Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention |
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| Institution: | 1. NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York;2. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York;3. Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden;4. Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey;5. Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada;6. Unità Operativa di Cardiologia, Policlinico S. Orsola, Bologna, Italy;7. University of Bristol, Bristol, United Kingdom;8. Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy;9. Mediterranea Cardiocentro, Napoli, Italy;10. Maasstad Zienkenhuis, Rotterdam, the Netherlands;11. Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands;12. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York;13. Imperial College of Science, Technology and Medicine, London, United Kingdom;14. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom |
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| Abstract: | BackgroundThe 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.ObjectivesThe purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type.MethodsIndividual 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.ResultsAmong 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 1 and 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.ConclusionsIn 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 long-term outcomes after PCI. |
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| Keywords: | clinical trials late events major adverse cardiovascular events PCI stents BES"} {"#name":"keyword" "$":{"id":"kwrd0040a"} "$$":[{"#name":"text" "_":"biolimus-eluting stents BMS"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"bare-metal stents BVS"} {"#name":"keyword" "$":{"id":"kwrd0150"} "$$":[{"#name":"text" "_":"bioresorbable vascular scaffolds CAD"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"coronary artery disease DES"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"drug-eluting stents DES1"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"first-generation drug-eluting stents DES2"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"second-generation drug-eluting stents EES"} {"#name":"keyword" "$":{"id":"kwrd0080a"} "$$":[{"#name":"text" "_":"everolimus-eluting stents ID-TLR"} {"#name":"keyword" "$":{"id":"kwrd0090"} "$$":[{"#name":"text" "_":"ischemia-driven target lesion revascularization IPD"} {"#name":"keyword" "$":{"id":"kwrd0100"} "$$":[{"#name":"text" "_":"individual patient data MACE"} {"#name":"keyword" "$":{"id":"kwrd0110"} "$$":[{"#name":"text" "_":"major adverse cardiovascular events MI"} {"#name":"keyword" "$":{"id":"kwrd0120"} "$$":[{"#name":"text" "_":"myocardial infarction PCI"} {"#name":"keyword" "$":{"id":"kwrd0130"} "$$":[{"#name":"text" "_":"percutaneous coronary intervention TLF"} {"#name":"keyword" "$":{"id":"kwrd0140"} "$$":[{"#name":"text" "_":"target lesion failure |
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