Are Paclitaxel-Eluting Stents Better in Unprotected Left Main Coronary Artery Disease? Three-Year Clinical and Intravascular Imaging Results From a Randomized Study

Background and Objective. Recent publications have demonstrated superior outcomes in unprotected left main patients after paclitaxel-eluting stent (PES) implantation. Long-term data in these patients are limited. The aim of this study was to evaluate if intravascular ultrasound (IVUS)-guided PES implantation is superior to bare metal stent (BMS) implantation in unprotected left main disease after lesion pretreatment with cutting balloon during long-term follow-up. Material and Methods. Unprotected left main patients were randomized to BMS (n=50) or PES implantation (n=53). All interventions were IVUS-guided and cutting balloon pretreatment before stenting was performed in all patients. All patients were scheduled for 6-month and 3-year follow-up. Subgroups of patients who underwend IVUS and OCT imaging at 3-year follow-up were analyzed. The primary endpoint was the major adverse cardiac events (MACEs) defined as death, Q-wave myocardial infarction, or target lesion revascularization. Results. Baseline characteristics were similar in both the groups with a mean SYNTAX score of 31.4 +/- 14.5 in BMS and 32.6 +/- 11.7 in PES patients (P=0.718). At 3 years, MACEs occurred in 18 patients (36.0%) in the BMS and 7 patients (13.2%) in the PES group (P=0.011). By IVUS, percent neointimal volume obstruction at 3 years was reduced from 18.1%+/- 8.7% with BMSs to 10.0%+/- 5.4% with PESs (P<0.001). The total number of uncovered stent struts per OCT image and IVUS image was 0.4 +/- 0.8 and 1.2 +/- 1.5, respectively (P<0.001). Conclusions. The current study demonstrated that IVUS-guided PES implantation was superior to BMS implantation after cutting balloon pretreatment in unprotected left main disease at 3 years. If compared with IVUS, OCT was more precise in the assessment of stent endothelization.