Babapulle Mohan N, Joseph Lawrence, Bélisle Patrick, Brophy James M, Eisenberg Mark J
Division of Cardiology, Royal Victoria Hospital/McGill University Health Center, Montreal, Quebec, Canada.
Lancet. 2004;364(9434):583-91. doi: 10.1016/S0140-6736(04)16850-5.
Drug-eluting stents (DES) are associated with lower restenosis rates than bare-metal stents (BMS), but the benefits and safety of the new devices have not been systematically quantified across different trials. We undertook a meta-analysis of randomised trials comparing BMS and stents eluting sirolimus or paclitaxel.
A systematic literature search aimed to identify all randomised clinical trials with 6-12 months of clinical follow-up. Results were pooled by a hierarchical Bayesian random-effects model with prespecified stratification for drug and the presence of carrier polymer. The primary outcomes examined were rates of death, myocardial infarction, target-lesion revascularisation, major adverse cardiac events (death, myocardial infarction, and target-vessel revascularisation), and angiographic restenosis.
We identified 11 eligible trials involving 5103 patients. The pooled mortality rates were low for both DES and BMS with no evidence of any difference between them (odds ratio 1.11 [95% credible interval 0.61-2.06]). Pooled rates of myocardial infarction showed no between-group difference (0.92 [0.65-1.25]). The rate of major adverse cardiac events was 7.8% with DES and 16.4% with BMS (0.42 [0.32-0.53]), and the angiographic restenosis rates were also lower for DES (8.9% vs 29.3%; 0.18 [0.06-0.40]). The pooled rates of major adverse cardiac events for each DES type and the respective BMS were: for sirolimus, 6.8% versus 21.0% (0.28 [0.17-0.41]); for polymer-based paclitaxel 8.7% versus 16.7% (0.47 [0.25-0.71]); and for non-polymer-based paclitaxel 7.7% versus 9.5% (0.64 [0.42-1.00]). We did not observe higher rates of edge restenosis, stent thrombosis, or late incomplete stent apposition with DES, although the credible intervals were wide.
Sirolimus-eluting and polymeric paclitaxel-eluting stents are effective at decreasing rates of angiographic restenosis and major adverse cardiac events compared with BMS. However, there is no evidence that they affect mortality or myocardial-infarction rates. They also appear to be safe in the short to medium term, although definitive conclusions are not possible. Larger studies with longer follow-up are needed to define better the role of these new devices.
药物洗脱支架（DES）与裸金属支架（BMS）相比，再狭窄率较低，但在不同试验中，这些新装置的益处和安全性尚未得到系统量化。我们对比较BMS与洗脱西罗莫司或紫杉醇的支架的随机试验进行了荟萃分析。
进行系统的文献检索，旨在识别所有有6至12个月临床随访的随机临床试验。结果通过分层贝叶斯随机效应模型进行汇总，该模型对药物和载体聚合物的存在进行了预先设定的分层。所检查的主要结局包括死亡率、心肌梗死、靶病变血管重建、主要不良心脏事件（死亡、心肌梗死和靶血管血管重建）以及血管造影再狭窄率。
我们识别出11项符合条件的试验，涉及5103例患者。DES和BMS的汇总死亡率均较低，没有证据表明两者之间存在任何差异（优势比1.11 [95%可信区间0.61 - 2.06]）。心肌梗死的汇总发生率在组间没有差异（0.92 [0.65 - 1.25]）。DES组的主要不良心脏事件发生率为7.8%，BMS组为16.4%（0.42 [0.32 - 0.53]），DES的血管造影再狭窄率也较低（8.9%对29.3%；0.18 [0.06 - 0.40]）。每种DES类型与相应BMS的主要不良心脏事件汇总发生率分别为：西罗莫司，6.8%对21.0%（0.28 [0.17 - 0.41]）；基于聚合物的紫杉醇，8.7%对16.7%（0.47 [0.25 - 0.71]）；以及非聚合物基紫杉醇，7.7%对9.5%（0.64 [0.42 - 1.00]）。尽管可信区间较宽，但我们未观察到DES的边缘再狭窄、支架血栓形成或晚期支架贴壁不全发生率更高。
与BMS相比，西罗莫司洗脱支架和聚合物紫杉醇洗脱支架在降低血管造影再狭窄率和主要不良心脏事件发生率方面有效。然而，没有证据表明它们会影响死亡率或心肌梗死发生率。尽管无法得出确定性结论，但它们在短期至中期似乎也是安全的。需要进行更大规模、随访时间更长的研究，以更好地确定这些新装置的作用。
