期刊
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
卷 75, 期 6, 页码 590-604出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2019.11.058
关键词
clinical trials; late events; major adverse cardiovascular events; PCI; stents
资金
- Abbott Vascular
- AMA Foundation
- National Institutes of Health/National Heart, Lung, and Blood Institute [T32 HL007854]
- Medtronic
- Boston Scientific
- Abiomed
- CSI
- CathWorks
- Siemens
- Philips
- ReCor Medical
- Terumo
- St. Jude Medical
- Biotronik
- Abbott Laboratories
- Bayer
- Beth Israel Deaconess
- Bristol-Myers Squibb
- Chiesi USA
- CSL Behring
- Eli Lilly/DSI
- Novartis Pharmaceuticals
- OrbusNeich
- PLC/Renal Guard
BACKGROUND The majority of stent-related major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are believed to occur within the first year. Very-late (>1-year) stent-related MACE have not been well described, OBJECTIVES The purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type. METHODS Individual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very-late MACE (a composite of cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]), and target lesion failure (cardiac death, target-vessel MI, or ID-TLR) were assessed within year 1 and between 1 and 5 years after PCI with bare-metal stents (BMS), first-generation drug-eluting stents (DES1) and second-generation drug-eluting stents (DES2). A network meta-analysis was performed to evaluate direct and indirect comparisons, RESULTS Among 25,032 total patients, 3,718, 7,934, and 13,380 were treated with BMS, DES1, and DES2, respectively. MACE rates within 1 year after PCI were progressively lower after treatment with BMS versus DES1 versus DES2 (17.9% vs. 8,2% vs. 5.1%, respectively, p < 0.0001). Between years land 5, very-late MACE occurred in 9.4% of patients (including 2.9% cardiac death, 3.1% MI, and 5.1% ID-TLR). Very-late MACE occurred in 9.7%, 11.0%, and 8.3% of patients treated with BMS, DES1, and DES2, respectively (p < 0.0001), linearly increasing between 1 and 5 years. Similar findings were observed for target lesion failure in 19,578 patients from 12 trials. Findings were confirmed in the network meta-analysis. CONCLUSIONS In this large-scale, individual patient data pooled study, very-late stent-related events occurred between 1 and 5 years after PCI at a rate of 2%/year with all stent types, with no plateau evident. New approaches are required to improve tong-term outcomes after PCI. (C) 2020 by the American College of Cardiology Foundation.
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