An everolimus‐eluting stent versus a paclitaxel‐eluting stent in small vessel coronary artery disease: A pooled analysis from the SPIRIT II and SPIRIT III trials

Objectives: To evaluate the safety and efficacy of the XIENCE V everolimus‐eluting stent compared to the TAXUS paclitaxel‐eluting stent in small vessels. Backgroud: The XIENCE V everolimus‐eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated. Methods: In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter <2.765 mm) by using patient and lesion level data from the SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel‐eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express2 PES was the control. Results: Mean angiographic in‐stent and in‐segment late loss was significantly less in the EES group compared with the PES group, (0.15 ± 0.37 mm vs. 0.30 ± 0.44 mm; P = 0.011 for in‐stent; 0.10 ± 0.38 mm vs. 0.21 ± 0.34 mm; P = 0.034 for in‐segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non‐Q‐wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non‐Q‐wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037). Conclusions: In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES. © 2010 Wiley‐Liss, Inc.

[1]  P. Serruys,et al.  Treatment of very small vessels with 2.25-mm diameter sirolimus-eluting stents (from the RESEARCH registry). , 2004, The American journal of cardiology.

[2]  AlbertSchömig,et al.  Vessel Size and Long-Term Outcome After Coronary Stent Placement , 1998 .

[3]  Jan J Piek,et al.  A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial. , 2005, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[4]  A. Kastrati,et al.  Predictive Factors of Restenosis After Coronary Implantation of Sirolimus- or Paclitaxel-Eluting Stents , 2006, Circulation.

[5]  P. Serruys,et al.  Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions , 2007, Circulation.

[6]  A. Gershlick,et al.  Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomized controlled trial (E-SIRIUS) , 2004 .

[7]  William Wijns,et al.  Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS) , 2003, The Lancet.

[8]  N. Weissman,et al.  An intravascular ultrasound analysis of the mechanisms of restenosis comparing drug-eluting stents with brachytherapy. , 2006, American Journal of Cardiology.

[9]  P. Fitzgerald,et al.  Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. , 2008, JAMA.

[10]  P. Serruys,et al.  A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. , 2006, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[11]  C. Di Mario,et al.  Angiographic and clinical outcome following coronary stenting of small vessels: a comparison with coronary stenting of large vessels. , 1998, Journal of the American College of Cardiology.

[12]  R. Virmani,et al.  Oral Everolimus Inhibits In-Stent Neointimal Growth , 2002, Circulation.

[13]  F. Eberli,et al.  Impact of vessel size on outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents: a subgroup analysis of the SIRTAX trial. , 2007, Journal of the American College of Cardiology.

[14]  M. Hadamitzky,et al.  Vessel size and long-term outcome after coronary stent placement. , 1998, Circulation.

[15]  Ciro Indolfi,et al.  Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. , 2004 .

[16]  A. Kastrati,et al.  Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. , 2006, European heart journal.

[17]  M. Pfisterer,et al.  Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET. , 2008, European heart journal.

[18]  Jeffrey W Moses,et al.  Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. , 2003, The New England journal of medicine.

[19]  Gregg W Stone,et al.  Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. , 2005, JAMA.

[20]  R. Virmani,et al.  Endothelial cell recovery between comparator polymer-based drug-eluting stents. , 2008, Journal of the American College of Cardiology.

[21]  G. Breithardt,et al.  Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents , 2005, Circulation.

[22]  A. Coats,et al.  Ethical authorship and publishing. , 2009, International journal of cardiology.

[23]  P. Serruys,et al.  One-year clinical outcome after coronary stenting of very small vessels using 2.25 mm sirolimus- and paclitaxel-eluting stents: a comparison between the RESEARCH and T-SEARCH registries. , 2005, The Journal of invasive cardiology.

[24]  J. Popma,et al.  The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). , 2004, Journal of the American College of Cardiology.

[25]  C M Gibson,et al.  Generalized model of restenosis after conventional balloon angioplasty, stenting and directional atherectomy. , 1993, Journal of the American College of Cardiology.

[26]  G. Stone,et al.  Intravascular ultrasound assessment of lesions with target vessel failure after sirolimus-eluting stent implantation. , 2005, The American journal of cardiology.