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Novel Dual Therapy: A Paradigm Shift in Anticoagulation in Patients of Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

ABSTRACT: Patients with atrial fibrillation (AF) on long-term oral anticoagulation (OAC) either have underlying coronary artery disease or suffer from acute coronary syndromes necessitating a percutaneous coronary intervention (PCI). In such a scenario, an amalgamation of antiplatelet and antithrombotic therapy (conventionally called as "triple therapy") is obligatory for preventing coronary ischemia and stroke. But such ischemic benefits are accrued at the cost of increased bleeding. We also now know that bleeding events following PCI are related to increased mortality. Balancing the bleeding and ischemic risks is often a clinical dilemma. With the advent of novel oral anticoagulants (NOAC's) with preserved efficacy and attenuated bleeding rates, anticoagulation in AF is undergoing paradigm shift. The spotlight is now shifting from conventional triple therapy (vitamin-K antagonist?+?dual antiplatelet therapy [VKA?+?DAPT]) to novel dual therapy (NOAC?+?single antiplatelet therapy [SAPT]) in situation of anticoagulated AF patients undergoing PCI. Such a strategy aims to ameliorate the higher bleeding risk with conventional VKA's while retaining the ischemic benefits. In this review, we briefly discuss the need for combination therapy, trials of novel dual therapy, strategies for mitigating bleeding, the current guidelines, and the future perspectives in AF undergoing PCI with stent(s).

SUBMITTER: Pradhan A

PROVIDER: S-EPMC7609168 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Novel Dual Therapy: A Paradigm Shift in Anticoagulation in Patients of Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

Pradhan Akshyaya A Bhandari Monika M Vishwakarma Pravesh P Sethi Rishi R

TH open : companion journal to thrombosis and haemostasis 20201031 4

Patients with atrial fibrillation (AF) on long-term oral anticoagulation (OAC) either have underlying coronary artery disease or suffer from acute coronary syndromes necessitating a percutaneous coronary intervention (PCI). In such a scenario, an amalgamation of antiplatelet and antithrombotic therapy (conventionally called as "triple therapy") is obligatory for preventing coronary ischemia and stroke. But such ischemic benefits are accrued at the cost of increased bleeding. We also now know tha ...[more]

PMID: 33163856

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Project description:Background and objectiveMost Asian patients with atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) receive only dual antiplatelet therapy (DAPT) without oral anticoagulants (vitamin K antagonists [VKA] or non-VKA oral anticoagulants [NOAC]). However, it has not been fully investigated whether the DAPT results in better clinical outcomes in the early period after PCI than the standard triple therapy with VKA or NOAC.MethodsWe analyzed the claims records of 11,039 Korean AF population who had PCI between 2013 and 2018. Patients were categorized according to the post-PCI antithrombotic therapy as VKA-based triple therapy (VKA-TT), NOAC-based triple therapy (NOAC-TT), and DAPT groups. After baseline adjustment using inverse probability weighting, we compared the risks of ischemic endpoints (ischemic stroke, myocardial infarction, and all-cause mortality) and major bleeding at 3 months post-PCI.ResultsIschemic stroke, MI, and all-cause mortality occurred in 105, 423, and 379 patients, respectively, and 138 patients experienced major bleeding. The DAPT group was associated with a lower risk of ischemic stroke and major bleeding (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.37-0.84) compared to the VKA-TT group, despite no significant differences in the risks of MI and all-cause mortality. In contrast, the DAPT group demonstrated no significant difference in the risks for ischemic endpoints compared to the NOAC-TT group. Additionally, the DAPT group had a numerically lower risk of major bleeding than the NOAC-TT group but this was not statistically significant (HR 0.69, 95% CI 0.45-1.07).ConclusionsAn outcome benefit of DAPT was observed in the early period after PCI compared to the VKA-TT, but not against NOAC-TT users among the Asian AF population. Given the potential long-term benefits of NOACs, greater efforts should be made to increase compliance in clinical practice with proper combination therapy with NOAC after PCI.

Project description:ImportanceAntithrombotic treatment in patients with atrial fibrillation (AF) and percutaneous coronary intervention (PCI) presents a balancing act with regard to bleeding and ischemic risks.ObjectivesTo evaluate the safety and efficacy of 4 antithrombotic regimens by conducting an up-to-date network meta-analysis and to identify the optimal treatment for patients with AF undergoing PCI.Data sourcesOnline computerized database (MEDLINE).Study selectionFive randomized studies were included (N?=?11?542; WOEST, PIONEER AF-PCI, RE-DUAL PCI, AUGUSTUS, ENTRUST-AF PCI).Data extraction and synthesisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used in this network meta-analysis, in which bayesian random-effects models were applied. The data were analyzed from September 9 to 29, 2019.Main outcomes and measuresThe primary safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding and the primary efficacy outcome was trial-defined major adverse cardiovascular events (MACE).ResultsThe total number of participants included in the study was 11 532. The mean age of the participants ranged from 70 to 72 years, 69% to 83% were male, 20% to 26% were female, and the participants were predominantly white (>90%). Compared with vitamin K antagonists (VKA) plus dual antiplatelet therapy (DAPT) (reference), the odds ratios (ORs) (95% credible intervals) for TIMI major bleeding were 0.57 (0.31-1.00) for VKA plus P2Y12 inhibitor, 0.69 (0.40-1.16) for non-VKA oral anticoagulant (NOAC) plus DAPT, and 0.52 (0.35-0.79) for NOAC plus P2Y12 inhibitor. For MACE, using VKA plus DAPT as reference, the ORs (95% credible intervals) were 0.97 (0.64-1.42) for VKA plus P2Y12 inhibitor, 0.95 (0.64-1.39) for NOAC plus DAPT, and 1.03 (0.77-1.38) for NOAC plus P2Y12 inhibitor.Conclusions and relevanceThe findings of this study suggest that an antithrombotic regimen of VKA plus DAPT should generally be avoided, because regimens in which aspirin is discontinued may lead to lower bleeding risk and no difference in antithrombotic effectiveness. The use of a NOAC plus a P2Y12 inhibitor without aspirin may be the most favorable treatment option and the preferred antithrombotic regimen for most patients with AF undergoing PCI.

Project description:AimsThe GRACE and CHA2DS2-VASc risk score are developed for risk stratification in patients with acute coronary syndrome and AF, respectively. We aimed to assess the predictive performance of the GRACE score and CHA2DS2-VASc score among patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI).MethodsConsecutive patients with a diagnosis of AF admitted to our hospital for PCI between January 2016 and December 2018 were included and followed up for at least 1 year. The primary endpoint was a composite of major adverse cardiac events (MACEs) including all-cause mortality, repeat revascularization, myocardial infarction, or ischaemic stroke.ResultsA total of 1452 patients were identified. Cox regression demonstrated that the GRACE (HR 1.014, 95% CI 1.008-1.020, p < 0.001) but not the CHA2DS2-VASc score was associated with the risk of MACEs. Both GRACE and CHA2DS2-VASc scores were predictive of all-cause mortality with HR of 1.028 (95% CI 1.020-1.037, p < 0.001) and 1.334 (95% CI 1.107-1.632, p = 0.003). Receiver operating characteristic analyses showed both scores had similar discrimination capacity for all-cause mortality (C-statistic: 0.708 for GRACE vs. 0.661 for CHA2DS2-VASc, p = 0.299). High GRACE score was also significantly associated with increased risk of ischaemic stroke (HR 1.018, 95% CI 1.005-1.031, p = 0.006) and major bleeding (HR 1.012, 95% CI 1.001-1.024, p = 0.039), whereas high CHA2DS2-VASc score was not.ConclusionsHigh GRACE score but not CHA2DS2-VASc score were both associated with an increased risk of MACEs after PCI in patients with AF. The GRACE and CHA2DS2-VASc scores have similar predictive performance for predicting all-cause mortality.Key messages:In patients with AF undergoing PCI, increasing GRACE but not CHA2DS2-VASc scores was independently associated high risk of MACEs.The GRACE score could also help identify patients at higher risk of stroke and major bleeding.Both GRACE and CHA2DS2-VASc scores showed good ability in the prediction of all-cause mortality.

Project description:BackgroundThe safety and effectiveness of dual therapy (direct oral anticoagulant [DOAC] plus P2Y12 inhibitor) versus triple therapy (vitamin K antagonist plus aspirin and P2Y12 inhibitor) in patients with nonvalvular atrial fibrillation (AF) after percutaneous coronary intervention (PCI) is unclear.PurposeTo examine the effects of dual versus triple therapy on bleeding and ischemic outcomes in adults with AF after PCI.Data sourcesSearches of PubMed, EMBASE, and the Cochrane Library (inception to 31 December 2019) and ClinicalTrials.gov (7 January 2020) without language restrictions; journal Web sites; and reference lists.Study selectionRandomized controlled trials that compared the effects of dual versus triple therapy on bleeding, mortality, and ischemic events in adults with AF after PCI.Data extractionTwo independent investigators abstracted data, assessed the quality of evidence, and rated the certainty of evidence.Data synthesisFour trials encompassing 7953 patients were selected. At the median follow-up of 1 year, high-certainty evidence showed that dual therapy was associated with reduced risk for major bleeding compared with triple therapy (risk difference [RD], -0.013 [95% CI, -0.025 to -0.002]). Low-certainty evidence showed inconclusive effects of dual versus triple therapy on risks for all-cause mortality (RD, 0.004 [CI, -0.010 to 0.017]), cardiovascular mortality (RD, 0.001 [CI, -0.011 to 0.013]), myocardial infarction (RD, 0.003 [CI, -0.010 to 0.017]), stent thrombosis (RD, 0.003 [CI, -0.005 to 0.010]), and stroke (RD, -0.003 [CI, -0.010 to 0.005]). The upper bounds of the CIs for these effects were compatible with possible increased risks with dual therapy.LimitationHeterogeneity of study designs, dosages of DOACs, and types of P2Y12 inhibitors.ConclusionIn adults with AF after PCI, dual therapy reduces risk for bleeding compared with triple therapy, whereas its effects on risks for death and ischemic end points are still unclear.Primary funding sourceNone.

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Novel Dual Therapy: A Paradigm Shift in Anticoagulation in Patients of Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

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Novel Dual Therapy: A Paradigm Shift in Anticoagulation in Patients of Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

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