David E Kandzari1, Anthony H Gershlick2, Patrick W Serruys3, Martin B Leon4,5, Marie-Claude Morice6, Charles A Simonton7, Nicholas J Lembo4,5, Adrian P Banning8, Béla Merkely9, Ad J van Boven10, Imre Ungi11, Arie Pieter Kappetein12, Joseph F Sabik13, Philippe Généreux5,14,15, Ovidiu Dressler5, Gregg W Stone4,5. 1. Piedmont Heart Institute, Atlanta, GA (D.E.K.). 2. Leicester Biomedical Research Centre, University Hospitals of Leicester, University of Leicester, United Kingdom (A.H.G.). 3. Imperial College of Science, Technology and Medicine, London, United Kingdom (P.W.S.). 4. Center for Interventional Vascular Therapy, Division of Cardiology, New York-Presbyterian Hospital/Columbia University Medical Center (M.B.L., N.J.L., G.W.S.). 5. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (M.B.L., N.J.L., P.G., O.D., G.W.S.). 6. Ramsay Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.). 7. Abbott Vascular, Inc, Santa Clara, CA (C.A.S.). 8. John Radcliffe Hospital, Oxford, United Kingdom (A.P.B.). 9. Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.). 10. Medisch Centrum Leeuwarden, The Netherlands (A.J.v.B.). 11. Cardiology Center, University of Szeged, Hungary (I.U.). 12. Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands (A.P.K.). 13. Department of Surgery, UH Cleveland Medical Center, OH (J.F.S.). 14. Gagnon Cardiovascular Institute, Morristown Medical Center, NJ (P.G.). 15. Hôpital du Sacré-Coeur de Montréal, Québec, Canada (P.G.).
Abstract
BACKGROUND:Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion. METHODS AND RESULTS: The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35-0.88; P=0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P=0.01) and myocardial infarction (7.7% versus 12.8%, P=0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P=0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P=0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P=0.36). CONCLUSIONS: Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.
RCT Entities:
BACKGROUND: Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion. METHODS AND RESULTS: The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35-0.88; P=0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P=0.01) and myocardial infarction (7.7% versus 12.8%, P=0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P=0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P=0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P=0.36). CONCLUSIONS: Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.
Authors: Wojciech Jan Skorupski; Marta Kałużna-Oleksy; Maciej Lesiak; Aleksander Araszkiewicz; Włodzimierz Skorupski; Stefan Grajek; Przemysław Mitkowski; Małgorzata Pyda; Marek Grygier Journal: J Pers Med Date: 2022-02-25