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1.
J Am Heart Assoc ; 10(22): e021418, 2021 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-34779234

RESUMO

BACKGROUND Whether there are differences in the risk profile and treatment effect in patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC) in a randomized multicenter trial remains unknown. METHODS AND RESULTS This study included 4018 patients with acute coronary syndrome recruited in the ISAR-REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) trial. The primary end point was a composite of all-cause death, myocardial infarction, or stroke. Overall, 3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258 to 628 patients; median, 413 patients) and 1007 patients (25%) were recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52 patients). Patients recruited in the LRCs had more favorable cardiovascular risk profiles than patients recruited in the HRCs. The primary end point occurred in 72 patients in the LRCs and 249 patients in the HRCs (cumulative incidence, 7.3% and 8.4%; P=0.267). All-cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%; P=0.031). There was no significant interaction between the treatment effect of ticagrelor versus prasugrel and patient recruitment category (LRC versus HRC) regarding the primary efficacy end point (LRC: hazard ratio [HR], 1.42 [95% CI, 0.89-2.28]; HRC: HR, 1.33 [95% CI, 1.04-1.72]; P for interaction=0.800). CONCLUSIONS Patients with acute coronary syndrome recruited in a LRC appear to have more favorable cardiovascular risk profiles and lower 1-year mortality rates compared with patients recruited in a HRC. The recruitment volume did not interact with the treatment effect of ticagrelor versus prasugrel. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.


Assuntos
Síndrome Coronariana Aguda , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/tratamento farmacológico , Humanos , Seleção de Pacientes , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Ticagrelor/efeitos adversos , Resultado do Tratamento
2.
Thromb Haemost ; 121(10): 1376-1386, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33401330

RESUMO

Compared with Caucasian patients, East Asian patients have the unique risk-benefit trade-off and different responsiveness to antithrombotic regimens. The aim of this study was to compare pharmacodynamic profile in East Asian patients with acute coronary syndromes (ACSs) treated with prasugrel standard-dose versus a de-escalation strategy. Before discharge, ACS patients with age <75 years or weight ≥60 kg (n = 255) were randomly assigned to the standard-dose (10-mg group) or de-escalation strategy (5-mg group or platelet function test [PFT]-guided group). After 1 month, VerifyNow P2Y12 assay-based platelet reactivity (P2Y12 reaction unit [PRU]) and bleeding episodes were evaluated. Primary endpoint was the percentage of patients with the therapeutic window (85 ≤ PRU ≤ 208). The 250 patients completed 1-month treatment. The percentage of patients within the therapeutic window was significantly lower in the 10-mg group (n = 85) compared with the 5-mg (n = 83) and PFT-guided groups (n = 82) (35.3 vs. 67.5 vs. 65.9%) (odds ratio [OR]: 3.80 and 3.54; 95% confidence interval [CI]: 2.01-7.21 and 1.87-6.69, respectively). Compared with the 10-mg group, the bleeding rate was tended to be lower with de-escalation strategies (35.3 vs. 24.1% vs. 23.2%) (hazard ratio [HR]: 0.58 and 0.55; 95% CI: 0.30-1.14 and 0.28-1.09, respectively). "PRU < 127" was the optimal cut-off for predicting 1-month bleeding events (area under the curve: 0.616; 95% CI: 0.543-0.689; p = 0.005), which criteria was significantly associated with early discontinuation of prasugrel treatment (HR: 2.00; 95% CI: 1.28-3.03; p = 0.001). In conclusion, compared with the standard-dose prasugrel, the prasugrel de-escalation strategy in East Asian patients presented with ACS showed a higher chance within the therapeutic window and a lower tendency toward bleeding episodes. REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier:NCT01951001.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Plaquetas/efeitos dos fármacos , Redução da Medicação , Hemorragia/prevenção & controle , Inibidores da Agregação Plaquetária/administração & dosagem , Cloridrato de Prasugrel/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/etnologia , Idoso , Povo Asiático , Plaquetas/metabolismo , Monitoramento de Medicamentos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/etnologia , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Testes de Função Plaquetária , Cloridrato de Prasugrel/efeitos adversos , Prevalência , Estudos Prospectivos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , República da Coreia/epidemiologia , Fatores de Tempo , Resultado do Tratamento
3.
Am J Cardiovasc Drugs ; 20(3): 259-269, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31586336

RESUMO

INTRODUCTION: Real-life data comparing clopidogrel, prasugrel, and ticagrelor for unselected patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) are lacking, as are data for the temporal distribution of ischemic and bleeding risks. METHODS: A total of 19,825 patients were enrolled from the RENAMI and BleeMACS registries. Both were multicenter, retrospective, observational registries including the data and outcomes of consecutive patients with ACS who underwent primary PCI and were discharged with dual antiplatelet therapy (DAPT). We evaluated the long-term outcome stratified by the different antiplatelet agents. RESULTS: A total of 14,105 patients (71.2%) were treated with clopidogrel, 2364 patients (11.9%) with prasugrel and 3356 patients (16.9%) with ticagrelor. After propensity score matching, at 1 year, prasugrel reduced the incidence of net adverse clinical events (NACE; a composite endpoint of all-cause death, myocardial infarction [MI] and Bleeding Academic Research Consortium [BARC] 3-5 bleeding) (4.2% vs.7.6%, p = 0.002) and of major adverse cardiovascular events (MACE; a composite endpoint of death and MI) compared with clopidogrel (2.6% vs. 5.2%, p = 0.007). Ticagrelor decreased rates of MACE compared with clopidogrel (2.7% vs. 6.2%, p < 0.001), but not of NACE (6.6% vs. 8.7%, p = 0.07). Ticagrelor presented similar performance in terms of MACE compared with prasugrel (2.8% vs. 2.4%, p = 0.56), with a trend towards a reduction in MI (0.2% vs. 0.4%, p = 0.56), but with higher risk of BARC 3-5 bleedings (3.8% vs. 1.7%, p = 0.04). In the daily risk analysis, clopidogrel presented a binomial distribution with a peak of ischemic risk at 3 months, which decreased towards bleedings; prasugrel had a constant equivalence between opposite risks; and ticagrelor constantly reduced recurrent MIs despite higher risk of BARC 3-5 events. CONCLUSION: In real life, ticagrelor is more effective in reducing ischemic events during the first year after ACS, despite an increased risk of major bleedings, while prasugrel assures a better balance between ischemic and bleeding recurrent events.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Clopidogrel , Hemorragia , Infarto do Miocárdio , Intervenção Coronária Percutânea , Cloridrato de Prasugrel , Ticagrelor , Síndrome Coronariana Aguda/epidemiologia , Clopidogrel/administração & dosagem , Clopidogrel/efeitos adversos , Clopidogrel/farmacocinética , Europa (Continente)/epidemiologia , Feminino , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Masculino , Conduta do Tratamento Medicamentoso/estatística & dados numéricos , Pessoa de Meia-Idade , Mortalidade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/farmacocinética , Cloridrato de Prasugrel/administração & dosagem , Cloridrato de Prasugrel/efeitos adversos , Cloridrato de Prasugrel/farmacocinética , Sistema de Registros/estatística & dados numéricos , Risco Ajustado/métodos , Equivalência Terapêutica , Ticagrelor/administração & dosagem , Ticagrelor/efeitos adversos , Ticagrelor/farmacocinética
4.
Pharmacotherapy ; 39(9): 912-920, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31332815

RESUMO

STUDY OBJECTIVE: To compare the effectiveness and safety of ticagrelor versus prasugrel in preventing recurrent cardiovascular disease (CVD) and major bleeding events in patients with acute coronary syndrome (ACS). DESIGN: Retrospective cohort analysis. DATA SOURCE: Truven Commercial and Medicare Supplemental claims database (2011-2016). PATIENTS: Study consisted of adults with ACS who newly initiated ticagrelor or prasugrel within 7 days of their first ACS diagnosis and had no prior use for at least 12 months; after propensity score matching, 10,073 patients were in each group. METHODS: The primary study outcomes, first occurrence of a recurrent nonfatal CVD event (composite of myocardial infarction and stroke) and occurrence of a major bleeding event, were compared between the ticagrelor and prasugrel groups. Secondary outcomes included occurrence of minor bleeding events, defined based on the presence of bleeding events in outpatient claims. Cox proportional hazards models after propensity score matching were used to obtain the hazard ratio (HR) and 95% confidence interval (CI). In the Cox proportional hazards model, the use of ticagrelor was associated with a decreased risk of recurrent nonfatal CVD events (HR 0.80, 95% CI 0.70-0.92) and major bleeding events (HR 0.54, 95% CI 0.41-0.70) compared with prasugrel. Additionally, the use of ticagrelor was associated with a lower risk of minor bleeding events compared with prasugrel (HR 0.71, 95% CI 0.65-0.78). CONCLUSION: In this population-based cohort of incident ACS patients, ticagrelor was associated with a reduced rate of recurrent nonfatal CVD events, major and minor bleeding events compared with prasugrel.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Prevenção Secundária/métodos , Ticagrelor/uso terapêutico , Fatores Etários , Idoso , Comorbidade , Feminino , Hemorragia/induzido quimicamente , Humanos , Revisão da Utilização de Seguros , Masculino , Medicare , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/administração & dosagem , Cloridrato de Prasugrel/efeitos adversos , Pontuação de Propensão , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores Sexuais , Ticagrelor/administração & dosagem , Ticagrelor/efeitos adversos , Estados Unidos
5.
Circ Cardiovasc Qual Outcomes ; 12(1): e004945, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30606052

RESUMO

BACKGROUND: Balancing ischemic and bleeding risk is an evolving framework. METHODS AND RESULTS: Our objectives were to simulate changes in risks for adverse events and event-driven costs with use of ticagrelor or prasugrel versus clopidogrel according to varying levels of ischemic and bleeding risk. Using the validated PARIS risk functions, we estimated 1-year ischemic (myocardial infarction or stent thrombosis) and bleeding (Bleeding Academic Research Consortium types 3 or 5) event rates among PARIS study participants who underwent percutaneous coronary intervention with drug-eluting stent implantation for an acute coronary syndrome and were discharged with aspirin and clopidogrel (n=1497). Simulated changes in adverse events with ticagrelor or prasugrel were calculated by applying treatment effects from randomized trials for a 1-year time horizon. Event costs were estimated using National Inpatient Sample data. Net costs were calculated between antiplatelet therapy groups according to level of ischemic and bleeding risk. After weighting events for quality-of-life impact, we calculated event rates and costs for risk-tailored treatment versus clopidogrel under multiple drug pricing assumptions. One-year rates (per 1000 person-years) for ischemic events were 12.6, 24.1, and 66.1, respectively, among those at low (n=630), intermediate (n=536), and high (n=331) ischemic risk. Analogous bleeding rates were 11.0, 23.9, and 66.2, respectively, among low (n=728), intermediate (n=634), and high (n=135) bleeding risk patients. Mean per event costs were $22 174 (ischemic) and $12 203 (bleeding). When risks for ischemia matched or exceeded bleeding, simulated utility-weighted event rates favored ticagrelor/prasugrel, whereas clopidogrel reduced utility-weighted events when bleeding exceeded ischemic risk. One-year costs were sensitive to drug pricing assumptions, and risk-tailored treatment with either agent progressed from cost incurring to cost saving with increasing generic market share. CONCLUSIONS: Tailoring antiplatelet therapy intensity to patient risk may improve health utility and could produce cost savings in the first year after percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00998127.


Assuntos
Síndrome Coronariana Aguda/terapia , Clopidogrel/administração & dosagem , Trombose Coronária/prevenção & controle , Isquemia Miocárdica/prevenção & controle , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Cloridrato de Prasugrel/administração & dosagem , Ticagrelor/administração & dosagem , Síndrome Coronariana Aguda/economia , Síndrome Coronariana Aguda/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisão Clínica , Clopidogrel/efeitos adversos , Clopidogrel/economia , Trombose Coronária/economia , Trombose Coronária/epidemiologia , Redução de Custos , Análise Custo-Benefício , Custos de Medicamentos , Stents Farmacológicos , Europa (Continente)/epidemiologia , Feminino , Hemorragia/induzido quimicamente , Hemorragia/economia , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/economia , Isquemia Miocárdica/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/economia , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/economia , Cloridrato de Prasugrel/efeitos adversos , Cloridrato de Prasugrel/economia , Sistema de Registros , Medição de Risco , Fatores de Risco , Ticagrelor/efeitos adversos , Ticagrelor/economia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
6.
Catheter Cardiovasc Interv ; 94(1): 53-60, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30656812

RESUMO

OBJECTIVE: To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS). BACKGROUND: AA patients are at higher risk for adverse cardiovascular outcomes after PCI and may derive greater benefit from the use of potent antiplatelet therapy. METHODS: Using the multicenter PROMETHEUS observational registry of ACS patients treated with PCI, we grouped patients by self-reported AA or other races. Clinical outcomes at 90-day and 1-year included non-fatal myocardial infarction (MI), major adverse cardiac events (composite of death, MI, stroke, or unplanned revascularization) and major bleeding. RESULTS: The study population included 2,125 (11%) AA and 17,707 (89%) non-AA patients. AA patients were younger, more often female (46% vs. 30%) with a higher prevalence of diabetes mellitus, chronic kidney disease, and prior coronary intervention than non-AA patients. Although AA patients more often presented with troponin (+) ACS, prasugrel use was much less common in AA vs. non-AA (11.9% vs. 21.4%, respectively, P = 0.001). In addition, the use of prasugrel increased with the severity of presentation in non-AA but not in AA patients. Multivariable logistic regression showed AA race was an independent predictor of reduced use of prasugrel (0.42 [0.37-0.49], P < 0.0001). AA race was independently associated with a significantly higher risk of MI at 90-days and 1 year after PCI. CONCLUSIONS: Despite higher risk clinical presentation and worse 1-year ischemic outcomes, AA race was an independent predictor of lower prasugrel prescription in a contemporary population of ACS patients undergoing PCI.


Assuntos
Síndrome Coronariana Aguda/terapia , Negro ou Afro-Americano , Clopidogrel/uso terapêutico , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde/etnologia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/etnologia , Síndrome Coronariana Aguda/mortalidade , Fatores Etários , Idoso , Causas de Morte , Clopidogrel/efeitos adversos , Comorbidade , Feminino , Hemorragia/induzido quimicamente , Hemorragia/etnologia , Hemorragia/mortalidade , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Prevalência , Estudos Prospectivos , Fatores Raciais , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores Sexuais , Acidente Vascular Cerebral/etnologia , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
7.
J Invasive Cardiol ; 29(10): 340-351, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28420804

RESUMO

OBJECTIVES: We sought to describe trends in the use of preprocedural P2Y12 inhibitors and their clinical impact in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Oral P2Y12 inhibitors are ubiquitously used medications; however, the specific timing of initial P2Y12 inhibitor administration remains intensely debated. METHODS: Our study population comprised 74,053 consecutive patients undergoing PCI at 47 hospitals in Michigan from January 2013 through June 2015. In-hospital outcomes included stent thrombosis, bleeding, need for transfusion, and death. Hierarchical logistic regression, propensity matching, and targeted maximum likelihood estimation were used to adjust for baseline patient differences and clustering, and to minimize bias. RESULTS: Of 24,733 patients who received a preprocedural P2Y12 inhibitor, 82% received clopidogrel, 8% prasugrel, and 10% ticagrelor. Preprocedural administration of P2Y12 inhibitors declined during the study (49.3% to 24.8%; P<.001), and varied greatly across hospitals (14.5%-95.9%). No significant differences in outcomes were observed between patients receiving preprocedural clopidogrel and a matched cohort of those not receiving any preprocedural P2Y12 inhibitor (stent thrombosis: adjusted odds ratio [OR], 1.55; 95% confidence interval [CI], 0.30-7.84; bleeding: OR, 0.96; 95% CI, 0.63-1.46; transfusion: OR, 1.03; 95% CI, 0.69-1.55; and death: OR, 0.95; 95% CI, 0.38-2.37). Similar findings were demonstrated for preprocedural ticagrelor and prasugrel. Results from a subgroup analysis of patients with non-ST segment elevation acute coronary syndrome (n = 28,072) were consistent with the overall findings. CONCLUSIONS: There was a substantial decline in the rate of preprocedural P2Y12 inhibitor administration during the study. Furthermore, there were no significant differences in outcomes between patients treated with preprocedural P2Y12 inhibitors and those who were not.


Assuntos
Adenosina/análogos & derivados , Hemorragia , Intervenção Coronária Percutânea , Cloridrato de Prasugrel , Ticlopidina/análogos & derivados , Adenosina/administração & dosagem , Adenosina/efeitos adversos , Idoso , Planos de Seguro Blue Cross Blue Shield/estatística & dados numéricos , Clopidogrel , Revisão de Uso de Medicamentos/estatística & dados numéricos , Etnicidade/estatística & dados numéricos , Feminino , Oclusão de Enxerto Vascular/epidemiologia , Oclusão de Enxerto Vascular/etiologia , Hemorragia/induzido quimicamente , Hemorragia/etnologia , Hemorragia/prevenção & controle , Mortalidade Hospitalar , Humanos , Masculino , Michigan/epidemiologia , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Cloridrato de Prasugrel/administração & dosagem , Cloridrato de Prasugrel/efeitos adversos , Período Pré-Operatório , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Stents/efeitos adversos , Ticagrelor , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Fatores de Tempo
8.
Am Heart J ; 187: 19-28, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28454802

RESUMO

BACKGROUND: Little is known about the use of platelet function testing to guide choice of P2Y12 receptor inhibitor therapy in routine clinical practice. METHODS: We studied 671 myocardial infarction (MI) patients treated with percutaneous coronary intervention in the TRANSLATE-ACS Registry who had VerifyNow platelet function testing performed while on clopidogrel treatment during their index hospitalization (April 2010-October 2012). RESULTS: High platelet reactivity (>208 platelet reactivity units [PRU]) was present in 261 (38.9%) patients. Clopidogrel was switched in-hospital to prasugrel in 80 (30.7%) patients with high platelet reactivity and 18 (4.4%) patients with therapeutic platelet reactivity (≤208 PRU). Among high platelet reactivity patients, switch to prasugrel was associated with lower major adverse cardiovascular events (death, MI, stroke, or unplanned revascularization) at 1year (10.0% vs 22.7%, P=.02; adjusted odds ratio [OR] 0.39, 95% CI 0.18-0.85, P=.02) and no significant difference in Bleeding Academic Research Consortium type 2 or higher bleeding (23.8% vs 22.1%, P=.77; adjusted OR 0.91, 95% CI 0.48-1.7, P=.77) compared with patients continued on clopidogrel. No significant differences in major adverse cardiovascular event (22.2% vs 12.8%, P=.25; adjusted OR 1.8, 95% CI 0.47-7.3, P=.38) or bleeding (22.2% vs 19.4%, P=.77; adjusted OR 1.3, 95% CI 0.27-6.8, P=.72) were observed among therapeutic platelet reactivity patients between switching and continuation on clopidogrel. CONCLUSIONS: Only one-third of percutaneous coronary intervention-treated MI patients with high on-clopidogrel platelet reactivity were switched to a more potent P2Y12 receptor inhibitor. Intensification of antiplatelet therapy was associated with lower risk of ischemic events at 1year among HPR patients.


Assuntos
Plaquetas/efeitos dos fármacos , Infarto do Miocárdio/tratamento farmacológico , Cloridrato de Prasugrel/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ticlopidina/análogos & derivados , Idoso , Isquemia Encefálica/induzido quimicamente , Clopidogrel , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea , Testes de Função Plaquetária , Cloridrato de Prasugrel/efeitos adversos , Estudos Prospectivos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ticlopidina/efeitos adversos , Ticlopidina/uso terapêutico
9.
Circ Cardiovasc Interv ; 9(11)2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27789517

RESUMO

BACKGROUND: Guidelines recommend the use of adenosine diphosphate receptor inhibitor (ADPri) therapy for 1 year postacute myocardial infarction; yet, early cessation of therapy occurs frequently in clinical practice. METHODS AND RESULTS: We examined 11 858 acute myocardial infarction patients treated with percutaneous coronary intervention discharged alive on ADPri therapy from 233 United States TRANSLATE-ACS study (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) participating hospitals to determine the prevalence of early ADPri cessation (within 1 year), patient-reported reasons for cessation, and associated risk of major adverse cardiovascular events at 1 year. Overall, 2514 (21.2%) of percutaneous coronary intervention-treated patients stopped ADPri by 1 year postmyocardial infarction; the median time from discharge to cessation was 200.5 days (25th, 75th percentiles: 71, 340). Among those with early ADPri cessation, 53.9% received drug-eluting stents and had a median duration of 301 treatment days (25th, 75th percentiles: 137, 353); 33.3% of drug-eluting stent patients stopped treatment within 6 months compared with 64.2% of bare metal stent patients. Those discharged on prasugrel (versus clopidogrel) had a slightly higher likelihood of early ADPri cessation (23.2% versus 21.0%; P=0.03; adjusted hazard ratio, 1.28; 95% confidence interval, 1.17-1.40). Patient-reported reasons for early ADPri cessation included physician-recommended discontinuation (54%), as well as patient self-discontinuation, because of cost (19%), medication side effects (9%), and procedural interruption (10%). Using a time-dependent covariate model, early cessation of ADPri therapy was associated with increased major adverse cardiovascular event (adjusted hazard ratio, 1.40; 95% confidence interval, 1.19-1.65; P<0.0001). CONCLUSIONS: One in 5 percutaneous coronary intervention-treated myocardial infarction patients stopped ADPri treatment within 1 year. Early cessation was associated with increased major adverse cardiovascular event risk. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503.


Assuntos
Síndrome Coronariana Aguda/terapia , Adesão à Medicação , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Padrões de Prática Médica , Cloridrato de Prasugrel/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Ticlopidina/análogos & derivados , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/economia , Síndrome Coronariana Aguda/mortalidade , Idoso , Clopidogrel , Esquema de Medicação , Custos de Medicamentos , Feminino , Gastos em Saúde , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/economia , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Cloridrato de Prasugrel/economia , Modelos de Riscos Proporcionais , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/economia , Recidiva , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Ticlopidina/economia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
10.
Int J Cardiol ; 223: 854-859, 2016 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-27592042

RESUMO

BACKGROUND: Dual antiplatelet therapy is recommended for patients with acute coronary syndrome (ACS) that undergo percutaneous coronary intervention (PCI). However, the effect of switching P2Y12 inhibitors between the loading dose and therapy after discharge is not well described. METHODS: This post-hoc analysis of a prospectively collected registry included 3219 consecutive ACS patients who underwent PCI. Patients were categorized into four groups: clopidogrel at load and discharge (C-C), loading dose of clopidogrel and discharged on prasugrel/ticagrelor (C-PT), loading dose of prasugrel/ticagrelor and discharged on clopidogrel (PT-C), and prasugrel/ticagrelor at load and discharge (PT-PT). RESULTS: While 77.6% of patients received the C-C treatment regimen and 13.6% received the PT-PT strategy, the strategy of P2Y12 switching was fairly common with 6.2% in the PT-C group and 2.6% in the C-PT group. While C-C was the most common treatment regimen, PT-C and PT-PT were more commonly used in STEMI patients than in NSTEMI or unstable angina patients. A significantly lower unadjusted incidence of the composite outcome (death, MI, and repeat revascularization) was appreciated in both the PT-C (1.0%) and PT-PT (2.3%) groups than the C-C group (4.0%). Propensity-score matched analysis still showed significantly reduced risk (HR=0.22, 95% CI 0.05-0.93, p=0.04) in the PT-C group vs. a matched group of C-C controls. CONCLUSIONS: The strategy of utilizing a newer P2Y12 inhibitor and then switching to clopidogrel in ACS patients following PCI is used with some frequency in routine clinical practice and further studies should evaluate the safety and efficacy of such a strategy.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Adenosina/análogos & derivados , Assistência ao Convalescente/métodos , Conduta do Tratamento Medicamentoso/organização & administração , Intervenção Coronária Percutânea/métodos , Cloridrato de Prasugrel , Ticlopidina/análogos & derivados , Síndrome Coronariana Aguda/epidemiologia , Síndrome Coronariana Aguda/cirurgia , Adenosina/administração & dosagem , Adenosina/efeitos adversos , Clopidogrel , Relação Dose-Resposta a Droga , Substituição de Medicamentos/métodos , Quimioterapia Combinada/métodos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/administração & dosagem , Cloridrato de Prasugrel/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Sistema de Registros , Ticagrelor , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Resultado do Tratamento , Estados Unidos/epidemiologia
11.
Pharmacogenomics ; 17(7): 701-13, 2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-27167099

RESUMO

AIM: This study aimed to compare the clinical and economic outcomes of pharmacogenetic-guided (PG-guided) and platelet reactivity testing-guided antiplatelet therapy for patients with acute coronary syndrome undergoing percutaneous coronary intervention. METHODS: A decision-analytic model was simulated including four antiplatelet strategies: universal clopidogrel 75 mg daily, universal alternative P2Y12 inhibitor (prasugrel or ticagrelor), PG-guided therapy, and platelet reactivity testing-guided therapy. RESULTS: PG-guided therapy was the preferred option with lowest cost (US$75,208) and highest quality-adjusted life years gained (7.6249 quality-adjusted life years). The base-case results were robust in sensitivity analysis. CONCLUSION: PG-guided antiplatelet therapy showed the highest probability to be preferred antiplatelet strategy for acute coronary syndrome patients with percutaneous coronary intervention.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Inibidores da Agregação Plaquetária/economia , Inibidores da Agregação Plaquetária/uso terapêutico , Síndrome Coronariana Aguda/genética , Adenosina/efeitos adversos , Adenosina/análogos & derivados , Adenosina/economia , Adenosina/uso terapêutico , Clopidogrel , Análise Custo-Benefício , Citocromo P-450 CYP2C19/genética , Técnicas de Apoio para a Decisão , Custos de Medicamentos , Humanos , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Testes Farmacogenômicos , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Cloridrato de Prasugrel/economia , Cloridrato de Prasugrel/uso terapêutico , Medicina de Precisão , Anos de Vida Ajustados por Qualidade de Vida , Ticagrelor , Ticlopidina/efeitos adversos , Ticlopidina/análogos & derivados , Ticlopidina/economia , Ticlopidina/uso terapêutico
12.
Am J Health Syst Pharm ; 73(6): 395-403, 2016 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-26953284

RESUMO

PURPOSE: Results of a study of bleeding events and other inhospital outcomes with the use of clopidogrel versus prasugrel in patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) are reported. METHODS: Demographic and clinical data on adults hospitalized for ACS, managed with PCI, and treated with clopidogrel or prasugrel during a two-year period were extracted from a large hospital claims database. Bleeding rates, hospital length of stay (LOS), and total hospital costs during the index hospitalization were evaluated. RESULTS: The study sample consisted of 75,297 patients who received clopidogrel and 9,477 who received prasugrel. The unadjusted bleeding rates were 5.7% with clopidogrel use and 3.2% with prasugrel use (p < 0.0001). After propensity score stratification to adjust for selection bias, rates of bleeding events were not significantly different between clopidogrel- and prasugrel-treated patients (odds ratio, 0.90; 95% confidence interval [CI], 0.80-1.02; p = 0.0949). The adjusted mean ± S.D. hospital LOS was 0.22 day lower (95% CI, 0.15-0.28; p < 0.001) with the use of prasugrel versus clopidogrel, and adjusted total mean hospital costs were $375 less for prasugrel-treated patients (p = 0.003). CONCLUSION: After adjustments for demographic and clinical characteristics, rates of inhospital bleeding in patients who received prasugrel and those who received clopidogrel were not significantly different. The adjusted analyses showed that the mean hospital LOS was shorter and total mean hospital costs were lower for patients treated with prasugrel.


Assuntos
Síndrome Coronariana Aguda/economia , Custos Hospitalares , Intervenção Coronária Percutânea/economia , Inibidores da Agregação Plaquetária/economia , Cloridrato de Prasugrel/economia , Ticlopidina/análogos & derivados , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Idoso , Clopidogrel , Bases de Dados Factuais/tendências , Gerenciamento Clínico , Feminino , Recursos em Saúde/economia , Recursos em Saúde/tendências , Hemorragia/induzido quimicamente , Hemorragia/economia , Custos Hospitalares/tendências , Humanos , Tempo de Internação/tendências , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Cloridrato de Prasugrel/efeitos adversos , Cloridrato de Prasugrel/uso terapêutico , Ticlopidina/efeitos adversos , Ticlopidina/economia , Ticlopidina/uso terapêutico , Resultado do Tratamento
13.
Am J Cardiovasc Drugs ; 15(5): 337-50, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26359016

RESUMO

OBJECTIVE: Our objective was to compare 1-year real-world healthcare resource utilization (HRU), associated charges, and antiplatelet treatment patterns among patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) and treated with ticagrelor or prasugrel. METHODS: Using the ProMetis-Lx database, adult ACS-PCI patients treated with ticagrelor or prasugrel post-discharge were identified between 1 August 2011 and 31 May 2013 and propensity matched to adjust for baseline differences. RESULTS: Before matching, ticagrelor-treated patients (n = 2991) were older with increased baseline ischemic and bleeding risks compared with prasugrel-treated patients (n = 12,797). After matching, ticagrelor patients had higher all-cause HRU (2.5 vs. 2.4 per patient per month; P = 0.012) and cardiovascular (CV) HRU (0.4 vs. 0.3 per patient per month; P = 0.026), with the difference in CV rehospitalizations (17.7 vs. 15.7 %; P = 0.011) primarily driven by congestive heart failure (CHF) (4.9 vs. 3.8 %; P = 0.02). All-cause charges within 1 year did not significantly differ between groups ($US5456 vs. 4844 per patient per month; P = 0.37), but dyspnea-related total charges were significantly higher with ticagrelor ($US139 vs. 95 per patient per month; P = 0.005). Although infrequent, switching was slightly higher with ticagrelor (8.3 vs. 6.0 %; P < 0.001) at 1 year, and mean persistence was slightly longer with prasugrel (150 vs. 159 days; P = 0.002), with no significant difference in mean adherence (61 vs. 63 %; P = 0.17). CONCLUSION: Overall monthly HRU was slightly lower with prasugrel than with ticagrelor, with no significant difference in bleeding HRU. Prasugrel was associated with slightly higher pharmacy charges, but lower dyspnea charges, resulting in no significant difference in total charges. Patients receiving prasugrel tended to use it for longer than those receiving ticagrelor as less switching occurred. These findings may aid decision making, but must be tempered due to inherent study limitations.


Assuntos
Síndrome Coronariana Aguda/terapia , Adenosina/análogos & derivados , Anticoagulantes/uso terapêutico , Serviços de Saúde/estatística & dados numéricos , Intervenção Coronária Percutânea/métodos , Cloridrato de Prasugrel/uso terapêutico , Adenosina/administração & dosagem , Adenosina/efeitos adversos , Adenosina/economia , Adenosina/uso terapêutico , Idoso , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Comorbidade , Feminino , Serviços de Saúde/economia , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Cloridrato de Prasugrel/administração & dosagem , Cloridrato de Prasugrel/efeitos adversos , Cloridrato de Prasugrel/economia , Estudos Retrospectivos , Ticagrelor
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