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 Resolute Onyx DES.
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:
Onyx ONE Clear AF Subgroup Sub-Analysis
- 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.
Onyx ONE Clear Complex PCI Sub-Analysis
- 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.