UNASSIGNED: PIONEER III was a multicenter, prospective, single-blind clinical trial, randomizing 1629 patients with either an acute or chronic coronary syndrome in a 2:1 ratio to the Supreme DES or DP-EES. Complex lesions (American College of Cardiology/American Heart Association type B2/C) were found in 1137 patients. Outcomes were also compared for specific parameters of lesion complexity: severe calcification, long length (>20 mm), and severe tortuosity. The primary end point was target lesion failure at 1 year.
UNASSIGNED: At 1 year, there was no difference in target lesion failure between the Supreme DES and DP-EES: (5.7% vs 5.6%; hazard ratio 1.00, 95% confidence interval 0.59-1.68, P = .99). Similarly, there were no differences in the secondary end points of lesion success (99.7% vs 99.4%, P = .41), device success (97.0% vs 98.5%, P = .14), target vessel failure (6.5% vs 7.4%, P = .50), major adverse cardiac events (7.8% vs 8.5%, P = .64), or stent thrombosis (0.7% vs 1.1%, P = .48). A trend was observed toward a higher rate of target lesion revascularization with the Supreme DES (2.5% vs 0.9%, P = .06).
UNASSIGNED: This study suggests that the Supreme DES is as effective and safe at 1 year compared with the standard DP-EES across a broad spectrum of lesion complexity.
■PIONEERIII是一个多中心,prospective,单盲临床试验,将1629例急性或慢性冠脉综合征患者以2:1的比例随机分配给SupremeDES或DP-EES。在1137例患者中发现了复杂的病变(美国心脏病学会/美国心脏协会B2/C型)。结果也比较了病变复杂性的具体参数:严重钙化,长(>20毫米),和严重的弯曲。主要终点是1年的靶病变失败。
■在1年,SupremeDES和DP-EES在靶病变失败方面无差异:(5.7%vs5.6%;风险比1.00,95%置信区间0.59-1.68,P=.99).同样,病变成功的次要终点无差异(99.7%vs99.4%,P=.41),设备成功(97.0%vs98.5%,P=.14),目标血管故障(6.5%对7.4%,P=.50),主要不良心脏事件(7.8%vs8.5%,P=.64),或支架血栓形成(0.7%vs1.1%,P=.48)。使用SupremeDES观察到靶病变血运重建率更高的趋势(2.5%vs0.9%,P=.06)。
■这项研究表明,与标准DP-EES相比,SupremeDES在1年时在广泛的病变复杂性中同样有效和安全。