Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis

Abstract

Aims This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA2DS2-VASc score parameters as predictors for clinical outcome. Methods Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y12 inhibitor and aspirin (100 mg OD, for 1–12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis. Results Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654–1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711–1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA2DS2-VASc score was associated with increased rates of all outcomes. CHA2DS2-VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024). Conclusion After PCI in AF patients, increasing CHA2DS2-VASc score was associated with increased bleeding rates and CHA2DS2-VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.

Atrial Cardiomyopathy: Pathophysiology and Clinical Consequences

“…These changes are not related to the presence of absence of AF, explaining why atrial thrombogenesis is still increased even during sinus rhythm in certain subgroups of patients [211,212]. Recently, post hoc studies from large randomized controlled trials suggested that the burden of AF (Figure 3) as well as the type of AF (paroxysmal versus persistent/permanent AF) might be a factor, which drives differences in patient outcome [213][214][215][216][217]. Such clinical differences might be explained at least to some extent by differences in atrial cardiomyopathies and ventricular oxidative stress levels during various types of AF [210].…”

Impact of atrial fibrillation pattern on outcomes after left atrial appendage closure: lessons from the prospective LAARGE registry

“…Interestingly, sub-analyses of the ENTRUST-AF and ENSURE-AF trials showed an association of MI and PAF not observed in patients with persistent AF [13,14]. The authors propose that PAF is associated with microcirculatory flow abnormalities and may increase events in vulnerable myocardium [13,14]. However, several limitations may limit the generalization of the findings.…”

“…Recently, a meta-analysis of 12 studies, with almost 100.000 patient showed that NPAF was associated with a higher risk for thromboembolism and all-cause mortality, no difference in bleeding was observed [11]. Interestingly, sub-analyses of the ENTRUST-AF and ENSURE-AF trials showed an association of MI and PAF not observed in patients with persistent AF [13,14]. The authors propose that PAF is associated with microcirculatory flow abnormalities and may increase events in vulnerable myocardium [13,14].…”

“…However, several limitations may limit the generalization of the findings. For Instance, patients with PAF in ENSURE-AF were significantly more likely to be without anticoagulation at baseline compared with NPAF patients (47% vs 23%, p < 0.0001) and follow-up encompassed only 58 days [13,14]. While the increased stroke risk and mortality for NPAF has been shown repeatedly, the influence of AF types on LAA thrombus formation and outcomes after LAAC has not been a focus of research [5].…”

Anti-thrombotic strategies in patients with atrial fibrillation undergoing PCI

“…When a patient with AF requires PCI with consecutive DAPT, combining ASA + OAC + clopidogrel can increase the risk of bleeding by 3–4-fold compared to OAC alone [ 10 , 40 ]. Thus, there had been a quest for alternative anti-thrombotic combination therapies with less bleeding risk.…”