Abstract 3346: Percutaneous Treatment Of Unprotected Left Main Coronary Stenoses With Paclitaxel-eluting Stents. Mid-term Results Of A French Prospective Multicenter Study (friend Register)
Purpose : We assessed early and mid-term results of patients (pts) treated for ULMCA disease in the FRIEND registry.
Methods: After ethical committee approval and informed consent, all consecutive pts with unprotected left main stenoses treated with Taxus stents were included in a multicenter prospective study from 23 centers. Major adverse cardiacl events (MACCE) : death, myocardial infarction, stroke, target lesion (TLR), target vessel revascularisation (TVR), acute, sub-acute and late thrombosis were adjudicated at 1and 6 months by an independent committee. Immediate and 9-month angiographic results were assessed by a central core lab. For the distal lesion of ULMCA, a strategy of main branch stenting with provisional T-stenting of the side branch followed by kissing balloon inflation was strongly recommanded.
Results : From December 2005 to July 2006, 155 pts were included, mean age 68 ± 11 years, 83 % male, 31 % unstable angina, 25% diabetics, 46 % 3-vessel disease. The mean Euroscore was 4.2 ± 2.8 (estimated in-hospital mortality rate after surgery 4.1%). The LM reference diameter was 3.6 ± 0.5mm. LM lesion was ostial-proximal in 28 %,mid shaft 18 % and distal 66%. In this group, 72 % were located at the bifurcation including LAD, LCX or both ostia affected. All patients were successfully treated on the LM (stent length 15.7 ± 5.2 mm) and a final kissing balloon inflation was performed in 90%. Apart from the LM stenosis, a total of 1.2 ± 0.8 lesions were treated during the hospitalisation (total stent length 47 ± 16mm). In-hospital MACCE rate was 4.5 % : death in 2.6% (3 acute stent thrombosis at day 2, 3, 5 and 1 before PCI) ; 2 Pts had asymptomatic non-Q-wave MI,1 pt Q-wave MI and 1CABG. At 9-month follow-up (122 pts) there was one extra-cardiac death, no cardiac failure and 3 pts (2.5 %) had recurrence of symptoms. The global rate of event-free survival was 93.5 % with a very low angiographic restenosis rate of 3 %.
Conclusion: LM PCI using the TAXUS stent is feasible and safe. Preliminary results showed favourable 9-month follow-up. Stenting deserves to be considered a safe and effective alternative to CABG in institutions performing large numbers of PCIs. Adjudicated clinical and angiographic long-term (9-month) data are warranted and will be available for presentation.