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[VIRTUAL] FINAL TWO-YEAR RESULTS FROM THE RANDOMIZED ONYX ONE TRIAL IN HIGH BLEEDING RISK PATIENTS TREATED WITH 1-MONTH DAPT (Topic Essentials 1) - Feb 17, 2021 - Abstract #ACC2021ACC_41; Patients received DAPT for 1 month after the procedure and single antiplatelet therapy (SAPT) thereafter (aspirin or clopidogrel at operator choice). Two-year results from Onyx ONE RCT demonstrate non-significant differences for the primary and powered secondary outcomes after PCI with Resolute Onyx DES compared with BioFreedom DCS in HBR patients treated with SAPT after 1-month DAPT.
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Trial completion, Trial completion date: The IRIS-Resolute Integrity (IRIS-Integrity) (clinicaltrials.gov) - Jan 27, 2021 P=N/A, N=3000, Completed, Trial completion date: Aug 2020 --> Aug 2021 Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> Mar 2020
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Enrollment closed, Trial completion date, Trial primary completion date: SUGAR: Second-generation Drug-eluting Stents in Diabetes (clinicaltrials.gov) - Jan 19, 2021 P4, N=1164, Active, not recruiting, However, more research is needed to support these results. Recruiting --> Active, not recruiting | Trial completion date: Oct 2023 --> Jan 2022 | Trial primary completion date: Oct 2020 --> Jan 2021
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Journal: Panta rhei, also drug eluting stent technology. (Pubmed Central) - Dec 16, 2020 This prospective, multicenter, single arm study, showed favorable 5-year outcomes in patients undergoing Resolute ZES implantation, with considerably low rate of repeated revascularization and stent thrombosis. Data on long-term performance of next-generation drug eluting stents are of paramount importance to adequately inform decision-making in contemporary clinical practice.
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Enrollment open, Trial completion date, Trial primary completion date: The Rolex Registry (Revascularization Of LEft Main With Resolute onyX) (clinicaltrials.gov) - Dec 3, 2020 P=N/A, N=450, Recruiting, Data on long-term performance of next-generation drug eluting stents are of paramount importance to adequately inform decision-making in contemporary clinical practice. Not yet recruiting --> Recruiting | Trial completion date: Dec 2020 --> Dec 2023 | Trial primary completion date: Dec 2020 --> Dec 2021
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Trial primary completion date: RESOLUTE ONYX China Single Arm Study (clinicaltrials.gov) - Oct 22, 2020 P=N/A, N=591, Active, not recruiting, At 30 days and 6-months R-ZES has an outstanding safety and efficacy even in this high-risk category of patients. Trial primary completion date: Sep 2020 --> Mar 2021
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Trial primary completion date: RESOLUTE ONYX China RCT Study (clinicaltrials.gov) - Oct 22, 2020 P=N/A, N=550, Active, not recruiting, Trial primary completion date: Sep 2020 --> Mar 2021 Trial primary completion date: Sep 2020 --> Mar 2021
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Clinical, Journal, Real-World Evidence: Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry. (Pubmed Central) - Sep 30, 2020 In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P = 0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%. In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.
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Trial completion date, Trial primary completion date: SHEAR-STENT: Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels (clinicaltrials.gov) - Sep 25, 2020 P=N/A, N=126, Recruiting, In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up. Trial completion date: Jun 2020 --> Dec 2020 | Trial primary completion date: Jun 2020 --> Dec 2020
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Trial completion date, Trial initiation date, Trial primary completion date, HEOR: IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact (clinicaltrials.gov) - Aug 13, 2020 P=N/A, N=3100, Not yet recruiting, RES performed as well as ZES in bifurcation and nonbifurcation lesions. Trial completion date: Dec 2024 --> Aug 2025 | Initiation date: Feb 2020 --> Sep 2020 | Trial primary completion date: Sep 2024 --> Apr 2024
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Clinical, Journal: Comparison of Durable-Polymer- and Biodegradable-Polymer-Based Newer-Generation Drug-Eluting Stents in Patients with Acute Myocardial Infarction and Prediabetes After Successful Percutaneous Coronary Intervention. (Pubmed Central) - Aug 13, 2020 The cumulative incidence of ST was also comparable between the DP-DES and BP-DES groups (aHR: 1.407; 95% CI, 0.476-4.158; P = 0.537). Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period.
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Trial completion: First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis (clinicaltrials.gov) - Aug 9, 2020 P2/3, N=168, Completed, Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period. Active, not recruiting --> Completed
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[VIRTUAL] Onyx ONE: Outcomes in patients with acute coronary syndrome () - Jul 30, 2020 - Abstract #ESC2020ESC_567; In Onyx ONE, high-bleeding risk patients presenting with ACS had similar safety and efficacy at 1 year in both the ZES and DCS stent groups. However, a trend was present for greater safety with the ZES with SAPT treatment beyond 30 days driven by lower myocardial infarction rates in that time period thus warranting additional confirmatory studies.
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