Krackhardt Florian, Kočka Viktor, Waliszewski Matthias W, Utech Andreas, Lustermann Meik, Hudec Martin, Studenčan Martin, Schwefer Markus, Yu Jiangtao, Jeong Myung Ho, Ahn Taehoon, Wan Ahmad Wan Azman, Boxberger Michael, Schneider André, Leschke Matthias
Kardiologie, Campus Virchow-Klinikum Charité, Berlin, Germany.
Department of Cardiology, University Hospital Královské Vinohrady, Prague, Czech Republic.
Open Heart. 2017 Jun 6;4(2):e000592. doi: 10.1136/openhrt-2017-000592. eCollection 2017.
The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied.
Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, 'all comers' observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated.
A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001).
PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).
NCT02629575.
本研究的目的是评估一种无聚合物西罗莫司涂层超薄支架药物洗脱支架（PF-SES）在未选择的患者群体中的安全性和有效性，重点关注急性冠状动脉综合征（ACS）。此外，还研究了稳定冠状动脉疾病（CAD）采用短期（≤6个月）与长期（>6个月）双联抗血小板治疗（DAPT）的情况。
在一项未选择的大规模国际单臂多中心“所有患者均可入组”的观察性研究中，对接受PF-SES的患者进行了调查。主要终点是9个月时的靶病变血运重建（TLR）率，次要终点包括9个月时的主要不良心脏事件（MACE）和手术成功率。对预先定义的亚组进行了调查，如ACS患者、糖尿病患者、病变亚组以及与DAPT相关的手术特征。
共有2877例患者接受了PF-SES治疗，其中1084例患有ACS（每位患者植入1.31±0.75个支架）。9个月时，累积的总体TLR率为2.3%（58/2513）。ACS和稳定CAD之间无显著差异（2.6%对2.1%，p = 0.389）。然而，总体MACE率为4.3%（108/2513），ACS患者的MACE率高于稳定CAD亚组（6.1%，58/947对3.2%，50/1566，p<0.001）。
在日常临床实践中，PF-SES血管成形术是安全有效的，在未选择的患者群体中TLR和MACE发生率较低。我们的数据与先前的临床研究结果一致，即对于稳定CAD患者，将DAPT持续时间延长至6个月以上并不能改善临床结局（ClinicalTrials.gov标识符NCT02629575）。
NCT02629575。
