scholarly journals Validation of the 4‐Item PRECISE‐DAPT Score: A SWEDEHEART Study

Author(s):  
Axel Wester ◽  
Moman A. Mohammad ◽  
Göran Olivecrona ◽  
Jasminka Holmqvist ◽  
Troels Yndigegn ◽  
...  

Background The Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE‐DAPT) score has been shown to predict out‐of‐hospital major bleeding after myocardial infarction treated with percutaneous coronary intervention and dual antiplatelet therapy (DAPT). However, large validation studies have been scarce and the discriminative ability for patients with a preexisting bleeding risk factor (elderly, underweight, women, anemia, kidney dysfunction, or cancer) in a real‐world setting is unknown. Methods and Results Patients undergoing percutaneous coronary intervention for myocardial infarction between 2008 and 2017 were included from the SWEDEHEART (Swedish Web System for Enhancement of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies) registry (n=66 295). The predictive value of the PRECISE‐DAPT score for rehospitalization with major bleeding during dual antiplatelet therapy was evaluated using receiver operating characteristic analyses. A high PRECISE‐DAPT score (≥25; n=13 894) was associated with increased risk of major bleeding (3.9% versus 1.8%; hazard ratio [HR], 2.2; 95% CI, 2.0–2.5; P <0.001) compared with a non‐high score (<25; n=52 401). The score demonstrated a c‐statistic of 0.64 (95% CI, 0.63–0.66). The discriminative ability of the score to further stratify bleeding risk in patients with preexisting bleeding risk factors was poor, especially in patients who are elderly (c‐statistic=0.57; 95% CI, 0.55–0.60) or underweight (c‐statistic=0.56; 95% CI, 0.51–0.61), for whom a non‐high PRECISE‐DAPT score was associated with similar bleeding risk as a high PRECISE‐DAPT score in the general myocardial infarction population. Conclusions In this nationwide population‐based study, the PRECISE‐DAPT score performed moderately in the general myocardial infarction population and poorly in patients with preexisting bleeding risk factors, where its usefulness seems limited.

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Renata Rogacka ◽  
Alaide Chieffo ◽  
Iassen Michev ◽  
Flavio Airoldi ◽  
Azeem Latib ◽  
...  

Objectives: To evaluate the safety of dual antiplatelet therapy in patients in whom long-term anticoagulation (AC) with warfarin is recommended. Background: It is well established that antiplatelet therapy with aspirin ad thienopiridines is required following percutaneous coronary intervention (PCI) with stent implantation. Some patients have also indication for long-term AC. The optimal antithrombotic strategy following PCI in such patients is unclear. Methods: All consecutive patients who underwent PCI with stent implantation discharged on triple therapy (defined as the combination of aspirin and thienopyridines and AC with warfarin) were analyzed. Results One-hundred and twenty-seven patients with 224 lesions: 86.6% males, mean age 69.9±8.8 years were included in the study. Drug-eluting stents (DES) were positioned in 71 (55.9%) and bare metal stent (BMS) in 53 (41.7%) patients. Atrial fibrillation (AF) was the main indication (59.1%) for AC treatment, followed by prosthetic valves (12.4%) and mural left ventricular (LV) thrombus (9.1%). Average risk of thromboembolic events in the subgroup with AF was 1.79 ± 1.23 according to CHADS2 score. The mean triple therapy duration was 5.6±4.6 and clinical follow-up 21.0±19.8 months. During the triple therapy period, 6 patients (4.7%) developed major bleeding complications; 67% of which occurred within the first month. No significant differences between DES and BMS were observed in the incidence of major (respectively 5.6% vs. 3.8%, p=1.0) and minor bleeding (respectively 1.4% vs. 3.8%, p=0.57) and mortality (respectively 5.6% vs. 1.9%, p=0.39). Four patients died in DES group: 3 of major bleeding complications and one of ischemic stroke. The only death in the BMS group was due to subarachnoid hemorrhage. A significant difference was observed in favor of DES in target vessel revascularization (14.1% vs. 28.3%, p=0.041). Conclusions: While on triple therapy, major bleeding complications occurred in 4.7% of patients, half of them were lethal and most (67%) occurred within the first month.


Author(s):  
Matteo Bianco ◽  
Alessandro Careggio ◽  
Paola Destefanis ◽  
Alessia Luciano ◽  
Maria Giulia Perrelli ◽  
...  

Abstract Aims Dual antiplatelet therapy (DAPT) reduces the incidence of thrombotic complications at the cost of an increase in bleedings. New antiplatelet therapies focused on minimizing bleeding and maximizing antithrombotic effects are emerging. The aim of this study is to collect the current evidence coming from randomized controlled trials (RCTs) on early aspirin interruption after percutaneous coronary intervention (PCI) and current drug-eluting stent (DES) implantation and to perform a meta-analysis in order to evaluate the safety and efficacy of this strategy. Methods and results MEDLINE/PubMed was systematically screened for RCTs comparing P2Y12 inhibitors (P2Y12i) monotherapy after a maximum of 3 months of DAPT (S-DAPT) vs. DAPT for 12 months (DAPT) in patients undergoing PCI with DES. Baseline features were appraised. Major adverse cardiac and cerebrovascular events (MACCE: all causes of death, myocardial infarction, and stroke) and its single composites, stent thrombosis (ST) and Bleeding Academic Research Consortium (BARC) type 3 or 5 were considered and pooled with fixed and random-effects with inverse-variance weighting. A total of four RCTs including a total of 29 089 patients were identified. Overall, the majority of included patients suffered a stable coronary artery disease, while ST-elevation myocardial infarction was the least represented clinical presentation. Complex anatomical settings like left main intervention, bifurcations, and multi-lesions treatment were included although representing a minor part of the cases. At 1-year follow-up, MACCE rate was similar [odds ratio (OR) 0.90; 95% confidence intervals (CIs) 0.79–1.03] and any of its composites (all causes of death rate: OR 0.87; 95% CIs 0.71–1.06; myocardial infarction: OR 1.06; 95% CIs 0.90–1.26; stroke: OR 1.12; 95% CIs 0.82–1.53). Similarly, also ST rate was comparable in the two groups (OR 1.17; 95% CIs 0.83–1.64), while BARC 3 or 5 bleeding resulted significantly lower, adopting an S-DAPT strategy (OR 0.70; 95% CIs 0.58–0.86). Conclusion After a PCI with current DES, an S-DAPT strategy followed by a P2Y12i monotherapy was associated with a lower incidence of clinically relevant bleeding compared to 12 months DAPT, with no significant differences in terms of 1-year cardiovascular events.


BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e005781 ◽  
Author(s):  
Günter Christ ◽  
Jolanta M Siller-Matula ◽  
Marcel Francesconi ◽  
Cornelia Dechant ◽  
Katharina Grohs ◽  
...  

ObjectiveTo evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients.SettingTertiary care single centre registry.Participants1008 consecutive PCI patients with stent implantation, without exclusion criteria.InterventionPeri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (≥50 U) and arachidonic acid (AA)-induced aggregation (>35 U).Outcome measuresThe primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE).Results53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both).ConclusionsIndividualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted.Trial registration numberhttp://www.clinicaltrials.gov; NCT01515345.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Dominguez Erquicia ◽  
S Raposeiras Roubin ◽  
E Abu-Assi ◽  
F D'Ascenzo ◽  
S Manzano Fernandez ◽  
...  

Abstract Introduction ESC guidelines recommend short-term dual antiplatelet therapy (DAPT) in patients with high bleeding risk. In this sense, patients with prior admissions by bleeding are considered of high-risk of bleeding. With our study, we aimed to show the ischemic-bleeding profile of patients with prior bleeding in comparison with those without prior bleeding during treatment with DAPT. Methods The data analyzed in this study were obtained from the fusion of 3 clinical registries of ACS patients: BleeMACS (2004–2013), CardioCHUVI/ARRITXACA (2010–2016) and RENAMI (2013–2016). All 3 registries include consecutive patients discharged after an ACS with DAPT and undergoing PCI. The merged data set contain 26,076 patients. A propensity-matched analysis was performed to match the baseline characteristics of patients with and without prior admission by bleeding. The impact of prior prior bleeding in the ischemic and bleeding risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For ischemic risk we have considered a new acute myocardial infarction, whereas for bleeding risk we have considered major bleeding defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 1,105 have PAD (4.2%). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), 640 had myocardial infarction (2.5%) and 685 had major bleeding (2.6%). After propensity-score matching, we obtained two matched groups of 1,101 patients. In comparison with patients without prior bleeding, those with prior bleeding had higher risk of major bleeding (sHR 2.03, 95% CI 1.33–3.11, p=0.001) with similar risk of myocardial infarction (sHR 0.98, 95% CI 0.61–1.59, p=0.945), in comparison with those without PAD. The cumulative incidence of myocardial infarction was 31 and 32 per 1,000 patients/year in patients with and without prior bleeding, respectively. The cumulative incidence of major bleeding was 63 and 29 per 1,000 patients/year in patients with and without prior bleeding, respectively. The difference between myocardial infarction rate and major bleeding rate was −32 and +3 per 1,000 patient-years in patients with and without prior bleeding (Figure). Conclusions Patients with ACS and prior history of bleeding have a significant increment of bleeding risk during treatment with DAPT. In these patients, short-term DAPT (6 months) should be recommended.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Huntae Kim ◽  
Jong-Il Park ◽  
Byung-Jun Kim ◽  
Jung-hee Lee ◽  
Ung Kim ◽  
...  

Background: Anemia is a known risk factor for future ischemic events and bleeding for patients with ischemic heart disease. However, there are little data about dual antiplatelet therapy (DAPT) duration for patients with anemia after percutaneous coronary intervention (PCI). Methods: From 2010 to 2013, a total of 1,470 patients who underwent PCI were investigated. We categorized the study population into four groups based on the DAPT duration and anemia (Hemoglobin <13g/dL for men and <12g/dL for women): Group A (non-anemia & ≤12m DAPT, n=521), Group B (non-anemia & >12m DAPT, n=501), Group C (anemia & ≤12m DAPT, n=226), and Group D (anemia & >12m DAPT, n=222). We evaluated major adverse cardiovascular and cerebrovascular events (MACCEs), defined as cardiac death, myocardial infarction, repeat target vessel revascularization, or stroke, and bleeding complication. Results: Even though anemic patients had more severe angiographic findings, such as three-vessel disease or diffuse long lesion, the DAPT duration was similar between anemia and non-anemia group. MACCEs occurred less frequently in Group B (16.9%) than Group A (24.7%), Group C (34.6%), and Group D (35.1%) (p<0.001) at 8 years. After multivariate analysis, with Group A as a reference, the adjusted hazard ratio for MACCEs was 0.711 (95% confidence interval [CI] 0.526-0.961, p=0.027) for Group B, 1.126 (95% CI 0.802-1.581, p=0.494) for Group C, and 0.995 (95% CI 0.706-1.405, p=0.980) for Group D. However, major bleeding occurred more frequently occurred in Group D (13.0%) than Group A (5.7%), Group B (7.5%), and Group C (11.2%) (p=0.035) at 8 years. Conclusions: Although extended DAPT showed reduced rate of MACCEs for non-anemic patients, it can be related with increased of major bleeding for anemic patients.


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