The Smoker’s Paradox RevisitedA Patient-Level Pooled Analysis of 18 Randomized Controlled Trials
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Author + information
- Mayank Yadav, MDa,
- Gary S. Mintz, MDb,
- Philippe Généreux, MDb,c,d,
- Mengdan Liu, MSb,
- Thomas McAndrew, PhDb,
- Björn Redfors, MD, PhDb,
- Mahesh V. Madhavan, MDe,
- Martin B. Leon, MDb,e and
- Gregg W. Stone, MDb,e,∗ (gs2184{at}columbia.edu), @greggwstone
- aDepartment of Medicine, Division of Cardiology, Bronx Lebanon Hospital Center, New York, New York
- bClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- cGagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey
- dHôpital du Sacré-Coeur de Montréal, Montréal, Canada
- eDepartment of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York
- ↵∗Address for correspondence:
Dr. Gregg W. Stone, Columbia University Medical Center, Cardiovascular Research Foundation, 1700 Broadway, 8th Floor, New York, New York 10019.
Central Illustration
Abstract
Objectives This study examined the smoker’s paradox using patient-level data from 18 prospective, randomized trials of patients undergoing percutaneous coronary intervention (PCI) with stent implantation.
Background Studies on the effects of smoking and outcomes among patients undergoing PCI have reported conflicting results.
Methods Data from the RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS IV and V, ENDEAVOR II to IV, SPIRIT II to IV, HORIZONS-AMI, COMPARE I and II, PLATINUM, and TWENTE I and II randomized trials were pooled. Patients were stratified by smoking status at time of enrollment. The 1- and 5-year ischemic outcomes were compared.
Results Among 24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers. Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions, more complex lesions, and more occlusions, but were less likely to have moderate or severe calcification or tortuosity. At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization). After multivariable adjustment for potential confounders, smoking was a strong independent predictor of death (hazard ratio [HR]: 1.86; 95% confidence interval [CI]: 1.63 to 2.12; p < 0.0001), cardiac death (HR: 1.68; 95% CI: 1.38 to 2.05; p < 0.0001), MI (HR: 1.38; 95% CI: 1.20 to 1.58; p < 0.0001), stent thrombosis (HR: 1.60; 95% CI: 1.28 to 1.99; p < 0.0001), and target lesion failure (HR: 1.17; 95% CI: 1.05 to 1.30; p = 0.005).
Conclusions The present large, patient-level, pooled analysis with 5-year follow-up clearly demonstrates smoking to be an important predictor of adverse outcomes after PCI.
Footnotes
This investigator-sponsored study was funded by Abbott Vascular (Santa Clara, California). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 21, 2019.
- Revision received May 16, 2019.
- Accepted June 11, 2019.
- 2019 American College of Cardiology Foundation
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