Response to Letter Regarding Article, “Outcomes in Patients With De Novo Left Main Disease Treated With Either Percutaneous Coronary Intervention Using Paclitaxel-Eluting Stents or Coronary Artery Bypass Graft Treatment in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) Trial”

Abstract

HomeCirculationVol. 123, No. 13Response to Letter Regarding Article, “Outcomes in Patients With De Novo Left Main Disease Treated With Either Percutaneous Coronary Intervention Using Paclitaxel-Eluting Stents or Coronary Artery Bypass Graft Treatment in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) Trial” Free AccessReplyPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReplyPDF/EPUBResponse to Letter Regarding Article, “Outcomes in Patients With De Novo Left Main Disease Treated With Either Percutaneous Coronary Intervention Using Paclitaxel-Eluting Stents or Coronary Artery Bypass Graft Treatment in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) Trial” Marie-Claude Morice, MD Marie-Claude MoriceMarie-Claude Morice Institut Hospitalier Jacques Cartier Massy, France (Morice) Search for more papers by this author Originally published5 Apr 2011https://doi.org/10.1161/CIRCULATIONAHA.110.003616Circulation. 2011;123:e399We thank Dr Uretsky for his interest in our study.1 He is correct that 248 of 705 patients who were visually assessed as having distal left main (LM) bifurcation disease by the site's Heart Team (interventional cardiologist, cardiothoracic surgeon, and study coordinator) were later determined by the core laboratory to not strictly meet the study protocol definition of LM disease (eg, the patients were determined to have B- [Medina type 0,1,0]- or E- [Medina type 0,0,1]-type distal LM bifurcation lesions). This discrepancy between the site and core laboratory determinations is typical of clinical trials that use a core laboratory for standardization. We have not separately assessed outcomes excluding those patients whom the core laboratory did not deem to have LM disease because, on an intent-to-treat basis, study investigators treated them as having LM disease.Because it is likely that clinicians will treat this group as having LM disease in the future, subanalysis of outcomes in this group, as Dr Uretsky suggests, is a good idea. We agree with Dr Uretsky that visual assessment of lesions identified by angiography does have limitations. We also agree that increased use of other techniques (such as fractional flow reserve, optical coherence tomography, or intravascular ultrasound) will aid in making appropriate treatment decisions in this patient population, and that increased use of these techniques should be encouraged. However, in clinical practice, most patients are treated by surgery or percutaneous coronary intervention without any additional evaluation. In this regard, we look forward to the results from the Evaluation of Xience Prime versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial, which will require fractional flow reserve or intravascular ultrasound confirmation of visual estimates in those patients who have more intermediate lesions.2Marie-Claude Morice, MD Institut Hospitalier Jacques Cartier Massy, FranceAcknowledgmentsThe authors for the SYNTAX Left Main Subset analysis were as follows: Patrick W. Serruys, MD, PhD and A. Pieter Kappetein, MD, PhD (Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands); Ted E. Feldman, MD (Evanston Hospital, Evanston, IL), Elisabeth Ståhle, MD (University Hospital Uppsala, Uppsala, Sweden); Antonio Colombo, MD and Lucia Torracca, MD (San Raffaele Scientific Institute, Milan, Italy); Michael J. Mack, MD (Heart Hospital Baylor Plano, Dallas, TX); David R. Holmes, MD (Mayo Clinic, Rochester, MN); Gerrit-Anne van Es, PhD (Cardialysis, Rotterdam, The Netherlands); Katrin Leadley, MD and Keith D. Dawkins, MD (Boston Scientific Corporation, Natick, MA); and Friedrich Mohr, MD (University of Leipzig Heart Center, Leipzig, Germany).DisclosuresDrs Serruys and Mohr were the SYNTAX Study Principal Investigators, and Drs Kappetein and Morice were co-Principal Investigators. Drs Leadley and Dawkins report being full-time employees of, and owning equity within, Boston Scientific Corporation. Dr van Es is a full-time employee of Cardialysis. Drs Ståhle and Colombo report receiving research grants from Boston Scientific Corporation. Dr Feldman reports receiving research grants and Speaker's Bureau/honoraria from Boston Scientific Corporation and Abbott Vascular. The other authors report no conflicts of interest.