Abstract 12686: Unprotected Left Main Stenting With a Second-Generation Drug-Eluting Stent Two-Year Results of the LEMAX Pilot Study
Background: CABG remains the gold standard treatment of unprotected left main (LM) stenosis. Advances in percutaneous coronary intervention have led to this technique being increasingly used as an alternative therapeutic option for LM stenosis. Studies using first generation drug-eluting stents (DES) have shown promising results however, data regarding use of second generation DES in this setting are lacking. We present the two-year follow-up of a French multicenter pilot study of unprotected LM stenting with Xience V everolimus eluting stent.
Methods: A feasibility and safety pilot study using the Xience V drug-eluting stent was set up in 4 French centers with vast experience in the treatment of unprotected LM stenosis. Patients were excluded if they had LM restenosis, acute ST elevation MI or cardiogenic shock. QCA analysis and adjudication of events were performed by an independent committee.
Results: Between December 2007 and May 2009, 172 patients were included (mean age 69.7±11.3 years, 76% male. 26% of patients were diabetics, 13% had a previous MI and 29% previous PCI. The mean SYNTAX score was 23.6 ±10.4 and logistic Euroscore 5.7 ± 8.1 %. Patients with distal LM lesions (74%) were treated using the provisional T stenting strategy in 92% of cases with final kissing inflation in 98%. When 2 stents were used (22% of patients), the T stenting technique was preferred and used in 84% of these cases. Immediate angiographic procedural success was 100%. At 2-year follow-up, cardiac death had occurred in 4 patients (2.3%). Target vessel MI occurred in 7 patients (4.1%) with 2 of these presenting as STEMI. Clinically indicated TLR was treated by PCI in 5 patients (2.9%) and CABG in 2 (1.2%), whereas TVR was treated with CABG and PCI in 2 (1.2%) and 12 (7.0%) respectively. MACE occurred in 21 patients (12.2%). 6 patients had a stroke within the 2-year period. Definite stent thrombosis occurred in 1 patient (0.6%)
Conclusion: Unprotected left main stenting with Xience V everolimus-eluting stents is feasible, safe and effective in the mid-term. Randomized clinical trials with prolonged follow-up will establish the role of these new second generation DES in patients with unprotected LM disease.
- © 2011 by American Heart Association, Inc.