BIOADAPTOR RCT: A randomized controlled trial of DynamX Bioadaptor vs drug-eluting stents

BIOADAPTOR RCT demonstrates sustained treatment benefits compared to contemporary DES

Evidence from the BIOADAPTOR RCT demonstrate sustained significant reduction of device-related events with bioadaptor compared to DES, confirming the durability of treatment benefit from 6 months and through long-term follow-up.

Study Design

Peer Review Publication
(2-year data)

Peer Review Publication
(1-year data)

Presentation

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Primary endpoint: target lesion failure at 12 months vs. 2.8% for Resolute Onyx™ (p < 0.001)

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Increase in blood flow with every heartbeat, as pulsatility returns

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Plaque volume regression in lipid rich lesions vs. +10% for DES (p = 0.008)

Low TLF with Bioadaptor Sustained at 4-year Follow-up

Sustained Treatment Effect

Sustained low adverse event rate from 6 months to 4 years for patients in the DynamX bioadaptor arm compared to drug-eluting stent arm.

Significant Treatment Effect in LAD

Significantly lower TLF rate demonstrated in LAD lesions in the DynamX bioadaptor arm compared to drug eluting stent arm at 4-year follow-up.

Key Findings:

The clinical trial met its primary endpoint of Target Lesion Failure (TLF) non-inferiority at 12 months.
The novel DynamX coronary bioadaptor achieved a very low 1.8% TLF rate compared to 2.8% for Resolute Onyx DES (p<0.001), as well as similar acute performance, acute lumen gain, and percent diameter stenosis at baseline.
Four-year results show that the TLF curves of the BIOADAPTOR RCT diverge further after the 1-year follow-up in favor of DynamX, with significantly lower rate of Cardiac Death (0.5% versus 3.7%, p=0.020) compared to DES, and lower rate of clinically driven revascularizations at 4-year follow up.

For the first time seen in a coronary revascularization implant, the bioadaptor showed normal pulsatility in the device treated segment. The bioadaptor also demonstrated novel findings of plaque stabilization and regression, confirming restoration of vessel function at 12 months.

Study Design:

The BIOADAPTOR RCT is an international, single-blinded, randomized controlled (1:1) trial comparing DynamX Coronary Bioadaptor with a contemporary zotarolimus-eluting stent, the Resolute Onyx.™

445 patients enrolled
1:1 randomization versus Resolute Onyx DES
Primary endpoint: TLF at 12 months (powered for non-inferiority)
Secondary endpoints: Imaging by QCA/IVUS/OCT at 12 months
Clinical follow-up to 5 years

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Frequently asked questions about the BIOADAPTOR RCT and DynamX

What clinical studies have been done on alternatives to drug-eluting stents for coronary artery disease?

One of the most important studies of alternatives to drug-eluting stents in PCI is the BIOADAPTOR Randomized Controlled Trial (RCT). This international trial evaluated the DynamX coronary bioadaptor against a leading drug-eluting stent (Resolute Onyx™ DES).

BIOADAPTOR RCT included 445 patients and compared both devices across clinical outcomes, imaging, and long-term follow-up. The study demonstrated that DynamX achieved comparable early results, including TLF at 12 months, and lower rates for TLF at 2 years and 3 years compared to DES.

How does the bioadaptor compare to drug-eluting stents in clinical studies?

The BIOADAPTOR RCT showed that while DynamX performed similarly to drug-eluting stents at 12 months, with a comparable target lesion failure percentage (TLF). At longer timeframes, DynamX had statistically significantly lower TLF rates at 2 years and 3 years compared to DES.

At three years:

Lower target lesion failure (TLF) rates
Reduced cardiac death
Increasing separation in outcomes vs. DES

These results suggest that DynamX may provide long-term advantages and not just short-term procedural success.

Can coronary plaque actually improve or regress after treatment?

In the BIOADAPTOR RCT, DynamX demonstrated:

-9% plaque volume regression in lipid-rich lesions
Compared to +10% plaque progression with DES

This data suggests that restoring vessel function may help create conditions that support plaque stabilization and reduction and not just containment.

What does “non-inferiority” mean in a cardiovascular clinical trial?

Non-inferiority means that a new treatment performs at least as well as the current standard of care in key outcomes.

In the BIOADAPTOR RCT:

DynamX met the non-inferiority endpoint for TLF at 12 months
Then went on to show superior outcomes over time

What is target lesion failure (TLF), and why does it matter?

Target Lesion Failure (TLF) is a key clinical endpoint that includes:

Cardiac death
Target vessel myocardial infarction
Need for repeat intervention

In the BIOADAPTOR RCT:

DynamX achieved low TLF rates (1.8%) at 12 months
And maintained statistically significant lower rates of TLF over time compared to DES

Lower TLF means fewer complications and better long-term patient outcomes.

What endpoints were evaluated in the BIOADAPTOR RCT?

The primary endpoint was target lesion failure (TLF) at 12 months. Secondary endpoints included imaging-based assessments of vessel motion, adaptive remodeling, and plaque stabilization using QCA, IVUS, and OCT.

PMN 2500 Rev A