Author + information
- Shridhar Kasturi
The biodegradable polymer-coated Sirolimus-eluting Coronary Stent (SES) System for the treatment of coronary artery diseases has resulted in substantial improvements in real-life scenario.
To evaluate the safety and performance of Metafor Sirolimus-eluting Coronary Stent System (SES) in consecutive patients with coronary artery disease (CAD) in a real-life scenario.
This was a retrospective, observational, postmarketing study conducted in 251 patients with CAD who were implanted with Metafor SES (Meril Life Sciences, Pvt .Ltd., Gujarat, India) and followed clinically/telephonically at one-year. The primary endpoint was a 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.
Out of them 251 participants, 191 (76.1%) were male, 95 (37.8%) patients had diabetes, 153 (61%) had MI, 161 (64.1%) had stable angina, and 134 (53.4%) had hypertension which is suggestive of a real-life scenario. Mean patient age was 56.35 ± 11.23 years and 17 patients underwent primary percutaneous coronary interventions (PCI). A total of 295 lesions were treated, out of which 13.6% of the lesions were 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 the “real-life” consecutive CAD patients, indicating low rates of MACE and ST at one-year follow-up.