Triple Antithrombotic Therapy Research Articles

Navigating Choices: A Questionnaire-based Study on Usage of Antiplatelet Therapies in Management of Acute Coronary Syndrome in India

Percutaneous coronary intervention (PCI) is a common invasive cardiac procedure used to treat acute coronarysyndrome (ACS). The main objective of anticoagulant therapy in PCI is to minimize the risk of plaque rupture and decreasethe formation of blood clots. Understanding clinicians' prescription patterns is crucial for optimizing treatment strategiesfor patients with ACS who have undergone PCI. Methods: It was a cross-sectional, questionnaire-based, noninterventionalstudy which included questionnaire responses from 136 cardiologists, regarding usage of antiplatelets in ACS management.Results: Ticagrelor and aspirin dual antiplatelet therapy (DAPT) is favored by 54% cardiologists in managing ACS patientswho have undergone PCI, regardless of the presence or absence of type 2 diabetes mellitus (T2DM). Further, 78% of theparticipants preferred long-term DAPT over short-term and medium-term alternatives. Forty percent respondents preferreda 1-month triple antithrombotic therapy (TAT) for PCI patients with atrial fibrillation. Additionally, the study emphasizedthe importance of considering factors like age, bleeding history, hemoglobin, and creatinine clearance in determining theoptimal antithrombotic strategy. Conclusion: This study contributes valuable insights into the real-world practices of healthcare practitioners, paving the way for more informed and personalized ACS management strategies in Indian patients.

PERCUTANEOUS CORONARY INTERVENTIONS IN PATIENTS TREATED WITH ORAL ANTICOAGULANT THERAPY: BASELINE CLINICAL CHARACTERISTICS OF THE PERSEO REGISTRY

Abstract Background International guidelines recommend a dual antithrombotic therapy (DAT) with direct oral anticoagulant (DOAC) for patients on chronic oral anticoagulant therapy (OAT) undergoing percutaneous coronary intervention with stent implantation (PCI–S). However, the implementation of practice Guidelines in the “real world” is often a complex exercise. Aim of the multicenter prospective observational PERSEO (PERcutaneouS coronary intErventions in patients treated with Oral anticoagulant therapy) registry was to evaluate the management of the different antithrombotic regimens strategies in patients with an indication for OAT undergoing PCI–S in a “real world” setting and its association with clinical outcomes. Methods The PERSEO registry has been designed to enrol patients requiring OAT and treated by PCI–S in 25 Italian Cardiology Centres. No exclusion criteria have been defined. The primary end–point was a combined measure of efficacy and safety outcome (NACE), including major bleeding events + major adverse cardiac and cerebral events at one year follow up in patients treated with DOAC compared to vitamin K antagonists. Results From February 2018 to February 2022, a total of 1233 patients were enrolled: mean age 74±9 years, 900 males and 333 females. The primary indication for OAT was atrial fibrillation (1066 patients, 87%) while an acute coronary syndrome was the leading reason for PCI–S (789 patients, 64%). Of those, 271 patients had an ST elevation myocardial infarction at admission. Mean CHA2DVAS2C score and HASBLED score were respectively 4±2 and 4±1. Six patients died during hospitalization and 1227 were discharged alive: 1027 on triple antithrombotic therapy (oral anticoagulant and dual antiplatelet therapy), 196 patients on DAT (oral anticoagulant and single antiplatelet therapy) and 4 patients on oral anticoagulant alone. The majority of patients enrolled were discharged on DOAC (1006 patients, 82%), whereas only a minority received vitamin K antagonists (221 patients, 18%). Conclusions The Italian PERSEO Registry is the largest prospective observational study comparing different antithrombotic strategies in patients with an indication for OAT undergoing PCI–S in a “real world” setting. Baseline characteristics, depicted a population at high thrombotic and haemorrhagic risk. In agreement with current guidelines the majority of patients were discharged on DOAC, yet the use of a DAT was still limited to a minority of the patients included.

Comparison of Dual vs. Triple Antithrombotic Therapy in Non-Valvular AF and Acute Coronary Syndrome: A Malaysian Cohort Study

Objectives: This study aimed to compare Dual Antithrombotic Therapy (DAT) and Triple Antithrombotic Therapy (TAT) concerning bleeding and thrombosis outcomes in Malaysian patients with non-valvular atrial fibrillation (NVAF) and acute coronary syndrome (ACS), considering demographic characteristics and comorbidities. Methodology: A retrospective observational cohort study was conducted at Hospital Serdang from January 1, 2020, to May 1, 2022. A total of 206 patients were selected via purposive sampling and divided into two groups. The TAT group received warfarin, clopidogrel, and aspirin, while the DAT group received warfarin and clopidogrel over a 1-year follow-up. Multivariate logistic regression analysis was employed. Results: A higher incidence of thromboembolic episodes was observed in the DAT group (24.3% vs. 8.7% in the TAT group; adjusted odds ratio (aOR) 4.53, 95% CI 1.806-11.379, P= 0.001), signifying a 4.5-fold increase in thromboembolic events in DAT compared to TAT. Conversely, more bleeding episodes were observed in the TAT group (25.2% vs. 15.5% in the DAT group; aOR 2.22, 95% CI 0.993-4.970, P= 0.52), although the difference was not statistically significant. Conclusion: The DAT protocol showed significantly more thrombosis episodes than the TAT protocol, while TAT exhibited a non-significant increase in bleeding events compared to DAT at one year follow-up in patients with NVAF and ACS.

Prevention of Perioperative Bleeding in Patients With Chronic Limb-Threatening Ischemia

Materials and methods: At stage I, we retrospectively studied histories and outpatient medical records of 766 patients with chronic limb-threatening ischemia (from 2006 to 2020) to identify hemorrhagic complications and potential risk factors for their development. We analyzed the effectiveness of different scores for assessment of the bleeding risk. Based on the obtained data, measures to prevent hemorrhagic complications in this cohort of patients were improved. During stage II, 114 patients with 1 or several risk factors for major bleeding underwent surgery between 2021 and 2023. We used the proposed and improved preventive measures for all the patients. Follow-up periods were during the hospital stay and in 6 and 12 months.Results: At stage I, 44 (5.74%) patients were found to have hemorrhagic complications in the early postoperative period: retroperitoneal hematoma, bleeding from an operating wound, and pulsating hematoma (15.9%); gastrointestinal hemorrhage (31.8%); gross hematuria (13.7%), and hemorrhagic stroke (6.8%). The most significant risk factors for bleeding were endovascular intervention using brachial and femoral approaches (P = .000), hybrid intervention (P = .000), dual antiplatelet therapy (P = .014), surgery duration above 60 minutes (P = .001), triple antithrombotic therapy (P = .001), and significant vascular calcification (P = .023). The PRECISE-DAPT score has proven to be of prognostic value (P = .073; odds ratio, 2.88). At stage II, due to the proposed preventive measures, bleeding that required blood transfusion was found in 5 (4.38%) of 114 patients: of them, 1 (0.9%) patient had acute coronary syndrome. There were no major amputations, whereas 3 (2.63%) patients underwent minor amputation. In 6 and 12 months of the follow-up, the total frequency of major cardiovascular complications (cardiac death, myocardial infarction), major and minor amputation was 0.9% and 2.6%, 0% and 1.75%, and 0.9% and 2.6%, respectively.Conclusions: Surgical treatment of patients with chronic limb-threatening ischemia and risk factors for hemorrhagic complications who underwent surgery with the proposed preventive measures demonstrated high efficiency in reducing the number of hemorrhages and associated cardiac complications and low frequency of major and minor amputations in the long-term follow-up.

Comparison of direct oral anticoagulants and warfarin in chronic limb-threatening ischemia

ObjectiveThe role of direct oral anticoagulants (DOACs) in chronic limb-threatening ischemia after revascularization is unknown. Current evidence-based guidelines do not provide clear guidance on the role of anticoagulation or the selection of anticoagulant. Current practice is highly varied and based on provider and patient preference. The purpose of this study was to measure the impact of different anticoagulants on the incidence of major adverse limb events (MALEs) after revascularization for chronic limb-threatening ischemia, major adverse cardiovascular events (MACEs), all-cause mortality, and hospitalization for major bleeding events. MethodsThis was a single-center, observational, retrospective cohort study. Subjects were eligible if they were 18 years or older; underwent endovascular or open revascularization for chronic limb-threatening ischemia, rest pain, or tissue loss; and were subsequently prescribed apixaban, rivaroxaban, or warfarin. The primary end point was the incidence of MALEs, including above-ankle amputation or major index-limb reintervention, within 1 year of index event. Secondary end points included the rate of all-cause mortality, MACEs, and incidence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding. ResultsFrom January 1, 2017, to September 20, 2022, 141 patients met the inclusion and exclusion criteria and were reviewed. The median age was 67 years, with 92 patients prescribed apixaban or rivaroxaban and 49 patients prescribed warfarin. Of these, 42 patients were prescribed triple antithrombotic therapy, 88 dual antithrombotic therapy, and 13 anticoagulant monotherapy. The primary outcome of 1-year MALEs occurred in 36.7% of the warfarin group and 33.7% of the DOAC group (relative risk [RR], 1.09; 95% CI, 0.53-2.25; P = .72). Secondary outcomes of 1-year MACEs (10.2% vs 4.3%; RR, 2.35; 95% CI, 0.60-9.18; P = .18) and 1-year all-cause mortality (26.5% vs 16.3%; RR, 1.63; 95% CI, 0.70-3.78; P = .15) did not differ between the groups. The secondary safety outcome of 1-year ISTH major bleeding occurred in 16.3% of the warfarin group and 4.3% of the DOAC group (RR, 3.76; 95% CI, 1.07-13.19; P = .015). ConclusionsIn patients with chronic limb-threatening ischemia who were revascularized and prescribed anticoagulation with apixaban, rivaroxaban, or warfarin on discharge, no difference in MALEs, MACEs, or all-cause mortality was found. However, 1-year admissions for ISTH major bleeding were significantly higher among patients prescribed warfarin. A randomized trial may confirm these findings.

Antithrombotic Therapy Optimization in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

The antithrombotic management of patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) poses numerous challenges. Triple antithrombotic therapy (TAT), which combines dual antiplatelet therapy (DAPT) with oral anticoagulation (OAC), provides anti-ischemic protection but increases the risk of bleeding. Therefore, TAT is generally limited to a short phase (1 week) after PCI, followed by aspirin withdrawal and continuation of 6-12 months of dual antithrombotic therapy (DAT), comprising OAC plus clopidogrel, followed by OAC alone. This pharmacological approach has been shown to mitigate bleeding risk while preserving adequate anti-ischemic efficacy. However, the decision-making process remains complex in elderly patients and those with co-morbidities, significantly influencing ischemic and bleeding risk. In this review, we discuss the available evidence in this area from randomized clinical trials and meta-analyses for post-procedural antithrombotic therapies in patients with non-valvular AF undergoing PCI.

Clinical impact of high platelet reactivity in patients with atrial fibrillation and concomitant percutaneous coronary intervention on dual or triple antithrombotic therapy

Abstract Background High platelet reactivity (HPR) on clopidogrel is an established thrombotic risk factor after percutaneous coronary intervention (PCI). The introduction of more potent antiplatelet drugs has partially surpassed this issue. However, in the setting of concomitant atrial fibrillation (AF) and PCI clopidogrel is still the most adopted P2Y12 inhibitor. Purpose We sought to evaluate the possible clinical relevance of genetic and platelet function testing (PFT) in a real-world population with concomitant AF and PCI on dual (DAT) or triple (TAT) antithrombotic therapy. Methods All consecutive patients with history of AF discharged from our cardiology ward with DAT or TAT after a PCI from April 2018 to March 2021 were enrolled in an observational registry. For all subjects, blood serum samples were collected and tested for platelet reactivity by arachidonic acid and ADP (VerifyNow system) and genotyping of the CYP2C19*2 loss-of-function polymorphism. We recorded at 3 and 12-months follow-up: (1) major adverse cardiac and cerebrovascular events (MACCE), (2) major hemorrhagic or clinically relevant non-major bleeding and (3) all-cause mortality. Results A total of 147 patients were included (91, 62% on TAT). In 93.4% of patients, clopidogrel was chosen as P2Y12 inhibitor. P2Y12 dependent HPR resulted an independent predictor of MACCE both at 3 and 12 months (HR 2.93, 95% C.I. 1.03 to 7.56, p=0.027 and HR 1.67, 95% C.I. 1.20 to 2.34, p=0.003, respectively). At 3-months follow-up the presence of CYP2C19*2 polymorphism was independently associated with MACCE (HR 5.21, 95% C.I. 1.03 to 26.28, p=0.045). Conclusions In a real-world unselected population on TAT or DAT, the entity of platelet inhibition on P2Y12 inhibitor is a potent predictor of thrombotic risk, suggesting the clinical utility of this laboratory evaluation for a tailored antithrombotic therapy in this high-risk clinical scenario.

Edoxaban in patients with non-valvular atrial fibrillation after percutaneous coronary intervention: ENCOURAGE-AF design

Approximately one fifth of patients diagnosed with atrial fibrillation (AF) undergo a percutaneous coronary intervention (PCI). Current guidelines recommend different combinations and durations of triple or dual antithrombotic therapy for these patients but data on the implementation of these recommendations in clinical routine are scarce. ENCOURAGE-AF is a prospective, non-interventional, non-comparative, multicentre study. Approximately 720 patients will be consecutively enrolled from 70 participating sites across Germany. Patients with non-valvular AF treated with edoxaban, who have undergone successful PCI, have no planned elective cardiac intervention during the study period, have capability, availability, and willingness for follow-up by telephone interview during the study, are aged ≥ 18 years with life expectancy ≥ 1 year, and provide written informed consent, will be included. Eligible patients will be enrolled between 4- and 72-h after completing a successful PCI. Duration of exposure to and dosing regimens of edoxaban, antiplatelet agents and other concomitant medications of interest will be monitored in line with the clinical practice. Physician- and patient-reported clinical events, adverse drug reactions, patient quality of life (EQ-5D-5L) and health resource utilisation (HRU) parameters will be evaluated at 30 days and 1-year post-PCI. The ENCOURAGE-AF non-interventional study will provide insights into the patterns of edoxaban usage in combination with antiplatelet treatment and other concomitant medications in AF patients with a successful PCI over a 1-year time period during routine clinical practice in Germany. The effectiveness and safety of edoxaban in this patient population, as well as patients’ quality of life and HRU will be evaluated.Trial registration: Clinicaltrial.gov NCT04519944, registered on 20 August 2020.

AGREE and ESA for Greenness Assessment of a Novel Validated RP-HPLC Method for Simultaneous Determination of Aspirin, Warfarin and Clopidogrel in Rat Plasma: Application to Pharmacokinetic Study of the Possible Interaction between the Three Drugs.

The green profile of the developed method is assessed and compared with previously reported methods. Percutaneous coronary intervention is a procedure where a catheter is utilized to place a stent in order to facilitate opening of the blood vessels in the heart. Triple antithrombotic therapy includes oral anticoagulation as warfarin and dual antiplatelet therapy (composed of aspirin and clopidogrel bisulfate). The aim of the current study was to evaluate the pharmacokinetic parameters of ASP, WAR and CLP and to investigate the possible interaction between the three drugs upon co-administration in rats. A selective and precise RP-HPLC method was developed for the simultaneous determination of ASP, WAR and CLP in rat plasma. Pharmacokinetic study was conducted in rats that received ASP, WAR and CLP as an application of the developed method. From the statistical evaluation of the pharmacokinetic parameters, it was observed that the co-administration of ASP, WAR and CLP significantly increased the ASP and CLP bioavailability in rats. A significant drug-drug interaction was confirmed in the current study. The elevated Cmax of ASP and CLP upon the co-administration of ASP, WAR and CLP may explain the reported bleeding.

Antithrombotic Treatment in Coronary Artery Disease.

Coronary artery disease exhibits growing mortality and morbidity worldwide despite the advances in pharmacotherapy and coronary intervention. Coronary artery disease is classified in the acute coronary syndromes and chronic coronary syndromes according to the most recent guidelines of the European Society of Cardiology. Antithrombotic treatment is the cornerstone of therapy in coronary artery disease due to the involvement of atherothrombosis in the pathophysiology of the disease. Administration of antiplatelet agents, anticoagulants and fibrinolytics reduce ischemic risk, which is amplified early post-acute coronary syndromes or post percutaneous coronary intervention; though, antithrombotic treatment increases the risk for bleeding. The balance between ischemic and bleeding risk is difficult to achieve and is affected by patient characteristics, procedural parameters, concomitant medications and pharmacologic characteristics of the antithrombotic agents. Several pharmacological strategies have been evaluated in patients with coronary artery disease, such as the effectiveness and safety of antithrombotic agents, optimal dual antiplatelet treatment schemes and duration, aspirin de-escalation strategies of dual antiplatelet regimens, dual inhibition pathway strategies as well as triple antithrombotic therapy. Future studies are needed in order to investigate the gaps in our knowledge, including special populations.

The problem of inpatient thrombosis of coronary arteries in patients with COVID-19 on the background of intensive antithrombotic therapy

Myocardial infarction claims million lives on the planet each year. Pharmacotherapy in combination with percutaneous coronary interventions have significantly reduced morbidity and mortality in this cohort. Despite optimal therapy and prophylaxis, there is a group of patients with recurrent, often fatal, coronary thromboses. During the COVID-19 pandemic, some patients developed episodes of thrombosis in blood vessels of various organs, including brain, heart or lungs, even on therapeutic anticoagulation. The patient was admitted to the department of cardiology and reperfusion therapy, with a confirmed diagnosis of COVID-19 resulted in acute ST-segment elevation myocardial infarction. Patient underwent urgent coronary angiography with thromboaspiration and stenting of the infarct-dependent right coronary artery followed by optimal medical treatment with the use of triple antithrombotic therapy. His condition became stable with the resolution of ST-segment elevation on electrocardiogram. A few days later, the condition of the patient deteriorated again with recurrent of chest pain and a new ST segment elevation. Repeated coronary angiography revealed recurrent thrombosis in the right coronary artery. The mechanisms of thrombosis in COVID-19 are not fully understood. Among possible, the direct effect of the virus on tissues, activation of pro-inflammatory system and coagulation system, impaired vasodilation, and decreased fibrinolytic activity are discussed. These mechanisms may lead to vascular thrombosis in different organs, particularly heart, lungs, and brain.

Complications and outcomes of carotid artery stenting in high-risk cases

ObjectivesCarotid artery stenting is sometimes adapted for some at-risk cases; however, appropriate treatment timing with stroke onset is controversial. This study aims to identify factors that have an impact on complications and outcomes, especially in patients at high risk. Materials and MethodsWe examined the characteristics of 152 consecutive patients treated by carotid artery stenting between January 2018 and March 2022 and retrospectively analyzed the risk factors for complications and poor outcomes (modified-Rankin-Scale deterioration), such as patient background, carotid artery stenting risks (access route tortuosity, severe calcification, vulnerable plaque, estimated glomerular filtration rate <30 mL/min/1.73 m2, etc.), characteristics of the stenosis, details of treatment, and treatment timing. ResultsThe average North American Symptomatic Carotid Endarterectomy Trial criteria score was 68.3% and the lesion length was 20.5±9.7mm. Among patients, 107 (70.4%) had a carotid artery stenting risk. In high-risk carotid artery stenting cases, symptomatic complications occurred in 32 (30.0%), and the 90-day modified Rankin scale score deteriorated in 15 cases (14.0%). Multivariate analysis showed that cases with triple antithrombotic therapy (p=0.003), stenting within 7 days (p=0.0032), and after 28+ days (p=0.0035) of stroke onset were independently associated factors for complications. ConclusionsThis study showed that among risk factors, triple antithrombotic therapy in particular was a risk factor for perioperative complications. Carotid artery stenting for patients with stroke after 28 days of onset affects the prognosis. Therefore, although further study is warranted, waiting more than one month for treatment in patients requiring carotid artery stenting is a potential risk.

Changes in Antithrombotic Therapy Prescription in Patients with a Combination of Atrial Fibrillation and Myocardial Infarction in a Specialised Inpatient Department from 2016-2019 and Associations with Prognosis.

Background and Objectives: The problem of treating patients with atrial fibrillation and myocardial infarction is relevant. The issue of optimal antithrombotic therapy in these patients has not been definitively resolved. This work analyzes the influence of clinical factors and treatment on the long-term prognosis of patients. Materials and Methods: The research included 360 patients with atrial fibrillation and myocardial infarction during 2016-2019. Results: The factors associated with fatal outcomes were age (hazard ratio (HR): 1.05; 95% confidence interval (CI): 1.03-1.07; p < 0.001); stroke (HR: 1.95; 95% CI: 1.27-3.00; p = 0.0002); glomerular filtration rate (HR: 0.988; 95% CI: 0.978-0.998; p = 0.03); left ventricular ejection fraction (HR: 0.975; 95% CI: 0.957-0.999; p = 0.007); and aspirin (HR: 0.48; 95% CI: 0.31-0.73; p < 0.001). The factors associated with the combined endpoint were chronic kidney disease (HR: 1.46; 95% CI: 1.01-2.10; p = 0.04); HAS-BLED (HR: 1.23; 95% CI: 1.06-1.43; p = 0.007); percutaneous coronary intervention (HR: 0.70; 95% CI: 0.51-0.96; p = 0.03); and aspirin (HR: 0.65; 95% CI: 0.44-0.97; p = 0.03). Conclusions: Double and triple antithrombotic therapy were not associated with outcomes. Aspirin improved the prognosis for survival and the combined endpoint.

Comparison of Various Regimens of Antithrombotic Therapy in Patients With Valvular Heart Disease and Coronary Artery Disease After Surgical and Interventional Interventions

To evaluate the postoperative incidence of bleeding, incidence of thromboembolic complications, and all-cause mortality in patients with valvular heart disease and ischemic heart disease (IHD) associated with various regimens of the antithrombotic treatment during one year after surgery. This study included 271 patients with valvular heart disease and IHD after heart valve replacement and myocardial revascularization from 2009 through 2018. However, during the follow-up period (12 months), contact with 12 patients was lost, and therefore these patients were excluded from the study. Further analysis included 259 patients. Coronary artery bypass grafting (CABG) in combination with heart valve intervention was performed in 217 (83.8 %) patients, and percutaneous coronary interventions (PCIs) were performed in 42 (16.2 %) patients. There were 197 (72.7 %) male participants; median age was 64.0 [58.0; 67.5] years. The patients were divided into two groups. Group 1 consisted of 113 patients who received postoperative dual antithrombotic therapy (DAT) with acetylsalicylic acid (ASA)/clopidogrel+vitamin K antagonist (VKA). Group 2 included 146 patients receiving postoperative triple antithrombotic therapy (TAT) with ASA+clopidogrel+VKA. Follow-up duration was 12 months after surgery. Due to significant intergroup differences in major clinical anamnestic data, the data were adjusted using pseudo-randomization (Propensity Score Matching, PSM). In result, 109 patients were selected for each group. The incidence of adverse hemorrhagic outcomes was significantly higher in the group treated with TAT than with DAT. Minor bleedings were observed in 19 (17.4 %) vs. 8 (7.3 %) cases; moderate, clinically significant bleedings in 16 (14.7 %) vs. 6 (5.5 %) cases; and the total number of bleedings was 35 (32.1 %) vs. 14 (12.8 %; p=0.02, p=0.02, and р=0.001, respectively). Comparing the incidence of major bleedings did not show and significant intergroup differences (p=1.000). The incidence rate of any bleeding during the follow-up period was 32.1 % in patients treated with TAT (n=109) and 12.8 % in patients treated with DAT (n=109; p=0.005). The incidence of no bleeding during one year after surgery was 87 % in the DAT treatment group and 67 % in the TAT treatment group (p=0.005). The incidence of secondary endpoints, including ischemic stroke, myocardial infarction, prosthetic valve thrombosis, and death, was statistically non-significant. Administration of DAT vs. TAT after heart valve replacement and myocardial revascularization significantly decreases the incidence of any bleedings in the absence of significant differences in the incidence of thromboembolic events and mortality.

Predictors of ischemic and hemorrhagic complications in patients with myocardial infarction at 18-month follow-up: a single-center registry study

Aim. To identify predictors of ischemic and hemorrhagic events in patients with myocardial infarction (MI) after 18 months of follow-up.Material and Methods. The single-center prospective study included 478 patients with MI. The exclusion criteria were as follows: age &lt; 18 years; MI as a complication of myocardial revascularization; atrial fibrillation; intake of anticoagulants after MI. During inpatient treatment, the risk of ischemic and hemorrhagic events was calculated according to the PRECISE-DAPT score, GRACE hospital discharge risk score, CRUSADE bleeding score. After 18 months, we evaluated the rate of ischemic (cardiovascular death, unstable angina, life-threatening arrhythmia, non-fatal MI and stroke, acute decompensated heart failure, elective repeated and/ or emergency revascularization) and haemorrhagic events and the amount of corresponding therapy.Results. At 18 months post-MI, patients were at high risk of developing both ischemic events (cardiovascular death: 32.0%; recurrent MI: 16.3%; repeated myocardial revascularization: 18.5%; unstable angina: 13.8%; stroke: 3.6%) and hemorrhagic events (bleeding rate of 39.7% according to the TIMI score), most of which occurred during the first 12 months post-MI. Double antiplatelet therapy (DAPT) was prescribed to 86.5% patients upon discharge (including a triple antithrombotic therapy in 8.6% patients). Patient adherence to treatment was 66.7% and 60.6% at 6 and 12 months of follow-up, respectively. After 18 months, DAPT was prescribed exclusively to patients suffered from recurrent ischemic events or those who underwent repeated myocardial revascularization (17.4% patients in total). The main reason to cancel DAPT was bleeding, although it was minor in most cases. Predictors of ischemic events (fatal and non-fatal) at 18 months of follow-up were PRECISE- DAPT score (odds ratio (OR) = 1.108, 95% confidence interval (CI) = 1.054-1.164, р &lt; 0.001), GRACE score (OR = 1.032, 95% CI = 1.016-1.048, р &lt; 0.001), left ventricular ejection fraction (LVEF) &lt; 40% (OR = 4.256, 95% CI = 1.510-12.001, р = 0.006). Predictors of hemorrhagic events at 18-month follow-up were PRECISE-DAPT score (OR = 1.025, 95% CI = 1.009-1.041, р = 0.002), peripheral artery disease (PAD) (OR = 2.459, 95% CI = 1.365-4.428, р = 0.003), intake of sulfonylurea for diabetes mellitus (OR = 2.523, 95% CI = 1.266-5.028; р = 0.009), unsuccessful percutaneous coronary intervention (PCI) or conservative treatment of MI (OR = 3.792, 95% CI = 1.799-7.996, р &lt; 0.001).Conclusion. Predictors of ischemic events (fatal and non-fatal) in the long-term period after MI include PRECISE-DAPT and GRACE scores, and LVEF below 40%. Predictors of hemorrhagic events at 18-month follow-up were PRECISE- DAPT scores, PAD, taking sulfonylurea for diabetes mellitus, unsuccessful PCI or conservative treatment of MI.

Dual antithrombotic therapy with oral anticoagulant and P2Y12 inhibitors in patients with atrial fibrillation after percutaneous coronary intervention

BackgroundThe efficacy and safety of dual antithrombotic therapy (DAT) with oral anticoagulant and P2Y12 inhibitors (P2Y12i) in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) have not been well investigated. The purpose of this study was first to evaluate clinical outcomes of DAT with P2Y12i compared with triple antithrombotic therapy (TAT), and then to compare DAT with low-dose prasugrel and DAT with clopidogrel, in patients with AF undergoing PCI. MethodsThis study was a multicenter, non-interventional, prospective and retrospective registry. A total of 710 patients with AF undergoing PCI between January 2015 and March 2021 at 15 institutions were analyzed. Clinical outcomes within 1 year, including major adverse cardiovascular events (MACE) and major bleeding events (BARC 3 or 5) were compared between patients receiving DAT (n = 239) and TAT (n = 471), and then, compared among prasugrel-DAT (n = 82), clopidogrel-DAT (n = 157), and TAT. ResultsThe DAT group showed significantly lower incidence of MACE and major bleeding events compared with the TAT group (log-rank p = 0.013 and 0.047). In the multivariable Cox regression analyses, DAT (p = 0.028), acute coronary syndrome (p = 0.025), and anemia (p = 0.015) were independently associated with MACE. In addition, anemia (p = 0.022) was independently associated with, and DAT (p = 0.056) and thrombocytopenia (p = 0.051) tended to be associated with, major bleeding events. When analyzed among the prasugrel-DAT, clopidogrel-DAT, and TAT groups, there were no significant differences in clinical outcomes between the prasugrel-DAT and clopidogrel-DAT groups, and similar trends were observed for both 2 groups in comparison with the TAT group. ConclusionsIn AF patients undergoing PCI, DAT was associated with lower incidence of MACE and major bleeding events compared with TAT. In comparison of P2Y12i, there might be no significant difference in the incidence of MACE and bleeding events between prasugrel-based DAT and clopidogrel-based DAT.

EE109 Cost Effectiveness of Dual Vs. Triple Therapy in Management of Atrial Fibrillation with Percutaneous Coronary Intervention

Current guidelines recommend the use of dual or triple antithrombotic therapy for patients with atrial fibrillation (AF) undergoing a percutaneous coronary intervention (PCI). Dual therapy has demonstrated favorable safety outcomes without compromising efficacy endpoints compared to triple therapy in four major clinical trials. In this study, we created a Markov model to evaluate the cost-effectiveness of dual versus triple antithrombotic therapy using data from the RE-DUAL PCI clinical trial.

P463 LEFT ATRIAL APPENDAGE CLOSURE VERSUS TRIPLE ANTITHROMBOTIC THERAPY IN PATIENTS WITH LONG TIME INDICATION TO DUAL ANTIPLATELET THERAPY

Abstract Introduction Recent guidelines suggest a limited duration of triple antithrombotic therapy (TAT) in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) at elevated bleeding risk. Indeed, in patients who are also at elevated thrombotic risk and with indication to prolonged dual antiplatelet therapy, percutaneous left atrial appendage closure (LAAC) could be a possible safe and effective option to prevent both bleeding and thrombotic events. Methods retrospective single–center study enrolling all consecutive patients between September 2012 and February 2020, comparing patients deemed at increased thrombotic and bleeding risk who received LAA percutaneous closure to avoid TAT before or after PCI with patients who received TAT after PCI. The aim of the study was to establish the safety and efficacy of LAAC in comparison to TAT. Results A total of 168 patients were included in the study: 56 underwent percutaneous LAAC while 112 were discharged in TAT. Median age was 75 (69–79). TAT patients had a CHA2DS2–VASc score of 4 (3–5) and a mean HAS–BLED score of 3 (2–3), whereas in LAAC patients the mean CHA2DS2–VASc was 4.9 (±1.5) and the mean HAS–BLED was 3.9 (±0.9); the difference in Score Points was statistically significant (p=0.001). The population who underwent LAAC was characterized by a remarkable procedural PCI complexity with a mean DAPT score of 1.4 (±1.3), with respect to the population discharged in TAT which was 0 (0–2). At follow–up (mean follow–up period in days: 727 [489–1000]), four bleeding episodes were recorded in LAAC population in comparison to 16 bleeding episodes observed in TAT population (12.6% vs. 15.4%; p–value=0.142): two bleeding episodes were major in LAAC group and five in TAT group (3.6% vs. 4.8%; p–value=1). One case of stroke (1.8%) occurred in LAAC population and two cases (1.8%) in TAT population (p=1.000). Conclusions In a single–centre retrospective study no significant difference was observed in terms of bleeding between TAT and LAAC, in patients at high ischemic and thrombotic risk with indication to prolonged dual antiplatelet therapy after PCI and anticoagulation for AF. Nevertheless, the non statistical trend to reduction of bleeding events in LAAC group might be explored in a larger study population.

P236 THE EARLY USE OF A PARTICULAR HEMODIALYTIC FILTER DURING SCA–STEMI COMPLICATED BY MULTIORGAN FAILURE

Abstract A 66–year–old man, hypertensive, obese and avid smoker, in apparent good health until, due to the onset of typical chest pain associated with vomiting and algid sweating, he went to the PS where a diagnosis of acute coronary syndrome with ST–segment elevation was made. As per the guidelines, antithrombotic therapy was administered and transfer to the HUB center was arranged to perform urgent coronarography; thrombotic occlusion of the I M.O. branch was revealed and treated with angioplasty and drug–eluting stent implantation. On admission to the NICU, the patient presented hypotensive, tachycardic and with repeated episodes of rectorrhagia and vomiting intermingled with blood. Cardiac echocolorDoppler showed mild reduction in global kinesthesia (FE 45%) with hypo–akinesis of the inferior and lateral walls, circumferential pericardial effusion that was not hemodynamically significant, dilated and fixed inferior vena cava with mild increase in systolic pulmonary artery pressure. On suspicion of gastro–intestinal ischemic damage, supported by the clinical and laboratory findings (creatinine increase with anuria for more than 12 hours and severe signs of hepato–pancreatic insufficiency) CT scan with mdc was performed showing hepato–renal hypoperfusion. Therefore, on suspicion of multi–organ dysfunction syndrome, renal replacement therapy was started in CVVHD mode with filter for clearance of medium molecular weight molecules (cut–off 40 kDa) to reduce possible cytokine and myoglobin damage. Already from the first hours of treatment, there was a rapid and exponential improvement in clinical–laboratory parameters with resumption of diuresis. During hospitalization, two episodes of paroxysmal atrial fibrillation treated with electrical and pharmacological cardioversion were detected; given a CHA2DS2VASc score 3 and a HAS–BLED score 2, triple antithrombotic therapy was initiated. At follow–up, there was improvement in echocardiographic parameters (minimal residual pericardial dislodgement and inferior vena cava of normal caliber and respiratory collapsibility) and clinical–laboratory.

P42 ACUTE STENT THROMBOSIS IN CATH LAB DURING OPTIMIZED PCI: HOW TO RECOGNIZE IT AND POSSIBLE TREATMENT

Abstract Angiographic Acute Stent Thrombosis occur in 0.5%–2% of procedures.OCT–PCI or Optimized PCI represents a new approach particularly indicated in complex high thrombotic risk lesions, in patients at high bleeding risk with need for short DAPT and in the treatment of vulnerable plaques. Post–stent OCT thrombus finding was defined in previous studies as mass with diameter ≥250μm attached to the stent struts, was present until 40% of cases and is associated with definite angiographic thrombosis. Outcome of OCT thrombus is generally favorable although in about 25% there may be a progression. Case 1: 75–y smoker female with hypertension and atrial fibrillation on NOAC therapy presented in ICU with NSTEMI. At angiography: 75% stenosis focal plaque at proximal circumflex (Fig1A). At OCT vulnerable plaque: ulcerated with intimal flap &amp;lt; 90°, thin fibrous cap 20 µm, MLA 2.17mm² and AS 63%, intimal micro–calcifications and cholesterol crystals (Fig1C). We implanted DES with post–dilatation. Treatment was Cangrelor, heparin 100 IU/kg and ASA 250 mg ev. OCT showed acute 660 µm thrombosis of the stent body although there was perfect angiographic result (Fig1D+B). Further multiple balloon dilatation of the stent was carried out with thrombosis persistence on OCT control (Fig1E) and new appearance of multiple thromboses adhering to the intravascular side stent struts (Fig1F–G). Switch from Cangrelor to Tirofiban was done. Patient‘s clinical course was uneventful with discharge after six days on triple antithrombotic therapy with low–dose NOAC, ASA and clopidogrel.Case 2: 63–y smoker man arrived in cath lab for anterior STEMI. He had already taken ASA 300 mg ev and Ticagrelor 180 mg oral bolus about 60 minutes earlier in the ambulance. In Cath Lab was done heparin 100 IU/kg. P–PCI was performed for acute sub–occlusion (Fig2A) of the ostial DA treated by pre–dilation, DES implantation on Left Main–DA and multiple post–dilations according to the POT technique. OCT control showing extensive stent malapposition (860 µm) with evidence of multiple thromboses adhering to the stent struts on Left Main (diameter 410 µm) although there was perfect angiographic result (Fig2B–E). Procedure was optimized by adequate post–dilatation of the LM and administration of Abciximab. Patient‘s clinical course was uneventful with discharge after five days on ASA and Ticagrelor. Conclusions Post–stent OCT thrombus may guide the choice of use of Glicoprotein IIb/IIIA Inhibitors in Cath Lab.