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.).
Circ Cardiovasc Interv. 2014 Jun;7(3):355-64. doi: 10.1161/CIRCINTERVENTIONS.113.001440. Epub 2014 May 20.
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.
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).
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.
http://www.clinicaltrials.gov. Unique identifier: NTC00962416.
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。
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）。
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。
