Early Aggressive Versus Initially Conservative Treatment in Elderly Patients With Non–ST-Segment Elevation Acute Coronary Syndrome - Italian Elderly ACS

Sep 17, 2012
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Promoted by the Italian Society of Interventional Cardiology (SICI-GISE) and the Italian Federation of Cardiology (FIC), and endorsed by the Italian Association of the Hospital Cardiologists (ANMCO).
Date Published:
01/01/2012
Date Updated:
09/17/2012
Original Posted Date:
09/17/2012
References

Description:

The goal of the trial was to evaluate early invasive therapy versus conservative management among elderly patients with non–ST-elevation acute coronary syndrome (NSTE-ACS).

Hypothesis:

Early invasive therapy will improve outcomes.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients ≥75 years of age with NSTE-ACS, defined as dynamic electrocardiogram changes and/or elevated cardiac biomarkers

    Number of screened applicants: 645
    Number of enrollees: 313
    Duration of follow-up: 1 year
    Mean patient age: 82 years
    Percentage female: 51%

Exclusions:

  • Secondary cause of myocardial ischemia
  • Ongoing myocardial ischemia or heart failure despite optimized therapy
  • Coronary revascularization within the last 30 days
  • Recent blood transfusion, gastrointestinal, or genitourinary bleeding within the last 6 weeks
  • Thrombocytopenia
  • Ongoing anticoagulation
  • Severe obstructive lung disease
  • Malignancy
  • Neurologic deficit limiting follow-up

Primary Endpoints:

  • Death, MI, disabling stroke, or rehospitalization for cardiovascular cause

Drug/Procedures Used:

Patients ≥75 years of age with NSTE-ACS were randomized to early invasive therapy (n = 154) versus conservative management (n = 159).

Patients randomized to invasive therapy underwent coronary angiography within 72 hours and revascularization if indicated. Patients randomized to conservative management only underwent coronary angiography if they demonstrated persistent myocardial ischemia, heart failure, or ventricular arrhythmias.

Concomitant Medications:

At the time of randomization, 73% of patients were receiving aspirin, 46% clopidogrel (or ticlopidine), 8% unfractionated heparin, and 28% enoxaparin.

At discharge, 92% of patients were receiving aspirin, 76% clopidogrel (or ticlopidine), and 80% statins.

Principal Findings:

Overall, 313 patients were randomized. The mean age was 82 years, 51% were women, 38% had diabetes, mean Thrombolysis in Myocardial Infarction (TIMI) risk score was 4.3, and 64% had elevated troponin levels. Radial access was used in 71%, and glycoprotein IIb/IIIa inhibitors were used in fewer than 25% of patients who underwent percutaneous coronary intervention (PCI).

Cardiac catheterization during the initial hospitalization was performed in 88% of the early invasive group versus 29% of the conservative group. Any revascularization during the initial hospitalization was performed in 56% versus 23%, while any revascularization within 1 year was performed in 58% versus 31%, respectively, for invasive versus conservative groups.

The primary outcome of death, MI, disabling stroke, or rehospitalization for cardiovascular cause at 1 year occurred in 28% of the early invasive group versus 35% of the conservative group (p = 0.26). The primary outcome was reduced among elderly patients with an elevated troponin level: 22% versus 40% (p = 0.015), respectively, for invasive versus conservative groups.

Individual outcomes (invasive vs. conservative):
- Death: 12.3% versus 13.8%
- MI: 7.1% versus 10.7%
- Disabling stroke: 0 versus 0

Rehospitalization for cardiovascular cause or severe bleeding: 11.7% versus 13.8%
- Severe recurrent ischemia: 0 versus 2.5%
- Severe bleeding: 1.3% versus 0.6%

During the initial hospitalization, outcomes were similar except for severe recurrent ischemia, which occurred in 0.6% of the early invasive group versus 9.4% of the conservative group (p = 0.0004).

Interpretation:

Among elderly patients with NSTE-ACS, early invasive therapy failed to demonstrate clear superiority compared with conservative management in the overall studied population, although the troponin-positive patients had a significant benefit. Although this trial was underpowered to detect a difference in clinical outcomes, adverse events were numerically lower in the invasive therapy group, which is consistent with previous meta-analyses on the topic. Bleeding was quite low, which may have been due to the high use of radial access and low use of glycoprotein IIb/IIIa inhibitors.

The role of invasive therapy in elderly patients with NSTE-ACS is an important topic that deserves further study. Women with NSTE-ACS are another relatively unstudied group.

References:

Savonitto S, Cavallini C, Petronio AS, et al., on behalf of the Italian Elderly ACS Trial Investigators. Early Aggressive Versus Initially Conservative Treatment in Elderly Patients with Non–ST-Segment Elevation Acute Coronary Syndrome: A Randomized Controlled Trial. JACC Cardiovasc Interv 2012;5:906-916.

Keywords: Stroke, Acute Coronary Syndrome, Myocardial Infarction, Follow-Up Studies, Cardiac Catheterization, Electrocardiography, Percutaneous Coronary Intervention, Biomarkers, Coronary Angiography, Heart Failure, Diabetes Mellitus, Troponin, Platelet Glycoprotein GPIIb-IIIa Complex


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