Author + information
- Received July 18, 2019
- Revision received November 12, 2019
- Accepted November 25, 2019
- Published online February 10, 2020.
- Mahesh V. Madhavan, MDa,b,
- Ajay J. Kirtane, MD, SMa,b,
- Björn Redfors, MD, PhDb,c,
- Philippe Généreux, MDb,d,e,
- Ori Ben-Yehuda, MDa,b,
- Tullio Palmerini, MDf,
- Umberto Benedetto, MD, PhDg,
- Giuseppe Biondi-Zoccai, MD, MStath,i,
- Pieter C. Smits, MDj,
- Clemens von Birgelen, MD, PhDk,
- Roxana Mehran, MDb,l,
- Thomas McAndrew, PhDb,
- Patrick W. Serruys, MDm,
- Martin B. Leon, MDa,b,
- Stuart J. Pocock, PhDn and
- Gregg W. Stone, MDb,l,∗ (, )@GreggWStone
- aNewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York
- bClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- cDepartment of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
- dGagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey
- eHôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada
- fUnità Operativa di Cardiologia, Policlinico S. Orsola, Bologna, Italy
- gUniversity of Bristol, Bristol, United Kingdom
- hDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy
- iMediterranea Cardiocentro, Napoli, Italy
- jMaasstad Zienkenhuis, Rotterdam, the Netherlands
- kThoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
- lThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- mImperial College of Science, Technology and Medicine, London, United Kingdom
- nDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
- ↵∗Address for correspondence:
Dr. Gregg W. Stone, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, New York 10019.
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 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.
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 long-term outcomes after PCI.
This investigator-initiated study was funded in part by Abbott Vascular. The funder had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. Dr. Madhavan has received a research grant from the AMA Foundation and reports being supported by an institutional grant by the National Institutes of Health/National Heart, Lung, and Blood Institute to Columbia University Irving Medical Center (T32 HL007854). Dr. Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical. Dr. Palmerini has received a speaker’s fee from Abbott. Dr. Smits has received institutional research grants and speaker fees from Abbott Vascular, Terumo, and St. Jude Medical. Dr. von Birgelen has received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. Dr. Mehran has served as a consultant (paid to the institution) for Abbott Laboratories and Spectranetics/Phillips/Volcano; has had personal speaking engagements with Abbott Laboratories; has received research funding (to institution) from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb, Chiesi USA, CSL Behring, Eli Lilly/DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, and PLC/Renal Guard; her spouse is a consultant for Abiomed and The Medicines Company; has served as a consultant for Boston Scientific, Bracco Group, Medscape/WebMD, Siemens Medical Solutions, Roivant Sciences, Sanofi, and Janssen Pharmaceuticals; has served on the Scientific Advisory Board and/or received personal fees from PLx Opco dba PLx Pharma Inc.; has served as a personal unpaid consultant for Regeneron Pharmaceuticals; has served as an advisor/speaker for Medtelligence (Janssen); has received Advisory Board Funding (to institution) from Bristol-Myers Squibb; and has received Data and Safety Monitoring Board membership payments (paid to the institution) from Watermark Research Partners. Dr. Stone has served as a consultant to Reva. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. P.K. Shah, MD, served as Guest Editor for this paper.
- Received July 18, 2019.
- Revision received November 12, 2019.
- Accepted November 25, 2019.
- 2020 American College of Cardiology Foundation
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