Introduction.Upper gastrointestinal (UGI) bleeding is a common complication of antiplatelet therapy. Data from real clinical practice that characterize the range of risk factors for UGI bleeding, prophylactic proton pump inhibitors (PPIs) therapy, bleeding frequency and their long-term effects in patients with stable coronary artery disease (CAD) are limited. Aim.To identify predictors of UGI bleeding in patients with stable CAD, to assess the role of PPI in the prevention of bleeding and the long-term prognosis of patients after bleeding. Materials and methods.934 patients with stable CAD (median age 61 [5368] years, 78.6% men) were included in the single institution prospective REGistry of Long-term AnTithrombotic TherApy (REGATTA). Atherosclerosis of peripheral arteries (APA) and abdominal aortic aneurysm (AAA) screening was performed by doctor decision, as well as esophagogastroduodenoscopy. 76% of patients received dual antiplatelet therapy for 612 months after elective PCI. PPIs were prescribed in 28.3% of cases. Results.The median follow-up was 2.5 [1.15.1] years. The frequency of overt UGI bleeding was 1.9 per 100 patients per year. Anamnesis of peptic ulcer disease (OR 4.7; 95% CI 1.911.8;p=0.001), erosion of the upper gastrointestinal tract (OR 6.7; 2.716.6;p=0.00004 ), as well as concomitant diseases associated with a decrease in blood supply to the mucosa, such as heart failure HF (OR 6.1; 2.316.0;p=0.0002), AAA (OR 9.3; 2.534.2;p=0.0008) and APA (OR 2.3; 0.985.5;p=0.05) turned out to be independent predictors of UGI bleeding. The frequency of AAA among those who underwent UGI bleeding was 19.6% (in patients without bleeding 1.4%;p0.001). 90.2% of patients with UGI bleeding received PPI; the frequency of UGI bleeding in patients receiving pantoprazole and omeprazole did not differ significantly. After UGI bleeding, rebleeding rate was 7.8%, thrombotic events (TE) rate 31.4%, mortality rate 17.7% for 30 days, 19.4% for 1 year and 35.3% for the entire observation period. The predictors of deaths were AAA (OR 92.5; 7.7107.9;p0.0001), APA (OR 4.2; 1.0317.2;p=0.045) and HF (OR 34.5; 8.5140.6;p0.0001). The worst prognosis was expected for patients who underwent UGI bleeding and thrombotic events: 2/3 of these patients died. Conclusion.In a prospective analysis of patients with stable CAD, we identified UGI bleeding was a significant risk factor for late thromboembolism and death, compared with patients without bleeding. Predictors of UGI bleeding and poor prognosis are factors that indicate atherothrombotic burden abdominal aortic aneurysm, peripheral atherosclerosis and HF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04347200.
Aim. To optimize the upper gastrointestinal bleeding (UGIB) risk scale in patients Material and methods. The UGIB risk scale was developed based on the with chronic coronary artery disease (CAD) receiving long-term antiplatelet therapy. prospective REGistry of long-term AnTithrombotic TherApy-1 REGATTA-1(ClinicalTrials.gov Identifier: NCT04347200). The registry includes 934 patients with stable CAD (men, 78,6%; median age, 61±10,7 years), 76% of whom were included after elective percutaneous coronary interventions and received dual antiplatelet therapy for 6-12 months. After a UGIB episode, patients were prescribed proton pump inhibitors. The 2015 European Society of Cardiology (ESC) scale was used for assessing the UGIB risk. In addition, we evaluated the ultrasound data on atherosclerotic burden (abdominal aorta and peripheral arteries).Results. The median follow-up was 2,5 years [1,1-14,7 years]. The incidence of UGIB was 1,9 cases per 100 patient/years. Recurrent UGIB episodes and thrombosis was recorded in 13,7% and 31,4%, respectively. Based on the results of a multivariate logistic regression, a novel scale for assessing the UGIB risk (REGATTA) has been developed. In accordance with the odds ratio, points were assigned for each independent risk factor (RF): age ≥80 years — 3 points, prior gastric erosion, peptic ulcer disease or UGIB — 3 points for each RF, anticoagulation therapy — 4 points, non-steroidal antiinflammatory drug therapy — 2 points. The atherosclerotic burden (peripheral atherosclerosis and/or abdominal aortic aneurysm; 2 points) and heart failure (in most cases after a myocardial infarction; 2 points) were marked as a new independent predictor. The cutoff value (≥4 points) was determined, reflecting the high UGIB risk (sensitivity, 80,4%; specificity, 84,5%). The REGATTA scale was more powerful than the traditional 2015 ESC scale: AUC of 0,88, (95% confidence interval, 0,86-0,9) vs AUC of 0,79, (95% confidence interval, 0,760,82) (p=0,04).Conclusion. The identified UGIB predictors (atherosclerotic burden and heart failure) and the developed REGATTA scale made it possible to improve the prognosis and prevention of UGIB in patients with stable CAD receiving long-term antiplatelet therapy.
Funding Acknowledgements Type of funding sources: None. Background Upper gastrointestinal bleeding (UGIB) is the most common hemorrhagic complication in stable CAD patients receiving antithrombotic therapy. It seems that atherosclerotic burden may increase the overall bleeding frequency. However, this factor has never been taken into account with UGIB risk assessment. We aimed to assess the predictive value of atherosclerotic burden (peripheral atherosclerosis – PAD and abdominal aortic aneurysm - AAA) for UGIB in patients with stable CAD receiving long-term antithrombotic therapy. Patients and Methods. A single center prospective Registry of Long-term AnTithrombotic TherApy (REGATTA-1 NCT04347200) included 934 pts with stable CAD (78.6% males, median age 61 [IQR 53-68] yrs). 77,3 % of patients received dual antiplatelet therapy due to recent PCI with a switch to aspirin monotherapy after 6 months. 17,6% of patients received aspirin only, 5,1 % of patients received oral anticoagulants because of concomitant atrial fibrillation. Risk assessment of UGIB was performed according to the 2015 European Society of Cardiology guidelines (we were not able to identify only Helicobacter pylori infection). Additional ultrasound screening for PAD (lower limbs and cerebrovascular beds) and AAA was applied. The primary outcome was any overt UGIB (BARC ≥2). Results The frequency of PAD was 18,8%, AAA – 2,4%, PAD and/or AAA - 20,5%. In a total 2335 person-years of follow-up (median follow-up - 2,5 yrs, IQR 1,1 – 5.1), UGIB occurred in 51 patients (incidence at 1 year 1,9 per 100 patients). The median time to first occurrence of UGIB was 72 [IQR 13-214] days. Comparing the Kaplan-Meyer curves, the UGIB developed three times more often in patients with coexisted PAD and/or AAA vs isolated CAD (19.8% vs 6.5%, Log-Rank p = 0.00006). The difference remains consisted in regression model taking in account 2015 ESC panel of UGIB risk factors (OR 3.4; CI 1.7–6.9, p = 0,0005). Conclusions Atherosclerotic burden (concomitant PAD and/or AAA) is an independent predictor of UGIB in patients with stable CAD receiving long-term antithrombotic therapy.
Background von Willebrand factor (VWF) is well known biochemical marker of endothelial dysfunction that increased may be associated with the development of thrombotic complications in patients with polyvascular disease (PD). We aimed to asses the relation of VWF to the development of bleeding outcomes in patients with PD receiving multicomponent antithrombotic therapy (MAT). Material and methods The data were obtained during the prospective register REGATA-1, NCT04347200. 95 patients (70 males), median age 67 [IQR 61; 72] with PD (coronary artery disease and peripheral atherosclerosis of at least one vascular territory ≥ 50%) were enrolled. 61% of patients received acetylsalicylic acid in combination with rivaroxaban 2.5 mg bid, other (39%)with clopidogrel. Median follow-up was 10 months [IQR 8.0; 12.0]. The safety end point was major and clinically relevant bleedings (type 2–5) according to the BARC classification. Plasma samples for VWF were taken at the inclusion and analyzed using ELISA. Results Frequency of BARC 2–5 bleedings was 20%. The most frequent (79%) was gastrointestinal bleedings. Median VWF plasma concentration was 154% [116; 196]. According to the quartile analysis, VWF values in the top three quartiles distribution (cut-off value > 122%) were associated with a higher frequency of bleeding events: 3.7% versus 36.7%, OR 8.8; CI 1,11-69,9, ? = 0.0392. Bleeding-free survival in groups formed depending on the VFW plasma concentration (122 > and ≤ 122%) was 96.2% vs. 73.9%, respectively, Log-Rank P = 0.0488. Conclusions Increase of VWF plasma concentration (> 122%) is associated with the development of major and clinically relevant bleedings in patients with PD receiving MAT.
The review focuses on upper gastrointestinal (GI) bleeding in patients with ischemic heart disease (IHD) receiving an antithrombotic therapy. Approaches to risk stratification for GI bleeding and correction of modifiable factors that determine the probability of such events are addressed in detail. Recommendations are provided for administration of stomach-protecting drugs. The interrelation of risk factors for thromboses and bleedings is stressed, and possible indications for a multicomponent antithrombotic therapy in patients with stable IHD are discussed.
Aim. To study the role of von Willebrand factor (VWF) and D-dimer (DD) as predictors of upper gastrointestinal bleeding (GIB) in patients with stable coronary artery disease (CAD).Material and methods. The study included patients with stable CAD who are members of the prospective registry of long-term antithrombotic therapy (REGATTA-1) (ClinicalTrials.gov Identifier: NCT04347200). The primary endpoints were actionable GIBs (Bleeding Academic Research Consortium type 2-5). Cut-off points for DD and VWF were determined by ROC analysis. The predictive significance of an increase in VWF and DD was assessed by the logistic regression.Results. The study included 408 patients (men, 77,5%; mean age, 61,3±10,8 years). The median follow-up period was 2,5 [1,1-14,7] years. DD was determined in all patients, including 36 patients with GIB, while VWF — in 169 patients (28 patients with GIB). An increase in DD >928 ng/ml was an independent predictor of GIB, including taking into account clinical risk factors (odds ratio (OR), 3,26 [95% confidence interval (CI), 1,43-7,42] (p=0,0047), or the previously developed REGATTA scale score (OR, 3,73, 95% CI: 1,65-8,43 (p=0,0015)). VWF >105% was also an independent predictor of GIB (OR, 14,02; 95% CI: 1,41-139,42 (p=0,023)); in the REGATTA scale model — OR 11,3, 95% CI: 1,43-88,83 (p=0,021). The increase in both markers was most unfavorable, since the proportion of those with GIB was 41,4%, while among patients with normal DD and increased VWF — 14,9%, and with low values of both markers — 0%. OR of GIB in patients with an increase in both markers was 4,1 (95% CI: 1,6-10,3 (p=0,003)).Conclusion. In patients with stable CAD, an increase in VWF and DD was associated with an increase in GIB risk regardless of the presence of clinical risk factors.
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