Author + information
- Received December 11, 2019
- Revision received January 25, 2020
- Accepted January 31, 2020
- Published online April 6, 2020.
- Ioanna Kosmidou, MD, PhDa,b,
- Martin B. Leon, MDa,b,
- Yiran Zhang, MSa,
- Patrick W. Serruys, MD, PhDc,d,
- Clemens von Birgelen, MDe,f,
- Pieter C. Smits, MDg,
- Ori Ben-Yehuda, MDa,b,
- Björn Redfors, MD, PhDa,b,h,
- Mahesh V. Madhavan, MDa,b,
- Akiko Maehara, MDa,b,
- Roxana Mehran, MDa,i@Drroxmehran and
- Gregg W. Stone, MDa,i,∗ (, )@GreggWStone
- aClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- bNewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York
- cImperial College of Science, Technology and Medicine, London, United Kingdom
- dDepartment of Cardiology, NUIG, National University of Ireland, Galway, Ireland
- eDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
- fDepartment of Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, the Netherlands
- gMaasstad Ziekenhuis, Rotterdam, the Netherlands
- hDepartment of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
- 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 Medical Center, Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, New York 10019.
Background Studies examining sex-related outcomes following percutaneous coronary intervention (PCI) have reported conflicting results.
Objectives The purpose of this study was to examine the sex-related risk of 5-year cardiovascular outcomes after PCI.
Methods The authors pooled patient-level data from 21 randomized PCI trials and assessed the association between sex and major adverse cardiac events (MACE) (cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]) as well as its individual components at 5 years.
Results Among 32,877 patients, 9,141 (27.8%) were women. Women were older and had higher body mass index, more frequent hypertension and diabetes, and less frequent history of surgical or percutaneous revascularization compared with men. By angiographic core laboratory analysis, lesions in women had smaller reference vessel diameter and shorter lesion length. At 5 years, women had a higher unadjusted rate of MACE (18.9% vs. 17.7%; p = 0.003), all-cause death (10.4% vs. 8.7%; p = 0.0008), cardiac death (4.9% vs. 4.0%; p = 0.003) and ID-TLR (10.9% vs. 10.2%; p = 0.02) compared with men. By multivariable analysis, female sex was an independent predictor of MACE (hazard ratio [HR:]: 1.14; 95% confidence interval [CI:]: 1.01 to 1.30; p = 0.04) and ID-TLR (HR: 1.23; 95% CI: 1.05 to 1.44; p = 0.009) but not all-cause death (HR: 0.91; 95% CI: 0.75 to 1.09; p = 0.30) or cardiac death (HR: 0.97; 95% CI: 0.73 to 1.29; p = 0.85).
Conclusions In the present large-scale, individual patient data pooled analysis of contemporary PCI trials, women had a higher risk of MACE and ID-TLR compared with men at 5 years following PCI.
This investigator-sponsored 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. Leon has received institutional grant support from Abbott, Boston Scientific, and Medtronic. Dr. Serruys has served as a consultant to 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. Smits has received institutional research grants and speaker fees from Abbott Vascular, Terumo, and St. Jude Medical. Dr. Madhavan has been 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. Maehara has received institutional grant support from Boston Scientific and Abbott; has served as a consultant to Boston Scientific and OCT Medical Imaging Inc.; and has received speaker fees from Abbott. Dr. Mehran has received institutional grant support from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo, Boston Scientific, Novartis Pharmaceuticals, and OrbusNeich; has received consulting fees from Medscape, Regeneron Pharmaceuticals (no fee), Sanofi, and Abbott Laboratories (personal fees for speaking engagements); has served as a consultant (paid to the institution) for Abiomed and The Medicines Company (spouse); has served on the Scientific Advisory Board/Advisory Board of PLx Opco Inc./PLx Pharma Inc. and Bristol-Myers Squibb (funding to the institution); has received equity (<1%) from Claret Medical and Elixir Medical; has served on the Executive Committee (paid to the institution) of Janssen Pharmaceuticals; and has served as a member of the Data Safety Monitoring Board of Watermark Research Partners. Dr. Stone has received speaker or other honoraria from Cook, Terumo, QooL Therapeutics, and Orchestra Biomed; has served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and Matrizyme; and has equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, 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. Michelle L. O'Donoghue, MD, served as Guest Editor for this paper.
- Received December 11, 2019.
- Revision received January 25, 2020.
- Accepted January 31, 2020.
- 2020 American College of Cardiology Foundation
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