Efficacy and safety of new oral anticoagulants as part of triple antithrombotic therapy in patients with atrial fibrillation and acute coronary syndrome. Data from an observational study

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 ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Treatment Group ◽  
Antithrombotic Therapy ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Coronary Syndrome ◽  
Warfarin Treatment ◽  
Ischemic Events ◽  
Triple Antithrombotic Therapy

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.

scholarly journals Double Antithrombotic versus Triple Antithrombotic Therapy in Patients with Atrial Fibrillation and Acute Coronary Syndrome

2020 ◽  
Vol 29 (02) ◽  
pp. 081-087
Author(s):  
Surya Dharma
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Vitamin K ◽  
Antithrombotic Therapy ◽  
Randomized Clinical Trials ◽  
Bleeding Event ◽  
Vitamin K Antagonist ◽  
Thromboembolic Complications ◽  
Coronary Syndrome ◽  
Triple Antithrombotic Therapy

AbstractIn atrial fibrillation (AF), oral anticoagulant (OAC) therapy with either vitamin K antagonist or non–vitamin K antagonist is used to prevent thromboembolic complications. In patients who presented with acute coronary syndrome (ACS) and were treated by percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces major adverse cardiac events (MACEs) and stent thrombosis. Consequently, in patients with AF who presented with ACS and were treated by PCI, the combination of OAC and DAPT, the so-called triple antithrombotic therapy (TAT) is needed to improve the outcome of the patients. However, the use of TAT increases the risk of bleeding. Several randomized clinical trials and a meta-analysis evaluated the use of TAT and double antithrombotic therapy (DAT) in this population, and DAT is defined as patients who receive combination of one antiplatelet and OAC. In general, the studies demonstrated a reduction in bleeding event in patients who received DAT as compared with TAT, with similar incidence of thromboembolic complications and MACE. To date, there is no established consensus or guideline for the most appropriate combination of antithrombotic agents in patients with AF and ACS who undergo PCI. Tailoring the treatment for each individual is likely the best approach to determine the balance of bleeding risk and ischemic events before starting antithrombotic therapy. Future trials with adequate sample size are needed to find the most appropriate combination of antiplatelet and OAC in patients with AF who presented with ACS and treated by PCI.

P4786Dual antithrombotic therapy is similarly effective to triple therapy in preventing thrombotic events in patients with atrial fibrillation and acute coronary syndrome

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Z Motovska ◽  
H Melicharova ◽  
J Knot ◽  
J Dusek ◽  
S S Simek ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Czech Republic ◽  
Triple Therapy ◽  
Antithrombotic Therapy ◽  
Oral Anticoagulant ◽  
The Czech Republic ◽  
Coronary Syndrome ◽  
One Year ◽  
Triple Antithrombotic Therapy

Abstract Background Antithrombotic therapy is effective in preventing ischemic and thromboembolic events, however it simultaneously increases the risk of bleeding. The efforts thus focus on balancing the intensity of combined antiplatelet and anticoagulant therapy. Purpose The study aimed to compare efficacy and safety of single (aspirin/clopidogrel) or dual (aspirin plus clopidogrel) antiplatelet therapy in combination with an oral anticoagulant in non-selected patient population with atrial fibrillation (AFib) and an acute coronary syndrome (ACS). Methods The analysis used data from National Registry of Reimbursed Health Services (NRRHS), which contains data of the entirety of health care paid from the public health insurance (almost 100% of healthcare in the Czech Republic) combined with the database of death records. Occurrence of an ACS, stroke, and bleeding requiring hospitalization within one year was compared in patients discharged on dual and triple antithrombotic therapy. Dual antithrombotic therapy consists of aspirin/clopidogrel plus an oral anticoagulant. Triple antithrombotic therapy was defined as combination of aspirin, clopidogrel and an oral anticoagulant. Results Over a four-year period (2012–2016) 104 000 patients with an ACS were hospitalized in the Czech Republic. AFib (any types) was reported in 12.4% (N=12 891) of them (21.2% in patients 75+ years old). +AFib (vs. −AFib) patients were a higher risk population with respect to the comorbidity (diabetes, hypertension, renal disease, stroke, heart failure) (p<0.05 for all comorbidities). Oral anticoagulant therapy was indicated in 25.3% of them. PCI was performed in 57.7% (−AFib) and 43.4% (+AFib) patients, respectively. Hospital mortality was significantly higher in +AFib patients (8.6% and 5.6%, OR (95% CI): 1.585 (1.481; 1.696), p<0.001). We identified 1017 patients discharged on dual and 967 patients on triple antithrombotic therapy. Risk of recurrent ACS within one year with dual therapy was comparable to that with triple therapy (OR (95% CI): 1.219 (0.766; 1.940), p=0.403). The same was also observed for the risk of stroke (1.273 (0.648; 2.501), p=0.483). After six months, persistence on dual antithrombotic therapy (33.4% patients) was higher than on triple therapy (10.3%, p<0.001). Within the first three months, de-escalation from triple antithrombotic therapy to dual antithrombotic therapy (in 212 patients) was accompanied by a significant increase of bleeding requiring hospitalization (0% on dual vs. 3.3% on triple therapy, p=0.048). Conclusion Protective effect of dual antithrombotic therapy on the occurence of recurrent major adverse cardiovascular event is comparable to that of the triple antithrombotic therapy in non-selected patients with an acute coronary syndrome and atrial fibrillation. Moreover, long-term persistence on triple therapy is significantly lower due to bleeding risk.

scholarly journals Triple Antithrombotic Therapy in Patients with Acute Coronary Syndrome and Atrial Fibrillation – Balancing Risks and Benefits

2021 ◽  
Vol 28 (1) ◽  
pp. 63-69
Author(s):  
Alexandru DEACONU ◽  
◽  
Silvia DEACONU ◽  
Andreea GATEJ ◽  
Maria DOROBANTU ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Retrospective Study ◽  
Antithrombotic Therapy ◽  
Antithrombotic Treatment ◽  
Coronary Syndrome ◽  
Risks And Benefits ◽  
Constant Change ◽  
Esc Guidelines ◽  
Triple Antithrombotic Therapy

Optimal antithrombotic therapy in patients with AF who undergo coronary stenting for an ACS has been a subject of constant change, with the addition of numerous trials in recent years. Objectives: The aim of our study was to assess current antithrombotic treatment in patients with AF and ACS treated with PCI. Material and methods: We performed a observational retrospective study on patients with nonvalvular AF, ACS and PCI between January 2017 and May 2019. We assessed both ischemic risk (IR) and haemorrhagic risk (HR) according to the 2018 ESC guidelines strategies. Results: 184 patients with nonvalvular AF and ACS treated with PCI were eligible for inclusion. In the whole cohort the HR was significantly higher than the IR (3.66+/-1.15 respectively 2.84+/-1.15, p < 0.001). NSTEMI carries both the highest IR and HR (p<0.05). The majority of patients (88.04%) received triple antithrombotic therapy mostly for one month (39%). Main drug combination used was Aspirin, Clopidogrel, antivitamin K (48.48%). Conclusions: In our registry of AF patients with ACS treated with PCI, triple antithrombotic therapy is still the strategy of choice with an initial duration of one month. In our cohort, HR is higher than IR, NSTEMI carrying the highest risks out of all the ACS.

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
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
High Risk ◽  
Antithrombotic Therapy ◽  
Heart Defects ◽  
Oral Anticoagulants ◽  
Prosthetic Heart Valve ◽  
Saratov Region ◽  
Coronary Syndrome ◽  
Risk Of Bleeding

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.

scholarly journals Prediction-Determining Outcomes and Their Predictors in Atrial Fibrillation Patients Receiving Multicomponent Antithrombotic Therapy in Real Clinical Practice

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 ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Antithrombotic Therapy ◽  
Coronary Occlusion ◽  
Oral Anticoagulants ◽  
Coronary Syndrome ◽  
Reduced Dose ◽  
Chronic Coronary Occlusion ◽  
Coronary Events ◽  
Pai 1

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. 

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