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| AATS/NHLBI: Cardiothoracic Surgery Exploring Collaborative Clinical Research Opportunities |
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Title and Author Hybrid Coronary Revascularization: Collaborative Innovation Combining Surgical and Percutaneous Therapies for Selected Patients with Coronary Artery DiseaseJohn D. Puskas, MD, FACS, FACC Abstract Background: The Syntax trial has demonstrated that coronary artery bypass surgery (CABG) is offers better survival and intervention-free survival than percutaneous therapy (PCI) with drug eluting stents (DES) for left main (LM) and multivessel coronary artery disease (CAD), albeit at the cost of greater perioperative morbidity, including stroke. Left internal thoracic artery (LITA) grafting of the left anterior descending (LAD) coronary artery is believed to provide a large portion of the mortality benefit of CABG. Nonetheless, DES are considered by many practitioners to be equivalent to saphenous vein grafting (SVG) to non-LAD coronary target vessels. While multiple arterial grafting may be better than any other treatment for multivessel CAD, obese and diabetic patients do not generally receive bilateral ITA or all-arterial grafting in the USA. Indeed, many patients with multivessel disease continue to be treated with multivessel PCI rather than CABG, at least in part due to strong patient preference for a less invasive therapy.Rationale: Hybrid coronary revascularization (HCR) seeks to combine the best features of surgical coronary revascularization with LITA grafting of the LAD coronary artery and PCI of non-LAD coronary targets with DES. HCR represents an important, innovative collaboration between surgery and cardiology to improve outcomes for selected patients with CAD. Methods: Informed by the results of a Challenge Grant-funded Hybrid Observational Study, the proposed pivotal multicenter, prospective, randomized, controlled trial (RCT) would test the safety, efficacy and comparative effectiveness of HCR versus multivessel PCI for patients with multivessel coronary artery disease deemed amenable to either treatment by a local multidisciplinary Heart Team. HCR will include off-pump, non-sternotomy, minimally invasive surgical grafting of the LAD with the LITA. Non-LAD lesions >70% stenosis will be treated by PCI with DES. Surgical and PCI components of the HCR may be staged (in either order) by hours or up to 6 weeks. Dual antiplatelet medical therapy will be used for all patients. Eligibility Criteria will include: coronary anatomy deemed suitable for HCR or multivessel PCI by the heart team at each enrolling site and ability to tolerate dual antiplatelet medical therapy. This will include LM and multivessel CAD. Emergency and redo patients will be excluded, as will those with evolving acute myocardial infarction. The primary endpoint will be a composite of death, stroke, MI, and repeat revascularization at 24 months. Preplanned secondary endpoints will include the composite endpoint at 1,3 and 5 years follow-up, post-procedural length of stay, cost during index hospitalization, as well as the individual components of the primary endpoint and quality of life (Seattle Angina Questionnaire and SF-36) annually during five years follow-up. Other goals of this pivotal trial will be to determine which patients benefit most from HCR, which patterns of CAD are most suitable for HCR, the relative effectiveness of alternative minimally invasive surgical approaches to the LITA-LAD procedure (including the role of robotics) and the relative benefit of HCR versus PCI for patients with LM CAD and for those with multivessel CAD without LM stenosis. Key Research Gap Requiring NHLBI Leadership A multicenter RCT is needed to compare the safety and efficacy of hybrid coronary revascularization and multivessel PCI with DES for patients with coronary artery disease amenable to either therapy. It is not known whether the mortality benefit of minimally invasive LIMA-LAD will provide better intervention-free survival for patients after HCR than after multivessel PCI, while avoiding the morbidity associated with conventional CABG. Key Citations 1: Halkos ME, Vassiliades TA, Douglas JS, Morris DC, Rab ST, Liberman HA, Kilgo P, Guyton RA and Puskas JD. Hybrid Coronary Revascularization versus Off-pump Coronary Artery Bypass Grafting for the Treatment of Multivessel Coronary Artery Disease, presented at Society of Thoracic Surgeons Annual Meeting, January 31, 2011, San Diego.2: Vassiliades TA, Jr., Douglas JS, Morris DC, et al. Integrated coronary revascularization with drug-eluting stents: immediate and seven-month outcome. J Thorac Cardiovasc Surg. May 2006;131(5):956-962. 3: Vassiliades TA, Kilgo PD, Douglas JS, et al. Clinical outcomes after hybrid coronary revascularization versus off-pump coronary artery bypass. Innovations. 2009;4:299-306. |
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Copyright © 2012 American Association for Thoracic Surgery
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.