Document Detail

Ethnic variation in adverse cardiovascular outcomes and bleeding complications in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) study.
MedLine Citation:
PMID:  19332192     Owner:  NLM     Status:  MEDLINE    
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).
Koon-Hou Mak; Deepak L Bhatt; Mingyuan Shao; Graeme J Hankey; J Donald Easton; Keith A A Fox; Eric J Topol
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2008-11-06
Journal Detail:
Title:  American heart journal     Volume:  157     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-03-31     Completed Date:  2009-04-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  658-65     Citation Subset:  AIM; IM    
Gleneagles Medical Centre, Singapore, Singapore.
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MeSH Terms
Atherosclerosis / drug therapy*,  ethnology
Cause of Death / trends
Double-Blind Method
Ethnic Groups*
Follow-Up Studies
Hemorrhage / ethnology*,  etiology
Middle Aged
Myocardial Ischemia / ethnology*,  etiology
Platelet Aggregation Inhibitors / adverse effects*,  therapeutic use
Prospective Studies
Risk Factors
Stroke / ethnology*,  etiology
Ticlopidine / adverse effects,  analogs & derivatives*,  therapeutic use
Time Factors
United States
Reg. No./Substance:
0/Platelet Aggregation Inhibitors; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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