Asunto(s)
Síndrome Coronario Agudo , Hemorragia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Intervención Coronaria Percutánea/efectos adversos , Síndrome Coronario Agudo/terapia , Hemorragia/inducido químicamente , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Terapia Antiplaquetaria Doble/efectos adversos , Terapia Antiplaquetaria Doble/métodos , Factores de Riesgo , Resultado del Tratamiento , Factores de TiempoRESUMEN
BACKGROUND: We conducted a post hoc analysis of the ATAMIS (Antiplatelet Therapy in Acute Mild to Moderate Ischemic Stroke) trial to investigate whether the priority of clopidogrel plus aspirin to aspirin alone was consistent between patients with and without stroke pathogenesis of large-artery atherosclerosis (LAA). METHODS AND RESULTS: Patients with stroke classification randomized to a clopidogrel-plus-aspirin group and aspirin-alone group in a modified intention-to-treat analysis set of ATAMIS were classified into LAA and non-LAA subtypes. The primary outcome was early neurologic deterioration at 7 days, defined as a >2-point increase in National Institutes of Health Stroke Scale score compared with baseline, and safety outcomes were bleeding events and intracranial hemorrhage. We compared treatment effects in each stroke subtype and investigated the interaction. Among 2910 patients, 225 were assigned into the LAA subtype (119 in the clopidogrel-plus-aspirin group and 106 in the aspirin-alone group) and 2685 into the non-LAA subtype (1380 in the clopidogrel-plus-aspirin group and 1305 in the aspirin-alone group). Median age was 66 years, and 35% were women. A lower proportion of early neurologic deterioration was found to be associated with dual antiplatelet therapy in the LAA subtype (adjusted risk difference, -10.4% [95% CI, -16.2% to -4.7%]; P=0.001) but not in the non-LAA subtype (adjusted risk difference, -1.4% [95% CI, -2.6% to 0.1%]; P=0.06). No significant interaction was found (P=0.11). CONCLUSIONS: Compared with the non-LAA subtype, patients with stroke of the LAA subtype may get more benefit from dual antiplatelet therapy with clopidogrel plus aspirin with respect to early neurologic deterioration at 7 days. REGISTRATION: URL: clinicaltrials.gov; UnIque identifier: NCT02869009.
Asunto(s)
Aspirina , Clopidogrel , Terapia Antiplaquetaria Doble , Accidente Cerebrovascular Isquémico , Inhibidores de Agregación Plaquetaria , Humanos , Femenino , Masculino , Anciano , Aspirina/administración & dosificación , Aspirina/uso terapéutico , Aspirina/efectos adversos , Clopidogrel/uso terapéutico , Clopidogrel/administración & dosificación , Clopidogrel/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Terapia Antiplaquetaria Doble/métodos , Terapia Antiplaquetaria Doble/efectos adversos , Persona de Mediana Edad , Resultado del Tratamiento , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/prevención & control , Accidente Cerebrovascular Isquémico/epidemiología , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/etiología , Aterosclerosis/tratamiento farmacológico , Aterosclerosis/diagnóstico , Aterosclerosis/complicaciones , Índice de Severidad de la Enfermedad , Quimioterapia CombinadaRESUMEN
BACKGROUND: Endovascular treatment (EVT) of tandem lesion (TL) in the anterior circulation acute ischemic stroke (IS) usually requires periprocedural antithrombotic treatment and early initiation of dual antiplatelet therapy (DAPT) after carotid stenting. However, it may contribute to an occurrence of symptomatic intracerebral hemorrhage (SICH) in some cases. We investigated factors influencing the SICH occurrence and assessed the possible predictors of SICH after EVT. METHODS: IS patients with TL in the anterior circulation treated with EVT were enrolled in the multicenter retrospective ASCENT study. A good three-month clinical outcome was scored as 0-2 points in modified Rankin Scale (mRS) and recanalization using the TICI scale. SICH was assessed using the SITS-MOST criteria. Logistic regression analysis was used for the assessment of possible predictors of SICH with adjustment for potential confounders. RESULTS: In total, 300 (68.7 % males, mean age 67.3 ± 10.2 years) patients with median of admission NIHSS 17 were analyzed. Recanalization (TICI 2b-3) was achieved in 290 (96.7 %) patients and 176 (58.7 %) had mRS 0-2. SICH occurred in 25 (8.3 %) patients. Patients with SICH did not differ from those without SICH in the rate of periprocedural antithrombotic treatment (64 vs. 57.5 %, p = 0.526) and in the rate of DAPT started within the first 12 h after EVT (20 vs. 42.2 %, p = 0.087). After adjustment, admission NIHSS and admission glycemia were found as the only predictors of SICH after EVT. CONCLUSION: Admission NIHSS and glycemia were found as the only predictors of SICH after EVT for TL. No associations between periprocedural antithrombotic treatment, early start of DAPT after EVT and SICH occurrence were found.
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Hemorragia Cerebral , Evaluación de la Discapacidad , Procedimientos Endovasculares , Fibrinolíticos , Accidente Cerebrovascular Isquémico , Inhibidores de Agregación Plaquetaria , Humanos , Masculino , Femenino , Anciano , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Estudios Retrospectivos , Hemorragia Cerebral/diagnóstico por imagen , Hemorragia Cerebral/etiología , Hemorragia Cerebral/terapia , Persona de Mediana Edad , Resultado del Tratamiento , Factores de Riesgo , Accidente Cerebrovascular Isquémico/etiología , Accidente Cerebrovascular Isquémico/terapia , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Factores de Tiempo , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Fibrinolíticos/administración & dosificación , Fibrinolíticos/efectos adversos , Medición de Riesgo , Stents , Anciano de 80 o más Años , Terapia Antiplaquetaria Doble/efectos adversos , JapónRESUMEN
BACKGROUND: Patients treated with left atrial appendage occlusion (LAAO) are at high bleeding risk. Intensive antithrombotic treatment is recommended after the procedure to prevent device-related thrombosis. OBJECTIVES: This study sought to evaluate the incidence, consequences, and predictors of early nonprocedural bleeding after LAAO. METHODS: This was a multicenter study including 1,649 patients undergoing LAAO in 9 centers. Early nonprocedural bleeding was defined as bleeding unrelated to the procedure occurring within 3 months after device implantation. The severity of bleeding was defined by the Valve Academic Research Consortium-2 classification. A sensitivity analysis was performed at 45 days. RESULTS: A total of 121 (7.3%) patients experienced early nonprocedural bleeding events, and 69 (57.0%) were classified as major bleeding (4.2% of patients). Independent predictors of early nonprocedural bleeding were dual antiplatelet therapy (DAPT) at discharge (adjusted HR [aHR]: 1.61; 95% CI: 1.12-2.33; P = 0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P < 0.001), and multiple locations of prior bleeding (aHR: 2.33; 95% CI: 1.34-4.05; P < 0.001). DAPT at discharge was predictive of both all and major nonprocedural bleeding at 3 months and 45 days. After a median follow-up of 2.3 years (Q1-Q3: 1.1-4.1 years), early nonprocedural bleeding was independently associated with an increased risk of all-cause death (aHR: 1.53; 95% CI: 1.15-2.06; P < 0.001). This heightened mortality risk was similar at 45 days. CONCLUSIONS: Early nonprocedural bleeding after LAAO occurred in â¼7% of patients within 3 months, with more than one-half being classified as major bleeding. Regardless of severity, early nonprocedural bleeding was associated with increased mortality. DAPT at discharge determined an increased risk of early nonprocedural bleeding after LAAO. These results emphasize the importance of bleeding risk for determining antithrombotic strategies after LAAO.
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Apéndice Atrial , Fibrilación Atrial , Cateterismo Cardíaco , Hemorragia , Inhibidores de Agregación Plaquetaria , Humanos , Apéndice Atrial/fisiopatología , Apéndice Atrial/diagnóstico por imagen , Masculino , Femenino , Anciano , Factores de Riesgo , Factores de Tiempo , Fibrilación Atrial/mortalidad , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/complicaciones , Resultado del Tratamiento , Medición de Riesgo , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Hemorragia/etiología , Incidencia , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Terapia Antiplaquetaria Doble/efectos adversos , Estados Unidos/epidemiología , Persona de Mediana Edad , Fibrinolíticos/efectos adversos , Fibrinolíticos/administración & dosificación , Estudios Retrospectivos , Europa (Continente) , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificaciónAsunto(s)
Síndrome Coronario Agudo , Aspirina , Terapia Antiplaquetaria Doble , Hemorragia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Stents , Ticagrelor , Humanos , Ticagrelor/uso terapéutico , Ticagrelor/efectos adversos , Síndrome Coronario Agudo/terapia , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/efectos adversos , Aspirina/uso terapéutico , Aspirina/efectos adversos , Aspirina/administración & dosificación , Hemorragia/inducido químicamente , Hemorragia/prevención & control , Terapia Antiplaquetaria Doble/métodos , Terapia Antiplaquetaria Doble/efectos adversos , Stents/efectos adversos , Resultado del Tratamiento , Quimioterapia Combinada , Factores de TiempoRESUMEN
OBJECTIVES: Minor stroke is defined by a score of 5 or less on the National Institutes of Health Stroke Scale (NIHSS). Prior trials have shown efficacy of short term dual antiplatelet therapy (DAPT) in secondary prevention of stroke among patients with transient ischemic attack (TIA) or minor ischemic stroke, but no randomized clinical trials have studied this benefit after intravenous thrombolysis (IVT). Our aim was to investigate the safety of DAPT within 90 days after IVT in patients with acute minor ischemic stroke. PATIENTS AND METHODS: We reviewed medical records of patients older than 18 years that received IVT between January 2015 and December 2022. Patients had a diagnosis of acute minor stroke or averted stroke (complete recovery and negative image on follow-up). Single or dual antiplatelet treatment was started 24 hours after thrombolysis according to the physician's judgment. Patients were divided in two groups: single and dual antiplatelet therapy. We assessed clinical outcome using the modified Rankin scale (mRS), symptomatic intracranial hemorrhage (SICH) and mortality at 90 days. RESULTS: Fifty-three patients met the inclusion criteria, 68% men aged 64±16,5 years. Seventy five percent had an ischemic stroke and 25% had an averted stroke. Median door-to-needle time was 50 minutes. Fifty one percent were in the single antiplatelet group and 49% in the dual antiplatelet therapy group. There were no differences in demographic and clinical characteristics between groups. The 90-day mRS did not show significant difference between groups. No patients had SICH nor died during follow-up. One patient in the single antiplatelet group had stroke recurrence. CONCLUSIONS: Dual antiplatelet therapy after IVT with rtPA for acute minor ischemic stroke appears not to increase the risk of bleeding and mortality compared to single antiplatelet therapy in the first three months after the event. This is the first study to assess this subject in a Latin American population.
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Terapia Antiplaquetaria Doble , Fibrinolíticos , Accidente Cerebrovascular Isquémico , Inhibidores de Agregación Plaquetaria , Terapia Trombolítica , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/mortalidad , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Factores de Tiempo , Terapia Antiplaquetaria Doble/efectos adversos , Resultado del Tratamiento , Estudios Retrospectivos , Terapia Trombolítica/efectos adversos , Fibrinolíticos/administración & dosificación , Fibrinolíticos/efectos adversos , Anciano de 80 o más Años , Factores de Riesgo , Esquema de Medicación , Evaluación de la Discapacidad , Hemorragias Intracraneales/inducido químicamente , Quimioterapia Combinada , Tiempo de Tratamiento , Administración IntravenosaRESUMEN
Dual antiplatelet therapy (DAPT) remains the gold standard in patients who underwent percutaneous coronary intervention (PCI). This meta-analysis aims to evaluate the clinical safety of 1-month DAPT followed by aspirin or a P2Y12 receptor inhibitor after PCI with drug-eluting stents (DES). We searched PubMed, MEDLINE, Embase, Scopus, Google Scholar, Cochrane Central Registry, and ClinicalTrials.gov databases and identified 5 randomized controlled trials with 29,831 patients who underwent PCI with DES and compared 1-month versus >1-month DAPT. The primary end point was major bleeding, and the co-primary end point was stent thrombosis. The secondary end point included all-cause mortality, cardiovascular death, myocardial infarction, stroke, and major adverse cardiovascular or cerebrovascular events. Compared with >1-month DAPT, the 1-month DAPT was associated with a lower rate of major bleeding (odds ratio [OR] 0.66, 95% confidence interval [CI] 0.45 to 0.97, p = 0.03, I2 = 71%), whereas stent thrombosis had a similar rate in both study groups (OR 1.08, 95% CI 0.81 to 1.44, p = 0.60, I2 = 0.0%). The study groups had similar risks for all-cause mortality (OR 0.89, 95% CI 0.77 to 1.04, p = 0.14, I2 = 0.0%), cardiovascular death (OR 0.84, 95% CI 0.59 to 1.19, p = 0.32, I2 = 0.0%), myocardial infarction (OR 1.04, 95% CI 0.89 to 1.21, p = 0.62, I2 = 0.0%), and stroke (OR 0.82, 95% CI 0.64 to 1.05, p = 0.11, I2 = 6%). The risk of major adverse cardiovascular or cerebrovascular events was lower (OR 0.86, 95% CI 0.76 to 0.97, p = 0.02, I2 = 25%) in the 1-month DAPT compared with >1-month DAPT. In conclusion, in patients who underwent PCI with DES, 1-month DAPT followed by aspirin or a P2Y12 receptor inhibitor reduced major bleeding with no risk of increased thrombotic risk compared with longer-term DAPT.
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Stents Liberadores de Fármacos , Terapia Antiplaquetaria Doble , Hemorragia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Aspirina/administración & dosificación , Aspirina/efectos adversos , Trombosis Coronaria/prevención & control , Trombosis Coronaria/epidemiología , Stents Liberadores de Fármacos/efectos adversos , Terapia Antiplaquetaria Doble/efectos adversos , Terapia Antiplaquetaria Doble/métodos , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de TiempoRESUMEN
BACKGROUND: Dual antiplatelet therapy (DAPT) reduces ischemic events but increases bleeding risk, especially in patients with high bleeding risk (HBR). This study aimed to compare outcomes of abbreviated versus standard DAPT strategies in patients with HBR with acute coronary syndrome undergoing percutaneous coronary intervention. METHODS AND RESULTS: Patients from the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-Based Bare in Heart Disease Evaluated According to Recommended Therapies) registry with at least 1 HBR criterion who underwent percutaneous coronary intervention for acute coronary syndrome were identified and included. Patients were divided into 2 groups based on their planned DAPT time at discharge: 12-month DAPT or an abbreviated DAPT strategy and matched according to their prescribed P2Y12 inhibitor at discharge. The primary outcome assessed was time to net adverse clinical events at 1 year, which encompassed cardiac death, myocardial infarction, ischemic stroke, or clinically significant bleeding. Time to major adverse cardiovascular events and the individual components of net adverse clinical events were considered secondary end points. A total of 4583 patients were included in each group. The most frequently met HBR criteria was age older than 75 years (65.6%) and Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy score ≥25 (44.6%) in the standard DAPT group and oral anticoagulant therapy (79.6%) and age 75 years and older (55.2%) in the abbreviated DAPT group. There was no statistically significant difference in net adverse clinical events (12.9% versus 13.1%; hazard ratio [HR], 0.99 [95% CI, 0.88-1.11], P=0.83), major adverse cardiovascular events (8.6% versus 7.9%; HR, 1.08 [95% CI, 0.94-1.25]), or their components between groups. The results were consistent among all of the investigated subgroups. CONCLUSIONS: In patients with HBR undergoing percutaneous coronary intervention due to acute coronary syndrome, abbreviated DAPT was associated with comparable rates of net adverse clinical events and major adverse cardiovascular events to a DAPT duration of 12 months.
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Síndrome Coronario Agudo , Terapia Antiplaquetaria Doble , Hemorragia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Sistema de Registros , Humanos , Síndrome Coronario Agudo/terapia , Síndrome Coronario Agudo/mortalidad , Síndrome Coronario Agudo/complicaciones , Intervención Coronaria Percutánea/efectos adversos , Masculino , Femenino , Anciano , Terapia Antiplaquetaria Doble/efectos adversos , Terapia Antiplaquetaria Doble/métodos , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Persona de Mediana Edad , Factores de Tiempo , Suecia/epidemiología , Factores de Riesgo , Medición de Riesgo , Resultado del Tratamiento , Esquema de Medicación , Anciano de 80 o más Años , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Antagonistas del Receptor Purinérgico P2Y/administración & dosificación , Antagonistas del Receptor Purinérgico P2Y/uso terapéuticoRESUMEN
AIMS: Screening logs have the potential to appraise the actual prevalence and distribution of predefined patient subsets, avoiding selection biases, which are inevitably and potentially present in randomised trials and real-world registries, respectively. We aimed to assess the prevalence of high bleeding risk (HBR) characteristics in the real world and the external validity of the MASTER DAPT trial. METHODS AND RESULTS: All consecutive patients who underwent percutaneous coronary intervention (PCI) for at least two consecutive weeks across 65 sites participating in the trial were entered into a screening log. Of 2,847 consecutive patients, 1,098 (38.6 %) were HBR and 109 (9.9 %) consented for trial participation. PRECISE-DAPT score ≥ 25 was the most frequent HBR feature, followed by advanced age, use of oral anticoagulation (OAC) and anaemia. Compared with consecutive HBR patients, consenting patients were older (≥ 75 years: 69 % versus 62 %, absolute standardized difference [SD] 0.16), more frequently male (78 % versus 71 %, absolute SD 0.18), had higher use of OAC (38 % versus 20 %, absolute SD 0.39), treatment with steroids or nonsteroidal anti-inflammatory drugs (10 % versus 5 %, SD 0.16), and prior cerebrovascular events (10 % versus 6 %, absolute SD 0.18) but lower PRECISE DAPT score ≥ 25 (54 % versus 66 %, absolute SD 0.24). CONCLUSIONS: The HBR criteria distribution differed between consecutive versus selectively included HBR patients, suggesting the existence of selection biases in the trial population.
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Hemorragia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Masculino , Anciano , Femenino , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Anciano de 80 o más Años , Factores de Riesgo , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Medición de Riesgo , Selección de Paciente , Terapia Antiplaquetaria Doble/efectos adversos , Terapia Antiplaquetaria Doble/métodosRESUMEN
BACKGROUND: Carriers of CYP2C19 loss-of-function alleles have increased adverse events after percutaneous coronary intervention, but limited data are available for older patients. We aimed to evaluate the prognostic impact of CYP2C19 genotypes on clinical outcomes in older patients after percutaneous coronary intervention. METHODS AND RESULTS: The study included 1201 older patients (aged ≥75 years) who underwent percutaneous coronary intervention and received clopidogrel-based dual antiplatelet therapy in South Korea. Patients were grouped on the basis of CYP2C19 genotypes. The primary outcome was 3-year major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, and stent thrombosis. Older patients were grouped into 3 groups: normal metabolizer (36.6%), intermediate metabolizer (48.1%), and poor metabolizer (15.2%). The occurrence of the primary outcome was significantly different among the groups (3.1, 7.0, and 6.2% in the normal metabolizer, intermediate metabolizer, and poor metabolizer groups, respectively; P=0.02). The incidence rate of all-cause death at 3 years was greater in the intermediate metabolizer and poor metabolizer groups (8.1% and 9.2%, respectively) compared with that in the normal metabolizer group (3.5%, P=0.03) without significant differences in major bleeding. In the multivariable analysis, the intermediate metabolizer and poor metabolizer groups were independent predictors of 3-year clinical outcomes. CONCLUSIONS: In older patients, the presence of any CYP2C19 loss-of-function allele was found to be predictive of a higher incidence of major adverse cardiac events within 3 years following percutaneous coronary intervention. This finding suggests a need for further investigation into an optimal antiplatelet strategy for older patients. REGISTRATION: URL: https://clinicaltrials.gov. Identifier: NCT04734028.
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Clopidogrel , Citocromo P-450 CYP2C19 , Genotipo , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Citocromo P-450 CYP2C19/genética , Citocromo P-450 CYP2C19/metabolismo , Intervención Coronaria Percutánea/efectos adversos , Masculino , Femenino , Anciano , Inhibidores de Agregación Plaquetaria/farmacocinética , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/efectos adversos , República de Corea/epidemiología , Clopidogrel/farmacocinética , Clopidogrel/uso terapéutico , Clopidogrel/efectos adversos , Anciano de 80 o más Años , Pronóstico , Resultado del Tratamiento , Factores de Tiempo , Enfermedad de la Arteria Coronaria/genética , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/terapia , Factores de Riesgo , Terapia Antiplaquetaria Doble/efectos adversos , Medición de Riesgo , Factores de Edad , Infarto del Miocardio/genética , Infarto del Miocardio/epidemiología , Variantes FarmacogenómicasRESUMEN
Importance: Intravenous alteplase (IV-tPA) can be administered to patients with acute ischemic stroke but is associated with symptomatic intracerebral hemorrhage (sICH). It is unclear if patients taking prestroke dual antiplatelet therapy (DAPT) are at higher risk of sICH. Objective: To determine the associated risk of sICH in patients taking prestroke dual antiplatelet therapy receiving alteplase for acute ischemic stroke using propensity score matching analysis. Design, Setting, and Participants: This cohort study used data from the American Heart Association and American Stroke Association Get With The Guidelines-Stroke (GWTG-Stroke) registry between 2013 and 2021. Data were obtained from hospitals in the GWTG-Stroke registry. This study included patients hospitalized with acute ischemic stroke and treated with IV-tPA. Data were analyzed from January 2013 to December 2021. Exposures: Prestroke DAPT before treatment with IV-tPA for acute ischemic stroke. Main Outcome Measures: sICH, In-hospital death, discharge modified Rankin scale score, and other life-threatening systemic hemorrhages. Results: Of 409â¯673 participants, 321â¯819 patients (mean [SD] age, 68.6 [15.1] years; 164â¯587 female [51.1%]) who were hospitalized with acute ischemic stroke and treated with IV-tPA were included in the analysis. The rate of sICH was 2.9% (5200 of 182â¯344), 3.8% (4457 of 117â¯670), and 4.1% (893 of 21â¯805) among patients treated with no antiplatelet therapy, single antiplatelet therapy (SAPT), and DAPT, respectively (P < .001). In adjusted analyses after propensity score subclassification, both SAPT (odds ratio [OR], 1.13; 95% CI, 1.07-1.19) and DAPT (OR, 1.28; 95% CI, 1.14-1.42) were associated with increased risks of sICH. Prestroke antiplatelet medications were associated with lower odds of discharge mRS score of 2 or less compared with no medication (SAPT OR, 0.92; 95% CI, 0.90-0.95; DAPT OR, 0.94; 95% CI, 0.88-0.98). Results of a subgroup analysis of patients taking DAPT exposed to aspirin-clopidogrel vs aspirin-ticagrelor combination therapy were not significant (OR, 1.35; 95% CI, 0.84-1.86). Conclusions and Relevance: Prestroke DAPT was associated with a significantly elevated risk of sICH among patients with ischemic stroke who were treated with thrombolysis; however, the absolute increase in risk was small. Patients exposed to antiplatelet medications did not have excess sICH compared with landmark trials, which demonstrated overall clinical benefit of thrombolysis therapy for acute ischemic stroke.
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Hemorragia Cerebral , Fibrinolíticos , Accidente Cerebrovascular Isquémico , Inhibidores de Agregación Plaquetaria , Terapia Trombolítica , Activador de Tejido Plasminógeno , Humanos , Femenino , Masculino , Anciano , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Hemorragia Cerebral/inducido químicamente , Hemorragia Cerebral/epidemiología , Persona de Mediana Edad , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Terapia Trombolítica/efectos adversos , Anciano de 80 o más Años , Fibrinolíticos/efectos adversos , Fibrinolíticos/administración & dosificación , Activador de Tejido Plasminógeno/efectos adversos , Activador de Tejido Plasminógeno/administración & dosificación , Sistema de Registros , Estudios de Cohortes , Terapia Antiplaquetaria Doble/efectos adversos , Aspirina/efectos adversos , Aspirina/administración & dosificaciónRESUMEN
BACKGROUND: Recent clinical trials established the benefit of dual antiplatelet therapy with aspirin and clopidogrel (DAPT-AC) in early-presenting patients with minor ischemic stroke. However, the impact of these trials over time on the use and outcomes of DAPT-AC among the patients with nonminor or late-presenting stroke who do not meet the eligibility criteria of these trials has not been delineated. METHODS AND RESULTS: In a multicenter stroke registry, this study examined yearly changes from April 2008 to August 2022 in DAPT-AC use for stroke patients ineligible for CHANCE/POINT (Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events/Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) clinical trials due to National Institutes of Health Stroke Scale >4 or late arrival beyond 24 hours of onset. A total of 32 118 patients (age, 68.1±13.1 years; male, 58.5%) with National Institutes of Health Stroke Scale of 4 (interquartile range, 1-7) were analyzed. In 2008, DAPT-AC was used in 33.0%, other antiplatelets in 62.7%, and no antiplatelet in 4.3%. The frequency of DAPT-AC was relatively unchanged through 2013, when the CHANCE trial was published, and then increased steadily, reaching 78% in 2022, while other antiplatelets decreased to 17.8% in 2022 (Ptrend<0.001). From 2011 to 2022, clinical outcomes nonsignificantly improved, with an average relative risk reduction of 2%/y for the composite of stroke, myocardial infarction, and all-cause mortality, both among patients treated with DAPT-AC and patients treated with other antiplatelets. CONCLUSIONS: Use of DAPT-AC in stroke patients with stroke ineligible for recent DAPT clinical trials increased markedly and steadily after CHANCE publication in 2013, reaching deployment in nearly 4 of every 5 patients by 2022. The secondary prevention in patients with ischemic stroke seems to be gradually improving, possibly due to the enhancement of risk factor control.
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Aspirina , Clopidogrel , Terapia Antiplaquetaria Doble , Accidente Cerebrovascular Isquémico , Inhibidores de Agregación Plaquetaria , Sistema de Registros , Humanos , Clopidogrel/uso terapéutico , Aspirina/uso terapéutico , Masculino , Anciano , Femenino , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/mortalidad , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/prevención & control , Terapia Antiplaquetaria Doble/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/efectos adversos , Persona de Mediana Edad , Resultado del Tratamiento , Anciano de 80 o más Años , Factores de Tiempo , Japón/epidemiología , Prevención Secundaria/métodos , Prevención Secundaria/tendencias , Quimioterapia Combinada , Factores de RiesgoRESUMEN
INTRODUCTION: Patients of acute coronary syndrome (ACS) at a high-bleeding risk (HBR) often require dual antiplatelet therapy (DAPT) to reduce the risk of recurrent cardiovascular events. Clopidogrel and ticagrelor are the most commonly used antiplatelet agents in DAPT regimens. However, the safety profiles of these drugs in ACS patients at HBR remain a subject of ongoing debate. AIM: To investigate any difference between the safety of clopidogrel and ticagrelor used as a part of DAPT regimen in ACS patients at HBR. METHODS: A systematic search on PubMed, Cochrane Library, and Google Scholar was conducted to identify experimental and observational studies published up to the knowledge cutoff date in September 2023. Studies comparing the safety of clopidogrel and ticagrelor in ACS patients at HBR were included for analysis. The primary outcomes assessed were major bleeding events, stroke, and myocardial infarction (MI), while secondary outcomes included all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE), and net adverse clinical and cerebral events (NACCE). RESULTS: We included a total of 8 observational studies in our meta-analysis. The pooled analysis revealed a statistically significant increase in the risk of MI (pooled RR = 1.43; 95% CI 1.12-1.83; P = 0.005) in the patients using clopidogrel. There were no statistically significant differences in major bleeding events (pooled RR = 0.94; 95% CI 0.82-1.09; P = 0.44), stroke (pooled RR = 1.36; 95% CI 0.86-2.14; P = 0.18), all-cause mortality (pooled RR = 1.17; 95% CI 0.97-1.41; P = 0.10), MACCE (pooled RR = 1.07; 95% CI 0.76-1.50; P = 0.69) and NACCE (pooled RR = 0.95; 95% CI 0.66-1.37; P = 0.78) between the two groups. Subgroup analyses based on region were performed. CONCLUSION: Both drugs are generally safe for treating ACS patients with HBR at baseline, although a higher risk of MI was observed with the use of clopidogrel. Nevertheless, drug choice should factor in regional variations, patient-specific characteristics, cost, accessibility, and potential drug interactions.
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Síndrome Coronario Agudo , Clopidogrel , Terapia Antiplaquetaria Doble , Hemorragia , Inhibidores de Agregación Plaquetaria , Ticagrelor , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Síndrome Coronario Agudo/mortalidad , Clopidogrel/efectos adversos , Clopidogrel/uso terapéutico , Clopidogrel/administración & dosificación , Terapia Antiplaquetaria Doble/efectos adversos , Hemorragia/inducido químicamente , Estudios Observacionales como Asunto , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/uso terapéutico , Medición de Riesgo , Factores de Riesgo , Ticagrelor/efectos adversos , Ticagrelor/uso terapéutico , Ticagrelor/administración & dosificación , Resultado del TratamientoRESUMEN
BACKGROUND: This work evaluated the effects of proton pump inhibitors (PPIs) on cardiovascular events (CVEs) and inflammatory factors in patients with upper gastrointestinal bleeding (UGIB) undergoing dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. Clinical data from these patients were analysis, intending to provide relevant theoretical evidence for clinical practice. MATERIALS AND METHODS: Data of 166 patients who underwent percutaneous coronary intervention and developed UGIB while on DAPT at The First People' Hospital of Linping District from April 2021 to April 2023 were retrospectively analyzed. The patients were rolled into two groups: those who received PPI treatment and those who did not, namely, PPI and non-PPI group, respectively. Furthermore, occurrence of CVEs and the levels of inflammatory factors of patients in all groups were statistically analyzed. RESULTS: In patients with UGIB, melena is a common presentation. The incidence of CVE in the PPI group showed no statistically significant difference compared to the control group, and there was no significant variance observed in the distribution of CVE incidence among different PPIs. However, levels of C-reactive protein (CRP) and tumor necrosis factor-alpha (TNF-α) were significantly lower in the PPI group compared to the non-PPI group (P < 0.05). CONCLUSION: Melena was the most frequent clinical manifestation in UGIB patients. The use of PPIs did not increase the risk of CVEs, and different PPI drugs did not affect the occurrence of CVEs. Furthermore, PPIs lowered CRP and TNF-α levels in serum of these patients.
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Enfermedades Cardiovasculares , Hemorragia Gastrointestinal , Inhibidores de Agregación Plaquetaria , Inhibidores de la Bomba de Protones , Humanos , Inhibidores de la Bomba de Protones/efectos adversos , Inhibidores de la Bomba de Protones/administración & dosificación , Masculino , Femenino , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios Retrospectivos , Hemorragia Gastrointestinal/inducido químicamente , Anciano , Persona de Mediana Edad , Terapia Antiplaquetaria Doble/métodos , Terapia Antiplaquetaria Doble/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Proteína C-Reactiva/metabolismo , Inflamación/tratamiento farmacológico , Factor de Necrosis Tumoral alfa/metabolismoRESUMEN
Coronary artery disease in older patients is more frequently diffuse and complex, and is often treated by percutaneous coronary intervention on top of medical therapy. There are currently no specific recommendations for antiplatelet therapy in patients aged≥75 years. Aspirin remains pivotal, and is still indicated as a long-term treatment after percutaneous coronary intervention. In addition, a P2Y12 inhibitor is administered for 6-12 months according to clinical presentation. Age is a minor bleeding risk factor, but because older patients often have several co-morbidities, they are considered as having a high bleeding risk according to different scoring systems. This increased bleeding risk has resulted in different therapeutic strategies for antithrombotic treatment after percutaneous coronary intervention; these include short dual antiplatelet therapy, a switch from potent to less potent antiplatelet therapy or single antiplatelet therapy with a P2Y12 inhibitor instead of aspirin, among others. A patient-centred approach, taking into account health status, functional ability, frailty, cognitive skills, bleeding and ischaemic risks and patient preference, is essential when caring for older adults with coronary artery disease. The present review focuses on the knowledge base, specificities of antiplatelet therapies, a balance between haemorrhagic and ischaemic risk, strategies for antiplatelet therapy and directions for future investigation pertaining to coronary artery disease in older patients.
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Enfermedad de la Arteria Coronaria , Hemorragia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Hemorragia/inducido químicamente , Anciano , Factores de Riesgo , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Factores de Edad , Medición de Riesgo , Anciano de 80 o más Años , Masculino , Toma de Decisiones Clínicas , Femenino , Terapia Antiplaquetaria Doble/efectos adversosRESUMEN
OBJECTIVES: To compare the safety and efficacy of Dual Antiplatelet Therapy (DAPT) and Intravenous (IV) Tissue Plasminogen Activator (t-PA) in minor Acute Ischemic Stroke (AIS). MATERIALS AND METHODS: Following Cochrane and PRISMA guidelines, we analyzed observational studies and clinical trials comparing DAPT and IV t-PA in patients with minor AIS. Databases included PubMed, Scopus, and Web of Science. Data extraction included study characteristics, patient demographics, and analyzed outcomes. RevMan 5.3 and OpenMetaAnalyst 2021 were used to analyze the data and assess heterogeneity, respectively. The risk of bias was determined using RoB 2.0 and the Newcastle-Ottawa scale. RESULTS: This meta-analysis included five studies with 3,978 DAPT-treated patients and 2,224 IV t-PA-treated patients. We found no significant differences in achieving modified Rankin scale (mRS) scores of 0-1 (OR 1.11, 95 % CI: 0.79, 1.55, p = 0.56) and 0-2 (OR 0.90, 95 % CI: 0.61, 1.31, p = 0.57), as well as combined mRS scores (OR 1.05, 95 % CI: 0.82, 1.34, p = 0.72). Similarly, there were no significant disparities between the two treatment groups in NIHSS score change from baseline (MD 0.32, 95 % CI: -0.35, 0.98, p = 0.35) and in mortality rates (OR 0.87, 95 % CI: 0.26, 2.93, p = 0.83). Notably, in comparison to the IV t-PA group, the DAPT group exhibited a significantly lower incidence of bleeding (OR 0.31, 95 % CI: 0.14, 0.69, p = 0.004) and symptomatic intracranial hemorrhage (sICH) (OR 0.10, 95 % CI: 0.04, 0.26, p < 0.00001). CONCLUSIONS: Our meta-analysis found no significant differences in efficacy between DAPT and IV t-PA. However, DAPT demonstrated a significantly lower risk of sICH and bleeding compared with IV t-PA.
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Terapia Antiplaquetaria Doble , Fibrinolíticos , Accidente Cerebrovascular Isquémico , Inhibidores de Agregación Plaquetaria , Terapia Trombolítica , Activador de Tejido Plasminógeno , Humanos , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/mortalidad , Activador de Tejido Plasminógeno/efectos adversos , Activador de Tejido Plasminógeno/administración & dosificación , Fibrinolíticos/efectos adversos , Fibrinolíticos/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Resultado del Tratamiento , Terapia Antiplaquetaria Doble/efectos adversos , Terapia Trombolítica/efectos adversos , Terapia Trombolítica/mortalidad , Factores de Riesgo , Masculino , Femenino , Anciano , Persona de Mediana Edad , Medición de Riesgo , Evaluación de la Discapacidad , Administración Intravenosa , Recuperación de la Función , Estudios Observacionales como Asunto , Anciano de 80 o más AñosRESUMEN
INTRODUCTION: Cerebral microbleeds (CMBs) on brain magnetic resonance imaging (MRI) are predictive of intracerebral hemorrhage (ICH). However, the risk of ICH in patients with CMBs who undergo percutaneous coronary intervention (PCI) while receiving dual antiplatelet therapy (DAPT) is unclear. MATERIALS AND METHODS: We conducted a study on 329 consecutive patients with coronary artery disease who underwent PCI and were evaluated using a 3T MRI scanner. Based on T2*-weighted imaging, patients were classified into three groups: no CMBs, < 5 CMBs, or ≥ 5 CMBs. We determined the occurrence of ICH during follow-up. RESULTS: At least 1 CMB was found in 109 (33%) patients. The mean number of CMBs per patient was 2.9 ± 3.6. Among the 109 patients with CMBs, 16 (15%) had ≥ 5 CMBs. Coronary stent implantation was performed in 321 patients (98%). DAPT was prescribed for 325 patients (99%). During a mean follow-up period of 2.3 years (interquartile range, 1.9-2.5 years), ICH occurred in one patient (1.1%) with four CMBs. There were no significant differences in the incidence of ICH (0% vs. 1.1% vs. 0%; p = 0.28). However, the rate of DAPT at 6 months of follow-up was significantly lower in patients with ≥ 5 CMBs than in patients with no CMBs or < 5 CMBs (89% vs. 91% vs. 66%, p = 0.026). Furthermore, there were no significant differences in systemic blood pressure during follow-up (123 ± 16 vs. 125 ± 16 vs. 118 ± 11 mmHg; p = 0.40). CONCLUSION: Although a substantial number of patients who underwent PCI had cerebral microbleeds, at approximately two years of follow-up, intracerebral hemorrhage was very rare in our study population.
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Hemorragia Cerebral , Enfermedad de la Arteria Coronaria , Terapia Antiplaquetaria Doble , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Intervención Coronaria Percutánea/efectos adversos , Masculino , Femenino , Anciano , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Hemorragia Cerebral/inducido químicamente , Hemorragia Cerebral/diagnóstico , Hemorragia Cerebral/etiología , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/uso terapéutico , Terapia Antiplaquetaria Doble/efectos adversos , Terapia Antiplaquetaria Doble/métodos , Persona de Mediana Edad , Estudios Retrospectivos , Incidencia , Factores de Riesgo , Resultado del Tratamiento , Imagen por Resonancia Magnética , Factores de Tiempo , Estudios de Seguimiento , Japón/epidemiologíaRESUMEN
BACKGROUND: Among patients treated with a novel oral anticoagulant (NOAC) undergoing percutaneous coronary intervention (PCI), combination therapy with clopidogrel (ie, known as dual antithrombotic therapy [DAT]) is the treatment of choice. However, there are concerns for individuals with impaired response to clopidogrel. OBJECTIVES: The authors sought to assess the pharmacodynamic (PD) effects of clopidogrel vs low-dose ticagrelor in patients with impaired clopidogrel response assessed by the ABCD-GENE score. METHODS: This was a prospective, randomized PD study of NOAC-treated patients undergoing PCI. Patients with an ABCD-GENE score ≥10 (n = 39), defined as having impaired clopidogrel response, were randomized to low-dose ticagrelor (n = 20; 60 mg twice a day) or clopidogrel (n = 19; 75 mg once a day). Patients with an ABCD-GENE score <10 (n = 42) were treated with clopidogrel (75 mg once a day; control cohort). PD assessments at baseline and 30 days post-randomization (trough and peak) were performed to assess P2Y12 signaling (VerifyNow P2Y12 reaction units [PRU], light transmittance aggregometry, and vasodilator-stimulated phosphoprotein); makers of thrombosis not specific to P2Y12 signaling were also assessed. The primary endpoint was PRU (trough levels) at 30 days. RESULTS: At 30 days, PRU levels were reduced with ticagrelor-based DAT compared with clopidogrel-based DAT at trough (23.0 [Q1-Q3: 3.0-46.0] vs 154.5 [Q1-Q3: 77.5-183.0]; P < 0.001) and peak (6.0 [Q1-Q3: 4.0-14.0] vs 129.0 [Q1-Q3: 66.0-171.0]; P < 0.001). Trough PRU levels in the control arm (104.0 [Q1-Q3: 35.0-167.0]) were higher than ticagrelor-based DAT (P = 0.005) and numerically lower than clopidogrel-based DAT (P = 0.234). Results were consistent by light transmittance aggregometry and vasodilator-stimulated phosphoprotein. Markers measuring other pathways leading to thrombus formation were largely unaffected. CONCLUSIONS: In NOAC-treated patients undergoing PCI with an ABCD-GENE score ≥10, ticagrelor-based DAT using a 60-mg, twice-a-day regimen reduced platelet P2Y12 reactivity compared with clopidogrel-based DAT. (Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI [SWAP-AC-2]; NCT04483583).
Asunto(s)
Anticoagulantes , Clopidogrel , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Antagonistas del Receptor Purinérgico P2Y , Receptores Purinérgicos P2Y12 , Ticagrelor , Humanos , Intervención Coronaria Percutánea/efectos adversos , Ticagrelor/efectos adversos , Ticagrelor/administración & dosificación , Masculino , Estudios Prospectivos , Femenino , Anciano , Persona de Mediana Edad , Clopidogrel/administración & dosificación , Clopidogrel/efectos adversos , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Antagonistas del Receptor Purinérgico P2Y/administración & dosificación , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Administración Oral , Resultado del Tratamiento , Factores de Tiempo , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Receptores Purinérgicos P2Y12/efectos de los fármacos , Receptores Purinérgicos P2Y12/sangre , Pruebas de Función Plaquetaria , Agregación Plaquetaria/efectos de los fármacos , Fosfoproteínas/sangre , Plaquetas/efectos de los fármacos , Plaquetas/metabolismo , Proteínas de Microfilamentos/sangre , Proteínas de Microfilamentos/genética , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Moléculas de Adhesión Celular/sangre , Resistencia a Medicamentos , Terapia Antiplaquetaria Doble/efectos adversosAsunto(s)
Terapia Antiplaquetaria Doble , Inhibidores de Agregación Plaquetaria , Humanos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Terapia Antiplaquetaria Doble/efectos adversos , Resultado del Tratamiento , Esquema de Medicación , Factores de Tiempo , Factores de Riesgo , Hemorragia/inducido químicamente , Intervención Coronaria Percutánea/efectos adversos , Medición de RiesgoRESUMEN
AIMS: Guidelines recommend extended dual pathway inhibition (DPI) with aspirin and rivaroxaban in patients with chronic coronary syndrome (CCS) at high ischaemic risk. The CHADS-P2A2RC score improves risk prediction and enables antithrombotic treatment allocation in these patients. This study evaluated the net clinical benefit of DPI treatment according to baseline risk as classified by the CHADS-P2A2RC score in patients with CCS included in the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial. METHODS AND RESULTS: COMPASS patients with CCS (n = 14 670), randomized to aspirin alone or DPI, were stratified according to cardiovascular risk using the CHADS-P2A2RC score. Endpoints were major adverse cardiovascular events (MACE), all-cause death, fatal/critical organ bleeding, and composite adverse events (MACE and bleeding). Net clinical benefit was the 30-month risk difference of MACE and bleeding. Thirty-month incidences of MACE [7.9% vs. 3.9%, hazard ratio (HR) 2.01, 95% confidence interval (CI) 1.83-2.18] and fatal/critical organ bleeding (1.2% vs. 0.8%, HR 1.49, 95% CI 1.06-1.92) were higher in high-risk (CHADS-P2A2RC ≥ 4) than in low/moderate-risk (CHADS-P2A2RC < 4) patients. DPI reduced MACE (low/moderate risk: HR 0.62, 95% CI 0.47-0.82; high risk: HR 0.82, 95% CI 0.68-0.99, P for interaction 0.09) and all-cause death (low/moderate risk: HR 0.65, 95% CI 0.46-0.91; high risk: HR 0.81, 95% CI 0.65-1.00, P for interaction 0.29), without substantially increasing fatal/critical organ bleeding (low/moderate risk: HR 1.35, 95% CI 0.72-2.53; high risk: HR 1.18, 95% CI 0.73-1.90, P for interaction 0.73). DPI provided net clinical benefit of similar magnitude in low/moderate-risk (-1.81%, 95% CI -3.00 to -0.62) and high-risk (-1.96%, 95% CI -3.60 to -0.33) CCS patients. CONCLUSION: As classified by the CHADS-P2A2RC score, low/moderate- and high-risk patients with CCS derived similar net clinical benefit and reduction in all-cause death from DPI treatment.