In-hospital and late results of coronary stents versus conventional balloon angioplasty in acute myocardial infarction (GRAMI trial). Gianturco-Roubin in Acute Myocardial Infarction.

One hundred four patients presenting with acute myocardial infarction < 24 hours after onset were randomized to 2 groups: group I (n = 52) was treated with balloon angioplasty followed electively with Gianturco Roubin II stents, and group II was treated with conventional balloon angioplasty alone (n = 52). All lesions were suitable for stenting. Baseline clinical, demographic, and angiographic characteristics were similar in the 2 groups. Procedural success was defined as no laboratory death or emergent coronary bypass, Thrombolysis In Myocardial Infarction (TIMI) trial 2 or 3 flow after the procedure in a culprit vessel, and a residual stenosis < or = 30% for coronary angioplasty and < 20% for stent. Procedural success was 98% in group I versus 94.2% in group II, p = NS. Thirteen patients in group II (25%) had bailout stenting during the initial procedure. Adverse in-hospital events including either death, nonelective coronary bypass, recurrent ischemia, and reinfarction occurred in 3.8% in group I versus 19.2% in group II, p = 0.03. Repeat angiography performed routinely before hospital discharge revealed TIMI 3 flow in the infarct-related artery in 98% in group I versus 83% in group II, p < 0.03. At late follow-up, event-free survival was significantly better in the stent (83%) than in the coronary angioplasty (65%) group (p = 0.002). The procedural in-hospital and late outcomes of this randomized study demonstrate that balloon angioplasty followed electively by coronary stents can be used as the primary modality for patients undergoing coronary interventions for acute myocardial infarction, increasing TIMI 3 flow, reducing in-hospital adverse events, and improving late outcome compared with balloon angioplasty alone.

RCT Entities:   Population Interventions Outcomes