NEW YORK (Reuters Health) – In most patients who receive drug-eluting stents for unprotected left main disease, restenosis can be managed with a minimally invasive approach, including placement of additional drug-eluting stents, according to results from the Failure in Left Main Study (FAILS).

“The FAILS study shows that repeat percutaneous coronary intervention (PCI) can be safely and effectively performed in most cases of left main restenosis,” Dr. Giuseppe Biondi-Zoccai from the University of Turin, Italy told Reuters Health by email. “Yet, in a small but still relevant subset of patients, coronary artery bypass grafting (CABG) will still be needed, especially when restenosis is diffuse or atherosclerotic disease elsewhere in the coronary vessels is progressing rapidly.”

Dr. Biondi-Zoccai and colleagues analyzed the incidence and management of restenosis in a cohort of 718 patients with unprotected left main disease who were managed with drug-eluting stents. Restenosis developed in 70 patients (9.7%).

Overall, 22.1% of cases were diagnosed during routine follow-up angiography, and 30.8% were found in patients who had been admitted for acute coronary syndrome.

According to the report in the September 22nd Journal of the American College of Cardiology, 59 of the 70 patients (84.3%) were treated again with PCI. In the repeat-PCI group, 34 patients had a new drug-eluting stent implanted, 1 received a bare metal stent, and 16 had balloon-only PCI. Six were treated with cutting balloons, and 2 underwent directional atherectomy.

Another 7 patients (10%) were managed with CABG, and 4 (5.7%) were treated with medical therapy only.

There was 1 in-hospital death in the repeat PCI group and none in the medical therapy or CABG groups.

Over an average of 25.6 months after restenosis, the major adverse coronary event rate was 25.7%, with death in 5.7%, myocardial infarction in 2.9%, target lesion revascularization in 21.4%, and PCI on other vessels in 21.4%. In the PCI group, there was 1 case of possible stent thrombosis, 1 case of probable stent thrombosis, and no cases of definite stent thrombosis, the investigators say.

“The bottom line of the FAILS study is that left main restenosis after PCI is not by default an indication to CABG,” Dr. Biondi-Zoccai told Reuters Health. “If, in a given patient, the same reasons leading to the choice of PCI vs. CABG still hold true, than repeat PCI is feasible, safe, and can effectively manage symptoms and signs of ischemia in most subjects.”

“However,” Dr. Biondi-Zoccai added, “if coronary disease is extensive, restenosis is diffuse, uncontrolled diabetes mellitus is present, surgical risk is not prohibitive, and/or the patient wishes to minimize the risk of repeat revascularization, then CABG should be viewed as the treatment of choice instead of PCI for unprotected left main restenosis.”

Reference:
J Am Coll Cardiol 2009;54:1131-1136.