Key result
Paclitaxel-eluting stent implantation significantly reduced the 3-year rate of major adverse cardiac events to 13.2% compared to 36.0% with bare-metal stents in patients with unprotected left main coronary artery disease.
Why the study?
Does paclitaxel-eluting stent implantation reduce major adverse cardiac events compared to bare-metal stent implantation in patients with unprotected left main coronary artery disease?
RCT (n=103)
1:1
No
Does paclitaxel-eluting stent implantation reduce major adverse cardiac events compared to bare-metal stent implantation in patients with unprotected left main coronary artery disease?
Absolute Event Rate: 13.2% vs 36%
p-value: p=0.011
In patients with unprotected left main coronary artery disease, IVUS-guided paclitaxel-eluting stent implantation with cutting balloon pre-treatment significantly reduced major adverse cardiac events at 3 years compared to bare-metal stents.
Supports paclitaxel-eluting stents over bare-metal stents for unprotected left main CAD; extends randomized evidence for DES in this high-risk anatomy.
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.
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Narbute et al. (2009) conducted an RCT in Unprotected left main coronary artery disease (n=103). Paclitaxel-eluting stent vs. Bare-metal stent was evaluated on Major adverse cardiac events (MACE) defined as death, Q wave myocardial infarction or target lesion revascularisation (p=0.011). Paclitaxel-eluting stent implantation significantly reduced the 3-year rate of major adverse cardiac events to 13.2% compared to 36.0% with bare-metal stents in patients with unprotected left main coronary artery disease.
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