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 - Gupta, Saurabh
N1 - Funding Information:
completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Yeh reported receiving research grant funding from Abiomed and Boston Scientific and reported serving on an advisory board for or as a consultant to Abbott and Boston Scientific. Dr Kereiakes reported receiving research funding from and serving as a consultant to Abbott Vascular, Boston Scientific, and Sanofi. Dr Cutlip reported receiving grant funding from Medtronic, Boston Scientific, and CeloNova. Dr Cohen reported receiving grant funding and personal fees from Medtronic and AstraZeneca and reported receiving grant funding from Abbott Vascular, Eli Lilly, and Daiichi Sankyo. Dr Steg reported receiving research grant funding from Merck, Sanofi, and Servier and reported receiving speaking or consulting fees from Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CSL Behring, Daiichi Sankyo, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and The Medicines Company. Dr Cannon reported receiving grant funding and personal fees from Arisaph, Boehringer Ingelheim, Merck, Takeda, Amgen, and Bristol-Myers Squibb; reported receiving personal fees from AstraZeneca, GlaxoSmithKline, Lipimedix, Pfizer, Sanofi, Regeneron, Kowa, and Alnylam; and reported receiving grant funding from Janssen and Daiichi Sankyo (all outside of the submitted work). Dr Massaro reported receiving personal fees from the Harvard Clinical Research Institute. During the conduct of the study, Dr Mauri reported receiving grant funding from Abbott, Boston Scientific, Cordis, Medtronic, Eli Lilly/Daiichi Sankyo, and Sanofi/Bristol-Myers Squibb. Outside of the submitted work, Dr Mauri reported receiving consulting fees from Amgen and St Jude Medical; reported serving on the steering committee for Biotronik and Corvia; reported being a lecturer for AstraZeneca, Sanofi, and Daiichi Sankyo; and reported being an investigator for Boehringer Ingelheim and ReCor. No other disclosures were reported.
Funding Information:
Funding/Support: This analysis was sponsored by
Funding Information:
the Harvard Clinical Research Institute; by grant K23 HL 118138 from the National Heart, Lung, and Blood Institute (Dr Yeh); and by grant 1R01FD003870-01 from the US Department of Health and Human Services. Eight stent and pharmaceutical manufacturers who contributed to the funding of the Dual Antiplatelet Therapy (DAPT) Study included Abbott Vascular (Xience everolimus-eluting stent), Boston Scientific (TAXUS paclitaxel-eluting and PROMUS everolimus-eluting stents), Cordis (Cypher sirolimus-eluting stent), Medtronic (Endeavor zotarolimus-eluting stent), Bristol-Myers Squibb, Sanofi, Eli Lilly, and Daiichi Sankyo.
PY - 2017/5
Y1 - 2017/5
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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U2 - 10.1001/jamacardio.2017.0063
DO - 10.1001/jamacardio.2017.0063
M3 - Article
C2 - 28297015
AN - SCOPUS:85024386820
VL - 2
SP - 478
EP - 487
JO - JAMA Cardiology
JF - JAMA Cardiology
SN - 2380-6583
IS - 5
ER -