Prospective randomized comparison of sirolimus- versus paclitaxel-eluting stents for the treatment of acute ST-elevation myocardial infarction: pROSIT trial

Catheter Cardiovasc Interv. 2008 Jul 1;72(1):25-32. doi: 10.1002/ccd.21510.

Abstract

Objective: The aim of this study was to compare effectiveness of the Sirolimus- (SES) and Paclitaxel-eluting stent (PES) in primary angioplasty for acute ST-elevation myocardial infarction (STEMI).

Background: It has been reported that SES and PES have been more effective than bare-metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there may be differences between these two drug-eluting stents in terms of efficacy in the setting of acute STEMI.

Methods: Acute STEMI patients (n = 308) undergoing primary angioplasty were randomly assigned to SES (n = 154) or PES (n = 154) deployment. The routine angiographic follow-up was performed at 6 months and clinical follow-up data was obtained at 12 months. The primary end point was major adverse cardiac events (MACE) including death, reinfarction, stent thrombosis, and target lesion revascularization (TLR) at 12 months.

Results: The baseline clinical, angiographic, and procedural characteristics were similar between the 2 groups. Two patients (all from the PES group) experienced stent thrombosis (1 acute and 1 subacute). The SES group revealed lower in-segment restenosis (5.9% vs. 14.8%, P = 0.03) and in-segment late loss (0.09 +/- 0.45 vs. 0.33 +/- 0.68 mm, P = 0.002) than PES group on follow-up angiography. Twelve-month TLR rates (2.6% vs. 6.5%, P = 0.17) were similar between two groups. MACE rates were lower in the SES group than in the PES group, but it did not reach statistical significance (5.8% vs. 11.7%, P = 0.07).

Conclusion: In the setting of primary angioplasty for STEMI, there were no statistically significant differences between the SES and the PES in terms of 12-month MACE. However, binary angiographic in-segment restenosis and in-segment late loss were significantly lower in the SES group.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary
  • Cohort Studies
  • Drug-Eluting Stents* / adverse effects
  • Female
  • Graft Occlusion, Vascular / diagnostic imaging
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / prevention & control
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Middle Aged
  • Myocardial Infarction / diagnostic imaging
  • Myocardial Infarction / physiopathology
  • Myocardial Infarction / therapy*
  • Paclitaxel / administration & dosage*
  • Radiography
  • Single-Blind Method
  • Sirolimus / administration & dosage*
  • Treatment Outcome
  • Tubulin Modulators / administration & dosage*

Substances

  • Immunosuppressive Agents
  • Tubulin Modulators
  • Paclitaxel
  • Sirolimus