Author + information
- Received February 5, 2020
- Revision received March 26, 2020
- Accepted April 14, 2020
- Published online July 6, 2020.
- Mordechai Golomb, MDa,
- Björn Redfors, MD, PhDa,b,c,
- Aaron Crowley, MAa,
- Pieter C. Smits, MDd,
- Patrick W. Serruys, MD, PhDe,f,
- Clemens von Birgelen, MD, PhDg,h,
- Mahesh V. Madhavan, MDa,b,
- Ori Ben-Yehuda, MDa,b,
- Roxana Mehran, MDa,i,
- Martin B. Leon, MDa,b and
- Gregg W. Stone, MDa,i,∗ ()
- aClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- bDivision of Cardiology, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York
- cSahlgrenska University Hospital, Gothenburg, Sweden
- dMaasstad Ziekenhuis, Rotterdam, the Netherlands
- eDepartment of Cardiology, NUIG, National University of Ireland, Galway, Ireland
- fImperial College of Science, Technology and Medicine, London, United Kingdom
- gDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
- hDepartment of Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, the Netherlands
- iThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- ↵∗Address for correspondence:
Dr. Gregg W. Stone, Mount Sinai Hospital, Cardiovascular Research Foundation, 1700 Broadway, 8th Floor, New York, New York 10019.
Objectives The aim of this study was to assess race-based differences in patients undergoing percutaneous coronary intervention from a large pooled database of randomized controlled trials.
Background Data on race-based outcomes after percutaneous coronary intervention are limited, deriving mainly from registries and single-center studies.
Methods Baseline characteristics and outcomes at 30 days, 1 year, and 5 years were assessed across different races, from an individual patient data pooled analysis from 10 randomized trials. Endpoints of interest included death, myocardial infarction, and major adverse cardiac events (defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization). Multivariate Cox proportional hazards regression was performed to assess associations between race and outcomes, controlling for differences in 12 baseline covariates.
Results Among 22,638 patients, 20,585 (90.9%) were white, 918 (4.1%) were black, 404 (1.8%) were Asian, and 473 (2.1%) were Hispanic. Baseline and angiographic characteristics differed among groups. Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07). Multivariate analysis demonstrated an independent association between black race and 5-year risk for major adverse cardiac events (hazard ratio: 1.28; 95% confidence interval: 1.05 to 1.57; p = 0.01).
Conclusions In the present large-scale individual patient data pooled analysis, comorbidities were significantly more frequent in minority-group patients than in white patients enrolled in coronary stent randomized controlled trials. After accounting for these differences, black race was an independent predictor of worse outcomes, whereas Hispanic ethnicity and Asian race were not. Further research examining race-based outcomes after percutaneous coronary intervention is warranted to understand these differences.
This investigator-initiated study was funded in part by a grant from Abbott. The funder had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. Dr. Smits has received institutional research grants from Abbott Vascular, Terumo, and St. Jude Medical; and has received speaking fees from Abbott Vascular, St. Jude Medical, and Terumo. Dr. Serruys is a consultant for Biosensors, SINOMED, Balton sp, Philips/Volcano, Xeltis, and HeartFlow. Dr. von Birgelen has received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. Dr. Madhavan has received an institutional grant to by the NIH/NHLBI (T32 HL007854). Dr. Mehran has reported institutional research grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich; consultant fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, Siemens Medical Solutions; has received consultant fees paid to the institution from Abbott Laboratories, Bristol-Myers Squibb; advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; consultant (spouse) from Abiomed, The Medicines Company; equity <1% from Claret Medical, Elixir Medical; has received Data Safety Monitoring Board membership fees paid to the institution from Watermark Research Partners; had been a consultant (no fee) for Idorsia Pharmaceuticals Ltd., Regeneron Pharmaceuticals; and is an Associate Editor for the ACC and the AMA. Dr. Leon has received institutional grant support from Abbott, Boston Scientific, and Medtronic. Dr. Stone has received speaking honoraria from Cook and Terumo; is a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and Matrizyme; holds equity or options in Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, the MedFocus family of funds, and Valfix. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received February 5, 2020.
- Revision received March 26, 2020.
- Accepted April 14, 2020.
- 2020 American College of Cardiology Foundation
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