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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Impact of Vessel Size on Outcome After Implantation of Sirolimus-Eluting and Paclitaxel-Eluting Stents

A Subgroup Analysis of the SIRTAX Trial

Mario Togni, MD^_*, Stéphanie Eber, BA^_*, Jeannette Widmer, BA^_*, Michael Billinger, MD^_*, Peter Wenaweser, MD^_*, Stéphane Cook, MD^_*, Rolf Vogel, MD, PhD^_*, Christian Seiler, MD, FACC^_*, Franz R. Eberli, MD, Willibald Maier, MD, Roberto Corti, MD, Marco Roffi, MD, Thomas F. Lüscher, MD, Ali Garachemani, MD^_*, Otto M. Hess, MD, FACC^_*, Simon Wandel, MS, Bernhard Meier, MD, FACC^_*, Peter Jüni, MD and Stephan Windecker, MD^_*,_*

^_* Department of Cardiology, University Hospital Bern, Switzerland
Department of Social and Preventive Medicine, University Hospital Bern, Switzerland
Department of Cardiology, University Hospital Zurich, Zurich, Switzerland.

Manuscript received January 22, 2007; revised manuscript received June 7, 2007, accepted June 25, 2007.

^_* Reprint requests and correspondence: Dr. Stephan Windecker, Professor and Head of Invasive Cardiology, Department of Cardiology, University Hospital, 3010 Bern, Switzerland. (Email: stephan.windecker{at}insel.ch).

Objectives: We assessed the impact of vessel size on angiographic and long-term clinical outcome after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) within a randomized trial (SIRTAX [Sirolimus-Eluting Stent Compared With Paclitaxel-Eluting Stent for Coronary Revascularization]).

Background: Percutaneous coronary intervention in small-vessel disease is associated with an increased risk of major adverse cardiac events (MACE).

Methods: A total of 1,012 patients were randomly assigned to treatment with SES (n = 503) or PES (n = 509). A stratified analysis of angiographic and clinical outcome was performed up to 2 years after PCI according to size of the treated vessel (reference vessel diameter 2.75 vs. >2.75 mm).

Results: Of 1,012 patients, 370 patients (37%) with 495 lesions underwent stent implantation in small vessels only, 504 patients (50%) with 613 lesions in large vessels only, and 138 patients (14%) with 301 lesions in both small and large vessels (mixed). In patients with small-vessel stents, SES reduced MACE by 55% (10.4% vs. 21.4%; p = 0.004), mainly driven by a 69% reduction of target lesion revascularization (TLR) (6.0% vs. 17.7%; p = 0.001) compared with PES at 2 years. In patients with large- and mixed-vessel stents, rates of MACE (large: 10.4% vs. 13.1%; p = 0.33; mixed: 16.7% vs. 18.0%; p = 0.83) and TLR (large: 6.9% vs. 8.6%; p = 0.47; mixed: 16.7% vs. 15.4%; p = 0.86) were similar for SES and PES. There were no significant differences with respect to death and myocardial infarction between the 3 groups.

Conclusions: Compared with PES, SES more effectively reduced MACE and TLR in small-vessel disease. Differences between SES and PES appear less pronounced in patients with large- and mixed-vessel disease. (The SIRTAX trial; http://clinicaltrials.gov/ct/show/NCT00297661?order=1; NCT00297661 [ClinicalTrials.gov] ).

Abbreviations and Acronyms   DES = drug-eluting stent(s)   MACE = major adverse cardiac events   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   RVD = reference vessel diameter   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization

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