2%, 12.5% and 13.3% in the CTO, rec-TO and non-TO groups, respectively, p=0.96). Stent thrombosis tended to occur more frequently for rec-TO compared to CTO and non-TO patients (2.6% vs 1.2% and 1.3%, respectively, p=0.11).. In this large population of patients who had R-ZES implanted, five-year clinical outcomes were similar whether or not the stents were implanted in total occlusions.

Topics: Cardiovascular Agents; China; Coronary Artery Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Limited research has detailed the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) with independent core laboratory and event adjudication. This study examined procedural, clinical, and patient-reported health status outcomes among patients undergoing CTO PCI with specific focus on outcomes for those treated with zotarolimus-eluting stents (ZES).. Among 500 consecutive patients undergoing attempted CTO PCI, procedural and in-hospital clinical outcomes were examined in addition to the 1-year composite endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events, MACE). In a pre-specified cohort of 250 patients, health status measures were ascertained at baseline and 1 year. A powered secondary endpoint was 1-year MACE among patients treated with ZES compared with a performance goal.. Demographic, lesion, and procedural characteristics for the overall population included prior bypass surgery, 29.8%; diabetes, 35.2%; occlusion length >20 mm, 71.3%; J-CTO score, 2.5 ± 1.1; and primary retrograde strategy, 30.8%. Overall guidewire crossing was 90.9%; clinical success following guidewire crossing, 94.3%; and 1-year MACE rate, 12.1%. One-year health status significantly improved from baseline with successful CTO-PCI (angina frequency, 72.7 ± 26.5 at baseline to 96.0 ± 10.8, p < .0001). Compared with a performance goal derived from prior CTO DES trials (1-year hierarchal MACE, 25.2%), treatment with ZES was associated with significantly lower MACE (18.2%, one-sided upper CI, 23.6%, p = .017).. Favorable procedural success, health status improvements and late-term clinical outcomes inform the relative risks and benefits of CTO PCI when performed in a clinically indicated, complex patient population representative of those treated in clinical practice.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Health Status; Humans; Male; Middle Aged; Patient Reported Outcome Measures; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Recovery of Function; Registries; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

This study sought to determine clinical outcomes between treatment groups over long-term follow-up.. The safety and efficacy of a ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively.. Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization.. A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39).. In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients.. Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.. Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (. Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Administration Schedule; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Hemorrhage; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States

To assess the long-term safety and efficacy of the Resolute zotarolimus-eluting stent (R-ZES).. The R-ZES has been associated with low rates of adverse events over short-intermediate term follow-up. However, reliable assessment of the safety and efficacy of any implanted device requires long-term evaluation.. The RESOLUTE US trial was a prospective, observational study conducted at 116 U.S. sites and enrolled patients with de novo coronary lesions. Patients were followed clinically for 5 years with independent event adjudication and data monitoring.. A total of 1,402 patients (1,573 lesions) were enrolled; 34% had diabetes mellitus and 75% had ACC type B2/C lesions. The 5-year rate of target lesion failure (TLF) was 12.3%, target lesion revascularization was 6.5%, target vessel myocardial infarction was 3.2%, and cardiac death was 4.1%. Dual antiplatelet therapy usage was 94% at 1 year and 47% at 5 years, with a 0.1% and 0.5% respective incidence of definite or probable stent thrombosis. The 5-year rate of TLF was 16.9% among patients with diabetes mellitus and 14.7% in patients with at least one small (≤2.5 mm) vessel treated. Covariates independently associated with 5-year TLF in multivariable analysis included diabetes mellitus (odds ratio [OR] 1.89, p < .001), prior coronary artery bypass grafting (OR 2.28, p < .001), prior myocardial infarction (OR 1.85, p = .002), and smaller reference vessel diameter (OR 1.75, p = .004).. Results from the fully adjudicated and monitored RESOLUTE US trial demonstrate long-term 5-year safety and efficacy of the R-ZES stent among a relatively low-risk population of patients, including a 0.5% rate of stent thrombosis at 5 years.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States

There are few studies which compare the efficacy and safety of the Resolute Onyx zotarolimus-eluting stent (O-ZES) and everolimus-eluting stent (EES) in patients with acute myocardial infarction (AMI). Therefore, the present study aimed to compare clinical outcomes of O-ZES and EES in patients with AMI undergoing successful percutaneous coronary intervention (PCI).. From January 2016 to December 2016, the Korea Acute Myocardial Infarction Registry (KAMIR) enrolled 3,364 consecutive patients. Among them, O-ZES was used in 402 patients and EES was used in 1,084 patients. The primary endpoint was target lesion failure (TLF), as defined by composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemic driven-target lesion revascularization (ID-TLR) at 6 month clinical follow-up.. At 6 months, the incidence of TLF was not significantly different between O-ZES and EES group (4.0% vs. 3.9%, adjusted hazard ratio [HR] 1.17, 95% confidential interval [CI] 0.58-2.35, p = 0.665). O-ZES also showed similar results of cardiac death (3.7% vs. 3.4%, adjusted HR 1.25, 95% CI 0.59-2.63, p = 0.560), TV-MI (0.2% vs. 0.6%, adjusted HR 0.56, 95% CI 0.07-4.85, p = 0.600), ID-TLR (0.0% vs. 0.3%, p = 0.524), and definite or probable stent thrombosis (0.2% vs. 0.3%, adjusted HR 0.63, 95% CI 0.06-6.41, p = 0.696) when compared with EES.. The present study shows that implantation of O-ZES or EES provided similar clinical outcomes with similar risk at 6-month of TLF and definite/probable ST in patients with AMI undergoing successful PCI.

Topics: Aged; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Republic of Korea; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution-technology in coronary stenting. We aimed to assess 1-year clinical outcomes of PF-AES as compared to latest-generation permanent polymer zotarolimus-eluting stents (PP-ZES) in a real-world all-comers setting.. A prospective registry of patients treated with either PF-AES or PP-ZES between 2014 and 2016 was conducted. The primary outcome was defined as major adverse cardiac and cerebrovascular events (MACCE), and the secondary outcome was defined as target-lesion failure (TLF) at 1 year. To account for measured confounders, a propensity-score adjusted Cox proportional-hazard model was built to evaluate clinical outcomes.. Our study suggests that implantation of PF-AES was safe and effective in real-world patients, with low-rates of MACCE and TLF at 1 year. Our data needs to be confirmed by a large trial to evaluate the clinical outcomes of this novel polymer-free, eluting-technology used in PF-AES.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Propensity Score; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Normalized optical density (NOD) measured by optical coherence tomography represents neointimal maturity after coronary stent implantation and is correlated with morphologic information provided by both light and electron microscopy. We aimed to test the hypothesis that even second generation drug-eluting stents (DESs) are problematic in terms of neointimal maturity. We implanted bare-metal stents (BMS: n = 14), everolimus-eluting stents (EESs: n = 15) or zotarolimus-eluting stents (ZESs: n = 12) at 41 sites in 32 patients with stable coronary artery disease. OCT was performed at up to 12 months of follow-up, and the average optical density of neointima covering struts was evaluated. NOD was calculated as the optical density of stent-strut covering tissue divided by the optical density of the struts. We also measured circulating CD34+ /CD133+ /CD45low cells, and serum levels of stromal cell-derived factor (SDF)-1, interleukin (IL)-8 and matrix metalloproteinase (MMP)-9 at baseline and follow-up. NOD was lower in the EES (0.70 ± 0.06) group than in the BMS (0.76 ± 0.07, P < 0.05) and ZES (0.76 ± 0.06, P < 0.05) groups. The mean neointimal area (R = 0.33, P < 0.05) and mean neointimal thickness (R = 0.37, P < 0.05) were correlated with NOD. Although NOD was not correlated with percent changes in circulating endothelial progenitor cells, and the levels of SDF-1 and IL-8, it was negatively correlated with the change in MMP-9 level (R = - 0.51, P < 0.01). Neointimal maturity might be lower at EES sites than BMS or ZES sites. This might lead to impaired neointimal tissue growth and matrix degradation. These results suggest a specific pathophysiology after DES implantation.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Chemokine CXCL12; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Endothelial Progenitor Cells; Everolimus; Female; Humans; Interleukin-8; Male; Matrix Metalloproteinase 9; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Remodeling

To assess clinical outcomes of Amphilimus Sirolimus-Eluting Stents (A-SES) as compared to Zotarolimus-Eluting Stents (ZES) in complex real-world diabetic patients.. Patients with diabetes mellitus represent one of the most challenging scenarios with high rates of restenosis and stent thrombosis in the current era of drug-eluting stents. Hence, we assessed the safety of A-SES versus ZES in complex diabetic patients.. In this observational study, we analyzed all consecutive patients with diabetes mellitus referred to our center from November 2012 to November 2014. The primary outcome was target-lesion failure at 1-year follow-up.. A total of 165 consecutive diabetic patients underwent percutaneous coronary intervention with A-SES or ZES for stable coronary artery disease in our tertiary center. Using the Kaplan Meier method the cumulative incidence of target-lesion failure was 6.7% (5.9% A-SES versus 7.5% ZES, p=0.19) at 1-year follow-up. Event-free survival at 1year follow-up was similar (89.4% A-SES vs. 83.3% ZES, p=0.29). Interestingly, we did not find any cases of definite-, and only one case of probable stent thrombosis in this high risk cohort.. In this real-world registry, A-SES and ZES seems to be associated with promising 1-year clinical safety outcomes following PCI in a contemporary cohort of high-risk diabetic patients. Our results should be considered hypothesis generating, as the clinical safety of A-SES has to be confirmed in a large trial.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Progression-Free Survival; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Time Factors

The aim of this study was to investigate whether the underlying plaque type affects the neointimal coverage after drug-eluting stent implantation.. A total of 1793 struts in 22 zotarolimus-eluting stents were assessed using optical coherence tomography imaging within 3 months of implantation. Neointimal coverage was evaluated within 5 mm from each stent edge on cross-sectional optical coherence tomography images at every 1-mm interval. The percentage of struts covered by neointima was compared among the normal segment group, the fibrous plaque group, and the lipid plaque group on the basis of the underlying plaque type.. The percentage of covered strut was significantly lower in the normal segment group than in the fibrous plaque group (35.9±30.2 vs. 57.1±31.0%, P<0.05) and the lipid plaque group (vs. 64.7±23.5%, P<0.01). The neointima was significantly thinner in the normal segment group than in the lipid plaque group (19.0±22.3 vs. 32.0±18.8 μm, P<0.01). The percentage of struts on the normal segment was significantly higher in cross-sections with a ratio of uncovered to total struts per section more than 0.3 than in cross-sections with a ratio up to 0.3 (32.4±31.7 vs. 19.5±33.8%, P<0.01).. Struts on the normal segment were less covered and had thinner neointima than struts on the lipid plaque at the stent edge within 3 months after zotarolimus-eluting stent implantation. Caution should be exercised when implanting longer drug-eluting stents to achieve uniform strut coverage in the early phase.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Fibrosis; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To evaluate long-term outcomes in patients undergoing either paclitaxel-eluting stents (PES) or endeavor zotarolimus-eluting stents (E-ZES) placement and to assess comparative effectiveness of PES vs. E-ZES in different "off-label" and "high-risk" patient subgroups.. PES and E-ZES are frequently used in percutaneous coronary interventions (PCIs). However, the long-term comparative effectiveness of PES vs. E-ZES in real practice is unknown.. We created a longitudinal database by linking the New York State (NYS) cardiac registries, the NYS hospital discharge file, the National Death Index, and the U.S. Census file for patients undergoing either PES or E-ZES placement from July 2008 through December 2009. All-cause mortality, acute myocardial infarction (AMI), target lesion PCI (TLPCI), and target vessel coronary artery bypass graft (TVCABG) surgery were compared for 9,264 propensity score matched patients for a 5-year follow-up period using the Kaplan-Meier method with further adjustment using Cox proportional hazards regression.. We did not detect significant differences between E-ZES and PES (reference) in 5-year mortality (adjusted hazard ratio : 1.02, 95% confidence interval : 0.91-1.14), AMI (AHR: 1.05, 95% CI: 0.90-1.22), TLPCI (AHR: 0.99, 95% CI: 0.86-1.13), and TVCABG (AHR, 1.07, 95% CI: 0.84-1.36). For six "off-label" and two "high-risk" subpopulations, we had similar findings for the two stent groups.. NYS observational data suggest that 5-year outcomes are comparable in patients receiving either PES or E-ZES placement, mirroring the findings of recent clinical trials. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Comparative Effectiveness Research; Coronary Artery Disease; Databases, Factual; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; New York; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

A 59-year-old man with critical claudication underwent left femoro-anterior bypass grafting, which was uneventful. The graft was tunneled medially across the knee, then anterior to the tibia. His symptoms recurred 1 year later and he was found to have critical stenosis of the vein graft just proximal to the anterior tibial arterial anastomosis. This was treated with scaffolded balloon angioplasty and implantation of a coronary, zotarolimus-eluting balloon-expandable stent, which was also uneventful. However, his claudication again recurred 1 year later. Diagnostic angiography revealed crush, deformation and restenosis of the balloon-expandable stent requiring surgical revision of the bypass graft.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Computed Tomography Angiography; Critical Illness; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Reoperation; Saphenous Vein; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Grafting; Vascular Patency

The third generation drug eluting Orsiro stent had shown already promising results in non-complex lesions.. We evaluated angiographic and 24 month clinical results of the sirolimus eluting Orsiro stents (O-SES) after recanalization of coronary chronic total occlusions (CTO). Results were compared with the zotarolimus eluting Resolute Integrity (R-ZES).. In a prospective series 57 patients were treated with a R-ZES followed by 74 patients treated with a O-SES stent. Angiographic follow up after 9 months and clinical follow-up after 12 and 24 months was performed.. In-stent late lumen loss was 0.24±0.53 mm for the O-SES compared with 0.59±0.72 (P=0.01) for R-ZES. Rates for TLR were similar (O-SES 10.0% versus R-ZES 11.1%, P=0.84). There was no definite stent thrombosis.. The O-SES resulted in a significant lower late lumen loss but with similar clinical results up to 24 month compared to the R-ZES after treatment of CTO lesions.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

There are limited data on the frequency of and factors associated with quantitative coronary angiography (QCA)-defined longitudinal stent deformation (LSD) in various contemporary drug-eluting stents platforms. This study sought to evaluate the predictors of LSD and its long-term clinical implication.. LSD is uncommon with contemporary drug-eluting stents, regardless of the type of stent platform. LSD is mainly associated with procedural factors, especially with additional downstream procedures which require the passage of devices through the stent. Careful manipulation of poststent imaging or procedural devices is required to prevent LSD. More data are needed to clarify the impact of LSD on clinical events.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Databases, Factual; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platinum; Prosthesis Design; Prosthesis Failure; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA.. Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited.. The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality.. At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P < 0.01 for all comparisons). The discriminatory power of a multivariable model for prediction of 3-year mortality was significantly improved after the inclusion of EuroSCORE (adjusted area under the receiver operating characteristic (ROC) curve = 0.779, 95% confidence interval 0.747 to 0.810, P = 0.008), but not after the inclusion of SxScore, SS II, or GRC.. In patients undergoing DES implantation for uLMCA disease, all evaluated risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Area Under Curve; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Decision Support Techniques; Discriminant Analysis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Patient Selection; Percutaneous Coronary Intervention; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; ROC Curve; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate neointimal coverage in the very early phase after second-generation drug-eluting stent (DES) implantation using optical coherence tomography (OCT). Patients who underwent staged percutaneous coronary intervention within 30 days after DES implantation were enrolled. OCT was performed to observe DES previously implanted. The median time interval from implantation to OCT examination was 21.5 days. A total of 10,625 struts of 54 stents (52 everolimus-eluting stents and 2 zotarolimus-eluting stents) in 42 lesions were analyzed. Strut tissue coverage was observed in 71.1 ± 19.2 % of the struts, malapposed struts in 2.56 ± 3.37 %, strut tissue coverage at the side branch orifice in 10.6 ± 17.2 %, and struts with protrusion in 0.95 ± 3.46 %. Mean tissue thickness on the covered struts was 39.8 ± 14.2 µm. The percentage of stent coverage was significantly lower in the overlapping segments than in the non-overlapping segments (48.4 ± 17.5 % vs. 74.4 ± 20.2 %, P < 0.05). Most of the stent struts were covered by tissue within 30 days after second-generation DES implantation. However, the percentage of strut coverage was lower in the overlapping segments than in the non-overlapping segments, suggesting that very early interruption of dual antiplatelet therapy might result in increased risk of stent thrombosis, even in second-generation DES.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Few studies have directly compared vascular responses to second-generation drug-eluting stents (DESs). We performed optical coherence tomography examinations in 56 consecutive patients with implanted single stent [19 cobalt-chromium everolimus-eluting stents (CoCr-EES), 22 platinum-chromium EES (PtCr-EES), and 15 resolute zotarolimus-eluting stents (R-ZES)] for de novo lesions, and who did not have restenosis at their 9-month follow-up. Neointimal thickness (NIT), stent apposition, and neointimal coverage were assessed in every strut. A neointimal unevenness score [(NUS), maximum NIT/average NIT in the same cross-section] was determined for every 1-mm cross-section (CS). A total of 8350 struts and 1159 CSs were analyzed. The CoCr- and PtCr-EES had significantly fewer malapposed struts compared to the R-ZES (CoCr-EES: 0.19 % vs. PtCr-EES: 0.19 % vs.. 0.61 %, p = 0.007). Furthermore, the PtCr-EES had a lower frequency of uncovered struts compared to the others (CoCr-EES: 2.0 % vs. PtCr-EES: 1.4 % vs.. 2.3 %, p = 0.047). The NUS correlated with the frequency of uncovered struts (p < 0.001, r = 0.54). The EESs demonstrated more homogenous neointimal growth, as shown in the NUS, compared to the R-ZES [CoCr-EES: 1.66 (1.38-1.97) vs. PtCr-EES: 1.67 (1.41-2.00) vs.. 1.94 (1.56-2.28), p < 0.001]. Our results demonstrate that unevenness neointimal growth may relate with strut coverage after second-generation DES implantation. The PtCr-EES had a high frequency of strut coverage with a homogeneous neointima, suggesting fewer risks for stent thrombosis.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation.. Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication.. The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated.. The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe.. In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

Topics: Aged; Asia; Australia; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Evidence-Based Medicine; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; North America; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Factors; Sirolimus; South America; Time Factors; Treatment Outcome

To compare the 1-year outcomes of a durable polymer Zotarolimus-eluting stent (ZES) versus a biodegradable polymer Biolimus-eluting stent (BES) in patients undergoing percutaneous coronary intervention.. A total of 2083 patients from 2 different registries, 1125 treated with BES in NOBORI registry and 858 received ZES in CONSTANT registry were included in this study. Clinical outcomes were compared with the use of propensity score matching (PSM). The primary endpoint was a composite of major adverse cardiovascular and cerebrovascular events (MACCEs) including cardiac death, myocardial infarction, clinically driven target lesion revascularization and stroke. Secondary end points were individual components of MACCEs as well as the incidence of stent thrombosis at 1-year follow-up.. After PSM, 699 matched pairs of patients (n=1398) showed no significant difference between BES and ZES in the risk of composite MACCEs at 1 year (2.6% vs. 1.7%; p=0.36). Cardiac death was not statistically different between groups (0.7% vs. 0.4%, p=0.73). Target lesion revascularization rate was also similar between BES and ZES (1.1% vs. 0.7%, p=0.579). Non-Q wave myocardial infarction, as well as target-vessel revascularization rate, was similar between the two groups (0.14% for BES and 0.72% for ZES). Both stent types were excellent with no cases of stent thrombosis and rate of Q wave myocardial infarction reported during the follow-up period.. In this cohort of patients treated with BES or ZES, the rate of MACCEs at 1 year was low and significantly not different between both groups.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Propensity Score; Registries; Sirolimus; Time Factors; Treatment Outcome

To evaluate the rate of clinical events and bleeding risk according to age in patients undergoing percutaneous coronary intervention (PCI) with a new-generation drug-eluting stent (DES) enrolled in the RESOLUTE Global Clinical Program.. This study represents a pooled analysis of five trials included in the RESOLUTE program including 5,130 patients, of whom 1,675 (32.6%) were ≥70 years old (elderly patients).. After adjusting for confounders, age ≥70 years was a significant predictor of high mortality at 30 days (0.6 vs. 0.1%, P = 0.017) and 2 years (7.2 vs. 2%, P < 0.001). No differences were seen with respect to acute myocardial infarction (MI) or target lesion and vessel revascularization rates between young and elderly patients. Bleeding rates were higher in the elderly throughout follow-up. In the elderly, 7 of the 27 (26%) patients with bleeding episodes died, with a median time between bleeding episode to death of 21 days. In the younger population, 1 patient of 17 with a bleeding episode died (400 days later).. Elderly patients undergoing PCI with a new-generation DES have increased mortality and bleeding risk, with similar rates of acute MI and repeat revascularization. Bleeding risk was higher in the elderly and strongly related to death. Target lesion failure rates were not significantly different between the two age groups, suggesting that the Resolute zotarolimus-eluting stent (R-ZES) is effective for patients younger and older than 70 years of age. R-ZES may be recommended for elderly patients when PCI with a DES is identified as a suitable option.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Observational Studies as Topic; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Very late stent thrombosis (VLST) is a serious complication after percutaneous coronary intervention. However, the best therapy for VLST with late-acquired incomplete stent apposition and incomplete neointimal coverage remains unknown. In these cases, neointimal coverage was nearly complete and no late-acquired malapposition was detected at 18 months after Endeavor zotarolimus-eluting stent (ZES) implantation for the treatment of VLST with late-acquired incomplete stent apposition after sirolimus-eluting stent implantation. We presented that Endeavor ZES implantation may become an attractive therapeutic strategy for the treatment of VLST with late-acquired incomplete stent apposition and incomplete neointimal coverage.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Thrombectomy; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

To compare the long-term clinical outcomes between Resolute zotarolimus-eluting stent (R-ZES) and paclitaxel-eluting stent (PES) in patients with small coronary artery disease.. Patients with a small vessel diameter are independently associated with increased risk of adverse cardiac events after drug-eluting stent implantation.. A cohort of 265 patients treated with R-ZES (185 patients with 211 lesions) or PES (80 patients with 100 lesions) in small vessel (≤2.5 mm) lesions were retrospectively analyzed. The primary end point of the study was the composite of major adverse cardiac events. The secondary end points included target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis at 3 years.. The baseline characteristics were similar between the 2 groups. In the R-ZES group, the mean stent diameter was smaller and the total stent length per lesion was longer. Major adverse cardiac events occurred in 8 (10%) patients who had received PES and in 7 (3.8%) patients who had received R-ZES (P = .07). The rates of 3-year TLR (2.2% vs 2.5%; P = 1.00) and TVR (5.4% vs 10.0%; P = .17) showed no statistically significant difference between the R-ZES and PES groups. The rate of stent thrombosis was 0.5% in the R-ZES group and 2.5% in the PES group (P = .21).. The rates of major adverse cardiac events and cardiac death were similar in the R-ZES-treated group compared with the PES-treated group.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

To evaluate angiographic and clinical results of ZES compared with EES after recanalization of CTOs.. ZES and EES showed similar clinical results in non-CTO lesions. Whether ZES and EES are also comparable in true CTO lesions (TIMI 0 flow, duration of occlusion of more than 3 months) with a higher risk of restenosis has not been addressed so far.. 125 patients with successful CTO recanalization via antegrade or retrograde approach were included. EES were implanted in 68 patients and ZES in 57 patients. Dual antiplatelet therapy was prescribed for 12 months. Follow-up angiography was scheduled at 9 months and clinical follow-up at 12 months. The primary angiographic outcome measure was in-stent late lumen loss. Primary clinical outcome measures were target lesion revascularization rate (TLR) and major adverse cardiac events (MACE) as a composite of cardiac death, TLR and myocardial infarction not clearly attributable to a non-target vessel.. Baseline characteristics were similar in both groups. Mean stent length was 72.8 ± 33.0mm with EES and 70.8 ± 31.5 mm with ZES (P = 0.72). In-stent late lumen loss was 0.50 ± 0.71 mm for EES compared with 0.59 ± 0.72 (P = 0.52) for ZES. There were similar rates for TLR (EES 10.3% versus ZES 10.5%, P = 0.97) and MACE (EES 10.3% versus ZES 12.3%). No definite or probable stent thrombosis occurred. Stent length but not type of stent was predictive for in-stent late loss and TLR.. ZES and EES showed similar angiographic and clinical outcomes for treatment of CTOs. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Our case reports the first migration of a stent already deployed at high pressure in the main vessel during a 2-stent strategy for a bifurcation lesion using T and protrusion technique. The Kissing balloon was not optimal and could have led to an insufficient strut/cell opening and then to LAD stent pulled back into the artery tree. This case report highlights the importance of an optimal Kissing Balloon in two stent bifurcation technique.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Device Removal; Drug-Eluting Stents; Everolimus; Foreign-Body Migration; Humans; Male; Middle Aged; Sirolimus; Treatment Outcome

We assessed long-term outcomes in patients with extra-small (XS) (≤2.25 mm) and small vessels (SV) (>2.25-2.75 mm) treated with the Resolute zotarolimus-eluting stent (R-ZES).. Data from eight studies including patients with XS or SV were pooled for this analysis. Among 2,141 patients (837 XS, 1,304 SV), three-year cumulative major adverse cardiac events (15.4% vs. 11.5%; adj. HR [95% CI]: 1.3 [1.0, 1.7], p=0.12), target lesion failure (12.4% vs. 9.3%, adj. HR: 1.1 [0.8, 1.5], p=0.56), and target lesion revascularisation (TLR: 6.9% vs. 4.5%, adj. HR 1.4 [0.9, 2.1], p=0.17) were greater in the XS cohort but were not significantly different after propensity adjustment. Target vessel revascularisation occurred more frequently in XS patients in both unadjusted and adjusted analyses (11.2% vs. 7.6%, adj. HR: 1.5 [1.1, 2.1], p=0.02). Stent thrombosis was low in both cohorts (1.2% vs. 0.6%, p=0.09). In the XS cohort, insulin-dependent diabetics had over twofold higher rates of TLR than non-diabetics (13.6% vs. 6.0%, p=0.02).. Long-term lesion-specific results among patients with XS vessels treated with the R-ZES were not significantly different from those among patients with SV, but specific patients with XS vessels (e.g., insulin-dependent diabetics) may remain at high risk for TLR.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

This study sought to assess the frequency and clinical impact of dual antiplatelet therapy (DAPT) nonadherence.. There are limited data on the impact of DAPT nonadherence during the first year after a second-generation drug-eluting stent placement.. After successful Endeavor zotarolimus-eluting stent implantation, 2,265 patients were enrolled in a registry with limited exclusions and monitored during 12 months of prescribed DAPT. Predictors of any nonadherence (ANA) at 6 months were analyzed by multivariable analysis, and the association between ANA at 6 or 12 months with the endpoints of death, myocardial infarction, and stent thrombosis was assessed.. The study population included 30% female patients, 34% with diabetes and 36% with acute coronary syndromes. ANA occurred in 208 patients (9.6%) before 6 months and 378 patients (18.5%) before 1 year. Major bleeding (odds ratio [OR]: 12.83, 95% confidence interval [CI]: 7.55 to 21.80, p < 0.001) was the only predictor of ANA at 6 months. In time-dependent analyses, ANA before 6 months was associated with an increased risk of death or myocardial infarction (7.6% vs. 3.0%, p < 0.001) and a numerical increase in stent thrombosis (2.0% vs. 0.9%, p = 0.12). After adjustment for baseline differences, ANA within 6 months remained associated with death or MI (OR: 1.95, 95% CI: 1.02 to 3.75). ANA occurring after 6 months did not increase the risk of subsequent ischemic events.. DAPT ANA occurs frequently and is associated with increased risk for thrombotic complications if it occurs within the first 6 months. Major bleeding was a significant correlate of DAPT ANA within 6 months. (EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events; NCT01069003).

Topics: Aged; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Ticlopidine; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Prosthesis Failure; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

Several studies have reported re-endothelialization and endothelial function after drug-eluting stent (DES) implantation; however, the relationship between re-endothelialization and endothelial function after DES implantation has not been investigated yet.. A total of 14 patients underwent evaluation of re-endothelialization by optical coherence tomography (OCT) and endothelial function by incremental Ach infusion at 9 months after DES implantation (ZES: N = 7, PES: N = 7). The neointimal thickness (NIT) inside each strut, strut coverage, and malapposition at every 1 mm cross-section were evaluated by OCT and the endothelial function was estimated by measuring the coronary vaso-reactivity in response to acetylcholine (Ach) infusion into coronary arteries.. Zotarolims eluting stent (ZES), compared with paclitaxcel eluting stent (PES), showed more homogeneous neointimal coverage of stent struts and low rate of malapposition. Vasoconstriction in response to Ach in the peri-stent region was also less pronounced in ZES than PES. In particular, vasoconstriction was more often observed in cases with inhomogeneous neointimal coverage of stent struts in the PES group.. Our findings suggest that endothelial function seems to be better preserved with ZES than PES, and homogeneous neointimal coverage of stent struts seem to be associated with the preserved endothelial function.

Topics: Acetylcholine; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Endothelial Cells; Female; Humans; Infusions, Intra-Arterial; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Re-Epithelialization; Retrospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vasoconstriction; Vasoconstrictor Agents

To analyze the effect of paclitaxel-coated balloon (PCB) treatment on patients with drug-eluting stent (DES) restenosis.. In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR® PCB.. Valentines I prospectively enrolled 250 patients with in-stent restenosis (ISR); 76 patients (30.4%) had restenosis of a previous paclitaxel or limus DES. Patients underwent balloon angioplasty followed by PCB treatment. Clinical outcomes of patients with paclitaxel-eluting DES restenosis (n=34; 41 lesions) and limus-eluting (sirolimus, everolimus and zotarolimus) DES restenosis (n=42; 43 lesions) treated with DIOR® PCB were compared.. Baseline characteristics were similar. There were more diffuse lesions >20mm treated in paclitaxel- compared to limus-eluting DES restenosis (50% vs. 26.8%, p=0.032). Number of PCB used per patient (1.08±0.31 overall), mean PCB diameter (2.99±0.42mm overall), mean PCB length (24.4±11.9mm overall), and bailout stenting (2.4% vs. 4.7%) were similar (p=NS). At mean follow-up of 231±43days, major adverse cardiac events was 0% vs. 23.8% in paclitaxel- vs. limus-eluting DES restenosis (p=0.002), driven mainly by less target vessel revascularization (0% vs. 21.4%, p=0.004). Target lesion revascularization was 0% vs. 16.7% for paclitaxel- vs. limus-eluting DES restenosis (p=0.015).. In Valentines I, PCB use was more effective in patients with paclitaxel DES restenosis compared to limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not limus resistance due to different mechanisms of DES failure.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Restenosis after drug eluting stent (DES) implantation in the distal/bifurcation left main (DBLM) remains challenging to manage. The aim of this study was to assess the in-stent restenosis (ISR) after DES implantation in DLM and to evaluate current management strategy.. The medical records of patients referred for LM distal/bifurcation percutaneous coronary interventions (PCI) from the same Cardiology Unit in the January 2007 to December 2012 period were reviewed for PCI technique, stent type, restenosis type, restenosis treatment and management (CABG, balloon angioplasty only, alternative DES implant, drug eluting balloon angioplasty).. Fourteen patients (5 females, mean age 75.1±8.3years) out of 89 (15.7%) having undergone a percutaneous coronary interventions on DBLM with DES, developed restenosis (everolimus stents in 10 patients, zotarolimus stents in 4 patients). Technique used at the first implant included stenting of the main branch in 4 patients, culottes stenting in 6 patients and T-stent in 4 patients. The mean time elapsed from the first angioplasty and ISR intervention was 7.6±3.6months. Restenosis treatments included: implantation of a different DES (in 3 patients), implantation of a bare-metal stent (in 2 patients), simple balloon angioplasty (in 4 patients), and drug-eluting balloon (5 patients). At 6-month angiographic control second restenosis rate was 14.2%. After a mean follow-up of 38.5±24.4months the target vessel revascularization was 14.3%: surgery was the final choice in two patients due to recurrent restenosis. Incidence of major adverse cardiac event was 28.5%.. The occurrence of restenosis after DBLM following DES implantation is not frequent but remains difficult to manage. In our small anecdotal series, all the different strategies including implantation of different DES, balloon angioplasty, bare-metal stent implantation and drug-eluting balloon angioplasty appeared equally effective in maintaining arterial patency.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Male; Middle Aged; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

The aim of this study was to compare the 2-year clinical outcomes of overlapping second-generation everolimus-eluting stents (EES) with those of overlapping resolute zotarolimus-eluting stents (R-ZES) in the treatment of long coronary artery lesions.. This retrospective analysis included 256 patients treated with overlapping EES (n=121) and R-ZES (n=135) for long coronary artery lesions (total stent length per lesion ≥34 mm). Study endpoints included major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, and target-vessel revascularization (TVR), as well as target-lesion revascularization and definite stent thrombosis separately at 2 years.. In the two groups, the mean age was older and the average number of disease vessel was higher in the R-ZES group. The mean lesion length and total stent length per lesion were longer in the R-ZES group. EES were more frequently implanted in the left anterior descending coronary artery. No significant differences in the estimated MACE (5.8% for EES vs. 8.1% for R-ZES; P=0.548) or TVR (3.4% for EES vs. 4.0% for R-ZES; P=0.806) rates were noted between the two groups at 2-year follow-up. The incidence of definite stent thrombosis was low and similar in both groups (0.83% for EES vs. 0% for R-ZES; P=0.473). No significant differences were noted with respect to MACE or TVR between the two groups following propensity score matching.. Stent overlap with second-generation EES or R-ZES was associated with low rates of MACE, TVR, and stent thrombosis at 2-year follow-up. Our results suggest that the use of overlapping EES or R-ZES in long coronary lesions is associated with good long-term clinical outcomes. These results need to be validated with randomized controlled trials.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

There are few studies comparing the long-term efficacy and safety of the zotarolimus-eluting stent (ZES) with sirolimus- (SES) and paclitaxel-eluting stents (PES) in the unselected cohorts that were subject to real life clinical practice.. Total 2,769 patient who underwent successful percutaneous coronary intervention (PCI) with the three drug-eluting stents (DES) between April 2006 and July 2008 were analyzed retrospectively. A total of 1,152 patients were treated with SES, 810 with PES, and 807 with ZES. The primary analysis endpoint was cumulative rate of target-lesion failure (TLF) at 24 months, defined as the composite of cardiac death, target-vessel-related myocardial infarction (MI), and target-lesion revascularization (TLR).. At 24 months, the incidence of TLF was significantly lower in the SES group compared with the ZES (7.6% vs. 11.3%, HR = 0.66, CI = 0.49–0.88, P = 0.005) or the PES group (7.6% vs. 10.2%, HR = 0.74, CI = 0.55–0.99, P = 0.048), while similar between the PES and the ZES groups (HR = 0.89, CI = 0.66–1.20, P = 0.443). The difference was mostly driven by higher rate of TLR in the ZES and PES groups compared with the SES group, mostly within the first year post-PCI. However, the rate of hard endpoints (cardiac death or nonfatal MI) was similar among the three groups. These results were reproduced in the propensity score-matched cohort.. This observational study shows that the use of SES is superior to PES or ZES for the TLF in the overall and matched analysis.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Republic of Korea; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Everolimus; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus; Ultrasonography, Interventional

This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention.. DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated.. Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization.. Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001).. After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Kidney Failure, Chronic; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Registries; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus

The impact of underexpansion and minimal stent area (MSA) criteria in the second generation drug-eluting stents (DES) has not been addressed yet.. Using intravascular ultrasound (IVUS), we assessed the optimal cut-off values of post-stenting MSA to prevent in-stent restenosis (ISR). Poststenting IVUS data and 9-month follow-up angiography were available in 912 patients with 990 lesions: 541 sirolimus-eluting stents (SES), 220 zotarolimus-eluting stents (ZES) and 229 everolimus-eluting stents (EES).. For the prediction of angiographic ISR, the MSA of each DES was measured. The poststenting MSA was 6.4 ± 1.8 mm(2) in SES, 6.2 ± 2.1 mm(2) in ZES and 6.2 ± 2.1 mm(2) in EES. At the 9-months follow-up, the incidence of angiographic ISR was similar between SES (3.3%) vs. ZES (4.5%) vs. EES. (4.4%), (P = 0.53). Multivariable logistic regression analysis identified the post-stenting MSA as the only independent predictor of angiographic ISR in ZES (Odds ratio 0.722, 95% confidence interval 0.581-0.897, P = 0.001) and in EES (Odds ratio 0.595, 95% confidence interval 0.392-0.904, P = 0.015). The best MSA cut-off value was 5.5 mm(2) for the prediction of SES restenosis (sensitivity 72.2% and specificity 66.3%). For ZES, the optimal MSA predicting ISR was 5.3 mm(2) (sensitivity 56.7% and specificity 61.8%). For EES, the MSA <5.4 mm(2) predicted ISR (sensitivity 60.0% and specificity 60.0%).. As a preventable mechanism of ISR, smaller stent area predicted angiographic restenosis of the second generation DES as well as the first generation. The optimal cut-off values of post-stenting MSA for preventing restenosis were similar between ZES vs. EES vs. SES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Everolimus; Female; Humans; Linear Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Arterial repair in the early phase following implantation of a zotarolimus-eluting stent (ZES) remains unknown.. Following implantation of 49 Endeavor ZES in 33 patients, follow-up angioscopy was performed in 13 patients (26 ZES) in the early phase (EP; 123±24 days) and in 20 patients (23 ZES) in the middle phase (MP; 247±17 days). Neointimal coverage (NIC) was graded as follows: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts were embedded by the neointima but were seen translucently; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous for NIC grade variation≥1. The presence of thrombus and yellow plaque was also investigated. Although NIC heterogeneity tended to be more frequent in EP than in MP (50% vs. 22%, P=0.070), and yellow plaque significantly more frequent (58% vs. 13%, P=0.0025), the majority of stents were dominant NIC grade 3 at both follow-up periods (73% in EP vs. 78% in MP, P=0.75). There was no significant difference in thrombus (23% in EP vs. 4% in MP, P=0.10) between the follow-ups.. Sufficient arterial repair may have occurred by 4 months after ZES implantation. 

Topics: Aged; Aged, 80 and over; Angioscopy; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus

This study was carried out to determine the effect of the use of dual antiplatelet therapy (DAPT) for more than 12 months on long-term clinical outcomes in patients who had undergone a percutaneous coronary intervention with the first and second generations of drug-eluting stents (DES).. The potential benefits of the use of DAPT beyond a 12-month period in patients receiving DES have not been established clearly. Moreover, it is also unclear whether the optimal duration of DAPT is similar for all DES types.. A total of 2141 patients with coronary artery disease treated exclusively with Cypher sirolimus-eluting stents (SES) or Endeavor zotarolimus-eluting stents (ZES) were considered for retrospective analysis. The primary endpoint [a composite of all-cause mortality, nonfatal myocardial infarction (MI), and stroke] was compared between the 12-month DAPT and the >12-month DAPT group.. A total of 1870 event-free patients on DAPT at 12 months were identified. The average follow-up was 28.2±7.4 months. The primary outcomes were similar between the two groups (4.1% 12-month DAPT vs. 1.9% >12-month DAPT; P=0.090). Incidences of death, MI, stroke, and target vessel revascularization did not differ significantly between the two groups. Subgroup analysis showed that in the patients with hypertension, >12-month DAPT significantly reduced the occurrence of death/MI/stroke compared with that in the 12-month DAPT group (P=0.04). In patients implanted with SES, the primary outcome was significantly lower with the >12-month DAPT group (5.2% 12-month DAPT vs. 1.6% >12-month DAPT; P=0.016), whereas in patients with ZES, the primary outcome was comparable between the two groups (2.3% 12-month DAPT vs. 2.0% >12-month DAPT; P=0.99).. In our study, for all patients, >12-month DAPT in patients who had received DES was not significantly more effective than 12-month DAPT in reducing the rate of death/MI/stroke. Our findings, that patients who received SES benefit from >12-month DAPT whereas extended use of DAPT was not significantly more effective in those implanted with ZES, implied that the optimal duration of DAPT was different depending on different types of DES.

Topics: Aged; Aspirin; Cardiovascular Agents; Chi-Square Distribution; Clopidogrel; Coronary Artery Disease; Disease-Free Survival; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stroke; Ticlopidine; Time Factors; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Metals; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Stents

Topics: Cardiovascular Agents; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus

To obtain imaging evidence by 2-week optical coherence tomography (OCT) on the completion of neointimal coverage (NIC; the percentage of stent strut coverage and thickness of the formed neointima) completion after implantation of the Endeavor zotarolimus-eluting stent (E-ZES).. Despite the fact that NIC is a cardinal process in the pathomechanism of late stent thrombosis, little imaging information is available on morphological changes thereof on a short-time interval basis.. 27 Japanese patients with stable angina pectoris and de novo native coronary artery lesions were enrolled, and 27 lesions (30 implantations) were examined. OCT was performed at weeks 2, 4, 6, 8, and 10 after E-ZES implantation. NIC was examined using cross-sectional OCT images obtained at the 1.0-mm intervals.. In total, 621 cross-sectional OCT images, which depicted 7,747 stent struts, were analyzed. The mean percentages of stent strut coverage at weeks 2, 4, 6, 8, and 10 after E-ZES implantation were 12.3, 70.4, 67.9, 86.0, and 99.2%, respectively; a marked increase was found between weeks 2 and 4. The mean thicknesses of the formed neointima were 40.2, 52.1, 48.1, 86.5, and 146.2 μm at respective weeks, with the high-signal and thick neointima (146 µm) at week 10. An intracoronary thrombus was detected in only one stent at week 4.. The full circumferential coverage of the vessel wall by the high-signal neointima was found at as early as week 10 after E-ZES implantation, imparting a surrogate index for vascular healing by NIC.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials.. ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR.. A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST).. Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively.. Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128).

Topics: Aged; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Propensity Score; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Polymer-coating represents a key component of drug-eluting stent (DES) technology and its possible impact on vessel-wall healing is a matter of debate. The clinical impact of different polymer-coating may be assessed by comparing the outcome of patients treated by DES having the same stent platform and drug, and differing in the polymer. Thus, we compared the clinical outcome of patients treated by Endeavor Zotarolimus-eluting stent (E-ZES) and Resolute Zotarolimus-eluting stent (R-ZES) as they differ in the polymer-coating only.. At our Institution, E-ZES was available during a first period and then it was substituted by the R-ZES during a second period. Clinical, angiographic, and procedural data were prospectively collected. Clinical follow-up was prospectively obtained up to 1-year. Primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12-month.. A total of 467 patients undergoing percutaneous coronary intervention were enrolled: 233 patients treated with E-ZES and 234 with R-ZES. Patients treated by R-ZES had similar clinical characteristics and worse angiographic characteristics compared with those treated by E-ZES. At 12-month follow-up, MACE rate was significantly lower in the R-ZES group compared with E-ZES group (4.2% vs. 14.6%; P < 0.01). This difference was due to nonsignificantly lower rates of death and myocardial infarction and to significant lower rate of target-lesion-revascularization (R-ZES 3.4% vs. E-ZES 10.3%, P < 0.01).. The results of this study suggest that the clinical outcome of patients treated by DES differing for the polymer coating only may be different. Polymer coating is a pivotal, probably underrated, component of DES technology which may influence the clinical performance of DES.

Topics: Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Rome; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

To compare 2-year outcomes (mortality, mortality/myocardial infarction (MI), target vessel PCI (TVPCI), and target lesion PCI (TLPCI)) for patients receiving EES and ZES.. The utilization of drug-eluting coronary stents (DES) among patients undergoing percutaneous coronary interventions (PCI) has increased dramatically in the last decade. Everolimus-eluting stents (EES) and ENDEAVOR zotarolimus eluting stents (ZES) constitute the latest generation of approved DES in the United States, but little is known about their relative effectiveness.. New York patients undergoing EES and ZES revascularization without any other type of stent between 7/08 and 12/08 were propensity matched at the hospital level using multiple patient, operator, and hospital characteristics, and matched patients were followed through the end of 2010 to obtain comparative 2-year outcomes.. A total of 3286 patients were propensity-matched. Patients receiving EES had a significantly lower TVPCI rate (9.0% vs. 11.9%, AHR = 1.31, 95% CI (1.04, 1.65)) and a significantly lower TLPCI rate (6.0% vs. 8.3%, AHR = 1.35, 95% CI (1.02, 1.79)). There was no significant difference between EES and ZES for mortality or MI/mortality.. There were no significant differences in the hard endpoints of death or MI between patients who received EES versus those who received ZES (ENDEAVOR). Patients with EES experienced lower repeat revascularization rates than patients with ZES at 24 months.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; New York; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To evaluate differences in strut coverage, inflammation and endothelialization between two second-generation polymer-based drug-eluting stents (DES) in an atherosclerotic rabbit double-injury iliac artery model at 28 days follow-up.. Rabbits with induced atheroma received bilateral iliac artery stents: everolimus-eluting stent (Xience V EES; Abbott Vascular), zotarolimus-eluting stent (Resolute ZES; Medtronic CardioVascular), or bare-metal stent (BMS; MultiLink Vision; Abbott Vascular). After 28 days, total neointimal coverage examined by scanning electron microscopy was >98% for all three stent types. Neointimal thickness above stent struts was decreased by 50% in Xience V EES (0.06 ± 0.01 mm; P = 0.00001) compared with BMS (0.15 ± 0.03 mm) and Resolute ZES (0.12 ± 0.04 mm). Luminal area was largest for Xience V EES (3.79 ± 0.33 mm(2) ; P = 0.0003 for Xience V EES vs. BMS), followed by Resolute ZES (3.46 ± 0.45 mm(2) ; P = 0.083 for Resolute ZES vs. BMS) and BMS (3.07 ± 0.53 mm(2) ). Percentage area stenosis was smallest for Xience V EES (17.23 ± 3.64%; P = 0.00001), while BMS (30.25 ± 7.48%) and Resolute ZES (30.79 ± 7.15%) did not differ. Endothelial monolayer regrowth was significantly lower in Resolute ZES (65 ± 13%) versus BMS (79 ± 11%; P = 0.004). There was no difference between Xience V EES (74 ± 10%) and BMS. Xience V EES was further associated with a lower number of inflammatory cells surrounding the stent struts (7 ± 2 per strut) in comparison to Resolute ZES (15 ± 6; P = 0.0001) and BMS (17 ± 9; P = 0.0005).. In this atherosclerotic rabbit model, Xience V EES suppressed neointimal thickening better, with normal endothelial regrowth as compared with BMS, and less strut-induced inflammation.

Topics: Angioplasty, Balloon; Animals; Atherosclerosis; Cardiovascular Agents; Cell Proliferation; Disease Models, Animal; Drug-Eluting Stents; Endothelial Cells; Everolimus; Iliac Artery; Inflammation; Male; Neointima; Prosthesis Design; Rabbits; Radiography; Sirolimus; Time Factors; Vascular System Injuries

A 73-year-old woman was admitted to our hospital with anterior acute myocardial infarction due to subacute thrombosis after coronary stenting with a zotarolimus-eluting stent (ZES), which is a newly developed drug-eluting stent that has been widely used since May 2009 in Japan. Five days before, she underwent implantation with a ZES in the left anterior descending artery due to stable angina pectoris. After stenting, the intravascular ultrasonography showed no malapposition from the proximal to the distal edge of the stent. She received aspirin 100 mg/day and clopidogrel 75 mg/day from 2 weeks before the stent was implanted. When we investigated the single nucleotide polymorphisms of CYP2C19 in this patient, both CYP2C19*2 and CYP2C19*3 were detected, and she was classified as a poor metabolizer. This report is the first to describe subacute stent thrombosis following the implantation of a newly developed ZES in a Japanese patient, which may be related to clopidogrel resistance.

Topics: Aged; Angioplasty, Balloon, Coronary; Anterior Wall Myocardial Infarction; Aryl Hydrocarbon Hydroxylases; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Cytochrome P-450 CYP2C19; Drug Resistance; Drug-Eluting Stents; Female; Genotype; Humans; Phenotype; Platelet Aggregation Inhibitors; Polymorphism, Single Nucleotide; Prosthesis Design; Sirolimus; Thrombectomy; Thrombosis; Ticlopidine; Treatment Outcome; Ultrasonography, Interventional

There have been little data regarding major determinants for the uncovered stent struts after drug-eluting stent (DES) implantation on optical coherence tomography (OCT). We investigated the major determinants of incomplete neointimal coverage of DES struts on OCT after implantation in a large cohort of patients. A total of 261 patients with 279 lesions who were treated with various DESs were selected from the OCT registry database. The lesions were divided into two groups based on the ratio of uncovered struts to total struts in all OCT cross-sections; an uncovered group (highest quartile with % uncovered struts ≥5.4%, n = 70), and covered group (the remaining lower quartiles with % uncovered struts <5.4%, n = 209). The uncovered group was more likely to have complex lesions, smaller reference vessel and stent diameter, and longer stent, more use of sirolimus-eluting stents, and less use of zotarolimus-eluting stents compared with the covered group. Of these variables, the most significant determinant of uncovered stent struts was DES type (odds ratio [OR] = 2.75, 95% confidence interval [CI] = 1.94-3.89, P < 0.001). The use of sirolimus-eluting stents (OR = 2.44, 95% CI, 1.15-5.47, P = 0.023) and zotarolimus-eluting stents (OR = 0.02, 95% CI = 0.01-0.25, P = 0.002) were the only significant risk and protective factors for uncovered stent struts, respectively. This study demonstrated that DES type might be associated with the most important determinants of uncovered struts compared to any other clinical or angiographic factor.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Logistic Models; Male; Middle Aged; Odds Ratio; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Previous optical coherence tomography (OCT) studies in patients with drug-eluting stents (DESs)-related very late stent thrombosis (VLST) were scarce. Therefore, we investigated OCT findings of VLST after implantation of DESs. Using OCT, we analyzed the status of stent struts and neointimal characteristics in 18 patients who developed VLST after DES implantation. These results were compared to those in 57 patients with neointimal hyperplasia causing >40% diameter stenosis. Lipid-laden neointima was defined as a region with marked signal attenuation and a diffuse border. Four (22.2%) of 18 patients with VLST had ruptured and lipid-laden neointima inside DESs without uncovered or malapposed stent struts. In the remaining 14 patients who developed VLST without neointimal rupture, uncovered and malapposed struts were observed in nine and seven patients, respectively, and lipid-laden neointima in four patients. Lipid-laden neointima was more frequently observed in four patients with neointimal rupture than in 14 patients without neointimal rupture (100% vs. 28.6%, respectively, P = 0.023). Of 57 patients with neointimal hyperplasia, eight (14.0%) had lipid-laden neointima. Time to OCT study after DES implantation was significantly longer in the eight patients with lipid-laden neointima than in 49 patients without lipid-laden neointima (45.5 ± 17.7 months vs. 11.7 ± 7.2 months, respectively, P < 0.001). Lipid-laden neointima was detected in some patients with neointimal hyperplasia > 1 year after DES implantation. In addition to uncovered or malapposed struts, rupture of lipid-laden neointima inside DESs was identified in some patients with DES-related VLST.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Lipid Metabolism; Male; Middle Aged; Neointima; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To assess clinical performance of the second-generation Endeavor Resolute(®) drug-eluting stents (DES) in an unrestricted high-risk cohort of patients.. New-generation DESs aim to further increase its clinical safety and efficacy by means of more biocompatible components limiting inflammatory response, assuring strut coverage and preserving endothelial vascular function.. Between January 2008 and April 2009 820 unselected consecutive high-risk patients (1,352 lesions) treated with the Endeavor Resolute(®) stent were enrolled in an independent multicenter registry. Primary end-points of this registry were immediate procedural outcome, incidence of target lesion failure (TLF, defined as composite of cardiac death, myocardial infarction, and target lesion revascularization) and rate of ARC stent thrombosis at 12-months follow-up.. High-risk patient/lesion profile included acute coronary syndrome diagnosis in 57% of patients, diabetes mellitus in 23% and ACC/AHA type B2/C lesion in 74%. Endeavor Resolute(®) stent was used in an off-label indication in 52% of cases with stent/patient ratio of 1.93 and average stented segment of 39.8±26.6 mm. Immediate procedural success was accomplished in 96.0% of cases and at median 12-month follow-up TLF rate was 7.1% with 4.0% of clinically driven repeat revascularizations and 1.1% of definite/probable stent thrombosis incidence. At multivariable analysis, nor off-label Endeavor Resolute(®) stent use or multiple stent implantations were associated to an increased risk of adverse events.. Extensive use of the new Endeavor Resolute(®) stent was associated with favorable procedural and 12-month outcomes despite the treatment of unselected complex clinical and anatomical presentation. Endeavor Resolute(®) stent showed excellent safety and efficacy profile also in off-label indications.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Italy; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Product Labeling; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

To report the safety and efficacy of zotarolimus eluting stents for treatment of unprotected left main coronary artery disease.. Percutaneous stent insertion is an increasingly popular alternative to bypass surgery for the management of left main (LM) coronary artery disease. While data support the use of sirolimus- and paclitaxel-coated stents in the LM coronary artery, there are no published series reporting results with Endeavor (zotarolimus) stents, particularly in the context of unprotected left main (ULM) lesions.. We retrospectively identified 40 consecutive patients who had ULM disease treated with Endeavor stents (ZES) and who had follow-up angiography. The primary endpoint was the prevalence of major adverse cardiac events (MACE), including cardiac/unexplained death, nonfatal myocardial infarction (MI), and in-stent restenosis (ISR)/target lesion revascularization (TLR).. Angiographic and procedural success was achieved in all cases. Follow-up angiography occurred on average 5.6 ± 0.9 months after the index procedure. There were three incidences of ISR requiring TLR and another patient who had a NSTEMI in the follow-up period. At late follow-up (12.4 ± 1.8 months) three patients underwent CABG (one for RCA stenosis) and four patients died without knowledge of the status of the ULM stent (two cardiovascular and two deaths related to cancer progression).. In conclusion, our experience with Endeavor stents for the treatment of ULM disease demonstrates excellent angiographic and clinical outcomes, with a 7.5% ISR/TLR rate and a 15% MACE rate, respectively, at an average clinical follow-up of 12.4 months.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cause of Death; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Ontario; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The Resolute zotarolimus-eluting stent (ZES-R) has a thinner stent strut with biocompatible polymer than first generation drug-eluting stents. However, minimal optical coherence tomography (OCT) data exists about vascular responses after ZES-R implantation. This study investigated OCT findings in ZES-R implantation and compared them to those in sirolimus-eluting stent (SES) implantation. A total of 123 lesions (43 ZES-R and 80 SES) in 111 patients were evaluated with OCT at 9 months after stent implantation. Strut apposition, neointimal hyperplasia (NIH) thickness, and stent coverage on each stent strut were evaluated. Mean NIH thickness was significantly greater in ZES-R-treated lesions than in SES-treated lesions (166 ± 73 μm vs. 96 ± 63 μm, respectively, P < 0.001). The percentage of uncovered strut was significantly lower in ZES-R-treated lesions than in SES-treated lesions (4.4 ± 4.8% vs. 10.3 ± 13.2%, respectively, P = 0.05). The percentage of malapposed struts was also significantly lower in ZES-R-treated than in SES-treated lesions (0.1 ± 0.4% vs. 1.5 ± 4.2%, respectively, P = 0.002). Intracoronary thrombus was less frequently detected in ZES-R-treated lesions (4.7% vs. 30.0%, respectively, P = 0.001). ZES-R showed a lower incidence of uncovered or malapposed stent struts and intracoronary thrombus than SES at 9-month follow-up OCT examination. Compared with SES, ZES-R may elicit more favorable vascular responses at the expense of an increased neointimal proliferation.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Linear Models; Male; Middle Aged; Multivariate Analysis; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Registries; Retrospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Neointima; Percutaneous Coronary Intervention; Sirolimus; Tomography, Optical Coherence

Bleeding events are common after percutaneous coronary intervention (PCI) and have been shown to increase mortality in studies of acute coronary syndrome (ACS) and anti-thrombotic therapy. Despite this evidence, bleeding has not been included as a traditional major endpoint in clinical trials of low-risk populations enrolled in PCI clinical trials. Thus, the impact of specific bleeding definitions has not been evaluated fully among these patients.. Using patient-level pooled data from sirolimus and zotarolimus drug-eluting stent clinical trials, we identified bleeding events using three common definitions of bleeding, ACUITY, TIMI, and GUSTO, and assessed the impact on mortality and MI at 12 months after PCI. The GUSTO, ACUITY, and TIMI classifications identified bleeding rates of 2.3%, 1.9%, and 2.1%, respectively. The GUSTO criteria classified all 118 suspected bleeding events. There were 22 (18.6%) and 8 (6.8%) suspected bleeding events that did not meet ACUITY and TIMI criteria, respectively. The combined endpoint of all-cause death or myocardial infarction (MI) at 12 months was significantly higher for patients with a bleeding event compared with those who did not bleed [hazard ratio 1.95 (95% CI 1.06-3.60)].. There is a substantial variability in the utility and inclusiveness of three widely used bleeding definitions in identifying clinically significant bleeding events in clinical trials of low risk patients undergoing PCI with DES. Patients with bleeding after elective PCI have an increased one-year risk of death or MI compared to those patients who do not bleed.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Clinical Trials as Topic; Drug-Eluting Stents; Endpoint Determination; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Terminology as Topic; Time Factors; Treatment Outcome

Renal impairment (RI) is a predictor of poor outcomes in patients with cardiovascular disease, but its influence in the setting of percutaneous coronary intervention and zotarolimus-eluting stent (ZES) implantation has not been described. This study evaluated the impact of RI on clinical outcomes in patients participating in the E-Five Registry.. E-Five was a prospective, multicenter, global registry of 8,314 patients; 2,116 patients were followed to 2 years.. Patients (excluding those who had undergone renal transplantation) were grouped according to renal function (normal function/mild RI, serum creatinine <110 μmol/L; moderate RI, 110-200 μmol/L; severe RI, >200 μmol/L) and their outcomes evaluated retrospectively. Major adverse cardiac events (MACE; i.e., death, myocardial infarction, emergency cardiac bypass surgery, or target lesion revascularization) and stent thrombosis events at 1 and 2 years were compared between groups.. The 1-year MACE rate in patients with mild RI was 6.8%, compared with 8.9 and 18.1% in patients with moderate and severe RI (P = 0.002 across groups). At 2 years, death occurred in 16% of those with severe RI, compared with 2.0 and 4.7% in those with mild and moderate RI (P = 0.002). There was no significant difference in the rates of target lesion revascularization or target vessel failure.. Greater severity of RI at intervention is associated with greater mortality and MACE but unchanged revascularization rates after ZES implantation.

Topics: Aged; Asia; Biomarkers; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Coronary Thrombosis; Creatinine; Drug-Eluting Stents; Europe; Female; Glomerular Filtration Rate; Humans; Kaplan-Meier Estimate; Kidney; Logistic Models; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Registries; Renal Insufficiency; Retrospective Studies; Risk Factors; Severity of Illness Index; Sirolimus; South America; Time Factors; Treatment Outcome

In this study we compared the outcomes of the everolimus-eluting stent (EES) versus the zotarolimus-eluting stent (ZES) in patients treated at a tertiary medical center, with up to one year of follow-up.. Unselected consecutive patients were retrospectively recruited following stenting with the ZES (n = 197) or EES (n = 190). The first 100 consecutive patients in each cohort underwent syntax scoring. The primary endpoint of the study was target vessel failure, defined as the combined endpoint of cardiac death, non-fatal myocardial infarction, or target vessel revascularization. Secondary endpoints included target lesion revascularization, target lesion failure, acute stent thrombosis, total death, cardiac death, and non-fatal myocardial infarction.. The two groups were similar, including for Syntax scores (19.6 ± 12.8 versus 20.6 ± 13.6), number of stents per patient (2.9 ± 1.9 versus 2.9 ± 2.1), and cardiovascular risk factors. By one year, the primary outcome occurred in 20.8% EES versus 26.7% ZES (P = 0.19) patients. The secondary endpoints were as follows: target lesion revascularization (8.9% versus 20.6%, P = 0.003), target vessel revascularization (18.9% versus 25.6%, P = 0.142), definite and probable stent thrombosis (0% versus 2.5%), non-fatal myocardial infarction (2.7% versus 3.6%), and mortality (3.2% versus 5.1%) for the EES versus the ZES, respectively.. EES had similar target vessel failure to ZES, but superior target lesion revascularization and target lesion failure at one year of follow-up in an unselected cohort of patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Iowa; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Retrospective Studies; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Both paclitaxel and zotarolimus are currently employed in vascular interventional therapies, such as drug-eluting stents, and are under investigation for use in other novel drug-device combination products. Paclitaxel is a microtubule-stabilizing compound with potent antiproliferative properties and antimigration effects, whereas zotarolimus is a potent mammalian target of rapamycin inhibitor with antiproliferative and antiinflammatory properties. This study was intended to compare paclitaxel and zotarolimus for intravascular applications in which drug exposure time may be reduced, such as in drug-coated balloons. These applications are generally aimed at reducing neointimal hyperplasia by limiting smooth muscle cell (SMC) proliferation and inflammatory cell recruitment, while minimally interfering with vessel reendothelialization after balloon denudation. In the cellular models described in this study, transient exposure of zotarolimus resulted in the sustained inhibition of SMC proliferation and reduced endothelial cell (EC) proinflammatory cytokine expression, while not affecting EC migration and viability. Transient exposure of paclitaxel inhibited SMC proliferation, EC migration, and overall cell viability, with no effect on expression of the proinflammatory biomarkers studied.

Topics: Apoptosis; Biomarkers; Cardiovascular Agents; Cell Death; Cell Movement; Cell Proliferation; Cell Survival; Cells, Cultured; Coronary Vessels; Cytokines; Dose-Response Relationship, Drug; Endothelial Cells; Humans; Inflammation Mediators; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Necrosis; Paclitaxel; Sirolimus; Time Factors

To evaluate the safety and efficacy of a balloon-mounted drug-eluting stent (DES) for recurrent carotid in-stent stenosis (ISS).. As part of our targeted carotid artery stenting (TARGET-CAS) protocol, neurological and ultrasound evaluations have been performed at 3, 6, and 12 months and then annually since 2001 in all carotid stent patients. For angiographically-confirmed >70% ISS, balloon angioplasty was performed as a first-line treatment. Recurrent ISS was treated with a 4.0-mm zotarolimus-eluting coronary stent (ZES) that was postdilated according to intravascular ultrasound imaging. Among the 1350 neuroprotected CAS procedures performed between January 2001 and March 2011, there were 7 (0.52%) patients (5 men; ages 51-72 years), all neurologically asymptomatic, with >70% recurrent ISS that occurred at 5 to 11 months after the initial balloon angioplasty treatment for ISS.. ZES implantation under distal embolic protection was technically successful and uncomplicated. Angiographic stenosis was reduced from 84.6%±7.5% to 10.7%±3.6% (p<0.01). In 5 patients with ZES implanted fully within the self-expanding carotid stent, duplex ultrasound follow-up (mean 17 months, range 6-36) revealed no evidence of restenosis or stent fracture/deformation. In the 2 other patients, the ZES had been implanted for distal edge ISS such that the ZES protruded beyond the original carotid stent. This protruding segment of the ZES demonstrated deformation/kinking in both; in one, this led to symptomatic stent occlusion.. The use of coronary ZES in the treatment of recurrent carotid ISS is feasible and appears effective provided the ZES is placed entirely within the original stent. Placement of a coronary ZES outside the carotid stent scaffold should be avoided.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Carotid Stenosis; Drug-Eluting Stents; Embolic Protection Devices; Female; Humans; Male; Middle Aged; Poland; Prosthesis Design; Recurrence; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional

Topics: Angioplasty, Balloon; Cardiovascular Agents; Carotid Stenosis; Drug-Eluting Stents; Female; Humans; Male; Sirolimus

This study sought to compare everolimus-eluting stents (EES) with zotarolimus-eluting stents (ZES) in patients with acute myocardial infarction (AMI).. There is a paucity of data to exclusively evaluate the safety and efficacy of second-generation drug-eluting stents (DES) in the setting of AMI.. The present study enrolled 3,309 AMI patients treated with ZES (n = 1,608) or EES (n = 1,701) in a large-scale, prospective, multicenter registry-KAMIR (Korea Acute Myocardial Infarction Registry). Propensity score matching was applied to adjust for differences in baseline clinical and angiographic characteristics, producing a total of 2,646 patients (1,343 receiving ZES, and 1,343 receiving EES). Target lesion failure (TLF) was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction, or target lesion revascularization. Major clinical outcomes at 1 year were compared between the 2 propensity score-matched groups.. After propensity score matching, baseline clinical and angiographic characteristics were similar between the 2 groups. Clinical outcomes of the propensity score-matched patients showed that, despite similar incidences of recurrent nonfatal myocardial infarction and in-hospital and 1-year mortality, patients in the EES group had significantly lower rates of TLF (6.5% vs. 8.7%, p = 0.029) and probable or definite stent thrombosis (0.3% vs. 1.6%, p < 0.001), compared with those in the ZES group. Furthermore, there was a numerically lower rate of target lesion revascularization (1.2% vs. 2.2%, p = 0.051) in the EES group than in the ZES group.. In this propensity-matched comparison, EES seems to be superior to ZES in reducing TLF and stent thrombosis in patients with AMI.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Hospital Mortality; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Propensity Score; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Recurrence; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We aimed to assess the influence of different sirolimus analogues released from a uniform stent platform on re-endothelialisation and vascular healing responses.. Bare metal stents (BMS) were coated with a fluoropolymer containing everolimus (EES), sirolimus (SES) or zotarolimus (ZES) to generate drug-eluting stents (DES) with identical stent backbones, drug loads and release kinetics. DES constructs and control BMS were implanted into the iliac arteries of rabbits and were analysed at 14 days by scanning electron microscopy (SEM) and confocal microscopy for en face evaluation of endothelialisation (n=6 for each stent), or at 28 days to determine histomorphometric characteristics (n=11 for each stent). SEM analysis revealed low degrees of strut re-endothelialisation within the DES without differences among groups, while the BMS control showed almost complete endothelialisation. Percent stenosis was significantly reduced in all DES compared to BMS. Strut-based fibrin analysis revealed significantly greater deposition in the DES compared to BMS, with EES showing maximum fibrin deposition among the DES groups.. Sirolimus and its derivatives have similar effects on endothelial regrowth and neointimal thickening. The observation of greatest fibrin deposition in the experimental EES group indicates that everolimus may affect vascular healing differently.

Topics: Angioplasty, Balloon; Animals; Biomarkers; Cardiovascular Agents; Drug-Eluting Stents; Endothelial Cells; Everolimus; Fibrin; Iliac Artery; Immunohistochemistry; Male; Metals; Microscopy, Confocal; Microscopy, Electron, Scanning; Models, Animal; Neointima; Platelet Endothelial Cell Adhesion Molecule-1; Prosthesis Design; Rabbits; Sirolimus; Time Factors; Wound Healing

The study evaluated serial quantitative and qualitative changes in vascular responses to drug-eluting stents (DES) using optical coherence tomography (OCT).. Serial changes in stent strut coverage and neointima characteristics in DES-treated lesions have not been sufficiently investigated using OCT.. Serial OCT was performed in 72 patients with 76 DES-treated lesions at 9 months and 2 years after DES implantation (sirolimus-eluting stent, n = 23; paclitaxel-eluting stent, n = 20; zotarolimus-eluting stent, n = 25; everolimus-eluting stent, n = 8). Serial changes in quantitative parameters (neointimal thickness, stent strut coverage, and apposition at each strut) and qualitative characteristics of the neointima were evaluated.. Mean neointimal thickness significantly increased from 164 μm to 214 μm between 9 months and 2 years (p < 0.001), and the percentage of uncovered stent struts significantly decreased (from 4.4% to 2.3%, p < 0.001). Completely covered lesions were more frequently observed at 2 years (44.7% vs. 59.2%, p = 0.07). However, the percentage of malapposed struts (0.6% vs. 0.9%, p = 0.24) and incidence of intracoronary thrombi (10.5% vs. 9.2%, p > 0.99) were similar. On qualitative evaluation of neointimal morphology, lipid-laden neointima (27.6% vs. 14.5%, p = 0.009) and thin-cap neoatheroma (13.2% vs. 3.9%, p = 0.07) were more frequently detected at 2-year follow-up compared with 9 months. In matched cross-sectional evaluation, the change of neointimal morphology from homogeneous to heterogeneous or lipid-laden pattern was observed in 23 (30.3%) of 76 lesions. There was a significant increase in percent neointimal hyperplasia cross-sectional area in those lesions.. This OCT study suggested that neointimal coverage improved from 9 months to 2 years without significant changes in the incidence of malapposed struts and intracoronary thrombus. Additionally, in-stent neoatherosclerosis including transformation to lipid-laden neointima might progress during extended follow-up periods after DES implantation.

Topics: Aged; Cardiovascular Agents; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Registries; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kidney; Male; Percutaneous Coronary Intervention; Renal Insufficiency; Sirolimus

Drug-eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus-eluting stents (SES) showed better outcomes than paclitaxel-eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor-eluting stents in the treatment of bifurcation lesions according to the provisional T-stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus-eluting stents (ZES) were implanted in 53 patients and everolimus-eluting stents (EvES) in 62 patients. Primary end-point of the study was the 12-month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of > 50% restenosis on the main vessel or TIMI flow < 3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non-ST-segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; TOR Serine-Threonine Kinases; Treatment Outcome

To present data from the cohort of patients in the all-comers Endeavor zotarolimus-eluting stent (ZES) registry (E-Five) who underwent 2-year follow-up.. The Endeavor ZES has been shown to be safe and efficacious for treatment of single, de novo lesions in patients with stable coronary artery disease. E-Five evaluated the ZES in over 8,000 real-world patients, at 188 sites followed to 1 year. A subset of sites continued follow-up through 2 years to evaluate late-term safety and effectiveness of the ZES in this population with diverse clinical and lesion characteristics.. E-Five, a prospective, multicenter, nonrandomized global registry, collected 2-year outcomes for 2,116 patients from 26 centers. Sites were selected for participation based on patient accrual rates and the ability to continue follow-up activities for an additional year. Complete data was available for 2,054 patients. To observe whether or not a sustained benefit was achieved, data for all patients from the selected sites were included in the analysis.. The outcomes in the 2-year cohort tracked with the results of randomized controlled trials using the Endeavor ZES. One year results were MACE 7.5%, TLR 4.5%, and ARC definite/probable stent thrombosis 0.6%. Outcomes at 2 years for MACE, TLR, and ARC definite/probable stent thrombosis were 8.5, 5.1, and 0.7%, respectively.. Long-term efficacy and safety outcomes were maintained between 1 and 2 years for the 2-year patient cohort, with only a small number of additional MACE, TLR, and very late stent thrombosis events.

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Latin America; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Our purpose was to investigate the clinical outcomes of Zotarolimus- and Paclitaxel-eluting stents in Turkish patients with coronary artery disease (CAD). In general, the outcome of drug-eluting stent (DES) placement has a proven efficacy in randomized trials. However, the difference in efficacy between the Zotarolimus and Paclitaxel-eluting stents in unselected Turkish patients is controversial. Therefore, we investigated the clinical outcomes of these two drug-eluting stents in the real-world.. We created a registry and prospectively analyzed data on a consecutive series of all patients who presented to our institution with symptomatic coronary artery disease between February 2005 and March 2007 and who were treated with the zotarolimus- or the paclitaxel-eluting stent. The follow-up period was approximately two years. The primary end-point was major cardiac events, and the secondary end-point was definite stent thrombosis. Informed consent was obtained from all subjects, and the study protocol was approved by the local ethical committee.. In total, 217 patients were treated with either the zotarolimus-eluting stent (n = 116) or the paclitaxel-eluting stent (n = 101). The lesions in the 2 arms of the study were treated similarly by conventional technique. At 24-month follow-up the paclitaxel-eluting stent group showed significantly higher non-Q wave myocardial infarction (2.6% vs 5.9%, p: 0.02), Q wave myocardial infarction (1.7% vs 5.9%, p: 0.049), coronary artery binding graft surgery (2.6% vs 6.9%, p: 0.002), and late stent thrombosis (1.7% vs 3.9%, p: 0.046).. Zotarolimus-eluting stents demonstrated better clinical outcomes than Paclitaxel-eluting stents in a daily routine practice of coronary intervention in an unselected Turkish population.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Middle Aged; Paclitaxel; Patient Selection; Postoperative Complications; Prospective Studies; Random Allocation; Registries; Retrospective Studies; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Turkey

Optical coherence tomography is a high-resolution imaging technology that allows in vivo assessment of neointimal hyperplasia and strut coverage after coronary stenting.. Assessment of spatial distribution of healing, 6 months after zotarolimus-eluting stent implantation.. Forty-two zotarolimus-eluting stents were monitored by optical coherence tomography 6 months after implantation. Mean neointimal strut coverage thickness and percentage of neointimal hyperplasia were measured every millimetre. Non-covered strut ratios were assessed on each slice. In addition, the spatial distribution of neointimal hyperplasia and strut coverage were analysed longitudinally on five stent segments and axially on each slice.. There were no clinical events at 6 months under dual antiplatelet therapy. The optical coherence tomography analysis showed a mean neointimal hyperplasia thickness of 333±147μm and neointimal hyperplasia obstruction of 36.1±12.3%. The percentage of covered struts at 6 months was very high (98.9%). Only 6/745 slices analysed (0.8%) had non-covered strut ratios exceeding 30%. There was no significant heterogeneity in either longitudinal or axial neointimal hyperplasia distribution. No thrombi were observed.. This optical coherence tomography study found relatively constant neointimal hyperplasia thickness, regardless of the zotarolimus-eluting stent length or diameter. This spatially homogeneous neointimal hyperplasia was associated with near-total coverage of all struts, 6 months after implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Female; France; Humans; Hyperplasia; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

The aim of this study was to compare the pharmacokinetics of the four limus-eluting stents used in Japanese patients.. There are presently no reports comparing human pharmacokinetics among drug-eluting stents (DESs).. We retrospectively analyzed data from pharmacokinetic studies of patients implanted with an 18-mm DES: Cypher stent (sirolimus, n = 10), Endeavor stent (zotarolimus, n = 7), Xience V stent (everolimus, n = 6), and Nobori stent (biolimus A9, n = 10), in multicenter trials of Japan. Total drug doses of the Cypher stent, Endeavor stent, Xience V stent, and Nobori stent were 150, 180, 88, and 293 μg, respectively. Drug concentrations were measured in serial whole blood samples after implantation and the pharmacokinetics were analyzed.. Mean peak drug levels were 0.86 ng mL(-1) for Cypher, 1.80 ng mL(-1) for Endeavor, 0.50 ng mL(-1) for Xience V, and 0.09 ng mL(-1) for Nobori. After adjustment for the loaded dose, mean peak drug levels of the Cypher and Xience V stents were similar (0.0057 ng mL(-1) μg(-1) each) while the Endeavor (0.0100 ng mL(-1) μg(-1)) was higher, and the Nobori (0.0003 ng mL(-1) μg(-1)) was lower, compared with the Cypher and Xience V stents. The other pharmacokinetic parameters of four DESs differed according to characteristics of the coated drug. The systemic exposure of biolimus A9 was much lower than that of the other DESs studied.. In Japanese patients, systemic exposure was low, regardless of the type of limus drug eluted from the stents; but specific pharmacokinetic activities were varied according to the drug characteristics, concentration, and DES design.

Topics: Aged; Analysis of Variance; Asian People; Cardiovascular Agents; Clinical Trials as Topic; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Linear Models; Male; Middle Aged; Models, Biological; Multicenter Studies as Topic; Prosthesis Design; Retrospective Studies; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

To compare zotarolimus-eluting stent (Endeavor Sprint®; ZES-S) and the everolimus-eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions.. Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated.. In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES-S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in-hospital and at 12 months of follow-up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow-up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia.. There were no significant differences in in-hospital MACE between the groups (ZES-S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES-S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES-S vs. one in EES; P = 0.14).. The treatment of coronary bifurcation lesions using everolimus-eluting stents results in better outcomes at 12 months of follow-up than zotarolimus-eluting stents.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Spain; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Sirolimus

The Endeavor zotarolimus-eluting coronary stent has been shown to reduce the restenosis rate compared to bare metal stents and has impacted other clinical measures such as mortality, acute myocardial infarctions (AMI) and target vessel revascularisation (TVR).. Using pooled efficacy data from the Endeavor clinical trial programme, a model was developed to compare the cost effectiveness of the Endeavor drug eluting stent (DES) with the Driver bare meal stent (BMS) over a four year time period. Endeavor was more costly but had an improved clinical outcome compared to Driver BMS over four years with a 4% reduction in deaths, 33% reduction in AMI and a 45% reduction in TVR. Late stent thrombosis was the only event showing an increased incidence for Endeavor of 0.2% compared to 0% for Driver. The incremental cost effectiveness ratio was pound3,757/quality adjusted life years (QALY).. Although much controversy has surrounded the appropriate way to assess the cost effectiveness of DES technology, a comprehensive analysis is presented and this suggests that by using extended clinical trial data out to four years, the Endeavor DES in particular, but DES technologies in general, are cost-effective approaches to percutaneous coronary intervention.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Health Care Costs; Humans; Markov Chains; Metals; Models, Economic; Myocardial Infarction; National Health Programs; Prosthesis Design; Quality-Adjusted Life Years; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; United Kingdom

We sought to compare the incidence of myonecrosis after elective implantation of bare metal stents with that of drug-eluting stents. The data of stable patients who were treated with stenting in a single native coronary artery were analyzed retrospectively. The stents used were bare metal in 119, sirolimus-eluting (Cypher Select Plus) in 119 patients, paclitaxel-eluting (Taxus Liberté) in 120, zotarolimus-eluting (Endeavor Sprint) in 122, and everolimus-eluting (Xience V) in 72. Endpoints included post-procedural myonecrosis (any elevation of creatine kinase-MB), myocardial infarction (creatine kinase-MB>3 times the upper limit of normal), and large myocardial infarction (creatine kinase-MB>5 times the upper limit of normal). The incidences of myonecrosis (16.7%-18.9%), myocardial infarction (3.3%-8.4%), and large myocardial infarction (1.7%-5.6%) were not significantly different among stent types. At the 30-day follow-up, there were 2 deaths in patients who had Taxus Liberté stents, one death each in those with Xience V and bare metal stents, and no cases of stroke or target vessel revascularization. In this study, bare metal stents and the 4 drug-eluting stents were associated with similar low incidences of myonecrosis, myocardial infarction, and large myocardial infarction.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Creatine Kinase, MB Form; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Male; Metals; Middle Aged; Myocardial Infarction; Myocardium; Necrosis; Paclitaxel; Prosthesis Design; Retrospective Studies; Singapore; Sirolimus; Stents; Time Factors; Treatment Outcome; Up-Regulation

The aim of this study was to evaluate and compare the clinical and angiographic outcomes of 3 drug-eluting stents (DES) in patients with large vessel diameter and single coronary artery lesions.. The efficacy of 3 DESs may be similar.. A total of 411 consecutive patients who visited 3 university hospitals from June 2004 to December 2007 and had a single coronary lesion which was treated with the use of a DES that was 3.5 mm in diameter were enrolled in this study. Patients were divided into 3 stent groups: Paclitaxel-eluting stent (PES, n = 105), Sirolimus-eluting stent (SES, n = 259), and Zotarolimus-eluting stent (ZES, n = 47). The study end point was a composite of major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI), and ischemia-driven target-vessel revascularization (TVR) for 12 months.. Baseline characteristics were not different. Late loss was higher in the ZES group than the other stents (0.5 +/- 0.4 mm in SES vs 0.3 +/- 0.5 mm in PES, 0.7 +/- 0.5 mm in ZES, P = 0.001). The total MACE-free survival rate was not significantly different between the SES group and the PES group (98.8% in SES vs 97.1% in PES, P = 0.252) or the PES group and the ZES group (97.1% in PES vs 93.6% in ZES, P = 0.301). However, the SES group showed a significantly better MACE-free survival rate compared with the ZES group (98.8% in SES vs 93.6% in ZES, P = 0.018).. Clinical and angiographic outcomes of DES in a large vessel diameter and single coronary artery is excellent and SES appears to show better angiographic and clinical outcomes than ZES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Hospital Mortality; Hospitals, University; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We examined angiographic and late-term clinical outcomes according to sex in recent percutaneous coronary intervention (PCI) trials involving zotarolimus-eluting stents (ZES).. Differences in outcome between men and women undergoing PCI have been inconsistently described with bare metal and first-generation drug-eluting stents.. Clinical and angiographic outcomes among ZES-treated patients were evaluated by sex using propensity score modeling in a patient-level systematic overview of six trials and were also compared to patients receiving bare metal stents (BMS).. Among 2,132 patients, 608 were female (28.5%). Compared to men, women were older and more frequently had diabetes, hypertension, and a smaller reference vessel diameter (P < 0.05 for all). For both sexes, the relative reductions in 8-month angiographic binary restenosis and late lumen loss were statistically significant and of similar extent with ZES compared to BMS. By 2 years, treatment with ZES resulted in significantly lower target vessel revascularization (TVR) and target vessel failure (TVF; 10.0% vs. 21.5%, P = 0.0003) among women that paralleled risk reductions for men. However, among ZES-treated patients, 2-year rates of TVR (8.2% vs. 10.4%, P = 0.005) and TVF (9.9% vs. 12.8%, P = 0.004) were significantly lower among women, although rates of death and myocardial infarction were similar.. Despite greater baseline clinical and angiographic risk than men, women undergoing PCI with ZES compared to BMS experienced significant reductions in angiographic restenosis and repeat revascularization yet similar safety. Among all patients treated with ZES, late-term safety and efficacy outcomes are similar, if not lower, among women compared to men.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Predictive Value of Tests; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

The ZoMaxx I and II trials were randomized controlled studies of the zotarolimus-eluting, phosphorylcholine-coated, TriMaxx stent for the treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus- (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound (IVUS).. Data were obtained from the ZoMaxx I and II trials, in which a standard IVUS parameter was available in 263 cases (baseline and 9-months follow up). Neointima-free frame ratio was calculated as the number of frames without IVUS-detectable neointima divided by the total number of frames within the stent. While an increase in vessel and plaque was observed in PES from baseline to follow up, there was no significant change in ZES. At follow up, % neointimal obstruction was significantly higher (15.4 ± 8.8% vs 11.3 ± 9.7%), and minimum lumen area at follow up was significantly smaller in ZES compared to PES. However, the incidence of IVUS-defined restenosis (maximum cross-sectional narrowing >60%) was similar in the 2 groups (3.2% vs 6.7%). Neointima-free frame ratio was significantly lower in ZES. There were 5 cases of late incomplete stent apposition in PES and none in ZES.. These IVUS results demonstrate a similar incidence of severe narrowing between these 2 DES. There was a moderate increase in neointimal hyperplasia that was associated with a greater extent of neointimal coverage in ZES compared with PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Multicenter Studies as Topic; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

The optimal duration of dual antiplatelet therapy remains controversial.. Between December 2006 and March 2008, 823 patients were enrolled in a prospective multicenter registry for 3-month dual antiplatelet therapy (aspirin 100-200mg+clopidogrel 75 mg daily) followed by aspirin mono-therapy after zotarolimus-eluting stents (ZES). Major exclusion criteria were: cardiogenic shock, stent thrombosis (ST)-segment elevation myocardial infarction (MI) within 48h, previous drug-eluting stent implantation, severe left ventricular dysfunction, bifurcation lesions requiring 2-stenting, left main and graft lesions. The primary outcome was a composite of cardiac death, MI, or ST at 1 year. The median duration of dual antiplatelet therapy was 95 days (interquartile range 90-101). At 1 year, 3 patients (0.4%) had cardiac deaths, 3 patients (0.4%) had MI, and 4 patients (0.5%) had definite or probable ST, leading to the primary outcome in 5 patients (0.6%). Death, MI, or any revascularization occurred in 68 patients (8.3%). Among patients who were event-free at 3 months (n=812), clopidogrel was discontinued at 3 months in 661 patients and was continued for longer than 3 months in 151 patients. Discontinuation of clopidogrel at 3 months did not increase the primary outcome (HR 0.90; 95%CI, 0.09-9.02), death, MI, or any revascularization (HR 0.89; 95%CI, 0.48-1.67) after adjustment for the propensity score.. Three-month dual antiplatelet therapy seems to be feasible after ZES implantation in relatively low-risk patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Chi-Square Distribution; Clopidogrel; Coronary Angiography; Coronary Stenosis; Disease-Free Survival; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Propensity Score; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Microvessels; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Predictive Value of Tests; Prosthesis Design; Risk Assessment; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

To evaluate the long-term follow-up of drug-eluting stents (DES) in the treatment of unprotected left main coronary artery (ULMCA).. One hundred and forty-eight patients (mean age 71 +/- 10 years) with ULMCA stenoses underwent percutaneous coronary intervention (PCI) with DES. Mean ejection fraction (EF) was 63 +/- 13% and distal ULMCA was involved in 63.5% of cases. In-hospital outcome showed one intra-procedural death, no stent thrombosis and 2% non Q-wave myocardial infarction (MI). Clinical follow-up was available in all patients (874 +/- 382 days): 10.1% of them had died, 8.8% had target lesion revascularisation (TLR) and 4.1% experienced MI. Major adverse cardiac events (MACE) occurred in 20.3%. Mortality predictors were EF < or = 55% (OR 3.6, 95%-C.I. 1.3-10.1, p = 0.016) and EuroSCORE > or = 6 (OR 3.9, 95%-CI 1.1-14.1, p = 0.037). TLR predictors were distal lesion (OR 8.5, 95%-CI 1.1-15, p = 0.041) and age < 64 years (OR 3.1, 95%-CI 1-9, p = 0.042). MACE predictor was EF < or = 55% (OR 2.4, 95%-CI 1.1-5.2, p = 0.027).. ULMCA stenting with DES is safe, with favourable in-hospital outcome. Long-term results are acceptable with a mortality rate of 10%, a TLR rate of 9%, and a MACE rate of 20%. Low EF and high EuroSCORE predict mortality, while younger age and distal lesions predict TLR. Low EF also predicts MACE.

Topics: Age Factors; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Hospital Mortality; Humans; Kaplan-Meier Estimate; Middle Aged; Odds Ratio; Paclitaxel; Proportional Hazards Models; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stroke Volume; Time Factors; Treatment Outcome

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Predictive Value of Tests; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Drug-eluting stents (DES) have become routine therapy in clinical practice because restenosis is significantly reduced in patients treated with these devices. New generations of DES bearing newer antiproliferative drugs have been developed. Sirolimus was the first antiproliferative drug eluted by a DES (SES) while zotarolimus represents a sirolimus-derived, newer antiproliferative drug borne by a different kind of DES (ZES). This report describes two cases of different vascular response to concurrent side by side implantation of SES and ZES in the same vessel and highlights significant early restenosis of ZES as compared with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Treatment Outcome

The aim of this study was to investigate the angiographic and intravascular ultrasound (IVUS) findings of the Endeavor zotarolimus-eluting stent (ZES) in patients from a "real-world" clinical practice.. From January to March 2006, 100 patients undergoing routine or emergency percutaneous intervention were prospectively enrolled at one institution. Overall, 39% of the patients were diabetics and 80.8% of lesions were type B2/C. A total of 140 lesions were successfully treated with 174 ZES, and procedural success was 98%. Mean vessel diameter was 2.69 mm and mean lesion length was 16.0 mm; at 6-month angiographic follow-up (completed in 96%), in-stent late lumen loss was 0.66 mm, and in-segment restenosis was 8.2%. Angiographic restenosis was increased among diabetics (15.5 vs. 2.6%, p=0.009), and diabetes was the only significant predictor of angiographic restenosis (OR=15.27 [95%CI 2.45-95.04], p=0.003). By IVUS (performed in 88% at 6-month), % volume obstruction was 14.4+/-13.4%, and there was no late acquired incomplete stent apposition (ISA). At 1-year, overall MACE rate was 6%, including 5 TLRs (4% of patients), with no occurrence of stent thrombosis.. In this prospective "real-world" experience, the ZES demonstrated favourable angiographic and IVUS results in complex patients, with overall in-stent late lumen loss of 0.66 mm, and absence of late acquired ISA. At 1-year, there were no safety concerns including absence of death and stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

There is limited information regarding the angiographic and clinical outcomes among the different drug-eluting stents (DESs) in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI).. A total 355 consecutive AMI patients who underwent PCI with a sirolimus- (SES, n=116) or paclitaxel- (PES, n=153) or zotarolimus-eluting stent (ZES, n=86) were enrolled. The 6-month angiographic and 1-year clinical outcomes were compared among the 3 groups. At 6 months, there was a trend toward a higher incidence of binary restenosis in the PES group (SES: 8.6%, PES: 19.8%, ZES: 8.3%, P=0.052). Percentage of restenosis was higher in the PES group compared with SES, but was similar to ZES (SES: 18.75 +/-18.16%, PES: 29.32 +/-24.16%, ZES: 23.91 +/-17.03%, P=0.006). Late loss was lower in the SES group compared with PES and ZES (SES: 0.44 +/-0.52, PES: 0.83 +/-0.87, ZES: 0.75 +/-0.63, P<0.001). However, clinical outcomes, including mortality, MI, repeat PCI and major adverse cardiac events, were not different among the 3 groups.. The angiographic benefit of SES did not translate into a clinical benefit for up to 1 year in AMI patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Hyperplasia; Myocardial Infarction; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Stenosis; Drug-Eluting Stents; Humans; Multicenter Studies as Topic; Myocardial Infarction; Patient Selection; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Myocardial infarction (MI) after drug-eluting stent placement has been associated with an unfavorable late prognosis. Although the etiology of periprocedural MI is multifactorial, sidebranch occlusion may be an important contributing factor. We sought to identify the incidence of sidebranch occlusion during zotarolimus-eluting stent (ZES) and paclitaxel-eluting stent (PES) placement and to relate sidebranch occlusion to the occurrence of periprocedural MI.. Angiograms were reviewed from patients randomly assigned to treatment with a ZES (597 patients; 943 sidebranches) or a PES (619 patients; 977 sidebranches). Sidebranch occlusion was defined as Thrombolysis in Myocardial Infarction flow grade 0 or 1. Sidebranch occlusion was correlated with frequency of MI, as assessed by the creatine phosphokinase MB isoenzyme. Sidebranch occlusion occurred less often after the first stent deployment in patients treated with ZES (2.2%) than in patients treated with PES (4.0%; P=0.032). A similar reduction in the frequency of sidebranch occlusion at any point during the procedure was found in patients treated with ZES (2.9% versus 4.8% in PES patients; P=0.042). Multivariable predictors of sidebranch occlusion included baseline sidebranch stenosis, complex lesion morphology, smaller baseline minimal lumen diameters, and the use of a PES. Of the 20 patients with MI within 30 days of the procedure, 30% had evidence of sidebranch occlusion during the stent procedure.. Patients treated with ZES were less likely to develop sidebranch occlusion during stent placement than patients treated with PES. Less frequent sidebranch occlusion with ZES may have contributed to the lower frequency rates of periprocedural MI in this study.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Occlusion; Creatine Kinase, MB Form; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Myocardium; Necrosis; Paclitaxel; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stents were developed and approved for the reduction of in-stent restenosis. However, restenosis still occurs, and stent fracture is suggested as a cause of restenosis after implantation. Although sirolimus-eluting stents are considered to carry a high risk of fracture, the risk is also present with other drug-eluting stents. Herein, we report the case of a 78-year-old woman who received a zotarolimus-eluting stent for a bifurcation lesion of the left anterior descending coronary artery. Ten months later, she underwent coronary angiography due to angina. The angiogram revealed in-stent restenosis, with a grade IV stent fracture. After percutaneous coronary angioplasty, the patient's clinical symptoms improved.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Prosthesis Failure; Sirolimus; Treatment Outcome

Drug-eluting stent (DES) therapy reduces restenosis in patients with diabetes when compared with bare metal stent implantation. There are significant differences between commercially available DES platforms both in terms of design characteristics and clinical outcomes. Randomized active-comparator inter-DES trials powered for clinical endpoints are unlikely to be performed in patients with diabetes, however, direct comparison randomized trials utilizing surrogate endpoints support a superior anti-restenotic efficacy with sirolimus- versus paclitaxel-eluting stents. Thrombotic stent occlusion may be higher in patients with diabetes compared with nondiabetic patients, though there is no clear signal of a safety differential between the two platforms. Insufficient data on comparative performance in diabetics exist in relation to the approved zotarolimus-eluting and everolimus-eluting stent platforms. If all other factors are equal, then there seems to be no reason why the diabetic patient should not receive treatment with the sirolimus-eluting stent, which appears to have superior antirestenotic efficacy in this patient group.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Humans; Hypoglycemic Agents; Insulin; Meta-Analysis as Topic; Metals; Paclitaxel; Patient Selection; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Sirolimus; Thrombosis; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Drug-Eluting Stents; Humans; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

There is evidence that endothelial coverage of drug-eluting stents might be delayed or absent, a risk factor for late thrombotic events. We studied the effects of different drug-polymer-device iterations on endothelium-dependent coronary vasomotion. Systemic markers of endothelial inflammation were correlated with coronary vasomotor changes.. Patients with paclitaxel-eluting stents (n=11), sirolimus-eluting stents (n=21), biolimus A9-eluting stents (n=28), zotarolimus-eluting stents (n=10), and bare-metal stents (n=13) were studied 10, 9, 9, 9, and 12 months after implantation, respectively. Endothelium-dependent coronary vasomotion was tested proximally and distally to the stent and at a reference vessel segment during atrial pacing at increasing heart rates by quantitative coronary angiography. Indexes of platelet-monocyte binding and other biomarkers were studied in a subgroup of 19 patients. The baseline characteristics and hemodynamics of the patients in the different stent groups were comparable. Significant differences were observed across the 5 stent groups, concerning the vasomotion of segments proximal (P=0.006) and distal (P=0.003) to the stent. Normal vasomotion (vasodilatation) was maintained in the biolimus A9-eluting stent, zotarolimus-eluting stent, and bare-metal stent groups, whereas vasoconstriction was observed in the sirolimus-eluting stent and paclitaxel-eluting stent groups. Platelet-monocyte binding in whole blood showed a significant inverse correlation with vasomotion in reference but not in segments adjacent to the stent (r=-0.57; P=0.01).. Paclitaxel-eluting stents and sirolimus-eluting stents seem to cause endothelial dysfunction of the implanted vessel, whereas biolimus A9-eluting stents and zotarolimus-eluting stents behave more closely to bare-metal stents, with preserved endothelial vasomotor response. Coronary vasoconstriction was not associated with detectable systemic endothelial activation.

Topics: Blood Platelets; Cardiovascular Agents; Cell Aggregation; Coronary Angiography; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Female; Humans; Male; Middle Aged; Monocytes; P-Selectin; Paclitaxel; Sirolimus; Vasoconstriction; Vasodilation

Vascular response at edges of drug-eluting stents is still not well established, particularly in diabetic patients who are prone to aggressive atherosclerosis progression. Recently, Biolimus and Zotarolimus have demonstrated potent antiproliferative effects.. To compare the vascular responses at edges of sirolimus analogous-eluting stents in patients with and without diabetes, using intravascular ultrasound (IVUS).. 306 edges were analyzed in 153 patients treated with drug-eluting stents and divided in: diabetics (122 edges) and nondiabetics (166 edges). IVUS was performed postintervention and at 6-month follow-up and included 5 mm distal and proximal to the stented segment. Vessel, lumen, and plaque volumes were calculated. Volume variation (follow-up minus basal) was also calculated. Edge restenosis was defined as obstruction >50%.. Baseline characteristics were similar between groups. In both groups the entire lesion length was covered (stent length/lesion length ratio was 1.5 for both groups). There were no differences in edge volumes and restenosis rate between the groups. Among diabetics, there was no significant volume variation. However, in nondiabetic patients there was significant increase in vessel volume in proximal (from 67.1 +/- 22 mm(3) to 72.2 +/- 25 mm(3): P = 0.02) and distal (from 54.4 +/- 22 mm(3) to 59.8 +/- 22 mm(3): P = 0.001) edges.. Nondiabetic patients showed a significant positive vascular remodeling in proximal and distal edges of sirolimus analogous-eluting stent. This vascular mechanism was not observed in diabetic patients. Although different vascular responses were observed, restenosis rates were equivalent between the 2 groups at 6-month follow-up.

Topics: Aged; Cardiovascular Agents; Case-Control Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional