Coronary stenting beyond standard indications. Immediate and follow-up results.

ABSTRACT

BACKGROUND: Coronary stent has become an accepted treatment modality for selected indications. However, the literature shows diverse results when indications for coronary stenting are different from those tested in large randomized trials. The purpose of this study was to determine immediate and follow-up clinical and angiographic results in patients treated with coronary stenting for indications not specifically tested in large randomized trials. METHODS: Coronary stents were implanted in a total of 2060 lesions (1757 patients) in seven groups with expanded indications left main coronary lesions, calcified lesions, small vessels (< 3 mm in size), small vessels with diffuse disease, large vessels with diffuse disease, and bifurcation lesions treated with stents in both branches or with one stent implanted only in the major branch. Stents were implanted using high balloon pressure for final inflation and in most cases with intravascular ultrasound. Clinical follow-up was achieved in 96% of patients at a mean time of 12+/-7 months. RESULTS: Primary success (range 89-96%) and acute complications (range 5.7-13%) were comparable in all groups. At follow-up, the mortality rate was highest in the group of left main stenting (12.5%) but 20% of these patients had coronary stenting on non-elective basis. The restenosis rates ranged between 16-43%. The restenosis rate was highest in the group of bifurcation lesions with stent implantation in both vessels leading to a major adverse cardiac event (MACE) rate of 62% in this group. However, the survival rate at 1 and 2 years in the overall study group was 97 and 96%, and the event free survival was 76 and 74%, respectively. The procedure-related predictors of MACE were final intravascular ultrasound result, use of stents with non-slotted tube morphology, final stent percent stenosis, and vessel size. CONCLUSIONS: Coronary stenting beyond standard indications is feasible, with acceptable primary success and complication rates. However, the overall MACE rates were relatively high (34-62%), in particular for the indication of bifurcation lesions with stents implanted in both vessels.