The sirolimus-eluting Bioadaptor implant shows superior functional performance in high-risk patients with dyslipidemia, compared to the contemporary Resolute Onyx drug-eluting stent (DES), reports a new subgroup analysis from the BIOADAPTOR-RCT. Findings were presented by lead researcher Shigeru Saito, MD, from the Shonan Kamakura General Hospital, Japan, on Tuesday at Cardiovascular Revascularization Technologies (CRT) 2024 in Washington, D.C. Speaking at CRT 2024, Saito noted that the DynamX Bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the Bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining dynamic support to the vessel – adding that the device aims to achieve the acute performance of DES with the advantages of restoration of vessel function. He noted that stent-related adverse events in percutaneous coronary intervention (PCI) continue to accrue after the first year at a non-plateauing rate of 2% to 3% a year, with no difference between second-generation DES, first-generation DES and BMS. “Bioresorbable scaffolds failed at improving short- and long-term outcomes compared to DES, driven by poor acute performance, material dismantling and long degradation profile, and lack of long-term vessel dynamic support after scaffold resorption,” he said, adding that published data have shown that DES and BRS lesions continue to see plaque progression after the procedure, despite patients being prescribed statins. “Plaque progression is a nidus for increased inflammation and future adverse events,” he added. Subgroup analysis Previously published data from the same BIOADAPTOR-RCT demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function. However, Saito noted that patients with dyslipidemia are considered a high-risk population when undergoing PCI because plaque vulnerability can lead to rupture, increased inflammation can result in future adverse events, and plaque progression can result in more frequent target lesion failure (TLF). Saito noted that approximately 80% of patients in both the DynamX and Resolute arms of the trial had dyslipidemia, as did 74% of patients in the imaging cohort. In line with findings from the overall trial, the analysis of the dyslipidemia subgroup of patients showed low 12-month TLF rates with Bioadaptor compared to DES (DynamX 1.7% vs. Onyx 2.3%), said Saito. Furthermore, the Bioadaptor technology showed significantly lower precent diameter stenosis at 12 months compared to DES (13% vs. 19%; p=0.003) and lower lumen re-narrowing – measured by late lumen loss at 12 months – compared to DES (0.08 mm vs 0.27 mm; p=0.040). Bioadaptor also showed significantly lower neointimal hyperplasia compared to DES, Saito added, noting that intravascular ultrasound (IVUS) at 12 months revealed neointimal volume of 6.21 mm3 for DynamX and 9.71 mm3 for the Onyx DES (p=0.023) and neointimal obstruction at 4% for DynamX and 5% for Onyx DES (p=0.038). IVUS data also indicated a consistent plaque stabilization for the Bioadaptor technology compared to plaque increase for DES, with a 5% change in plaque volume for DynamX and 14% change in plaque volume reported for Onyx DES. For lipid-containing lesions, IVUS data also indicated consistent plaque regression for DynamX (-1% change in plaque volume) versus plaque increase for DES (+14% plaque volume). “For the first time, the BIOADAPTOR-RCT demonstrated the superior functional performance of the Bioadaptor technology compared to Resolute Onyx, including in the high-risk patients with dyslipidemia,” said Saito. The BIOADAPTOR-RCT is sponsored by Elixir Medical Corp., the device manufacturer. Photo Credit: Jason Wermers/CRTonline.org Photo Caption: Shigeru Saito, MD, presents results from a BIOADAPTOR-RCT substudy Tuesday at CRT 2024 in Washington, D.C.