RESUMEN

Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is fundamental in all patients undergoing percutaneous coronary intervention (PCI) to prevent coronary thrombosis. In patients with atrial fibrillation (AF), an oral anticoagulant gives protection against ischemic stroke or systemic embolism. AF-PCI patients are at high bleeding risk and decision-making regarding the optimal antithrombotic therapy remains challenging. Dual antithrombotic therapy (DAT) has been shown to reduce bleeding events but at the cost of a higher risk of stent thrombosis. Further studies are needed to clarify the optimal duration of triple antithrombotic therapy (TAT) or DAT and the role of more potent antiplatelet drugs.

Asunto(s)

Anticoagulantes , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Intervención Coronaria Percutánea/métodos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/uso terapéutico , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Administración Oral , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/cirugía , Terapia Antiplaquetaria Doble/métodos , Hemorragia/inducido químicamente , Hemorragia/prevención & control , Trombosis Coronaria/prevención & control

RESUMEN

BACKGROUND: Triple antithrombotic therapy (TAT) with aspirin, a P2Y12 inhibitor, and oral anticoagulation in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) raises concerns about increased bleeding. Regimens incorporating more potent P2Y12 inhibitors over clopidogrel have not been investigated adequately. RESEARCH DESIGN AND METHODS: A retrospective observational study was performed on 387 patients with AF receiving TAT for 1 month (n = 236) or ≤1 week (n = 151) after PCI. Major and clinically relevant non-major bleeding and major adverse cardiac and cerebrovascular events (MACCE) were assessed up to 30 days post-procedure. RESULTS: Bleeding was less frequent with ≤1 week versus 1 month of TAT (3.3 vs 9.3%; p = 0.025) while MACCE were similar (4.6 vs 4.7%; p = 0.998). No differences in bleeding or MACCE were observed between ticagrelor/prasugrel and clopidogrel regimens. For patients receiving ≤1 week of TAT, no excess of MACCE was seen in the subgroup given no further aspirin post-PCI compared with those given aspirin for up to 1 week (3.6 vs 5.2%). CONCLUSIONS: TAT post-PCI for ≤1 week was associated with less bleeding despite greater use of ticagrelor/prasugrel but similar MACCE versus 1-month TAT. These findings support further studies on safety and efficacy of dual therapy with ticagrelor/prasugrel immediately after PCI.

Asunto(s)

Anticoagulantes , Aspirina , Fibrilación Atrial , Clopidogrel , Quimioterapia Combinada , Hemorragia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Antagonistas del Receptor Purinérgico P2Y , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Intervención Coronaria Percutánea/métodos , Masculino , Femenino , Estudios Retrospectivos , Anciano , Persona de Mediana Edad , Hemorragia/inducido químicamente , Aspirina/administración & dosificación , Aspirina/uso terapéutico , Aspirina/efectos adversos , Clopidogrel/administración & dosificación , Clopidogrel/uso terapéutico , Clopidogrel/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Antagonistas del Receptor Purinérgico P2Y/administración & dosificación , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Fibrinolíticos/administración & dosificación , Fibrinolíticos/uso terapéutico , Fibrinolíticos/efectos adversos , Anciano de 80 o más Años , Ticagrelor/administración & dosificación , Ticagrelor/uso terapéutico , Ticagrelor/efectos adversos

RESUMEN

OBJECTIVE: Patients with symptomatic lower extremity arterial disease (LEAD) are recommended to receive antiplatelet therapy, while direct oral anticoagulants (DOACs) are standard for stroke prevention in patients with atrial fibrillation (AF). For patients with concomitant LEAD and AF, data comparing dual antithrombotic therapy (an antiplatelet agent used in conjunction with a DOAC) vs. DOAC monotherapy are scarce. This retrospective cohort study, based on data from the Taiwan National Health Insurance Research Database, aimed to compare the efficacy and safety of these antithrombotic strategies. METHODS: Patients with AF who underwent revascularisation for LEAD between 2012 - 2020 and received any DOAC within 30 days of discharge were included. Patients were grouped by antiplatelet agent exposure into the dual antithrombotic therapy and DOAC monotherapy groups. Inverse probability of treatment weighting was used to mitigate selection bias. Major adverse limb events (MALEs), ischaemic stroke or systemic embolism, and bleeding outcomes were compared. Patients were followed until the occurrence of any study outcome, death, or up to two years. RESULTS: A total of 1 470 patients were identified, with 736 in the dual antithrombotic therapy group and 734 in the DOAC monotherapy group. Among them, 1 346 patients received endovascular therapy as the index revascularisation procedure and 124 underwent bypass surgery. At two years, dual antithrombotic therapy was associated with a higher risk of MALEs than DOAC monotherapy (subdistribution hazard ratio [SHR] 1.34, 95% confidence interval [CI] 1.15 - 1.56), primarily driven by increased repeat revascularisation. Dual antithrombotic therapy was also associated with a higher risk of major bleeding (SHR 1.43, 95% CI 1.05 - 1.94) and gastrointestinal bleeding (SHR 2.17, 95% CI 1.42 - 3.33) than DOAC monotherapy. CONCLUSION: In patients with concomitant LEAD and AF who underwent peripheral revascularisation, DOAC monotherapy was associated with a lower risk of MALEs and bleeding events than dual antithrombotic therapy.

Asunto(s)

Fibrilación Atrial , Hemorragia , Extremidad Inferior , Enfermedad Arterial Periférica , Inhibidores de Agregación Plaquetaria , Puntaje de Propensión , Humanos , Masculino , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/cirugía , Femenino , Estudios Retrospectivos , Anciano , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/tratamiento farmacológico , Enfermedad Arterial Periférica/diagnóstico , Extremidad Inferior/irrigación sanguínea , Persona de Mediana Edad , Hemorragia/inducido químicamente , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Medición de Riesgo , Resultado del Tratamiento , Taiwán/epidemiología , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/uso terapéutico , Anciano de 80 o más Años , Terapia Antiplaquetaria Doble/efectos adversos , Factores de Riesgo , Fibrinolíticos/efectos adversos , Fibrinolíticos/uso terapéutico , Bases de Datos Factuales , Quimioterapia Combinada , Accidente Cerebrovascular Isquémico/prevención & control , Accidente Cerebrovascular Isquémico/etiología

RESUMEN

Background: Patients with symptomatic lower-extremity peripheral artery disease (LE-PAD) are prone to serious cardiovascular and limb events. Few studies have evaluated the effect of rivaroxaban-based dual antithrombotic therapy in high-risk patients with LE-PAD in Asian populations. Objectives: To investigate the efficacy and safety of rivaroxaban-based dual antithrombotic therapy in symptomatic patients with LE-PAD. Design: Retrospective cohort study. Methods: This study included patients with LE-PAD treated at the Nanjing Drum Tower Hospital from 1 January 2018 to 31 December 2021. These participants were divided into antiplatelet (APT) or antiplatelet therapy combined with rivaroxaban (RAPT) groups. The efficacy outcomes in this study were the occurrence of major adverse cardiovascular events (MACE), including myocardial infarction, ischemic stroke, or death from cardiovascular causes, and major adverse limb events (MALE), including urgent revascularization, acute limb ischemia, and major amputation. The safety outcomes included major and clinically relevant non-major (CRNM) bleeding. Patients were followed up until the time of death or the end of the study (31 March 2023). Results: We included 1144 patients with LE-PAD (APT: 502 patients; RAPT: 642 patients). The RAPT group had a lower risk of primary composite efficacy outcomes [hazard ratio (HR): 0.40] and a nonsignificant increase in major bleeding risk (HR: 2.33) than the APT group. The RATP group also had a significantly lower risk of secondary efficacy outcomes, including ischemic stroke (HR: 0.41), myocardial infarction (HR: 0.31), cardiovascular death (HR: 0.40), and MALE (HR: 0.65), than the APT group. The CRNM bleeding incidence varied between the two groups (HR: 3.96). Moreover, no significant interactions were observed between the subgroups and treatment groups in the composite efficacy analysis. Conclusion: Rivaroxaban-based dual antithrombotic therapy significantly reduced the occurrence of MACE in patients with LE-PAD without increasing major bleeding events. High-risk patients benefited from the dual antithrombotic therapy.

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Background: Serious cardiovascular and limb events are common adverse effects in patients with symptomatic lower-extremity peripheral artery disease (LE-PAD).Few studies have reported the benefits of dual antithrombotic therapy with rivaroxaban in patients with high risk of LE-PAD in Asian populations. Methods: We collected data from in-patients with LE-PAD from January 1, 2018 to December 31, 2021.Depending on the antithrombotic medication administered, we classified the patients into antiplatelet therapy (e.g., aspirin and clopidogrel; APT group) and antiplatelet therapy combined with rivaroxaban (RAPT group) groups.The primary efficacy outcome was major adverse cardiovascular events (MACE), which was a composite of myocardial infarction, ischemic stroke or death from cardiovascular causes. The primary safety outcome was major bleeding.Secondary clinical outcomes included myocardial infarction, ischemic stroke, death from cardiovascular causes, clinically relevant non-major (CRNM) bleeding, and major adverse limb events (MALE), including urgent revascularization, acute limb ischemia, and major amputation.Follow-up continued until death or the end of the study (March 31, 2023). Results: The RAPT group had a lower risk of primary composite efficacy outcome and a non-significant increase in the risk of major bleeding than the APT group.The risk of secondary efficacy was significantly lower in the RAPT group than in the APT groups. The incidence of CRNM bleeding varied between the two groups.The subgroups and treatment groups had no significant interactions with the risk of composite efficacy outcomes. Conclusions: Rivaroxaban-based dual antithrombotic therapy has a clear therapeutic advantage over single antiplatelet therapy in Asian populations and does not increase the risk of major bleeding.Rivaroxaban-based combination therapy reduces the risk of serious adverse cardiovascular and limb events with an acceptable safety profile.

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Comparison of rivaroxaban-based dual antithrombotic and antiplatelet therapies for symptomatic patients with lower-extremity peripheral artery disease post-revascularization: a retrospective cohort study.

RESUMEN

BACKGROUND: The 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. METHODS: This 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. RESULTS: The 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. CONCLUSIONS: In 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.

Asunto(s)

Fibrilación Atrial , Intervención Coronaria Percutánea , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Clorhidrato de Prasugrel , Clopidogrel/uso terapéutico , Fibrinolíticos/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Intervención Coronaria Percutánea/efectos adversos , Estudios Retrospectivos , Estudios Prospectivos , Anticoagulantes/uso terapéutico , Hemorragia/inducido químicamente , Hemorragia/epidemiología

RESUMEN

BACKGROUND: Triple antithrombotic therapy (TAT), a combination of an oral anticoagulant and dual antiplatelet therapy (DAPT), is a key treatment for prevention of ischemic events in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, TAT is not extensively used because of the risk of bleeding. This study aimed to determine the utilization and influencing factors of TAT using real-world data in the non-vitamin K antagonist oral anticoagulants (NOACs) era. METHODS: We analyzed National Inpatient Sample data compiled by the Health Insurance Review & Assessment Service (HIRA-NIS) from 2011 to 2020. Patients with AF who underwent PCI with stent implantation and with an increased stroke risk were selected as candidates for TAT therapy. Demographic and clinical factors associated with TAT use were investigated using the chi-squared test and the Student t-test, and influencing factors were identified using multiple logistic regression. RESULTS: The TAT utilization rate steadily increased from 30.3% in 2011 to 65.4% in 2020 (Cochran-Armitage trend test: p < 0.001) with an average of 45.9%. Positive influencing factors for TAT use were identified as congestive heart failure, history of previous stroke/transient ischemic attack/thromboembolism, valvular heart disease, and year. Negative influencing factors included insurance type (medical aid or Patriots & Veterans Insurance), type of medical institution (general hospitals or primary medical institutions), and comorbidities such as renal disease, liver disease, and history of the previous hemorrhage. CONCLUSIONS: The utilization of TAT following PCI among high-stroke risk AF patients steadily increased from 2011 to 2020, reaching 65.4% by the end of the study period. However, in 2020, a significant proportion of 29.4% of patients still received DAPT, indicating that many AF patients undergoing PCI did not receive adequate antithrombotic therapy.

Asunto(s)

Fibrilación Atrial , Intervención Coronaria Percutánea , Accidente Cerebrovascular , Humanos , Anticoagulantes , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria , Fibrinolíticos , Intervención Coronaria Percutánea/efectos adversos , Administración Oral , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Accidente Cerebrovascular/tratamiento farmacológico , Quimioterapia Combinada

RESUMEN

Antithrombotic therapy is the cornerstone of secondary cardiovascular prevention after percutaneous coronary intervention (PCI). Improvements in drug-eluting stent (DES) design and materials over the last 2 decades have prompted the development of new antithrombotic strategies. Current guidelines recommend to tailor dual antiplatelet therapy (DAPT) according to clinical presentation and individual ischemic and bleeding risk. Given the growing number of complex PCI procedures performed nowadays, it is a priority to define the optimal antithrombotic treatment in this challenging patient subset. In this review article, we sought to summarize and discuss the current evidence on antiplatelet therapy in patients undergoing complex PCI.

Asunto(s)

Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Terapia Antiplaquetaria Doble , Fibrinolíticos/uso terapéutico , Humanos , Intervención Coronaria Percutánea/métodos , Inhibidores de Agregación Plaquetaria/uso terapéutico

RESUMEN

PURPOSE: Outcomes from randomized controlled trials (RCTs) inform the latest recommendations on percutaneous coronary intervention (PCI) management of a short period of oral anticoagulation (OAC), a P2Y12 receptor inhibitor, and aspirin for 1 week or until hospital discharge in patients with atrial fibrillation (AF) undergoing PCI, and up to 4 weeks in individuals considered to be at high-risk for ischemic events, followed by discontinuation of aspirin and continuation of OAC and a P2Y12 inhibitor for up to 12 months. METHODS: We examined and summarized the outcomes of bleeding and major adverse cardiac events (MACEs) from RCTs and meta-analyses, published between 2013 and 2022, comparing therapy with OAC and a P2Y12 inhibitor with and without aspirin in AF patients undergoing PCI with stenting. RESULTS: Data comparing dual therapy with OAC and a P2Y12 inhibitor alone to triple therapy with OAC, a P2Y12 inhibitor, and aspirin with respect to the risks of MACEs, including stent thrombosis within the first 30 days, are underpowered and inconclusive. The addition of aspirin does not appear to be associated with a decreased risk of ischemic events, even in patients with high-risk CHA2DS2-VASc scores, but does significantly increase bleeding hazards. The increased safety of newer generation drug-eluting stents may have further minimized any theoretical anti-ischemic benefits of aspirin. The possible attenuation of the pleiotropic effects of concomitant cardiovascular medications by aspirin may also have been a contributing factor. CONCLUSION: The addition of aspirin to OAC and a P2Y12 inhibitor is likely associated with a net clinical harm in patients with AF who undergo PCI with stenting, even within the first 1-4 weeks after PCI. Revisiting the guideline recommendations to administer aspirin in this timeframe may be warranted.

RESUMEN

Acute coronary syndrome (ACS) is one of the leading causes of death worldwide. Percutaneous coronary intervention (PCI) is the treatment of choice for ACS as this procedure reduces the morbidity and mortality rates of patients in clinical trials and daily practice. However, patients with a history of prior ACS who undergo PCI are still at high risk for recurrent major adverse cardiac events (MACE). Because the antithrombotic drugs reduce the rate of MACE and minimize stent-related complications such as target vessel failure or stent thrombosis, the utilization of these agents is the cornerstone treatment for secondary prevention of ACS patients after PCI. Unfortunately, using the antithrombotic agents may be associated with bleeding complications, including major or fatal bleeding. Therefore, premature discontinuation of antithrombotic regimens regarding the hemorrhagic events is sometimes inevitable and possibly leads to fatal complications such as stent thrombosis. To minimize the bleeding issues, shorten antithrombotic regimens have been proposed, which theoretically offers improved safety. Nevertheless, inappropriate withdrawal of antithrombotic drugs may increase the rate of ischemic events. On the other hand, an unnecessary prolonged antithrombotic regimen may cause avoidable bleeding. Balancing the risk of bleeding against the benefits of using antithrombotic drugs is therefore challenging especially for the patients who contain both bleeding and ischemic risks such as ACS patients who are concomitant using the anticoagulants. Currently, the treatment paradigms are shifting from the "one size fits all approach" toward the "tailored approach". This means that the antithrombotic regimens can be adjustable individually. As a result, various clinical risk scoring systems have been established to help physicians with their decision-making. However, besides the development of these dedicated scoring tools, clinical judgment for balancing the safety versus the efficacy before deciding on the antithrombotic plan is still imperative.

RESUMEN

Patients with atrial fibrillation (AF) are at increased risk for coronary artery disease (CAD). After percutaneous coronary intervention (PCI), the antithrombotic therapy consists of a combination of anticoagulant and antiplatelet agents to reduce the ischemic and thromboembolic risk, at the cost of increased bleeding events. In the past few years, several randomized clinical trials involving over 12,000 patients have been conducted to compare the safety of vitamin K antagonist (VKA) and direct-acting oral anticoagulants (DOACs) in association with a single- or double-antiplatelet agent, in the so-called dual- (DAT) or triple-antithrombotic therapy (TAT). These studies and several meta-analyses showed a consistent benefit for reducing bleeding events of DAT over TAT and of DOAC over VKA, without concerns about ischemic endpoints, except for a trend for increased stent thrombosis risk. The present paper examines current international guidelines' recommendations and reviews clinical trials, meta-analyses, and observational studies conducted on AF patients treated with DAT or TAT after PCI for acute coronary syndromes.

RESUMEN

AIM: To analyze the prevalence and clinical implications of the eligibility criteria for prolonged dual antithrombotic therapy with ticagrelor 60 mg twice daily and/or rivaroxaban 2.5 mg twice daily in a contemporary real-world ACS registry. METHODS: Patients from the START-ANTIPLATELET registry (NCT02219984) were stratified according to the eligibility criteria of the PEGASUS and COMPASS studies to investigate the proportion of patients eligible for prolonged dual antithrombotic therapy at discharge and after 1-year of DAPT. Net adverse clinical events (NACE), defined as all-cause death, myocardial infarction, stroke, and major bleeding, at 1 year were also evaluated and compared among groups. RESULTS: 1844 were considered for the analysis at baseline. Out of 849 event-free patients continually receiving dual antiplatelet therapy for at least 1 year, 577 (68%) and 583 (68.7%) met at least one eligibility criterion for ticagrelor and rivaroxaban, respectively. In the PEGASUS-like patients, age was the most common criterion (71% of cases). The presence ≥2 cardiovascular risk factors was the most common eligibility criterion in the COMPASS-like patients (80.8%). At 1-year follow-up, 211 (11.4%) and 119 (6.5%) patients experienced NACE and MACE, respectively. The incidence of NACEs was higher in the PEGASUS-only group (15.4% vs. 8.4%; p = 0.008) and numerically higher in the COMPASS-only group (10.9% vs. 8.4%; p = 0.299). CONCLUSIONS: In a contemporary real-world ACS cohort, approximately two-thirds of patients that complete 1-year DAPT met the eligibility criteria for ticagrelor 60 mg twice daily or rivaroxaban 2.5 mg twice daily, showing a higher risk of NACEs.

Asunto(s)

Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/tratamiento farmacológico , Síndrome Coronario Agudo/epidemiología , Aspirina , Fibrinolíticos , Humanos , Fenotipo , Inhibidores de Agregación Plaquetaria , Prevalencia , Sistema de Registros , Resultado del Tratamiento

RESUMEN

BACKGROUND: A regimen of dual (DAT) vs. triple (TAT) antithrombotic therapy reduces bleeding in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, recent evidence suggests that DAT may be associated with an increased ischemic risk. This raises the question whether DAT rather than TAT should be recommended to AF patients that undergo PCI for acute coronary syndrome (ACS), carrying a particularly high risk of both bleeding and ischemic events, studied only as subgroups of previous trials. METHODS AND DESIGN: The APPROACH-ACS-AF-(DZHK-7) trial is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE) trial which will include patients presenting with an ACS managed by PCI and requiring oral anticoagulation (OAC) due to AF. The trial will test, whether a DAT-regimen comprising clopidogrel plus the non-Vitamin-K-antagonist oral anticoagulant (NOAC) apixaban is superior to a TAT-regimen of vitamin-K-antagonist (VKA) plus dual anti-platelet therapy (APT) with respect to bleeding. A total of 400 patients will be randomized 1:1 to a control-arm with guideline-recommended TAT with VKA plus clopidogrel and acetylsalicylic-acid and a study arm receiving DAT comprising apixaban plus clopidogrel. Patients will be followed-up for 6 months. The primary endpoint of the study is the cumulative incidence of BARC type ≥2 bleeding, secondary endpoints include a composite clinical ischemic outcome and net clinical outcome. CONCLUSIONS: APPROACH-ACS-AF is the first trial dedicated to ACS patients, testing whether in terms of bleeding a DAT with NOAC is superior to a TAT regimen with VKA in high-risk ACS patients with AF.

RESUMEN

BACKGROUND: The RE-DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y12 inhibitor, either clopidogrel or ticagrelor, reduced the risk of bleeding without an increased risk of thromboembolic events as compared to triple therapy with warfarin in addition to a P2Y12 inhibitor and aspirin. What remains unclear is whether this effect is consistent between males and females undergoing PCI. HYPOTHESIS: The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y12 inhibitor in comparison to triple therapy with warfarin, a P2Y12 inhibitor and aspirin is consistent in females and males. METHODS: The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non-major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint. RESULTS: A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47-1.01, males: HR 0.46, 95% CI 0.37-0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48-1.16, males HR 0.71, 95% CI 0.56-0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively). CONCLUSIONS: Consistent with the overall study results, the risk of bleeding was lower with dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.

Asunto(s)

Fibrilación Atrial , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Anticoagulantes/efectos adversos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Dabigatrán/efectos adversos , Quimioterapia Combinada , Femenino , Fibrinolíticos/efectos adversos , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Warfarina/efectos adversos

Asunto(s)

Coagulación Sanguínea , Inhibidores de Agregación Plaquetaria , Anticoagulantes/efectos adversos , Humanos , Inhibidores de Agregación Plaquetaria/efectos adversos , Resultado del Tratamiento

RESUMEN

BACKGROUND: The optimal antithrombotic regimen in patients with a concomitant indication for oral anticoagulation (OAT) presenting with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI) remains unclear. OBJECTIVES: To perform a network meta-analysis of all randomized controlled trials (RCTs) evaluating different antithrombotic regimens among patients with ACS or undergoing PCI requiring OAT. METHODS: Network meta-analysis was performed in a frequentist framework. Antithrombotic regimens were categorized by OAC type (vitamin K antagonist-based [VKA]; non-VKA OAT [NOAC]) and antiplatelet agents (P2Y inhibitor only: dual therapy [DAT]; P2Y plus aspirin: triple therapy [TAT]). Safety outcomes were Thrombolysis in Myocardial Infarction (TIMI) major bleeding and intracranial hemorrhage (ICH). Efficacy outcomes were cardiovascular death, myocardial infarction, stroke and stent-thrombosis (ST). RESULTS: Five RCTs were included, encompassing 10,797 patients (atrial fibrillation 69-100%, ACS 28-62%, PCI 77-100%). Both VKA and NOAC-based DAT regimens reduced the occurrence of TIMI major bleeding compared to VKA TAT (VKA DAT: RR 0.62, 95% CI 0.39-0.98; NOAC DAT: RR 0.52, 95% CI 0.39-0.70). Nevertheless, only NOAC DAT significantly reduced the occurrence of ICH compared to VKA TAT (RR 0.33, 95% CI 0.17-0.64). Ischemic outcomes were similar among the four treatment regimens. However, numerical, potentially clinically important, higher ST occurrence was observed for NOAC DAT as compared to both VKA TAT (1.50, 95% confidence interval [CI] 0.96-2.33) and NOAC TAT (1.86, 95% CI 0.93-3.73). CONCLUSION: DAT regimens present the highest safety profile among antithrombotic strategies, with a NOAC-specific impact on ICH reduction. NOAC DAT might entail clinically important higher ST occurrence, warranting a case-by-case comprehensive evaluation that integrates patient- and procedure-related residual ischemic risk with the patient-specific bleeding risk.

Asunto(s)

Fibrilación Atrial , Intervención Coronaria Percutánea , Anticoagulantes/efectos adversos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Fibrinolíticos/efectos adversos , Humanos , Metaanálisis en Red , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Resultado del Tratamiento

Asunto(s)

Síndrome Coronario Agudo/diagnóstico , Humanos , Guías de Práctica Clínica como Asunto , Medición de Riesgo

Asunto(s)

Síndrome Coronario Agudo , Síndrome Coronario Agudo/tratamiento farmacológico , Anticoagulantes/uso terapéutico , Quimioterapia Combinada , Fibrinolíticos/uso terapéutico , Heparina/uso terapéutico , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria

Asunto(s)

Síndrome Coronario Agudo , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/terapia , Manejo de la Enfermedad , Humanos

RESUMEN

INTRODUCTION AND OBJECTIVES: Dual antiplatelet therapy (DAPT) is a mainstay for myocardial infarction (MI) therapy. However, in patients with myocardial infarction with non-obstructive coronary artery disease (MINOCA), clear recommendations are lacking in the literature. This study aims to identify the cases in which DAPT is currently prescribed at discharge for MINOCA. METHODS: The authors analyzed a cohort of patients from a multicenter national registry enrolling patients who suffered their first MI between 2010 and 2017, and underwent coronary angiography revealing absence of stenosis ≥50%. Individual antithrombotic therapy was identified. A logistic regression analysis was applied to search for predictors of DAPT. RESULTS: From a total of 16 237 patients analyzed, 709 (4.4%) were categorized as MINOCA. Mean age was 64±13 years, 46.3% (n=409) were females. 390 (55.0%) of MINOCA patients were discharged on DAPT. Males (OR 1.67, CI 95 [1.05-2.38], p=0.027), active smokers (OR=1.82, CI 95 [1.05-3.16], p=0.033), previous percutaneous intervention (OR 3.18, CI 95 [1.48-6.81], p=0.003), ST elevation MI (OR 2.70, CI 95 [1.59-4.76], p<0.001) and sinus rhythm at admission (OR=3.94, CI 95 [2.07-7.48], p<0.001) were independent predictors of DAPT use. CONCLUSION: In this nationwide registry, DAPT was prescribed at discharge in 55% of MINOCA patients. Beyond sinus rhythm, the variables presented as independent predictors for DAPT use identify subgroups of patients who are classified as more prone to thrombotic events. The issue of how to handle antithrombotic agents in MINOCA patients is a topic open for discussion.

Asunto(s)

Enfermedad de la Arteria Coronaria , Infarto del Miocardio , Anciano , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/efectos adversos , Sistema de Registros , Factores de Riesgo

RESUMEN

Patients with atrial fibrillation who undergo percutaneous coronary intervention with drug-eluting stent implantation often require oral anticoagulation (OAC) and antiplatelet therapies. Triple antithrombotic therapy (OAC, a P2Y12-receptor inhibitor, and aspirin) has been the default antithrombotic strategy. Evidence from randomized trials indicates, however, that a dual antithrombotic therapy strategy (OAC plus a P2Y12-receptor inhibitor) reduces bleeding risk without increasing the risk of ischemic events. This review provides an overview of advancements in this field as well as European and North American guidelines and consensus documents to inform clinical decision making around antithrombotic therapies for patients with atrial fibrillation who undergo percutaneous coronary intervention.

Asunto(s)

Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/terapia , Fibrinolíticos/uso terapéutico , Intervención Coronaria Percutánea , Administración Oral , Fibrilación Atrial/complicaciones , Clopidogrel/uso terapéutico , Enfermedad de la Arteria Coronaria/complicaciones , Quimioterapia Combinada , Fibrinolíticos/efectos adversos , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Guías de Práctica Clínica como Asunto , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico