The Smoker's Paradox Revisited: A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials

Mayank Yadav, Gary S. Mintz, Philippe Généreux, Mengdan Liu, Thomas McAndrew, Björn Redfors, Mahesh V. Madhavan, Martin B. Leon, Gregg W. Stone

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1941-1950
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume12
Issue number19
DOIs
StatePublished - Oct 14 2019

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Randomized Controlled Trials
Percutaneous Coronary Intervention
Smoking
Confidence Intervals
Myocardial Infarction
Stents
Thrombosis
Taxus
Hyperlipidemias
Coronary Artery Bypass
Diabetes Mellitus
Hypertension
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Yadav, Mayank ; Mintz, Gary S. ; Généreux, Philippe ; Liu, Mengdan ; McAndrew, Thomas ; Redfors, Björn ; Madhavan, Mahesh V. ; Leon, Martin B. ; Stone, Gregg W. / The Smoker's Paradox Revisited : A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials. In: JACC: Cardiovascular Interventions. 2019 ; Vol. 12, No. 19. pp. 1941-1950.
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title = "The Smoker's Paradox Revisited: A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials",
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.",
author = "Mayank Yadav and Mintz, {Gary S.} and Philippe G{\'e}n{\'e}reux and Mengdan Liu and Thomas McAndrew and Bj{\"o}rn Redfors and Madhavan, {Mahesh V.} and Leon, {Martin B.} and Stone, {Gregg W.}",
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Yadav, M, Mintz, GS, Généreux, P, Liu, M, McAndrew, T, Redfors, B, Madhavan, MV, Leon, MB & Stone, GW 2019, 'The Smoker's Paradox Revisited: A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials', JACC: Cardiovascular Interventions, vol. 12, no. 19, pp. 1941-1950. https://doi.org/10.1016/j.jcin.2019.06.034

The Smoker's Paradox Revisited : A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials. / Yadav, Mayank; Mintz, Gary S.; Généreux, Philippe; Liu, Mengdan; McAndrew, Thomas; Redfors, Björn; Madhavan, Mahesh V.; Leon, Martin B.; Stone, Gregg W.

In: JACC: Cardiovascular Interventions, Vol. 12, No. 19, 14.10.2019, p. 1941-1950.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The Smoker's Paradox Revisited

T2 - A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials

AU - Yadav, Mayank

AU - Mintz, Gary S.

AU - Généreux, Philippe

AU - Liu, Mengdan

AU - McAndrew, Thomas

AU - Redfors, Björn

AU - Madhavan, Mahesh V.

AU - Leon, Martin B.

AU - Stone, Gregg W.

PY - 2019/10/14

Y1 - 2019/10/14

N2 - 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.

AB - 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.

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