Lee Da Hyon, Park Taek Kyu, Song Young Bin, Chun Woo Jung, Choi Rak Kyeong, Jeong Jin-Ok, Im Eul Soon, Kim Sang Wook, Lee Joo Myung, Yang Jeong Hoon, Hahn Joo-Yong, Choi Seung-Hyuk, Choi Jin-Ho, Lee Sang Hoon, Gwon Hyeon-Cheol
Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.
PLoS One. 2017 Aug 10;12(8):e0183079. doi: 10.1371/journal.pone.0183079. eCollection 2017.
There are limited data about clinical outcomes of biodegradable polymer biolimus-eluting BioMatrix stents (BP-BES) and durable polymer everolimus-eluting Xience stents (DP-EES) in real world practice. We sought to compare the clinical outcomes of BP-BES and DP-EES in real world cohorts of patients undergoing percutaneous coronary intervention. A prospective multicenter registry enrolled 999 patients treated with BP-BES and 1,000 patients treated with DP-EES. The primary outcome was target lesion failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization. Definite or probable stent thrombosis was also compared in total and propensity score-matched cohorts. The median follow-up duration was 24 months, and mean age was 65 years (interquartile range, 56-72 years). Patients receiving BP-BES had a lower prevalence of acute coronary syndrome, prior myocardial infarction, multi-vessel disease, bifurcation lesions, and left anterior descending artery lesions than those receiving DP-EES. After propensity score matching (692 pairs), target lesion failure occurred in 22 patients receiving BP-BES and in 25 patients receiving DP-EES (3.2% versus 3.6%; adjusted hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.53 to 1.60; p = 0.77). The risk of definite or probable stent thrombosis did not differ between the 2 groups (0.4% versus 0.4%; adjusted HR, 1.03; 95% CI, 0.21 to 4.98; p = 0.97). The results were consistent across various subgroups. In the propensity score-matched analysis of real world cohorts, BP-BES showed similar clinical outcomes compared to DP-EES. We need to investigate about whether differences in clinical outcome emerge during long-term follow-up.
在实际临床应用中,关于可生物降解聚合物生物雷帕霉素洗脱BioMatrix支架(BP - BES)和耐用聚合物依维莫司洗脱Xience支架(DP - EES)临床结局的数据有限。我们试图比较在接受经皮冠状动脉介入治疗的真实世界患者队列中,BP - BES和DP - EES的临床结局。一项前瞻性多中心注册研究纳入了999例接受BP - BES治疗的患者和1000例接受DP - EES治疗的患者。主要结局为靶病变失败,定义为心源性死亡、靶血管相关心肌梗死或靶病变血运重建的复合终点。还对总队列和倾向评分匹配队列中的明确或可能的支架血栓形成情况进行了比较。中位随访时间为24个月,平均年龄为65岁(四分位间距,56 - 72岁)。与接受DP - EES的患者相比,接受BP - BES的患者急性冠状动脉综合征、既往心肌梗死、多支血管病变、分叉病变和左前降支病变的患病率较低。在倾向评分匹配(692对)后,接受BP - BES的22例患者和接受DP - EES的25例患者发生了靶病变失败(3.2%对3.6%;调整后风险比[HR],0.92;95%置信区间[CI],0.53至1.60;p = 0.77)。两组之间明确或可能的支架血栓形成风险无差异(0.4%对0.4%;调整后HR,1.03;95% CI,0.21至4.98;p = 0.97)。结果在各个亚组中均一致。在真实世界队列的倾向评分匹配分析中,BP - BES与DP - EES显示出相似的临床结局。我们需要研究在长期随访期间临床结局是否会出现差异。