Mortality following cardiovascular and bleeding events occurring beyond 1 year after coronary stenting

A secondary analysis of the Dual Antiplatelet Therapy (DAPT) Study

Dual Antiplatelet Therapy (DAPT) Study Investigators

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective: To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participants: This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Results: Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1%female)were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9%) died. The annualized mortality rate after an ischemic event was 27.2 (95%CI, 20.3-35.7) per 100 person-years. The cumulative incidence of death after an ischemic event among the total randomized study population was 0.5%(0.3% with myocardial infarction,0.1% with stent thrombosis, and 0.1% with ischemic stroke). Among individuals with bleeding events, 41 (17.7%) died. The annualized mortality rate after a bleeding event was 21.5 (95%CI, 15.4-29.1) per 100 person-years. The cumulative incidence of death after a bleeding event among the total randomized study population was 0.3%(0.1% with moderate and 0.2% with severe bleeding). Conclusions and Relevance: In patients treated with dual antiplatelet therapy for at least 1 year after coronary stenting, ischemic events were more frequent than bleeding events, and both events were associated with high risk of mortality.

Original languageEnglish (US)
Pages (from-to)478-487
Number of pages10
JournalJAMA Cardiology
Volume2
Issue number5
DOIs
StatePublished - May 1 2017

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Hemorrhage
Mortality
Stents
Thrombosis
Therapeutics
Stroke
Myocardial Infarction
Aspirin
Random Allocation
Streptokinase
Incidence
Tissue Plasminogen Activator
Population
Arteries
Placebos
Outcome Assessment (Health Care)
Morbidity

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Mortality following cardiovascular and bleeding events occurring beyond 1 year after coronary stenting : A secondary analysis of the Dual Antiplatelet Therapy (DAPT) Study. / Dual Antiplatelet Therapy (DAPT) Study Investigators.

In: JAMA Cardiology, Vol. 2, No. 5, 01.05.2017, p. 478-487.

Research output: Contribution to journalArticle

@article{90f43cd58cbb45b39d3800c36323ea22,
title = "Mortality following cardiovascular and bleeding events occurring beyond 1 year after coronary stenting: A secondary analysis of the Dual Antiplatelet Therapy (DAPT) Study",
abstract = "Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective: To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participants: This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Results: Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1{\%}female)were randomized. After randomization, 478 individuals (4.1{\%}) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0{\%}) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9{\%}) died. The annualized mortality rate after an ischemic event was 27.2 (95{\%}CI, 20.3-35.7) per 100 person-years. The cumulative incidence of death after an ischemic event among the total randomized study population was 0.5{\%}(0.3{\%} with myocardial infarction,0.1{\%} with stent thrombosis, and 0.1{\%} with ischemic stroke). Among individuals with bleeding events, 41 (17.7{\%}) died. The annualized mortality rate after a bleeding event was 21.5 (95{\%}CI, 15.4-29.1) per 100 person-years. The cumulative incidence of death after a bleeding event among the total randomized study population was 0.3{\%}(0.1{\%} with moderate and 0.2{\%} with severe bleeding). Conclusions and Relevance: In patients treated with dual antiplatelet therapy for at least 1 year after coronary stenting, ischemic events were more frequent than bleeding events, and both events were associated with high risk of mortality.",
author = "{Dual Antiplatelet Therapy (DAPT) Study Investigators} and Secemsky, {Eric A.} and Yeh, {Robert W.} and Kereiakes, {Dean J.} and Cutlip, {Donald E.} and Cohen, {David J.} and Steg, {P. Gabriel} and Cannon, {Christopher P.} and Apruzzese, {Patricia K.} and D'Agostino, {Ralph B.} and Massaro, {Joseph M.} and Laura Mauri and Aaron Kaplan and Abdel Ahmed and Ahmed, {Abdel Hamid} and Abdulhay Albirini and Abel Moreyra and Abram Rabinowitz and Adhir Shroff and Alan Moak and Alice Jacobs and Ameer Kabour and Amit Gupta and Anand Irimpen and Andrew Rosenthal and Andrew Taussig and Angelo Ferraro and Anil Chhabra and Anthony Pucillo and Anthony Spaedy and Anthony White and Antonis Pratsos and Arif Shakir and Arnold Ghitis and Arvind Agarwal and Ash Jain and Atul Chawla and Aylmer Tang and Barbara Barker and Barry Bertolet and Barry Uretsky and Bernard Erickson and Bhola Rama and Brent McLaurin and Brian Dearing and Brian Negus and Brian Price and Brigitta Brott and Brijesh Bhambi and Bruce Bowers and Patricia Best",
year = "2017",
month = "5",
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doi = "10.1001/jamacardio.2017.0063",
language = "English (US)",
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TY - JOUR

T1 - Mortality following cardiovascular and bleeding events occurring beyond 1 year after coronary stenting

T2 - A secondary analysis of the Dual Antiplatelet Therapy (DAPT) Study

AU - Dual Antiplatelet Therapy (DAPT) Study Investigators

AU - Secemsky, Eric A.

AU - Yeh, Robert W.

AU - Kereiakes, Dean J.

AU - Cutlip, Donald E.

AU - Cohen, David J.

AU - Steg, P. Gabriel

AU - Cannon, Christopher P.

AU - Apruzzese, Patricia K.

AU - D'Agostino, Ralph B.

AU - Massaro, Joseph M.

AU - Mauri, Laura

AU - Kaplan, Aaron

AU - Ahmed, Abdel

AU - Ahmed, Abdel Hamid

AU - Albirini, Abdulhay

AU - Moreyra, Abel

AU - Rabinowitz, Abram

AU - Shroff, Adhir

AU - Moak, Alan

AU - Jacobs, Alice

AU - Kabour, Ameer

AU - Gupta, Amit

AU - Irimpen, Anand

AU - Rosenthal, Andrew

AU - Taussig, Andrew

AU - Ferraro, Angelo

AU - Chhabra, Anil

AU - Pucillo, Anthony

AU - Spaedy, Anthony

AU - White, Anthony

AU - Pratsos, Antonis

AU - Shakir, Arif

AU - Ghitis, Arnold

AU - Agarwal, Arvind

AU - Jain, Ash

AU - Chawla, Atul

AU - Tang, Aylmer

AU - Barker, Barbara

AU - Bertolet, Barry

AU - Uretsky, Barry

AU - Erickson, Bernard

AU - Rama, Bhola

AU - McLaurin, Brent

AU - Dearing, Brian

AU - Negus, Brian

AU - Price, Brian

AU - Brott, Brigitta

AU - Bhambi, Brijesh

AU - Bowers, Bruce

AU - Best, Patricia

PY - 2017/5/1

Y1 - 2017/5/1

N2 - Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective: To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participants: This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Results: Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1%female)were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9%) died. The annualized mortality rate after an ischemic event was 27.2 (95%CI, 20.3-35.7) per 100 person-years. The cumulative incidence of death after an ischemic event among the total randomized study population was 0.5%(0.3% with myocardial infarction,0.1% with stent thrombosis, and 0.1% with ischemic stroke). Among individuals with bleeding events, 41 (17.7%) died. The annualized mortality rate after a bleeding event was 21.5 (95%CI, 15.4-29.1) per 100 person-years. The cumulative incidence of death after a bleeding event among the total randomized study population was 0.3%(0.1% with moderate and 0.2% with severe bleeding). Conclusions and Relevance: In patients treated with dual antiplatelet therapy for at least 1 year after coronary stenting, ischemic events were more frequent than bleeding events, and both events were associated with high risk of mortality.

AB - Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective: To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participants: This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Results: Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1%female)were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9%) died. The annualized mortality rate after an ischemic event was 27.2 (95%CI, 20.3-35.7) per 100 person-years. The cumulative incidence of death after an ischemic event among the total randomized study population was 0.5%(0.3% with myocardial infarction,0.1% with stent thrombosis, and 0.1% with ischemic stroke). Among individuals with bleeding events, 41 (17.7%) died. The annualized mortality rate after a bleeding event was 21.5 (95%CI, 15.4-29.1) per 100 person-years. The cumulative incidence of death after a bleeding event among the total randomized study population was 0.3%(0.1% with moderate and 0.2% with severe bleeding). Conclusions and Relevance: In patients treated with dual antiplatelet therapy for at least 1 year after coronary stenting, ischemic events were more frequent than bleeding events, and both events were associated with high risk of mortality.

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