Long-term Clinical Results for Randomised Comparison of Paclitaxel-eluting versus Bare-metal Stents in Unprotected Left Main Coronary Artery Disease

Abstract

Long-term Clinical Results for Randomised Comparison of Paclitaxel-eluting versus Bare-metal Stents in Unprotected Left Main Coronary Artery Disease To optimise percutaneous coronary intervention (PCI) strategy for unprotected left main (ULMCA) disease we performed a randomised study: IVUS-guided bare metal stent (BMS) versus paclitaxel-eluting stent (PES) implantation after lesion pre-treatment with cutting balloon (CB) for unprotected LM lesions. The purpose of this randomized study was to evaluate six-month and three-year clinical results. Several recent publications have demonstrated good short- and midterm outcomes in patients with left main artery disease after stent implantation. However, data on long-term comparison of BMS and PES for LM lesions are limited. Patients with left main coronary artery disease enrolled at Latvian Centre of Cardiology were randomly assigned to either BMS (n = 50) or PES implantation (n = 53). All interventions were IVUS-guided and CB pre-treatment before stenting was performed in all patients. All patients were scheduled for six-month and three-year follow-up. The primary endpoint was major adverse cardiac events (MACE) defined as death, Q wave myocardial infarction or target lesion revascularisation (TLR). Baseline clinical and procedural characteristics were comparable in both groups. At six months, the MACE-free survival rate was 70% in BMS and 87% in PES patients (P < 0.05). At three years, MACE occurred in 18 patients (36.0%) in the BMS and seven patients (13.2%) in the PES group (P < 0.05). The current study demonstrates the benefit of IVUS guided paclitaxel-eluting stent implantation after cutting balloon pre-treatment in left main coronary artery disease over bare metal stent implantation at six months and three years.