Author + information
- Received July 19, 2012
- Revision received November 20, 2012
- Accepted November 29, 2012
- Published online April 1, 2013.
- Michael J. Mack, MD⁎,⁎ (, )
- Stuart J. Head, MSc†,
- David R. Holmes Jr, MD‡,
- Elisabeth Ståhle, MD§,
- Ted E. Feldman, MD∥,
- Antonio Colombo, MD¶,
- Marie-Claude Morice, MD#,
- Felix Unger, MD⁎⁎,
- Andrejs Erglis, MD††,
- Robert Stoler, MD‡‡,
- Keith D. Dawkins, MD§§,
- Patrick W. Serruys, MD, PhD†,
- Friedrich W. Mohr, MD, PhD∥∥ and
- A. Pieter Kappetein, MD, PhD†
- ↵⁎Reprint requests and correspondence:
Dr. Michael J. Mack, Baylor Healthcare System, The Heart Hospital, 1100 Allied Drive, Plano, Texas 75075
Objectives This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial's randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease.
Background The SYNTAX trial compared PCI to CABG in patients with de novo 3-vessel and/or left main coronary disease.
Methods The SYNTAX randomized trial was conducted at 85 U.S. and European sites (n = 1,800). All strokes (up to 4 years) were independently adjudicated by a clinical events committee that included a neurologist. An additional 1,077 (of which 644 were followed for 5 years) and 198 patients were included in the CABG and PCI registries, respectively.
Results In the randomized cohort, 31 CABG and 19 PCI patients experienced 33 and 20 strokes post-randomization at 4-year follow-up, respectively (p = 0.062). Three strokes occurred pre-procedurally but following randomization in CABG-treated patients. After CABG, a large proportion of strokes occurred acutely (0 to 30 days: 9 of 33), whereas in the PCI arm, most strokes occurred >30 days after the procedure (18 of 20). Stroke resulted in death in 3 patients in both the PCI and CABG groups. Of the patients who developed stroke, 68% (21 of 31) in the CABG group had residual deficits at discharge; in the PCI group, 47% (9 of 19) had residual deficits. In a multivariate analysis, treatment with CABG was not significantly associated with increased stroke rates (odds ratio: 1.67, 95% confidence interval: 0.93 to 3.01, p = 0.089). The incidence and outcomes of stroke were similar in the randomized trial and registries.
Conclusions There is a higher risk of periprocedural stroke in patients undergoing CABG versus PCI; however, the risk converges over the first 4 years of follow-up. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972)
- coronary artery bypass graft
- drug-eluting stent(s)
- percutaneous coronary intervention
This work was supported by Boston Scientific Corporation. Drs. Stahle and Colombo have reported that they have received payment for the SYNTAX Steering Committee membership made to the institution and coverage of cost for participation in scientific meetings and travel expenses related to SYNTAX. Dr. Feldman has received consulting fees and institutional research grants from Boston Scientific, Abbott, and Edwards; has served as on the advisory boards of Boston Scientific and Abbott; and is on the Speakers' Bureau of Boston Scientific. Dr. Morice has received institutional research grants related to SYNTAX. The authors are unaware of any conflicts for Felix Unger; they were not able to contact him for disclosures. Dr. Erglis has received research grant support from Boston Scientific; and has served on the Speakers' Bureau of Boston Scientific. Dr. Stoler has served on the medical advisory board of Boston Scientific. Dr. Dawkins is a full-time employee of Boston Scientific with stock ownership. Dr. Kappetein has received institutional research grants related to SYNTAX and has served on the SYNTAX steering committee. George Dangas, MD, served as Guest Editor for this paper.
- Received July 19, 2012.
- Revision received November 20, 2012.
- Accepted November 29, 2012.
- American College of Cardiology Foundation