Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
Department of Community Medicine, University of Tromsø-Arctic University of Norway, Tromsø, Norway.
Lancet. 2019 Jun 22;393(10190):2503-2510. doi: 10.1016/S0140-6736(19)30474-X. Epub 2019 May 2.
New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.
We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.
We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78-0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71-0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78-1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88-1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50-0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50-0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year.
The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year.
Bern University Hospital.
新一代药物洗脱支架（DES）主要在与早期一代 DES 的头对头非劣效性试验中进行了研究，通常显示出相似的疗效和更高的安全性。新一代 DES 的安全性与裸金属支架（BMS）相比如何尚不清楚。
我们对接受经皮冠状动脉介入治疗的患者进行了新一代 DES 或 BMS 植入后随机临床试验的个体患者数据荟萃分析。主要结局是心脏死亡或心肌梗死的复合结局。数据以一阶随机效应荟萃分析进行汇总，并在最大随访和 1 年时间点进行了检查。风险估计值以风险比（HR）和 95%置信区间（CI）表示。本研究在 PROSPERO 注册，编号为 CRD42017060520。
我们从 20 项随机试验中获得了 26616 名患者的个体数据。平均随访时间为 3.2（标准差 1.8）年。与 BMS 组相比，DES 组的主要结局风险降低（HR 0.84，95%CI 0.78-0.90，p<0.001），这归因于心肌梗死风险降低（0.79，0.71-0.88，p<0.001）和可能略有但无统计学意义的心脏死亡率获益（0.89，0.78-1.01，p=0.075）。全因死亡未受影响（DES 组 HR 0.96，95%CI 0.88-1.05，p=0.358），但确定的支架血栓形成（0.63，0.50-0.80，p<0.001）和靶血管血运重建（0.55，0.50-0.60，p<0.001）风险降低。我们观察到一种时间依赖性的治疗效果，即与 BMS 相比，DES 在植入后 1 年内与较低的主要结局风险相关。虽然这种效果在长期内得以维持，但在 1 年后与 BMS 没有进一步的差异。
新一代 DES 在植入后 1 年内的表现意味着 BMS 不应再被视为安全性的金标准。DES 技术的进一步发展应针对 1 年以上的临床结局改善。
伯尔尼大学附属医院。
