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1.
J Am Coll Cardiol ; 78(21): 2060-2072, 2021 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-34794687

RESUMO

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown. OBJECTIVES: The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation. METHODS: The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI. RESULTS: A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference -0.2%; 95% CI: -2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference -2.5%; 95% CI: -4.6% to -0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference -1.1%; 95% CI: -2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015). CONCLUSIONS: Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742).

2.
JACC Cardiovasc Interv ; 14(17): 1870-1883, 2021 09 13.
Artigo em Inglês | MEDLINE | ID: mdl-34503737

RESUMO

OBJECTIVES: The aim of this study was to evaluate 2 abbreviated dual-antiplatelet therapy (DAPT) regimens in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). BACKGROUND: Current-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown. METHODS: The XIENCE Short DAPT program included 3 prospective, multicenter, single-arm studies enrolling HBR patients who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. After 1 month (XIENCE 28 USA and XIENCE 28 Global) or 3 months (XIENCE 90) of DAPT, event-free patients discontinued the P2Y12 inhibitor. The postmarketing approval XIENCE V USA study was used as historical control in a propensity score-stratified analysis. RESULTS: A total of 3,652 patients were enrolled. The propensity-adjusted rate of the primary endpoint of all-cause mortality or myocardial infarction was 5.4% among 1,693 patients on 3-month DAPT versus 5.4% in the 12-month DAPT historical control (Pnoninferiority = 0.0063) and 3.5% among 1,392 patients on 1-month DAPT versus 4.3% in the 6-month DAPT historical control (Pnoninferiority = 0.0005). Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding was not significantly lower with 3- or 1-month DAPT, while BARC types 3 to 5 bleeding was reduced in both experimental groups. The rate of definite or probable stent thrombosis was 0.2% in XIENCE 90 (P < 0.0001 for the performance goal of 1.2%) and 0.3% in XIENCE 28. CONCLUSIONS: Among HBR patients undergoing PCI with cobalt-chromium everolimus-eluting stents, DAPT for 1 or 3 months was noninferior to 6 or 12 months of DAPT for ischemic outcomes and may be associated with less major bleeding and a low incidence of stent thrombosis.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Quimioterapia Combinada , Everolimo/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento
4.
Am Heart J ; 231: 147-156, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33031789

RESUMO

Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI); however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3 months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short DAPT Program will provide insights into the safety and efficacy of 2 abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Aspirina/administração & dosagem , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação Plaquetária/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Aspirina/efeitos adversos , Canadá , Causas de Morte , Esquema de Medicação , Stents Farmacológicos/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Acidente Vascular Cerebral , Trombose , Estados Unidos
5.
JACC Cardiovasc Interv ; 13(21): 2467-2478, 2020 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-33153563

RESUMO

OBJECTIVES: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS). BACKGROUND: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm. METHODS: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively. RESULTS: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm2, and a 4.1% rate of moderate paravalvular leak at 30 days. CONCLUSIONS: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Austrália , Europa (Continente) , Feminino , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
6.
JACC Cardiovasc Interv ; 10(23): 2349-2359, 2017 12 11.
Artigo em Inglês | MEDLINE | ID: mdl-29216997

RESUMO

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Desenho de Prótese , Tomada de Decisão Clínica , Consenso , Doença da Artéria Coronariana/diagnóstico por imagem , Reestenose Coronária/etiologia , Trombose Coronária/etiologia , Difusão de Inovações , Medicina Baseada em Evidências , Humanos , Seleção de Pacientes , Intervenção Coronária Percutânea/efeitos adversos , Falha de Prótese , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
7.
Rev Cardiovasc Med ; 14(2-4): e136-43, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24448255

RESUMO

Fibromuscular dysplasia (FMD) is a nonatheromatous, noninflammatory arteriopathy with segmental involvement of medium-sized arteries in multiple vascular beds. It most commonly involves the renal and carotid arteries. The etiology is unknown, although various hormonal and mechanical factors have been suggested. The disease can occur at any age but is usually diagnosed in middle-aged individuals, predominantly women. FMD is much more common than previously thought, perhaps affecting as many as 4% of adult women. Clinical manifestations of the internal carotid artery involvement are transitory ischemic attacks or cerebral infarction, as well as nonspecific symptoms such as headache and vertigo. In cases of cerebrovascular events, endovascular or surgical treatment is recommended; therefore, detection of FMD is of considerable importance. The gold standard for diagnosing FMD is catheter angiography (with the classic "string of beads" pattern), but this invasive procedure is only used for patients in whom it is clinically pertinent to proceed with revascularization. The optimal noninvasive modality for diagnosis and quantification for FMD is not known and little information has been recently published about new diagnostic modalities. Although angiography, computed tomography angiography, and magnetic resonance angiography are excellent in confirming the morphologic diagnosis of FMD, they are less accurate in assessing the hemodynamic significance of the lesions. Ultrasonography is useful in assessing the degree of carotid artery stenosis. Use of power Doppler ultrasound improves the ability to detect the morphologic features of carotid FMD.


Assuntos
Doenças das Artérias Carótidas/diagnóstico por imagem , Displasia Fibromuscular/diagnóstico por imagem , Ultrassonografia Doppler , Aspirina/administração & dosagem , Fármacos Cardiovasculares/administração & dosagem , Doenças das Artérias Carótidas/tratamento farmacológico , Feminino , Displasia Fibromuscular/tratamento farmacológico , Humanos , Angiografia por Ressonância Magnética , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Tomografia Computadorizada por Raios X , Ultrassonografia Doppler em Cores
10.
J Thorac Oncol ; 3(7): 800-2, 2008 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-18594329

RESUMO

This report describes a patient diagnosed with a cardiac angiosarcoma. The patient presented with cardiac tamponade. A pericardiocentesis revealed a bloody effusion, but cytology was nondiagnostic and a chest computed tomography showed only mediastinal lymphadenopathy. His pericardial effusion recurred 3 weeks later, at which time he was found to have a large right atrial mass which proved to be a cardiac angiosarcoma. This case report underscores the difficulties encountered in the diagnosis of cardiac angiosarcoma.


Assuntos
Neoplasias Cardíacas/complicações , Hemangiossarcoma/complicações , Derrame Pericárdico/etiologia , Tamponamento Cardíaco/etiologia , Neoplasias Cardíacas/diagnóstico , Neoplasias Cardíacas/patologia , Hemangiossarcoma/diagnóstico , Hemangiossarcoma/patologia , Humanos , Masculino , Pessoa de Meia-Idade
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