12-month primary endpoint outcomes of the BIOADAPTOR-RCT

Dr. Ömer Işık

Presented congress: EuroPCR 2023

Link: https://www.jacc.org/doi/epdf/10.1016/j.jcin.2023.01.051

BACKGROUND

Conventional drug-eluting stents (DES) permanently restrict coronary arteries by closing them from the inside. It limits the movement and function of the vessel. Unlike DESs, the DynmaX sirolimus-eluting coronary bioadaptor system is a 71 µm cobalt chromium form. Since it does not cage like conventional stents, it does not limit vascular movement and function. over 6 months it can be bioabsorbed across the entire vessel surface and, unlike conventional DES, does not limit remodeling.

OBJECTIVE

DynamX bioadaptor is designed to address the shortcomings of DESs and investigate their efficacy in the treatment of coronary artery disease.

METHOD

The BIOADAPTOR-RCT study is a prospective, randomized single-blind multicenter study and is powered for the primary endpoint of target lesion failure at 12 months.

In 35 centers in Japan (n:223 people), Europe and New Zealand (n:222 people), 445 patients, mostly with chronic coronary syndrome, were randomly selected (1:1 dynamX BIOADAPTOR : resolute onyx).

In the Japanese cohort study, 80 people had angiography and IVUS images at baseline and 12 months and a subset of 20 people had angiography, IVUS and OCT images at baseline and 12 months.

All patients will be followed up at 1, 6, 12 months and annually for 5 years. Inclusion criteria were up to 2 new lesions in up to 2 native coronary arteries, lesion diameter between 2.25-4.0 mm in diameter and lesion length < 34 mm.

Patients with AMI within 72 hours, left main lesion and chronic total occlusion (CTO) were excluded. Dual anti-aggregant therapy plan was according to DES guidelines. Clinical endpoint events are decided by an independent CEC Images will be analyzed by the Core laboratory and clinical site follow-up will be conducted throughout the study.

CONCLUSION

Four hundred and forty-five randomized subjects and an additional 9 non-randomized PC subjects have been enrolled up to 6-month follow-up.

The unique opening mechanisms of the DynamX bioadaptor are an important advance designed to address the shortcoming of DES in the treatment of coronary artery disease.

DynamX bioadaptor's unique opening mechanisms are a significant advance in the treatment of coronary artery disease designed to address the deficiency of DES.

dynamX bioadaptor opens to improve the vascular function of treated arteries.

This randomized controlled trial will evaluate the safety and efficacy of dynamX BIOADAPTOR in comparison to current DES and will use vascular function data to confirm its effect on clinical benefit over the long term.

The unique opening mechanisms of the DynamX bioadaptor are an important advance designed to address the shortcoming of DES in the treatment of coronary artery disease.

DynamX bioadaptor's unique opening mechanisms are a significant advance in the treatment of coronary artery disease designed to address the deficiency of DES.

dynamX bioadaptor opens to improve the vascular function of treated arteries.

This randomized controlled trial will evaluate the safety and efficacy of dynamX BIOADAPTOR in comparison to current DES and will use vascular function data to confirm its effect on clinical benefit over the long term.