PDF(Pubmed)
Abstract：
UNASSIGNED: The Supreme healing-targeted drug-eluting stent (DES) is designed to promote endothelial healing to reduce stent-related adverse events. This may be particularly relevant among complex lesions that have a higher rate of adverse events. We sought to compare 1-year outcomes of percutaneous coronary intervention in complex lesions between the Supreme DES and contemporary durable-polymer, everolimus-eluting stents (DP-EES).
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.
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.
摘要：
■Supreme愈合靶向药物洗脱支架（DES）旨在促进内皮愈合，以减少与支架相关的不良事件。这在具有较高不良事件发生率的复杂病变中可能特别相关。我们试图比较SupremeDES和当代耐久聚合物在复杂病变中经皮冠状动脉介入治疗的1年结局。依维莫司洗脱支架（DP-EES）。
■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。
■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。
