Long-term safety and efficacy of sirolimus- vs. paclitaxel-eluting stent implantation for acute ST-elevation myocardial infarction: 3-year follow-up of the PROSIT trial.

Meta-analysis of randomized trials showed superior efficacy and similar safety of drug-eluting stent over bare-metal stent in acute ST-elevation myocardial infarction (STEMI) patients. However, long-term relative outcomes of sirolimus- (SES) vs. paclitaxel-eluting stent (PES) have not been fully evaluated in randomized studies. This study compared long-term safety and efficacy of these two stents in STEMI.
A total of 308 STEMI patients were randomly treated with SES (n = 154) or PES (n = 154). Three-year clinical outcomes were assessed. Primary outcome of interest was incidence of major adverse cardiac events (MACE) including death, myocardial infarction (MI), stent thrombosis or target vessel revascularization (TVR). Secondary outcome of interest was occurrence of very late stent thrombosis.
Both groups had similar baseline characteristics. During follow-up, there was no difference between the two groups in terms of death (6.5% for SES and 10.4% for PES, p = 0.22), MI (2.6% vs. 3.9%, p = 0.75), stent thrombosis (1.9% vs. 3.2%, p = 0.72), TVR (3.9% vs. 8.4%, p = 0.15) and MACE (12.3% vs. 18.8%, p = 0.12). Eight patients in overall population had stent thrombosis: definite 3, probable 1, and possible 4. Cumulative incidence of stent thrombosis was gradually increased; 0.6% at 30 days, 0.6% at 1 year, 1.6% at 2 years, and 2.6% at 3 years. Very late stent thrombosis, definite or probable, occurred in 0.6% for both.
Among non-selected STEMI patients who underwent primary angioplasty, both SES and PES might be safe and SES showed similar three-year clinical outcomes compared to PES.
AuthorsHyun-Sook Kim, Jae-Hwan Lee, Seung-Whan Lee, Young-Hak Kim, Jae-Hyeong Park, Si-Wan Choi, Jin-Ok Jeong, In-Whan Seong, Kyoung-Suk Rhee, Jae-Ki Ko, Sang-Ho Jo, Young Jin Choi
JournalInternational journal of cardiology (Int J Cardiol) Vol. 147 Issue 2 Pg. 253-7 (Mar 3 2011) ISSN: 1874-1754 [Electronic] Netherlands
PMID19783056 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
CopyrightCopyright © 2009 Elsevier Ireland Ltd. All rights reserved.
Chemical References
  • Immunosuppressive Agents
  • Tubulin Modulators
  • Paclitaxel
  • Sirolimus
  • Angioplasty, Balloon, Coronary (adverse effects, mortality)
  • Cause of Death
  • Coronary Restenosis (mortality)
  • Disease-Free Survival
  • Drug-Eluting Stents (adverse effects, statistics & numerical data)
  • Electrocardiography
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents (therapeutic use)
  • Incidence
  • Kaplan-Meier Estimate
  • Myocardial Infarction (diagnosis, mortality, therapy)
  • Paclitaxel (therapeutic use)
  • Randomized Controlled Trials as Topic (mortality)
  • Sirolimus (therapeutic use)
  • Tubulin Modulators (therapeutic use)

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