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3.
Physiol Genomics ; 51(10): 506-515, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31530226

RESUMO

The genomic regulatory networks underlying the pathogenesis of non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are incompletely understood. As intermediate traits, protein biomarkers report on underlying disease severity and prognosis in NSTE-ACS. We hypothesized that integration of dense microRNA (miRNA) profiling with biomarker measurements would highlight potential regulatory pathways that underlie the relationships between prognostic biomarkers, miRNAs, and cardiovascular phenotypes. We performed miRNA sequencing using whole blood from 186 patients from the TRILOGY-ACS trial. Seven circulating prognostic biomarkers were measured: NH2-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity C-reactive protein, osteopontin (OPN), myeloperoxidase, growth differentiation factor 15, monocyte chemoattractant protein, and neopterin. We tested miRNAs for association with each biomarker with generalized linear models and controlled the false discovery rate at 0.05. Ten miRNAs, including known cardiac-related miRNAs 25-3p and 423-3p, were associated with NT-proBNP levels (min. P = 7.5 × 10-4) and 48 miRNAs, including cardiac-related miRNAs 378a-3p, 20b-5p and 320a, -b, and -d, were associated with OPN levels (min. P = 1.6 × 10-6). NT-proBNP and OPN were also associated with time to cardiovascular death, myocardial infarction (MI), or stroke in the sample. By integrating large-scale miRNA profiling with circulating biomarkers as intermediate traits, we identified associations of known cardiac-related and novel miRNAs with two prognostic biomarkers and identified potential genomic networks regulating these biomarkers. These results, highlighting plausible biological pathways connecting miRNAs with biomarkers and outcomes, may inform future studies seeking to delineate genomic pathways underlying NSTE-ACS outcomes.

5.
N Engl J Med ; 2019 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-31556978

RESUMO

BACKGROUND: Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS: In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS: We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% CI, -0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority). CONCLUSIONS: Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.).

7.
Artigo em Inglês | MEDLINE | ID: mdl-31435999

RESUMO

In this review, we report a contemporary appraisal of the available evidence focusing on adjunctive antithrombotic therapy and technical aspects of percutaneous coronary interventions (PCI) in patients with acute myocardial infarction and cardiogenic shock (AMICS). Only few randomized trials have been conducted to evaluate the optimal arterial access choice, antithrombotic therapy, stent type, or the role of aspiration thrombectomy in this population. Observational data suggest that a transradial approach should be preferred for experienced operators, although knowledge and experience of transfemoral access is required to place any mechanical support device. In the absence of high-quality evidence to guide choice of the adjunctive antithrombotic drugs to support PCI in patients with AMICS, knowledge of the altered pharmacokinetics and pharmacodynamics in shock is required to inform decisions. Drug-eluting stents should be favored over bare-metal stents, and routine thrombectomy is not encouraged. Owing to the challenges inherent to the conduct of randomized trials in this acutely ill patient population, concerted multicenter, and international efforts are paramount to orchestrate the development of high-quality evidence to guide clinical practice.

8.
Eur Heart J ; 40(32): 2671-2683, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31274157

RESUMO

Cardiogenic shock (CS) remains the most common cause of death in patients admitted with acute myocardial infarction (AMI) and mortality remained nearly unchanged in the range of 40-50% during the last two decades. Early revascularization, vasopressors and inotropes, fluids, mechanical circulatory support, and general intensive care measures are widely used for CS management. However, there is only limited evidence for any of the above treatment strategies except for revascularization and the relative ineffectiveness of intra-aortic balloon pumping. This updated review will outline the management of CS complicating AMI with major focus on state-of-the art treatment.

9.
Artigo em Inglês | MEDLINE | ID: mdl-31313448

RESUMO

OBJECTIVES: Patient centeredness is an essential component of high-quality care, yet little is known regarding the patient experience during procedures performed in the cardiac catheterization lab. BACKGROUND: Available literature focuses on the safe delivery of sedation, but does not address patient-reported satisfaction or comfort. Further delineation of how procedural factors impact the patient experience is needed. METHODS: We conducted a retrospective, exploratory analysis of adult cardiac catheterization outpatients (n = 375) receiving physician ordered, nurse administered procedural sedation (benzodiazepine and/or opioids) between April and June, 2017. Data were abstracted from the procedural database, Electronic Health Record, and Press Ganey© surveys. RESULTS: The mean age was 63 (SD 12.2), a majority were male (n = 226; 60%), white (n = 271; 73%), and overweight (mean body mass index = 29, SD 6.8). Patient-reported satisfaction with pain control and perceived staff concern for comfort were >75th percentile (Press Ganey© survey), with no difference in preprocedure and postprocedure pain scores (p = .596). Intraprocedural medication dose range and mean frequency were highly variable: midazolam (0.25-5.5 mg; 1.48); fentanyl (12.5-200 mcg; 1.63); and hydromorphone (0.5-2.5 mg; 1.33). Median time interval between administration of initial sedation and local anesthetic was 6 min. Patients with longer intervals had less frequent dosing (p < .001) and less total procedural sedation (p < .001). Sensitivity analysis revealed that trainee/fellow involvement (p = .001), younger age (p = .002), and shorter time intervals (p < .001) were associated with increased frequency and larger total dose. CONCLUSIONS: Waiting to gain vascular access following administration of procedural was associated with less frequent subsequent dosing, lower overall administration, and similar patient satisfaction. Optimizing processes for administering periprocedural sedation may allow for less medication without impacting patient experience.

10.
J Am Coll Cardiol ; 73(25): 3281-3291, 2019 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-31248549

RESUMO

BACKGROUND: The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial found clinical benefit of low-dose rivaroxaban plus aspirin, but at the expense of increased bleeding risk in patients with stable vascular disease. OBJECTIVES: This study evaluated the balance of ischemic and bleeding risks according to the presence of ≥1 enrichment criteria in "COMPASS-eligible" patients. METHODS: Key COMPASS selection criteria were applied to identify a COMPASS-eligible population (n = 16,875) from the REACH (REduction of Atherothrombosis for Continued Health) Registry of stable atherothrombotic patients. Ischemic outcome was the composite of cardiovascular death, myocardial infarction, or stroke. Bleeding outcome was serious bleeding (hemorrhagic stroke, hospitalization for bleeding, transfusion). RESULTS: Patients were categorized according to the enrichment criteria: age >65 years (81.5%), diabetes (41.0%), moderate renal failure (40.2%), peripheral artery disease (33.7%), current smoker (13.8%), heart failure (13.3%), ischemic stroke (11.1%), and asymptomatic carotid stenosis (8.7%). Each criterion was associated with a consistent increase in ischemic and bleeding events, but no individual subgroup derived a more favorable trade-off. Patients with multiple criteria had a dramatic increase in ischemic risk (7.0% [95% confidence interval (CI): 5.6% to 8.7%], 12.5% [95% CI: 11.1% to 14.1%], 16.6% [95% CI: 14.7% to 18.6%], and 21.8% [95% CI: 19.9% to 23.9%] with 1, 2, 3, and ≥4 enrichment criteria, respectively), but a more modest absolute increase in bleeding risk (1.5% [95% CI: 0.9% to 2.1%], 1.8% [95% CI: 1.3% to 2.2%], 2.0% [95% CI: 1.5% to 2.6%], 3.2% [95% CI: 2.6% to 3.9%]). CONCLUSIONS: In a population of stable vascular patients at high risk of atherothrombotic events, the subset with multiple enrichment criteria had a greater absolute increase in ischemic than in bleeding risk and may be good candidates for low-dose rivaroxaban in addition to aspirin.

11.
JAMA Cardiol ; 4(7): 680-684, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31141104

RESUMO

Importance: Physician behavior in response to knowledge of a patient's CYP2C19 clopidogrel metabolizer status is unknown. Objective: To investigate the association of mandatory reporting of CYP2C19 pharmacogenomic testing, provided to investigators with no direct recommendations on how to use these results, with changes in P2Y12 inhibitor use, particularly clopidogrel, in the Randomized Trial to Compare the Safety of Rivaroxaban vs Aspirin in Addition to Either Clopidogrel or Ticagrelor in Acute Coronary Syndrome (GEMINI-ACS-1) clinical trial. Design, Setting, and Participants: The GEMINI-ACS-1 trial compared rivaroxaban, 2.5 mg twice daily, with aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor (provided), in patients with recent acute coronary syndromes (ACS). The trial included 371 clinical centers in 21 countries and 3037 patients with ACS. Data were analyzed between May 2017 and February 2019. Interventions: Investigators were required to prestipulate their planned response to CYP2C19 metabolizer status. In response to a regulatory mandate, results for all patients were reported to investigators approximately 1 week after randomization. Main Outcomes and Measures: Reasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events were collected. Results: Of 3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with clopidogrel. Investigators prestipulated that they would use CYP2C19 metabolizer status to change P2Y12 inhibitor in 48.5% of genotyped clopidogrel-treated patients (n = 642 of 1324) and 5.5% of genotyped ticagrelor-treated patients (n = 93 of 1692). P2Y12 inhibitor switching for any reason occurred in 197 patients and was more common in patients treated with ticagrelor (146 of 1704 [8.6%]) compared with clopidogrel (51 of 1333 [3.8%]). Of patients initially treated with ticagrelor, only 1 (0.1% overall; 0.7% of all who switched) was switched based on CYP2C19 status. Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status. Of 48 patients (3.6%) with reduced metabolizer status treated initially with clopidogrel, 15 (31.3%) were switched based on metabolizer status, including 48.1% (13 of 27) in which switching was prestipulated. Conclusions and Relevance: Physicians were evenly split on how to respond to knowledge of CYP2C19 metabolizer status in clopidogrel-treated patients. Mandatory provision of this information rarely prompted P2Y12 inhibitor switching overall, including a minority of patients with reduced metabolizer status. These findings highlight the clinical equipoise among physicians regarding use of this information and the reluctance to use information from routine genotyping in the absence of definitive clinical trial data demonstrating the efficacy of this approach. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT02293395.

12.
Int J Cardiol ; 291: 36-41, 2019 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-30929973

RESUMO

BACKGROUND: The STICH trial showed superiority of coronary artery bypass plus medical treatment (CABG) over medical treatment alone (MED) in patients with left ventricular ejection fraction (LVEF) ≤35%. In previous publications, percutaneous coronary intervention (PCI) prior to CABG was associated with worse prognosis. OBJECTIVES: The main purpose of this study was to analyse if prior PCI influenced outcomes in STICH. METHODS AND RESULTS: Patients in the STICH trial (n = 1212), followed for a median time of 9.8 years, were included in the present analyses. In the total population, 156 had a prior PCI (74 and 82, respectively, in the MED and CABG groups). In those with vs. without prior PCI, the adjusted hazard-ratios (aHRs) were 0.92 (95% CI = 0.74-1.15) for all-cause mortality, 0.85 (95% CI = 0.64-1.11) for CV mortality, and 1.43 (95% CI = 1.15-1.77) for CV hospitalization. In the group randomized to CABG without prior PCI, the aHRs were 0.82 (95% CI = 0.70-0.95) for all-cause mortality, 0.75 (95% CI = 0.62-0.90) for CV mortality and 0.67 (95% CI = 0.56-0.80) for CV hospitalization. In the group randomized to CABG with prior PCI, the aHRs were 0.76 (95% CI = 0.50-1.15) for all-cause mortality, 0.81 (95% CI = 0.49-1.36) for CV mortality and 0.61 (95% CI = 0.41-0.90) for CV hospitalization. There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05). CONCLUSION: In the STICH trial, prior PCI did not affect the outcomes of patients whether they were treated medically or surgically, and the superiority of CABG over MED remained unchanged regardless of prior PCI. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov; Identifier: NCT00023595.

13.
Can J Cardiol ; 35(4): 430-437, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30935633

RESUMO

BACKGROUND: The effect of sex on self-reported frailty in acute coronary syndromes (ACS) is unclear. We examined the prevalence of self-reported frailty and its association with all-cause death among men and women. METHODS: Elderly (≥ 65 years) male (n = 2691) and female (n = 2305) patients with ACS enrolled in the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial were screened using the Fried Frailty Index. Sex differences in prevalence of frailty symptoms and categories (not frail; prefrail [1 to 2 symptoms]; and frail [≥ 3 symptoms]) and their prognostic importance were examined. RESULTS: Women were older and had higher rates of comorbidities than men. A total of 739 (27.5%) men and 645 (28%) women reported ≥ 1 frailty symptom. Prevalence of frailty increased with age among men but not women. During a median follow-up of 17.3 months, 353 (13.1%) men and 266 (11.5%) women died. After adjusting for age, prefrail men had a 35% increased risk (hazard ratio [HR] 1.35; 95% confidence interval [CI], 1.07-1.71), and frail men had an 80% increased risk (HR 1.80; 95% CI, 1.22-2.67) of death relative to not-frail men. The age-adjusted HR for death in prefrail women was 1.40 (95% CI, 1.07-1.84), and 1.55 (95% CI, 0.96-2.49) in frail women relative to not-frail women. Self-reported slow walk time and decreased physical activity appeared to provide the most prognostic information. CONCLUSION: Self-reported frailty was similar among men and women with ACS. Frailty increased with age only among men, in whom it added more prognostic information. Patient-reported frailty may identify elderly patients with ACS, particularly men, at high-risk of mortality.

14.
Am J Cardiol ; 123(7): 1026-1034, 2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30642606

RESUMO

International variability in infarct size following acute anterior ST-elevation myocardial infarction without shock treated with primary percutaneous coronary intervention (PCI) has been little studied. Patients enrolled in the Counterpulsation to Reduce Infarct Size pre-PCI for Acute Myocardial Infarction international randomized trial were analyzed according to their region of enrollment: United States (US) (n = 60), Europe/Australia (EU/AU) (n = 104), or India (n = 123). Cardiac magnetic resonance imaging was performed 3-5 days after PCI to assess infarct size, expressed as percentage of left ventricular mass, and analyzed by an imaging core laboratory. The relation between infarct size and region was modelled using multivariable linear regression adjusting for time from symptom onset to first hospital contact, myocardial infarction severity, and baseline characteristics. Infarct size was 36.4% of left ventricular mass in US patients (95% confidence interval [CI] 31.5 to 41.4), 36.5% (95% CI 32.6 to 40.4) in EU/AU patients, and 44.7% (95% CI 41.1 to 48.2) in patients from India (p = 0.01). In multiplicity-adjusted regression analysis, mean infarct size in patients from India was higher than in US patients (mean difference of 8.3%; 95% CI 0.7 to 15.8; p = 0.03), and EU/AU patients (mean difference of 8.2%; 95% CI 1.6 to 14.8; p = 0.01). There was no significance difference in infarct size between patients from the EU/AU and the US (mean difference of 0.1%; 95% CI -7.5 to 7.4; p = 0.99). ln conclusion, in patients with anterior ST-elevation myocardial infarction without cardiogenic shock treated with primary PCI, infarct size was larger in India compared to the United States and EU/AU, even after adjustment for performance metrics, including time to treatment, and other potential confounders. Future studies are needed to better elucidate this discrepancy.

15.
Circ Cardiovasc Qual Outcomes ; 11(12): e004755, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30562068

RESUMO

Background Cardiovascular clinical trials have traditionally incorporated separate time-to-first-event analyses for their primary efficacy and safety comparisons, but this framework has a number of limitations, including limited patient-centeredness and a traditional requirement for central adjudication. Days alive and out of the hospital (DAOH) has the potential to provide additional insight. Methods and Results TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a randomized, multinational clinical trial that compared the effect of prasugrel versus clopidogrel in patients stabilized after non-ST segment elevation acute coronary syndrome treated without revascularization; the trial had a neutral result. DAOH was calculated for each patient using site-submitted adverse event reporting data. We described patterns of DAOH overall, and among younger adults (<75 years old), older adults (≥75 years old), and frail/prefrail patients over 12 months follow-up and used Poisson regression to compare DAOH for patients randomized to prasugrel versus clopidogrel. Of 9249 patients in the overall trial population, 500 (5.4%) died, and 2504 (27.1%) were hospitalized 4150 times over 12 months' follow-up; the mean±SD DAOH was 317±86. The distribution of DAOH over 12 months was left-skewed, with median DAOH 363 days. Among younger adults, older adults, and frail/prefrail patients, mean DAOH were 323, 293, and 304 days, respectively. There were no differences in DAOH by treatment arm in the overall population (rate ratio, 1.00; 95% CI, 0.99-1.01) or any subgroup. Conclusions These results support the feasibility of determining DAOH, a patient-centered outcome that can potentially overcome many of the disadvantages of the traditional time-to-composite-event framework in the clinical trial setting. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00699998.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Clopidogrel/uso terapêutico , Hospitalização , Infarto do Miocárdio sem Supradesnível do Segmento ST/tratamento farmacológico , Assistência Centrada no Paciente/métodos , Inibidores da Agregação de Plaquetas/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Idoso , Clopidogrel/efeitos adversos , Método Duplo-Cego , Estudos de Viabilidade , Feminino , Nível de Saúde , Humanos , Tempo de Internação , Masculino , Infarto do Miocárdio sem Supradesnível do Segmento ST/sangue , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Inibidores da Agregação de Plaquetas/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
16.
Annu Rev Med ; 2018 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-30477393

RESUMO

Atrial fibrillation (AF) increases a patient's stroke risk four- to five-fold. Anticoagulation with the vitamin K antagonist (VKA) warfarin reduces the risk of stroke by 67%, but warfarin carries a significant risk of major bleeding and has unpredictable pharmacodynamics with a narrow therapeutic window, necessitating frequent monitoring of its anticoagulant effect. The non-vitamin K antagonist oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, and edoxaban provide more predictable anticoagulant activity than warfarin with a lower risk of major bleeding, and each is noninferior to warfarin for the prevention of stroke. All have earned regulatory approval in the past eight years. At least one of the NOACs is approved for use in all patients with AF, except those with mechanical valves and rheumatic mitral valve disease, for whom warfarin remains the only option. Recent clinical trials have shown that antithrombotic regimens including NOACs are safe and effective in patients with AF who need potent antiplatelet therapy. Expected final online publication date for the Annual Review of Medicine Volume 70 is January 27, 2019. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

17.
Circ Cardiovasc Interv ; 11(9): e007214, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30354607
18.
Am J Cardiol ; 122(8): 1322-1329, 2018 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-30135019

RESUMO

Patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) are sometimes treated with medical management alone rather than an invasive strategy. Among those medically managed without revascularization and discharged, a proportion will require revascularization later on, but little is known about this population. In TRILOGY ACS, 9,326 patients with NSTE ACS who were selected for medical management alone were randomized to treatment with prasugrel or clopidogrel and discharged without revascularization. Patient characteristics and ischemic and bleeding outcomes through 30 months were compared between patients who underwent downstream revascularization after the index hospitalization and those who did not. A total of 662 patients (7.1%) underwent later revascularization by percutaneous coronary intervention (73.1%), coronary artery bypass graft surgery (26.4%), or the two (0.5%). Median time to revascularization was 121 days (twenty-fifth, seventy-fifth percentiles: 41, 326). Revascularized patients were younger, more likely to be male, and had higher rates of hyperlipidemia, diabetes mellitus, prior myocardial infarction, and prior revascularization compared with those not revascularized. Europe and North America had the highest rates of revascularization. During the follow-up period, those who underwent revascularization had a higher rate of the composite outcome of cardiovascular death, myocardial infarction, or stroke occurring after revascularization compared with those not revascularized (hazard ratio [HR] 2.73 [95% confidence interval {CI} 2.21 to 3.38], p < 0.001) as well as a higher rate of each of the individual outcomes. Major bleeding was also higher in those who underwent revascularization (GUSTO severe or life-threatening: HR 2.61 [95% CI 1.02 to 6.67], p = 0.045; TIMI major: HR 2.24 [95% CI 1.12 to 4.48], p = 0.022). There was no evidence that bleeding and ischemic outcomes varied by treatment with clopidogrel versus prasugrel. In conclusion, among patients initially medically managed after NSTE ACS, a small proportion later require revascularization and have a high rate of ischemic and major bleeding outcomes compared with those not requiring downstream revascularization.

19.
Acad Med ; 93(11): 1631-1637, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30024472

RESUMO

Grateful patients provide substantial philanthropic funding for health care institutions, resulting in important societal benefits. Although grateful patient fundraising (GPFR) is widespread, it raises an array of ethical issues for patients, physicians, development professionals, and institutions. These issues have not been described comprehensively, and there is insufficient guidance to inform the ethical practice of GPFR. Consequently, the authors convened a "Summit on the Ethics of Grateful Patient Fundraising," with the goal of identifying primary ethical issues in GPFR and offering recommendations regarding how to manage them. Participants were 29 experts from across the United States who represented the perspectives of bioethics, clinical practice, development, law, patients, philanthropy, psychology, and regulatory compliance. Intensive discussions resulted in articulating ethical issues for physicians and other clinicians (discussions with patients about philanthropy; physician-initiated discussions; clinically vulnerable patients; conflicts of obligation and equity regarding physician's time, attention, and responsiveness and the provision of special services; and transparency and respecting donor intent) as well as for development officers and institutions (transparency in the development professional-donor relationship; impact on clinical care; confidentiality and privacy; conflicts of interest; institution-patient/donor relationship; concierge services for grateful patients; scientific merit and research integrity; transparency in use of philanthropic gifts; and institutional policies and training in responsible GPFR). While these recommendations promise to mitigate some of the ethical issues associated with GPFR, important next steps include conducting research on the ethical issues in GPFR, disseminating these recommendations, developing standardized training for clinicians regarding them, and revising them as warranted.

20.
JACC Heart Fail ; 6(6): 527-529, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29852934
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