sirolimus and Death--Sudden--Cardiac

The coronavirus disease 2019 (COVID-19) has affected approximately 2 million individuals worldwide; however, data regarding fatal cases have been limited.. To report the clinical features of 162 fatal cases of COVID-19 from 5 hospitals in Wuhan between December 30, 2019 and March 12, 2020.. The demographic data, signs and symptoms, clinical course, comorbidities, laboratory findings, computed tomographic (CT) scans, treatments, and complications of the patients with fatal cases were retrieved from electronic medical records.. Young patients with moderate COVID-19 without comorbidity at admission could also develop fatal outcomes. The in-hospital survival time of the fatal cases was similar among the hospitals of different levels in Wuhan.

Topics: Adolescent; Adult; Animals; Asthma; Atrial Fibrillation; Autoantibodies; Biomarkers; Breast Neoplasms; Child; Conjunctivitis, Allergic; Cornea; COVID-19; Cyclosporine; Cytokines; Death, Sudden, Cardiac; Defibrillators, Implantable; Diet; Disease Models, Animal; Docetaxel; Double-Blind Method; Dry Eye Syndromes; Educational Status; Emulsions; Female; Fluorescein Angiography; Fluoresceins; Focus Groups; Heart Failure; Hemothorax; Humans; Inflammation; Keratoconus; Male; Meibomian Glands; Mice; Middle Aged; Multiple Sclerosis; Myocardial Infarction; Myocardium; Nerve Fibers; Nigeria; Obesity; Overweight; Pandemics; Primary Prevention; Prospective Studies; Qualitative Research; Registries; Retinal Ganglion Cells; Retinal Vessels; Schools; Sirolimus; Tertiary Care Centers; Th1 Cells; Th2 Cells; Tomography, Optical Coherence; Troponin I; Tumor Necrosis Factor-alpha; United States; Ventricular Remodeling

The optimal duration of dual antiplatelet therapy (DAPT) following the use of new generation drug-eluting stents is unknown.. The association between DAPT interruption and the rates of stent thrombosis (ST) and cardiac death/target-vessel myocardial infarction (CD/TVMI) in patients receiving a Resolute zotarolimus-eluting stent (R-ZES) was analysed in 4896 patients from the pooled RESOLUTE clinical programme. Daily acetylsalicylate (ASA) and a thienopyridine for 6-12 months were prescribed. A DAPT interruption was defined as any interruption of ASA and/or a thienopyridine of >1 day; long interruptions were >14 days. Three groups were analysed: no interruption, interruption during the first month, and >1-12 months. There were 1069 (21.83%) patients with a DAPT interruption and 3827 patients with no interruption. Among the 166 patients in the 1-month interruption group, 6 definite/probable ST events occurred (3.61%; all long DAPT interruptions), and among the 903 patients in the >1-12 months (60% occurred between 6 and 12 months) interruption group, 1 ST event occurred (0.11%; 2-day DAPT interruption). Among patients with no DAPT interruption, 32 ST events occurred (0.84%). Rates of CD/TVMI were 6.84% in the 1-month long interruption group, 1.41% in the >1-12 months long interruption group, and 4.08% in patients on continuous DAPT.. In a pooled population of patients receiving an R-ZES, DAPT interruptions within 1 month are associated with a high risk of adverse outcomes. Dual antiplatelet therapy interruptions between 1 and 12 months were associated with low rates of ST and adverse cardiac outcomes. Randomized clinical trials are needed to determine whether early temporary or permanent interruption of DAPT is truly safe. ClinicalTrials.gov Identifiers: NCT00617084; NCT00726453; NCT00752128; NCT00927940.

Topics: Aspirin; Blood Vessel Prosthesis; Clinical Trials as Topic; Clopidogrel; Coronary Thrombosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Fibrinolytic Agents; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Failure; Sirolimus; Ticlopidine; Time Factors; Treatment Outcome; Withholding Treatment

The problem of drug eluting stents (DES) safety has been actively discussed throughout 2006 because of increase of frequency of development of late stent thromboses which were noted during almost 2 years after stenting. In December 2006 US Food and Drug Administration (FDA) advisory panel acknowledged increase of development of late stent thrombosis. At the same time FDA accepted new definition of stent-thrombosis suggested by the Academic Research Consortium. According to this definition thrombosis can be definite, probable and possible. Any unexplained death before end of follow-up in a trial should be considered thrombosis related. Recalculation of thrombosis rate using this definition caused pronounced increase of this parameter in previously conducted trials. Thrombosis rate rose from 0,6 to 3,3% for bare metal stents, from 0,8 to 3,6% for sirolimus eluting stents and from 1,3 to 3,5% for paclitaxel eluting stents. Professional cardiological and angiographical societies (ACC, AHA, SCAI) responding to FDA advisory panel published their proofs and vision of the problem of stent thrombosis. In February 2007 ACC, AHA, SCAI, American College of Surgeons and Association of Dentists published scientific bulletin in which described preventive measures aimed at lowering of risk of thrombosis development. This document contains strict recommendation to continue double antithrombotic therapy with aspirin and clopidogrel for 12 months after implantation of DES or abandonment of the use of this type of stents when long term double antithrombotic therapy is not possible.

Topics: Aspirin; Clopidogrel; Death, Sudden, Cardiac; Drug-Eluting Stents; Fibrinolytic Agents; Humans; Incidence; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Sirolimus; Terminology as Topic; Thrombosis; Ticlopidine; Turkey

Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or bare metal stents.. An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a bare metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6+/-0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 bare metal stent patients and 4.1% among 878 sirolimus-eluting stent patients (P=0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P=0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently.. At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or bare metal stents.

Topics: Aged; Cause of Death; Coronary Restenosis; Death, Sudden, Cardiac; Female; Heart Failure; Humans; Immunosuppressive Agents; Male; Middle Aged; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Regression Analysis; Sirolimus; Stents

This meta-analysis was conducted to compare the effects of drug (paclitaxel and sirolimus)-eluting stents with bare metal stents on major adverse cardiac events, restenosis rates and late loss of arterial lumen diameter in patients with obstructive coronary artery disease.. Randomized, controlled clinical trials comparing sirolimus- and paclitaxel-eluting stents with bare metal stents were identified through electronic and manual search. Fixed effects method of Mantel-Haenszel and random effects method of DerSimonian and Laird were used for computing the pooled odds ratio (OR) and 95% confidence intervals (CI) for major adverse cardiac events and restenosis rates. Standardized mean difference with 95% CI was calculated for late-loss of arterial lumen diameter.. A total of 13 studies were included in the meta-analysis. As compared with bare metal stents, the use of sirolimus- and paclitaxel-eluting stents significantly reduced the major adverse cardiac events (pooled OR 0.35; 95% CI 0.24-0.50), restenosis rates (pooled OR 0.27; 95% CI 0.15-0.47), and late loss of arterial lumen diameter (mean difference 0.57 mm, 95% CI 0.49-0.68).. Paclitaxel- and sirolimus-eluting stents significantly reduced the incidence of major adverse cardiac events, restenosis rates, and late loss of arterial lumen diameter as compared with bare metal stents.

Topics: Cell Proliferation; Coronary Restenosis; Coronary Stenosis; Death, Sudden, Cardiac; Drug Implants; Drug Therapy, Combination; Humans; Immunosuppressive Agents; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome; Tunica Intima

Topics: Angina, Unstable; Atherectomy, Coronary; Catheterization; Coronary Artery Disease; Coronary Thrombosis; Death, Sudden, Cardiac; Humans; Immunosuppressive Agents; Myocardial Infarction; Sirolimus; Stents; Syndrome

The coronavirus disease 2019 (COVID-19) has affected approximately 2 million individuals worldwide; however, data regarding fatal cases have been limited.. To report the clinical features of 162 fatal cases of COVID-19 from 5 hospitals in Wuhan between December 30, 2019 and March 12, 2020.. The demographic data, signs and symptoms, clinical course, comorbidities, laboratory findings, computed tomographic (CT) scans, treatments, and complications of the patients with fatal cases were retrieved from electronic medical records.. Young patients with moderate COVID-19 without comorbidity at admission could also develop fatal outcomes. The in-hospital survival time of the fatal cases was similar among the hospitals of different levels in Wuhan.

Topics: Adolescent; Adult; Animals; Asthma; Atrial Fibrillation; Autoantibodies; Biomarkers; Breast Neoplasms; Child; Conjunctivitis, Allergic; Cornea; COVID-19; Cyclosporine; Cytokines; Death, Sudden, Cardiac; Defibrillators, Implantable; Diet; Disease Models, Animal; Docetaxel; Double-Blind Method; Dry Eye Syndromes; Educational Status; Emulsions; Female; Fluorescein Angiography; Fluoresceins; Focus Groups; Heart Failure; Hemothorax; Humans; Inflammation; Keratoconus; Male; Meibomian Glands; Mice; Middle Aged; Multiple Sclerosis; Myocardial Infarction; Myocardium; Nerve Fibers; Nigeria; Obesity; Overweight; Pandemics; Primary Prevention; Prospective Studies; Qualitative Research; Registries; Retinal Ganglion Cells; Retinal Vessels; Schools; Sirolimus; Tertiary Care Centers; Th1 Cells; Th2 Cells; Tomography, Optical Coherence; Troponin I; Tumor Necrosis Factor-alpha; United States; Ventricular Remodeling

The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation has not been established yet. The objectives of this study were to evaluate the optimal duration of DAPT after the DES implantation.. From three randomized controlled trials investigating DAPT duration after coronary stent implantation, we evaluated the clinical outcomes of short-term (6 months or less) DAPT compared with prolonged DAPT (12 months or more) in 1661 DES-treated pairs matched by propensity scores. At follow-up of 1 year, net adverse clinical event (NACE) was defined as cardiac death, myocardial infarction, target vessel revascularization, definite/probable stent thrombosis, or thrombolysis in myocardial infarction major bleeding.. Short-term DAPT as compared with prolonged DAPT was not associated with 1-year NACEs after DES implantation [hazard ratio (HR) 1.068, 95 % confidence interval (CI) 0.787-1.450, p = 0.671]. Predictors for NACEs were old age (>75 years), hypertension, diabetes mellitus, renal dysfunction (serum creatinine ≥2.0 mg/dL), and multi-vessel disease. The DAPT strategy differentially contributed to the occurrence of NACEs according to the risk burden (p for interaction <0.001). In patients with low risk for NACEs, bleeding events were less in short-term DAPT than in prolonged DAPT (HR 0.332, 95 % CI 0.130-0.849, p = 0.021) (p for interaction = 0.098). Meanwhile, short-term DAPT was associated with more ischemic events that included cardiac death, myocardial infarction, target vessel revascularization, or definite/probable stent thrombosis (HR 2.164, 95 % CI 1.340-3.494, p = 0.002) (p for interaction <0.001) in patients with high risk for NACEs.. One-year clinical outcomes of DAPT after DES implantation depended on the burden of cardiovascular risk.

Topics: Aged; Aspirin; Clopidogrel; Coronary Artery Disease; Death, Sudden, Cardiac; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Republic of Korea; Risk Factors; Sirolimus; Ticlopidine; Time Factors

Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer patients of two third-generation stents that are often used clinically, but that have not yet been compared, and one of which has not previously been assessed in a randomised trial.. In this investigator-initiated, single-blind, multicentre, randomised, two-arm, non-inferiority trial, patients aged 18 years and older who required a percutaneous coronary intervention with implantation of a drug-eluting stent were recruited from four study sites in the Netherlands. We randomly assigned patients by independently managed computer-generated allocation sequences in a 1:1 ratio to receive either cobalt-chromium-based zotarolimus-eluting stents (Resolute Integrity, Medtronic, Santa Rosa, CA, USA) or platinum-chromium-based everolimus-eluting stents (Promus Element, Boston Scientific, Natick, MA, USA). Patients and analysts were masked to the allocated stent, but treating clinicians were not. The primary endpoint of target-vessel failure was a composite of safety (cardiac death or target-vessel-related myocardial infarction) and efficacy (target-vessel revascularisation) at 12 months, analysed by intention to treat (with a non-inferiority margin of 3·6%). This trial is registered with ClinicalTrials.gov, number NCT01331707.. Between Nov 25, 2010, and May 24, 2012, 1811 eligible all-comer patients, with 2371 target lesions, were enrolled in the study. 370 (20%) patients presented with ST-elevation myocardial infarction and 447 (25%) with non-ST-elevation myocardial infarction. 906 patients were assigned to receive zotarolimus-eluting stents and 905 to receive everolimus-eluting stents. Ease of stent delivery was shown by very low numbers of patients requiring treatment other than their assigned study treatment (six [1%] in the zotarolimus-eluting stent group vs five [1%] in the everolimus-eluting stent group; p=0·22). 12-month follow-up results were available for 1810 patients (one patient in the zotarolimus-eluting stent group withdrew consent). The primary endpoint was met by 55 (6%) of 905 patients in the zotarolimus-eluting stent group and 47 (5%) of 905 in the everolimus-eluting stent group. The zotarolimus-eluting stent was non-inferior to the everolimus-eluting stent (absolute risk difference 0·88%, 95% CI -1·24% to 3·01%; upper limit of one-sided 95% CI 2·69%; non-inferiority p=0·006). We noted no significant between-group differences in individual components of the primary endpoint. Definite stent thrombosis occurred in three (0·3%) patients in the zotarolimus-eluting stent group and six (0·7%) patients in the everolimus-eluting stent group (p=0·34). Longitudinal stent deformation was seen only in the everolimus-eluting stent group (nine [1·0%] of 905 vs 0 of 906, p=0·002; nine of 1591 [0·6%] everolimus-eluting stents implanted became deformed), but was not associated with any adverse events.. Both stents were similarly efficacious and safe, and provided excellent clinical outcomes, especially in view of the large number of patients who presented with acute myocardial infarctions.. Boston Scientific, Medtronic.

Topics: Adult; Aged; Aged, 80 and over; Coronary Occlusion; Death, Sudden, Cardiac; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Single-Blind Method; Sirolimus; Treatment Outcome; Young Adult

This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents (BMSs) in the COMFORTABLE trial (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) were sustained during long-term follow-up.. A total of 1161 patients were randomly assigned to biolimus-eluting stent (BES) and BMS at 11 centers, and follow-up rates at 2 years were 96.3%. A subgroup of 103 patients underwent angiography at 13 months. At 2 years, differences in the primary end point of cardiac death, target-vessel myocardial infarction, and target lesion revascularization continued to diverge in favor of BES-treated patients (5.8%) compared with BMS-treated patients (11.9%; hazard ratio = 0.48; 95% confidence interval, 0.31-0.72; P < 0.001) with a significant risk reduction during the second year of follow-up (hazard ratio 1-2 years = 0.45; 95% confidence interval, 0.20-1.00; P = 0.049). Differences in the primary end point were driven by a reduction in target lesion revascularization (3.1% versus 8.2%; P < 0.001) and target-vessel reinfarction (1.3% versus 3.4%; P = 0.023). The composite of death, any reinfarction and revascularization (14.5% versus 19.3%; P = 0.03), and cardiac death or target-vessel myocardial infarction (4.2% versus 7.2%; P = 0.036) were less frequent among BES-treated patients compared with BMS-treated patients. The 13-month angiographic in-stent percent diameter stenosis amounted to 12.0 ± 7.2 in BES- and 39.6 ± 25.2 in BMS-treated lesions (P < 0.001).. Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, BES continued to improve cardiovascular events compared with BMS beyond 1 year.. http://www.clinicaltrials.gov. Unique identifier: NTC00962416.

Topics: Aged; Coronary Angiography; Coronary Vessels; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Longitudinal Studies; Male; Metals; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Recurrence; Sirolimus; Stents; Treatment Outcome

In the RESOLUTE All Comers trial, the Resolute zotarolimus-eluting stent was non-inferior to the Xience V everolimus-eluting stent for the primary stent-related endpoint of target lesion failure (cardiac death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation) at 1 year. However, data for long-term safety and efficacy from randomised studies of new generation drug-eluting coronary stents in patients treated in routine clinical practice are scarce. We report the prespecified 2-year clinical outcomes from the RESOLUTE All Comers trial.. In 2008, patients with at least one coronary lesion 2.25-4.0 mm in diameter, with greater than 50% stenosis, were randomly assigned to a Resolute zotarolimus-eluting stent or a Xience V everolimus-eluting stent at 17 centres in Europe and Israel. Randomisation was by an interactive voice response system stratified by centre. Study investigators were not masked to treatment allocation; but those who did data management and analysis, and patients were masked. There were no restrictions as to the number of vessels or lesions treated, or the number of stents implanted. We assessed prespecified safety and efficacy outcomes at 2 years with specific focus on patient-related composite (all death, all myocardial infarction, all revascularisation) and stent-related composite outcomes. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00617084.. 1140 patients were assigned to the zotarolimus-eluting stent and 1152 to the everolimus-eluting stent; 1121 and 1128 patients, respectively, completed 2-year follow-up. The patient-related outcome (231 [20.6%] zotarolimus vs 231 [20.5%] everolimus; difference 0.1%, 95% CI-3.2 to 3.5; p=0.958) and stent-related outcome (126 [11.2%] vs 121 [10.7%]; difference 0.5%, -2.1 to 3.1; p=0.736) did not differ between groups, although rates of the stent-related outcome were substantially lower than were those for the patient-related outcome. Three patients in each group (0.3%) had very late (after 1 year) stent thrombosis.. Similar safety and efficacy outcomes were sustained between two new generation drug-eluting stents at 2-year follow-up. The greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasises that during long-term follow-up, the optimisation of secondary prevention is at least as important as the selection of which new generation drug-eluting stent to implant in a specific lesion.. Medtronic (USA).

Topics: Adult; Aged; Confounding Factors, Epidemiologic; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Europe; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Israel; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Secondary Prevention; Sirolimus; Treatment Outcome

We aimed to compare the long-term clinical outcomes of patients treated with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) for coronary bifurcation lesions.. There are limited data regarding comparisons of SES and PES for the treatment of bifurcation lesions.. Patients who received percutaneous coronary intervention for non-left main bifurcation lesions were enrolled from 16 centers in Korea between January 2004 and June 2006. We compared major adverse cardiac events (MACE [cardiac death, myocardial infarction, or target lesion revascularization]) between the SES and PES groups in patients overall and in 407 patient pairs generated by propensity-score matching.. We evaluated 1,033 patients with bifurcation lesions treated with SES and 562 patients treated with PES. The median follow-up duration was 22 months. Treatment with SES was associated with a lower incidence of MACE (hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.32 to 0.89, p < 0.01) and target lesion revascularization (HR: 0.55, 95% CI: 0.31 to 0.97, p = 0.02), but not of cardiac death (HR: 2.77, 95% CI: 0.40 to 18.99, p = 0.62) and cardiac death or myocardial infarction (HR: 0.97, 95% CI: 0.38 to 2.49, p = 0.94). After propensity-score matching, patients with SES still had fewer MACE and target lesion revascularization incidences than did patients with PES (HR: 0.52, 95% CI: 0.30 to 0.91, p = 0.02, and HR: 0.48, 95% CI: 0.25 to 0.91, p = 0.02, respectively). There was no significant difference in the occurrences of stent thrombosis between the groups (0.7% vs. 0.7%, p = 0.94).. In patients with bifurcation lesions, the use of SES resulted in better long-term outcomes than did the use of PES, primarily by decreasing the rate of repeat revascularization. (Coronary Bifurcation Stenting Registry in South Korea [COBIS]; NCT00851526).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Korea; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Registries; Retrospective Studies; Sirolimus; Survival Rate; Treatment Outcome

It has been demonstrated that, in comparison with bare-metal stents (BMS), sirolimus-eluting stents (SES) reduce restenosis after the percutaneous revascularization of small coronary arteries, but the long-term clinical outcomes of this treatment have not yet been investigated.. The long-term SES-SMART clinical study was a multicentre, prospective, randomized, single-blind study of 257 patients receiving a SES or BMS in a small coronary artery, who were evaluated at discharge, 30 days, 8 and 24 months after stenting. The clinical endpoint of the study was a 24 months composite of major adverse cardiac and cerebrovascular events, which included death, non-fatal myocardial infarction, ischaemia-driven target lesion revascularization (TLR), and cerebrovascular accident. The 24 months follow-up was completed by 254 patients (98.8%). The use of SES was associated with a significantly lower incidence of the clinical endpoint (12.6% vs. 33.1%; HR 0.30, 95% CI: 0.17-0.55; P < 0.0001), which was not only due to a reduction in TLR (7.9% vs. 29.9%; HR 0.30, 95% CI: 0.16-0.59; P < 0.0001), but also to a reduction in myocardial infarction (1.6% vs. 10.2%; HR 0.09, 95% CI: 0.01-0.66; P = 0.018).. In comparison with BMS, the use of SES in the percutaneous revascularization of small coronary arteries is associated with improved clinical outcomes after 2 years follow-up.

Topics: Aged; Cerebrovascular Disorders; Coronary Restenosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Risk Factors; Single-Blind Method; Sirolimus; Treatment Outcome; Tubulin Modulators

The purpose of this study was to assess the 3-year outcome of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) in patients who had multivessel coronary artery disease with and without diabetes mellitus.. The optimal method of revascularization in diabetic patients remains in dispute.. The ARTS-II (Arterial Revascularization Therapies Study-Part II) trial is a single-arm study (n = 607) that included 159 diabetic patients treated with SES whose 3-year clinical outcome was compared with that of the historical diabetic and nondiabetic arms of the randomized ARTS-I trial (n = 1,205, including 96 diabetic patients in the CABG arm and 112 in the PCI arm).. At 3 years, among nondiabetic patients, the incidence of the primary composite of death, CVA, myocardial infarction (MI), and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]), was significantly lower in ARTS-II than in ARTS-I PCI (adjusted odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.26 to 0.64) and similar to ARTS-I CABG. The ARTS-II patients were at significantly lower risk for death, CVA, and MI as compared with both the ARTS-I PCI (adjusted OR: 0.55; 95% CI: 0.34 to 0.91) and ARTS-I CABG patients (adjusted OR: 0.56; 95% CI: 0.35 to 0.92). Among diabetic patients, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA, and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR: 0.67; 95% CI: 0.27 to 1.65) and was similar to that of ARTS-I CABG.. At 3 years, PCI using SES for patients with multivessel coronary artery disease seems to be safer and more efficacious than PCI using bare-metal stents, irrespective of the diabetic status of the patient. Hence, PCI using SES appears to be a valuable alternative to CABG for both diabetic and nondiabetic patients.

Topics: Angioplasty, Balloon, Coronary; Case-Control Studies; Confidence Intervals; Coronary Artery Bypass; Coronary Artery Disease; Death, Sudden, Cardiac; Diabetes Complications; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Odds Ratio; Prospective Studies; Risk Factors; Sirolimus; Stroke; Time Factors; Treatment Outcome

Sirolimus stent implantation has been demonstrated to be safe and effective in diabetics; however, the long-term outcomes in this high-risk population remain unknown. The aim of this study was to determine the long-term safety and efficacy of the sirolimus-eluting stent (SES) when compared with the bare metal stent (BMS) in patients included in the DIABETES (DIABETes and sirolimus Eluting Stent) trial.. The prospective multicentre DIABETES trial randomized 160 diabetic patients with one or more significant coronary stenoses in one, two, or three vessels to either SES or BMS implantation. One-year dual antiplatelet therapy (aspirin plus clopidogrel) was routinely prescribed. Clinical follow-up was scheduled at 1, 9, 12, and 13 months and 2 years. Baseline clinical and angiographic characteristics were comparable between groups. At 2 years, the rate of target lesion revascularization was significantly lower in the SES group compared with the BMS group (7.7 vs. 35.0%, P < 0.001). However, the total revascularization rate at 2 years increased in both groups due to progression of atherosclerosis in coronary segments remote from the target lesion (rate of atherosclerosis progression: 7.7% in SES group vs. 10% in BMS group; P = 0.7). During dual antiplatelet treatment (1 year), there was no stent thrombosis in the SES group, whereas two patients presented it in the BMS group. However, after clopidogrel withdrawal, three patients allocated to the SES group presented stent thromboses vs. none in the BMS group.. SES implantation in diabetic patients remains effective at 2-year follow-up. However, clinical efficacy appeared to be reduced by the occurrence of stent thrombosis between 1 and 2 years.

Topics: Aged; Aspirin; Blood Vessel Prosthesis; Clopidogrel; Coronary Restenosis; Coronary Stenosis; Death, Sudden, Cardiac; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Myocardial Revascularization; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Failure; Reoperation; Sirolimus; Ticlopidine; Treatment Outcome

Background Sarcoidosis is an inflammatory, granulomatous disease of unknown cause affecting multiple organs, including the heart. Untreated, unresolved granulomatous inflammation can lead to cardiac fibrosis, arrhythmias, and eventually heart failure. Here we characterize the cardiac phenotype of mice with chronic activation of mammalian target of rapamycin (mTOR) complex 1 signaling in myeloid cells known to cause spontaneous pulmonary sarcoid-like granulomas. Methods and Results The cardiac phenotype of mice with conditional deletion of the

Topics: Animals; Death, Sudden, Cardiac; Disease Models, Animal; Everolimus; Fibrosis; Humans; Mammals; Mechanistic Target of Rapamycin Complex 1; Mice; Multiprotein Complexes; Myocarditis; Sarcoidosis; Sirolimus; TOR Serine-Threonine Kinases; Tuberous Sclerosis Complex 2 Protein; Tumor Suppressor Proteins

Previous studies reporting long-term (≥5 year) clinical outcome in patients with unprotected left main coronary artery (LMCA) disease undergoing drug-eluting stent (DES) implantation are currently limited, although late adverse events beyond 1 year are one of the major concerns of DES. We evaluated long-term clinical outcomes in 134 consecutive patients who underwent sirolimus-eluting stents (SES) for unprotected LMCA lesion in a single center from 2004 to 2009. The median follow-up duration was 3.8 (range: 0.5-7.9) years. Eight patients suffered from serious cardiovascular events potentially related to LMCA lesion (primary outcome measure) (sudden cardiac death: N = 5, emergent coronary revascularization for the LMCA lesion: N = 2, and acute congestive heart failure related to LMCA lesion: N = 1) with the cumulative 5-year incidence of only 4.4 %. The cumulative 5-year incidence of all-cause death, cardiac death, target vessel myocardial infarction, definite stent thrombosis, and target-lesion revascularization was 26.5, 8.1, 0, 0, and 12.9 %, respectively. In a subgroup analysis, the cumulative incidence of the primary outcome measure was significantly higher in patients with 2-stenting (N = 27) than in patients with 1-stenting (N = 107) (14.0 and 2.2 %, P < 0.001). All 8 patients with serious adverse events had a true bifurcation lesion and 5 patients received 2-stenting for the LMCA lesion. SES implantation in patients with unprotected LMCA lesion was associated with a favorable long-term outcome with acceptably low rate of serious adverse event potentially related to LMCA lesion. However, complex LMCA lesions necessitating 2-stenting strategy might be associated with higher risk for serious adverse events.

Topics: Aged; Aged, 80 and over; Coronary Artery Disease; Coronary Thrombosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Myocardial Infarction; Postoperative Complications; Prognosis; Prosthesis Implantation; Sirolimus; Treatment Outcome

The aim of the present study was to investigate the long-term outcome of sirolimus-eluting stent (SES) implantation in lesions with severe calcification that may disturb adequate stent expansion and increase the risk of restenosis and target lesion revascularization (TLR).. The Cypher Post-Marketing Surveillance Registry study has been conducted since August 2004 in Japan to evaluate the efficacy and safety of SES in a real-world setting. Data on 2,458 lesions in 2,050 patients were reviewed, and the angiographical outcomes at 240 days and clinical outcomes at 1,080 days after implantation compared between calcified lesions and non-calcified lesions in dialysis patients and non-dialysis patients. In non-dialysis patients, the rates of major adverse cardiac events (MACE; 16.0% vs. 12.8%; P=0.144) including TLR (4.9% vs. 6.0%; P=0.457), and restenosis (10.1% vs. 7.8%; P=0.207) were similar in calcified lesions and non-calcified lesions. In dialysis patients, the rate of MACE was similar in calcified lesions and non-calcified lesions (51.1% vs. 43.1%; P=0.544), but the rates of TLR (29.8% vs. 9.8%; P=0.020), and restenosis (39.5% vs. 17.0%; P=0.029) were significantly higher in calcified lesions than in non-calcified lesions.. There is a differential impact of calcification on the long-term outcome of SES implantation in dialysis and non-dialysis patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Calcinosis; Coronary Angiography; Coronary Artery Disease; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Humans; Incidence; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Product Surveillance, Postmarketing; Registries; Renal Dialysis; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

There is a scarcity of long-term data from large-scale drug-eluting stent registries with a large enough sample to evaluate low-frequency events such as stent thrombosis (ST).. Five-year outcomes were evaluated in 12 812 consecutive patients undergoing sirolimus-eluting stent (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30 day, 0.3%; 1 year, 0.6%; and 5 years, 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after sirolimus-eluting stent implantation (0.26%/y). Cumulative incidence of target lesion revascularization within the first year was low (7.3%). However, late target lesion revascularization beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/y). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting the presence of different pathophysiological mechanisms of ST according to the timing of ST onset: acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST; side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST; and current smoking and total stent length >28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization.. Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Coronary Restenosis; Coronary Thrombosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Japan; Male; Middle Aged; Registries; Risk Factors; Sirolimus; Time Factors

The aim of this study was to assess the clinical outcomes of percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES) for the treatment of unprotected left main coronary artery (ULMCA) disease.. The standard of care for the treatment of ULMCA disease is coronary artery bypass grafting (CABG). Data suggest that PCI with drug-eluting stents is a viable alternative to CABG for the treatment of ULMCA disease. Randomized trials demonstrated superior event-free survival with EES compared with paclitaxel-eluting stents in non-ULMCA lesions. However, data with ULMCA PCI with EES are limited.. This multicenter international registry included 178 patients from the United States, South Korea, and Italy who underwent ULMCA PCI with EES from 2008 to 2010. The primary endpoint was freedom from target lesion failure (TLF), defined as cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR) at 1 year.. At 30 days, 4 patients (2.2%) died from cardiac causes, and no patient experienced MI or TLR. One-year freedom from TLF was 94.4%. One-year freedom from cardiac death, MI, and ischemia-driven TLR was 96.6%, 98.9%, and 98.3%, respectively. Two patients (1.1%) had definite or probable stent thrombosis.. PCI with EES is safe and effective and may be a viable option for the treatment of ULMCA disease.

Topics: Aged; Coronary Artery Disease; Death, Sudden, Cardiac; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Incidence; International Cooperation; Italy; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Registries; Regression Analysis; Republic of Korea; Retrospective Studies; Sirolimus; Treatment Outcome; United States

We compared safety and efficacy outcomes of 3 limus-based drug-eluting stents in the 'all-comers' PROENCY (PROmus/ENdeavor/CYpher) registry.. Limited data are available on head-to-head comparisons of the everolimus-eluting stent (EES) with the zotarolimus-eluting stent (ZES) or the sirolimus- eluting stent (SES) in the treatment of patients with coronary artery disease.. PROENCY was a prospective, open-label, multicenter, observational study including consecutive patients undergoing planned treatment with EES, ZES, or SES. Seventeen centers were designated to place an EES or SES, 14 other centers were designated to place EES or ZES. The primary endpoint was the composite of cardiac death, myocardial infarction, and target vessel revascularization (TVR) at 12 months. Unadjusted and propensity-adjusted outcomes were compared between groups.. A total of 1921 patients were enrolled in the study from February to December 2008, of which 1704 patients received only study stents and were analyzed. At 12 months, the unadjusted major adverse event rate was significantly lower in the EES group versus the ZES group (3.1% vs 8.7%; P=.001) and the SES group (5.2% vs 9.6%; P=.01). This was mainly driven by lower TVR rates [2.6% with EES vs 8.2% with ZES [P<.001] and 4.1% with EES vs 7.0% with SES [P=.05]. Stent thrombosis rates were low and comparable. Adjusted analyses confirmed the unadjusted results.. There were no differences in safety outcomes of EES, ZES, and SES at 12 months in PROENCY. However, differences in efficacy were observed between the 3 "limus"-based stents in a real-world patient population.

Topics: Aged; Coronary Artery Disease; Death, Sudden, Cardiac; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; France; Germany; Humans; Incidence; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Registries; Sirolimus; Thrombosis; Treatment Outcome

In post-coronary artery bypass graft (CABG) patients undergoing drug-eluting stent implantation of either the saphenous vein graft (SVG) versus the native coronary artery supplying the same myocardial perfusion territory, which option confers better clinical outcomes when both lesions are technically feasible?. From 2005 to 2008 at a single medical center, a total of 178 post-CABG patients (with 241 lesions) underwent PCI due to progressive SVG disease. Of them, 23 patients (with 29 lesions) had amenable disease for PCI in both the SVG and native coronary artery matching the same myocardial perfusion territory; chronic total occlusions were excluded. All patients included in the study were treated with drug-eluting stents. Sixteen patients (19 lesions) underwent PCI of the SVG, and 9 patients (10 lesions) underwent PCI in the native vessels.. Primary endpoints were in-hospital and 3-year rates of death, myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). There were 2 in-hospital MIs in the SVG-treated group and 0 for the native vessel-treated group. The 3-year clinical follow-up showed 3 MIs, 2 TLRs, 4 TVRs, and 6 deaths in the SVG-treated group; only 1 MI occurred in the native-vessel treated group (P=.02). More PCIs of the SVG were performed than in the native coronary artery (19 vs 10 lesions).. This small study suggests improved clinical outcomes with PCI of the native vessel, but a tendency of operators to choose PCI of the SVG instead. Large, prospective, multicenter, randomized clinical trials with long-term follow-up can validate the advantage of selecting PCI of the native vessel over the SVG when both options are available.

Topics: Aged; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Vessels; Death, Sudden, Cardiac; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Pilot Projects; Retrospective Studies; Saphenous Vein; Sirolimus; Treatment Outcome

The feasibility of percutaneous coronary intervention (PCI) using drug-eluting stents and its comparability with bypass surgery in treatment of unprotected left main coronary artery (LMCA) stenosis has been shown previously. We compared the mid-to long-term outcome between sirolimus-(SES) vs. paclitaxel-eluting stents (PES) in an all-comer analysis that included all patients with unprotected LMCA stenosis who underwent PCI with SES or PES.. From March 2003 and June 2007, 196 patients underwent PCI with SES or PES for unprotected LMCA stenosis at Seoul National University Main or Bundang Hospital; SES was implanted in 141 patients and PES in 55 patients. The baseline clinical and procedural characteristics were mostly similar between the SES and PES group.. After 2 years of follow-up, there were no differences in the rate of cardiac death (9.1% vs. 8.5%) and nonfatal MI (5.5% vs. 2.8%) between the two groups. However, the risk of repeat revascularization tended to be lower in the SES group compared with the PES group [TLR, 9.9% vs. 20.0% (P=0.06); TVR, 17.7% vs. 30.9% (P=0.05)], which did not reach statistical significance. The rate of stent thrombosis (ST) was also similar between the two groups (3.6% vs. 2.1% for definite ST, 3.6% vs. 2.8% for definite+probable ST).. In all-comers undergoing first generation DES implantation for unprotected LMCA stenosis, PES and SES showed comparable 2-year clinical results regarding hard endpoints and major adverse cardiac events.

Topics: Aged; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Stenosis; Coronary Thrombosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Predictive Value of Tests; Registries; Risk Factors; Sirolimus

Topics: Coronary Angiography; Coronary Restenosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Multicenter Studies as Topic; Myocardial Infarction; Myocardial Revascularization; Randomized Controlled Trials as Topic; Secondary Prevention; Sirolimus; Treatment Outcome

Zotarolimus-eluting stents (ZESs) have been shown to be safe and effective in randomised trials. We sought to report the clinical outcomes after implantation of ZES in real-world clinical practice.. ZES have been approved for clinical use in Singapore since April 2005. Until December 31, 2007, a total of 219 patients had undergone implantation of ZES. After excluding 11 foreign patients with whom contact was lost, 208 patients (246 lesions, 305 stents) formed the study cohort. A high-proportion of diabetic patients (n=90, 43.3%) was included. Recommended dual antiplatelet therapy was at least 3 months (n=147) for patients treated before or 12 months (n=61) after January 2007. As of January 2008, the median follow-up duration was 19 months (range: 1 to 33 months). There were 10 (4.8%) deaths, including 7 (3.4%) cardiac deaths. Myocardial infarction occurred in 11 (5.3%) patients. The numbers of patients requiring target vessel revascularisation and target lesion revascularisation were 10 (4.8%) and 5 (2.4%) respectively. Using the ARC definition, there were two cases of definite stent thrombosis on days 7 and 17, and one case of probable stent thrombosis on day 15.. In this real-world clinical experience, ZES was associated with a low incidence of adverse cardiac events at a medium follow-up of one and half years.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Inpatients; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Retrospective Studies; Sirolimus

Topics: Coronary Restenosis; Death, Sudden, Cardiac; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Sirolimus; Stents

Late stent thrombosis (LST) after Cypher and Taxus drug-eluting stent placement has emerged as a major concern. Although the clinical predictors of LST have been reported, specific morphological and histological correlates of LST remain unknown.. From a registry totaling 81 human autopsies of drug-eluting stents, 46 (62 lesions) had a drug-eluting stent implanted >30 days. We identified 28 lesions with thrombus and compared those with 34 of similar duration without thrombosis using computer-guided morphometric and histological analyses. LST was defined as an acute thrombus within a coronary artery stent in place >30 days. Multiple logistic generalized estimating equations modeling demonstrated that endothelialization was the best predictor of thrombosis. The morphometric parameter that best correlated with endothelialization was the ratio of uncovered to total stent struts per section. A univariable logistic generalized estimating equations model of occurrence of thrombus in a stent section versus ratio of uncovered to total stent struts per section demonstrated a marked increase in risk for LST as the number of uncovered struts increased. The odds ratio for thrombus in a stent with a ratio of uncovered to total stent struts per section >30% is 9.0 (95% CI, 3.5 to 22).. The most powerful histological predictor of stent thrombosis was endothelial coverage. The best morphometric predictor of LST was the ratio of uncovered to total stent struts. Heterogeneity of healing is a common finding in drug-eluting stents with evidence of LST and demonstrates the importance of incomplete healing of the stented segment in the pathophysiology of LST.

Topics: Aged; Angioplasty, Balloon, Coronary; Anthropometry; Aspirin; Clopidogrel; Coronary Restenosis; Coronary Thrombosis; Death, Sudden, Cardiac; Drug Implants; Drug Utilization; Endothelium, Vascular; Equipment Design; Equipment Failure; Female; Follow-Up Studies; Humans; Hyperplasia; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Platelet Aggregation Inhibitors; Sirolimus; Stents; Ticlopidine; Tunica Intima; Wound Healing

This study examined human drug-eluting stents (DES) to determine the long-term effects of these stents on coronary arterial healing and identified mechanisms underlying late stent thrombosis (LST).. Although DES reduce the need for repeat revascularization compared with bare-metal stents (BMS), data suggest the window of thrombotic risk for Cypher (Cordis Corp., Miami Lakes, Florida) and Taxus (Boston Scientific Corp., Natick, Massachusetts) DES extends far beyond that for BMS.. From a registry of 40 autopsies of DES (68 stents), 23 DES cases of >30 days duration were compared with 25 matched autopsies of BMS implantation. Late stent thrombosis was defined as an acute thrombus within a stent >30 days old.. Of 23 patients with DES >30 days old, 14 had evidence of LST. Cypher and Taxus DES showed greater delayed healing characterized by persistent fibrin deposition (fibrin score 2.3 +/- 1.1 vs. 0.9 +/- 0.8, p = 0.0001) and poorer endothelialization (55.8 +/- 26.5%) compared with BMS (89.8 +/- 20.9, p = 0.0001). Moreover, DES with LST showed more delayed healing compared with patent DES. In 5 of 14 patients suffering LST, antiplatelet therapy had been withdrawn. Additional procedural and pathologic risk factors for LST were: 1) local hypersensitivity reaction; 2) ostial and/or bifurcation stenting; 3) malapposition/incomplete apposition; 4) restenosis; and 5) strut penetration into a necrotic core.. The Cypher and Taxus DES result in delayed arterial healing when compared with BMS of similar implant duration. The cause of DES LST is multifactorial with delayed healing in combination with other clinical and procedural risk factors playing a role.

Topics: Adult; Aged; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Death, Sudden, Cardiac; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Sirolimus; Stents; Wound Healing

Sirolimus-eluting stents (SES) have recently been shown to reduce restenosis in selected patients. The impact of this new stent on the use of coronary bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) in clinical practice is yet unknown. Therefore, we investigated the impact of SES on the clinical practice of CABG and PCI in a series of unselected consecutive patients.. Between April and October 2002, a policy of SES implantation for all procedures has been instituted in our hospital. In total, 798 patients were referred to PCI and 275 to CABG (SES group). A control group was composed of all interventions (806 PCI and 314 CABG) performed during the preceding 6 months (pre-SES). The main outcome was the occurrence of major adverse cardiac events (MACE) at 15 months. In the SES era, a significant shift was noted in the PCI group towards more multi-vessel stenting (28 vs. 24%; P<0.05), more bifurcation stenting (18 vs. 7%; P<0.0001), and the use of more stents (1.9 vs. 1.5; P<0.05). In the PCI elective patients, a shift was noted towards more three-vessel disease (pre-SES: 16% vs. SES: 23%; P=0.02). Furthermore, we observed a shift in the CABG group towards more impaired LV function (pre-SES: 34% vs. SES: 41%; P=0.02) and towards more three-vessel disease (pre-SES: 67% vs. SES: 75%; P=0.03). Overall, the cumulative MACE percentages at 1 year after coronary revascularization (PCI and CABG combined) decreased from 16.8 to 13.8% (P=0.03). The cumulative MACE percentages in the pure SES group and the pre-SES bare metal stent group at 12 months were 15.6 and 19.8%, respectively (P<0.01).. The introduction of the SES has certainly had an impact on the treatment strategy of coronary artery disease (CAD). Increased use of these stents allows more complex coronary anatomy to be treated by PCI, and results in lower repeat revascularization rates.

Topics: Case-Control Studies; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Death, Sudden, Cardiac; Drug Implants; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Between April 2002 and May 2004, 174 consecutive patients who underwent percutaneous coronary intervention of bifurcational lesions with sirolimus-eluting stents were identified. Two strategies were used: stenting only 1 branch (group 1S, n = 57) or stenting both branches (group 2S, n = 117). The incidence of major adverse cardiac events was evaluated in the hospital and at 9-month follow-up. There were no statistically significant differences between the 2 groups with regard to the incidence of target lesion revascularization (5.4% vs 8.9%, p = 0.76), target vessel revascularization (5.4% vs 11.1%, p = 0.51), and cumulative major adverse cardiac events (18.9% vs 23.3%, p = 0.76) at 9 months.

Topics: Aged; Angina, Unstable; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Death, Sudden, Cardiac; Female; Follow-Up Studies; Hospital Mortality; Humans; Male; Middle Aged; Myocardial Infarction; Outcome and Process Assessment, Health Care; Risk Factors; Sirolimus; Stents

To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO).. We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up.. Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.

Topics: Case-Control Studies; Chronic Disease; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Death, Sudden, Cardiac; Drug Implants; Female; Follow-Up Studies; Hospitalization; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Sirolimus; Stents; Survival Analysis; Treatment Outcome