Abstract 2982: Unprotected Left Main Stenting With Drug-eluting Stents In High Surgical Risk Patients: Long Term Follow-up Reveals Frequent Events
Background: Previous studies have demonstrated low in-hospital complication rates with unprotected left main (ULM) stenting, but the long term efficacy remains uncertain. The purpose of the present study was to determine long term clinical outcomes in patients (pts) with increased surgical risk who were managed with drug-eluting stents (DES).
Methods: 100 symptomatic pts with increased surgical risk underwent elective ULM stenting (78 Taxus, 22 Cypher) between 6/03 and 12/05. Patient risk was estimated by EuroSCORE, a predictor of 30 day surgical mortality. Disease was confined to the ostium or main stem in Group A (31 pts) and involved the bifurcation in Group B (69 pts). The preferred bifurcation strategy was to stent the main branch followed by kissing balloon inflations and provisional side branch stenting. Study endpoints were MI, TVR, and death.
Results: Mean age 68±1, EF 52±1%. Mean EuroSCORE was 5.2±4 and 41% pts had a EuroSCORE of ≥6 (predicted surgical mortality of 10 –12%). At time of index procedure 15% pts had cancer. In Group A, 87% of lesions were directly stented. In Group B, 61% pts received 1 stent, 39% 2 stents. Primary success was 95% (3 MI, 1 TVR, 1 death). Follow-up data (mean 28 mos, range 13– 45 mo) were obtained in 100% of patients. TVR was performed in 9 pts; restenosis occurred at the proximal stent margin in 5/9. During the follow-up period, 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 (one had stopped clopidogrel) and 2 additional pts after 1 year. Sudden death did not occur in Group A. Event free survival was 65% in Group A (1 MI, 2 TVR, 8 deaths) and 67% in Group B (2 MI, 8 TVR, 13 deaths).
Conclusion: Despite high in-hospital procedural success with ULM stenting using DES, a substantial number of adverse events occurred during the follow-up period in the present study. Events occurred in both ostial and bifurcation groups with equal frequency. Stent thrombosis was a probable cause of death only in the bifurcation group. Cardiac survival at two years was 88% in this high surgical risk group, but caution is urged in performing ULM stenting pending results of randomized trials.