Comparison of baseline characteristics, management and outcome of patients with non-ST-segment elevation acute coronary syndrome in versus not in clinical trials
Center for Outcomes Research
Medical Subject Headings
Acute Coronary Syndrome; Aged; Female; Humans; Male; Multicenter Studies as Topic; Prospective Studies; Randomized Controlled Trials as Topic; Registries; Treatment Outcome
Health Services Research
Previous studies have questioned the external validity of randomized controlled trial results of acute coronary syndrome (ACS) because of potential selection bias toward healthier patients. We sought to evaluate differences in clinical characteristics and management of patients admitted with non-ST-elevation ACS according to participation in clinical trials over the previous decade. The Canadian ACS I (1999 to 2001), ACS II (2002-2003), GRACE (2004-2007), and CANRACE (2008) were prospective, multicenter registries of patients admitted to hospitals with ACS. We examined 13,556 patients with non-ST-elevation ACS, of whom 1,126 (8.3%) participated in clinical trials. Data were collected on baseline characteristics, medication use at admission and discharge, in-hospital procedures, and in-hospital adverse events. Patients enrolled in clinical trials were younger, more likely to be men, and had fewer co-morbidities. They were significantly more likely to be on several guideline-recommended medications and were significantly more likely to undergo invasive procedures, including coronary angiography, percutaneous coronary intervention, and coronary bypass surgery (all p values <0.001). Unadjusted in-hospital (2.1% vs 0.7%, p = 0.001) and 1-year (8.9% vs 6.3%, p = 0.037) mortality rates were higher in non-enrolled patients. In multivariable analysis, patients who were older, women, had a history of heart failure, and increased creatinine levels on presentation were less likely to be enrolled into clinical trials. In conclusion, significant differences persist in baseline characteristics, treatment, and outcomes between patients enrolled and those not enrolled in clinical trials. Consequently, generalization of ACS clinical trials over the previous decade to the "real-world" patient may remain in question.
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Citation: Am J Cardiol. 2010 Nov 15;106(10):1389-96. Link to article on publisher's site
Hutchinson-Jaffe, Adam B.; Goodman, Shaun G.; Yan, Raymond T.; Wald, Ron; Elbarouni, Basem; Rose, Barry; Eagle, Kim A.; Lai, Christopher C.; Baer, Carolyn; Langer, Anatoly; Yan, Andrew T.; Canadian Global Registry of Acute Coronary Events (GRACE/GRACE 2) Investigators; and Canadian Acute Coronary Syndromes (ACS) Registry I and II Investigators, "Comparison of baseline characteristics, management and outcome of patients with non-ST-segment elevation acute coronary syndrome in versus not in clinical trials" (2010). GRACE2 (Expanded GRACE) Publications. 4.