Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction.

AIMS: To compare the efficacy and safety of drug-eluting stents vs. bare-metal stents in patients with acute ST-segment elevation myocardial infarction. METHODS AND RESULTS: We performed a meta-analysis of eight randomized trials comparing drug-eluting stents (sirolimus-eluting or paclitaxel-eluting stents) with bare-metal stents in 2786 patients with acute ST-segment elevation myocardial infarction. All patients were followed up for a mean of 12.0-24.2 months. Individual data were available for seven trials with 2476 patients. The primary efficacy endpoint was the need for reintervention (target lesion revascularization). The primary safety endpoint was stent thrombosis. Other outcomes of interest were death and recurrent myocardial infarction. Drug-eluting stents significantly reduced the risk of reintervention, hazard ratio of 0.38 (95% CI, 0.29-0.50), P < 0.001. The overall risk of stent thrombosis: hazard ratio of 0.80 (95% CI, 0.46-1.39), P = 0.43; death: hazard ratio of 0.76 (95% CI, 0.53-1.10), P = 0.14; and recurrent myocardial infarction: hazard ratio of 0.72 (95% CI, 0.48-1.08, P = 0.11) was not significantly different for patients receiving drug-eluting stents vs. bare-metal stents. CONCLUSION: The use of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction is safe and improves clinical outcomes by reducing the risk of reintervention compared with bare-metal stents.     

Review of randomized clinical trials of drug-eluting stents for the prevention of in-stent restenosis

Drug-eluting stents (DESs) have shown significant promise at reducing rates of restenosis and subsequent revascularization compared with bare metal stents (BMSs). The purpose of this report is to provide a systematic review of the randomized clinical trials that have evaluated the efficacy and safety of DESs. A total of 28 randomized clinical trials were identified: 21 comparing a DES (sirolimus, paclitaxel, ABT-578, actinomycin, everolimus, or 7-hexanoyltaxol) with a BMS and 7 comparing a DES with another DES (sirolimus vs paclitaxel). Early sirolimus and polymeric paclitaxel studies in low-risk populations demonstrated marked reductions in restenosis according to angiographic and clinical parameters, compared with BMSs. These promising findings led to the more recent evaluations of DESs in higher risk patients in controlled and head-to-head comparisons. In these subsequent trials, sirolimus and paclitaxel DESs continued to exceed the therapeutic potential of BMSs, with a slight but consistent angiographic advantage being observed with the sirolimus DESs.     

吡格列酮降低非糖尿病患者冠状动脉药物洗脱支架再狭窄的研究

目的:探讨吡格列酮对非糖尿病患者冠状动脉(冠脉)支架内再狭窄的影响及其可能机制。方法:选择置入雷帕霉素洗脱支架的非糖尿病患者128例,并排除糖耐量异常者,随机分成吡格列酮组(71例)和对照组(57例),吡格列酮组在对照组常规治疗的基础上加用吡格列酮(30mg,qd);冠脉支架置入术后6～8个月行选择性冠脉造影术,于治疗前及随访6～8个月复查时先后分别测定血脂、空腹血糖、空腹胰岛素、血清瘦素及血清脂联素,并计算胰岛素抵抗指数(HOMA-IR)。结果:吡格列酮组支架内再狭窄的发生率显著低于对照组(2.82%∶12.28%,P=0.037);冠脉支架术后6～8个月,2组血脂指标、空腹血糖差异无统计学意义,但HOMA-IR、脂联素及脂联素/瘦素比值均差异有统计学意义(均P<0.05)。结论:吡格列酮能够降低非糖尿病患者药物洗脱支架的再狭窄,这种作用独立于调整血糖、血脂之外,改善胰岛素抵抗和血管内皮功能可能是吡格列酮阻止支架内再狭窄的重要机制。     

Critical role of bare-metal stent controls in trials of drug-eluting stents.

We have read with interest the randomized trial comparing sirolimus-elutingstents (Cypher, Cordis) to thin-strut bare-metal stents (BMSs)(BeStent 2, Medtronic).¹ Indeed, as the authors have previouslypointed out, any novel treatment should be compared with thebest performing control treatment, and thus, thin-strut BMSwere the only correct benchmark for the thorough appraisal ofdrug-eluting stents     

Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials

Purpose

Drug-eluting stents are commonly used for percutaneous coronary intervention. Despite excellent clinical efficacy, the association between drug-eluting stents and the risk for late thrombosis remains imprecisely defined.

Methods

We performed a meta-analysis on 14 contemporary clinical trials that randomized 6675 patients to drug-eluting stents (paclitaxel or sirolimus) compared with bare metal stents. Eight of these trials have reported more than a year of clinical follow-up.

Results

The incidence of very late thrombosis (>1 year after the index procedure) was 5.0 events per 1000 drug-eluting stent patients, with no events in bare metal stent patients (risk ratio [RR] = 5.02, 95% confidence interval [CI], 1.29 to 19.52, P = .02). Among sirolimus trials, the incidence of very late thrombosis was 3.6 events per 1000 sirolimus stent patients, with no events in bare metal stent patients (RR = 3.99, 95% CI, .45 to 35.62, P = .22). The median time of late sirolimus stent thrombosis was 15.5 months, whereas with bare metal stents it was 4 months. Among paclitaxel trials, the incidence of very late thrombosis was 5.9 events per 1000 paclitaxel stent patients, with no events in bare metal stent patients (RR = 5.72, 95% CI, 1.08 to 32.45, P = .049). The median time of late paclitaxel stent thrombosis was 18 months, whereas it was 3.5 months in bare metal stent patients.

Conclusions

Although the incidence of very late stent thrombosis more than 1 year after coronary revascularization is low, drug-eluting stents appear to increase the risk for late thrombosis. Although more of this risk was seen with paclitaxel stents, it remains possible that sirolimus stents similarly increase the risk for late thrombosis compared with bare metal stents.     

Incidence and predictors of recurrent restenosis following implantation of drug-eluting stents for in-stent restenosis.

OBJECTIVES: We investigated the incidence and predictors of recurrent restenosis after drug-eluting stent (DES) implantation for in-stent restenosis (ISR) in routine clinical practice. BACKGROUND: Although DESs have been increasingly used for treatment of ISR, little is known about the predictors of DES failure. METHODS: We determined the incidence of recurrent restenosis and major adverse cardiac events (MACE) in 224 consecutive patients with 239 lesions treated with sirolimus-eluting (n=217 lesions) or paclitaxel-eluting (n=22 lesions) stents for the first episode of ISR. RESULTS: The procedural success rate was 99.2%, and in-hospital complications did not occur in any patient. Follow-up angiography at 6 months was obtained in 73.7% of patients. Angiographic re-restenosis rate was 12.6%, and target lesion revascularization was required in 7.6% of patients. Of the 22 incidents of re-restenosis, 15 were focal (68.2%), 5 were diffuse (22.7%), and 2 were total (9.1%) restenosis. Univariate analysis showed that lesion length, use of paclitaxel-eluting stent, and number of stents per lesion were significant predictors of re-restenosis. In multivariate analysis, however, lesion length and use of paclitaxel-eluting stent were independent predictors of re-restenosis. During the follow-up (mean, 18.3+/-8.1 months), there were 4 deaths (1 cardiac, 3 noncardiac), but no nonfatal myocardial infarctions (MIs). MACE occurred in 18 patients. The cumulative probability of MACE-free survival was 92.9+/-1.8% at 1 year and 90.5+/-2.4% at 2 years. CONCLUSIONS: DESs are highly effective for treatment of ISR, with recurrent restenosis related to lesion length and type of DES.     

Critical role of bare-metal stent controls in trials of drug-eluting stents: reply

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