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1.
J Cardiovasc Med (Hagerstown) ; 21(6): 453-459, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32355067

RESUMO

BACKGROUND: Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy. METHODS: Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission. RESULTS: Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (P = 0.01) more extensive coronary disease (P = 0.02), more advanced Killip class at presentation (P = 0.003), use at admission of statins (P = 0.004) and diuretics at discharge (P < 0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = 1.89 (0.93-3.87), P = 0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), P = 0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabetic patients [HR (95% CI) 2.02 (1.14-3.6), P = 0.02; adjusted HR (95% CI) = 2.1 (1.01-4.3), P = 0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome. CONCLUSION: Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.

2.
Artigo em Inglês | MEDLINE | ID: mdl-32371657

RESUMO

BACKGROUND: Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy. METHODS: Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission. RESULTS: Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (P = 0.01) more extensive coronary disease (P = 0.02), more advanced Killip class at presentation (P = 0.003), use at admission of statins (P = 0.004) and diuretics at discharge (P < 0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = 1.89 (0.93-3.87), P = 0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), P = 0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabetic patients [HR (95% CI) 2.02 (1.14-3.6), P = 0.02; adjusted HR (95% CI) = 2.1 (1.01-4.3), P = 0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome. CONCLUSION: Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.

3.
ESC Heart Fail ; 2020 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-32426906

RESUMO

AIMS: The optimization of guideline-directed medical therapy (GDMT) in reduced ejection fraction heart failure (HFrEF) is associated with improved survival and can reduce the severity of secondary mitral regurgitation (SMR). Highest tolerated doses should be achieved before percutaneous mitral valve repair (pMVR) and drugs titration further pursued after procedure. The degree of GDMT titration in patients with HFrEF and SMR treated with pMVR remains unexplored. We sought to evaluate the adherence to GDMT in HFrEF in patients undergoing pMVR and to explore the association between changes in GDMT post-pMVR and prognosis. METHODS AND RESULTS: We included all the patients with HFrEF and SMR ≥ 3 + treated with pMVR between 2012 and 2019 and with available follow-up. GDMT, comprehensive of dosages, was systematically recorded. The study endpoint was a composite of death and heart transplantation. Among 133 patients successfully treated, 121 were included (67 ± 12 years old, 77% male patients). Treatment rates of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor neprilysin inhibitor (ACEIs/ARBs/ARNI), beta-blockers, and mineralcorticoid receptor antagonist at baseline and follow-up were 73% and 79%, 85% and 84%, 70% and 70%, respectively. At baseline, 33% and 32% of patients were using >50% of the target dose of ACEI/ARB/ARNI and beta-blockers. At follow-up (median time 4 months), 33% of patients unchanged, 34% uptitrated, and 33% of patients downtitrated GDMT. Downtitration of GDMT was independently associated with higher risk of death/heart transplantation (hazard ratio: 2.542, 95%confidence interval: 1.377-4.694, P = 0.003). CONCLUSIONS: Guideline-directed medical therapy is frequently underdosed in HFrEF patients with SMR undergoing pMVR. Downtitration of medications after procedure is associated with poor prognosis.

4.
Am J Emerg Med ; 2020 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-32139214

RESUMO

BACKGROUND: The impact of patient delay on left ventricular ejection fraction (LVEF), when system delay has performance that meets the current recommended guidelines, is poorly investigated. METHODS: We evaluated a cohort of STEMI patients treated with primary percutaneous coronary intervention (pPCI) and with an ECG STEMI diagnosis to wire crossing time (ETW) ≤120 min. Independent predictors of pre-discharge decreased LVEF (≤45%) were analyzed. RESULTS: 490 STEMI patients with both ETW time ≤120 min and available pre-discharge LVEF were evaluated. Mean age was 64.2 ± 12 years, 76.2% were male, 19.5% were diabetics, 42.7% had and anterior myocardial infarction (MI), and 9.8% were in Killip class III-IV. Median time of patient's response to initial symptoms (patient delay) was 58,5 (IQR 30;157) minutes and median ETW time was 78 (IQR 62-95) minutes. 115 patients (23.4%) had pre-discharge LVEF ≤45%. At multivariable analysis independent predictors of decreased LVEF (≤45%) were anterior MI (OR 4,659, 95% CI 2,618-8,289, p < 0,001), Killip class (OR 1,449, 95% CI 1,090-1,928, p = 0,011) and patients delay above the median (OR 2,030, 95% CI 1,151-3.578, p = 0,014). These independent predictors were confirmed in patients with ETW time ≤90 min. CONCLUSIONS: When system delay meets the recommended criteria for pPCI, patient delay becomes an independent predictor of pre-discharge LVEF. These findings provide further insights into the potential optimization of STEMI management and identify a target that needs to be improved, considering that still a significant proportion of patients continue to delay seeking medical care.

5.
Nutr Metab Cardiovasc Dis ; 30(5): 730-737, 2020 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-32127336

RESUMO

BACKGROUND AND AIM: Elderly patients are at increased risk of hemorrhagic and thrombotic complications after an acute coronary syndrome (ACS). Frailty, comorbidities and low body weight have emerged as conditioning the prognostic impact of dual antiplatelet therapy (DAPT). The aim of the present study was to investigate the prognostic impact of body mass index (BMI) on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study comparing low-dose (5 mg) prasugrel vs clopidogrel among elderly patients with ACS. METHODS AND RESULTS: Our population is represented by 1408 patients enrolled in the Elderly-ACS 2 trial. BMI was calculated at admission. The primary endpoint of this analysis was cardiovascular (CV) mortality. Secondary endpoints were all-cause death, recurrent MI, Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding, and re-hospitalization for cardiovascular reasons or stent thrombosis within 12 months after index admission. Patients were grouped according to median values of BMI (

7.
J Card Surg ; 35(2): 460-463, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31778572

RESUMO

AIMS: The case we report, shows a successful treatment of right ventricle endomyocardial fibrosis. MATERIALS AND METHODS: Surgical therapy by endocardial decortication seems to be beneficial for many patients with advanced disease who are in functional-therapeutic class III or IV. The operative mortality rate is high, but successful surgery has a clear benefit on symptoms and seems to favourably affect survival as well.

8.
G Ital Cardiol (Rome) ; 20(12): 706-721, 2019 Dec.
Artigo em Italiano | MEDLINE | ID: mdl-31834295

RESUMO

The management of patients with heart disease or suspected heart disease, who are hospitalized and/or who should undergo surgery or an invasive procedure, is very complex for the comorbidities often present, the multiple therapies taken and the frequent presence of advanced cardiac devices.The purpose of this document is to provide indications and standardize the behavior of different clinicians in the management of heart disease patients or those with suspected heart disease in order (i) to manage acute cardiac conditions with appropriate timing and accuracy, and (ii) to define the cardiovascular risk in the individual patient with appropriate timing and indications, allowing patients to face any surgery or invasive procedure with the lowest risk correlated to his heart disease.

9.
Curr Cardiol Rep ; 21(11): 139, 2019 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-31734930

RESUMO

PURPOSE OF REVIEW: To analyze the current state of the art of functional mitral regurgitation (FMR) treatment. RECENT FINDINGS: The first-line treatment of severe FMR consists of guideline medical therapy (GMT) and resynchronization therapy when indicated; the impact of new medical therapies like sacubitril/valsartan needs further assessment. Valvular intervention may be considered in FMR symptomatic patients despite GMT, and can be performed surgically or percutaneously. MitraClip is a safe percutaneous procedure associated with symptoms improvement. Recently, the COAPT trial showed superior outcomes for MitraClip versus GMT contrasting the MITRA-FR trial which showed no benefit of MitraClip compared with GMT. These results should be interpreted as complementary rather than opposite. The COAPT trial provided a "proof of concept" that percutaneous treatment of severe FMR in patients without too advanced left ventricular disease translates into a prognostic benefit. Careful patient selection will play a critical role in defining the clinical niche for successful interventions.

10.
Eur Heart J Acute Cardiovasc Care ; : 2048872619884858, 2019 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-31696727

RESUMO

BACKGROUND: Pericardial effusion is frequent in the acute phase of ST-segment elevation myocardial infarction. However, its prognostic role in the era of primary percutaneous coronary intervention is not completely understood. METHODS: We investigated the association between pericardial effusion, assessed by transthoracic echocardiography, and survival in a large cohort of ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention, enrolled in the Trieste primary percutaneous coronary intervention registry from January 2007 to March 2017. Multivariable analysis and a propensity score approach were performed. RESULTS: A total of 1732 ST-segment elevation myocardial infarction patients were included. Median follow-up was 45 (interquartile range 19-79) months. Pericardial effusion was present in 246 patients (14.2%). Thirty-day all-cause mortality was similar between patients with and without pericardial effusion (7.8% vs. 5.4%, P=0.15), whereas crude long-term survival was worse in patients with pericardial effusion (26.2% vs. 17.7%, P≤0.01). However, at multivariable analyses the presence of pericardial effusion was not associated with long-term mortality (hazard ratio 1.26, 95% confidence interval 0.86-1.82, P=0.22). Matching based on propensity scores confirmed the lack of association between pericardial effusion and both 30-day (hazard ratio 1, 95% confidence interval 0.42-2.36, P=1) and long-term (hazard ratio 1.14, 95% confidence interval 0.74-1.78, P=0.53) all-cause mortality. Patients with pericardial effusion experienced a higher incidence of free wall rupture (2.8% vs. 0.5%, P<0.0001) independently of the entity of pericardial effusion. CONCLUSIONS: In acute ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention, the onset of pericardial effusion after ST-segment elevation myocardial infarction is not independently associated with short and long-term higher mortality. Free wall rupture has to be considered rare compared to the fibrinolytic era and occurs more frequently in patients with pericardial effusion, suggesting a close monitoring of these patients in the early post-primary percutaneous coronary intervention phase.

11.
J Cardiovasc Echogr ; 29(3): 89-94, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31728298

RESUMO

Sudden death accounts for 400,000 deaths annually in the United States. Most sudden deaths are cardiac and are related to arrhythmias secondary to structural heart disease or primary electrical abnormalities of the heart. Implantable cardioverter defibrillator significantly improves survival in patients at increased risk of life-threatening arrhythmias, but better selection of eligible patients is required to avoid unnecessary implantation and identify those patients who may benefit most from this therapy. Left ventricular (LV) ejection fraction (EF) measured by echocardiography has been considered the most reliable parameter for long-term outcome in many cardiac diseases. However, LVEF is an inaccurate parameter for arrhythmic risk assessment as patients with normal or mildly reduced LV systolic function could experience sudden cardiac death (SCD). Among other tools for arrhythmic stratification, magnetic resonance (CMR) provides the most comprehensive cardiac evaluation including in vivo tissue characterization and significantly aids in the identification of patients at higher SCD risk. Most of the evidence are related to late gadolinium enhancement (LGE), which was proven to detect cardiac fibrosis. LGE has been reported to add incremental value for prognostic stratification and SCD prediction across a wide range of cardiac diseases, including both ischemic and nonischemic cardiomyopathies. In addition, T1, T2 mapping and extracellular volume assessment were reported to add incremental value for arrhythmic assessment despite suffering from several technical limitations. CMR should be part of a multiparametric approach for patients' evaluation, and it will play a pivotal role in prognostic stratification according to the current evidence.

12.
J Am Soc Echocardiogr ; 32(11): 1436-1443, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31551186

RESUMO

PURPOSE: Patients with symptomatic heart failure (HF), reduced left ventricular ejection fraction (LVEF), and high-grade functional mitral regurgitation (MR) may benefit from percutaneous edge-to-edge mitral valve repair (PMVR). However, patient selection still remains a central issue. We sought to investigate the potential role of the global longitudinal strain- (GLS-) based left ventricular contractile reserve (LVCR) at dobutamine stress echocardiography (DSE) in this setting. METHODS: Thirty-three stable HF patients (MR grade ≥ 3+; median LVEF, 29%; median GLS, -8.3%) who were candidates for PMVR were prospectively enrolled. All patients underwent DSE to assess LVCR (LVEF increase ≥ 5%; GLS increase ≥ 2%; stroke volume [SV] increase ≥ 20% of the measured SV value). RESULTS: After DSE, a positive LVCRLVEF was detected in 21 patients (64%), positive LVCRGLS in 12 patients (36%), and positive LVCRSV in 14 patients (42%). LVCRGLS was associated with better symptom relief, MR improvement, and LV reverse remodeling in a short-term follow-up. A significant improvement of GLS during DSE (hazard ratio [HR], 0.549; 95% CI, 0.395-0.765; P < .001), along with history of HF hospitalization (HR, 1.48; 95% CI, 1.119-1.967; P = .006) and beta-blocker therapy (HR, 0.146; 95% CI, 0.046-0.462; P = .001), were independently associated with risk of death/heart transplantation/HF-related hospitalizations. CONCLUSIONS: LVCR, assessed by speckle-tracking DSE, is associated with better results after PMVR in the setting of advanced HF. Improvement of longitudinal function emerged, beyond the ejection fraction, as an independent predictor of outcomes and could improve the selection of best candidates for the percutaneous correction of functional MR.

15.
G Ital Cardiol (Rome) ; 20(4 Suppl 1): 27S-35S, 2019 04.
Artigo em Italiano | MEDLINE | ID: mdl-30994631

RESUMO

Tricuspid regurgitation is a frequent valvular heart disease, particularly in the elderly and in association with other left-sided heart diseases. It has an adverse prognostic impact, with progressively increasing mortality as the degree of regurgitation increases. Isolated or combined (with mitral and/or aortic) surgery remains the treatment of choice, provided operative risk is acceptable. Several transcatheter treatment techniques, currently in early clinical or preclinical study phase, could provide alternative treatment options for patients with high surgical risk.


Assuntos
Cateterismo Cardíaco/métodos , Insuficiência da Valva Tricúspide/cirurgia , Idoso , Humanos , Prognóstico , Índice de Gravidade de Doença , Insuficiência da Valva Tricúspide/mortalidade , Insuficiência da Valva Tricúspide/fisiopatologia
16.
Am J Med ; 132(2): 209-216, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30447205

RESUMO

INTRODUCTION: Acute coronary syndromes (ACS) have been classified according to the finding of ST-segment elevation on the presenting electrocardiogram, with different treatment strategies and practice guidelines. However, a comparative description of the clinical characteristics and outcomes of acute coronary syndrome elderly patients undergoing percutaneous coronary intervention during index admission has not been published so far. METHODS: Retrospective cohort study of patients enrolled in the Elderly ACS-2 multicenter randomized trial. Main outcome measures were crude cumulative incidence and cause-specific hazard ratio (cHR) of cardiovascular death, noncardiovascular death, reinfarction, and stroke. RESULTS: Of 1443 ACS patients aged >75 years (median age 80 years, interquartile range 77-84), 41% were classified as ST-elevation myocardial infarction (STEMI), and 59% had non-ST-elevation ACS (NSTEACS) (48% NSTEMI and 11% unstable angina). As compared with those with NSTEACS, STEMI patients had more favorable baseline risk factors, fewer prior cardiovascular events, and less severe coronary disease, but lower ejection fraction (45% vs 50%, P < .001). At a median follow-up of 12 months, 51 (8.6%) STEMI patients had died, vs 39 (4.6%) NSTEACS patients. After adjusting for sex, age, and previous myocardial infarction, the hazard among the STEMI group was significantly higher for cardiovascular death (cHR 1.85; 95% confidence interval [CI], 1.02-3.36), noncardiovascular death (cHR 2.10; 95% CI, 1.01-4.38), and stroke (cHR 4.8; 95% CI, 1.7-13.7). CONCLUSIONS: Despite more favorable baseline characteristics, elderly STEMI patients have worse survival and a higher risk of stroke compared with NSTEACS patients after percutaneous coronary intervention.


Assuntos
Síndrome Coronariana Aguda/terapia , Eletrocardiografia , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
18.
Am J Cardiol ; 122(3): 490-497, 2018 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-29958711

RESUMO

Defining short-term prognosis in nonischemic cardiomyopathy (NICM) is challenging in clinical practice. Although left ventricular reverse remodeling (LVRR) is a key prognostic marker in NICM there are few parameters able to predict it. We investigated whether a complete structural and functional cardiac magnetic resonance imaging (cMRI) evaluation was incremental to the classic clinical-echocardiographic approach in predicting LVRR in a large cohort of NICM patients receiving evidence-based treatment. Patients with a recent diagnosis of NICM (<3 months) who underwent complete clinical, echocardiographic and cMRI assessment were consecutively enrolled from 2008 to 2016. LVRR was defined as an increase in ≥10 points or normalization of left ventricular ejection fraction, associated with a ≥10% reduction or normalization of left ventricular end-diastolic diameter at midterm (median time 20 months) echocardiographic follow-up. Among 80 NICM patients included in the study, LVRR was observed in 43 (54%). At multivariate analysis, the clinical-echocardiographic evaluation failed to identify independent predictors of LVRR. However, absence of late gadolinium enhancement (odds ratio [OR] 9.07; confidence interval [CI] 2.7 to 13.1; p value 0.0003), left ventricular mass (OR 1.018; CI 1.001 to 1.036; p value 0.045) and peak circumferential strain (OR 1.213; CI 1.011 to 1.470; p value 0.049) assessed by cMRI were independently associated with LVRR. A model for LVRR prediction based on cMRI and clinical-echocardiographic parameters performed significantly better than the clinical-echocardiographic model alone (area under curve 0.84 vs 0.72; p value 0.023). In conclusion, an integrated imaging approach with the addition of a structural and functional cMRI study to the standard-of-care evaluation improves the prediction of LVRR in a large cohort of patients with recently diagnosed NICM receiving evidence-based treatment.


Assuntos
Cardiomiopatias/diagnóstico , Ecocardiografia/métodos , Ventrículos do Coração/diagnóstico por imagem , Imagem Cinética por Ressonância Magnética/métodos , Função Ventricular Esquerda/fisiologia , Remodelação Ventricular/fisiologia , Adulto , Idoso , Cardiomiopatias/fisiopatologia , Eletrocardiografia Ambulatorial , Feminino , Seguimentos , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos
19.
G Ital Cardiol (Rome) ; 19(6): 371-378, 2018 Jun.
Artigo em Italiano | MEDLINE | ID: mdl-29912226

RESUMO

Hypertrabeculation is a feature of the left ventricle that, by itself, does not coincide with left ventricular non compaction (LVNC), which represents a specific cardiomyopathy. Nowadays, in the absence of gold standard diagnostic criteria, the clinician must integrate imaging aspects together with medical history. The family inheritance for LVNC, presence of neuromuscular disorders, symptoms or signs of heart failure, thromboembolic events, unexplained syncope, pathological findings at rest ECG, Holter ECG, stress test, systolic/diastolic dysfunction at rest echocardiogram, late gadolinium enhancement at cardiac magnetic resonance, and identification of specific mutations are all considered features useful for the diagnosis. Many aspects are not fully understood: multicenter studies, registers and observational studies are needed for a better comprehension of the pathology, adequate risk stratification and targeted follow-up.


Assuntos
Ecocardiografia/métodos , Eletrocardiografia/métodos , Miocárdio Ventricular não Compactado Isolado/diagnóstico , Meios de Contraste/administração & dosagem , Eletrocardiografia Ambulatorial/métodos , Teste de Esforço/métodos , Gadolínio/administração & dosagem , Humanos , Miocárdio Ventricular não Compactado Isolado/fisiopatologia , Imagem por Ressonância Magnética/métodos
20.
Circulation ; 137(23): 2435-2445, 2018 06 05.
Artigo em Inglês | MEDLINE | ID: mdl-29459361

RESUMO

BACKGROUND: Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome and display higher on-clopidogrel platelet reactivity compared with younger patients. Prasugrel 5 mg provides more predictable platelet inhibition compared with clopidogrel in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding. METHODS: In a multicenter, randomized, open-label, blinded end point trial, we compared a once-daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years of age with acute coronary syndrome undergoing percutaneous coronary intervention. The primary end point was the composite of mortality, myocardial infarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg. RESULTS: Enrollment was interrupted, according to prespecified criteria, after a planned interim analysis, when 1443 patients (40% women; mean age, 80 years) had been enrolled with a median follow-up of 12 months, because of futility for efficacy. The primary end point occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (hazard ratio, 1.007; 95% confidence interval, 0.78-1.30; P=0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel versus 1.9% with clopidogrel (odds ratio, 0.36; 95% confidence interval, 0.13-1.00; P=0.06). Bleeding Academic Research Consortium types 2 and greater rates were 4.1% with prasugrel versus 2.7% with clopidogrel (odds ratio, 1.52; 95% confidence interval, 0.85-3.16; P=0.18). CONCLUSIONS: The present study in elderly patients with acute coronary syndromes showed no difference in the primary end point between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in light of the premature termination of the trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01777503.


Assuntos
Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/terapia , Clopidogrel/administração & dosagem , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Cloridrato de Prasugrel/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Clopidogrel/efeitos adversos , Intervalo Livre de Doença , Feminino , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Humanos , Masculino , Intervenção Coronária Percutânea , Cloridrato de Prasugrel/efeitos adversos , Taxa de Sobrevida
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