Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve

Jawitz, Oliver K.; Wang, Tracy Y.; Lópes, Renato D.; Chavez, Alma; Boyer, Brittanny; Kim, Hwasoon; Anstrom, Kevin J.; Becker, Richard C.; Blackstone, Eugene H.; Ruel, Marc; Thourani, Vinod H.; Puskas, John D.; Gerdisch, Marc W.; Johnston, Douglas; Capps, Scott B.; Alexander, John H.; Svensson, Lars

doi:10.1016/j.ahj.2020.06.014

Cited by 70 publications

(48 citation statements)

References 32 publications

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“…The PROACT Xa is a multicenter, prospective, and open-label study, which is in the phase of recruitment. The study estimates the randomized enrollment of 1,000 patients from 60 sites in North America who underwent aortic valve replacement at least 3 months prior, with an expected duration of 2 years of follow-up ( 34 ). The RENOVATE study (Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor vs. Vitamin K Antagonist After Mechanical Aortic Valve Replacement) is also being conducted.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Direct Oral Anticoagulants and Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

Bitar

Durães

Roever

et al. 2021

Front. Cardiovasc. Med.

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Background: Direct oral anticoagulants (DOACS) are approved for use in non-valvular atrial fibrillation (AF). This systematic review and meta-analysis aimed to evaluate the efficacy and safety of DOACs vs. warfarin and update the evidence for treatment of AF and valvular heart disease (VHD).Methods: We identified randomized clinical trials (RCTs) and post-hoc analyses comparing the use of DOACS and Warfarin in AF and VHD, including biological and mechanical heart valves (MHV), updating from 2010 to 2020. Through systematic review and meta-analysis, by using the “Rev Man” program 5.3, the primary effectiveness endpoints were stroke and systemic embolism (SE). The primary safety outcome was major bleeding, while the secondary outcome included intracranial hemorrhage. We performed prespecified subgroup analyses. Data were analyzed by risk ratio (RR) and 95% confidence interval (CI) and the I-square (I2) statistic as a quantitative measure of inconsistency. Risk of bias and methodological quality assessment of included trials was evaluated with the modified Cochrane risk-of-bias tool.Results: We screened 326 articles and included 8 RCTs (n = 14.902). DOACs significantly reduced the risk of stroke/SE (RR 0.80, 95% CI: 0.68–0.94; P = 0.008; moderate quality evidence; I2 = 2%) and intracranial hemorrhage (RR 0.40, 95% CI: 0.24–0.66; P = 0.0004; I2 = 49%) with a similar risk of major bleeding (RR 0.83, 95% CI: 0.56–1.24; P = 0.36; I2 = 88%) compared to Warfarin.Conclusions: In this update, DOACs remained with similar efficacy and safety compared to warfarin in thromboprophylaxis for AF and VHD.

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Section: Discussionmentioning

confidence: 99%

Comparison of the Direct Oral Anticoagulants and Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

Bitar

Durães

Roever

et al. 2021

Front. Cardiovasc. Med.

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“…This expanded the possibility of targeting a higher‐risk population with lower‐intensity anticoagulation from the results of the LOWERING‐IT trial, which supported an INR goal of 1.5–2.0 in a low thromboembolic risk population 44 . Given the lower antithrombotic needs of this valve type, there is hope that DOACs could represent a safe alternative to warfarin; however, current data still only support the use of warfarin for anticoagulation in all types of prosthetic valves 34,45 …”

Section: Resultsmentioning

confidence: 99%

“…44 Given the lower antithrombotic needs of this valve type, there is hope that DOACs could represent a safe alternative to warfarin; however, current data still only support the use of warfarin for anticoagulation in all types of prosthetic valves. 34,45…”

Section: Prosthetic Valvementioning

confidence: 99%

A review of indications and comorbidities in which warfarin may be the preferred oral anticoagulant

et al. 2021

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What is known and objective: Direct oral anticoagulants (DOACs) are increasingly prescribed instead of warfarin for chronic anticoagulation for ease of dosing, fewer interactions, and less stringent monitoring. However, it is important to consider indications and comorbidities for which warfarin is still the preferred anticoagulant. This review aims to capture these clinical scenarios in which warfarin may still be preferred over DOACs. Methods: We undertook a comprehensive literature search using the PubMed database. Key search terms were based on DOAC clinical trial exclusion criteria, as well as indications and conditions in which the use of DOACs for anticoagulation has suggested harm. Society guidelines and tertiary literature were used to inform expert opinion where necessary. Studies were included if they investigated the use of DOACs or warfarin in the identified indications or conditions. Results and Discussion: Currently, evidence for the use of warfarin over DOACs for anticoagulation is strongest for patients with prosthetic valves, antiphospholipid syndrome, or a high risk of gastrointestinal bleeding. For several clinical situations, including mitral stenosis, obesity, altered gastrointestinal anatomy, pulmonary arterial hypertension, renal or hepatic impairment, and left ventricular thrombus, evidence is lacking but may eventually support the use of DOACs. Depending on indication and condition, appropriateness of DOAC use may vary by agent.What is new and conclusion: New evidence continues to support new indications and conditions in which DOACs may be appropriate to use for anticoagulation. There are key clinical scenarios, however, in which emerging literature continues to support warfarin as the preferred anticoagulant.

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“… 12 Ongoing randomized trials are needed to demonstrate the efficacy and safety of apixaban vs. warfarin in patients with a mechanical aortic heart valve. 13 …”

Section: Discussionmentioning

confidence: 99%

Apixaban use in an atrial fibrillation patient with double mechanical heart valves: a case report

Eom

Shin

Kwon

2021

European Heart Journal - Case Reports

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Background Warfarin is the only approved oral anticoagulant for long-term prophylaxis against valve thrombosis and thromboembolism in patients with mechanical heart valves. To date, apixaban for patients with double (aortic and mitral) mechanical heart valves has not been reported in the literature. Case summary We report the case of a 50-year-old female who underwent double (aortic and mitral) mechanical valve replacement in February 2017. Warfarin was prescribed after mechanical valve replacement. However, she complained of side effects of warfarin, including tingling sensation and numbness of legs, urticaria, skin rash, and nausea and voluntarily stopped taking medication. In December 2018, she was admitted to the emergency room due to ongoing chest pain. Coronary angiogram revealed embolic myocardial infarction at the left circumflex coronary artery. Nevertheless, she continued to refuse to take warfarin after anticoagulant therapy for coronary artery embolism. Given the patient’s objection, we prescribed apixaban 5 mg b.i.d. since February 2019. When she was diagnosed with atrial fibrillation in April 2020, no intracardiac thrombosis was confirmed on computed tomography and electrical cardioversion was performed safely. While on apixaban, no evidence of prosthetic valve thrombosis or thrombo-embolic events was observed during a 24-month period. Conclusion We report the efficacy and safety of apixaban in a patient with atrial fibrillation and double mechanical heart valves for preventing prosthetic valve thrombus and systemic embolism.

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Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve

Cited by 70 publications

References 32 publications

Comparison of the Direct Oral Anticoagulants and Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

Comparison of the Direct Oral Anticoagulants and Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

A review of indications and comorbidities in which warfarin may be the preferred oral anticoagulant

Apixaban use in an atrial fibrillation patient with double mechanical heart valves: a case report

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