Duk-Woo Park1, Jung-Min Ahn1, Hanbit Park1, Sung-Cheol Yun2, Do-Yoon Kang1, Pil Hyung Lee1, Young-Hak Kim1, Do-Sun Lim3, Seung-Woon Rha4, Gyung-Min Park5, Hyeon-Cheol Gwon6, Hyo-Soo Kim6,7, In-Ho Chae8, Yangsoo Jang9, Myung-Ho Jeong10, Seung-Jea Tahk11, Ki Bae Seung12, Seung-Jung Park1. 1. Department of Cardiology (D.-W.P., J.-M.A., H.P, D.-Y.K., P.H.L., Y.-H.K., S.-J.P.), Asan Medical Center, Seoul, Korea. 2. Division of Biostatistics (S.-C.Y.), Asan Medical Center, Seoul, Korea. 3. Korea University Anam Hospital, Seoul (D.-S.L.). 4. Korea University Kuro Hospital, Seoul (S.-W.R.). 5. Ulsan University Hospital, Korea (G.-M.P.). 6. Samsung Medical Center, Seoul, Korea (H.-C.G., H.-S.K.). 7. Seoul National University Hospital, Korea (H.-S.K.). 8. Seoul National University Bundan Hospital, Seongnam, Korea (I.-H.C.). 9. Yonsei University Severance Hospital, Seoul, Korea (Y.J.). 10. Chonnam National University Hospital, Gwangju, Korea (M.-H.J.). 11. Ajou University Medical Center, Suwon, Korea (S.-J.T.). 12. Catholic University of Korea, St. Mary's Hospital, Seoul (K.B.S.).
Abstract
BACKGROUND: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents and coronary-artery bypass grafting (CABG) for left main coronary artery disease are highly debated. METHODS: In the PRECOMBAT trial (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease), patients with unprotected left main coronary artery disease were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300) in 13 hospitals in Korea from April 2004 to August 2009. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). RESULTS: At 10 years, a primary outcome event occurred in 29.8% of the PCI group and in 24.7% of the CABG group (hazard ratio [HR] with PCI vs CABG, 1.25 [95% CI, 0.93-1.69]). The 10-year incidence of the composite of death, myocardial infarction, or stroke (18.2% vs 17.5%; HR 1.00 [95% CI, 0.70-1.44]) and all-cause mortality (14.5% vs 13.8%; HR 1.13 [95% CI, 0.75-1.70]) were not significantly different between the PCI and CABG groups. Ischemia-driven target-vessel revascularization was more frequent after PCI than after CABG (16.1% vs 8.0%; HR 1.98 [95% CI, 1.21-3.21). CONCLUSIONS: Ten-year follow-up of the PRECOMBAT trial of patients with left main coronary artery disease randomized toPCI or CABG did not demonstrate significant difference in the incidence of major adverse cardiac or cerebrovascular events. Because the study was underpowered, the results should be considered hypothesis-generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03871127 and NCT00422968.
RCT Entities:
BACKGROUND: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents and coronary-artery bypass grafting (CABG) for left main coronary artery disease are highly debated. METHODS: In the PRECOMBAT trial (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease), patients with unprotected left main coronary artery disease were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300) in 13 hospitals in Korea from April 2004 to August 2009. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). RESULTS: At 10 years, a primary outcome event occurred in 29.8% of the PCI group and in 24.7% of the CABG group (hazard ratio [HR] with PCI vs CABG, 1.25 [95% CI, 0.93-1.69]). The 10-year incidence of the composite of death, myocardial infarction, or stroke (18.2% vs 17.5%; HR 1.00 [95% CI, 0.70-1.44]) and all-cause mortality (14.5% vs 13.8%; HR 1.13 [95% CI, 0.75-1.70]) were not significantly different between the PCI and CABG groups. Ischemia-driven target-vessel revascularization was more frequent after PCI than after CABG (16.1% vs 8.0%; HR 1.98 [95% CI, 1.21-3.21). CONCLUSIONS: Ten-year follow-up of the PRECOMBAT trial of patients with left main coronary artery disease randomized to PCI or CABG did not demonstrate significant difference in the incidence of major adverse cardiac or cerebrovascular events. Because the study was underpowered, the results should be considered hypothesis-generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03871127 and NCT00422968.
Authors: Giovanni Luigi De Maria; Luca Testa; Jose M de la Torre Hernandez; Dimitrios Terentes-Printzios; Maria Emfietzoglou; Roberto Scarsini; Francesco Bedogni; Ernest Spitzer; Adrian Banning Journal: PLoS One Date: 2022-01-07 Impact factor: 3.240
Authors: Moman A Mohammad; Jonas Persson; Sergio Buccheri; Jacob Odenstedt; Giovanna Sarno; Oskar Angerås; Sebastian Völz; Tim Tödt; Matthias Götberg; Nazim Isma; Troels Yndigegn; Patrik Tydén; Dimitrios Venetsanos; Mats Birgander; Göran K Olivecrona Journal: J Am Heart Assoc Date: 2022-03-30 Impact factor: 6.106