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CLINICAL RESEARCH: FOCUS ISSUE: TREATMENT OF BIFURCATION LESIONS

The FRONTIER Stent Registry

Safety and Feasibility of a Novel Dedicated Stent for the Treatment of Bifurcation Coronary Artery Lesions

Thierry Lefèvre, MD^_*,_*, John Ormiston, MD, Giulio Guagliumi, MD, Heinz-Peter Schultheiss, MD, Laurent Quilliet, MD^||, Bernhard Reimers, MD^¶, Philippe Brunel, MD^#, Williams Wijns, MD^**, H.J. Buettner, MD, F. Hartmann, MD, Susan Veldhof, RN, Karin Miquel, PhD, Xiaolu Su, MS and Willem J. van der Giessen, MD^||||

^_* Institut Jacques Cartier, Massy, France
Green Lane/Mercy Hospital, Auckland, New Zealand
Ospedali Riuniti, Bergamo, Italy
Hospital Benjamin Franklin, Berlin, Germany
^|| Hopital Trousseau, Tours, France
^¶ Ospedale Civile, Mirano, Italy
^# Clinique St Henri, Nantes, France
^** OLVG Aalst, Aalst, Belgium
Herz-Zentrum, Bad Krozingen, Germany
Universitatsklinikum Lubeck, Lubeck, Germany
Guidant Europe, Diegem, Belgium
^|||| Erasmus Medical Centre, Rotterdam, the Netherlands

Manuscript received November 2, 2004; revised manuscript received March 8, 2005, accepted March 22, 2005.

^_* Reprint request and correspondence: Dr. Thierry Lefèvre, Institut Hospitalier Jacques Cartier, Rue du Noyer Lambert, 91300 Massy, France (Email: t.lefevre{at}icps.com.fr).

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.

Abbreviations and Acronyms   MACE = major adverse cardiac events   MB = main branch   MI = myocardial infarction   ML = Multi-Link   PCI = percutaneous coronary intervention   QCA = quantitative coronary angiography   SB = side branch   TLR = target lesion revascularization   TVR = target vessel revascularization

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