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Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte - ALKK
Description:
The goal of the ALKK trial was to evaluate whether percutaneous transluminal coronary angioplasty (PTCA) of the infarct-related artery in stable survivors of acute myocardial infarction (MI) is associated with improved clinical outcomes compared with medical therapy.
Hypothesis:
PTCA of the infarct-related artery in stable survivors of acute MI will be associated with improved clinical outcomes compared with medical therapy.
Study Design
Study Design:
Patients Enrolled: 300
Mean Follow Up: mean 56 months
Mean Patient Age: mean age 58 years
Female: 13%
Patient Populations:
Stable patients 8-42 days after an ST elevation acute MI; MI had to be documented by typical chest pain lasting ≥30 minutes, ST elevations in ≥2 continuous ECG leads, and the development of elevations of the creatine kinase (CK) or CK-MB fraction or ≥2 new Q waves in the 12-lead ECG; significant stenosis or total occlusion of the infarct-related artery on coronary angiography with clearly identifiable infarct vessel technically feasible for PTCA or recanalization; and no or only mild angina pectoris (Canadian Cardiovascular Society [CCS] class 1 or 2)
Exclusions:
Angina pectoris CCS class 3 or 4, a stenosis >70% in another coronary artery, a coronary artery bypass graft as infarct vessel, an indication for CABG (e.g., left main stenosis, left ventricular aneurysm, or significant valve disease), or a noncardiac disease reducing life expectancy of the patient
Primary Endpoints:
Survival free of reinfarction, ischemia-driven (re)PTCA, CABG, or rehospitalization for severe angina at one year
Secondary Endpoints:
Survival, reinfarctions, and revascularization procedures during long-term follow-up; long-term survival alone was not a prespecified endpoint.
Drug/Procedures Used:
Stable patients 8-42 days after an ST elevation acute MI were randomized to angioplasty (n=149) or medical therapy (n=151).
Concomitant Medications:
100 mg aspirin and beta-blockers
Principal Findings:
The trial intended to enroll 800 patients, but was discontinued early due to slow enrollment after 300 patients were randomized. The mean time from the index MI to randomization was 18 days (range 14-28 days).
Event-free survival at one year trended lower in the medical group versus the angioplasty group (82% vs. 90%, p=0.06), primarily due to a difference in the need for (re)interventions (20 vs. 8, p=0.03). At a mean long-term follow-up of 56 months, survival was 89% and 96%, respectively (p=0.02), and survival free of reinfarction, (re)intervention, or coronary artery bypass surgery (CABG) was 66% and 80%, respectively (p=0.05). Nitrates were used significantly less frequently in the angioplasty group at one year (38% vs. 67%, p=0.001) and at long-term follow-up (36% vs. 55%, p=0.006).
Interpretation:
Among stable survivors of acute MI with single-vessel disease, treatment with PTCA 1-6 weeks following the MI was associated with a trend toward higher rates of event-free survival at one year, driven primarily by a reduction in reinterventions. Additionally, survival was significantly higher during long-term follow-up, although this was not a prespecified endpoint.
Current ACC/AHA guidelines for percutaneous coronary intervention (PCI) classify PCI in stable post-MI patients as class IIb (occluded artery) or class III (stenosis without evidence of spontaneous or provocable angina) indication. Further studies are warranted to confirm if intervention in low-risk, stable post-MI patients should be recommended.
References:
Randomized Comparison of Percutaneous Transluminal Coronary Angioplasty and Medical Therapy in Stable Survivors of Acute Myocardial Infarction With Single Vessel Disease: A Study of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte. Circulation 2003;108:1324-8.
Keywords: Coronary Artery Disease, Myocardial Infarction, Creatine Kinase, Coronary Angiography, Nitrates, Disease-Free Survival, Constriction, Pathologic, Electrocardiography, Coronary Artery Bypass, Angioplasty, Balloon, Coronary
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