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Diabetic and Nondiabetic Patients With Left Main and/or 3-Vessel Coronary Artery Disease

Comparison of Outcomes With Cardiac Surgery and Paclitaxel-Eluting Stents

Adrian P. Banning, MD^_*,_*, Stephen Westaby, MS, PhD^_*, Marie-Claude Morice, MD, A. Pieter Kappetein, MD, PhD, Friedrich W. Mohr, MD, Sergio Berti, MD^||, Mattia Glauber, MD^||, Mirle A. Kellett, MD^¶, Robert S. Kramer, MD^¶, Katrin Leadley, MD^#, Keith D. Dawkins, MD^# and Patrick W. Serruys, MD, PhD

^_* John Radcliffe Hospital, Oxford, United Kingdom
Institut Hospitalier Jacques Cartier, Massy, France
Thorax Center, Erasmus University Medical Center, Rotterdam, the Netherlands
Herzzentrum Universität Leipzig, Leipzig, Germany
^|| Institute of Clinical Physiology, CNR Massa, Massa, Italy
^¶ Maine Medical Center, Portland, Maine
^# Boston Scientific Corporation, Natick, Massachusetts

Manuscript received June 8, 2009; revised manuscript received September 16, 2009, accepted September 30, 2009.

^_* Reprint requests and correspondence: Dr. Adrian Banning, Room 2557, Cardiology Department, Level 2, John Radcliffe Hospital, Headley Way, Headington, Oxford 0X3 9DU, United Kingdom. (Email: adrian.banning{at}orh.nhs.uk).

Objectives: This study was designed to compare contemporary surgical revascularization (coronary artery bypass graft surgery [CABG]) versus TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stents (PES) in diabetic and nondiabetic patients with left main and/or 3-vessel disease.

Background: Although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients with complex multivessel disease remains controversial.

Methods: The SYNTAX (SYNergy Between Percutaneous Coronary Intervention With TAXus and Cardiac Surgery) study randomly assigned 1,800 patients (452 with medically treated diabetes) to receive PES or CABG.

Results: The overall 1-year major adverse cardiac and cerebrovascular event rate was higher among diabetic patients treated with PES compared with CABG, but the revascularization method did not impact the death/stroke/myocardial infarction rate for nondiabetic patients (6.8% CABG vs. 6.8% PES, p = 0.97) or for diabetic patients (10.3% CABG vs. 10.1% PES, p = 0.96). The presence of diabetes was associated with significantly increased mortality after either revascularization treatment. The incidence of stroke was higher among nondiabetic patients after CABG (2.2% vs. PES 0.5%, p = 0.006). Compared with CABG, mortality was higher after PES use for diabetic patients with highly complex lesions (4.1% vs. 13.5%, p = 0.04). Revascularization with PES resulted in higher repeat revascularization for nondiabetic patients (5.7% vs. 11.1%, p < 0.001) and diabetic patients (6.4% vs. 20.3%, p < 0.001).

Conclusions: Subgroup analyses suggest that the 1-year major adverse cardiac and cerebrovascular event rate is higher among diabetic patients with left main and/or 3-vessel disease treated with PES compared with CABG, driven by an increase in repeat revascularization. However, the composite safety end point (death/stroke/myocardial infarction) is comparable between the 2 treatment options for diabetic and nondiabetic patients. Although further study is needed, these exploratory results may extend the evidence for PES use in selected patients with less complex left main and/or 3-vessel lesions. (SYNergy Between PCI With TAXus and Cardiac Surgery [SYNTAX]; NCT00114972 [ClinicalTrials.gov] )

Key Words: drug-eluting stent • coronary artery bypass grafting • diabetes • paclitaxel • multivessel

Abbreviations and Acronyms   CABG = coronary artery bypass graft surgery   CVA = cerebrovascular accident   DES = drug-eluting stent(s)   MACCE = major adverse cardiac and cerebrovascular event   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   TIA = transient ischemic attack

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