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OBJECTIVE: A critical goal in the care of patients with peripheral artery disease (PAD) is to optimize their health status; their symptoms, function, and quality of life. Social support has been proposed to be a predictor of disease-specific health status in PAD. However, the prevalence of low perceived social support, the association with health status outcomes, and the interaction with other biopsychosocial variables, is unknown. Our aim was to assess the association of baseline perceived social support with health status at 12 months in patients with PAD. METHODS: The PORTRAIT registry, which enrolled patients with PAD in the United States, Netherlands, and Australia from 2011-2015, was used. Perceived social support was assessed at baseline with the ENRICHD Social Support Inventory (ESSI), while disease-specific (Peripheral Artery Disease Questionnaire [PAQ]) and generic health status (EuroQoL Visual Analog Scale (VAS) and EQ-5D-3L Index) questionnaires were assessed at baseline and 12 months. Low social support was defined as a score ≤ 3 on 2 items and an ESSI score ≤ 18. A hierarchical mixed level linear regression model adjusting for biopsychosocial variables was used to assess the association between low perceived social support and the ESSI score with health status at 12 months. RESULTS: A total of 949 patients were included (mean age 67.64±9.32 years, 37.9% females), with low social support being present in 18.2%. Patients with low social support were more likely to not be married or to be living alone (50.0% vs 77.5%; p<0.001), have more financial constraints, have more depressive, stress, and anxiety symptoms, and have lower disease-specific and generic health status at baseline and at 12 months. In the unadjusted model, low social support was associated with a -7.02 (95%CI -10.97; -3.07) point reduction in the PAQ, -7.43 (95%CI -10.33; -4.54) in the VAS, and -0.06 (95%CI -0.09; -0.03) in the EQ-5D-3L Index. Adjusting for biopsychosocial factors minimally attenuated these associations (PAQ: -6.52 95%CI -10.55; -2.49 p=0.002 , VAS: -5.39 95%CI 8.36; -2.42 p <0.001 , EQ-5D-3L Index -0.04 95%CI -0.07; 0.01 p=0.022). The ESSI per-point score was associated with a decrease of 0.51 (95%CI 0.18; 0.85; p=0.003) in PAQ and 0.46 (95%CI 0.12; 0.61; p=0.004) in the VAS. CONCLUSION: Among patients with PAD, low social support was frequent and associated with lower health status at 1 year independently of other biopsychosocial variables. Improving social support could improve health status and outcomes in PAD.
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Recent studies have shown similar safety and efficacy of short-term dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor (P2Y12i) monotherapy when compared with standard DAPT. However, the optimal DAPT duration and regimen in acute coronary syndrome (ACS) patients who underwent percutaneous coronary intervention is still unclear. Online databases were searched for randomized controlled trials evaluating P2Y12i monotherapy after short DAPT (≤3 months) versus standard DAPT (≥12 months) in ACS patients. The outcomes of interest were all-cause death, cardiovascular death, myocardial infarction, stent thrombosis, target-vessel revascularization, and major bleeding. Random-effects model was used to calculate pooled odds ratios (OR) and 95% confidence intervals (CI). Six randomized controlled trials with a total of 23,884 patients (n = 11,904 P2Y12i monotherapy, n = 11,980 standard DAPT) were included. Compared with standard DAPT, P2Y12i monotherapy after short DAPT was associated with similar odds of all-cause death (OR 0.86, 95% CI 0.65 to 1.12, p = 0.26) and cardiovascular death (OR 0.75, 95% CI 0.43 to 1.29, p = 0.29) at 1 year. Similarly, there were no significant differences in rates of myocardial infarction (OR 1.09, 0.83 to 1.43, p = 0.53), stent thrombosis (OR 1.09, 95% CI 0.71 to 1.67, p = 0.70) and target-vessel revascularization (OR 0.81, 95% CI 0.65 to 1.01, p = 0.07) between the P2Y12i monotherapy and standard DAPT arms. The P2Y12i monotherapy group had significantly lower major bleeding (OR 0.49, 95% CI 0.38 to 0.64, p < 0.001) when compared with standard DAPT. In conclusion, in patients with ACS who underwent percutaneous coronary intervention, P2Y12i monotherapy after short DAPT significantly reduces bleeding without increasing ischemic risk when compared with standard DAPT therapy.
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Síndrome Coronariana Aguda , Terapia Antiplaquetária Dupla , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária , Antagonistas do Receptor Purinérgico P2Y , Humanos , Síndrome Coronariana Aguda/tratamento farmacológico , Causas de Morte/tendências , Terapia Antiplaquetária Dupla/métodos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Patients with normal-flow low-gradient (NFLG) severe aortic stenosis present both diagnostic and management challenges, with debate about the whether this represents true severe stenosis and the need for valve replacement. Studies exploring the natural history without intervention have shown similar outcomes of patients with NFLG severe aortic stenosis to those with moderate aortic stenosis and better outcomes after valve replacement than those with low-flow low-gradient severe aortic stenosis. Most studies (all observational) have shown that aortic valve replacement was associated with a survival benefit vs surveillance. Based on available data, the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines and European Association of Cardiovascular Imaging/American Society of Echocardiography suggest that these patients are more likely to have moderate aortic stenosis. This clinical entity is not mentioned in the American Heart Association/American College of Cardiology guidelines. Here we review the definition of NFLG severe aortic stenosis, potential diagnostic algorithms and points of error, the data supporting different management strategies, and the differing guidelines and outline the unanswered questions in the diagnosis and management of these challenging patients.
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Estenose da Valva Aórtica , Valva Aórtica , Implante de Prótese de Valva Cardíaca , Hemodinâmica , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Índice de Gravidade de Doença , Humanos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/terapia , Europa (Continente) , Estados Unidos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Valva Aórtica/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: There has been an evolution in the disease severity and complexity of patients presenting to the cardiac intensive care unit (CICU). There are limited data evaluating the role of palliative care in contemporary CICU practice. METHODS: PubMed Central, CINAHL, EMBASE, Medline, Cochrane Library, Scopus, and Web of Science databases were evaluated for studies on palliative care in adults (≥18 years) admitted with acute cardiovascular conditions - acute myocardial infarction, cardiogenic shock, cardiac arrest, advanced heart failure, post-cardiac surgery, spontaneous coronary artery dissection, Takotsubo cardiomyopathy, and pulmonary embolism - admitted to the CICU, coronary care unit or cardiovascular intensive care unit from 1/1/2000 to 8/8/2022. The primary outcome of interest was the utilization of palliative care services. Secondary outcomes of included studies were also addressed. Meta-analysis was not performed due to heterogeneity. RESULTS: Of 5711 citations, 30 studies were included. All studies were published in the last seven years and 90 % originated in the United States. Twenty-seven studies (90 %) were retrospective analyses, with a majority from the National Inpatient Sample database. Heart failure was the most frequent diagnosis (47 %), and in-hospital mortality was reported in 67 % of studies. There was heterogeneity in the timing, frequency, and background of the care team that determined palliative care consultation. In two randomized trials, there appeared to be improvement in quality of life without an impact on mortality. CONCLUSIONS: Despite the growing recognition of the role of palliative care, there are limited data on palliative care consultation in the CICU.
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BACKGROUND: Predictors of in-hospital mortality after myocardial infarction (MI) have been reported dichotomously: survival vs death. Predictors of time from admission to death have not been reported. METHODS: A total of 7335 patients were enrolled in a prospective multicentre registry of acute MI. In-hospital mortality was classified by time from admission as acute (≤ 2 days), subacute (3 to 7 days), late (8 to 14 days), and very late (≥ 15 days) to identify factors associated with time to death in patients who died before discharge. Patient and MI characteristics, in-hospital interventions, and electrocardiographic findings were screened for differences in time to in-hospital death. RESULTS: In-hospital death affected 351 patients (4.8%). Mean age was 72.0 ± 12.4 years, and 40.5% were female patients. Median survival was 5 days (interquartile range: 2-12), and 41% of in-hospital deaths occurred after 1 week. Cardiac biomarkers and ejection fraction were not related to time to in-hospital death. Previous MI, systolic blood pressure, pharmacologic therapy, and interventional treatments were different among the 4 groups. The factors associated with late in-hospital death were coronary artery bypass graft surgery (CABG), new-onset atrial fibrillation or flutter, heart failure or pulmonary edema, bleeding, and lung disease. Acute and subacute in-hospital death was associated with ST-elevation MI, lower systolic blood pressure, and cardiac arrest on admission. CABG was performed in 12% of post-MI patients who died in hospital. CONCLUSIONS: Clinical risk factors for in-hospital mortality evolve over time immediately after acute MI. Understanding the time-dependent risk factors may allow for the development of new approaches to curtail the "later" in-hospital mortality.
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Infarto do Miocárdio , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Mortalidade Hospitalar , Estudos Prospectivos , Ponte de Artéria Coronária/efeitos adversos , Sistema de RegistrosRESUMO
Background: Although variation in the management of patients with non-ST-elevation myocardial infarction (NSTEMI) is well documented across US hospitals, few data exist characterizing variation in outcomes following specific management strategies. Methods: Admissions for NSTEMI to hospitals performing coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) surgery between 2016 and 2018 were identified from the National Inpatient Sample. Patients were categorized according to treatment rendered (medical therapy alone, angiography without revascularization, PCI, or CABG). The primary end point was variation in the incidence of composite in-hospital death, postprocedure myocardial infarction, or stroke, stratified by treatment rendered. Secondary outcomes included variation in length of stay (LOS), cost, and use of each treatment modality. Variation was characterized by the median odds ratio. Results: Among 140,194 hospitalizations for NSTEMI, 35,748 (25.5%) patients received medical therapy alone, 28,678 (20.5%) underwent angiography without revascularization, 58,383 (41.6%) underwent PCI, and 17,385 (12.4%) underwent CABG. Despite adjusting for patient- and hospital-related factors, 2 similar patients were 25% more likely to experience the composite primary outcome following PCI and 45% more likely following CABG at 1 randomly selected hospital than at another. Significant hospital-level variations in LOS and cost were also apparent following each treatment modality. Conclusions: In a large national analysis of hospitalizations for NSTEMI, significant variation was observed in clinical outcome, LOS, and cost associated with each treatment modality, despite adjustment for patient- and hospital-related factors.
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BACKGROUND: Nonsurgical centers (NSC) contribute significantly to the capacity of overall percutaneous coronary intervention (PCI) in the United Kingdom. Although previous studies have demonstrated similar PCI outcomes in surgical centers (SC) versus NSC, it is unknown whether this applies to more complex procedures such as left main stem (LMS) PCI. We compared patient characteristics and outcomes of LMS PCI performed across SC and NSC in England and Wales. METHODS: A retrospective analysis of procedures between January 2006 and March 2020 was performed using the British Cardiovascular Intervention Society database and stratified according to the surgical status of the center. The primary outcomes assessed were in-hospital major adverse cardiovascular and cerebrovascular events, all-cause mortality, and Bleeding Academic Research Consortium stage 3 to 5 bleeding. RESULTS: Forty thousand seven hundred forty-four patients underwent LMS PCI during the period, of which 13 922 (34.2%) had their procedure performed at an NSC. The proportion of LMS PCI performed in NSC increased >2-fold (15.9% in 2006 to 36.7% in 2020). There was no association between surgical cover location and in-hospital mortality (odds ratio, 0.92 [95% CI, 0.69-1.22]), in-hospital major adverse cardiovascular and cerebrovascular events (odds ratio, 1.00 [95% CI, 0.79-1.25]), or emergency coronary artery bypass graft surgery (odds ratio, 1.00 [95% CI, 0.95-1.06]). NSC had lower Bleeding Academic Research Consortium 3 to 5 bleeding complications (odds ratio, 0.53 [95% CI, 0.34-0.82]). CONCLUSIONS: There has been an increase in LMS PCI volumes at NSC, particularly elective LMS PCI. LMS PCI performed at NSC was not associated with increased mortality, in-hospital major adverse cardiovascular and cerebrovascular events, or emergency coronary artery bypass graft surgery, despite higher disease complexity.
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Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Hemorragia/etiologia , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgiaRESUMO
BACKGROUND: Ticagrelor or prasugrel are recommended to reduce ischemic events in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI). However, in clinical practice, patients are often switched from a potent P2Y12 inhibitor to clopidogrel prior to or at discharge ('de-escalation'). We sought to assess the incidence and predictors of de-escalation. METHODS: Consecutive patients who received either a ticagrelor or prasugrel loading dose for AMI PCI at two tertiary centers between Jan 2015-Mar 2019 who survived to discharge were included. Data were obtained from the electronic health record and institutional NCDR CathPCI data. Patients who were de-escalated to clopidogrel were compared with those who remained on potent P2Y12 inhibitors through the time of discharge. RESULTS: Of the1818 patients in the cohort, 1146 (63%) were de-escalated. Patients in the de-escalation group were older, more often Black, had lower prevalence of co-morbidities, less often had private insurance, and had less complex PCI. After adjustment, older age remained positively associated (OR 1.2, CI 1.08-1.34, p = .001) and Caucasian race (OR 0.5, CI 0.33-0.77, p = .002), prior MI (OR 0.7, CI 0.5-0.97, p = .032), bifurcation lesion (OR 0.71, CI 0.53-0.95, p = .019), and greater number of stents (OR 0.82, CI 0.75-0.91, p = .0001) were negatively associated with de-escalation. In de-escalated patients, the rationale was not documented in 75.9% of cases. CONCLUSIONS: De-escalation occurred frequently in patients with AMI and was associated with both non-clinical and clinical factors. Medical decision making was poorly documented and represent an area for improvement.
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Síndrome Coronariana Aguda , Infarto do Miocárdio , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/terapia , Clopidogrel/efeitos adversos , Hospitais , Humanos , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ticagrelor/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. STUDY DESIGN: AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. CONCLUSION: This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.
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Angioplastia Coronária com Balão , Cateteres Cardíacos/classificação , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária , Paclitaxel/farmacologia , Reoperação , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/métodos , Antineoplásicos Fitogênicos/farmacologia , Materiais Revestidos Biocompatíveis/farmacologia , Reestenose Coronária/diagnóstico , Reestenose Coronária/etiologia , Reestenose Coronária/cirurgia , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Reoperação/efeitos adversos , Reoperação/instrumentação , Reoperação/métodosRESUMO
INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic's impact on vascular procedural volumes and outcomes has not been fully characterized. METHODS: Volume and outcome data before (1/2019 - 2/2020), during (3/2020 - 4/2020), and following (5/2020 - 6/2020) the initial pandemic surge were obtained from the Vascular Quality Initiative (VQI). Volume changes were determined using interrupted Poisson time series regression. Adjusted mortality was estimated using multivariable logistic regression. RESULTS: The final cohort comprised 57,181 patients from 147 US and Canadian sites. Overall procedure volumes fell 35.2% (95% CI 31.9%, 38.4%, p < 0.001) during and 19.8% (95% CI 16.8%, 22.9%, p < 0.001) following the surge, compared with presurge months. Procedure volumes fell 71.1% for claudication (95% CI 55.6%, 86.4%, p < 0.001) and 15.9% for chronic limb-threatening ischemia (CLTI) (95% CI 11.9%, 19.8%, p < 0.001) but remained unchanged for acute limb ischemia (ALI) when comparing surge to presurge months. Adjusted mortality was significantly higher among those with claudication (0.5% vs 0.1%; OR 4.38 [95% CI 1.42, 13.5], p = 0.01) and ALI (6.4% vs 4.4%; OR 2.63 [95% CI 1.39, 4.98], p = 0.003) when comparing postsurge with presurge periods. CONCLUSION: The first North American COVID-19 pandemic surge was associated with a significant and sustained decline in both elective and nonelective lower-extremity vascular procedural volumes. When compared with presurge patients, in-hospital mortality increased for those with claudication and ALI following the surge.
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Amputação Cirúrgica , COVID-19 , Procedimentos Endovasculares/métodos , Doença Arterial Periférica/cirurgia , COVID-19/epidemiologia , Canadá/epidemiologia , Isquemia Crônica Crítica de Membro , Humanos , Salvamento de Membro , Extremidade Inferior , Pandemias , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/epidemiologia , Estudos Retrospectivos , Fatores de Risco , SARS-CoV-2 , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The aims of this study were to examine rates of radial artery access in post-coronary artery bypass grafting (CABG) patients undergoing diagnostic catherization and/or percutaneous coronary intervention (PCI), whether operators with higher procedural volumes and higher percentage radial use were more likely to perform diagnostic catherization and/or PCI via the radial approach in post-CABG patients, and clinical and procedural outcomes in post-CABG patients who undergo diagnostic catherization and/or PCI via the radial or femoral approach. BACKGROUND: There are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI. METHODS: Using the National Cardiovascular Data Registry CathPCI Registry, all diagnostic catheterizations and PCIs performed in patients with prior CABG from July 1, 2009, to March 31, 2018 (n = 1,279,058, 1,173 sites) were evaluated. Temporal trends in transradial access were examined, and mortality, bleeding, vascular complications, and procedural metrics were compared between transradial and transfemoral access. RESULTS: The rate of transradial access increased from 1.4% to 18.7% over the study period. Transradial access was associated with decreased mortality (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.75 to 0.91), decreased bleeding (OR: 0.57; 95% CI: 0.51 to 0.63), decreased vascular complications (OR: 0.38; 95% CI: 0.30 to 0.47), increased PCI procedural success (OR: 1.11; 95% CI: 1.06 to 1.16; p < 0.0001), and significantly decreased contrast volume across all procedure types. Transradial access was associated with shorter fluoroscopy time for PCI-only procedures but longer fluoroscopy time for diagnostic procedures plus ad hoc PCI and diagnostic procedures only. Operators with a higher rate of transradial access in non-CABG patients were more likely to perform transradial access in patients with prior CABG. CONCLUSIONS: The rate of transradial artery access in patients with prior CABG undergoing diagnostic catheterization and/or PCI has increased over the past decade in the United States, and it was more often performed by operators using a transradial approach in non-CABG patients. Compared with transfemoral access, transradial access was associated with improved clinical outcomes in patients with prior CABG.
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Cateterismo Periférico , Intervenção Coronária Percutânea , Cateterismo Cardíaco , Ponte de Artéria Coronária , Artéria Femoral/diagnóstico por imagem , Humanos , Artéria Radial/diagnóstico por imagem , Fatores de Risco , Resultado do Tratamento , Estados UnidosRESUMO
Background The relationship between local hospital culture and transfusion rates following endovascular and surgical cardiovascular procedures has not been well studied. Methods and Results Patients undergoing coronary revascularization, aortic valve replacement, lower extremity peripheral vascular intervention, or carotid artery revascularization from up to 852 US hospitals in the Nationwide Readmissions Database were identified. Crude and risk-standardized red blood cell transfusion rates were determined for each procedure. Pearson correlation coefficients were calculated between respective procedural transfusion rates. Median odds ratios were estimated to reflect between-hospital variability in red blood cell transfusion rates following the same procedure for a given patient. There was wide variation in red blood cell transfusion rates across different procedures, from 2% following carotid endarterectomy to 29% following surgical aortic valve replacement. For surgical and endovascular modalities, transfusion rates at the same hospital were highly correlated for aortic valve replacement (r=0.67; P<0.001), moderately correlated for coronary revascularization (r=0.56; P<0.001) and peripheral vascular intervention (r=0.51; P<0.001), and weakly correlated for carotid artery revascularization (r=0.19, P<0.001). Median odds ratios were all >2, highest for coronary artery bypass graft surgery and surgical aortic valve replacement, indicating substantial site variation in transfusion rates. Conclusions After adjustment for patient-related factors, wide variation in red blood cell transfusion rates remained across surgical and endovascular procedures employed for the same cardiovascular condition. Transfusion rates following these procedures are highly correlated at individual hospitals and vary widely across hospitals. In aggregate, these findings suggest that local institutional culture significantly influences the decision to transfuse following invasive cardiovascular procedures and highlight the need for randomized data to inform such decisions.
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Procedimentos Cirúrgicos Cardíacos/estatística & dados numéricos , Procedimentos Endovasculares/estatística & dados numéricos , Transfusão de Eritrócitos/estatística & dados numéricos , Tomada de Decisão Clínica , Feminino , Número de Leitos em Hospital , Humanos , Masculino , Razão de Chances , Readmissão do Paciente , Seleção de Pacientes , Utilização de Procedimentos e Técnicas , Estados UnidosRESUMO
Importance: After percutaneous coronary intervention (PCI), patients with CYP2C19*2 or *3 loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown. Objective: To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes in CYP2C19 LOF carriers after PCI. Design, Setting, and Participants: Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019. Interventions: Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping. CYP2C19 LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months. Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients with CYP2C19 LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50. Results: Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 with CYP2C19 LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903 CYP2C19 LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02]; P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07]; P = .16). Conclusions and Relevance: Among CYP2C19 LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT01742117.
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Clopidogrel/uso terapêutico , Doença da Artéria Coronariana/genética , Inibidores do Citocromo P-450 CYP2C19/uso terapêutico , Citocromo P-450 CYP2C19/genética , Intervenção Coronária Percutânea/efeitos adversos , Medicina de Precisão , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ticagrelor/uso terapêutico , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/genética , Síndrome Coronariana Aguda/cirurgia , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Clopidogrel/efeitos adversos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/terapia , Inibidores do Citocromo P-450 CYP2C19/efeitos adversos , Feminino , Genótipo , Técnicas de Genotipagem , Hemorragia/induzido quimicamente , Heterozigoto , Humanos , Mutação com Perda de Função , Masculino , Pessoa de Meia-Idade , Testes Imediatos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ticagrelor/efeitos adversosRESUMO
BACKGROUND: Contrast-induced acute kidney injury (CIAKI) is a frequent and serious complication of transcatheter aortic valve replacement (TAVR). The most important procedural risk factor for CIAKI is contrast volume. OBJECTIVES: Because contrast volume is a modifiable factor that directly predicts CIAKI, we sought to identify predictors of increased contrast volume in TAVR patients. Identification of such predictors may allow both prediction and mitigation of CIAKI risk following TAVR. METHOD: We retrospectively analyzed data from consecutive patients not on hemodialysis who underwent successful TAVR at a single US center from 2013 to 2018. Using multivariable linear regression modelling, we assessed the relationships between contrast volumes and 49 patient and procedural factors hypothesized to be potential predictors. RESULTS: In 295 patients, we identified 17 factors that independently predicted contrast volume, 10 of which contributed 90% of the complete model's r2 value. Procedure year (suggesting a learning curve), aortic insufficiency, radiation dose, prior AVR, and previous pacemaker placement were statistically the most significant predictors of CIAKI. TAVR device and diabetes were notably not predictors. CONCLUSIONS: To predict and reduce contrast use in TAVR, patients at risk for increased contrast volume may be identified using the predictors elucidated in this study. For such patients, strategies for contrast reduction and renal protection may be employed.
Assuntos
Injúria Renal Aguda/induzido quimicamente , Estenose da Valva Aórtica/cirurgia , Meios de Contraste/administração & dosagem , Meios de Contraste/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Próteses Valvulares Cardíacas , Humanos , Modelos Lineares , Análise Multivariada , Estudos Retrospectivos , Medição de Risco , Fatores de RiscoRESUMO
OBJECTIVES: To examine temporal trends, predictors, and outcomes of red blood cell (RBC) transfusion in patients undergoing transcatheter aortic valve replacement (TAVR) in the United States. METHODS: We used the National Inpatient Sample databases to identify TAVR procedures performed between January 2012 and September 2015 in the United States. Patients were propensity matched (within the strata of overt and no bleeding) on the likelihood of receiving RBC transfusion, and in-hospital outcomes were compared between the 2 groups in the matched cohort. RESULTS: Among 46,710 TAVR procedures performed during the study period, rates of RBC transfusion were 17.3% (95% confidence interval [CI], 16.1%-18.5%). RBC transfusion rates decreased significantly from 29.5% during the first quarter of 2012 to 10.8% during the third quarter of 2015 (P < .001). Older age, female sex, peripheral vascular disease, chronic kidney disease, anemia, coagulopathy, and fluid/electrolyte disorders were associated with increased odds, whereas elective admission, obesity, and endovascular access were associated with decreased odds of RBC transfusion. In the propensity-matched cohort (7995 pairs with and without RBC transfusion), RBC transfusion was associated with increased risk of in-hospital mortality, infection, and transient ischemic attack/stroke in patients without bleeding (odds ratio [OR]Mortality, 2.29; 95% CI, 1.31-4.02; ORInfection, 2.13; 95% CI, 1.03-4.39; ORTransient ischemic attack/Stroke, 3.36; 95% CI, 1.52-7.45), but not in those with overt bleeding (ORMortality, 1.10; 95% CI, 0.68-1.48; ORInfection, 0.80; 95% CI, 0.45-1.45; ORTransient ischemic attack/Stroke, 1.16; 95% CI, 0.74-1.85); Pinteraction < .05 for all. CONCLUSIONS: RBC transfusion is associated with worse clinical outcomes in TAVR patients without bleeding, but not in those with overt bleeding. The utility and optimal threshold for RBC transfusion in TAVR patients, especially among those with overt bleeding, warrants further prospective investigation.