Abstract

Drug-eluting stents (DES) have reduced restenosis rate and are now emerging as an alternative to bypass surgery (CABG) for treating unprotected left main (ULM) stenosis. A prospective registry was set up in France to explore the role of DES in this setting. Consecutive patients (Pts) with de novo ULM stenosis undergoing PCI with Paclitaxel eluting stent (PES) in 4 French centers were prospectively included in this real world study. Acute MI and cardiogenic shock were the only criteria for exclusion. Pts had a loading dose (450 to 600 mg) of plavix before the procedure, aspirin (≥75 mg) and plavix (75 to 150 mg/day) for at least 6 months. Clinical outcome was planned up to 3 years and repeat angiography was strongly recommended at 6 months. Between March 2003 and June 2005, 291 Pts were included: 69±11 yrs old, 77% male, 29% diabetic, 5% renal failure, 17% previous or recent MI, 38% acute coronary syndrome and 25% 3-vessel disease. Euroscore was 4.8±3.4 (predicted in-hospital mortality in case of CABG 6.3±10.4). Provisional T stenting (distal LM in 78.4%) was used in 92% of cases and final kissing balloon in 96.8%. Angiographic success was obtained in 99.7%. Other lesions (1.2±0.9) were treated during the same hospitalization in 77%. Repeat angiogram was performed in 182 Pts (63%) at 7.0±4.0 months. Restenosis was observed in 8.7%. The clinical outcome is summarized below: By multivariate analysis Euroscore (OR 1.245; 95% CI 1.077–1.439; p=0.003), terminal renal failure with dialysis therapy (OR 0.018; 95% CI 0.002– 0.172; p=<0.001) and LM bifurcation angle T-type (OR 0.205; 95% CI 0.071– 0.593; p=0.003) were the only independent predictors of death. The incidence of definite or probable LM stent thrombosis (ST) as defined by the ARC was at 2-years 2.09% (3 early ST and 3 late or very late ST). LM stenting using PES with a strategy of provisional side branch T stenting in case of distal lesion provides excellent acute angiographic results and very acceptable long-term outcome.

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