van Houwelingen K Gert, Lam Ming Kai, Löwik Marije M, Danse Peter W, Tjon Joe Gin R Melvyn, Jessurun Gillian A, Anthonio Rutger L, Sen Hanim, Linssen Gerard C M, IJzerman Maarten J, Doggen Carine J M, von Birgelen Clemens
Cardiology Department, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
Cardiology Department, Rijnstate Hospital, Arnhem, The Netherlands.
Rev Esp Cardiol (Engl Ed). 2016 Dec;69(12):1152-1159. doi: 10.1016/j.rec.2016.05.029. Epub 2016 Aug 29.
In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI.
The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non-ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization.
Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non-ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56).
Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.
在急性心肌梗死（MI）中，新型高可输送性药物洗脱支架（DES）可能特别有价值，因为其灵活的支架设计可能减少对罪犯病变的器械诱导创伤。本研究的目的是评估在急性MI患者中使用两种新型耐用聚合物涂层DES进行经皮冠状动脉介入治疗的安全性和有效性。
前瞻性、随机的荷兰同行（特温特II）多中心试验在1811例所有患者中比较了Resolute Integrity和Promus Element支架，其中817例（45.1%）接受了ST段抬高型MI或非ST段抬高型MI治疗，2年结局数据的可得率为99.9%。主要临床终点是靶血管失败（TVF），这是一个包括心源性死亡、靶血管相关MI或靶血管血运重建的复合终点。
在所有817例接受急性MI治疗的患者中，421例（51.5%）接受了Resolute Integrity支架治疗，396例（48.5%）接受了Promus Element支架治疗。在2年随访时，两个支架组的TVF发生率（7.4%对6.1%；P = 0.45）、靶病变血运重建率（3.1%对2.8%；P = 0.79）和明确的支架内血栓形成率（1.0%对0.5%；P = 0.69）均较低。与所有急性MI患者的这些发现一致，两种DES的结局均良好且相似，其中370例ST段抬高型MI患者（TVF，5.1%对4.9%；P = 0.81）和447例非ST段抬高型MI患者（TVF，9.0%对7.5%；P = 0.56）。
Resolute Integrity和Promus Element支架在治疗急性MI患者时均安全有效。目前的2年随访数据强调了在这一特定临床环境中使用这些器械的安全性。
