Clinical safety of drug-eluting stents in the Korea acute myocardial infarction registry.

BACKGROUND Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may be useful in patients with acute myocardial infarction (AMI), but safety issues still need to be solved. This study was undertaken to investigate the incidence of major adverse cardiac events (MACE) and stent thrombosis in DES-implanted AMI patients in real-life clinical practice. METHODS AND RESULTS On-line registry of AMI cases at the web site www.kamir.or.kr has been performed in 41 primary PCI centers in Korea and between November 2005 and September 2006, 1,541 surviving patients who had been implanted with either Cypher or Taxus stents were enrolled for analysis during a 6-month clinical follow-up. There were 2 groups: group I [834 patients, 61.9+/-11.9 years: sirolimus-eluting stent (Cypher)], group II [707 patients, 62.9+/-12.0 years: paclitaxel-eluting stent (Taxus)]. At both 1 and 6 months the incidence of MACE was not significantly different between the 2 groups. There were 17 cases of stent thrombosis, but the incidence of stent thrombosis was not significantly different between the 2 groups (group I:II=9 (1.1%):8 (1.1%), p=1.000). The stent type, length, number, lesion complexity and diabetes were not significant for the incidence of MACE or stent thrombosis after adjustment. CONCLUSION MACE and stent thrombosis rates did not differ between 2 types of DES identified in Korea Acute Myocardial Infarction Registry (KAMIR). DES can be used in patients with AMI with a relatively low 6-month MACE rate.

[1]  M. Pfisterer,et al.  Targeted stent use in clinical practice based on evidence from the Basel Stent Cost Effectiveness Trial (BASKET). , 2007, European heart journal.

[2]  Arianna Azzellino,et al.  Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). , 2007, Journal of the American College of Cardiology.

[3]  Johan Lindbäck,et al.  Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. , 2007, The New England journal of medicine.

[4]  Marco Valgimigli,et al.  Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. , 2007, The New England journal of medicine.

[5]  S. Saito,et al.  Late angiographic stent thrombosis after sirolimus-eluting stent implantation. , 2007, Circulation journal : official journal of the Japanese Circulation Society.

[6]  Patrick Hunziker,et al.  Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. , 2006, Journal of the American College of Cardiology.

[7]  Y. Higashikuni,et al.  Clinical and angiographic outcomes of sirolimus-eluting stents implantation in Japanese patients in daily practice. , 2006, Circulation journal : official journal of the Japanese Circulation Society.

[8]  A. Santarelli,et al.  Focus Issue: Cardiac InterventionSirolimus-Paclitaxel ComparisonClinical Outcomes for Sirolimus-Eluting Stents and Polymer-Coated Paclitaxel-Eluting Stents in Daily Practice: Results From a Large Multicenter Registry , 2006 .

[9]  E. Bramucci,et al.  Sirolimus-eluting versus uncoated stents in acute myocardial infarction. , 2006, The New England journal of medicine.

[10]  J. Tijssen,et al.  Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. , 2006, The New England journal of medicine.

[11]  Harlan M. Krumholz,et al.  Prevalence, Predictors, and Outcomes of Premature Discontinuation of Thienopyridine Therapy After Drug-Eluting Stent Placement: Results From the PREMIER Registry , 2006, Circulation.

[12]  P. Serruys,et al.  Sirolimus-eluting stents remain superior to bare-metal stents at two years: medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. , 2006, Journal of the American College of Cardiology.

[13]  J. Moses,et al.  Two-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial. , 2006, Journal of the American College of Cardiology.

[14]  P. Serruys,et al.  Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. , 2006, JAMA.

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

[16]  A. Kastrati,et al.  Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. , 2005, The New England journal of medicine.

[17]  F. Eberli,et al.  Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. , 2005, The New England journal of medicine.

[18]  P. Serruys,et al.  Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents: Three-Year Results of the RAVEL Trial , 2005, Circulation.

[19]  G. Stone,et al.  Polymer-based paclitaxel-eluting stents in percutaneous coronary intervention: a review of the TAXUS trials. , 2004, Journal of interventional cardiology.

[20]  J. Stauffer,et al.  Use of sirolimus‐eluting coronary stents in routine clinical practice , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[21]  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.

[22]  P. Heidenreich,et al.  Racial Disparity in Cardiac Procedures and Mortality Among Long‐Term Survivors of Cardiac Arrest , 2003, Circulation.

[23]  N. Weissman,et al.  A paclitaxel-eluting stent for the prevention of coronary restenosis. , 2003, The New England journal of medicine.

[24]  P. Serruys,et al.  A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. , 2002, The New England journal of medicine.

[25]  L. Clark,et al.  Primary stent implantation compared with primary balloon angioplasty for acute myocardial infarction: a meta-analysis of randomized clinical trials. , 2001, The American journal of cardiology.

[26]  Bruce R. Brodie,et al.  Coronary Angioplasty with or without Stent Implantation for Acute Myocardial Infarction , 1999 .

[27]  M. Pfisterer,et al.  BASKET-LATE INVESTIGATORS, LATE CLINICAL EVENTS AFTER CLOPIDOGREL DISCONTINUATION MAY LIMIT THE BENEFIT OF DRUGELUTING STENTS: AN OBSERVATIONAL STUDY OF DRUG-ELUTING VERSUS BARE-METAL STENTS , 2006 .