Non-vitamin K antagonist oral anticoagulants in atrial fibrillation patients undergoing elective cardioversion.

Aims: Non-vitamin K antagonist oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF). The aim of this study was to investigate the complications and the use of NOACs in AF patients undergoing elective cardioversion. Methods and results: This nationwide multicentre study included consecutive elective cardioversions in AF patients treated with NOACs between October 2011 and May 2016. Data on patient characteristics, antithrombotic treatment and acute (<30 days) complications were collected. One thousand twenty-one patients (mean age 64 years, 70% men) underwent 1291 elective cardioversions, of which 680 (52.7%) cardioversions were performed in patients using dabigatran, 431 (33.4%) rivaroxaban, and 159 (12.3%) apixaban. Mean CHA2DS2-VASc score was 1.8 (±1.5). A total of 3 thromboembolic events occurred after the cardioversion (0.2%): 1 patient receiving dabigatran experienced an ischaemic stroke on Day 2 and 1 rivaroxaban treated patient on Day 4. One patient receiving dabigatran experienced a transient ischaemic attack on Day 11. All 3 patients had used recommended doses of the NOAC. A total of 6 (0.5%) clinically relevant, but not serious bleeding events occurred. Only short duration of AF was associated with lower rate of AF recurrence. Conclusion: Thrombotic and bleeding complications related to NOACs were uncommon (<0.5%) in real life AF patients undergoing elective cardioversion.

The management of patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation: in-hospital-data from the Atrial Fibrillation undergoing Coronary Artery Stenting study.

Current recommendations on the management of patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent (PCI-S) essentially derive from small, single-center, retrospective datasets. To obtain larger and better quality data, we carried out the prospective, multicenter Atrial Fibrillation undergoing Coronary Artery Stenting (AFCAS) study. Therefore, consecutive patients with history of or ongoing AF undergoing PCI-S were enrolled, and occurrence of adverse ischemic and bleeding events recorded during 12 months follow-up. In this article, we report the in-hospital observations. Out of the 963 patients, in the majority of cases (49.1%) AF was permanent. The associated risk of stroke, as defined by a CHADS2 -score ≥2, was in 70% of patients moderate to high. Upon enrollment in the registry, 69.3% of patients were on VKA therapy. Overall occurrence of in-hospital major adverse cardiac events was 4.5% (cardiovascular death 1.9%, urgent revascularization in 1.5%, and stroke/arterial thromboembolism in 0.6%). Bleeding complications occurred in 7.1% of patients, being severe in 2.5%. In a logistic regression analysis, no risk factor was independently associated with bleeding events, whereas Clopidogrel treatment decreased and female gender/treatment with gpIIb/IIIa-antagonists, respectively increased the risk for the combined ischemic endpoint. The majority of AF patients undergoing PCI-S are at high stroke risk, and therefore VKA treatment should not be withdrawn and combined anticoagulant and antiplatelet treatment is warranted. Current management appears largely in accordance with current recommendations, whereby accounting for the limited occurrence of in-hospital adverse ischemic and bleeding events.

Heparin bridging vs. uninterrupted oral anticoagulation in patients with Atrial Fibrillation undergoing Coronary Artery Stenting. Results from the AFCAS registry.

BACKGROUND: The anti-thrombotic strategy during coronary stenting is challenging in patients on long-term oral anticoagulation (OAC) because of atrial fibrillation (AF). Uninterrupted OAC (UAC) is increasingly used, but bridging therapy (BT) is still in common use. METHODS AND RESULTS: Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting (AFCAS) is a prospective multicenter European registry that recruited 963 patients with AF undergoing coronary stenting. To compare the safety of UAC and BT, bleeding complications and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction, target vessel revascularization, stent thrombosis and stroke) were assessed in 290 patients treated with UAC and 161 patients with BT during a 30-day follow-up period. In the BT group, OAC was interrupted for a median of 5 days. Overall bleeding complications tended to be more common in the BT group (18.6% vs. 12.1%, P=0.07), with no significant difference in the rate of major bleeding (2.5% vs. 1.4%) or MACCE (6.2% vs. 3.8%). After adjustment for propensity score, BT was not associated with bleeding complications (odds ratio [OR], 1.38; 95% confidence interval [CI]: 0.77-2.48, P=0.28) or MACCE (OR, 1.16; 95%CI: 0.44-3.05, P=0.76). Periprocedural international normalized ratio was not associated with bleeding or MACCE. CONCLUSIONS: UAC does not increase perioperative complications during coronary stenting and is a simple and cost-effective alternative to conventional heparin bridging.

Outcome of octogenarians with atrial fibrillation undergoing percutaneous coronary intervention: insights from the AFCAS registry.

BACKGROUND: More evidence is needed on the optimal antithrombotic regimen in elderly patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). HYPOTHESIS: Octogenarian patients (aged ≥80 years) with AF who underwent PCI have worse 12-month clinical outcome, compared with younger patients. METHODS: We performed a post-hoc analysis of data from the prospective, multicenter AFCAS registry, which enrolled consecutive patients with AF who underwent PCI and stenting. Outcome measures included major adverse cardiac/cerebrovascular events (MACCE; all-cause death, myocardial infarction, repeat revascularization, stent thrombosis, or stroke/transient ischemic attack) and bleeding events at 12-month follow-up. RESULTS: Out of 925 AF patients enrolled in AFCAS registry, 195 (21.1%) were ≥80 years. Mean age was 82.9 ± 2.6 years; 41.5% were women; 32.3% had diabetes mellitus. Compared with patients aged <80 years, there were more females among the octogenarians (P < 0.001). Compared with younger patients, octogenarians smoked and had dyslipidemia less often, and presented more frequently with acute coronary syndrome. The frequency and duration of antithrombotic regimens prescribed at discharge were comparable. At 12-month follow-up, overall MACCE rate was higher in octogenarians compared with younger patients (27.7% vs 20.1%, P = 0.02). The rate of acute myocardial infarction was higher in octogenarians (9.2% vs 4.9%, P = 0.02), but the rates of all bleeds and BARC >2 bleeds were similar (P = 0.13, P = 0.29, respectively). CONCLUSIONS: In real-world patients with AF undergoing PCI, patients aged ≥80 years had higher incidence of MACCE at 12-month follow-up compared with younger patients, although they received comparable antithrombotic treatment. The rates of bleeding events were similar.

Renal Impairment and Prognosis of Patients with Atrial Fibrillation Undergoing Coronary Intervention - The AFCAS Trial.

BACKGROUND: Renal impairment is a well-known risk factor for cardiovascular complications, but the effect of different stages of renal impairment on thrombotic/thromboembolic and bleeding complications in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) remains largely unknown. We sought to evaluate the incidence and clinical impact of four stages of renal impairment in patients with AF undergoing PCI. METHODS: We assessed renal function by estimated glomerular filtration rate (eGFR) and outcomes in 781 AF patients undergoing PCI by using the data from a prospective European multicenter registry. End-points included all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE) and bleeding events at 12 months. RESULTS: A total of 195 (25%) patients had normal renal function (eGFR ≥90 mL/min), 290 (37%) mild renal impairment (eGFR 60-89), 263 (34%) moderate renal impairment (eGFR 30-59) and 33 (4%) severe renal impairment (eGFR <30). Degree of renal impairment remained an independent predictor of mortality and MACCE in an adjusted a Cox regression model. Even patients with mild renal impairment had a higher risk of all-cause mortality (HR 2.25, 95%CI 1.02-4.98, p=0.04) and borderline risk for MACCE (HR 1.56, 95%CI 0.98- 2.50, p=0.06) compared to those with normal renal function. CONCLUSIONS: Renal impairment is common in patients with AF undergoing PCI and even mild renal impairment has an adverse prognostic effect in these patients requiring multiple antithrombotic medications.

Performance of bleeding risk-prediction scores in patients with atrial fibrillation undergoing percutaneous coronary intervention.

The hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, and drugs/alcohol (HAS-BLED); anticoagulation and risk factors in atrial fibrillation (ATRIA); modified Outpatient Bleeding Risk Index (mOBRI); and reduction of atherothrombosis for continued health (REACH) schemes are validated bleeding risk-prediction tools, but their predictive performance in patients with AF receiving multiple antithrombotic drugs after percutaneous coronary intervention (PCI) is unknown. We sought to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation (AF) undergoing PCI. Management of patients with AF undergoing coronary artery stenting is a multicenter European prospective registry enrolling patients with AF undergoing PCI. We calculated HAS-BLED, ATRIA, mOBRI, and REACH bleeding risk-prediction scores and assessed the rate of bleeding complications as defined by Bleeding Academic Research Consortium at 12 months follow-up in 929 consecutive patients undergoing PCI. Increasing age, femoral access site, and previous peptic ulcer were independent determinants of bleeding. Low bleeding risk scores as determined by HAS-BLED 0 to 2, ATRIA 0 to 3, mOBRI 0, and REACH 0 to 10 were detected in 23.7%, 73.0%, 7.8%, and 5.7% of patients of the cohort, respectively. No significant differences were detected in the rates of any bleeding or major bleeding events for low versus intermediate/high scores with each risk-prediction tool. In conclusion, the performance of ATRIA, HAS-BLED, mOBRI, and REACH scores in predicting bleeding complications in this high-risk patient subset was useless.

Are glycoprotein inhibitors safe during percutaneous coronary intervention in patients on chronic warfarin treatment?

The aim of this study was to evaluate the safety of glycoprotein IIb/IIIa inhibitors (GPIs) during percutaneous coronary intervention (PCI) in patients on chronic warfarin therapy due to atrial fibrillation (AF). We analysed all consecutive AF patients (N = 377, mean age 70 years, male 71%) on warfarin therapy referred for PCI in seven centres. Major bleeding, access site complications and major adverse cardiovascular events were recorded during hospitalisation. A total of 111 patients (29%) received periprocedural GPIs with a wide inter-hospital variation in their use (range 3-68%). The use of GPIs increased with the severity of the disease presentation and 49% of patients with ST-elevation myocardial infarction received GPIs. Mean periprocedural international normalised ratio (INR) of patients who received GPIs was 1.89 (range 1.1-3.3). Major bleeding was more common in the patients treated with GPIs (9.0% vs. 1.5%, p = 0.001) than in those without GPIs, but there was no difference in major adverse cardiovascular events between the groups. In multivariable analysis, use of GPIs (odds ratio [OR] 5.1, 95% confidence interval [CI] 1.3-20.6, p = 0.02) and old age (OR 1.2, 95% CI 1.0-1.3, p= 0.02) remained as the only independent predictors of major bleeding. Also after adjusting for propensity score, GPIs remained as a significant predictor of major bleeding (OR 3.8, 95% CI 1.03-14.1, p = 0.045). In the GPI group, major bleeding was not predicted by INR level or warfarin pause. GPIs increase the risk of major bleeding events irrespective of periprocedural INR levels and should be used with caution in this fragile patient group.