ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting

Background In patients receiving aspirin, the optimal duration of clopidogrel therapy after drug-eluting stent (DES) implantation remains unclear. Methods This multicentre, randomized, double-blind, placebo-controlled trial tested the hypothesis that in patients undergoing DES implantation, 6 months of clopidogrel is non-inferior to 12 months in terms of clinical outcomes. At 6 months after DES implantation, patients on clopidogrel were randomly assigned to either a 6-month period of placebo or an additional 6-month period of clopidogrel. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, and thrombolysis in myocardial infarction major bleeding at 9 months after randomization. Results Owing to slow recruitment and low event rates, the trial was stopped prematurely after enrolment of 4005 of 6000 planned patients. Of 4000 patients included in the final analysis, 1997 received 6 months of clopidogrel and 2003 received 12 months. The primary endpoint occurred in 29 patients (1.5%) assigned to 6 months of clopidogrel and 32 patients (1.6%) assigned to 12 months, observed difference –0.1%, upper limit of one-sided 95% confidence interval (CI) 0.5%, limit of non-inferiority 2%, Pfor noninferiority
Source: European Heart Journal - Category: Cardiology Authors: Tags: Thrombosis and antithrombotic therapy Source Type: research

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In conclusion, the effects of 1-month DAPT for the primary and major secondary endpoints were consistent in HBR and non-HBR patients without any significant interactions. The benefit of 1-month DAPT in reducing major bleeding was numerically greater in HBR patients.Clinical trial registration Short and optimal duration of dual antiplatelet therapy after everolimus-eluting cobalt –chromium stent-2 [STOPDAPT-2]; NCT02619760.
Source: Cardiovascular Intervention and Therapeutics - Category: Cardiology Source Type: research
This study is registered at ClinicalTrials.gov (NCT02027896).FindingsBetween March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4–9) in the accelerated-surgery group and 24 h (10–42) in the standard-care group (p
Source: The Lancet - Category: General Medicine Source Type: research
sagne G, Torre-Amione G Abstract Background: Fast-track worldwide reperfusion programs improve outcomes in ST-elevation myocardial infarction and stroke. Similar programs called Program Evaluation and Review Technique (PERT) focus on submassive and massive pulmonary embolism (PE) excluding deep venous thrombosis (DVT). Methods: PREVENTION-team (Hospital Zambrano Hellion Venous Thromboembolism [VTE] Rapid Response). Primary objective: Fast-track stratification, diagnostics, and treatment (60-90 min) to improve proximal DVT and submassive and massive PE patients care. Secondary objectives: Increase di...
Source: Archivos de Cardiologia de Mexico - Category: Cardiology Authors: Tags: Arch Cardiol Mex Source Type: research
Conclusions: Compared to the non-HBR population, HBR patients experienced worse 4-year outcomes after PCI with CoCr everolimus-eluting stent. Both CTE and MB had a significant impact on subsequent risk of mortality irrespective of bleeding risk. PMID: 31992063 [PubMed - as supplied by publisher]
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
CONCLUSION: In real-world patients at high risk of bleeding, implantation of the polymer-free metallic stent coated with Biolimus-A9 (Biofreedom®; Biosensors Europe, Morges, Switzerland) followed by 1 -month DAPT showed encouraging results without any stent thrombosis. PMID: 31965195 [PubMed - as supplied by publisher]
Source: Herz - Category: Cardiology Tags: Herz Source Type: research
Publication date: Available online 23 January 2020Source: The Annals of Thoracic SurgeryAuthor(s): Malak Elbatarny, Derrick Y. Tam, J. James Edelman, Rodolfo V. Rocha, Michael W.A. Chu, Mark D. Peterson, Ismail El-Hamamsy, Jehangir J. Appoo, Jan O. Friedrich, Munir Boodhwani, Bobby Yanagawa, Maral Ouzounian, Canadian Thoracic Aortic Collaborative (CTAC) InvestigatorsAbstractBackgroundAortic valve sparing operations theoretically have fewer stroke and bleeding complications but may increase late reoperation risk, versus composite valve grafts.MethodsWe meta-analyzed all studies comparing aortic valve sparing (reimplantation...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Background: It is important to understand the risk of thromboembolism and bleeding in patients with nonvalvular atrial fibrillation (NVAF) receiving direct oral anticoagulants; however, data on risk factors in Japanese patients are limited. Methods: XAPASS (Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation) is a prospective observational study examining the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. We investigated risk factors for stroke/noncentral nervous system systemic embolism (non-CNS SE)/myocardial infarction (MI) and major ...
Source: Journal of Stroke and Cerebrovascular Diseases - Category: Neurology Authors: Source Type: research
Abstract BACKGROUND: Aortic valve sparing operations theoretically have fewer stroke and bleeding complications but may increase late reoperation risk, versus composite valve grafts. METHODS: We meta-analyzed all studies comparing aortic valve sparing (reimplantation and remodelling) and composite valve grafting (bioprosthetic and mechanical) procedures. Early outcomes were: all-cause mortality, reoperation for bleeding, myocardial infarction, thromboembolism/stroke. Long-term outcomes included: all-cause mortality, reintervention, bleeding, and thromboembolism/stroke. Studies exclusively investigating dissec...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Ann Thorac Surg Source Type: research
CONCLUSIONS: Monotherapy with clopidogrel, compared to aspirin, after DAPT showed similar clinical outcomes in patients with acute MI treated with DES. PMID: 31845550 [PubMed - as supplied by publisher]
Source: Korean Circulation Journal - Category: Cardiology Tags: Korean Circ J Source Type: research
CONCLUSIONS: Very low- to moderate-certainty evidence suggests no meaningful difference in efficacy outcomes between non-vitamin K antagonist oral anticoagulants (NOAC) and vitamin K antagonists following percutaneous coronary interventions (PCI) in people with non-valvular atrial fibrillation. NOACs probably reduce the risk of recurrent hospitalisation for adverse events compared with vitamin K antagonists. Low- to moderate-certainty evidence suggests that dabigatran may reduce the rates of major and non-major bleeding, and apixaban and rivaroxaban probably reduce the rates of non-major bleeding compared with vitamin K an...
Source: Cochrane Database of Systematic Reviews - Category: General Medicine Authors: Tags: Cochrane Database Syst Rev Source Type: research
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