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

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).

CONCLUSIONS

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.