Treatment of bifurcation lesions remains a technical challenge. Among 13 stents previously tested in a bench study, the Bestent seemed of particular interest in this indication as it provided good access to the side branch after stent implantation in the main branch associated with a satisfactory coverage of the lesion after kissing balloon inflation. The use of Bestent implanted in the main branch or both branches for treatment of bifurcation lesions involving a side branch > or = 2.2 mm in diameter was prospectively evaluated in a dual-center prospective study with a prospective 6-month clinical follow-up. All angiographic documents were analyzed by an independent corelab (CORISIS). Between 11 September 1997 and 21 February 1998, 96 patients were consecutively included (mean age, 63.7 +/- 11.4 years; 81.3% male; 58.3% with unstable angina and 6.3% acute myocardial infarction). The lesion involved the left anterior descending-diagonal coronary bifurcation in 55% of cases, left circumflex-marginal 23%, posterior descending-postero-lateral 12%, distal left main 6%, and others 4%. The main branch (proximal reference diameter: 3.43 +/- 0.45 mm) was stented in 98% of cases and the side branch (2.72 +/- 0.38 mm) in 38% (both branches in 34% of cases). T-stenting or provisional T-stenting was used in 88% of cases and final kissing balloon inflation was performed in 78% of cases. Procedural success was obtained in 100% of cases in the main branch and 98% in both branches. Major cardiac and cerebral events (MACCE) during hospitalization occurred in 4.2% of cases, non-Q-wave myocardial infarction (MI) in 3.1%, Q-wave MI in 1.0%, repeat PTCA in 2.1%; there were no major access site complication, no emergency coronary artery bypass grafting operation, no death. At 6-month follow-up, total MACCE rate was 14.6% (Q-wave MI, 3.1%; non-Q-wave MI, 3.1%; target vessel revascularization, 9.4%; death, 2.1%). Patients with target vessel revascularization (TVR) had restenosis of both branches in 22.2% of cases, main branch in 22.2%, and side branch in 55.6%. This study shows that using a simple strategy of provisional T-stenting of the side branch in the majority of cases, the Bestent can be used for treating bifurcation lesions with a high rate of success and an acceptable rate of TVR at 6-month follow-up.
Copyright 2002 Wiley-Liss, Inc.