载有雷帕霉素的可降解聚合物涂层支架与裸金属支架治疗急性心肌梗死的两年临床结果：COMBATIBLE AMI 试验。
Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial.
机构信息
From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (L.R., M.T., A.M., P.W., B.M., S.W.); Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark (H.K., T.E.); Department of Cardiology, Clinical Center of Serbia, Belgrade, Serbia (M.O.); Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (D.H., P.J.); Bristol Heart Institute, Bristol, United Kingdom (A.B.); Thoraxcenter Twente and Twente University, Enschede, The Netherlands (C.v.B.); Division of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Cardiocentro, Lugano, Switzerland (G.P.); Rabin Medical Center, Petach Tikva, Israel (R.K.); Tel Aviv University, Tel Aviv, Israel (R.K.); Kantonsspital Winterthur, Winterthur, Switzerland (K.W.); Department of Cardiology, University Hospital Zurich, Zurich, Switzerland (T.F.L., C.M.M.); and Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland (P.J., S.W.).
出版信息
Circ Cardiovasc Interv. 2014 Jun;7(3):355-64. doi: 10.1161/CIRCINTERVENTIONS.113.001440. Epub 2014 May 20.
BACKGROUND
This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents (BMSs) in the COMFORTABLE trial (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) were sustained during long-term follow-up.
METHODS AND RESULTS
A total of 1161 patients were randomly assigned to biolimus-eluting stent (BES) and BMS at 11 centers, and follow-up rates at 2 years were 96.3%. A subgroup of 103 patients underwent angiography at 13 months. At 2 years, differences in the primary end point of cardiac death, target-vessel myocardial infarction, and target lesion revascularization continued to diverge in favor of BES-treated patients (5.8%) compared with BMS-treated patients (11.9%; hazard ratio = 0.48; 95% confidence interval, 0.31-0.72; P < 0.001) with a significant risk reduction during the second year of follow-up (hazard ratio 1-2 years = 0.45; 95% confidence interval, 0.20-1.00; P = 0.049). Differences in the primary end point were driven by a reduction in target lesion revascularization (3.1% versus 8.2%; P < 0.001) and target-vessel reinfarction (1.3% versus 3.4%; P = 0.023). The composite of death, any reinfarction and revascularization (14.5% versus 19.3%; P = 0.03), and cardiac death or target-vessel myocardial infarction (4.2% versus 7.2%; P = 0.036) were less frequent among BES-treated patients compared with BMS-treated patients. The 13-month angiographic in-stent percent diameter stenosis amounted to 12.0 ± 7.2 in BES- and 39.6 ± 25.2 in BMS-treated lesions (P < 0.001).
CONCLUSIONS
Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, BES continued to improve cardiovascular events compared with BMS beyond 1 year.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NTC00962416.
背景
本研究旨在确定 COMFORTABLE 试验（比较生物可降解聚合物洗脱的比马前列素支架与裸金属支架在急性 ST 段抬高型心肌梗死中的应用）中生物可降解聚合物洗脱的比马前列素支架（BES）与裸金属支架（BMS）之间 1 年主要不良心脏事件的差异是否在长期随访中得以维持。
方法和结果
共 1161 例患者在 11 个中心随机分配至 BES 和 BMS 组，2 年随访率为 96.3%。103 例患者的亚组在 13 个月时进行了血管造影。2 年时，BES 组患者的主要终点（心脏死亡、靶血管心肌梗死和靶病变血运重建）较 BMS 组患者（5.8% 比 11.9%；风险比=0.48；95%置信区间，0.31-0.72；P<0.001）继续呈现差异，且在随访的第二年仍具有显著的风险降低（风险比 1-2 年=0.45；95%置信区间，0.20-1.00；P=0.049）。主要终点的差异是由于靶病变血运重建（3.1%比 8.2%；P<0.001）和靶血管再梗死（1.3%比 3.4%；P=0.023）的减少所致。BES 组患者的死亡、任何再梗死和血运重建复合终点（14.5%比 19.3%；P=0.03）以及心脏死亡或靶血管心肌梗死（4.2%比 7.2%；P=0.036）的发生率均低于 BMS 组患者。BES 组的支架内 13 个月时的百分比直径狭窄率为 12.0±7.2，而 BMS 组为 39.6±25.2（P<0.001）。
结论
在接受直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中，与 BMS 相比，BES 在 1 年以上时间内持续改善心血管事件。
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