Unprotected left main disease managed with drug-eluting stents: long-term outcome of 100 patients with increased surgical risk.

ABSTRACT

OBJECTIVES: The purpose of this study was to determine long-term clinical outcomes in high surgical risk patients (pts) with unprotected left main (ULM) disease who were managed with drug-eluting stents (DES). BACKGROUND: The long-term efficacy of unprotected left main (ULM) stenting with DES remains uncertain. METHODS: From June 2003 to December 2005, 100 pts with increased surgical risk underwent ULM stenting with DES. Patient risk was estimated by EuroSCORE. Disease was confined to the ostium/main stem in Group A (31 pts) and involved the bifurcation in Group B (69 pts). Study endpoints were MI, TVR, and death. RESULTS: Mean age was 68 +/- 1 years, EF 52 +/- 1%. Mean EuroSCORE was 5.2 +/- 0.4, and 41% pts had a EuroSCORE of >6. In Group A, 87% of lesions were directly stented. In Group B, 61% of pts received one stent and 39% received two stents. Primary success was 95%. Follow-up data (mean 28 +/- 1 months) were obtained in all patients. Restenosis occurred at the proximal stent margin in 5/9 pts. There were 12 cardiac deaths (88% cardiac survival) and 9 noncardiac deaths (79% total survival). In Group B, 5 pts died suddenly 3 within the first week and 2 additional pts after 1 year. Sudden death did not occur in Group A. All cause event-free survival was 65% in Group A and 67% in Group B. CONCLUSION: A substantial number of late adverse events occurred in both ostial and bifurcation groups with equal frequency. Until definitive data from randomized trials are available, ULM stenting should be performed only in patients with prohibitive surgical risk.