scholarly journals External validation of the PRECISE-DAPT score in a large nationwide population of myocardial infarction patients: a SWEDEHEART study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Wester ◽  
M.A Mohammad ◽  
D Erlinge ◽  
S Koul

Abstract Background/Introduction Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with stent placement in myocardial infarction (MI) patients has improved ischemic outcomes but increased the risk of bleeding. The PRECISE-DAPT (Predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy) score has been implemented in recent guidelines to tailor the duration of DAPT based on each patient's individual risk profile. However, to date it has only been externally validated on small data samples or exclusively for subgroups of PCI treated MI patients. Purpose To assess the performance of the PRECISE-DAPT score in a nationwide cohort of MI patients undergoing PCI with subsequent DAPT. This will be the world's largest validation of the PRECISE-DAPT score in approximately 20.000 unique real-world MI patients. Methods Data from the Swedish Websystem for Enhancement of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry on MI patients treated with DAPT after PCI between 2008 and 2016 in Sweden were obtained and merged with the Swedish Patient Registry as well as the Prescribed Drugs Registry that holds data from all Swedish pharmacies. The ability of PRECISE-DAPT to predict bleeding and ischemic outcomes in relation to DAPT duration was determined. Results Results are to be announced. Conclusions Whether the PRECISE-DAPT score can be validated or not in a large nationwide cohort of MI patients in relation to DAPT duration, has the potential to impact current DAPT guidelines and clinical decision making in everyday practice. Further results and conclusions are to be announced. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Märta Winkler's research foundation and Thorsten Westerström's research foundation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.S Yeh ◽  
C.Y Hsu ◽  
C.Y Huang ◽  
W.T Chen ◽  
Y.C Hsieh ◽  
...  

Abstract Aims To examine the effect of de-escalation of P2Y12 inhibitor in dual antiplatelet therapy (DAPT) on major adverse cardiovascular events (MACE) and bleeding complications after acute myocardial infarction (AMI) in Taiwanese patients undergoing percutaneous coronary intervention (PCI). Methods and results We retrospectively evaluated patients who had received PCI during AMI hospitalisation and were initially on aspirin and ticagrelor and without adverse events at 3 months between 2013 and 2016. In total, 1,901 and 8,199 patients were identified as switched DAPT (switched to aspirin and clopidogrel) and unswitched DAPT (continued on aspirin and ticagrelor) cohorts, respectively. With a mean follow-up of 8 months, the incidence rates (per 100 person-year) of death, AMI readmission and MACE were 2.89, 3.68 and 4.91 in the switched cohort and 2.42, 3.28 and 4.72 in the unswitched cohort, respectively based on an inverse probability of treatment weighted method. (Table) After adjustment for patients' clinical variables, two groups were no significant difference in death (A), AMI admission (B) and MACE (C). Additionally, there was no difference in the risk of major (D) or non-major clinically relevant bleeding (E) (Figure 1). Conclusions Unguided de-escalation of P2Y12 inhibitor in DAPT was not associated with higher risk of death, MACE, AMI readmission in Taiwanese patients with AMI undergoing PCI. Figure 1 Funding Acknowledgement Type of funding source: Private hospital(s). Main funding source(s): Taipei Medical University


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.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sami J Natour ◽  
May Myint Thanda Kyaw ◽  
Ronald W Busuttil ◽  
Jonathan M Tobis ◽  
Henry M Honda

Introduction: Randomized trials have demonstrated the safety and efficacy of one month of dual antiplatelet therapy (DAPT) after placement of drug-eluting stents in patients with high bleeding risk. Patients with end-stage liver disease (ESLD) are underrepresented in these trials. Patients who undergo percutaneous coronary intervention (PCI) in preparation for orthotopic liver transplantation (OLT) exhibit a high incidence of bleeding complications on DAPT. The rates of bleeding versus thrombotic complications in ESLD patients placed on DAPT following PCI are poorly described. Methods: We retrospectively collected data from 61 patients who were evaluated for OLT between 2016 and 2019 and underwent PCI prior to listing. Bleeding events were classified using the Bleeding Academic Research Consortium (BARC) definitions and included if the following criteria were met: events occurred in the setting of DAPT, were non-procedural in etiology, and occurred during the time following PCI and prior to OLT. Ischemic complications were evaluated by the incidence of myocardial infarction (MI), stent thrombosis, in-stent restenosis (>50%) and all-cause mortality at 1 year follow-up. Results: A total of 55/61 patients (90%) were placed on DAPT following PCI. Among them, 21/55 patients (38%) bled while taking DAPT, including 15 patients (27%) with BARC types 3-5 first-time bleeding events and 10 patients (18%) requiring early discontinuation of therapy. The median time to first bleeding event was 8 days (range 1 to 477 days, 85 th percentile 17 days). Among ischemic complications, MI occurred in 11/55 patients (20%) however only one patient had a type 1 MI with the remaining being type 2 in etiology. There were no episodes of stent thrombosis and 2 episodes of in-stent restenosis during the 1 year follow-up. A total of 12/55 patients (22%) went on to receive OLT and 18/55 (33%) passed away by 1 year post-PCI. Conclusions: Patients with ESLD exhibit a high rate of clinically significant bleeding on DAPT when compared to overall thrombotic events. The majority of bleeds occurred within the first month after PCI. These findings illustrate the need for larger studies to assess the safety of single instead of dual antiplatelet therapy in patients with ESLD who receive PCI.


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.


2016 ◽  
Vol 2016 ◽  
pp. 1-4
Author(s):  
Ashwad Afzal ◽  
Bimal Patel ◽  
Neel Patel ◽  
Sudhakar Sattur ◽  
Vinod Patel

Clopidogrel resistance from CYP2C19 polymorphism has been associated with stent thrombosis in patients undergoing percutaneous coronary intervention with drug-eluting stents. We present a case of a 76-year-old male who received drug-eluting stents to the right coronary artery and left anterior descending artery for non-ST elevation myocardial infarction and was discharged on dual antiplatelet therapy with aspirin and clopidogrel. He subsequently presented with chest pain from anterior, anteroseptal, and inferior ST segment elevation myocardial infarction. An emergent coronary angiogram revealed acute stent thrombosis with 100% occlusion of RCA and LAD that was successfully treated with thrombus aspiration and angioplasty. Although he was compliant with his dual antiplatelet therapy, he developed stent thrombosis, which was confirmed as clopidogrel resistance from homozygous CYP2C19 polymorphism.


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.


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.


2020 ◽  
Vol 2020 ◽  
pp. 1-12 ◽  
Author(s):  
Monica Verdoia ◽  
Cyril Camaro ◽  
Elvin Kedhi ◽  
Marco Marcolongo ◽  
Harry Suryapranata ◽  
...  

Conflicting results have been reported so far in pooled analyses and studies evaluating the optimum duration of dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS) patients. However, randomized clinical trials dedicated to this specific setting of higher thrombotic risk patients have only recently been completed, pointing at the noninferiority of a shorter strategy as compared to the traditional 12-month DAPT, furthermore allowing to reduce the risk of major bleeding complications. Therefore, a reconsideration of current clinical practice and guidelines should be certainly be advocated in light of the most recent updates, especially among ACS patients treated with percutaneous coronary intervention (PCI) and modern drug-eluting stents (DES). Our aim was to provide a comprehensive review of the available evidence on the optimal DAPT duration in ACS patients.


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