CLINICAL RESEARCH: CLINICAL TRIALS
A Randomized Comparison of Paclitaxel-Eluting Stents Versus Bare-Metal Stents for Treatment of Unprotected Left Main Coronary Artery Stenosis
Andrejs Erglis, MD, PhD, FESC, FACC*,*,
Inga Narbute, MD*,
Indulis Kumsars, MD*,
Sanda Jegere, MD*,
Iveta Mintale, MD*,
Ilja Zakke, MD, FESC*,
Uldis Strazdins, MD* and
Andris Saltups, MD, FACC, FRACP, MRACP
* Latvian Center of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia
Cabrini Medical Centre and Monash Medical Centre, Melbourne, Australia
Manuscript received September 6, 2006;
revised manuscript received March 5, 2007,
accepted March 6, 2007.
* Reprint requests and correspondence: Dr. Andrejs Erglis, Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Pilsonu 13, Riga, Latvia, LV 1002 (Email: a.a.erglis{at}stradini.lv).
Objectives: To optimize percutaneous coronary intervention (PCI) strategy for unprotected left main (LM) disease, we performed a randomized study: intravascular ultrasound (IVUS)-guided bare-metal stent (BMS) or paclitaxel-eluting stent (PES) implantation after lesion pre-treatment with cutting balloon (CB) for unprotected LM lesions.
Background: Recent studies have shown promising results in terms of safety and feasibility for patients with LM disease who underwent PCI with stent implantation. However, comparison of BMS and PES for LM lesions has not yet been evaluated.
Methods: One hundred three patients were randomly assigned to receive BMS (n = 50) or PES (n = 53) implantation. All interventions were IVUS guided, and CB pre-treatment before stenting was performed in all patients. All patients were scheduled for 6-month follow-up.
Results: Baseline clinical characteristics were comparable in both cohorts. Stent implantation was successful in all lesions. Follow-up analysis showed binary restenosis in 11 (22%) BMS and in 3 (6%) PES patients (p = 0.021). By IVUS, percentage of neointimal volume obstruction at 6 months was reduced from 25.20 ± 22.02% with BMS to 16.60 ± 17.25% with PES (p = 0.02). At 6 months, the major adverse cardiac event-free survival rate was 70% in BMS and 87% in PES patients (p = 0.036).
Conclusions: This study demonstrates that PCI of LM with IVUS guidance and CB pre-treatment is safe and effective. No serious procedure-related complications were observed, and clinical outcomes appeared to be good. Finally, the findings demonstrate that implantation of PES may be superior to BMS in the large-diameter LM vessel at 6 months, warranting the performance of a large-scale randomized trial.
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Abbreviations and Acronyms
| | BMS = bare-metal stent(s) | | CABG = coronary artery bypass grafting | | CB = cutting balloon | | IVUS = intravascular ultrasound | | LAD = left anterior descending | | LCX = left circumflex | | LM = left main | | MLA = minimum lumen area | | MLD = minimal lumen diameter | | PCI = percutaneous coronary intervention | | PES = paclitaxel-eluting stent(s) | | QCA = quantitative coronary analysis | | TLR = target lesion revascularization |
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