Trends in Enrollment, Clinical Characteristics, Treatment, and Outcomes According to Age in Non–ST-Segment–Elevation Acute Coronary Syndromes Clinical Trials

Abstract

Background Representation by age ensures appropriate translation of clinical trial results to practice, but historically, older patients were underrepresented in clinical trial populations. As the general population has aged, it is unknown whether clinical trial enrollment has changed in parallel. Methods and Results We studied time trends in enrollment, clinical characteristics, treatment, and outcomes by age among 76,141 NSTE ACS patients enrolled in 11 phase III clinical trials over 17 years (1994–2010). Overall, 19.7% of patients were ≥75 years; this proportion increased from 16% during 1994–1997 to 21% during 1998–2001 and 23.2% during 2002–2005, but declined to 20.2% in 2006–2010. The number of comorbidities increased with successive time periods irrespective of age. There were substantial increases in use of evidence-based medication in-hospital and at discharge regardless of age. While predicted 6-month mortality increased slightly over time, observed 6-month mortality declined significantly in all age strata (1994–1997 vs. 2006–2010: <65 years: 3.0% vs. 1.9%; 65–74 years: 7.5% vs. 3.4%; 75–79 years: 13.0% vs. 6.5%; 80–84 years: 17.6% vs. 8.2%; and ≥85 years: 24.8% vs. 12.6%). Conclusions The distribution of enrollment by age in phase III NSTE ACS trials was unchanged over time. Irrespective of age, post-myocardial infarction mortality decreased significantly over time, concurrent with increased evidence-based care and despite increasing comorbidities. Clinical Trial Registration Information ClinicalTrials.gov. Identifier: NCT00089895.

Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease

“…One study of 194 randomized controlled trials cited in American Heart Association guidelines for acute coronary syndromes found that the mean age of participants was 61, with 18% of trials attaining a mean participant age of 65 and older and none with a mean age of 75 and older . Another study examining 11 Phase III clinical trials of individuals with non‐ST‐segment‐elevation acute coronary syndrome between 1994 and 2010 revealed that 53% of participants were aged 65 and older and that only 20% were aged 75 and older . The current study adds to these findings by examining 839 randomized controlled trials conducted over the past 10 years and addressing the wide spectrum of IHD.…”

“…16 Another study examining 11 Phase III clinical trials of individuals with non-STsegment-elevation acute coronary syndrome between 1994 and 2010 revealed that 53% of participants were aged 65 and older and that only 20% were aged 75 and older. 15 The current study adds to these findings by examining 839 randomized controlled trials conducted over the past 10 years and addressing the wide spectrum of IHD. It provides new data indicating that elderly adults continue to be excluded from the most rigorous clinical studies-randomized controlled trials-and that this practice has the greatest impact on the clinical evidence available to guide care for individuals aged 75 and older.…”

“…Age‐specific pathophysiological processes and unique features of disease management in elderly adults require treatment decisions that are carefully made for this population . A number of trials examining cardiovascular disease over the past decade have specifically focused on the study of elderly persons, but many trials—including those influencing current treatment guidelines—study primarily younger individuals . Quantifying this gap and identifying the types of trials most likely to exclude elderly adults may inform policies addressing research needs.…”

“…13,14 A number of trials examining cardiovascular disease over the past decade have specifically focused on the study of elderly persons, but many trials-including those influencing current treatment guidelines-study primarily younger individuals. 13,15,16 Quantifying this gap and identifying the types of trials most likely to exclude elderly adults may inform policies addressing research needs. The aim was to measure the extent to which elderly persons are excluded from randomized trials studying drug interventions for IHD and describe the characteristics of these trials.…”

Invasive Management Strategies and Antithrombotic Treatments in Patients With Non–ST-Segment–Elevation Acute Coronary Syndrome in China

“…[20][21][22] One explanation for the longer hospital stay in China is that a much smaller proportion of patients underwent early PCI than in the US or European countries, 45.0% of patients undergoing PCI ≥3 days after admission. Moreover, the lack of appropriate rehabilitation or implementation of secondary prevention measures after hospital discharge for patients with NSTE-ACS may have contributed to prolonged hospital stays.…”