Onyx ONE Clear design
Onyx ONE Clear enrolled a total of 1,506 patients, including more than 1,000 patients who received the Onyx stent in the Onyx ONE trial and an additional 752 patients enrolled in the United States and Japan, but 263 of these patients had an adverse event during their first 30 days or follow-up leaving 1,506 patients eligible to continue into the Onyx ONE Clear analysis, and with 1,491 patients followed through 12 months. Patients were an average age of 74 years, a little over two-thirds were men, 49% had a recent acute coronary syndrome event and 41% had chronic coronary syndrome. The choice of which antiplatelet agent to continue when patients transitioned to SAPT after 30 days on DAPT was left to the discretion of the physicians for each enrolled patient.
One issue these studies did not address was whether 1 month is the ideal duration for DAPT before switching to SAPT in HBR patients following coronary stenting, or whether longer DAPT durations produce even better outcomes. “It was important to establish what happens if we need to stop DAPT early.” The Onyx ONE and Onyx ONE Clear studies “provide much-needed data informing clinicians of the risks and safety of SAPT after 1 month in appropriately selected patients,” Dr. Kirtane said.
“The results do not indicate that all HBR patients should be treated with 1 month [of] DAPT, but instead demonstrate the safety and effectiveness of this strategy when clinically appropriate.” This scenario “is quite common, given that HBR patients represent up to a third” of patients undergoing percutaneous coronary intervention, Dr. Kandzari said.
Onyx ONE and Onyx ONE Clear were sponsored by Medtronic, the company that markets the Onyx coronary stent. Dr. Kirtane’s institution has received research support from Medtronic, and from Abbott Vascular, Abiomed, Boston Scientific, Cathworks, CSI, Philips, ReCor Medical, and Siemens. Dr. Kandzari has received personal fees and research grants from medtronic, personal fees from Biotronik and Cardiovascular Systems, and research grants from Biotronik, Boston Scientific, and Cardiovascular Systems. Dr. Rao has received personal fees from Medtronic, as well as from CSI and Philips.
SOURCE: Kirtane AJ et al. ACC 2020, Abstract 903-06.