Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry
Gregory Y.H. LipAgnieszka KotalczykChristine TeutschHans‐Christoph DienerSérgio DubnerJonathan L. HalperinChangsheng MaKenneth J. RothmanSabrina MarlerVenkatesh Kumar GurusamyMenno V. HuismanDzifa Wosornu AbbanEmad F. AzizMarica Bracic KalanNasser AbdulLuciano Marcelo BackesDrew BradmanAtilio Marcelo AbudErik BadingsDonald BrautigamFran AdamsErmentina BagniNicolas BretonSrinivas AddalaSeth BakerPaul J.A.M. BrouwersPedro AdragãoRichard BalaKevin F. BrowneWalter AgenoAntonio BaldiJordi Bruguera CortadaRajesh AggarwalShigenobu BandoAdriana BruniSergio AgostiSubhash BanerjeeClaude BrunschwigPiergiuseppe AgostoniAlan J. BankHervé BuathierFrancisco AguilarGonzalo Barón‐EsquiviasAurélie BuhlJulio Aguilar LinaresCraig BarrJohn BullingaLuis AguinagaMaria BartlettJose Walter CabreraJameel AhmedVanja Bašić KesAlberto CaccavoAllessandro AielloGiovanni BaulaShanglang CaiPaul AinsworthSteffen BehrensSarah CaineJorge Roberto AiubAlan BellLeonardo CalòRaed Al-DallowRaffaella BenedettiValéria CalviLisa AldersonJuan Benezet MazuecosMauricio Camarillo SánchezJorge Antonio Aldrete VelascoBouziane BenhalimaRui CandeiasDimitrios AlexopoulosJutta Bergler‐KleinVincenzo CapuanoFernando Alfonso ManterolaJean-Baptiste BerneauAlessandro CapucciPareed AliyarRichard A. BernsteinRonald CaputoDavid AlonsoPercy BerrospiTatiana Cárdenas RizoFernando Augusto Alves da CostaSergio BertiFrancisco CardonaJosé AmadoAndrea BerzFrancisco DarrieuxW. AmaraElizabeth A. BestYan Carlos Duarte VeraMathieu AmelotPaulo BettencourtAntonio CaroleiNima AmjadiRobert BetzuSusana CarreñoFabrizio AmmiratiRavi BhagwatPaula CarvalhoMarianna AndradeLuna BhattaSusanna CaryNabil AndrawisFrancesco BiscioneGavino CasuGiorgio AnnoniGiovanni BisignaniClaudio CavalliniGerardo AnsaloneToby BlackGuillaume CaylaM. Kevin ArianiMichael J. BlochAldo CelentanoJuan Carlos AriasStephen R. BloomTae‐Joon ChaSébastien ArmeroEdwin BlumbergKwang SooChander AroraMario BoJei Keon ChaeMuhammad Shakil AslamEllen BøhmerKathrine ChalamidasM. AsselmanAndreas BollmannKrishnan ChallappaPhilippe AudouinMaria Grazia BongiorniSunil Prakash ChandCharles AugenbraunGiuseppe BorianiHarinath ChandrashekarŞenay AydınD. J. BoswijkLudovic ChartierŞenay AydınJochen BottKausik ChatterjeeIvaneta AyryanovaE. BottacchiCarlos Antero Chavez AyalaAamir CheemaGershan DavisRudolph EvonichAmjad CheemaJean‐Marc DavyOksana EvseevaLin ChenMark DayerAndrey EzhovShih‐Ann ChenMarzia De BiasioRaed FahmyJyh Hong ChenSilvana De BonisQuan FangFu‐Tien ChiangRaffaele De CaterinaRamin FarsadFrancesco ChiarellaTeresiano De FranceschiLaurent FauchierLin Chih-ChanJoris R. de GrootStefano FavaleYong Keun ChoJosé de Anchieta C. Horta‐JúniorMaxime FayardJong‐Il ChoiAxel De La BriolleJosé Luis FedeleDong Ju ChoiGilberto de la Peña TopeteFrancesco FedeleGuy ChouinardÂngelo Amato Vicenzo de PaolaOlga FedorishinaDanny Hoi-Fan ChowWeimar Kunz Sebba BarrosoSteven R. FeraDimitrios ChrysosA. de VeerLuís Gustavo Gomes FerreiraГ. А. ЧумаковаLuc De WolfJorge FerreiraEduardo Julián José Roberto Chuquiu ValenzuelaEric DecoulxClaudio FerriNicoleta Cindea NicaSasalu DeepakAnna FerrierDavid J. CislowskiPascal DefayeHugo FerroAnthony ClayFreddy Del‐Carpio MunozAlexandra Vanessa FinsenPiers CliffordDiana Delić-BrkljačićBrian FirstAndrew S. CohenN. Joseph DeumiteStuart G. FischerMichael N. CohenSilvia Di LeggeAna Catarina FonsecaSerge X. CohenIgor DiembergerLuísa Fonseca AlmeidaFurio ColivicchiDenise DietzSteven L. FormanRónán CollinsPedro DionísioBrad FrandsenPaolo ColonnaQiang DongWilliam J. FrenchS. ComptonFabio Rossi dos SantosKeith FriedmanDerek ConnollyElena DotchevaAthena FrieseAlberto ContiRami DoukkyAna Gabriela FruntelataGabriel Contreras BuenostroAnthony D’SouzaShigeru FujiiGregg CoodleySimon W DubreyStefano FumagalliMartin CooperXavier DucrocqMarta FundamenskiJulián CoronelDmitry DupljakovYutaka FurukawaGiovanni CorsoMauricio DuqueM. GabelmannJuan Cosı́n-SalesDipankar DuttaNashwa GabraYves CottinNathalie DuvillaNiels GadsbøllJohn CovaleskyA DuygunMichel GalinierAurel CracanRainer DziewasAnders GammelgaardFilippo CreaCharles B. 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Abstract Background and purpose Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF). Methods In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Results The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79–2.03), major bleeding 0.59 (0.40–0.88), myocardial infarction 0.68 (0.40–1.16), and all-cause death 0.86 (0.67–1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76–1.78), myocardial infarction 0.84 (0.48–1.46), major bleeding 0.98 (0.63–1.52) and all-cause death 1.01 (0.79–1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52–1.19), myocardial infarction 0.96 (0.63–1.45), major bleeding 1.54 (1.14–2.08), and all-cause death 0.97 (0.80–1.19). Conclusions Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death. Registration URL: https://www.clinicaltrials.gov . Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013. Graphical abstractKeywords:
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Stroke
New, non-vitamin K antagonist oral anticoagulants (NOACs) have been developed to overcome the limitations of warfarin. These include dabigatran, which inhibits thrombin, and rivaroxaban, apixaban, and edoxaban, which inhibit factor Xa. In the US, rivaroxaban and apixaban are licensed for thromboprophylaxis after elective hip or knee arthroplasty, and rivaroxaban and dabigatran are approved for treatment of venous thromboembolism. Dabigatran, rivaroxaban, and apixaban also are licensed for stroke prevention in eligible patients with atrial fibrillation. Designed to be given in fixed doses without routine coagulation monitoring, the NOACs are more convenient to administer than warfarin. Phase III clinical trials have shown that the NOACs are at least as effective as warfarin and are associated with less intracranial bleeding. This article compares the pharmacological properties of the NOACs with those of warfarin, describes the clinical trial data with the NOACs in the approved indications, outlines the unmet medical needs that the NOACs address, highlights the potential limitations of the NOACs, and provides guidance on the optimal use of the NOACs.
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There are presently new oral anticoagulants (NOAC) for prevention and the treatment of thromboembolic diseases and they are registered in CZ. It concerns of orally direct inhibitors of thrombin (dabigatran etexilate), inhibitors of factor Xa (apixaban, rivaroxaban), respectively, with advantage of some properties not being seen in "classical" anticoagulants. In the use of new anticoagulants, however, are some problems - such as laboratory monitoring in urgent situations of effective treatment and the absence of specific antidote - resolved. The text below brings indications, dosage of the drugs, their elimination, follow-up of efficacy of the treatment or risk of the bleeding as well as the therapy of bleeding complications.Key words: apixaban - dabigatran etexilate - NOAC - rivaroxaban.
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Dabigatran, rivaroxaban and apixaban are oral anticoagulants used to prevent or treat thrombosis in a variety of situations. Like all anticoagulants, these drugs can provoke bleeding. How should patients be managed if bleeding occurs during dabigatran, rivaroxaban or apixaban therapy? How can the risk of bleeding be reduced in patients who require surgery or other invasive procedures? To answer these questions, we reviewed the available literature, using the standard Prescrire methodology. In clinical trials, warfarin, enoxaparin, dabigatran, rivaroxaban and apixaban were associated with a similar frequency of severe bleeding. Numerous reports of severe bleeding associated with dabigatran have been recorded since this drug was first marketed. Some situations are associated with a particularly high bleeding risk, including: even mild renal failure, advanced age, extremes in body weight and drug-drug interactions, particularly with antiplatelet agents (including aspirin), nonsteroidal antiinflammatory drugs, and many drugs used in cardiovascular indications. In patients treated with dabigatran, rivaroxaban or apixaban, changes in the INR (international normalised ratio) and activated partial thromboplastin time (aPTT) do not correlate with the dose. In early 2013, there is still no routine coagulation test suitable for monitoring these patients; specific tests are only available in specialised laboratories. In early 2013 there is no antidote for dabigatran, rivaroxaban or apixaban, nor any specific treatment with proven efficacy for severe bleeding linked to these drugs. Recommendations on the management of bleeding in this setting are based mainly on pharmacological parameters and on scarce experimen-Haemodialysis reduces the plasma concentration of dabigatran, while rivaroxaban and apixaban cannot be eliminated by dialysis. Prothrombin complex concentrates and recombinant activated factor VII seem to have little or no efficacy, and they carry a poorly documented risk of thrombosis. For patients undergoing surgery or other invasive procedures, clinical practice guidelines are primarily based on pharmacokinetic parameters and on extrapolation of data on vitamin K antagonists. The decision on whether or not to discontinue anticoagulation before the procedure mainly depends on the likely risk of bleeding. In patients at high risk of thrombosis, heparin can be proposed when the anticoagulant is withdrawn. In early 2013, difficulties in the management of bleeding and of situations in which there is a risk of bleeding weigh heavily in the balance of potential harm versus potential benefit of dabigatran, rivaroxaban and apixaban. When an oral anticoagulant is required, it is best to choose warfarin, a vitamin K antagonist, and the drug with which we have the most experience, except in those rare situations in which the INR cannot be maintained within the therapeutic range.
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OBJECTIVES: This study sought to perform an indirect comparison analysis of dabigatran etexilate (2 doses), rivaroxaban, and apixaban for their relative efficacy and safety against each other.BACKGROUND: Data for warfarin compared against the new oral anticoagulants (OACs) in large phase III clinical trials of stroke prevention in atrial fibrillation (AF) are now available for the oral direct thrombin inhibitor, dabigatran etexilate, in 2 doses (150 mg twice daily [BID], 110 mg BID), and the oral Factor Xa inhibitors, rivaroxaban and apixaban. A "head-to-head" direct comparison of drugs is the standard method for comparing different treatments, but in the absence of such head-to-head direct comparisons, another alternative to assess the relative effect of different treatment interventions would be to perform indirect comparisons, using a common comparator. Nonetheless, any inter-trial comparison is always fraught with major difficulties, and an indirect comparison analysis has many limitations, especially with the inter-trial population differences and thus, should not be overinterpreted.METHODS: Indirect comparison analysis was performed using data from the published trials.RESULTS: There was a significantly lower risk of stroke and systemic embolism (by 26%) for dabigatran (150 mg BID) compared with rivaroxaban, as well as hemorrhagic stroke and nondisabling stroke. There were no significant differences for apixaban versus dabigatran (both doses) or rivaroxaban; or rivaroxaban versus dabigatran 110 mg BID in preventing stroke and systemic embolism. For ischemic stroke, there were no significant differences between the new OACs. Major bleeding was significantly lower with apixaban compared with dabigatran 150 mg BID (by 26%) and rivaroxaban (by 34%), but not significantly different from dabigatran 110 mg BID. There were no significant differences between apixaban and dabigatran 110 mg BID in safety endpoints. Apixaban also had lower major or clinically relevant bleeding (by 34%) compared with rivaroxaban. When compared with rivaroxaban, dabigatran 110 mg BID was associated with less major bleeding (by 23%) and intracranial bleeding (by 54%). There were no significant differences in myocardial infarction events between the dabigatran (both doses) and apixaban.CONCLUSIONS: Notwithstanding the limitations of an indirect comparison study, we found no profound significant differences in efficacy between apixaban and dabigatran etexilate (both doses) or rivaroxaban. Dabigatran 150 mg BID was superior to rivaroxaban for some efficacy endpoints, whereas major bleeding was significantly lower with dabigatran 110 mg BID or apixaban. Only a head-to-head direct comparison of the different new OACs would fully answer the question of efficacy/safety differences between the new drugs for stroke prevention in AF.Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. PMID: 22575324
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Within the past 5 years, the oral anticoagulants rivaroxaban, apixaban, and dabigatran etexilate have been approved for the prevention of venous thromboembolism in adult patients after elective hip or knee arthroplasty in the European Union and many other countries worldwide. These agents differ from the previously available anticoagulants because they selectively and directly inhibit a single factor in the coagulation cascade—rivaroxaban and apixaban inhibit Factor Xa, and dabigatran inhibits Factor IIa (thrombin)—potentially enhancing the predictability of their anticoagulant effect. Currently, although some guidelines provide recommendations for the use of rivaroxaban, dabigatran etexilate, and apixaban in clinical practice, there are still questions regarding the optimal practical management of patients receiving these agents. This article briefly reviews the practical limitations associated with conventional anticoagulants, discusses potential issues with the practical management of the newer oral anticoagulants, and provides clinical experience from a single institution where rivaroxaban and dabigatran etexilate have been used within their approved indications.
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