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Ethnic variation in adverse cardiovascular outcomes and bleeding complications in the Clopidogrel for High
Koon-Hou Mak1, Deepak L Bhatt, Mingyuan Shao
1Gleneagles Medical Centre, Singapore, Singapore. makheart@gmail.com
Insights
Ethnicity did not predict major cardiovascular events in antiplatelet therapy trials. However, Black and Hispanic patients had higher mortality, while Black and Asian patients faced increased moderate bleeding risks.
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Health Disparities
Background:
- Atherothrombosis affects global populations, but its impact across diverse ethnic groups on evidence-based therapies remains unclear.
- Understanding ethnic variations in cardiovascular event risk and bleeding complications is crucial for personalized medicine.
Purpose of the Study:
- To investigate if ethnicity independently predicts cardiovascular events and bleeding complications in patients receiving antiplatelet therapy.
- To analyze ethnic differences in outcomes within a large contemporary clinical trial.
Main Methods:
- Prospective observational study of 15,603 patients from the CHARISMA trial.
- Median follow-up of 28 months, with primary endpoints for efficacy (cardiovascular death, myocardial infarction, stroke) and safety (bleeding).
Main Results:
- No significant difference in the primary composite cardiovascular endpoint across White, Black, Asian, and Hispanic groups.
- Black and Hispanic patients showed higher rates of cardiovascular and all-cause mortality compared to Asians.
- Asian and Black patients had a higher likelihood of moderate bleeding complications than Hispanic patients.
Conclusions:
- Ethnicity was not an independent predictor of the primary composite cardiovascular event in this antiplatelet therapy trial.
- Ethnicity significantly predicted secondary outcomes, including cardiovascular/all-cause mortality (Black and Hispanic groups) and moderate bleeding (Black and Asian groups).
Background:
Atherothrombosis is a common condition affecting individuals worldwide. Its impact on different ethnic groups receiving evidence-based therapy is unclear. We aimed to determine if ethnicity is an independent predictor for cardiovascular events and bleeding complications in a contemporary clinical trial on antiplatelet therapy.
Methods:
This was a prospective observational study of 15,603 patients enrolled in the CHARISMA trial followed up every 6 months for a median of 28 months. The primary efficacy end point was the first occurrence of cardiovascular death, myocardial infarction, or stroke. The primary safety end point was bleeding.
Results:
The cohort comprised 12,502 (80.1%) white, 486 (3.1%) black, 775 (5.0%) Asian, and 1,613 (10.3%) Hispanic patients. There was no difference in the occurrence of the primary composite end point among the 4 ethnic groups. Compared with Asians, cardiovascular and all-cause mortality occurred more frequently among black (adjusted hazard 2.19 and 2.04) and Hispanic (adjusted hazard, 1.83 and 1.69) patients. Although the occurrence of severe bleeding was similarly low among the 4 ethnic groups, Asian (adjusted hazard, 2.21) and black (adjusted hazard, 3.06) patients were more likely to have moderate bleeding complications than Hispanic patients.
Conclusion:
In this trial of individuals at risk of vascular events, ethnicity was not a significant, independent predictor of the primary composite cardiovascular event. However, ethnicity was a significant, independent predictor of the secondary outcomes, cardiovascular and all-cause mortality (blacks and Hispanics), and moderate bleeding complications (blacks and Asians).
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