scholarly journals Changes in Antithrombotic Therapy of Atrial Fibrillation in the Hospital in 2011-2012 and 2016-2017 (Pharmacoepidemiological Analysis)

2020 ◽  
Vol 16 (5) ◽  
pp. 686-692
Author(s):  
O. V. Reshetko ◽  
A. V. Sokolov ◽  
N. V. Furman ◽  
V. V. Agapov

Aim. To study the changes that have occurred in the pharmacotherapy of atrial fibrillation (AF) in the Saratov Region for 5 years by analyzing the antithrombotic therapy of patients who were admitted in a specialized department of the multidisciplinary hospital in Saratov in 2011-2012 and in 2016-2017.Material and methods. A pharmacoepidemiological retrospective study was conducted. The object of the study was the medical records of inpatients (Form 003/y) with the diagnosis “Atrial fibrillation” (ICD-X code I48), that consecutively admitted to the cardiology department of the multidisciplinary hospital in Saratov from January 1, 2011 to December, 31, 2012 (n=211) and from January 1, 2016 to December, 31, 2017 (n=227). Criteria for inclusion in the study: patients over 18 years of age, established diagnosis of non-valvular AF of ischemic genesis. Exclusion criteria from the study: non-ischemic cardiomyopathy, thyrotoxicosis, congenital heart defects, rheumatic heart damage, acute coronary syndrome, endocarditis, myocarditis, pericarditis, pulmonary thromboembolism, the presence of prosthetic heart valve. Pharmacoepidemiological analysis was carried out for the drugs prescribed during hospitalization and given by doctors at discharge of patients from the hospital. The risk of ischemic stroke was assessed using the CHA2DS2-VASc score, and the risk of bleeding – according to the HAS-BLED score.Results. When analyzing the risk of ischemic stroke, it was found that 100% of patients in 2011-2012 years and 98.2% in 2016-2017 years had indications for the prescription of oral anticoagulants (OAСs). In 2011-2012 there were no patients with a low risk of stroke (CHA2DS2-VASc=0). High risk of bleeding (HAS-BLED≥3) occurred in 4.7% of patients in 2011-2012 and in 10.6% in 2016-2017, however, due to the high risk of stroke, the refusal to prescribe OAC in these patients was inappropriate in accordance with the recommendations for the treatment of AF. In the group of patients with CHA2DS2-VASc=0 in 2016-2017 antiplatelet therapy was prescribed in 100% at the hospital stage and at discharge, which contradicts the guidelines, according to which antithrombotic therapy is not recommended to patients with CHA2DS2-VASc=0. In patients with CHA2DS2-VASc=1, a low percentage of anticoagulants prescription was noted. In 2016-2017 OACs were prescribed only in 12.5% of patients at all stages of observation. In 2011-2012 OAC alone was prescribed only to 1 person (20%) at the hospital stage, which does not comply with modern guidelines for the treatment of patients with AF, according to which patients with a risk score CHA2DS2-VASc=1 are recommended to receive OACs in the absence of contraindications. OACs prescription in group CHA2DS2-VASc≥2 occurred only in 15% of patients in 2011-2012 and in a third of patients in 2016-2017 (p<0.05). The frequency of isolated use of OACs significantly increased in 2016-2017 compared to 2011-2012 mainly due to the increase in the spectrum of direct OACs (DOACs) (p<0.05).Conclusion. For 5 years there have been significant changes in the antithrombotic therapy of AF in the Saratov Region. The frequency of prescribing OACs according to indications has increased mainly due to the introduction of the DOACs into clinical practice. However, prevention of stroke remains insufficient.

2020 ◽  
pp. 56-64
Author(s):  
E. P. Panchenko

The article presents an analytical review of the studies aimed at determining the optimal antithrombotic therapy in patients with atrial fibrillation undergoing elective or emergency percutaneous coronary intervention (PCI) due to the development of acute coronary syndrome (ACS). The results of the WOEST study are analysed. This study was the first to demonstrate an opportunity to safely discontinue administration of aspirin as part of the multicomponent antithrombotic therapy that included warfarin as an anticoagulant. Three studies were analysed - PIONEER AF-PCI, RE-DUAL-PCI and AUGUSTUS, where direct oral anticoagulants (DOACs) - rivaroxaban, dabigatran and apixaban were used as anticoagulants as part of the multicomponent therapy. The results of these studies formed the backbone of the updated European guidelines for the diagnosis and treatment of atrial fibrillation, 2020. The guidelines offer to divide patients with AF and ACS, who require multicomponent antithrombotic therapy, into two categories. The first group includes AF patients with uncomplicated PCI without a high risk of stent thrombosis, as well as patients with a risk of bleeding that prevails over the risk of stent thrombosis. The second category of patients, in contrast, is characterized by a high risk of stent thrombosis, which prevails over the risk of bleeding. In the absence of contraindications, the patients of both categories should choose DOAC as an anticoagulant and be prescribed clopidogrel as a P2Y12 inhibitor for 12 months. In AF patients with uncomplicated PCI without a high risk of stent thrombosis, as well as in patients with a risk of bleeding, which prevails over the risk of stent thrombosis, the period of treatment with the second antiplatelet drug (aspirin) should belimited to the hospital stay. Patients at increased risk of stent thrombosis and reduced risk of bleeding can extend the aspirin therapy for 1 month. The approaches to the choice of the duration and composition of the multicomponent antithrombotic therapy in AF patients taking oral anticoagulants after elective PCI are similar to those in ACS patients, except for the duration of clopidogrel therapy, which is reduced to 6 months in all patients.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
S A Chen

Abstract Background The use of oral anticoagulants (OACs) for patients with atrial fibrillation (AF) for stroke prevention should be balanced between the reduction on stroke risk and the increase in bleeding. Our aim was to investigate net clinical benefits of OACs among AF patients with a CHA2DS2-VASc score of 1 (males) or 2 (females) who had a HAS-BLED score ≥3. Method A total of 404,949 newly diagnosed AF patients were identified from the Taiwan National Health Insurance Research Database. The stroke risk was assessed using the CHA2DS2-VASc score and patients were classified as low (score 0 for males, 1 for females), intermediate (1 for males and 2 for females) and high risk (≥2 for males and ≥3 for females). A high risk of bleeding was defined as a HAS-BLED score ≥3. Results The CHA2DS2-VASc and HAS-BLED scores were significantly correlated (r=0.70). Around 72.7% of patients with a high-risk of stroke had a HAS-BLED score ≥3 (Figure A). Among patients with a CHA2DS2-VASc score of 1 (males) or 2 (females) who had a HAS-BLED score ≥3, the use of OACs was associated with a lower risk of adverse events (ischemic stroke, intra-cranial hemorrhage or mortality) with an adjusted hazard ratio of 0.781 (p=0.037) (Figure B). Conclusion Even among patients with an intermediate risk of ischemic stroke (CHA2DS2-VASc score 1 for males, 2 for females) having a high risk for bleeding (HAS-BLED score ≥3), use of OACs was associated with a better clinical outcome and should still be considered.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Gregory Piazza ◽  
Shelley Hurwitz ◽  
Brett Carroll ◽  
Samuel Z Goldhaber

Introduction: A perceived increased risk of bleeding is one of the most frequent reasons for failure to prescribe anticoagulation for stroke prevention in atrial fibrillation (AF). We previously conducted a randomized controlled trial of alert-based computerized decision support (CDS) to increase prescription of antithrombotic therapy in 458 high-risk hospitalized patients with AF who were not being anticoagulated. Hypothesis: We hypothesized that patients with a perceived high risk for bleeding would have a similar HAS-BLED score and rate of major and clinically-relevant non-major bleeding. Methods: To determine the clinical characteristics and outcomes of these patients determined to be high-risk for bleeding, we analyzed the 248 patients in the alert group. Results: A perceived high risk of bleeding was the most common reason (77%) for omitting antithrombotic therapy. Median HAS-BLED scores were similar in these patients compared with those who were not deemed to have an increased bleeding risk (3 vs. 3, p=0.44). Despite being categorized as too high-risk for bleeding to receive antithrombotic therapy for stroke prevention at the time of the alert, nearly 12% of these patients were ultimately prescribed anticoagulation over the ensuing 90 days. The frequency of major and clinically-relevant non-major bleeding was similar between the two groups. Conclusions: In conclusion, a perceived high risk of bleeding was the most common reason for failure to prescribe antithrombotic therapy after the CDS alert. History of a prior bleeding event or underlying bleeding disorder was not reflected in a higher HAS-BLED score. Implementation of an alert-based CDS with specific attention to assessment of bleeding risk and mitigation warrants further study to encourage adherence to evidence-based clinical practice guideline recommendations for stroke prevention in AF.


Kardiologiia ◽  
2020 ◽  
Vol 60 (8) ◽  
pp. 33-45
Author(s):  
E. N. Krivosheeva ◽  
E. P. Panchenko ◽  
E. S. Kropacheva ◽  
A. B. Dobrovolsky ◽  
E. V. Titaeva ◽  
...  

Aim      Searching for clinical, angiographic, and biochemical predictors of cardiovascular complications (CVC) and hemorrhagic complications in patients with atrial fibrillation (AF) receiving a multicomponent antithrombotic therapy (MAT) for an elective percutaneous coronary intervention (PCI). Patients with ischemic heart disease (IHD) and AF who require MAT for PCI are at a high risk of thrombotic complications (stroke, systemic embolism, coronary events) and hemorrhage. This warrants searching for new risk factors determining prediction of the outcome.Materials and methods This study included 207 patients (146 males aged 70.1±8.3 years) with IHD and AF who received direct oral anticoagulants (DOAC) as a part of their MAT therapy. Median duration of the follow-up was 12 [8.0; 12.0] months. The efficacy endpoint was a sum of CVCs combining cardiovascular death, ischemic stroke, venous thromboembolic complications, acute coronary syndrome (ACS), and requirement for an unscheduled PCI. “Coronary events”, including ACS and requirement for an unscheduled PCI were analyzed separately. The safety endpoint was BARC type 2-5 bleeding. Upon admission, biomarkers (growth-differentiation factor 15 (GDF-15), D-dimer, thrombin-activated fibrinolysis inhibitor (TAFI), and plasminogen activator inhibitor-1 (PAI-1)) were measured for all patients. Searching for prognostically significant indexes was performed with the Cox proportional hazards regression.Results Incidence of all CVCs was 16.4 %. Independent predictors of CVC included the DOAC treatment at a reduced dose (odds ratio (OR) 2.5 at 95 % confidence interval (CI) 1.02-6.15; p=0.0454), GDF-15 >1191 pg /ml (OR 3.76 at 95 % CI, 1.26-11.18; p=0.0172), PAI-1 >13.2 U/ml (OR 2.67 at 95 % CI, 1.13-6,26; p=0.0245). Incidence of coronary complications was 9.2 %. Independent predictors of coronary complications included a SYNTAX index >26.5 (OR 4.5 at 95 % CI, 1.45-13.60; p=0.0090), PCI for chronic coronary occlusion (OR 3.21 at 95 % CI, 1.10-9.33; p=0.0326), a GDF-15 >1191 pg/ml (ОR 4.70 at 95 % CI, 1.32-16.81; p=0.0172). Incidence of BARC type 2-5 bleeding was 26.1 %. The only independent predictor for hemorrhage complications was the total PRECISE-DAPT score >30 (ОR 3.22; 95 % CI, 1.89-5.51; р<0.0001).Conclusion      Three independent predictors of CVC were identified for patients with IHD and AF treated with MAT following an elective PCI: treatment with a reduced dose of DOAC, GDF-15 >1191 pg /ml, and PAI-1>13.2 U/ml. Independent predictors of coronary complications included a SYNTAX index >26.5, PCI for chronic coronary occlusion, and GDF-15 >1191 pg/ml. The factor associated with a risk of bleeding was the total PRECISE-DAPT score >30. 


Kardiologiia ◽  
2020 ◽  
Vol 60 (7) ◽  
pp. 53-63
Author(s):  
N. A. Sycheva ◽  
L. Yu. Koroleva ◽  
V. P. Nosov ◽  
G. V. Kovaleva ◽  
N. N. Paikova ◽  
...  

Aim To study efficacy and safety of a triple antithrombotic therapy with direct oral anticoagulants (DOAC) versus warfarin in patients with atrial fibrillation after acute coronary syndrome, for 12 months following discharge from the hospital.Materials and methods This single-site cohort, prospective, observational study performed at the Regional Vascular Center 2 of the N.A. Semashko Nizhniy Novgorod Regional Clinical Hospital included 402 patients. It was possible to maintain contacts with 206 patients for 12 months. These patients were divided into two groups, the DOAC treatment (n=105) and the warfarin treatment (n=101) as a part of triple antithrombotic therapy upon discharge. Clinical observation was performed at 1, 3, 6, and 12 months after the discharge by structured telephone interview. Predetermined efficacy endpoints included cardiovascular death, myocardial infarction, stent thrombosis, and ischemic stroke. Safety endpoints included bleeding defined as small, medium (clinically significant), and major in accordance with the TIMI classification.Results At 12 months of follow-up, 80 patients (76.19%) continued taking DOAC and 39 patients (38.61%, p<0.001) continued taking warfarin; in this process, only 25 patients (24.75%) monitored their INR on a regular basis. With a regular INR monitoring and TTR >70%, death rate did not differ in the warfarin and the DOAC treatment groups. However, there was a difference in reaching the composite efficacy endpoint (p=0.048): ischemic events occurred statistically significantly more frequently in the warfarin treatment group than in the DOAC treatment group.Conclusions In 12 months after discharge from the hospital, compliance with the DOAC treatment as a part of the antithrombotic therapy was significantly higher than compliance with the warfarin treatment. The triple antithrombotic therapy with DOAC was safer than the warfarin treatment by the number of hemorrhagic complications and more effective in prevention of ischemic events, primarily due to no need for monitoring of lab test values.


Author(s):  
N. N. Kryukov ◽  
E. V. Sayutina ◽  
A. M. Osadchuk ◽  
M. A. Osadchuk

Patients with atrial fibrillation have a high risk of developing stroke and death, which requires constant anticoagulant support. In this regard, the physician faces the difficult task of selecting the appropriate oral anticoagulant for patient with individual risk factors and comorbidities. Currently, three non-vitamin K antagonist oral anticoagulants or directly acting oral anticoagulants have been registered in the Russia, which in large randomized clinical trials (RCTs) were compared with warfarin in the prevention of stroke and systemic embolism. The present article analyzes the data of RCTs, postmarketing studies of oral anticoagulants, and presents groups of patients for whom these drugs are preferred. The choice of oral anticoagulants for the prevention of stroke in the following subgroups of patients with atrial fibrillation is discussed: patients with one stroke risk factor (CHA2DS2VASc1 in men or 2 in women), patients of different age groups, patients with concomitant coronary artery disease/acute coronary syndrome, a history of stroke, patients with chronic kidney disease, patients with a high risk of gastrointestinal bleeding, and a group of patients with concomitant arterial hypertension and chronic heart failure. We compared the efficacy and safety of oral non-vitamin K antagonist oral anticoagulants or directly acting oral anticoagulants with vitamin K antagonists in patients with non-valvular atrial fibrillation.


2019 ◽  
Vol 7 (4S) ◽  
pp. 135-145 ◽  
Author(s):  
T. B. Pecherina ◽  
V. O. Zlydneva ◽  
V. V. Kashtalap ◽  
O. L. Barbarash

Current clinical practice faces the challenges in selecting optimal drugs and the duration of antithrombotic treatment in patients with acute coronary syndrome with atrial fibrillation. A continuous increase of using non-vitamin K oral anticoagulants (NOAC), dabigatran, rivaroxaban, apixaban, edoxaban, and novel antiplatelet agents, prasugrel and ticagrelor, has complicated the decision-making process in this group of patients. The presented clinical case reports the use of dabigatran as a part of double antithrombotic therapy in an elderly patient with type 2 myocardial infarction, paroxysmal AF and a high risk for hemorrhage. The drug choice and its dosage were chosen using the personalized risk assessment. The presented approach has been early proved by the results of the recent randomized clinical trials and, therefore, may be translated into routine clinical practice.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Takeshi Morimoto ◽  
Norito Kinjo ◽  
Fumihiro Sakakibara ◽  
Kazutaka Uchida ◽  
Shinichiro Ueda

Introduction: Antiplatelet (APT) therapy is challenging in patients on oral anticoagulants (OACs) for nonvalvular atrial fibrillation (NVAF) who have coronary artery diseases (CAD). Analyzing large scale registry of consecutive patients with NVAF should provide further guide for the safety and efficacy of combination therapy. Methods: We conducted historical multicenter registry at 71 centers in Japan between March 2017 and March 2018. The eligibility criteria were patients on OACs for NVAF on February 2013. There were no exclusion criteria and consecutive patients who met the eligibility criteria were registered. All patients were followed until March 2017. Co-primary endpoints were ischemic strokes including transient ischemic attack and hemorrhagic stroke including subarachnoid hemorrhage. The secondary endpoints were all-cause mortality, ischemic events (acute coronary syndrome, ischemic strokes, or systemic embolism), and major bleedings defined by ISTH and TIMI criteria. We estimated HRs of OACs and APT combination relative to OACs alone by Cox proportional hazard model adjusting for clinically relevant confounders. Results: Median age was 74 (range 20-101) years of 7826 registered patients. Sustained NVAF accounted for 49% and 73% of patients had history of CAD. Cumulative incidences of ischemic stroke and hemorrhagic stroke at 4 years were 3.8% and 0.91% in No-APT group while 5.3% and 1.2% in APT group, respectively (Figure). Adjusted HRs (95%CI) of APT group for ischemic stroke and hemorrhagic stroke were 1.03 (0.76-1.40) and 1.27 (0.67-2.4), respectively. Adjusted HRs (95%CI) for all-cause mortality, ischemic events, and major bleedings were 0.98 (0.79-1.23), 0.98 (0.74-1.32), and 1.25 (1.00-1.57), respectively. Conclusions: Adding APT in patients on AOC for NVAF did not decrease ischemic strokes and not increase hemorrhagic strokes. Because combination therapy might increase the risk of major bleedings, OAC alone should be prioritized.


2020 ◽  
pp. 17-26
Author(s):  
E. S. Kropacheva ◽  
E. P. Panchenko

This review focuses on some aspects of anticoagulant therapy in the updated clinical guidelines for atrial fibrillation of the European society of cardiology, published in 2020. Atrial fibrillation is a polymorbid continuously developing syndrome, and therefore the treatment strategy is based on a comprehensive assessment of the patient, including the risk of stroke, the presence and severity of symptoms, and an assessment of structural heart disease and comorbidities. The review describes the principles of the proposed integrated approach, abbreviated “ABC pathway”, as reflecting the three main directions of the treatment strategy. According to experts, the clinical picture of AF (i.e. first detected, paroxysmal, persistent, long-term persistent or permanent) should not determine the indications for the appointment of anticoagulant therapy. The CHA2DS2-VASc scale continues to be the basis for stratification of thromboembolic risk. The role of dabigatran in primary and secondary prevention of stroke and systemic embolism in patients with atrial fibrillation is described. Changes in the position of experts regarding the assessment of bleeding risk are highlighted in order to help identify unmodified and eliminate modifiable risk factors for bleeding, as well as to identify AF patients who are potentially at high risk of bleeding for more frequent monitoring and monitoring of their condition. Questions about the use of direct oral anticoagulants in the choice of rhythm control tactics are highlighted separately. The use of dabigatran in patients undergoing cardioversion and catheter ablation is justified. Practical questions about the continuous strategy of anticoagulant therapy during ablation are highlighted separately. Changes related to multicomponent therapy after percutaneous coronary intervention are highlighted. The main measure to improve the safety of combined antithrombotic therapy is to minimize the duration of triple therapy. The updated recommendations supportlimiting the duration of triple antithrombotic therapy to 1 month, and also provide for early discontinuation of aspirin (≤1 week) and continuation of double antithrombotic therapy in cases of uncomplicated stenting and low risk of thrombosis, or when the risk of bleeding exceeds the risk of thrombotic events.


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