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.
RCT Entities:
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%) PESpatients (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 PESpatients (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.
Authors: Sanjay B Pandya; Young-Hak Kim; Sheridan N Meyers; Charles J Davidson; James D Flaherty; Duk-Woo Park; Anuj Mediratta; Karen Pieper; Eric Reyes; Robert O Bonow; Seung-Jung Park; Nirat Beohar Journal: JACC Cardiovasc Interv Date: 2010-06 Impact factor: 11.195
Authors: Tobias Härle; Uwe Zeymer; Arne Kristian Schwarz; Claus Lüers; Matthias Hochadel; Harald Darius; Wolfgang Kasper; Karl Eugen Hauptmann; Dietrich Andresen; Albrecht Elsässer Journal: Clin Res Cardiol Date: 2014-01-17 Impact factor: 5.460
Authors: Gilles Montalescot; David Brieger; Kim A Eagle; Frederick A Anderson; Gordon FitzGerald; Michael S Lee; Ph Gabriel Steg; Alvaro Avezum; Shaun G Goodman; Joel M Gore Journal: Eur Heart J Date: 2009-08-30 Impact factor: 29.983