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单支冠状动脉支架置入患者中可生物降解聚合物药物洗脱支架与第二代耐用聚合物药物洗脱支架的9个月血管造影随访及长期临床结果比较

Comparison of 9-Month Angiographic Follow-Up and Long-Term Clinical Outcomes of Biodegradable Polymer Drug-Eluting Stents and Second-Generation Durable Polymer Drug-Eluting Stents in Patients Undergoing Single Coronary Artery Stenting.

作者信息

Tsai Ming-Lung, Hsieh Ming-Jer, Chen Chun-Chi, Chang Shang-Hung, Wang Chao-Yung, Chen Dong-Yi, Yang Chia-Hung, Yeh Jih-Kai, Ho Ming-Yun, Hsieh I-Chang

机构信息

Division of Cardiology, Department of Medicine and Percutaneous Coronary Intervention Center, Chang Gung Memorial Hospital; Chang Gung University College of Medicine, Taoyuan, Taiwan.

出版信息

Acta Cardiol Sin. 2020 Mar;36(2):97-104. doi: 10.6515/ACS.202003_36(2).20190729A.

Abstract

BACKGROUND

The durable polymers (DP) used in first-generation drug-eluting stents (DESs) were associated with long-term cardiovascular events, and thus biodegradable polymer DESs (BP-DESs) and second-generation DP-DESs were designed to overcome this problem. In this study, we compared angiographic follow-up and long-term clinical outcomes between patients who received BP-DESs or second-generation DP-DESs.

METHODS

We enrolled 436 patients with single coronary lesions who received a second-generation DP-DES or BP-DES between June 2009 and October 2012. All patients received follow-up angiography when new clinical events developed or at 9 months after index stenting. All participants received follow-up for 5 years.

RESULTS

There were no significant differences in patient and lesion characteristics between the two groups. The 9-month angiographic follow-up showed a lower net gain in the second-generation DP-DES group (2.19 mm vs. 2.41 mm, p = 0.040), but a similar binary restenosis rate between the two groups (5.4% vs. 8.7%, p = 0.276). During the 5-year follow-up period, no significant differences were observed between the two groups in major adverse cardiac events (MACEs), cardiovascular death, nonfatal myocardial infarction (MI), target vessel revascularization (TVR), all revascularization, stent thrombosis (ST), or MACE-free survival.

CONCLUSIONS

No significant differences were observed in cardiovascular death, nonfatal MI, TVR, all revascularization, ST, or MACE-free survival between the patients undergoing single coronary artery stenting with BP-DESs and second-generation DP-DESs.

摘要

背景

第一代药物洗脱支架(DES)中使用的耐久性聚合物(DP)与长期心血管事件相关,因此设计了可生物降解聚合物DES(BP-DES)和第二代DP-DES来克服这一问题。在本研究中,我们比较了接受BP-DES或第二代DP-DES的患者的血管造影随访结果和长期临床结局。

方法

我们纳入了436例单支冠状动脉病变患者,这些患者在2009年6月至2012年10月期间接受了第二代DP-DES或BP-DES治疗。所有患者在出现新的临床事件时或在首次支架置入术后9个月接受随访血管造影。所有参与者均接受了5年的随访。

结果

两组患者的患者和病变特征无显著差异。9个月的血管造影随访显示,第二代DP-DES组的净增益较低(2.19 mm对2.41 mm,p = 0.040),但两组之间的二元再狭窄率相似(5.4%对8.7%,p = 0.276)。在5年的随访期内,两组在主要不良心脏事件(MACE)、心血管死亡、非致死性心肌梗死(MI)、靶血管血运重建(TVR)、所有血运重建、支架血栓形成(ST)或无MACE生存率方面均未观察到显著差异。

结论

在接受BP-DES和第二代DP-DES进行单支冠状动脉支架置入的患者之间,在心血管死亡、非致死性MI、TVR、所有血运重建、ST或无MACE生存率方面未观察到显著差异。

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