One-year outcome of small-vessel disease treated with sirolimus-eluting stents: a subgroup analysis of the e-SELECT registry.

OBJECTIVES To investigate the characteristics and one-year outcomes following sirolimus-eluting CYPHER Select Plus stent (SES) implantation in small (SmVD) and non-small vessel disease (NSmVD) in the international e-SELECT registry. BACKGROUND Large-scale registry data are lacking on DES outcomes in SmVD treatment. METHODS There were 4,700 SmVD (at least one vessel with estimated reference vessel diameter [RVD] < 2.5 mm, excluding 283 patients with unknown RVD vessels) and 10,139 NSmVD only patients. RESULTS The SmVD population was older, with more women, diabetics, and vessels treated, higher mean Charlson Comorbidity Index score (CCI), shorter lesions, and less STEMI presentation. The 1-year stent thrombosis (ST) rate (primary end-point), was significantly higher (1.3% vs. 0.7%) in SmVD versus NSmVD, mainly driven by early events. One-year major adverse cardiac event (MACE), myocardial infarction (MI), and clinically indicated target-lesion revascularization (TLR) rates were significantly higher in SmVD although death and major bleeding rates were similar in both groups. Complication rates were similar between pure (3,188 patients; only RVD < 2.5 mm) and mixed (1,795 patients; some RVD < 2.5 mm or unknown RVD) SmVD. Multivariate predictors for 1-year MACE in SmVD included saphenous vein graft or bifurcation lesions, major bleeding, any antiplatelet therapy discontinuation within 1 month, age, number of stents implanted, CCI, acute coronary syndrome, and insulin-dependent diabetes mellitus. CONCLUSION SES implantation for SmVD occurs more frequently in women, diabetics, and those with multivessel disease and comorbidities. One-year ST, MACE, MI, and clinically indicated TLR rates are higher, although low overall, in SmVD or mixed SmVD patients while death rates are similar to NSmVD.

[1]  Jennifer Taylor The Journal of Interventional Cardiology. , 2012, European heart journal.

[2]  S. Ellis,et al.  One-year clinical outcomes after sirolimus-eluting coronary stent implantation for acute myocardial infarction in the worldwide e-SELECT registry. , 2012, Journal of interventional cardiology.

[3]  F. Neumann,et al.  The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry. , 2012, JACC: Cardiovascular Interventions.

[4]  M. Jeong,et al.  Outcomes in patients undergoing multivessel percutaneous coronary intervention using sirolimus-eluting stents: a report from the e-SELECT registry. , 2011, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[5]  M. Jeong,et al.  Sirolimus-eluting coronary stents in octogenarians: a 1-year analysis of the worldwide e-SELECT Registry. , 2011, JACC. Cardiovascular interventions.

[6]  M. Jeong,et al.  Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry. , 2011, Journal of the American College of Cardiology.

[7]  J. Popma,et al.  A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial. , 2011, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[8]  L. Sim,et al.  Long-term outcomes after coronary bare-metal-stent and drug-eluting-stent implantations: a ‘real-world’ comparison among patients with diabetes with diffuse small vessel coronary artery disease , 2011, Coronary artery disease.

[9]  J. Hermiller,et al.  Percutaneous coronary intervention for small-vessel coronary disease: highlight on the everolimus-eluting stent , 2010, Expert review of cardiovascular therapy.

[10]  Patrick W Serruys,et al.  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 , 2010, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[11]  G. Biondi-Zoccai,et al.  Percutaneous coronary intervention for small vessel coronary artery disease. , 2010, Cardiovascular revascularization medicine : including molecular interventions.

[12]  D. Capodanno,et al.  Sirolimus versus paclitaxel-eluting stents in small coronary vessels: long-term outcomes from a single-center registry , 2010, Journal of cardiovascular medicine.

[13]  P. Fitzgerald,et al.  Sirolimus-eluting stent implantation in small coronary arteries: a three dimensional intravascular ultrasound study from the SIRIUS trial. , 2010, International journal of cardiology.

[14]  H. Ackermann,et al.  Treatment of small coronary arteries with a paclitaxel-coated balloon catheter , 2010, Clinical Research in Cardiology.

[15]  G. Stone,et al.  Clinical and angiographic comparison of everolimus-eluting and paclitaxel-eluting stents in small coronary arteries: a post hoc analysis of the SPIRIT III randomized trial. , 2009, American heart journal.

[16]  F. Eberli,et al.  Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy. , 2009, JACC. Cardiovascular interventions.

[17]  R. Jabara,et al.  Clinical and Angiographic Features of Small Vessel Stenting in the Drug‐Eluting Stent Era , 2009, Clinical cardiology.

[18]  H. Izawa,et al.  Safety and efficacy of 2.5-mm sirolimus-eluting stent implantation at lower deployment pressures in very small vessels (<2.5 mm) , 2009, Coronary artery disease.

[19]  D. Baim,et al.  Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut TAXUS Liberté stent: 1-year results from the TAXUS ATLAS program. , 2008, JACC. Cardiovascular interventions.

[20]  E. Romagnoli,et al.  Clinical and angiographic follow-up of small vessel lesions treated with paclitaxel-eluting stents (from the TRUE Registry). , 2008, The American journal of cardiology.

[21]  K. Kadota,et al.  The impact of lesion length and vessel size on outcomes after sirolimus-eluting stent implantation for in-stent restenosis , 2007, Heart.

[22]  R. Antolín,et al.  Fracaso en la implantacin de stent liberadores de frmacos. Frecuencia y factores relacionados , 2007 .

[23]  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.

[24]  A. Colombo,et al.  Drug-Eluting Stent Update 2007: Part III: Technique and Unapproved/Unsettled Indications (Left Main, Bifurcations, Chronic Total Occlusions, Small Vessels and Long Lesions, Saphenous Vein Grafts, Acute Myocardial Infarctions, and Multivessel Disease) , 2007, Circulation.

[25]  A. Colombo,et al.  Incidence and Predictors of Drug-Eluting Stent Thrombosis During and After Discontinuation of Thienopyridine Treatment , 2007, Circulation.

[26]  J. E. Sousa,et al.  Small coronary arteries treated with sirolimus-eluting stents: one-year results of the PORTO multicentre registry. , 2007, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[27]  C. Di Mario,et al.  Testing prospectively the effectiveness and safety of paclitaxel-eluting stents in over 1000 very high-risk patients: design, baseline characteristics, procedural data and in-hospital outcomes of the multicenter Taxus in Real-life Usage Evaluation (TRUE) Study. , 2007, International journal of cardiology.

[28]  Seung‐Jung Park,et al.  Factors predictive of cardiac events and restenosis after sirolimus‐eluting stent implantation in small coronary arteries , 2007, Catheterization and cardiovascular interventions.

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

[30]  B. Xu,et al.  Drug-eluting stent for the treatment of small coronary lesion: comparison between sirolimus- and paclitaxel-eluting stent. , 2007, Chinese medical journal.

[31]  J. E. Sousa,et al.  Anatomical and physiologic assessments in patients with small coronary artery disease: final results of the Physiologic and Anatomical Evaluation Prior to and After Stent Implantation in Small Coronary Vessels (PHANTOM) trial. , 2007, American heart journal.

[32]  P. Serruys,et al.  Two‐year clinical outcome after coronary stenting of small vessels using 2.25‐mm sirolimus‐ and paclitaxel‐eluting stents: Insight into the RESEARCH and T‐SEARCH registries , 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[33]  R. H. Hernández Antolín,et al.  [Failure in the implantation of drug eluting stents. Frequency and related factors]. , 2007, Medicina intensiva.

[34]  Hong Wang,et al.  Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial. , 2006, The American journal of cardiology.

[35]  J. Ottervanger,et al.  Comparison between stenting and balloon angioplasty in patients undergoing primary angioplasty of small coronary vessels. , 2006, American heart journal.

[36]  A. Kastrati,et al.  Vessel size and outcome after coronary drug-eluting stent placement: results from a large cohort of patients treated with sirolimus- or paclitaxel-eluting stents. , 2006, Journal of the American College of Cardiology.

[37]  S. Steinhubl,et al.  Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. , 2006, The New England journal of medicine.

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

[39]  S. Windecker,et al.  Sirolimus-eluting coronary stents in small vessels. , 2006, American heart journal.

[40]  B. Xu,et al.  Comparison of drug-eluting stent and bare-mental stent in the complex small vessel intervention. , 2006, Chinese medical journal.

[41]  Mattos La,et al.  Análise comparativa da hiperplasia intimal após o implante de stents com e sem sirolimus em artérias coronárias de pequeno calibre , 2006 .

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

[43]  F. Feres,et al.  [Comparative analysis of intimal hyperplasia after sirolimus-eluting stent and thin-strut bare-metal stent implantation in small coronary arteries]. , 2006, Arquivos brasileiros de cardiologia.

[44]  E. Bramucci,et al.  Effect of sirolimus-eluting stent in diabetic patients with small coronary arteries (a SES-SMART substudy). , 2005, The American journal of cardiology.

[45]  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.

[46]  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.

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

[48]  D. Holmes,et al.  The approach to small vessels in the era of drug-eluting stents. , 2005, Reviews in cardiovascular medicine.

[49]  E. Bramucci,et al.  Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. , 2004, JAMA.

[50]  Y. Ikari,et al.  Cutting balloon angioplasty is superior to balloon angioplasty or stent implantation for small coronary artery disease , 2004, Coronary artery disease.

[51]  David J Cohen,et al.  Stent Thrombosis After Successful Sirolimus-Eluting Stent Implantation , 2004, Circulation.

[52]  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.

[53]  Iijima Raisuke,et al.  Predictors of restenosis after implantation of 2.5 mm stents in small coronary arteries. , 2004, Circulation journal : official journal of the Japanese Circulation Society.

[54]  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.

[55]  A. Kastrati,et al.  Predictive factors for early cardiac events and angiographic restenosis after coronary stent placement in small coronary arteries. , 2002, Journal of the American College of Cardiology.

[56]  M. Borggrefe,et al.  Role of vessel size as a predictor for the occurrence of in-stent restenosis in patients with diabetes mellitus. , 2001, The American journal of cardiology.

[57]  K. Hung,et al.  Acute and long‐term outcomes of stenting in coronary vessel > 3.0 mm, 3.0–2.5 mm, and < 2.5 mm , 2001, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[58]  T. Feldman,et al.  Acute and late outcome after use of 2.5‐mm intracoronary stents in small (< 2.5 mm) coronary arteries , 2000, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

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

[60]  J. Birkmeyer,et al.  Effect of coronary artery diameter in patients undergoing coronary bypass surgery. Northern New England Cardiovascular Disease Study Group. , 1996, Circulation.

[61]  C. Mackenzie,et al.  A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. , 1987, Journal of chronic diseases.