Several studies have shown that stent implantations in acute myocardial infarction (AMI) result in better short- and long-term outcomes than primary balloon angioplasty. These results, however, have not been ascertained in randomized trials. We randomized 136 patients out of 208 patients with AMI within 12 hr from onset into two groups: 69 patients with primary balloon angioplasty (POBA group) and 67 patients with primary stent implantation (STENT group). We compared the incidences of major cardiac events (repeat MI, target lesion revascularization, and cardiac death) and angiographic parameters during hospitalization and follow-up periods up to 12 months in these two groups. There was no significant difference in the reperfusion success rates. The incidences of major cardiac events were lower in the STENT group than in the POBA group during hospitalization, the first 6 months and 12 months (6% vs. 19%, P = 0.023; 21% vs. 46%, P < 0.0001; 22% vs. 49%, P = 0.0011). Minimum lumen diameters were significantly bigger in the STENT group than the POBA group at predischarge angiogram and 6-month follow-up (2.85 +/- 0.62 vs. 2.08 +/- 0.82 mm, P < 0.0001; 2.24 +/- 0.64 vs. 1.72 +/- 0.76, P = 0.002). Restenosis rates at 6-month follow-up were significantly lower in the STENT group than in the POBA group (17% vs. 37.5%, P = 0.02). In selected patients with AMI, primary stent implantation results in a lower incidence of major cardiac events during the first 12 months, postprocedure, and less frequent 6-month restenosis than primary balloon angioplasty.
Copyright 1999 Wiley-Liss, Inc.