WASHINGTON — A variety of stent designs have tried and failed to reduce the number of stent-related adverse events over time, but now a new device with a unique design has shown some initial promise in addressing that weakness.
A single-blind randomized trial of the DynamX Coronary Bioadaptor (Elixir Medical, Milpitas, California) found fewer adverse events after 12 months compared with a traditional drug-eluting stent, reported David Erlinge, MD, PhD, head of Cardiology at Skåne University Hospital in Lund, Sweden. In the first 6 months, the stents performed comparably, he said at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference.
And after 12 months, the bioadaptor was associated with significantly lower rates of target lesion failure and target vessel failure, he said.
The stent consists of three 71 µm helical strands coated with a polymer. The unique feature is that the coating is fully resorbed about 6 months after placed in a target lesion.
The strands are initially locked into position but are unlocked after the polymer is resorbed. This allows the device to adjust to normal vessel hemodynamics including pulsatility, compliance, and adaptive coronary flow, Erlinge explained. This greater adaptability is intended to avoid the problems associated with the way more rigid conventional stents disrupt vessel function.
Benefits Accrue Between 6 and 12 Months
The INFINITY-SWEDEHEART trial, conducted using Sweden’s SWEDEHEART online cardiac registry, enrolled more than 2000 patients. They were randomized to receive either the bioadapt