BIOADAPTOR RCT– 2-Year Outcomes Randomized Controlled Trial of Sirolimus-Eluting Bioadaptor versus Zotarolimus-Eluting Drug-Eluting Stent

Published in Congress: Euro PCR 2024

Link: https://www.pcronline.com/Cases-resources-images/Resources/Course-videos-slides/2024/EuroPCR/Hotline-new-coronary-devices-DES-BRS-DCB

Dr. Cemalettin Yılmaz

Introduction:
Stent related adverse events increase after the first year at a steady rate of 2-3% a year, reaching 20% at 5 years and 50% at 10 years. 12-month results from BIOADAPTOR randomized controlled trial (RCT) demonstrated the safety and efficacy of DynamX Bioadaptor and established new benchmarks in restoring arterial viability.

Objective:
The aim of this study was to report clinical outcomes at 2 years and to confirm outcomes with imaging showing hemodynamic restoration assessed with intravascular ultrasound (IVUS)/ optical coherence tomography (OCT)/ quantitative coronary angiography (QCA).

Methods:
The BIOADAPTOR RCT is an international, single-blind, RCT comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients (223 were randomized to DynamX Bioadaptor and 222 to RESOLUTE ONY) in 34 centers (Japan, Germany, Belgium, and New Zealand). Target lesion failure (TLF) was primary endpoint in the study. Both arms had large randomized multi-modality imaging subgroups. Secondary endpoints were diameter stenosis (%DS), target vessel failure (TVF), and pulsatility by IVUS/OCT/QCA.

Results:
The average age of the study population was 67 years and the majority were male. The most common clinical presentation was stable angina, and the left anterior descending artery (LAD) was the most affected artery. Approximately 23% of patients had bifurcation lesions, and approximately 20% had occlusions involving moderate to severe calcification. There was a 65% reduction in TLF (1.9% vs. 5.5%, p=0.046) with further separation of Kaplan-Meier (KM) curves at two-year follow-up. The TLF event rate flattened after 1 year, compared to a non-plateauing increase in events for DES. Additionally, there was a 68% reduction in TVF (1.9% vs. 6.0%, p=0.029). For lesions at higher risk of restenosis, DynamX demonstrated significant benefits. In LAD lesions, there was a significant reduction in TLF (1.9% vs. 8.7%, p=0.028). For small vessels, the event rate was lower (0% vs. 3.6%). Similarly, for long lesions, the event rate was also lower (0% vs. 2.3%), confirming 1-year QCA outcomes.

Conclusions:
DynamX Bioadaptor is the first technology with an innovative design. It has a mechanism of action that restores hemodynamic modulation to the artery and delivers sustained significant clinical benefit. This establishes a new treatment option for patients with coronary artery disease.

Comment:
The DynamX bioadaptor is the first coronary stent technology designed to restore coronary artery hemodynamic modulation by improving vessel pulsatility, compliance, and adaptive flow volume, as well as achieving plaque stabilization and regression. These data show that the bioadaptor consistently offers very low event rates across all major endpoints, making it a superior option compared to DES. Additionally, the 78% reduction in clinical events in LAD lesions is particularly significant because this artery supplies 50% of the heart muscle's blood and undergoes significant hemodynamic movement during each heart cycle.