Restenosis Rates Following Bifurcation Stenting With Sirolimus-Eluting Stents for De Novo Narrowings Kengo Tanabe, MD, Angela Hoye, MB ChB, Pedro A. Lemos, MD, Jiro Aoki, MD, Chourmouzios A. Arampatzis, MD, Francesco Saia, MD, Chi-hang Lee, MBBS, Muzzafer Degertekin, MD, Sjoerd H. Hofma, MD, Georgios Sianos, MD, PhD, Eugene McFadden, MB ChB, Pieter C. Smits, MD, PhD, Willem J. van der Giessen, MD, PhD, Pim de Feyter, MD, PhD, Ron T. van Domburg, PhD, and Patrick W. Serruys, MD, PhD The percutaneous treatment of coronary bifurcation stenoses is hampered by an increased rate of subse- quent restenosis. The present study reports on the outcomes of a consecutive series of 58 patients with 65 de novo bifurcation stenoses treated with siroli- mus-eluting stent implantation in both the main vessel and side branch. At 6 months, the incidence of major adverse cardiac events was 10.3% (1 death and 5 target lesion revascularizations) with no episodes of acute myocardial infarction or stent thrombosis. 2004 by Excerpta Medica, Inc. (Am J Cardiol 2004;91:115–118) P ercutaneous coronary intervention of bifurcation lesions is associated with lower procedural suc- cess rates 1 and an increased subsequent rate of major adverse cardiac events (MACEs) and restenosis. Var- ious techniques and strategies have been applied in an attempt to improve outcomes, including kissing bal- loon dilatation and the use of stent implantation in both branches. 2 The use of adjunctive atherectomy was found to be disadvantageous in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) trial. 3 Although there was an improved initial angiographic result with less residual stenosis, this was at the expense of a higher rate of side branch occlusion and acute myocardial infarction. In the long-term, results of angioplasty in bifurcations have been hampered by problems of restenosis, particularly after stent implantation within the side branch. 4,5 Re- cently, sirolimus-eluting stents (SESs) have demon- strated dramatically reduced restenosis rates in pa- tients with relatively simple lesions. 6,7 We sought to investigate the safety and efficacy of SESs in a con- secutive series of unselected patients with de novo bifurcation lesions enrolled in the Rapamycin-Eluting Stent Evaluation At Rotterdam Cardiology Hospital (RESEARCH) registry. 8 ••• Since April 2002, SES implantation (Cypher, John- son & Johnson–Cordis, Miami, Florida) has been used as the default strategy for all patients treated in our institution, as part of the RESEARCH registry. 8 Briefly, this single-center registry aims to evaluate the efficacy of SES implantation in the “real world” of interventional cardiology. All consecutive patients were enrolled, irrespective of clinical presentation and lesion characteristics, and the incidence of MACEs was prospectively evaluated during follow-up. At 6 months, a total of 563 consecutive patients were treated solely with SESs. Of these, 58 patients (10.3%) with de novo bifurcation lesions were treated with SES implantation in both the main and side branches; these patients comprise the present study population. The patients’ informed written consent was obtained in accordance with the rules of the institutional ethics committee, which approved the study. All procedures were performed with standard in- terventional techniques, except with the use of the SES as the device of choice. The strategy of bifurca- tion stenting employed and the use of kissing balloon dilatation after procedure was at the operators’ discre- tion. One of 4 methods of stenting was used: T- stenting, culotte stenting, kissing stents, or the “crush” technique. T-stenting and culotte stenting have been previously described. 5,9 Kissing stents involved simul- taneous implantation of the stents within both branches, with the proximal edges alongside each other, thereby bringing forward the point of diver- gence. The crush technique involves positioning both stents, with the proximal part of the side branch stent lying well within the main vessel, while ensuring that the edge of the stent in the main vessel is more proximal than the side branch stent. The side branch stent is deployed first, and the balloon and wire are carefully withdrawn. The main vessel stent is then deployed, thereby crushing the proximal part of the side branch stent. 10 SESs were available in diameters from 2.25 to 3.00 mm and lengths from 8 to 33 mm. During the procedure, intravenous heparin was given to maintain an activated clotting time of 250 sec- onds. All patients were prescribed lifelong aspirin and clopidogrel for 6 months. The use of glycoprotein IIb/IIIa inhibitors was at the discretion of the operator. Clinical and angiographic follow-up was per- formed at 6 months. MACEs were predefined as death, myocardial infarction, or target lesion revascu- From the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Neth- erlands. This study was supported by a grant from Cordis Corporation, a Johnson & Johnson Company. Dr. Serruys’ address is: Thoraxcenter, Bd 406, Erasmus MC, Dr Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail: p.w.j.c.serruys@erasmusmc.nl. Manuscript received December 2, 2003; revised manuscript received and ac- cepted March 19, 2004. 115 ©2004 by Excerpta Medica, Inc. All rights reserved. 0002-9149/04/$–see front matter The American Journal of Cardiology Vol. 91 July 1, 2004 doi:10.1016/j.amjcard.2004.03.040