Deutsches Herzzentrum, Technische Universität, Munich, Germany.
Lancet. 2011 Sep 17;378(9796):1071-8. doi: 10.1016/S0140-6736(11)61255-5. Epub 2011 Aug 26.
Comparative assessment of clinical outcomes after use of drug-eluting stents versus bare-metal stents for treatment of aortocoronary saphenous vein graft lesions has not been undertaken in large randomised trials. We aimed to undertake a comparison in a randomised trial powered for clinical endpoints.
In this randomised superiority trial, patients with de-novo saphenous vein graft lesions were assigned by computer-generated sequence (1:1:1:3) to receive either drug-eluting stents (one of three types: permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or biodegradable-polymer sirolimus-eluting stents) or bare-metal stents. Randomisation took place immediately after crossing of the lesion with a guidewire, and was stratified for each participating centre. Investigators assessing data were masked to treatment allocation; patients were not masked to allocation. The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularisation at 1 year. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00611910.
610 patients were allocated to treatment groups (303 drug-eluting stent, 307 bare-metal stent). Drug-eluting stents reduced the incidence of the primary endpoint compared with bare-metal stents (44 [15%] vs 66 [22%] patients; hazard ratio [HR] 0.64, 95% CI 0.44-0.94; p=0.02). Target lesion revascularisation rate was reduced by drug-eluting stents (19 [7%] vs 37 [13%] patients; HR 0.49, 95% CI 0.28-0.86; p=0.01). No significant differences were seen between drug-eluting stents and bare-metal stents regarding all-cause mortality (15 [5%] vs 14 [5%] patients; HR 1.08, 95% CI 0.52-2.24; p=0.83), myocardial infarction (12 [4%] vs 18 [6%]; HR 0.66, 95% CI 0.32-1.37; p=0.27), or definite or probable stent thrombosis (2 [1%] in both groups; HR 1.00, 95% CI 0.14-7.10; p=0.99).
In patients undergoing percutaneous coronary intervention for de-novo saphenous vein graft lesions, drug-eluting stents are the preferred treatment option because they reduce the risk of adverse events compared with bare-metal stents.
Deutsches Herzzentrum.
在大型随机试验中，尚未对药物洗脱支架与裸金属支架治疗冠状动脉旁路移植术后病变的临床结局进行比较评估。我们旨在通过一项针对临床终点的随机试验进行比较。
在这项随机优效性试验中，将新出现的隐静脉移植物病变患者按计算机生成的序列（1:1:1:3）随机分配接受药物洗脱支架（三种类型之一：永久性聚合物紫杉醇洗脱支架、永久性聚合物西罗莫司洗脱支架或可生物降解聚合物西罗莫司洗脱支架）或裸金属支架治疗。随机分配在导丝穿过病变后立即进行，并按每个参与中心进行分层。评估数据的研究人员对治疗分配进行了设盲；患者未对分配设盲。主要终点是 1 年时死亡、心肌梗死和靶病变血运重建的综合发生率。分析按意向治疗进行。该试验在 ClinicalTrials.gov 注册，编号为 NCT00611910。
610 名患者被分配到治疗组（药物洗脱支架 303 例，裸金属支架 307 例）。与裸金属支架相比，药物洗脱支架降低了主要终点的发生率（44[15%]例 vs 66[22%]例；风险比[HR]0.64，95%CI 0.44-0.94；p=0.02）。药物洗脱支架降低了靶病变血运重建率（19[7%]例 vs 37[13%]例；HR 0.49，95%CI 0.28-0.86；p=0.01）。药物洗脱支架与裸金属支架在全因死亡率（15[5%]例 vs 14[5%]例；HR 1.08，95%CI 0.52-2.24；p=0.83）、心肌梗死（12[4%]例 vs 18[6%]例；HR 0.66，95%CI 0.32-1.37；p=0.27）或确定或可能的支架血栓形成（两组均为 2[1%]例；HR 1.00，95%CI 0.14-7.10；p=0.99）方面无显著差异。
在接受经皮冠状动脉介入治疗新出现的隐静脉移植物病变的患者中，与裸金属支架相比，药物洗脱支架是首选治疗方法，因为它降低了不良事件的风险。
德国心脏中心。
