Objectives: The goal of this study was to evaluate the safety and performance of the Multi-Link Frontier coronary bifurcation stent system (Guidant Corp., Santa Clara, California), a novel dedicated device designed for permanent side branch (SB) access, stent delivery by simultaneous kissing balloon inflation, and optimal main branch (MB) and SB ostium scaffolding.
Background: The treatment of coronary bifurcation lesions remains challenging, and various approaches using stents have been proposed.
Methods: The primary end point was the 180-day incidence of major adverse cardiac events (MACE) per intent-to-treat analysis. Secondary end points included device success, 30-day MACE, angiographic restenosis, and target lesion revascularization (TLR) rates at 180 days.
Results: After a learning phase of two cases per center, 105 patients were prospectively included in 11 centers. The left anterior descending coronary artery/diagonal bifurcation was the target in 80% of cases. The Frontier stent was successfully implanted in 96 patients (91%), and procedural success was obtained in 93%. Two patients suffered in-hospital myocardial infarction (MI) secondary to SB occlusion, and one patient underwent elective coronary artery bypass grafting. At 30 days and 6 months, the MACE rates were 2.9% and 17.1% (no death, no subacute stent thrombosis, Q-wave MI 1.0% and 1.9%, non-Q-wave MI 1.0% and 1.9%, TLR 1.0% and 13.3%). The MB in-stent restenosis was 25.3%, in-segment 29.9%. The SB restenosis was 29.1%. The overall restenosis rate for any branch was 44.8%.
Conclusions: The results of this Frontier registry demonstrate the safety and performance of this dedicated stent system for the treatment of bifurcation lesions. The device can be successfully implanted in more than 90% of all cases, with a high procedural success rate and low 30-day and 6-month MACE rates.