Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary
Hironori Hara1, Kuniaki Takahashi1, Norihiro Kogame1
1Department of Cardiology, Academic Medical Center, University of Amsterdam, the Netherlands (H.H., K.T., N.K., L.S.M.K., M.O., H.K. J.J.W., R.J.d.W.).
Insights
Bleeding and myocardial infarction (MI) after percutaneous coronary intervention significantly increase mortality risk, even beyond one year. Repeated events or combined bleeding and MI lead to poorer outcomes, highlighting the need for careful management of antiplatelet therapy.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Bleeding and myocardial infarction (MI) are independent risk factors for mortality following percutaneous coronary intervention (PCI).
- Understanding the impact of individual, repeated, or combined bleeding and MI events on mortality is crucial for patient outcomes.
Purpose of the Study:
- To investigate the association between site-reported bleeding and MI, as individual or repeated events, and all-cause mortality after PCI.
- To evaluate the long-term impact of bleeding and MI on mortality post-PCI.
Main Methods:
- Utilized data from the GLOBAL LEADERS trial, including 15,968 patients undergoing PCI.
- Defined bleeding as Bleeding Academic Research Consortium (BARC) 2, 3, or 5, and MI according to the Third Universal Definition (periprocedural and spontaneous).
Main Results:
- At 2-year follow-up, bleeding occurred in 6.64% and MI in 3.12% of patients.
- Patients experiencing bleeding or MI had significantly higher mortality rates (10.8% and 10.4%, respectively) compared to the overall mortality of 2.99%.
- Repeated bleeding or MI events, or both, were associated with substantially increased 2-year mortality (HRs ranging from 5.57 to 8.58).
Conclusions:
- The fatal impact of bleeding and MI persists beyond one year post-PCI, with cumulative events worsening prognosis.
- De-escalation of antiplatelet therapy following BARC 3 bleeding showed a significant reduction in subsequent bleeding or MI events.
- These findings underscore the importance of assessing net clinical benefit, balancing ischemic and bleeding risks in PCI patients.
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.
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