紫杉醇洗脱与依维莫司洗脱冠状动脉支架在糖尿病中的应用。
Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes.
机构信息
From the Fortis Escorts Heart Institute (U.K., A.S., P.A.) and Dharma Vira Heart Centre, Sir Ganga Ram Hospital (R.J.), New Delhi, L.R.G. Naidu Cardiology Research Institute and Clinic, G. Kuppuswamy Naidu Memorial Hospital, Coimbatore (R.K.A.), SAL Hospital and Medical Institute (T.M.P.) and Apex Heart Institute (S.S.), Ahmedabad, Bankers Heart Institute, Vadodara (D.B.), Shree B.D. Mehta Mahavir Heart Institute, Surat (A.A.), Institute of Cardiovascular Diseases, the Madras Medical Mission, Chennai (A.S.M.), Krishna Institute of Medical Sciences, Secunderabad (P.R.K.), and the Ananthapuri Hospitals and Research Institute, Trivandrum (C.G.B.) - all in India; and New York University School of Medicine, New York (S.B.).
出版信息
N Engl J Med. 2015 Oct 29;373(18):1709-19. doi: 10.1056/NEJMoa1510188. Epub 2015 Oct 14.
BACKGROUND
The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.
METHODS
We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.
RESULTS
At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).
CONCLUSIONS
In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).
背景
在接受经皮冠状动脉介入治疗（PCI）的糖尿病合并冠状动脉疾病患者中，药物洗脱支架的选择一直存在争议。先前比较紫杉醇洗脱支架与雷帕霉素洗脱支架（现称西罗莫司）或其类似物（依维莫司或佐他莫司）的研究结果相互矛盾，支架类型之间的等效性或依维莫司洗脱支架的优越性均有报道。
方法
我们将 1830 例糖尿病合并冠状动脉疾病并接受 PCI 的患者随机分配至紫杉醇洗脱支架组或依维莫司洗脱支架组。我们采用非劣效性试验设计，以置信区间上限的 95%置信区间的风险差的 4 个百分点作为非劣效性边界。主要终点为靶血管失败，定义为 1 年随访时的心脏死亡、靶血管心肌梗死或缺血驱动的靶血管血运重建的复合终点。
结果
1 年时，紫杉醇洗脱支架组在主要终点方面未达到优于依维莫司洗脱支架的非劣效性标准（靶血管失败率，5.6%比 2.9%；风险差，2.7 个百分点[95%置信区间，0.8 至 4.5]；相对风险，1.89[95%置信区间，1.20 至 2.99]；非劣效性 P=0.38）。紫杉醇洗脱支架组 1 年时靶血管失败的发生率明显高于依维莫司洗脱支架组（P=0.005），靶血管心肌梗死（3.2%比 1.2%，P=0.004）、支架血栓形成（2.1%比 0.4%，P=0.002）、靶血管血运重建（3.4%比 1.2%，P=0.002）和靶病变血运重建（3.4%比 1.2%，P=0.002）的发生率也更高。
结论
在接受 PCI 的糖尿病合并冠状动脉疾病患者中，与依维莫司洗脱支架相比，紫杉醇洗脱支架并未显示出非劣效性，并且在 1 年时靶血管失败、心肌梗死、支架血栓形成和靶血管血运重建的发生率更高。（由波士顿科学公司资助；TUXEDO-India 临床试验注册中心-印度注册号，CTRI/2011/06/001830）。
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