The one-way sensitivity analysis indicated the largest source of variation was through the transfusion parameters, however even the most extreme values indicated there would be a substantial cost benefit if these adverse outcomes could be prevented. CONCLUSIONS: Using Floseal has the potential to reduce the risk of patients bleeding during cardiac surgery and consequently reduce other adverse outcomes, and total costs.
Introduction There have been conflicting comparative data on the predictive value of the HAS-BLED and the GARFIELD-AF bleeding risk scores. Furthermore, there are limited data in Asian patients with atrial fibrillation (AF) who are at higher risk of bleeding compared to non-Asians. We compared the performance of the HAS-BLED score with the GARFIELD-AF score in predicting major bleeding in AF patients treated with OAC in the Cohort of antithrombotic use and Optimal INR Level in patients with non-valvular AF in Thailand (COOL-AF) registry. Since the sex and body weight seem to impact bleeding events in Asians, we explored an update of the HAS-BLED risk score by incorporating sex and body weight. Methods The COOL-AF registry was a nationwide study enrolling AF patients from 27 hospitals in Thailand between 2014 and 2017. The registry aimed to assess antithrombotic patterns, quality of oral anticoagulant (OAC) control and clinical outcomes. Data were collected every 6 months and until 3 years. AF patients treated with oral anticoagulants (OAC, either warfarin or non-vitamin K antagonist OAC (NOAC)) were included into the present study. We fitted the variables of the HA-SBLED and GARFILED-AF score to major bleeding in Cox regression model. We also explored a modified HAS-BLED by addition of two additional predictors (sex and body weight). Discrimination, calibration, net reclassification index and decision curve analysis were used to compare the predictive performance of the three models. Results Of 3,402 patients in the COOL-AF registry, 2,568 patients (mean age 68.4 years; 43.4% female) who received OAC at baseline were studied. The proportion of patients with prior bleeding was 10.6%. Majority of patients (68.7%) received warfarin. The incidence rate of major bleeding was 2.11 (1.79–2.48) per 100 person-years. The C-indexes of the GARFIELD-AF, HASBLED and modified HASBLED score were 0.65 (95% CI 0.63–0.67), 0.66 (95% CI 0.64–0.68) and 0.69 (95% CI 0.67–0.71) respectively. Calibration plot showed good agreement between predicted and observed bleeding in the deciles of original HAS-BLED and GARFIELD-AF scores, while the modified HAS-BLED score overestimated the risk in the last decile (Figure 1). The modified HASBLED score has superior NRI than the original HASBLED score (26.9%, 95% CI 9.7% to 42.2%). The NRI between the modified HASBLED and GARFIELD score was similar (20%, 95% CI −1.2% to 40.4%). The net benefit curve of the three models were overlapping among different risk thresholds (Figure 2). Conclusion The clinical utility for bleeding prediction GARFIELD-AF, HAS-BLED and modified HAS-BLED scores were similar in Asian patients with AF participating in the COOL-AF registry. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): This study was funded by the Health Systems Research Institute (HSRI) (grant no. 59-053), the HeartAssociation of Thailand under the Royal Patronage of H.M. the King.
Background In the PEGASUS-TIMI 54 trial, the long-term use of low-dose ticagrelor in addition to aspirin in patients with prior myocardial infarction (MI) more than 1 year could reduce the composite endpoints of major adverse cardiac events (MACE). However, it came with the expense of bleeding complication compared with the patients taking aspirin alone. Purpose We sought to describe the proportion of patients who would have benefit from low-dose ticagrelor according to the PEGASUS-TIMI 54 trial and to explore the long-term prognosis of those patients in comparison with the patients who did not meet the trial criteria in the real-world practice. Method The Cohort Of patients with high Risk for cardiovascular Events (CORE-Thailand) registry is a prospective, multicentre, observational, longitudinal study of Thai patients with high atherosclerotic risk. The study included the patients with established coronary artery disease (CAD), cerebrovascular disease (CVD) or peripheral arterial disease (PAD), or with at least three atherosclerosis risk factors. The PEGASUS-TIMI 54 inclusion and exclusion criteria were applied to the CORE-Thailand population and stratified the patients into 4 groups as follows; prior MI patients with PEGASUS-TIMI 54 eligible criteria (PE group); prior MI patients without PEGASUS-TIMI 54 eligible criteria according to the time of index MI occurred <1 year (NP1 group), 1–3 years (NP1–3 group) and >3 years (NP3 group). The baseline characteristics and the incidence of MACE (cardiovascular death, MI or stroke) according to the PEGASUS TIMI-54 trial were compared among the four groups. Results From the 9,390 enrolled patients, 2,109 had prior MI. Six hundred and ninety-nine (33.1%) of the patients were stratified to the PE group whereas 15.7%, 14.7% and 36.5% were NP1, NP1–3 and NP3, respectively. The incidence of MACE at 730 days in the PE group was 5.2% followed by 4.5%, 2.9%, 2.2%, in the NP1 group, NP3 group and NP1–3, respectively. Interestingly, the incidence of MACE in NP 1–3 group and NP3 were comparable between the groups, p=0.53. When compared the MACE rates between the PE group the NP1–3 group, the PE group significantly experienced MACE more than the NP1–3 group (hazard ratio [HR] 2.34, confidence interval [CI] 1.95–5.28; p=0.039). The incidence of all-cause death in the PE group was also higher than the NP1–3 (5.2% vs. 2.2%, HR 2.37 CI 1.05–5.33, p=0.037). Conclusion The proportion of the patients in the CORE-Thailand registry who would have benefit from the low-dose ticagrelor represent in one-third of the entire population reflecting that the external applicability of the PEGASUS in the CORE-Thailand registry is feasible. The presence of PEGASUS-TIMI 54 eligible criteria is associated with the higher MACE rates and all-cause mortality compared with the patients who had prior MI between 1 and 3 years but did not meet trial criteria. Cumulative incidence of MACE Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): The Heart Association of Thailand under the Royal Patronage of H.M. the King and the National Research Council of Thailand
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