Real-world five-year outcomes of FlexyRap®cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease

BACKGROUND The use of biodegradable polymer drug-eluting stents(BP-DES)has been proven to minimize restenosis and stent thrombosis.The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap®DES in the real world.AIM To assess the safety and effectiveness of FlexyRap®DES at the 5-year follow-up in real-world settings.METHODS Findings from a retrospective,multi-center,observational,post-market clinical follow-up study of patients treated with FlexyRap®DES for de novo coronary artery disease(CAD)were reported.During the 12-mo follow-up,the primary endpoint was target lesion failure,which was defined as the composite of cardiovascular death, target vessel myocardial infarction(TV-MI), and clinically driven target lesion revascularization.RESULTS The data of 500 patients received with FlexyRap®DES was obtained at the completion of the surveillance timeline of 5-year.After the implantation of FlexyRap®DES,the device success rate was 100%.Adverse events that led to major bleeding,permanent disability,or death were not experienced in the patients.The major adverse cardiac event rate at 12-mo,3-year,and 5-year follow-up was 1(0.2%),0(0%),and 1(0.2%)respectively with 0(0%)cardiovascular death,2(0.4%)TV-MI,and 0(0%)TLR compositely.Furthermore,late stent thrombosis was found in 2(0.4%)patients at the follow-up of 12-mo,very late stent thrombosis was observed in 2 patients(0.4%)at 3-year follow-up.CONCLUSION FlexyRap®DES was proved to be safe and efficacious in real-world patients with de novo CAD,indicating a lowered rate of cardiac events and stent thrombosis at 5-year follow-up.

Safety and performance of the EverProTM everolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario

BACKGROUND The EverProTM(Sahajanand Laser Technology Ltd.,India)everolimus-eluting coronary stent system(EES)is a second-generation drug-eluting stent with a biodegradable polymer.AIM To determine the safety and performance of the EverProTM EES in patients with coronary artery disease(CAD)during a 1-year clinical follow-up.METHODS This observational,retrospective,single-center study enrolled patients who had been implanted with the EverProTM stent between June 1,2018 and January 31,2019,and had completed a 1-year follow-up period after the index procedure.The primary clinical endpoint was major adverse cardiac events(MACE)at 6 mo defined as the composite of cardiac death,myocardial infarction(MI),and target lesion revascularization(TLR).Secondary endpoints were the incidence of TLR at 1,6 and 12 mo follow-up,MACE at 1 and 12 mo follow-up,and stent thrombosis up to 1 year after the index procedure.RESULTS The study population comprised 77 patients(98 lesions).A total of 37(48.1%)patients had comorbid hypertension.In total,26(33.8%)patients presented with ST segment elevation MI and 10.4%patients with non-ST segment elevation MI.Treated lesions were located mainly in the left anterior descending artery(49%)followed by the right coronary artery(29.6%),left circumflex(12.2%)and obtuse marginal(9.2%)arteries.The majority of patients were with single-vessel disease(79%),22.2%of lesions had a mild to severe thrombus load,and 94.9%were American College of Cardiology/American Heart Association type B or C.De novo stenting was performed in 96.9%of patients and 3%were treated for in-stent restenosis.Procedural success was attained in all patients.In-hospital or followup MACE and stent thrombosis were not reported during the 1-year follow-up period.CONCLUSION These findings suggest that the EverProTM EES is a safe and effective treatment option with no MACE or stent thrombosis reported during the 1-year study period in patients with CAD.

One-year outcomes of a Neo Hexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from Neo Registry in India

BACKGROUND Biodegradable polymer drug-eluting stents(BP-DES)have shown to reduce restenosis rates and have low rates of stent thrombosis.The present postmarketing surveillance assessed 1-year clinical outcomes of patients who had received Neo Hexa DES in real practice.AIM To investigate 1-year clinical outcomes of Neohexa DES in real practice.METHODS Data obtained from a single-center cohort of patients who had received Neo Hexa stents as part of routine treatment of coronary artery disease(CAD)were retrospectively investigated.The primary study endpoint was the rate of major adverse cardiac events(MACEs)defined as the composite of death,myocardial infarction(MI),and target lesion revascularization(TLR)during the follow-up at1 mo,6 mo,and 1 year after the index procedure.RESULTS A total of 129 patients with 172 lesions were enrolled.The most common comorbid conditions were hypertension(49.61%)and diabetes mellitus(39.53%).Procedural success was achieved in all patients,and no in-hospital MACE was reported.The incidence of composite MACE at 30 d,6 mo,and 1 year was 0.78%,3.94%,and 4.87%,respectively.The rate of possible and probable late stent thrombosis was 0.78%.The cumulative incidences of death,MI,and TLR at 1 year were 2.44%,0.81%,and 1.63%,respectively.CONCLUSION The relatively low rates of MACE and stent thrombosis in this study support safety and performance of Neo Hexa stents,suggesting it to be an effective alternative to other contemporary stents for the treatment of de novo lesions in native coronary arteries.