Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.

BACKGROUND: Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. OBJECTIVES: This study reports the final 2-year results of the randomized Onyx ONE trial. METHODS: The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. RESULTS: A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54). CONCLUSIONS: Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).

One-month dual antiplatelet therapy after pci with resolute onyx des: final 2-year results from onyx one clear

BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) varies based on ischemic and high bleeding risk (HBR) factors. METHODS Onyx ONE Clear was a prospective, global, multicenter study to assess the safety and effectiveness of 1-month DAPT in patients with HBR treated with Resolute Onyx zotarolimus-eluting stents (ZES). Patients with coronary artery disease and at least 1 HBR criterion were enrolled and prescribed DAPT for 1 month post-ZES implantation, followed by single antiplatelet therapy (SAPT) thereafter. The primary endpoint was composite of cardiac death or myocardial infarction (MI) from 1 month to 1 year. The current analysis presents final 2-year results from the study. RESULTS A total of 1,507 patients were analyzed at 2 years. Mean age was 74.0 9.5 years, 32.2% female, 38.8% with type 2 diabetes, 36.0% with previous revascularization, and 48.7% presented with an acute coronary syndrome. Patients were enrolled with mean 1.6 HBR criteria and 44.6% met 2 HBR criteria. Lesion characteristics included 50.0% moderate-to-severe calcification and 78.5% B2/C lesions. At 2 years, 81.1% of patients remained on SAPT, 5.6% received DAPT, and 12.5% were prescribed oral anticoagulation only. The composite of cardiac death or MI between 1 month and 2 years was 11.7%, with rates of 5.3% for cardiac death and 7.4% for MI. Most MIs were non-Q wave (6.7%). Rates of other secondary endpoints between 1 month and 2 years included 0.9% definite or probable stent thrombosis, 13.0% targetlesion failure, 4.7% clinically driven target-lesion revascularization, 2.6% stroke, and 6.2% Bleeding Academic Research Consortium (BARC) 3 to 5 bleeding events (Table 1). CONCLUSION Among patients with HBR treated with Resolute Onyx DES and SAPT after 1 month, 2-year ischemic event rates were acceptable despite an ongoing risk of major bleeding.

Clinical outcomes in patients with high bleeding risk and bifurcations after percutaneous coronary intervention with resolute onyx and 1-month dual antiplatelet therapy

BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) in patients with high bleeding risk (HBR) undergoing percu taneous coronary intervention (PCI) varies based on individual clinical and lesion characteristics. It is unknown whether patients with HBR and bifurcation lesions can be safely treated with an abbreviated DAPT. In this analysis, we examined ischemic and bleeding outcomes at 1 year in patients with and without bifurcations who underwent PCI in the Onyx ONE Clear study. METHODS Patients meeting at least 1 HBR criterion undergoing PCI with Resolute Onyx zotarolimus-eluting stents (Medtronic) were enrolled. DAPT was required for the first month post-procedure and single antiplatelet therapy (SAPT) thereafter. In this analysis, 1-year outcomes were assessed in patients with and without treated index procedure bifurcation lesions as reported by the study investigators. RESULTS Of 1,506 patients in the Onyx ONE Clear study, 218 (14.5%) had treated index procedure bifurcation lesions. Among these, 89% were treated with a provisional stenting technique and 11% with a 2- stent technique. Patients with versus without bifurcation lesions had similar baseline clinical characteristics; however, procedure time was greater for patients with bifurcations (49.2 3 4.6 vs 40.6 28.7 minutes, P < 0.001), as was total stent length (45.3 32.5 vs 35.5 24.9 mm, P < 0.001). SAPT use after 1 month was 97% for patients both with and without bifurcations. The primary study endpoint of com posite cardiac death or myocardial infarction at 1 year was nonsig nificantly different but was numerically higher for patients with versus without bifurcations (9.8% vs 6.5%, P » 0.08), as were the rates of other ischemic events (Table 1). Conversely, major bleeding events (Bleeding Academic Research Consortium [BARC] 3-5) were less prevalent for patients with bifurcations, in part relating to differences in rates of oral anticoagulation between groups. CONCLUSION In the Onyx ONE Clear study, patients with HBR and bifurcations treated with Resolute Onyx zotarolimus-eluting stents and only 1-month DAPT tended to have nonsignificantly different but numerically slightly higher ischemic event rates and less major bleeding compared with patients without bifurcation lesions. Further studies are required to determine the optimal DAPT duration following PCI for HBR patients with coronary bifurcation lesions.

One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.

BACKGROUND: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. METHODS: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. RESULTS: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001). CONCLUSIONS: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.

One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients

BACKGROUND: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. METHODS: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. RESULTS: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001). CONCLUSIONS: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention.

Ischemic and bleeding outcomes in patients with versus without atrial fibrillation: analysis from the onyx one month dapt program

BACKGROUND The Onyx ONE and Onyx ONE CLEAR studies demonstrated favorable safety and effectiveness in patients at high bleeding risk (HBR) who were event-free 1 month following Resolute Onyx zotarolimus-eluting stent (ZES) implantation and were then treated with single antiplatelet therapy (SAPT) through to 1 year. The present analysis assessed outcomes in patients with versus without history of atrial fibrillation (AF) in whom oral anticoagulant (OAC) use is common. METHODS HBR patients who were event-free at 1 month were sepa rated into 2 groups according to history of AF. Clinical outcomes be tween 1 and 12 months were assessed. RESULTS Among 1,506 patients who were event-free at 1 month in whom treatment with SAPT was intended, 536 (35.6%) had a history of AF and 970 (64.4%) did not. The mean number of HBR criteria at enrollment was 1.7 for AF compared with 1.5 for non-AF patients (p < 0.001). AF patients were more likely to be men (73% vs. 65%; p » 0.001), were more likely to have had prior PCI (34% vs. 28%; p » 0.03) or CABG (16% vs. 11%; p » 0.003), and were more likely taking OACs (80.6% vs. 10.6%; p < 0.001). At 1 year, 89% of AF and non-AF patients were taking SAPT (p » 1.00), although 85.8% of AF patients and 12.4% of non-AF patients were taking OAC (p < 0.001). Ischemic event rates were similar between AF and non-AF groups: target lesion failure (8.5% vs. 7.9%), cardiac death (2.8% vs. 2.5%), myocardial infarction (4.7% vs. 4.9%), target lesion revascularization (2.8% vs. 3.6%), and definite/probable stent thrombosis (0.4% vs. 0.8%), all p > 0.05. BARC 2 to 5 (16.0% vs. 9.4%) bleeding events were higher for AF compared with non-AF patients (p < 0.001) driven by BARC 2 bleeding; BARC 3 to 5 events were similar (4.5% vs. 3.7%; p » 0.49). CONCLUSION After Resolute Onyx ZES implantation in HBR patients and intended treatment of SAPT after 1 month, despite differences in baseline characteristics, ischemic events were similar but moderate bleeding events were higher in patients with versus without a history of AF. Further studies are warranted to optimize management of AF patients post-stenting to minimize the bleeding.