Abstract 2527: Randomized, Multicenter Trial between PCI with Sirolimus Eluting Stent and CABG for Patients with Unprotected Left Main Stenosis. 1-Year-Results
Background: Unprotected left main stenosis is still considered an indication for bypass surgery. We conducted a randomized, multicenter study to compare PCI with Sirolimus eluting stents with bypass revascularisation for patients with significant left main stenosis.
Methods and Demographics: From 8/2003 to 5/2007 159 patients with significant left main stenosis were recruited for the study. Additonal lesions in the remaining coronary arteries have been treated as well. They were randomized to undergo CABG or PCI using drug eluting stents (Sirolimus). Angiographic control was performed at 12 month. Primary endpoints were death, acute myocardial infarction an reintervention at 12 month. Out of the 159 pts 80 were randomized for CABG and 79 for PCI. Mean age was 66,7 years. Left ventricular function was well preserved. There were no significant differences between both groups with respect to other baseline variables. The left main lesion was located at the ostium in 22%, midshaft in 7% and at the bifurcation in 71%. An average of 2.6±1.1 stents were implanted, and 2.5±0.8 bypass grafts were performed. Half of operated pts received complete arterial revascularization.
Results: Intrahospital: Early success was 96% in PCI and 100% in CABG. 3 pts assigned to PCI had to be converted to CABG, without complications. One of the operated pt. unterwent graft revision. Periprocedural infarction was noted in 3 pts after CABG, none in the PCI-group. Early mortality rate in surgery was 1.3%, no patient died after PCI. 1-year-Follow Up: Over the course of one year 3 pts from the surgical group and 2 pts of the PCI cohort died. No further MI appeared within one year. In 12 pts after PCI we found restenosis and in 17 pts bypass occlusion, 10 of PCI pts (12.6%) and 4 CABG pts (5%) required reintervention. Cumulative MACE rate after 12 month was comparable for PCI group with 15,2% to 13.8% for the CABG group
Conclusions: In pts with unprotected left main stenosis both CABG and PCI using drug eluting stents can be performed with few periprocedural complications and low mortality. At 12 month MACE rate and survival compare favourably, reintervention rate is higher in PCI.