Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 515
Filtrar
1.
J Evid Based Med ; 2023 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-36632678

RESUMO

BACKGROUND: FAVOR III China (F3C) is a large-scale randomized trial comparing QFR-guided and angiography-guided percutaneous coronary intervention (PCI) strategies. The aim of current study was to assess the feasibility of predicting the 1-year outcomes of the F3C trial using simulation of retrospectively assessed quantitative flow ratio (QFR) data obtained from the all-comers PANDA III trial. METHODS: Among 2348 subjects from the PANDA III trial, angiography from 1391 patients was able to be analyzed with QFR. Each subject from the F3C was matched to a PANDA III patient according to the five baseline characteristics (age, sex, diabetes, multivessel disease, and existence of any vessel with diameter stenosis % >90% and thrombolysis in myocardial infarction flow <3) through a bootstrapping sampling process. Outcome predictions were based on these blinded baseline data. The primary endpoint was a composite of death, myocardial infarction, or revascularization at 1 year. RESULTS: Among the patients with analyzable QFR, 814 patients were able to be matched to F3C patients undergoing a QFR-guided treatment strategy. After 10,000 simulations, the patients in the QFR-guided group were simulated to have a 1.9% (95% predictive intervals: -3.5% to -0.3%) absolute reduction of the occurrence of the primary study endpoint compared with the angiography-guided group. In total, 72.7% (7266/10,000) simulated point estimates fell within the actual 95% CI of F3C (-4.7% to -1.4%). CONCLUSIONS: Using a simulation process based on a comparison to an existing trial cohort, the primary results of a prospectively conducted randomized controlled trial could be predicted with reasonable precision.

2.
J Am Heart Assoc ; 12(1): e026482, 2023 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-36565189

RESUMO

Background Diabetes mellitus and high platelet reactivity (HPR) on clopidogrel are both associated with increased risk of ischemic events after percutaneous coronary intervention, but whether the HPR-associated risk of adverse ischemic events differs by diabetes mellitus status is unknown. Methods and Results ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. HPR was defined as P2Y12 reaction units >208 by the VerifyNow point-of-care assay. Cox multivariable analysis was used to assess whether HPR-associated risk of major adverse cardiac events (MACE; cardiac death, myocardial infarction, or stent thrombosis) varied for patients with insulin-treated diabetes mellitus (ITDM), non-ITDM, and no diabetes mellitus. Diabetes mellitus and HPR were included in an interaction analysis. Of 8582 patients enrolled, 2429 (28.3%) had diabetes mellitus, of whom 998 (41.1%) had ITDM. Mean P2Y12 reaction units were higher in patients with diabetes mellitus versus without diabetes mellitus, and HPR was more frequent in patients with diabetes mellitus. HPR was associated with consistently increased 2-year rates of MACE in patients with and without diabetes mellitus (Pinteraction=0.36). A significant interaction was present between HPR and non-insulin-treated diabetes mellitus versus ITDM for 2-year MACE (adjusted hazard ratio [HR] for non-ITDM, 2.28 [95% CI, 1.39-3.73] versus adjusted HR for ITDM, 1.02 [95% CI, 0.70-1.50]; Pinteraction=0.01). Conclusions HPR was more common in patients with diabetes mellitus and was associated with an increased risk of MACE in both patients with and without diabetes mellitus. In patients with diabetes mellitus, a more pronounced effect of HPR on MACE was present in lower-risk non-ITDM patients than in higher-risk patients with ITDM. Registration URL: https://clinicaltrials.gov/ct2/show/NCT00638794; Unique identifier: NCT00638794. ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents).


Assuntos
Doença da Artéria Coronariana , Diabetes Mellitus , Intervenção Coronária Percutânea , Humanos , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Fatores de Risco , Plaquetas , Clopidogrel/uso terapêutico , Clopidogrel/farmacologia , Isquemia/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Doença da Artéria Coronariana/complicações , Diabetes Mellitus/etiologia
3.
JACC Cardiovasc Interv ; 15(21): 2206-2217, 2022 11 14.
Artigo em Inglês | MEDLINE | ID: mdl-36357025

RESUMO

BACKGROUND: Although the presence of severe stenosis in the left main coronary artery (LMCA) is a well-established predictor of mortality, whether this extends to nonobstructive atherosclerosis in the LMCA is unknown. OBJECTIVES: The aim of this study was to evaluate the association between LMCA disease by intravascular ultrasound (IVUS) and long-term mortality. METHODS: Between 2005 and 2013, 3,239 patients with LMCA IVUS imaging without LMCA revascularization (either before angiography or scheduled based on index angiography or IVUS) were included. The primary and secondary endpoints were all-cause and cardiac mortality at a minimum of 5 years obtained from the National Death Index. RESULTS: The IVUS-measured LMCA minimum lumen area (MLA) and plaque burden were 13.1 ± 5.0 mm2 and 41.7% ± 15.6%, respectively. The median follow-up was 8.2 years. The Kaplan-Meier estimated 12-year all-cause and cardiac death rates were 37.5% and 17.0%, respectively. Greater plaque burden (unadjusted HR per 10%: 1.17; 95% CI: 1.12-1.22; P < 0.0001) and smaller IVUS MLA (unadjusted HR per 1 mm2: 0.98; 95% CI: 0.96-0.99; P = 0.0008) were associated with all-cause death. After adjusting for clinical, angiographic, and IVUS factors, plaque burden (adjusted HR per 10%: 1.12; 95% CI: 1.04-1.21; P = 0.003) but not MLA (adjusted HR per 1 mm2: 1.02; 95% CI: 0.99-1.04; P = 0.18) was associated with long-term all-cause death. These findings were also consistent for long-term cardiac mortality. CONCLUSIONS: In the present large-scale study with a 12-year follow-up, increasing LMCA plaque burden was associated with long-term all-cause and cardiac mortality in patients not undergoing LMCA revascularization, even when the lumen area was preserved.


Assuntos
Aterosclerose , Doença da Artéria Coronariana , Placa Aterosclerótica , Humanos , Vasos Coronários/diagnóstico por imagem , Angiografia Coronária/métodos , Ultrassonografia de Intervenção/métodos , Resultado do Tratamento , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia
4.
JAMA Cardiol ; 2022 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-36350593

RESUMO

Importance: Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial. Objectives: To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications. Design, Setting, and Participants: This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. This was an international, multicenter study conducted in the US and Europe. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m2 or greater were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment. Interventions: uRDN vs sham procedure in conjunction with added medications to target BP control. Main Outcomes and Measures: Six-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP and medications, and safety. Results: A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m2 had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 [1.0] medications) vs sham (mean [SD], 1.1 [1.1] medications; P = .045) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (26 of 65 [40.0%] vs 39 of 64 [60.9%]; P = .02). Despite less intensive standardized stepped-care antihypertensive treatment, mean (SD) daytime ambulatory BP at 6 months was 138.3 (15.1) mm Hg with uRDN vs 139.0 (14.3) mm Hg with sham (additional decreases of -2.4 [16.6] vs -7.0 [16.7] mm Hg from month 2, respectively), whereas home SBP was lowered to a greater extent with uRDN by 4.3 mm Hg (95% CI, 0.5-8.1 mm Hg; P = .03) in a mixed model adjusting for baseline and number of medications. Adverse events were infrequent and similar between groups. Conclusions and Relevance: In this study, in patients with RHTN initially randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, standardized stepped-care antihypertensive treatment escalation resulted in similar BP reduction in both groups at 6 months, with fewer additional medications required in the uRDN group. Trial Registration: ClinicalTrials.gov Identifier: NCT02649426.

5.
J Am Coll Cardiol ; 80(22): 2119-2134, 2022 11 29.
Artigo em Inglês | MEDLINE | ID: mdl-36423996

RESUMO

The treatment of left main (LM) coronary artery disease (CAD) requires complex decision-making. Recent clinical practice guidelines provide clinicians with guidance; however, decisions regarding treatment for individual patients can still be difficult. The American College of Cardiology's Cardiac Surgery Team and Interventional Council joined together to develop a practical approach to the treatment of LM CAD, taking into account randomized clinical trial, meta-analyses, and clinical practice guidelines. The various presentations of LM CAD based on anatomy and physiology are presented. Recognizing the complexity of LM CAD, which rarely presents isolated and is often in combination with multivessel disease, a treatment algorithm with medical therapy alone or in conjunction with percutaneous coronary intervention or coronary artery bypass grafting is proposed. A heart team approach is recommended that accounts for clinical, procedural, operator, and institutional factors, and features shared decision-making that meets the needs and preferences of each patient and their specific clinical situation.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Humanos , Ponte de Artéria Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Guias de Prática Clínica como Assunto
6.
J Am Coll Cardiol ; 80(22): 2089-2101, 2022 11 29.
Artigo em Inglês | MEDLINE | ID: mdl-36424680

RESUMO

BACKGROUND: In the multicenter, randomized, sham-controlled FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial, quantitative flow ratio (QFR)-based lesion selection improved 1-year clinical outcomes compared with conventional angiographic guidance for percutaneous coronary intervention (PCI). OBJECTIVES: The purpose of this study was to determine whether the benefits of QFR guidance persist at 2 years, particularly for patients in whom QFR changed the revascularization strategy. METHODS: Eligible patients were randomized to a QFR-guided strategy (PCI performed only if QFR ≤0.80) or a standard angiography-guided strategy. Major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization occurring within 2 years were analyzed in the intention-to-treat population. RESULTS: Among 3,825 randomized participants, 2-year MACE occurred in 161 of 1,913 (8.5%) patients in the QFR-guided group and in 237 of 1,912 (12.5%) patients in the angiography-guided group (HR: 0.66; 95% CI: 0.54-0.81; P < 0.0001), driven by fewer MIs (4.0% vs 6.8%; HR: 0.58; 95% CI: 0.44-0.77; P = 0.0002) and ischemia-driven revascularizations (4.2% vs 5.8%; HR: 0.71; 95% CI: 0.53-0.95; P = 0.02) in the QFR-guided group. Landmark analysis showed consistent results within the first year and between 1-2 years (Pint = 0.99). Although the 2-year MACE rate was lower in the QFR-guided group in both patients with and without revascularization strategy changes, the extent of outcome improvement was greater (Pint = 0.009) among those patients in whom the preplanned PCI strategy was modified by QFR. CONCLUSIONS: QFR-guided lesion selection improved 2-year clinical outcomes compared with standard angiography guidance. The benefits were most pronounced among patients in whom QFR assessment altered the planned revascularization strategy. (FAVOR III China Study [The Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease] NCT03656848).


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Coração , Angiografia
7.
Kidney Int Rep ; 7(10): 2129-2140, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36217529

RESUMO

Arterial hypertension is the most prevalent global modifiable risk factor for cardiovascular morbidity and mortality. Despite the availability of numerous pharmacologic treatments, many patients do not achieve guideline-recommended blood pressure targets. Therefore, renal sympathetic denervation (RDN), a process in which catheter-directed techniques are used to ablate portions of the renal artery to reduce sympathetic activity, has been extensively investigated as a complementary and nonpharmacologic approach for the treatment of arterial hypertension. This review seeks to discuss the pathophysiological rationale of this strategy, to survey its history and development, and to highlight the current clinical evidence and possible future directions of its employment. In sum, RDN has demonstrated itself to be a safe and well-tolerated endovascular intervention that can reliably contribute to improved blood pressure control and, perhaps ultimately, significant cardiovascular prognosis.

8.
Circ Cardiovasc Interv ; 15(9): e011693, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-36126137

RESUMO

BACKGROUND: Clinical and morphological factors associated with lipidic versus calcified neoatherosclerosis within second-generation drug-eluting stents and the impact of lipidic versus calcified neoatherosclerosis on long-term outcomes after repeat intervention have not been well studied. METHODS: A total of 512 patients undergoing optical coherence tomography before percutaneous coronary intervention for second-generation drug-eluting stents in-stent restenosis were included. Neoatherosclerosis was defined as lipidic or calcified neointimal hyperplasia in ≥3 consecutive frames or ruptured lipidic neointimal hyperplasia. The primary outcome was target lesion failure (cardiac death, target vessel myocardial infarction, definite stent thrombosis, or clinically driven target lesion revascularization). RESULTS: The overall prevalence of neoatherosclerosis was 28.5% (146/512): 56.8% lipidic, 30.8% calcified, and 12.3% both lipidic and calcific. The prevalence increased as a function of time from stent implantation: 20% at 1 to 3 years, 30% at 3 to 7 years, and 75% >7 years. Renal insufficiency, poor lipid profile, and time from stent implantation were associated with lipidic neoatherosclerosis, whereas severe renal insufficiency, female sex, and time from stent implantation were associated with calcified neoatherosclerosis. Multivariable Cox regression revealed that female sex and lipidic neoatherosclerosis were associated with more target lesion failure, whereas stent age and final minimum lumen diameter after reintervention were related to lower target lesion failure. Calcified neoatherosclerosis was not related to adverse events after reintervention for in-stent restenosis given a large enough minimum lumen diameter was achieved. CONCLUSIONS: Lipidic but not calcified neoatherosclerosis was associated with poor subsequent outcomes after repeat revascularization if optimal stent expansion was achieved in lesions with calcified neoatherosclerosis.


Assuntos
Reestenose Coronária , Stents Farmacológicos , Insuficiência Renal , Constrição Patológica/etiologia , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/epidemiologia , Reestenose Coronária/etiologia , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Hiperplasia/etiologia , Lipídeos , Prevalência , Insuficiência Renal/etiologia , Resultado do Tratamento
11.
EuroIntervention ; 18(8): e677-e685, 2022 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-35913759

RESUMO

BACKGROUND: While the blood pressure (BP)-lowering effect of renal denervation (RDN) has been established, long-term durability is a key prerequisite for a broader clinical implementation. AIMS: Our aims were to assess the long-term durability of the office BP (OBP)-lowering efficacy, antihypertensive medication (AHM) use, and safety of ultrasound RDN (uRDN). METHODS: Four weeks after withdrawal of AHM, patients with untreated daytime ambulatory BP ≥135/85 mmHg and <170/105 mmHg were randomised to uRDN (n=74) or sham (n=72) in the RADIANCE-HTN SOLO trial. Initiation of AHM was encouraged for home BP >135/85 mmHg following primary endpoint ascertainment at 2 months. Patients and physicians were unblinded at 6 months.  Results: Fifty-one of 74 patients (age: 53.9±11 years; 67% men) originally randomised to uRDN completed the 36-month follow-up. Initial screening OBP upon study entry was 145/92±14/10 mmHg on a mean of 1.2 AHM (range: 0-2.0). Baseline OBP after AHM washout was 154/99±13/8 mmHg. At 36 months, patients were on an average of 1.3 AHM (range: 0-3.0) with 8 patients on no AHM. OBP decreased by 18/11±15/9 mmHg from baseline to 36 months (p<0.001 for both). Overall, OBP control (<140/90 mmHg) improved from 29.4% at screening to 45.1% at 36 months (p=0.059). For patients uncontrolled at screening (n=36), systolic OBP decreased by 10.8 mmHg (p<0.001) at 36 months on similar AHM (p=0.158). CONCLUSIONS: The safety and effectiveness of uRDN was durable to 36 months, with reduced OBP and improved OBP control despite a similar starting medication burden. No new uRDN-related long-term safety concerns were identified.


Assuntos
Anti-Hipertensivos , Hipertensão , Adulto , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea , Monitorização Ambulatorial da Pressão Arterial , Denervação , Feminino , Seguimentos , Humanos , Rim/diagnóstico por imagem , Rim/cirurgia , Masculino , Pessoa de Meia-Idade , Simpatectomia , Resultado do Tratamento
12.
Artigo em Inglês | MEDLINE | ID: mdl-35953406

RESUMO

INTRODUCTION: The COVID-19 pandemic had an unprecedented impact on cardiovascular clinical research. The decision-making and state of study operations in cardiovascular trials 1-year after interruption has not been previously described. METHODS: In the spring of 2020, we created a pandemic impact task force to develop a landscape of use case scenarios from 17 device trials of peripheral artery disease (PAD) and coronary artery disease (CAD) interventions. In conjunction with publicly available (clinictrials.gov) study inclusion criteria, primary endpoints and study design, information was shared for this use-case landscape by trial leadership and data owners. RESULTS: A total of 17 actively enrolling trials (9 CAD and 8 PAD) volunteered to populate the use case landscape. All 17 were multicenter studies (12 in North America and 5 international). Fifteen studies were industry-sponsored, of which 13 were FDA approved IDEs, one was PCORI-sponsored and two were sponsored by the NIH. Enrollment targets ranged from 150 to 9000 pts. At the time of interruption, 5 trials were <20 % enrolled, 9 trials were 50-80 % enrolled and 3 trials were >80 % enrolled. At 1 year, the majority of studies were continuing to enroll in the context of more sporadic but ongoing pandemic activity. CONCLUSIONS: At 1 year from the first surge interruptions, most trials had resumed enrollment. Trials most heavily interrupted were trials early in enrollment and those trials not able to pivot to virtual patient and site visits. Further work is needed to determine the overall impact on vascular intervention trials disrupted during the COVID-19 pandemic.

13.
N Engl J Med ; 387(15): 1426-1427, 2022 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-36027562
14.
JAMA Cardiol ; 7(8): 866-872, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-35731530

RESUMO

Importance: Subclinical leaflet thrombosis affects approximately 15% of patients after transcatheter aortic valve replacement (TAVR). The pathophysiology and clinical significance of leaflet thrombosis remain incompletely understood. Defining the optimal management strategy in patients who are asymptomatic, including the role for oral anticoagulation (OAC), is a key challenge for the field. Observations: Three recent randomized trials have evaluated the role of OAC in patients after TAVR. These studies have confirmed prior observational data suggesting that OAC is effective at prevention of subclinical leaflet thrombosis. Overall, however, OAC does not lead to a clinical benefit over the period studied, and in some patients may be harmful owing to bleeding risk. Conclusions and Relevance: Strategies for identification of patients in whom the benefit of OAC outweighs the risks are required for optimization of long-term outcome after TAVR. This requires clearer insights into the mechanisms of asymptomatic leaflet thrombosis, its clinical significance, and patient-specific risks of bleeding and structural valve degeneration.


Assuntos
Trombose , Substituição da Valva Aórtica Transcateter , Anticoagulantes/uso terapêutico , Valva Aórtica/cirurgia , Hemorragia/induzido quimicamente , Humanos , Trombose/tratamento farmacológico , Trombose/etiologia , Trombose/prevenção & controle , Substituição da Valva Aórtica Transcateter/efeitos adversos
15.
JAMA Cardiol ; 7(7): 747-759, 2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35648414

RESUMO

Importance: Dose-reduced regimens of direct oral anticoagulants (DOACs) may be used for 2 main purposes: dose-adjusted treatment intended as full-intensity anticoagulation (eg, for stroke prevention in atrial fibrillation [AF] in patients requiring dose reduction) or low-intensity treatment (eg, extended-duration treatment of venous thromboembolism [VTE]). We reviewed randomized clinical trials (RCTs) to understand the scenarios in which dose-adjusted or low-intensity DOACs were tested and reviewed the labeled indications by regulatory authorities, using data from large registries to assess whether the use of dose-reduced DOACs in routine practice aligned with the findings of RCTs. Observations: Among 4191 screened publications, 35 RCTs that used dose-adjusted DOACs were identified for dabigatran, apixaban, rivaroxaban, and edoxaban. Of these 35 RCTs, 29 were related to stroke prevention in AF. Efficacy and safety results for dose-adjusted DOACs in large RCTs of AF were similar to those found for full-dose DOACs. To our knowledge, dabigatran, apixaban, and rivaroxaban have not been studied as dose-adjusted therapy for acute VTE treatment. Low-intensity DOACs were identified in 37 RCTs. Low-intensity DOACs may be used for extended-duration treatment of VTE (apixaban and rivaroxaban), primary prevention in orthopedic surgeries (dabigatran, apixaban, and rivaroxaban), primary prevention in ambulatory high-risk cancer patients (apixaban and rivaroxaban) or (postdischarge) high-risk medical patients (rivaroxaban), in stable atherosclerotic vascular disease, or after a recent revascularization for peripheral artery disease in conjunction with aspirin (rivaroxaban). Minor variations exist between regulatory authorities in different regions regarding criteria for dose adjustment of DOACs. Data from large registries indicated that dose-reduced DOACs were used occasionally with doses or for clinical scenarios different from those studied in RCTs or recommended by regulatory authorities. Conclusions and Relevance: Dose adjustment and low-intensity treatment are 2 different forms of dose-reduced DOACs. Dose adjustment is mostly relevant for AF and should be done based on the approved criteria. Dose adjustment of DOACs should not be used for acute VTE treatment in most cases. In contrast, low-intensity DOACs may be used for primary or secondary VTE prevention for studied and approved indications. Attention should be given to routine practice patterns to align the daily clinical practice with existing evidence of safety and efficacy.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Tromboembolia Venosa , Administração Oral , Anticoagulantes , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/uso terapêutico , Humanos , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/complicações , Tromboembolia Venosa/complicações , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle
16.
JACC Cardiovasc Interv ; 15(11): 1153-1163, 2022 06 13.
Artigo em Inglês | MEDLINE | ID: mdl-35680195

RESUMO

BACKGROUND: Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. OBJECTIVES: This study reports the final 2-year results of the randomized Onyx ONE trial. METHODS: The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. RESULTS: A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54). CONCLUSIONS: Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Stents Farmacológicos/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Polímeros , Desenho de Prótese , Stents/efeitos adversos , Resultado do Tratamento
17.
Card Fail Rev ; 8: e14, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35516793

RESUMO

Right ventricular (RV) failure is associated with significant morbidity and mortality, with in-hospital mortality rates estimated as high as 70-75%. RV failure may occur following cardiac surgery in conjunction with left ventricular failure, or may be isolated in certain circumstances, such as inferior MI with RV infarction, pulmonary embolism or following left ventricular assist device placement. Medical management includes volume optimisation and inotropic and vasopressor support, and a subset of patients may benefit from mechanical circulatory support for persistent RV failure. Increasingly, percutaneous and surgical mechanical support devices are being used for RV failure. Devices for isolated RV support include percutaneous options, such as micro-axial flow pumps and extracorporeal centrifugal flow RV assist devices, surgically implanted RV assist devices and veno-arterial extracorporeal membrane oxygenation. In this review, the authors discuss the indications, candidate selection, strategies and outcomes of mechanical circulatory support for RV failure.

19.
JAMA Netw Open ; 5(5): e2211946, 2022 05 02.
Artigo em Inglês | MEDLINE | ID: mdl-35552723

RESUMO

Importance: Little is known about the long-term outcomes of mild valvular lesions. Objective: To examine the associations of 3 major types of valvular lesions (aortic stenosis, trace or mild aortic regurgitation, and trace or mild mitral regurgitation) with risk of cardiovascular mortality, coronary heart disease (CHD), stroke, heart failure, and atrial fibrillation. Design, Setting, and Participants: This cohort study analyzed data from the ongoing Atherosclerosis Risk in Communities study and focused on Black participants in the Jackson, Mississippi, site who underwent echocardiography at visit 3 from 1993 to 1995. Data analysis was conducted between April 2021 and February 2022. Exposures: Three valvular lesions were analyzed: aortic sclerosis, aortic regurgitation (trace or mild), and mitral regurgitation (trace or mild). Main Outcomes and Measures: The outcomes were cardiovascular mortality, coronary heart disease, heart failure, stroke, and atrial fibrillation. Multivariable Cox proportional hazards regression models were used to examine the independent associations between the 3 valvular lesions and these outcomes. Results: A total of 2106 Black participants were included, with a mean (SD) age of 59.1 (5.6) years and 1354 women (64.3%). The baseline prevalence was 7.7% for aortic sclerosis, 15.1% for aortic regurgitation (6.1% with trace, and 9.0% with mild), and 43.0% for mitral regurgitation (29.4% with trace, and 13.6% with mild). During a median (interquartile interval) follow-up of 22.5 (15.6-23.5) years, 890 participants developed at least 1 cardiovascular outcome. Each valvular lesion was significantly associated with at least 1 cardiovascular outcome: aortic sclerosis was associated with cardiovascular mortality (adjusted hazard ratio [HR], 1.54; 95% CI, 1.06-2.22), mild mitral regurgitation was associated with atrial fibrillation (HR, 1.47; 95% CI, 1.09-1.99), and trace or mild aortic regurgitation was associated with all outcomes (HRs ranging from 1.45 [95% CI, 1.17-1.81] to 1.75 [95% CI, 1.29-2.37]) except stroke. The total number of valvular lesions had graded associations with all cardiovascular outcomes except stroke: the HR of cardiovascular mortality was 1.77 (95% CI, 1.18-2.65) for those with 2 to 3 lesions and was 1.44 (95% CI, 1.05-1.96) for those with 1 lesion vs no lesions. Conclusions and Relevance: Results of this study indicate an association between valvular lesions, even at mild stage, and a long-term risk of cardiovascular events, suggesting the importance of recognizing and monitoring these valvular conditions.


Assuntos
Insuficiência da Valva Aórtica , Fibrilação Atrial , Insuficiência Cardíaca , Insuficiência da Valva Mitral , Acidente Vascular Cerebral , Adulto , Insuficiência da Valva Aórtica/complicações , Insuficiência da Valva Aórtica/epidemiologia , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Estudos de Coortes , Feminino , Insuficiência Cardíaca/epidemiologia , Humanos , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/epidemiologia , Esclerose/complicações , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/epidemiologia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...