Further information: Coronary Artery Bypass Surgery and Percutaneous Coronary Revascularization: Impact on Morbidity and Mortality in Patients with Coronary Artery Disease (see p1073) from Cardiovascular Medicine, 3rd Edn*

Results of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial were published in 2006 in The New England Journal of Medicine [1] and the trial was the longest and largest study ever conducted to evaluate the risks of dual antiplatelet therapy (DAPT) in patients who had undergone percutaneous coronary intervention with either bare metal or drug-eluting stents. The study determined that dual antiplatelet therapy (DAPT), aspirin and clopidogrel, reduced thrombotic events in patients with ST-segment elevation acute coronary syndromes and with non-ST-segment elevation acute coronary syndromes.

Two areas of uncertainly addressed by the current analysis [2] of the CHARISMA data were the amount of time DAPT should be continued in patients with known risk factors, as well as in stable patients with known vascular disease, by studying the frequency and time course of bleeding and whether bleeding is associated with mortality. Data from 15,603 patients were analyzed. Bleeding risk was found to be greatest in the first year: with clopidogrel, severe bleeding occurred in 1.7% vs. 1.3% on placebo (P=0.087), moderate bleeding occurred in 2.1% vs. 1.3%, respectively (P=0.001). Investigators found that when a patient did not have either severe or moderate bleeding the first year, bleeding thereafter was no more likely than for placebo patients. Multivariable analysis showed a strong relationship between moderate bleeding and all-cause mortality (hazard ratio [HR], 2.55; 95% confidence interval [CI], 1.71–3.80; P<0.0001), as well as with myocardial infarction (HR, 2.92; 95% CI, 2.04–4.18; P<0.0001), and stroke (HR, 4.20; 95% CI, 3.05–5.77; P<0.0001). This analysis of the CHARISMA data provides important data for the clinician as to the risks and benefits of DAPT in the treatment of stable patients or patients with vascular disease or known risk factors for vascular disease.

[1] Bhatt DL, Fox KA, Hacke W, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med 2006;354:1706-17

[2] Berger PB, Bhatt DL, Fuster V, et al. Bleeding complications with dual antiplatelet therapy among patients with stable vascular disease or risk factors for vascular disease (CHARISMA). Circulation 2010;121:2575-83

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