Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial.

BACKGROUND: The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis. METHODS/DESIGN: The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020-000,137-40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR. SUMMARY: The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial.

Clinical safety and performance of the world's thinnest-strut Evermine50 everolimus-eluting stent: a 24-month follow-up of the Evermine 50 EES - 1 study.

Background: Ultrathin-strut stents are considered the future of percutaneous coronary intervention for treating coronary artery disease (CAD). These drug-eluting stents with biodegradable-polymer technology have the potential to improve clinical outcomes in CAD patients. Aims: This study aimed to evaluate the safety and performance of newer-generation ultrathin-strut (50 µm) Evermine50 everolimus-eluting stents (EES) in patients with single or multiple long lesions. Methods: This is a prospective, single-arm, multicentre study conducted in India that enrolled 118 patients with de novo coronary lesions. The endpoints were defined based on the major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction [MI] and clinically driven target lesion revascularisation) up to 24-month follow-up. A subset of patients (n=21) underwent angiographic follow-up for a mean follow-up period of 12 mon. Results: A total of 138 lesions were successfully treated in 118 patients, the majority of whom were males (80.51%). The average stent length and diameter deployed were 26.02±9.24 mm and 2.97±0.36 mm, respectively. The results exhibited low MACE at 24-month follow-up (0.87%) with no stent thrombosis and 1 death (0.87%, which was cardiac). The core lab angiographic assessment showed in-segment and in-device late lumen loss of 0.12±0.31 mm and 0.17±0.31 mm, respectively, at a mean follow-up of 12 months, with clinically acceptable outcomes. Conclusions: The Evermine50 EES showed satisfactory primary clinical as well as angiographic outcomes, reaffirming the safety and performance of the world's thinnest-strut stent by exhibiting low rates of MACE at 24-month follow-up with an absence of any stent thrombosis and MI. Clinical Trials Registry-India (CTRI) number: CTRI/2017/02/007781.

Real-world evidence of BioMime sirolimus-eluting stent in obstructive coronary artery disease: the meriT-2 trial.

Background: The efficacy and safety of the ultrathin BioMime sirolimus-eluting coronary stent (SES) system in treating single or multiple de novo native coronary lesions, in-stent restenosis, and bifurcation lesions have been evidenced at 1 year. Aims: We sought to investigate the long-term safety and efficacy of the BioMime SES in a real-world population with obstructive coronary artery disease (CAD). Methods: The prospective, single-arm, multicentre meriT-2 trial enrolled 250 patients from 11 sites across India. The safety endpoint was the cumulative frequency of major adverse cardiovascular events (MACE) at 5 years, defined as a composite of cardiac death, myocardial infarction (MI), emergent coronary artery bypass grafting or clinically indicated target lesion revascularisation (CI-TLR). Stent thrombosis (ST) was evaluated according to the Academic Research Consortium definitions. Results: A total of 214 (85.6%) subjects completed the 5-year follow-up. The mean age of patients was 57.44±10.75 years, and 82.71% were males. A total of 308 lesions were treated with BioMime SES. Most of the lesions were localised in the left anterior descending artery (45.46%) and were type B2 lesions (44.81%). The cumulative MACE rate at 5 years was 8.9% (n=19), including 0.9% cardiac deaths, 1.9% MI and 6.1% CI-TLR. The rate of ST was only 0.5%. The Kaplan-Meier survivor analysis revealed actuarial survivorship of 95.6% for the intention-to-treat population (n=250) over 5 years. Conclusions: The long-term clinical outcomes of the meriT-2 trial established the safety and efficacy of the ultrathin-strut biodegradable-polymer-based BioMime SES with satisfactory clinical outcomes at 5 years.