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

Kandzari, David E.; Kirtane, Ajay J.; Windecker, Stephan; Latib, Azeem; Kedhi, Elvin; Mehran, Roxana; Price, Matthew J.; Abizaid, Alexandre; Simon, Daniel I.; Worthley, Stephen G.; Zaman, Azfar; Choi, James W.; Caputo, Ronald P.; Kanitkar, Mihir; McLaurin, Brent T.; Potluri, Srinivasa; Smith, Timothy D.; Spriggs, Douglas; Tolleson, Thaddeus R.; Nazif, Tamim; Parke, Maria; Lee, Lilian C.; Lung, Te Hsin; Stone, Gregg W.

doi:10.1161/circinterventions.120.009565

Cited by 55 publications

(44 citation statements)

References 21 publications

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“…24 In addition, it showed no between-stent difference in the risk of ST. Another analysis that included 1,506 HBR patients, who did not have any major adverse events during the first month, confirmed the safety and efficacy of the RO-ZES following 1 month of DAPT by meeting the prespecified performance goal. 25 In the O-SES group of our study, the 3-year rate of definite-or-probable ST (1.2%) was in line with that of other all-comer trials. 18,26 Looking at all the available evidence, the RO-ZES appears to be associated with a particularly low risk of ST.…”

Section: Discussionsupporting

confidence: 90%

First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial

Ploumen

Buiten

Zocca

et al. 2021

Circ J

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Background: At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting stent (O-SES). Although the RO-ZES is used in daily practice, no clinical results have been published beyond 2 years. Methods and Results:We assessed 3-year clinical outcomes of 2,488 all-comers after percutaneous coronary intervention (PCI) with RO-ZES vs. O-SES. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. Time-to-endpoints was assessed by Kaplan-Meier methods and between-group comparisons by log-rank tests. Follow-up was available in 2,433/2,488 (97.8%) patients. There was no significant between-stent difference in TVF (RO-ZES 112/1,243 [9.2%] vs. O-SES 109/1,245 [8.9%], hazard ratio [HR]: 1.03, 95% confidence interval [CI] 0.79-1.34; Plog-rank=0.85) and its individual components. The all-cause mortality was significantly lower after PCI with RO-ZES (3.7% vs.5.4%, HR: 0.67, 95% CI 0.46-0.97; Plog-rank=0.034), but cardiac mortality did not differ significantly (1.1% vs.1.9%, HR: 0.56, 95% CI 0.28-1.11; Plog-rank=0.09). Definite-or-probable stent thrombosis rates were low for both groups (0.6% vs.1.2%, HR: 0.46, 95% CI 0.19-1.14; Plog-rank=0.09). Conclusions:This first 3-year randomized assessment of the RO-ZES showed a favorable rate of TVF that matched the outcomes of patients treated with O-SES. We observed a lower rate of all-cause death in the RO-ZES group, but long-term clinical follow-up is of interest.

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Section: Discussionsupporting

confidence: 90%

First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial

Ploumen

Buiten

Zocca

et al. 2021

Circ J

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“…Due to high rate of radial access in our study, vascular access strategies were minimally associated with these observed reductions in bleeding rates over time. The use of new-generation DES featuring much lower strut thickness and biodegradable polymers or polymer- free designs allows the shortening of DAPT ( 18 – 20 ). Also, use of intravascular imaging to optimize the PCI procedure and achieve more complete endothelialization is important in patients at high risk of bleeding who might need a short duration of DAPT ( 21 ).…”

Section: Discussionmentioning

confidence: 99%

Trends in Bleeding Events Among Patients With Acute Coronary Syndrome in China, 2015 to 2019: Insights From the CCC-ACS Project

Xiao

Zhao

Zhou

et al. 2021

Front. Cardiovasc. Med.

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Objective: Major bleeding is a common complication following treatment for an acute coronary syndrome (ACS) and is associated with increased mortality. We aimed to explore the temporal trend of bleeding events in relation to changes of therapeutic strategies among patients hospitalized for ACS in China.Methods: The CCC-ACS project (Improving Care for Cardiovascular Disease in China–Acute Coronary Syndrome) is a collaborative initiative of the American Heart Association and the Chinese Society of Cardiology. We analyzed 113,567 ACS patients from 241 hospitals in China from 2015 to 2019. Major bleeding was defined as intracranial bleeding, retroperitoneal bleeding, a decline in hemoglobin levels ≥3 g/dL, transfusion with overt bleeding, bleeding requiring surgical intervention, and fatal bleeding. Kruskal–Wallis test was used to examine the trend of major bleeding over time.Results: The rate of in-hospital major bleeding decreased from 6.3% in 2015 to 4.7% in 2019 (unadjusted OR = 0.74, 95% CI: 0.68–0.80, and P < 0.001). The relative changes were consistent across almost all subgroups including patients with NSTE-ACS and STEMI, although the trend was more pronounced in NSTE-ACS patients. The decrease in bleeding was accompanied by a decrease in use of GP IIb/IIIa inhibitors and parenteral anticoagulation therapy during hospitalization. The annual reduced risk of bleeding (OR = 0.91, 95% CI: 0.89–0.93) was attenuated after stepwise adjusting for baseline characteristics and antithrombotic treatments (OR = 0.95, 95% CI: 0.93–0.97), but did not change after adjusting for invasive treatment (OR = 0.95, 95% CI: 0.93–0.97).Conclusions: There was a temporal reduction in in-hospital bleeding among Chinese ACS patients during the last 5 years, which was associated with more evidence-based use of antithrombotic therapies.Clinical Trial Registration:https://www.clinicaltrials.gov, identifier: NCT02306616.

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“…20 Finally, there is increasing evidence that with a number of third generation DESs 1 month of DAPT can safely be used in patients at high bleeding risk without an increase in ischaemic events. [21][22][23] A single antiplatelet agent is continued in all cases after discontinuation of DAPT, this tends to be aspirin. In some cases, for example, patients who had a previous stroke, the patients may have aspirin stopped at the end of the DAPT course and clopidogrel continued long-term.…”

Section: P2y12 Receptor Antagonistsmentioning

confidence: 99%

Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update

Veitch

Radaelli

Alikhan

et al. 2021

Gut

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This is a collaboration between the British Society of Gastroenterology (BSG) and the European Society of Gastrointestinal Endoscopy (ESGE), and is a scheduled update of their 2016 guideline on endoscopy in patients on antiplatelet or anticoagulant therapy. The guideline development committee included representatives from the British Society of Haematology, the British Cardiovascular Intervention Society, and two patient representatives from the charities Anticoagulation UK and Thrombosis UK, as well as gastroenterologists. The process conformed to AGREE II principles and the quality of evidence and strength of recommendations were derived using GRADE methodology. Prior to submission for publication, consultation was made with all member societies of ESGE, including BSG. Evidence-based revisions have been made to the risk categories for endoscopic procedures, and to the categories for risks of thrombosis. In particular a more detailed risk analysis for atrial fibrillation has been employed, and the recommendations for direct oral anticoagulants have been strengthened in light of trial data published since the previous version. A section has been added on the management of patients presenting with acute GI haemorrhage. Important patient considerations are highlighted. Recommendations are based on the risk balance between thrombosis and haemorrhage in given situations.

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

Cited by 55 publications

References 21 publications

First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial

First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial

Trends in Bleeding Events Among Patients With Acute Coronary Syndrome in China, 2015 to 2019: Insights From the CCC-ACS Project

Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update

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