Safety and Efficacy of a Novel Everolimus-Eluting Stent System in “Real-World” Patients with Coronary Artery Disease: A Report of Preliminary Outcomes

Introduction: Tetrilimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) is a recently-introduced biodegradable-polymer coated everolimus-eluting cobalt-chromium coronary stent system with an ultra-thin strut thickness. We aimed to evaluate the clinical outcomes with Tetrilimus coronary stents in “real-world” patients with coronary artery disease. Methods: In this retrospective, single-arm, open-label, multi-center registry, all consecutive patients who received Tetrilimus stents between July-2015 and April-2016 at two tertiary-care centers in India were analyzed. Primary endpoint was 30-day incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target lesion revascularization, and target vessel revascularization. The Academic Research Consortium (ARC)-defined stent thrombosis was assessed as additional safety endpoint. Results: During the study period, 280 Tetrilimus stents (1.4 ± 0.5 stent/patient) were implanted to treat 252 coronary lesions (1.1 ± 0.3 stent/lesion) in 208 patients (age: 57.5 ± 11.9 years). Of study population, 65.9% were males, 46.6% were hypertensives, 25% were diabetics, 36.5% were alcoholics, 29.3% were smokers, 13.9% were tobacco chewers, 5.3% had previous revascularization, and 45.2% displayed multi-vessel disease. Of treated lesions, 67.5% were complex and 18.7% had total occlusion. Average length and diameter of implanted stents were 25.5 ± 8.8 mm and 2.9 ± 0.3 mm respectively. Subsequently, 30-day MACE were reported in 2 (0.96%) patients;both cases owing to in-hospital cardiac deaths. Events of stent thrombosis or noncardiac death were not reported in any patient. Conclusion: Low MACE rates and absence of stent thrombosis at early 30-day follow-up indicates that Tetrilimus everolimus-eluting stents may have encouraging safety and efficacy in unselected “real-world” patients with coronary artery disease.

One-Year Clinical Outcomes of Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stent System in Patients with Coronary Artery Disease

Background: The biodegradable polymer-coated sirolimus-eluting coro-nary stent (SES) system for the treatment of coronary artery disease (CAD) has been implanted in a real-world patient population. Aim: The present study was designed to evaluate the safety and performance of MetaforTM sirolimus- eluting coronary stent (SES) system in consecutive patients with CAD in a real-world patient population. Methods: All the consecutive 251 patients who underwent percutaneous coronary interventions with the use of Metafor sirolimus-eluting stents were included in this study. Patients were clinically/tele- phonically followed-up at one-year from August 2015 to August 2016. 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. Results: We collected and analyzed the data for 251 patients. Out of 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 ≥40 mm. 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%). Conclusions: This retrospective data demonstrated excellent safety and performance of Metafor SES in a “real-world” consecutive CAD patient, indicating low rates of MACE and ST at one-year follow-up.

A Real World Experience of Guidewire-Induced Perforations during Percutaneous Intervention and Their Successful Management

Complication rates following percutaneous interventions have decreased over the past decade due to advancement in both interventional equipment and procedure technique. Despite these advances, the risk of iatrogenic perforations still exists with associated high morbidity and mortality. We are presenting three cases of guidewire-induced perforations including coronary artery and renal artery perforation with their complications and successful management in these case-series.