Bioadaptor meets expectations in reducing target lesion failures in coronary artery disease

A novel drug-eluting bioadaptor was associated with reduced target lesion failure (TLF) after 6 months compared with a regular drug-eluting stent (DES) in a large population of patients with coronary artery disease (CAD). According to the authors, the bioadaptor can restore the haemodynamic modulation of the target vessel, resulting in improved long-term outcomes.

“Stent-related adverse events continue to accumulate after the first year at a rate of 2–3% per year,” outlined Prof. David Erlinge (Lund University, Sweden) [1]. The bioadaptor is designed to restore the haemodynamic modulation of the vessel after 6 months. The INFINITY-SWEDEHEART trial compared the conventional Onyx DES with the DynamX bioadaptor in a broad population of patients with CAD, including patients with acute coronary syndrome. The participants (n=2,400) were randomised in a 1:1 fashion, and TLF at 1 year was the primary non-inferiority endpoint.

The primary endpoint was met, with event rates of 2.35% and 2.77% for the experimental arm and control arm, respectively (P_{non-inferiority}<0.001). “The most interesting endpoint of this trial is, however, the pre-specified powered secondary endpoint of TLF after 6 months,” according to Prof. Erlinge. Between months 6 and 12, the TLF event rate was significantly lower in the bioadaptor arm than in the conventional DES arm (P_log-rank=0.003; see Figure).

Figure: Significant reduction and plateau in TLF events after 6 months [1]



DES, drug-eluting stent; TLF, target lesion failure.

Moreover, the incidence of target-vessel myocardial infarction (P_log-rank=0.012) and target lesion revascularisation (P=0.003) was lower in the bioadaptor arm than in the control arm between months 6 and 12 of the study. Finally, target vessel failure was significantly reduced in the experimental arm after month 6 (P_log-rank=0.008).

“This large randomised-controlled trial confirmed that the unique ‘unlocking’ mechanism of a bioadaptor at 6 months leads to a plateauing of adverse events, resulting in better outcomes with a bioadaptor than a conventional DES in patients with CAD,” concluded Prof. Erlinge.

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   1. Erlinge D, et al. INFINITY-SWEDEHEART: percutaneous coronary intervention with a Bioadaptor compared to a contemporary drug-eluting stent (DES) in a large broad clinical population. HOTLINE 11, ESC Congress 2024, 30 Aug–02 Sept, London, UK.

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Posted on 7 November 20247 November 2024