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.
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.
Funding Acknowledgements Type of funding sources: None. Background PRECISE-DAPT score has become developed for predicting the risk of bleedings in patients treated with coronary stenting and subsequent 1-year dual antiplatelet therapy. The utility of PRECISE-DAPT score in the setting of all-comer CAD population with different regimes of long-term antithrombotic therapy remains unclear. Upper gastrointestinal bleeding (UGIB) is the predominant hemorrhagic complication in CAD patients; however, the PRECISE-DAPT capacity with respect to this type of bleeding has never been evaluated. Purpose to evaluate the role of PRECISE-DAPT score in the assessment of upper gastrointestinal bleeding risk in patients with stable coronary artery disease (CAD) receiving long-term antithrombotic therapy. Methods Data were obtained from single center prospective Registry of Long-term AnTithrombotic TherApy (REGATTA-1 NCT04347200). The PRECISE-DAPT score was calculated in a total of 434 patients with stable CAD (77,4% males, median age 61 [IQR 55-69] yrs). Most of the patients 93,6 % received DAPT due to recent PCI with a switch to aspirin monotherapy after 6 months. 1,4 % of patients received aspirin only, 22 (5,1%) of patients received oral anticoagulants because of concomitant atrial fibrillation. The primary outcome was any overt UGIB (BARC ≥2). Results In a total of 451 person-years of follow-up (median follow-up was 378 days, IQR 365-421), UGIB occurred 40 patients (incidence at 1 year 8.9 per 100 patients). The median time to first occurrence of UGIB was 55 [IQR 8-115] days. Median PRECISE-DAPT score was 12 points [IQR 6; 20]. The cut-off value for PRECISE-DAPT score to predict UGIB was 16 points (AUC = 0.732, p = 0.0001, 95% CI 0.367-0.827) that correspond to at least moderate bleeding risk according to original score discrimination. Kaplan-Meier bleeding rates were separated by score cut-off (Log-Rank p < 0,001) and the risk difference remains consisted in regression model (OR 2.79 [1.07-7.29]; p = 0.0348). Conclusion(s): PRECISE DAPT score demonstrated good discriminatory capacity (cut-off 16 points) with respect to UGIB in patients with stable CAD receiving long-term antithrombotic therapy.
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