Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention.
Options
BORIS DOI
Publisher DOI
PubMed ID
32838554
Description
BACKGROUND
Bleeding and myocardial infarction (MI) after percutaneous coronary intervention are independent risk factors for mortality. This study aimed to investigate the association of all-cause mortality after percutaneous coronary intervention with site-reported bleeding and MI, when considered as individual, repeated, or combined events.
METHODS
We used the data from the GLOBAL LEADERS trial (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-Platelet Therapy After Stent Implantation), an all-comers trial of 15 968 patients undergoing percutaneous coronary intervention. Bleeding was defined as Bleeding Academic Research Consortium (BARC) 2, 3, or 5, whereas MI included periprocedural and spontaneous MIs according to the Third Universal Definition.
RESULTS
At 2-year follow-up, 1061 and 498 patients (6.64% and 3.12%) experienced bleeding and MI, respectively. Patients with a bleeding event had a 10.8% mortality (hazard ratio [HR], 5.97 [95% CI, 4.76-7.49]; P<0.001), and the mortality of patients with an MI was 10.4% (HR, 5.06 [95% CI, 3.72-6.90]; P<0.001), whereas the overall mortality was 2.99%. Albeit reduced over time, MI and even minor BARC 2 bleeding significantly influenced mortality beyond 1 year after adverse events (HR of MI, 2.32 [95% CI, 1.18-4.55]; P=0.014, and HR of BARC 2 bleeding, 1.79 [95% CI, 1.02-3.15]; P=0.044). The mortality rates in patients with repetitive bleeding, repetitive MI, and both bleeding and MI were 16.1%, 19.2%, and 19.0%, and their HRs for 2-year mortality were 8.58 (95% CI, 5.63-13.09; P<0.001), 5.57 (95% CI, 2.53-12.25; P<0.001), and 6.60 (95% CI, 3.44-12.65; P<0.001), respectively. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding was associated with a lower subsequent bleeding or MI rate, compared with continuation of antiplatelet therapy (HR, 0.32 [95% CI, 0.11-0.92]; P=0.034).
CONCLUSIONS
The fatal impact of bleeding and MI persisted beyond one year. Additional bleeding or MIs resulted in a poorer prognosis. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding could have a major safety merit. These results emphasize the importance of considering the net clinical benefit including ischemic and bleeding events. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01813435.
Bleeding and myocardial infarction (MI) after percutaneous coronary intervention are independent risk factors for mortality. This study aimed to investigate the association of all-cause mortality after percutaneous coronary intervention with site-reported bleeding and MI, when considered as individual, repeated, or combined events.
METHODS
We used the data from the GLOBAL LEADERS trial (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-Platelet Therapy After Stent Implantation), an all-comers trial of 15 968 patients undergoing percutaneous coronary intervention. Bleeding was defined as Bleeding Academic Research Consortium (BARC) 2, 3, or 5, whereas MI included periprocedural and spontaneous MIs according to the Third Universal Definition.
RESULTS
At 2-year follow-up, 1061 and 498 patients (6.64% and 3.12%) experienced bleeding and MI, respectively. Patients with a bleeding event had a 10.8% mortality (hazard ratio [HR], 5.97 [95% CI, 4.76-7.49]; P<0.001), and the mortality of patients with an MI was 10.4% (HR, 5.06 [95% CI, 3.72-6.90]; P<0.001), whereas the overall mortality was 2.99%. Albeit reduced over time, MI and even minor BARC 2 bleeding significantly influenced mortality beyond 1 year after adverse events (HR of MI, 2.32 [95% CI, 1.18-4.55]; P=0.014, and HR of BARC 2 bleeding, 1.79 [95% CI, 1.02-3.15]; P=0.044). The mortality rates in patients with repetitive bleeding, repetitive MI, and both bleeding and MI were 16.1%, 19.2%, and 19.0%, and their HRs for 2-year mortality were 8.58 (95% CI, 5.63-13.09; P<0.001), 5.57 (95% CI, 2.53-12.25; P<0.001), and 6.60 (95% CI, 3.44-12.65; P<0.001), respectively. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding was associated with a lower subsequent bleeding or MI rate, compared with continuation of antiplatelet therapy (HR, 0.32 [95% CI, 0.11-0.92]; P=0.034).
CONCLUSIONS
The fatal impact of bleeding and MI persisted beyond one year. Additional bleeding or MIs resulted in a poorer prognosis. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding could have a major safety merit. These results emphasize the importance of considering the net clinical benefit including ischemic and bleeding events. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01813435.
Date of Publication
2020-09
Publication Type
Article
Subject(s)
Keyword(s)
bleeding myocardial infarction
Language(s)
en
Contributor(s)
Hara, Hironori | |
Takahashi, Kuniaki | |
Kogame, Norihiro | |
Tomaniak, Mariusz | |
Kerkmeijer, Laura S M | |
Ono, Masafumi | |
Kawashima, Hideyuki | |
Wang, Rutao | |
Gao, Chao | |
Wykrzykowska, Joanna J | |
de Winter, Robbert J | |
Neumann, Franz-Josef | |
Plante, Sylvain | |
Lemos Neto, Pedro Alves | |
Garg, Scot | |
Jüni, Peter | |
Vranckx, Pascal | |
Hamm, Christian | |
Steg, Philippe Gabriel | |
Onuma, Yoshinobu | |
Serruys, Patrick W |
Additional Credits
Series
Circulation. Cardiovascular interventions
Publisher
American Heart Association
ISSN
1941-7632
Access(Rights)
restricted