Author + information
- Sridhar Kasturi1
The biodegradable polymer-coated Sirolimus-eluting Coronary Stent (SES) System for the treatment of atherosclerotic lesions has been implanted in a real-world patient population. The aim of the present study was to evaluate the safety and performance of Metafor Sirolimus-eluting Coronary Stent System (SES) in consecutive patients with atherosclerotic lesions in a real-world patient population.
This was a retrospective, observational, postmarketing study. We retrospectively collected and analyzed the data for 251 patients who underwent percutaneous coronary intervention (PCI) at the Sunshine Heart Institute from August 2015 to August 2016. We collected and analyzed data for 251 patients with atherosclerotic lesions who were implanted with Metafor SES and followed clinically/telephonically at one-year. We observed and analyzed major adverse cardiac event (MACE) defined as the aggregate of cardiac death, myocardial infarction (MI), and any target lesion revascularization (TLR) at one-year. Also, stent thrombosis (ST) was observed at one-year patients follow-up.
We collected and analyzed the data for 251 patients. Out of them 251 participants, 191(76.1%) were males, 95 (37.8%) patients had diabetes, 117 (46.6%) had ST-segment-elevation myocardial infarction (STEMI), and 134 (53.4%) had hypertension. Mean patient age was 56.35 ± 11.23 years. A total of 295 lesions were treated, out of which 13.6% of the lesions were the long lesion of ≥ 40mm. At one-year, MACE occurred in 4 (1.6%) of 251 patients, consisting of 2 (0.8%) cardiac deaths, 2 (0.8%) MI, and 0 (0%) TLR. Stent thrombosis was reported in one patient (0.4%).
This retrospective data demonstrated excellent safety and performance of Metafor SES in a “real- world” consecutive atherosclerotic lesions patient, indicating low rates of MACE and ST at one-year follow-up.