Fifty-six patients treated with the self-expanding intracoronary stent for acute occlusion during percutaneous transluminal coronary angioplasty (PTCA) or restenosis were followed for 24 to 43 months (mean 34). Successful deployment and positioning were achieved in 55 of 56 patients. Occlusion of the stent was documented in 8 patients, the earliest occurring 30 minutes and the latest 8 months after implantation. Three of the occluded stents were recanalized by PTCA. Coronary artery bypass grafts (CABG) were required in 4 patients: 1 for symptomatic restenosis, 1 for left main stenosis adjacent to the stent and 2 for acute ischemia during the in-hospital stay (less than 7 days). Myocardial infarction occurred in the territory of the stented vessel in 8 patients. Seven patients died between 1 day and 19 months after implantation. Local bleeding complications occurred in 10 patients, with 5 requiring blood transfusion. Restenosis within the stent was angiographically documented in 5 patients (9%). A new lesion in the treated vessel was found in 10 patients, followed by implantation of a second stent in 5 and a third stent in 1 patient. Medical treatment was instituted in the remaining 4 patients. Forty-nine patients (88%) are alive. Twenty-nine patients (51%) remained asymptomatic, and 44 (78%) are in a better functional class than before the implantation. Eleven of 15 (79%) major complications (acute occlusions or deaths) occurred in patients who received a stent in the left anterior descending coronary artery. In conclusion, implantation of the self-expanding intracoronary stent appears to be a new therapeutic option for treating acute occlusion or restenosis after PTCA.(ABSTRACT TRUNCATED AT 250 WORDS)