Abstract
Introduction: Whereas individuals aged ≥75 years account for >1/3 of non-ST-segment elevation (NSTE) ACS episodes and the majority of deaths due to NSTE ACS in current practice, little is known about their participation in NSTE ACS clinical trials. Methods: We studied 79,133 NSTE ACS patients enrolled in 11 phase III clinical trials (GUSTO IIb, PURSUIT, PARAGON-A, PARAGON-B, PRISM, PRISM-PLUS, GUSTO IV-ACS, SYNERGY, EARLY ACS, TRACER, APPRAISE-2) during 5 time periods (1994-97, 1998-01, 2002-05, 2006-10) over 17 years. We characterized the population according to age, patient characteristics, medical therapy, and outcomes (severe bleeding, 30-day mortality, 6-month mortality, 30-day composite of death or MI) and examined changes in these parameters over time. Results: Overall, 19.7% of patients enrolled in the selected trials were aged ≥75 years; while this proportion increased during the 1998-01 and 2002-05 periods, it declined in 2006-10 (Table). The prevalence of comorbidities varied (Table). Use of evidence-based medications at discharge among patients aged ≥75 years increased overall (aspirin 66.6 to 93.5%; beta-blockers 40.9 to 78.2%; thienopyridines 5.8 to 76.9%, lipid-lowering drugs 8.0 to 83.4%, ACE inhibitors 24.6 to 62.6% in 1994-97 to 2006-10). 30-day and 6-month mortality consistently declined. During the interval between 1994-97 and 2006-10, severe bleeding and the 30-day composite of death or MI for patients aged ≥75 years declined overall (2.0% to 1.6% for severe bleeding, and 17.6% to 9.3% for composite of 30-day death or MI). Conclusions: Despite significant improvements in clinical care and outcomes among patients aged ≥75 years, their enrollment in NSTE ACS clinical trials is not representative of the NSTE ACS population. Representative enrollment of elderly patients in clinical trials constitutes a critical unmet need to advance their evidence-based care and apply more novel approaches to lower morbidity and mortality.
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