Early aggressive vs. initially conservative treatment in elderly patients with non-ST-elevation acute coronary
Stefano Savonitto1, Stefano De Servi, Anna Sonia Petronio
1Angelo De Gasperis Department of Cardiology, Niguarda Ca Granda Hospital, Milan, Italy. stefano.savonitto@fastwebnet.it
Insights
Elderly patients with non-ST-elevation acute coronary syndrome (NSTEACS) benefit from an early aggressive treatment strategy, including timely coronary angiography and revascularization, leading to improved outcomes compared to a conservative approach.
Area of Science:
- Cardiology
- Geriatric Medicine
- Clinical Trials
Background:
- Elderly patients (over 74 years) constitute a significant portion of non-ST-elevation acute coronary syndrome (NSTEACS) admissions.
- This demographic exhibits higher risk and poorer outcomes but often receives less aggressive treatment due to limited evidence.
Purpose of the Study:
- To compare an early aggressive versus an initially conservative treatment strategy for elderly patients with NSTEACS.
- To enroll patients over 74 years in a multicenter randomized clinical trial (Italian Elderly ACS study).
- A registry will collect data on patients not enrolled in the trial.
Main Methods:
- Multicenter randomized clinical trial comparing early aggressive (angiography within 48h, revascularization if indicated) versus conservative (medical therapy, angiography for refractory ischemia) approaches.
- Eligible patients admitted within 48h of symptoms with ECG changes or biomarker elevation.
- Exclusion criteria include secondary ischemia, heart failure, high bleeding risk, and severe comorbidities.
Main Results:
- The primary endpoint is a composite of all-cause mortality, myocardial infarction, disabling stroke, and rehospitalization for cardiovascular diseases or severe bleeding within 6 months.
- Expected primary endpoint rates: 30% (conservative) vs. 20% (invasive).
- The study aims to enroll 700 patients from 50 centers.
Conclusions:
- The study will provide crucial evidence on the optimal treatment strategy for elderly patients with NSTEACS.
- Findings will guide clinical decision-making for this high-risk population.
- The results are expected to impact treatment guidelines and improve patient outcomes.
Background:
Elderly patients represent one-third of all admissions for non-ST-elevation acute coronary syndrome (NSTEACS) in the coronary care units. Despite their high-risk characteristics and worse outcomes, compared with younger patients, the elderly receive less aggressive treatments, also due to less clear evidence regarding the most effective treatment strategy.
Purpose:
The Italian Elderly ACS study includes patients older than 74 years of age with NSTEACS in a multicenter randomized clinical trial, comparing an early aggressive and an initially conservative approach. Patients not enrolled due to specific exclusion criteria or any other reason will be enrolled in a Registry.
Centers:
Centers with on-site interventional cathlab and centers without on-site cathlab refering patients to a cathlab within a consolidated percutaneous coronary intervention network.
Patients:
Patients admitted within 48 h of the most recent ischemic symptoms are eligible if they show transient ischemic ECG changes and/or CKMB/Tn elevation. Patients with secondary ischemia, ongoing ischemia, or heart failure, despite optimal therapy or recent coronary intervention, serum creatinine more than 2.5 mg/dl, high bleeding risk, and severe concomitant disease, are excluded from the study.
Design:
Central randomization to a systematic early aggressive approach (coronary angiography within 48 h of admission and, when indicated, coronary revascularization) or an initially conservative approach (optimal medical therapy with coronary angiography in selected cases with refractory ischemia). Follow-up will include patient visits and ECG at 30 days, 6 months, and 1 year, post randomization. PRIMARY END POINT: The composite of all-cause mortality, myocardial (re)infarction, disabling stroke, and rehospitalization for cardiovascular diseases or severe bleeding within 6 months.
Sample Size:
Expected primary end point rates of 30% in the conservative arm vs. 20% in the invasive arm. According to these estimates, with two-tailed alpha of 0.05, power will be 80, 85, or 90% with 252, 289, and 338 patients per group, respectively. The goal is to enroll 700 patients from 50 centers.
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