Open-labeled randomized controlled trial to evaluate the 1-year clinical outcomes of polymer-free sirolimus-eluting coronary stents as compared with biodegradable polymer-based sirolimus-eluting coronary stents.

ABSTRACT:

Background

Head to head trials of clinical outcomes of sirolimus eluting polymer free vs. biodegradable polymer stents are lacking.

Methods

Single centre prospective open labeled randomised controlled clinical trial. Basis for sample size calculation was the rate of MACE from the ISAR TEST 3 trial in which the absolute difference was 10.25% with a standard deviation of 0.24. Assuming null hypothesis, 80% power and 5% alpha error, to detect a 10% difference, adjusting for 10% loss of follow up, sample size was 204.

Inclusion criteria

Patients with stable coronary artery disease or recent acute coronary syndrome ( >1 week from the date of STEMI), being taken up for elective angioplasty.

End points

Primary end point was MACE at 1 year and secondary end points at t

SUBMITTER: Viswanathan S 

PROVIDER: S-EPMC6310072 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature