Laura S Kerkmeijer1, Bimmer E Claessen2, Usman Baber3, Samantha Sartori3, Jaya Chandrasekhar3, Giulio G Stefanini4, Gregg W Stone5, P Gabriel Steg6, Alaide Chieffo7, Giora Weisz8, Stephan Windecker9, Ghada W Mikhail10, Adnan Kastrati11, Marie-Claude Morice12, George D Dangas3, Robbert J de Winter2, Roxana Mehran13. 1. AMC Heart Center, Academic Medical Center-University of Amsterdam, Amsterdam, The Netherlands; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA. 2. AMC Heart Center, Academic Medical Center-University of Amsterdam, Amsterdam, The Netherlands. 3. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA. 4. Department of Biomedical Sciences, Humanitas Universit, Rozzano-Milan, Italy. 5. Division of Cardiology, Columbia University Medical Center, New York City, NY, USA. 6. Cardiology Department, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France. 7. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. 8. Shaare Zedek Medical Center, Jeruzalem, Israel. 9. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 10. Department of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom. 11. ISAResearch Center, Deutsches Herzzentrum and Deutsches Zentrum fur Herz-Kreislauf-Forschung, partner site Munich Heart Alliance, Munich, Germany. 12. Institut Cardiovasculaire Paris Sud, Ramsay Générale de Santé, Massy, France. 13. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY, USA. Electronic address: roxana.mehran@mountsinai.org.
Abstract
BACKGROUND: Predictors and clinical outcomes of stent thrombosis (ST) in women have not been well investigated. Present study aimed to identify predictors of definite ST and its impact on mortality in women undergoing percutaneous coronary intervention (PCI). METHODS: Patient-level data of women enrolled in 26 randomized trials of DES was pooled. The study population was stratified based on the presence or absence of definite ST. Cox proportional hazards models were used to determine the predictors of definite ST. To analyze the temporal impact of definite ST on mortality Cox regression with ST entered as time-updated covariate was used. RESULTS: Of 11,557 patients undergoing PCI with stent implantation, definite ST occurred in 105 patients (0.9%) over median follow-up of 3years. Independent predictors of ST were age (HR 1.03 per year decrease, 95% CI 1.00-1.05; p=0.041), diabetes mellitus (HR 2.25, 95% CI 1.27-3.99; p=0.005), non-ST-segment elevation myocardial infarction (NSTEMI) at presentation (HR 1.97, 95% CI 1.04-3.75; p=0.037) and stent diameter (HR 3.76 per mm decrease, 95% CI 1.66-8.53; p=0.002). Compared to women without ST, the adjusted hazard ratios for mortality in the first 7days, 8-30days, and beyond 30days from ST were 115.81 (95% CI 68.96-194.47); 37.44 (95% CI 17.31-80.98); 3.54 (95% CI 2.20-5.69), respectively. CONCLUSIONS: In this large-scale pooled analysis of women, definite ST was uncommon yet associated with substantial mortality risk, which peaked early and rapidly attenuated over time. Younger age, diabetes, NSTEMI and stent diameter were found to be predictors of ST.
BACKGROUND: Predictors and clinical outcomes of stent thrombosis (ST) in women have not been well investigated. Present study aimed to identify predictors of definite ST and its impact on mortality in women undergoing percutaneous coronary intervention (PCI). METHODS:Patient-level data of women enrolled in 26 randomized trials of DES was pooled. The study population was stratified based on the presence or absence of definite ST. Cox proportional hazards models were used to determine the predictors of definite ST. To analyze the temporal impact of definite ST on mortality Cox regression with ST entered as time-updated covariate was used. RESULTS: Of 11,557 patients undergoing PCI with stent implantation, definite ST occurred in 105 patients (0.9%) over median follow-up of 3years. Independent predictors of ST were age (HR 1.03 per year decrease, 95% CI 1.00-1.05; p=0.041), diabetes mellitus (HR 2.25, 95% CI 1.27-3.99; p=0.005), non-ST-segment elevation myocardial infarction (NSTEMI) at presentation (HR 1.97, 95% CI 1.04-3.75; p=0.037) and stent diameter (HR 3.76 per mm decrease, 95% CI 1.66-8.53; p=0.002). Compared to women without ST, the adjusted hazard ratios for mortality in the first 7days, 8-30days, and beyond 30days from ST were 115.81 (95% CI 68.96-194.47); 37.44 (95% CI 17.31-80.98); 3.54 (95% CI 2.20-5.69), respectively. CONCLUSIONS: In this large-scale pooled analysis of women, definite ST was uncommon yet associated with substantial mortality risk, which peaked early and rapidly attenuated over time. Younger age, diabetes, NSTEMI and stent diameter were found to be predictors of ST.