Stent or PTCA for Occluded Coronary Arteries in Patients With Acute MI - STOP-AMI 3
The goal of the trial was to evaluate treatment with percutaneous transluminal coronary angioplasty (PTCA) versus stenting in patients with acute myocardial infarction (MI) who were ineligible for thrombolytic therapy.
Patients Enrolled: 611
Mean Follow Up: 6 months
Mean Patient Age: Mean age 64 years
Presence of acute MI and ineligible for thrombolytic therapy, defined as the presence of ≥1 of the following: non–ST-segment elevation infarction, presentation of the patient >12 hours from onset of symptoms, and any contraindication to thrombolysis as defined previously
Presentation to hospital >48 hours after onset of pain
Myocardial salvage index (i.e., proportion of the initial myocardial perfusion defect that was salvaged by reperfusion)
Mortality through six months
Patients were randomized to stent (n=305) or PTCA (n=306). Stenting was allowed in the PTCA group if the result after conventional balloon angioplasty was not optimal. SPECT was performed at 6-8 hours and again at 7-14 days.
All patients received aspirin (500 mg) and heparin intravenously (5,000 U) prior to the procedure. Crossover from the PTCA group to stenting was permitted if suboptimal results were present after PTCA. Following the procedure, patients received aspirin (100 mg twice daily indefinitely) and ticlopidine (250 mg twice daily) or clopidogrel (75 mg) for at least four weeks.
Reason for ineligibily for thrombolytic therapy included non-ST elevation MI (42.3% in stent group and 37.9% in PTCA group), presentation >12 hours after symptom onset (39.3% and 40.8%, respectively), and contraindication (18.4% and 21.3%, respectively). Median time from symptom onset to admission was 12.7 hours and 11.5 hours, respectively. Multivessel disease was present in nearly two-thirds of patients. Stents were used in 30.4% of patients in the PTCA arm.
There was no difference in salvage index between the stent group (median 0.54) and the PTCA group (median 0.50, p=0.20). There was also no difference when analyzed per protocol by excluding patients who did not receive the randomized therapy (median 0.54 vs. 0.52, p=0.50) or when analyzed according to the actual treatment received (median 0.52 vs. 0.53, p=0.98). Final infarct size was 8.0% in the stent group and 9.4% in the PTCA group (p=0.10).
Mortality did not differ between the two groups at 30 days (5.6% in the stent group vs. 4.9% in the PTCA group, p=0.71) or six months (8.2% vs. 9.2%, p=0.69). Death or MI occurred in 10.5% in each group. There was no difference in the rate of coronary artery bypass graft (2.3% vs. 2.0%, p=0.77) or repeat percutaneous coronary intervention (8.2% vs. 10.5%, p=0.34). Major bleeding occurred in 1.3% of the stent group and 2.0% of the PTCA group (p=0.76).
Among patients with acute MI ineligible for thrombolytic therapy, there was no difference in myocardial salvage index by treatment with stent versus PTCA. The crossover rate from PTCA to stenting was relatively high in the present trial (30%). The overall salvage index was substantial in both groups, indicating the benefit of early reperfusion despite ineligibility for thrombolytic therapy. The population of patients ineligible for thrombolytic therapy represents a substantial portion of patients presenting with acute MI, but randomized trials in these patients are somewhat sparse.
In the MATE trial, which compared an invasive strategy with a medical strategy in patients with acute MI ineligible for thrombolytic therapy, there was no significant difference in outcomes between the two groups, but 37% of patients in the medical strategy arm were treated with revascularization during the index hospitalization.
Kastrati A, Mehilli J, Nekolla S, et al. A randomized trial comparing myocardial salvage achieved by coronary stenting versus balloon angioplasty in patients with acute myocardial infarction considered ineligible for reperfusion therapy. J Am Coll Cardiol 2004;43:734-41.
Keywords: Thrombolytic Therapy, Myocardial Infarction, Tomography, Emission-Computed, Single-Photon, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Stents
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