Geographical variations in left main coronary artery revascularisation: a prespecified analysis of the EXCEL trial
Aung Myat, David Hildick-Smith, Adam J de Belder, Uday Trivedi, Aaron Crowley, Marie-Claude Morice, David E Kandzari, Nicholas J Lembo, W Morris Brown III, Patrick W Serruys, Arie Pieter Kappetein, Joseph F Sabik III, Gregg Stone, Aung Myat, David Hildick-Smith, Adam J de Belder, Uday Trivedi, Aaron Crowley, Marie-Claude Morice, David E Kandzari, Nicholas J Lembo, W Morris Brown III, Patrick W Serruys, Arie Pieter Kappetein, Joseph F Sabik III, Gregg Stone
Abstract
Background: The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD).
Aims: We sought to determine whether these outcomes remained consistent regardless of geography of enrolment.
Methods: We performed a prespecified subgroup analysis based on regional enrolment.
Results: Among 1,905 patients randomised to PCI (n=948) or CABG (n=957), 1,075 (56.4%) were recruited at 52 European Union (EU) centres, and 752 (39.5%) were recruited at 67 North American (NA) centres. EU versus NA patients varied according to numerous baseline demographics, anatomy, pharmacotherapy and procedural characteristics. Nonetheless, the relative rates of the primary endpoint after PCI versus CABG were consistent across EU versus NA centres at 30 days and 5 years. However, NA participants had substantially higher late rates of ischaemia-driven revascularisation (IDR) after PCI, driven predominantly by the need for greater target vessel and lesion revascularisation. This culminated in a significant difference in the relative risk of the secondary composite outcome of death, MI, stroke, or IDR at 5 years (pinteraction=0.02).
Conclusions: In the EXCEL trial, the relative risks for the 30-day and five-year primary composite outcome of death, MI or stroke after PCI versus CABG were consistent irrespective of geography. However, five-year rates of IDR after PCI were significantly higher in NA centres, a finding the Heart Team and patients should consider when making treatment decisions. ClinicalTrials.gov identifier: NCT01205776.
Conflict of interest statement
A. de Belder reports grant support from Abbott Vascular and Medtronic, and consultancy/honoraria from Boston Scientific Corporation. D.E. Kandzari reports institutional research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Medtronic, and Teleflex, personal consulting honoraria from Cardiovascular Systems, and Medtronic. N.J. Lembo reports being on the advisory board of Abbott Vascular, and on the speakers bureau of Abbott Vascular, Boston Scientific, Medtronic, and Abiomed. P.W. Serruys reports being a consultant for Biosensors, Sinomed, SMT, Balton sp, Philips/Volcano, Xeltis, HeartFlow, Novartis, and Meril Life, and being a DSMB member for PROSPECT ABSORB. A.P. Kappetein reports being an employee of Medtronic. J.F. Sabik III reports being a consultant for Medtronic, being on the advisory board of Medtronic Cardiac Surgery, and being Abbott North America Surgical PI for the EXCEL trial (no payments). G.W. Stone reports speaker or other honoraria from Terumo, Infraredx, and Cook, being a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Reva, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore, and equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus family of funds. In addition, Mount Sinai Hospital receives grants from Abbott for research, and the Cardiovascular Research Foundation receives payments to the institution from Abbott for biostatistics, clinical events committee and core laboratory work on the clinical trials and for support to attend meetings. The other authors have no conflicts of interest to declare.
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Source: PubMed