The Efficacy and Safety of PRO-Kinetic Metal Alloy Stent in Hospitalized Patients with Acute ST-Elevation Myocardial Infarction (The PROMETHEUS Study)

Abstract

Background. We evaluated the clinical and angiographic outcomes of silicon carbide-coated cobalt chromium PRO-Kinetic bare-metal stent in patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI). Methods. Patients with acute STEMI (2.75-5.00 mm vessels; lesion length <= 30 mm by visual estimation) were treated with PRO-Kinetic stents at 5 centers in Korea. The primary endpoint was the rate of major adverse cardiac events (MACE), defined as all-cause death, new myocardial infarction, and target lesion revascularization (TLR) at 6-month follow-up. Follow-up angiography was recommended after the completion of the 6-month clinical follow-up. Results. A total of 64 patients (56.6 +/- 12.9 years old, 56 male) were enrolled in the study. Procedural success was achieved in 100% of the lesions. The mean stent size was 3.51 +/- 0.67 mm and the mean stent length was 20.3 +/- 4.4 mm. There was 1 case of in-hospital death due to cardiac tamponade. During the 6-month clinical follow-up, 4 patients (6.3%) received TLR. Therefore, the total rate of MACE was 7.8%. Angiographic follow-up data were available for 42 patients (65.6%) and the in-stent late lumen loss was 1.02 +/- 0.62 mm and in-segment late lumen loss was 0.99 +/- 0.64 mm. Binary restenosis occurred in 53% of reference vessel diameters (RVDs) <= 3.0 mm, 25% of RVDs between 3.0 and 3.5 mm, and 0% of RVDs >3.5 mm (P=.006). Conclusions. The use of the PRO-Kinetic stent seems to be safe and feasible in primary PCI for acute STEMI, and shows favorable clinical and angiographic outcomes in large (>3.0 mm) coronary arteries, but not in small arteries.