October 16, 2020 — Investigators unveiled new clinical data from two Onyx ONE Clear sub analyses, each demonstrating that highly complex, high bleeding risk patients (HBR), such as those with atrial fibrillation (AF) and complex PCI, had similar safety and efficacy rates at one year as patients without a history of AF or complex lesions after discontinuation of dual antiplatelet therapy (DAPT) after one month following a PCI with Medtronic's Resolute Onyx DES[i]. Data were announced at Transcatheter Cardiovascular Therapeutics (TCT) Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation, held October 14-18, 2020.
Resolute Onyx DES recently became the first DES in the U.S. to receive an expanded indication for HBR patients with one-month DAPT labeling . It is also the first DES to receive CE mark indication for one-month DAPT in HBR patients. Following are details from the TCT data:
• A post-hoc sub-analysis from the Onyx ONE Clear analysis assessed outcomes in atrial fibrillation (AF) patients compared to non-AF patients, with 87% of AF patients on OAC.
• Based on the Onyx ONE Clear Analysis of highly complex HBR patients on one-month DAPT, AF patients presented similar ischemic outcomes as those of patients without AF, with moderate and but no major bleeding events following a PCI with Resolute Onyx in at one year.
• Bleeding risk in patients on triple therapy (DAPT and OACs) is magnified. Therefore, strategies to minimize bleeding risk without increasing the risk of ischemic events post PCI is critical in patients with AF.
• At one year, HBR patients observed in the Complex PCI group compared to non-Complex PCI group treated with one-month DAPT following PCI with Resolute Onyx demonstrated no difference in safety and efficacy endpoints, despite increased lesion complexity.
• The Onyx ONE Clear Analysis included a highly complex HBR patient population with complex lesions that included 50% ACS, 36% AF, 40% diabetes, 79% B2/C lesions and 50% severe calcification. Patients with the greatest lesion and procedural complexity are at higher ischemic risk.
About the Onyx ONE Program
The Onyx ONE Global Study was the first prospective, randomized, one-month DAPT trial comparing two DES in approximately 2,000 highly complex HBR patients. Onyx ONE featured the broadest HBR inclusion criteria with no lesion or vessel limitations and >50% ACS patients. Resolute Onyx met its primary endpoint of non-inferiority vs. the DES in comparison.
The Onyx ONE Clear Study, coupled with the Onyx ONE Global Study, make up the Onyx ONE Month DAPT Program. More than 22,000 patients have been evaluated in either sponsored or funded studies that support the advancement of DAPT evidence, initiated by physicians and Medtronic.
Clinical studies have demonstrated that Resolute Onyx DES and its biocompatible polymer and stent design promote fast vessel healing and is well-suited for patients who may benefit from a DAPT duration as short as one month[ii]. The Resolute Onyx DES is the first-and-only DES in the U.S. that has been proven safe and effective utilizing a one-month regimen of DAPT following a PCI in patients at high bleeding risk.