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1.
J Am Coll Cardiol ; 84(10): 875-885, 2024 Sep 03.
Article in English | MEDLINE | ID: mdl-39197976

ABSTRACT

BACKGROUND: The optimal antithrombotic regimen for patients with atrial fibrillation (AF) who had an acute coronary syndrome (ACS) or have undergone percutaneous coronary intervention (PCI) is not known. OBJECTIVES: The authors sought to determine which antithrombotic regimen best balances safety and efficacy. METHODS: AUGUSTUS, a multicenter 2 × 2 factorial design randomized trial compared apixaban with vitamin K antagonist (VKA) and aspirin with placebo in patients with AF with recent ACS and/or PCI treated with a P2Y12 inhibitor. We conducted a 4-way analysis comparing safety and efficacy outcomes in the 4 randomized groups. The primary outcome was a composite of all-cause death, major or clinically relevant nonmajor bleeding, or hospitalization for cardiovascular causes over 6-month follow-up. Secondary outcomes included individual components of the primary endpoint. RESULTS: A total of 4,614 patients were enrolled. All patients were treated with a P2Y12 inhibitor. The primary endpoint occurred in 21.9% of patients randomized to apixaban plus placebo, 27.3% randomized to apixaban plus aspirin, 28.0% randomized to VKA plus placebo, and 33.3% randomized to VKA plus aspirin. Rates of major or clinically relevant nonmajor bleeding and hospitalization for cardiovascular causes were lower with apixaban and placebo compared with the other 3 antithrombotic strategies. There was no difference between the 4 randomized groups with respect to all-cause death. CONCLUSIONS: In patients with AF and a recent ACS and/or PCI, an antithrombotic regimen that included a P2Y12 inhibitor and apixaban without aspirin resulted in a lower incidence of the composite of death, bleeding, or cardiovascular hospitalization than regimens including VKA, aspirin, or both. (An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention; NCT02415400).


Subject(s)
Acute Coronary Syndrome , Aspirin , Atrial Fibrillation , Fibrinolytic Agents , Percutaneous Coronary Intervention , Pyrazoles , Pyridones , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Percutaneous Coronary Intervention/methods , Male , Female , Acute Coronary Syndrome/drug therapy , Acute Coronary Syndrome/complications , Aged , Aspirin/therapeutic use , Middle Aged , Pyrazoles/therapeutic use , Pyridones/therapeutic use , Pyridones/adverse effects , Pyridones/administration & dosage , Fibrinolytic Agents/therapeutic use , Vitamin K/antagonists & inhibitors , Treatment Outcome , Factor Xa Inhibitors/therapeutic use , Hemorrhage/chemically induced , Hemorrhage/epidemiology
2.
Value Health Reg Issues ; 44: 101019, 2024 Nov.
Article in English | MEDLINE | ID: mdl-38924820

ABSTRACT

OBJECTIVES: To measure the direct cost of treating acute ischemic stroke (IS) from the perspective of a public hospital in Brazil (HCFMB) and compare it with the reimbursement by the Unified Health System (SUS), through the Procedure Table Management System, Medicines, Orthoses/Prostheses and Special Materials of the Unified Health System (SIGTAP). METHODS: We performed a micro-costing study; four scenarios were evaluated: standard (1); alteplase (2); alteplase and mechanical thrombectomy (3); mechanical thrombectomy (4). Based on the number of patients hospitalized for ischemic stroke in 2019, hospital cost, and SUS billing were calculated for each scenario. Hospital costs were adjusted for inflation using CCEMG-EPPI-Centre Cost Converter. RESULTS: In 2019, 258 patients were hospitalized due to IS, 89.5% in scenario 1, 8% in scenario 2, 1.5% in scenario 3, 1% in scenario 4. From the hospital's perspective, the cost per patient was estimated at R$7780.13, R$15 741.23, R$28 988.49, R$25 739.79, for scenarios 1, 2, 3 and 4, respectively. The reimbursement by SIGTAP was estimated at R$3079.87, R$5417.21, R$10 901.92, R$10 286.28, respectively. If thrombectomy had been included in the SIGTAP, the last two values would be R$25 393.34 and R$24 248.89. CONCLUSIONS: The hospital cost of treating acute IS in 2019 was estimated at R$2 295 209, the SUS reimbursement at R$889 391.54. With the inclusion of thrombectomy at SIGTAP, this reimbursement would be R$975 282.44, and the loss in the cost of HCFMB per patient in relation to reimbursement by the SUS is greater in scenarios without this procedure.


Subject(s)
Hospitals, Public , Ischemic Stroke , Humans , Ischemic Stroke/economics , Ischemic Stroke/therapy , Hospitals, Public/economics , Brazil , Thrombectomy/economics , Thrombectomy/methods , Tertiary Care Centers/economics , Tertiary Care Centers/statistics & numerical data , Fibrinolytic Agents/economics , Fibrinolytic Agents/therapeutic use , Hospital Costs/statistics & numerical data , Tissue Plasminogen Activator/therapeutic use , Tissue Plasminogen Activator/economics
3.
Turk Neurosurg ; 34(4): 543-553, 2024.
Article in English | MEDLINE | ID: mdl-38874256

ABSTRACT

AIM: To determine the effectiveness of extraventricular drainage (EVD) combined with fibrinolytics in reducing morbidity and mortality rates associated with intraventricular cerebral hemorrhage (IVH). MATERIAL AND METHODS: A literature review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO registration number: CRD42022332152). Articles were selected from various sources, including PubMed, Trip Database, LILACS, Cochrane Library, and ScienceDirect. Clinical trials focusing on IVH treatment using EVD and/or fibrinolytics were considered. The Risk of Bias in Non-randomized Studies of Interventions (ROB 2) tool was employed for bias assessment. A fixed-effects regression model was used following heterogeneity analysis. Treatment effectiveness was evaluated based on mortality outcomes. RESULTS: A total of 531 patients from four studies were included. The use of fibrinolytics significantly decreased IVH mortality compared with a placebo. The odds ratio (OR) for recombinant tissue plasminogen activator (rtPA) or alteplase was 0.54 [0.36; 0.82]. For urokinase (UK), the OR was 0.21 [0.03; 1.54], rendering it statistically non-significant. The overall OR was 0.52 [0.35; 0.78], and the heterogeneity I2 was 0% (indicating low heterogeneity). CONCLUSION: While EVD alone is a common approach for managing hydrocephalus, its effectiveness is limited by potential blockages and infections. Combining EVD with UK or rtPA demonstrated improved patient outcomes. rtPA stands out as a reliable and effective option, while limited data are available regarding UK's effectiveness in reducing IVH mortality.


Subject(s)
Fibrinolytic Agents , Humans , Fibrinolytic Agents/therapeutic use , Cerebral Hemorrhage/drug therapy , Cerebral Hemorrhage/mortality , Tissue Plasminogen Activator/therapeutic use , Treatment Outcome , Cerebral Intraventricular Hemorrhage/drug therapy , Thrombolytic Therapy/methods
4.
Am J Med ; 137(10): 958-965, 2024 Oct.
Article in English | MEDLINE | ID: mdl-38876331

ABSTRACT

OBJECTIVE: We aimed to evaluate the safety and efficacy of antithrombotic strategies by age in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention in AUGUSTUS. METHODS: Patients were stratified into 3 age groups: <65, 65-74, and ≥75 years. Outcomes of interest were major or clinically relevant non-major bleeding, major bleeding, death or rehospitalization, and ischemic events. Treatment effects of apixaban vs. vitamin K antagonist (VKA) and aspirin vs. placebo were assessed across age groups using Cox models. RESULTS: Of 4614 patients, 1267 (27.5%) were <65, 1802 (39.0%) were 65-74, and 1545 (33.5%) were ≥75 years. Apixaban was associated with lower rates of major or clinically relevant non-major bleeding than VKA (<65: HR 0.69 [0.47-1.00]; 65-74: HR 0.57 [0.43-0.75]; ≥75: HR 0.81 [0.63-1.04]). Death or hospitalization occurred less often with apixaban, regardless of age. No differences were observed in rates of ischemic events between apixaban and VKA according to age. Aspirin was associated with higher rates of bleeding than placebo (<65: HR 1.67 [1.15-2.43]; 65-74: HR 2.32 [1.73-3.10]; ≥75: HR 1.69 [1.31-2.19]). Rates of death or rehospitalization and ischemic events were similar among patients receiving aspirin or placebo across age groups. CONCLUSIONS: Apixaban was associated with greater absolute reduction in bleeding than VKA in older age groups, reflecting their higher hemorrhagic risk. Aspirin increased bleeding in all age groups vs. placebo. Our findings support the use of apixaban plus a purinergic receptor P2Y12(P2Y12) inhibitor without aspirin in patients with atrial fibrillation and recent acute coronary syndrome/percutaneous coronary intervention, regardless of age.


Subject(s)
Acute Coronary Syndrome , Aspirin , Atrial Fibrillation , Fibrinolytic Agents , Hemorrhage , Percutaneous Coronary Intervention , Pyrazoles , Pyridones , Humans , Aged , Pyridones/therapeutic use , Pyridones/adverse effects , Pyrazoles/therapeutic use , Pyrazoles/adverse effects , Male , Female , Aspirin/therapeutic use , Aspirin/adverse effects , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Acute Coronary Syndrome/drug therapy , Age Factors , Hemorrhage/chemically induced , Middle Aged , Fibrinolytic Agents/therapeutic use , Fibrinolytic Agents/adverse effects , Vitamin K/antagonists & inhibitors , Factor Xa Inhibitors/therapeutic use , Factor Xa Inhibitors/adverse effects , Aged, 80 and over
6.
Clinics (Sao Paulo) ; 79: 100394, 2024.
Article in English | MEDLINE | ID: mdl-38820696

ABSTRACT

BACKGROUND AND PURPOSE: Intravenous Thrombolysis (IVT) prior to Mechanical Thrombectomy (MT) for Acute Ischaemic Stroke (AIS) due to Large-Vessel Occlusion (LVO) remains controversial. Therefore, the authors performed a meta-analysis of the available real-world evidence focusing on the efficacy and safety of Bridging Therapy (BT) compared with direct MT in patients with AIS due to LVO. METHODS: Four databases were searched until 01 February 2023. Retrospective and prospective studies from nationwide or health organization registry databases that compared the clinical outcomes of BT and direct MT were included. Odds Ratios (ORs) and 95 % Confidence Intervals (CIs) for efficacy and safety outcomes were pooled using a random-effects model. RESULTS: Of the 12 studies, 86,695 patients were included. In patients with AIS due to LVO, BT group was associated with higher odds of achieving excellent functional outcome (modified Rankin Scale score 0-1) at 90 days (OR = 1.48, 95 % CI 1.25-1.75), favorable discharge disposition (to the home with or without services) (OR = 1.33, 95 % CI 1.29-1.38), and decreased mortality at 90 days (OR = 0.62, 95 % CI 0.56-0.70), as compared with the direct MT group. In addition, the risk of symptomatic intracranial hemorrhage did not increase significantly in the BT group. CONCLUSION: The present meta-analysis indicates that BT was associated with favorable outcomes in patients with AIS due to LVO. These findings support the current practice in a real-world setting and strengthen their validity. For patients eligible for both IVT and MT, BT remains the standard treatment until more data are available.


Subject(s)
Ischemic Stroke , Thrombectomy , Thrombolytic Therapy , Humans , Ischemic Stroke/surgery , Ischemic Stroke/therapy , Thrombectomy/methods , Treatment Outcome , Thrombolytic Therapy/methods , Fibrinolytic Agents/therapeutic use , Fibrinolytic Agents/administration & dosage , Mechanical Thrombolysis/methods
7.
J Thromb Thrombolysis ; 57(6): 929-935, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38722520

ABSTRACT

The efficacy and safety of dual antiplatelet therapy (DAPT) relative to intravenous (IV) alteplase in patients with acute minor ischemic stroke are insufficiently established. Therefore, we aimed to perform a meta-analysis to compare DAPT with IV alteplase in patients with acute minor stroke. MEDLINE, Embase, and Cochrane were searched for studies comparing DAPT with IV alteplase in patients with minor stroke. Functional and safety outcomes in 90 days were analyzed. Statistical analysis was performed using Rstudio 4.3.1. Subanalyses were performed restricted to non-disabling minor strokes and NIHSS score ≤ 3. PROSPERO (CRD42023440986). We included five studies with a total of 6,340 patients, of whom 4,050 (63.9%) received DAPT. The follow-up period for all included studies was 90 days. There was no significant difference for individual outcomes of mRS 0-1 (OR 1.26; 95% CI 0.85-1.89; p = 0.25), mRS 0-2 (OR 0.99; 95% CI 0.69-1.43; p = 0.97), or all-cause mortality (OR 0.80; 95% CI 0.20-3.13; p = 0.75) between groups. Symptomatic intracranial hemorrhage (sICH) was significantly lower (OR 0.11; 95% CI 0.003-0.36; p < 0.001) in patients treated with DAPT compared with IV alteplase. In terms of mRS 0-1 and mRS 0-2, we found no significant difference in both subgroup analyses. We found no statistically significant difference between DAPT and IV alteplase regarding functional outcome (mRS scores of 0-1 and 0-2) or all-cause mortality at 90 days in patients with minor ischemic stroke. Additionally, DAPT was associated with a significantly lower rate of sICH.


Subject(s)
Dual Anti-Platelet Therapy , Fibrinolytic Agents , Ischemic Stroke , Tissue Plasminogen Activator , Humans , Ischemic Stroke/drug therapy , Tissue Plasminogen Activator/therapeutic use , Tissue Plasminogen Activator/administration & dosage , Tissue Plasminogen Activator/adverse effects , Fibrinolytic Agents/therapeutic use , Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/adverse effects , Dual Anti-Platelet Therapy/methods , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Treatment Outcome , Adult
8.
Semin Neurol ; 44(2): 119-129, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38513704

ABSTRACT

Although stroke prevention and treatment strategies have significantly advanced in recent years, implementation of these care elements in resource-limited settings can be challenging, since the burden of stroke is higher and access to stroke care is lower. Barriers to stroke care in resource-limited settings include insufficient prevention, reduced awareness of stroke symptoms, limited prehospital care and lack of triage systems, limited access to comprehensive stroke centers, inadequate personnel education, lack of staff and resources, as well as limited access to neuroimaging, thrombolytics, mechanical thrombectomy, neurosurgical care, and rehabilitation. Here, we suggest strategies to improve stroke care in these settings, including public health campaigns, protocols for prehospital notification, organized flow to specialized stroke centers, development of dedicated stroke units, and utilization of telemedicine and telerehabilitation. We also highlight the role of international organizations and governments in reducing the global burden of stroke.


Subject(s)
Resource-Limited Settings , Stroke , Humans , Stroke/therapy , Triage/methods , Fibrinolytic Agents/therapeutic use
9.
Braz J Biol ; 84: e271083, 2024.
Article in English | MEDLINE | ID: mdl-38422281

ABSTRACT

Cardiovascular disorders, including acute myocardial infarction (AMI), often lead to blood clot formation, impacting blood circulation. Streptokinase, a cost-effective and widely available thrombolytic agent, is crucial in treating thrombosis. This study aimed to produce streptokinase from Streptococcus pyogenes EBL-48 and compare its efficacy with heparin in an animal model. We evaluated the clot-lysing effectiveness of streptokinase produced from Streptococcus pyogenes EBL-48, emphasizing its low cost and ease of production. Streptokinase was produced using pre-optimized fermentation media and purified through ion exchange and gel-filtration chromatography. In vivo analysis involved inducing clots in a trial animal model using ferric chloride, comparing streptokinase with heparin. Ultrasonography assessed the clot-lysing activity of streptokinase. Streptokinase (47 kDa) effectively lysed clots, proving its low cost, easy production, and minimal adverse effects. Ultrasonography confirmed its fibrinolytic efficacy. These findings highlight potential as an affordable and easily produced thrombolytic agent, particularly relevant in resource-limited settings. Streptokinase efficacy and minimal adverse effects make it a promising option for thrombolytic therapy, especially in economically constrained regions. Future studies could optimize production techniques, explore different strains, and conduct clinical trials for human validation. Comparative studies with other thrombolytic agents would enhance understanding of their advantages and limitations.


Subject(s)
Fibrinolytic Agents , Streptokinase , Animals , Fermentation , Fibrinolytic Agents/pharmacology , Fibrinolytic Agents/therapeutic use , Heparin , Streptokinase/pharmacology , Streptokinase/therapeutic use , Treatment Outcome
10.
Am J Cardiol ; 218: 7-15, 2024 05 01.
Article in English | MEDLINE | ID: mdl-38402926

ABSTRACT

Although primary percutaneous coronary intervention (pPCI) is the treatment of choice in ST-elevation myocardial infarction (STEMI), challenges may arise in accessing this intervention for certain geodemographic groups. Pharmacoinvasive strategy (PIs) has demonstrated comparable outcomes when delays in pPCI are anticipated, but real-world data on long-term outcomes are limited. The aim of the present study was to compare long-term outcomes among real-world patients with STEMI who underwent either PIs or pPCI. This was a prospective registry including patients with STEMI who received reperfusion during the first 12 hours from symptom onset. The primary objective was cardiovascular mortality at 12 months according to the reperfusion strategy (pPCI vs PIs) and major cardiovascular events (cardiogenic shock, recurrent myocardial infarction, and congestive heart failure), and Bleeding Academic Research Consortium type 3 to 5 bleeding events were also evaluated. A total of 799 patients with STEMI were included; 49.1% underwent pPCI and 50.9% received PIs. Patients in the PIs group presented with more heart failure on admission (Killip-Kimbal >I 48.1 vs 39.7, p = 0.02) and had a lower proportion of pre-existing heart failure (0.2% vs 1.8%, p = 0.02) and atrial fibrillation (0.25% vs 1.2%, p = 0.02). No statistically significant difference was observed in cardiovascular mortality at the 12-month follow-up (hazard ratio for PIs 0.74, 95% confidence interval 0.42 to 1.30, log-rank p = 0.30) according to the reperfusion strategy used. The composite of major cardiovascular events (hazard ratio for PIs 0.98, 95% confidence interval 0.75 to 1.29, p = 0.92) and Bleeding Academic Research Consortium type 3 to 5 bleeding rates were also comparable. A low socioeconomic status, Killip-Kimball >2, age >60 years, and admission creatinine >2.0 mg/100 ml were predictors of the composite end point after multivariate analysis. In conclusion, this prospective real-world registry provides additional support that long-term major cardiovascular outcomes and bleeding are not different between patients who underwent PIs versus primary PCI.


Subject(s)
Heart Failure , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , Middle Aged , ST Elevation Myocardial Infarction/therapy , Fibrinolytic Agents/therapeutic use , Thrombolytic Therapy/adverse effects , Percutaneous Coronary Intervention/adverse effects , Mexico , Treatment Outcome , Hemorrhage/chemically induced , Heart Failure/drug therapy
11.
J Thromb Thrombolysis ; 57(3): 381-389, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38281231

ABSTRACT

BACKGROUND: In patients with atrial fibrillation (AF) and normal or slightly impaired renal function, the use of direct oral anticoagulants (DOACs) is preferable to vitamin K antagonists (VKAs). However, in patients undergoing hemodialysis, the efficacy, and safety of DOACs compared with VKAs are still unknown. PURPOSE: To review current evidence about the safety and efficacy of DOACs compared to VKAs, in patients with AF and chronic kidney disease under hemodialysis. METHODS: We systematically searched PubMed, Scopus, and Cochrane databases for RCTs comparing DOACs with VKAs for anticoagulation in patients with AF on dialysis therapy. Outcomes of interest were: (1) stroke; (2) major bleeding; (3) cardiovascular mortality; and (4) all-cause mortality. Statistical analysis was performed using RevMan 5.1.7 and heterogeneity was assessed by I2 statistics. RESULTS: Three randomized controlled trials were included, comprising a total of 383 patients. Of these, 218 received DOACs (130 received apixaban; 88 received rivaroxaban), and 165 were treated with VKAs (116 received warfarin; 49 received phenprocoumon). The incidence of stroke was significantly lower in patients treated with DOACs (4.7%) compared with those using VKAs (9.5%) (RR 0.42; 95% CI 0.18-0.97; p = 0.04; I2 = 0%). However, the difference was not statistically significant in the case of ischemic stroke specifically (RR 0.42; 95% CI 0.17-1.04; p = 0.06; I2 = 0%). As for the major bleeding outcome, the DOAC group (11%) had fewer events than the VKA group (13.9%) but without statistical significance (RR 0.75; 95% CI 0.45-1.28; p = 0.29; I2 = 0%). There was no significant difference between groups regarding cardiovascular mortality (RR 1.23; 95% CI 0.66-2.29; p = 0.52; I2 = 13%) and all-cause mortality (RR 0.98; 95% CI 0.77-1.24; p = 0.84; I2 = 16%). CONCLUSION: This meta-analysis suggests that in patients with AF on dialysis, the use of DOACs was associated with a significant reduction in stroke, and a numerical trend of less incidence of major bleeding compared with VKAs, but in this case with no statistical significance. Results may be limited by a small sample size or insufficient statistical power.


Subject(s)
Atrial Fibrillation , Kidney Failure, Chronic , Stroke , Humans , Atrial Fibrillation/complications , Renal Dialysis/adverse effects , Randomized Controlled Trials as Topic , Anticoagulants/therapeutic use , Hemorrhage/chemically induced , Hemorrhage/drug therapy , Stroke/etiology , Kidney Failure, Chronic/complications , Fibrinolytic Agents/therapeutic use , Vitamin K , Administration, Oral
12.
Rev. urug. cardiol ; 39(1): e401, 2024. tab
Article in Spanish | LILACS, BNUY, UY-BNMED | ID: biblio-1560457

ABSTRACT

La migraña es una enfermedad que se ha visto asociada a defectos septales auriculares y a su cierre percutáneo, estipulándose en la literatura que sería una rara complicación, pero la evidencia al respecto es escasa. Se realizó una revisión narrativa sobre definiciones, epidemiología, fisiopatología y tratamiento de la migraña y de la entidad migraña poscierre percutáneo de defectos del septum auricular, incluyendo trabajos observacionales (retrospectivos, prospectivos), estudios randomizados, reportes de casos, artículos de revisión y metaanálisis existentes en PubMed y Cochrane, para aportar al conocimiento de esta entidad.


Migraine is a disease that has been associated with atrial septal defects and its percutaneous closure, stipulating in the literature that it would be a rare complication, but evidence is scarce. A narrative review was conducted on definitions, epidemiology, pathophysiology and treatment of migraine and the migraine entity after percutaneous closure of atrial septum defects, including observational studies (retrospective, prospective), randomized studies, case reports, review articles and meta-analyses existing in PubMed and Cochrane, to contribute to the knowledge of this entity.


A enxaqueca é uma doença que tem sido associada a defeitos do septo atrial e seu fechamento percutâneo, estipulando na literatura que seria uma complicação rara, mas as evidências são escassas. Foi realizada uma revisão narrativa sobre definições, epidemiologia, fisiopatologia e tratamento da enxaqueca e da entidade migranosa após fechamento percutâneo de defeitos do septo atrial, incluindo estudos observacionais (retrospectivos, prospectivos), estudos randomizados, relatos de caso, artigos de revisão e metanálises existentes no PubMed e Cochrane, para contribuir com o conhecimento dessa entidade.


Subject(s)
Humans , Fibrinolytic Agents/therapeutic use , Percutaneous Coronary Intervention , Heart Septal Defects, Atrial/surgery , Migraine Disorders/therapy , Treatment Outcome , Heart Septal Defects, Atrial/complications , Migraine Disorders/etiology
14.
J Am Coll Cardiol ; 82(18): 1765-1773, 2023 10 31.
Article in English | MEDLINE | ID: mdl-37611779

ABSTRACT

BACKGROUND: The optimal antithrombotic therapy following left atrial appendage occlusion (LAAO) in patients with nonvalvular atrial fibrillation (AF) remains uncertain. OBJECTIVES: In this study, the authors sought to compare the efficacy and safety of various antithrombotic strategies after LAAO. METHODS: We searched the Medline, Cochrane, EMBASE, LILACS, and ClinicalTrials.gov databases for studies reporting outcomes after LAAO, stratified by antithrombotic therapy prescribed at postprocedural discharge. Direct oral anticoagulants (DOACs), vitamin K antagonists (VKAs), single antiplatelet therapy (SAPT), dual antiplatelet therapy (DAPT), DOAC plus SAPT, VKA plus SAPT, and no antithrombotic therapy were analyzed. We performed a frequentist random effects model network meta-analysis to estimate the OR and 95% CI for each comparison. P-scores provided a ranking of treatments. RESULTS: Forty-one studies comprising 12,451 patients with nonvalvular AF were included. DAPT, DOAC, DOAC plus SAPT, and VKA were significantly superior to no therapy to prevent device-related thrombosis. DOAC was associated with lower all-cause mortality than VKA (OR: 0.39; 95% CI: 0.17-0.89; P = 0.03). Compared with SAPT, DAPT was associated with fewer thromboembolic events (OR: 0.50; 95% CI: 0.29-0.88; P = 0.02), without a difference in major bleeding. In the analysis of P-scores, DOAC monotherapy was the strategy most likely to have lower thromboembolic events and major bleeding. CONCLUSIONS: In this network meta-analysis comparing initial antithrombotic therapies after LAAO, monotherapy with DOAC had the highest likelihood of lower thromboembolic events and major bleeding. DAPT was associated with a lower incidence of thromboembolic events compared with SAPT and may be a preferred option in patients unable to tolerate anticoagulation.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Thromboembolism , Humans , Platelet Aggregation Inhibitors , Fibrinolytic Agents/therapeutic use , Atrial Appendage/surgery , Network Meta-Analysis , Anticoagulants , Hemorrhage/etiology , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Thromboembolism/epidemiology , Thromboembolism/etiology , Thromboembolism/prevention & control , Stroke/etiology , Treatment Outcome
15.
Arq Neuropsiquiatr ; 81(7): 624-631, 2023 07.
Article in English | MEDLINE | ID: mdl-37402398

ABSTRACT

BACKGROUND: The efficacy of intravenous thrombolysis (IVT) is time-dependent. OBJECTIVE: To compare the door-to-needle (DTN) time of stroke neurologists (SNs) versus non-stroke neurologists (NSNs) and emergency room physicians (EPs). Additionally, we aimed to determine elements associated with DTN ≤ 20 minutes. METHODS: Prospective study of patients with IVT treated at Clínica Alemana between June 2016 and September 2021. RESULTS: A total of 301 patients underwent treatment for IVT. The mean DTN time was 43.3 ± 23.6 minutes. One hundred seventy-three (57.4%) patients were evaluated by SNs, 122 (40.5%) by NSNs, and 6 (2.1%) by EPs. The mean DTN times were 40.8 ± 23, 46 ± 24.7, and 58 ± 22.5 minutes, respectively. Door-to-needle time ≤ 20 minutes occurred more frequently when patients were treated by SNs compared to NSNs and EPs: 15%, 4%, and 0%, respectively (odds ratio [OR]: 4.3, 95% confidence interval [95%CI]: 1.66-11.5, p = 0.004). In univariate analysis DTN time ≤ 20 minutes was associated with treatment by a SN (p = 0.002), coronavirus disease 2019 pandemic period (p = 0.21), time to emergency room (ER) (p = 0.21), presence of diabetes (p = 0.142), hypercholesterolemia (p = 0.007), atrial fibrillation (p < 0.09), score on the National Institutes of Health Stroke Scale (NIHSS) (p = 0.001), lower systolic (p = 0.143) and diastolic (p = 0.21) blood pressures, the Alberta Stroke Program Early CT Score (ASPECTS; p = 0.09), vessel occlusion (p = 0.05), use of tenecteplase (p = 0.18), thrombectomy (p = 0.13), and years of experience of the physician (p < 0.001). After multivariate analysis, being treated by a SN (OR: 3.95; 95%CI: 1.44-10.8; p = 0.007), NIHSS (OR: 1.07; 95%CI: 1.02-1.12; p < 0.002) and lower systolic blood pressure (OR: 0.98; 95%CI: 0.96-0.99; p < 0.003) remained significant. CONCLUSION: Treatment by a SN resulted in a higher probability of treating the patient in a DTN time within 20 minutes.


ANTECEDENTES: La respuesta a la trombólisis intravenosa (TIV) es dependiente del tiempo. OBJECTIVO: Comparar los tiempo puerta-aguja (TPAs) de neurólogos vasculares (NVs) contra los de neurólogos no vasculares (NNVs) y médicos emergencistas (MEs), y determinar los elementos asociados a un PTA ≤ 20 minutos. MéTODOS: Análisis observacional prospectivo de pacientes con TIV tratados en Clínica Alemana entre junio de 2016 y septiembre de 2021. RESULTADOS: En total, 301 pacientes con TIV fueron tratados. El TPA promedio fue de 43,3 ± 23,6 minutos. Un total de 173 (57,4%) pacientes fueron evaluados por NVs, 122 (40,5%), por NNVs, y 6 (2,1%), por MEs; los TPAs promedios fueron de 40,8 ± 23; 46 ± 24,7 y 58 ± 22,5 minutos, respectivamente. Los TPAs ≤ 20 minutos fueron más frecuentes en pacientes tratados por NVs versus NNVs y MEs: 15%, 4% y 0%, respectivamente (odds ratio [OR]: 4,3; intervalo de confianza del 95% [IC95%]: 1,66­11,5; p = 0,004). El análisis univariado demostró que TPA ≤ 20 minutos se asoció con: tratamiento por NVs (p = 0,002), periodo de la pandemia de enfermedad por coronavirus 2019 (COVID-19; p = 0,21), tiempo a urgencia (p = 0,21), diabetes (p = 0,142), hipercolesterolemia (p = 0,007), fibrilación auricular (p < 0,09), puntaje en la National Institutes of Health Stroke Scale [NIHSS] (p = 0,001), presión arterial sistólica (p = 0,143) y diastólica menores (p = 0,21), Alberta Stroke Program Early CT Score (ASPECTS ; p = 0,09), oclusión de vasos cerebrales (p =0,05), uso de tecneteplase (p = 0,18), trombectomía (p = 0,13) y años de experiencia del médico (p < 0,001). El análisis multivariado demostró que ser tratado por NVs (OR: 3,95; IC95%: 1,44­10,8; p = 0,007), el puntaje en la NIHSS (OR: 1,07; IC95%: 1,02­1,12; p < 0,002) y la presión arterial sistólica (OR: 0,98; IC95%: 0,96­0,99; p < 0,003) se asociaron a TPA ≤ 20 minutos. CONCLUSIóN: El tratamiento por NVs resultó en un TPA menor y en una mayor probabilidad de tratamiento ≤ 20 minutos.


Subject(s)
Brain Ischemia , COVID-19 , Stroke , Humans , Fibrinolytic Agents/therapeutic use , Thrombolytic Therapy/adverse effects , Thrombolytic Therapy/methods , Prospective Studies , COVID-19/complications , Stroke/complications , Emergency Service, Hospital , Time-to-Treatment , Treatment Outcome , Brain Ischemia/complications , Tissue Plasminogen Activator/therapeutic use
16.
Emerg Med Pract ; 25(8): 1-28, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37486075

ABSTRACT

Patients with pulmonary emboli present both diagnostic and therapeutic challenges to the emergency clinician, because initial symptoms can be variable and overlap with other medical conditions. This issue reviews treatment options for patients with pulmonary emboli based on risk stratification scores of low, intermediate-low, intermediate-high, and high risk classifications. The evidence on laboratory testing and imaging is presented, as well as treatment strategies that include anticoagulation, thrombolytics, and mechanical or surgical thrombectomy. Management decisions regarding pregnancy and COVID-19 are discussed, as well as considerations for outpatient treatment of low-risk patients.


Subject(s)
COVID-19 , Pulmonary Embolism , Female , Pregnancy , Humans , COVID-19/therapy , Fibrinolytic Agents/therapeutic use , Pulmonary Embolism/diagnosis , Pulmonary Embolism/therapy , Thrombectomy , Emergency Service, Hospital
17.
Rev Med Inst Mex Seguro Soc ; 61(3): 370-379, 2023 May 02.
Article in Spanish | MEDLINE | ID: mdl-37216692

ABSTRACT

Background: acute pulmonary embolism (APE) is a complex and potentially deadly entity, with a variable clinical course, considered the third cardiovascular cause of death. Its management varies according to the stratified risk from anticoagulation to reperfusion therapy, suggesting systemic thrombolysis as a first-choice strategy; however, in a large group of patients their use will be contraindicated, discouraged or will have failed, thus recommending as options in such cases endovascular therapies or surgical embolectomy. With the presentation of 3 clinical cases and a review of the literature, we seek to communicate our initial experience in the use of ultrasound-accelerated thrombolysis with the EKOS system and to investigate key elements for its understanding and application. Clinical cases: the cases of 3 patients with APE of high and intermediate risk with contraindications for systemic thrombolysis taken to accelerated thrombolysis therapy by ultrasound are discussed. They presented adequate clinical and hemodynamic evolution in the short term, achieving a rapid decrease in thrombolysis, systolic and mean pulmonary arterial pressure, improvement of right ventricular function and reduction of thrombotic burden. Conclusion: Ultrasound-accelerated thrombolysis is a novel pharmaco-mechanical therapy that combines the emission of ultrasonic waves with the infusion of a local thrombolytic agent, a strategy that, according to different trials and clinical registries, has a high success rate and a good safety profile.


Introducción: la tromboembolia pulmonar (TEP) aguda es una entidad compleja y potencialmente mortal, de curso clínico variable, considerada como la tercera causa cardiovascular de muerte. Su manejo varía de acuerdo con el riesgo estratificado desde anticoagulación hasta terapia de reperfusión, por lo que se sugiere como estrategia de primera elección la trombólisis sistémica; sin embargo, en un grupo amplio de pacientes su empleo estará contraindicado, desaconsejado o habrá fallado y se recomendarán como opciones en tales casos terapias endovasculares o embolectomía quirúrgica. A partir de la presentación de 3 casos clínicos y una revisión de la literatura, buscamos comunicar nuestra experiencia inicial en el uso de trombólisis acelerada por ultrasonido con sistema EKOS e indagar elementos claves para su entendimiento y aplicación. Caso clínico: se discuten los casos de 3 pacientes con TEP aguda de riesgo alto e intermedio con contraindicaciones para la trombólisis sistémica, llevados a terapia de trombólisis acelerada por ultrasonido, los cuales presentaron adecuada evolución clínica y hemodinámica a corto plazo, y lograron una rápida disminución de la presión arterial pulmonar sistólica y media, mejoría de función ventricular derecha y reducción de la carga trombótica. Conclusión: la trombólisis acelerada por ultrasonido es una terapia fármaco-mecánica novedosa que combina la emisión de ondas ultrasónicas con la infusión de un agente trombolítico local, estrategia que según diferentes ensayos y registros clínicos presenta una alta tasa de éxito y un buen perfil de seguridad.


Subject(s)
Hominidae , Pulmonary Embolism , Humans , Animals , Treatment Outcome , Fibrinolytic Agents/therapeutic use , Thrombolytic Therapy/adverse effects , Pulmonary Embolism/drug therapy , Contraindications
18.
Ann Hematol ; 102(6): 1581-1588, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37055582

ABSTRACT

Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare disease with an acute and severe clinical presentation. The anti-von Willebrand factor caplacizumab was licensed for adults with aTTP based on prospective controlled trials. However, until now, there was no Brazilian experience with this new treatment modality. This retrospective, multicenter, single-arm, expanded access program (EAP) with caplacizumab, plasma exchange (PEX), and immunosuppression was conducted between 02/24/21 and 04/14/21, and enrolled 5 Brazilian patients with aTTP. EAP allowed access to caplacizumab in Brazil and real-world data was collected, at a time when the medication was not commercially available in Brazil. The median age was 31 years old, most patients were women (80%), and neurological manifestation was observed in 80% of cases. The median of laboratory tests was hemoglobin (Hb) of 11 g/dL, platelets (16.1 × 109/L), lactic dehydrogenase (LDH) of 1471 U/L, creatinine (0.7 mg/dL), ADAMTS13 activity lower than 0.71%, and PLASMIC score of 6. All patients received immunosuppression, PEX, and caplacizumab. Until clinical response was achieved, the median was 3 sessions of PEX and 3 days of treatment. The median time of caplacizumab use was 35 days, with platelet normalization in 2 days after starting the drug. The median total length of stay was 8 days. All patients achieved clinical response and clinical remission, with a good safety profile. There was rapid clinical response, few PEX sessions were necessary, and there were short hospital stay, absence of refractoriness, little exacerbation, no death, and resolution of signs and symptoms at diagnosis.


Subject(s)
Purpura, Thrombotic Thrombocytopenic , Adult , Humans , Female , Male , Purpura, Thrombotic Thrombocytopenic/diagnosis , Purpura, Thrombotic Thrombocytopenic/drug therapy , Prospective Studies , Retrospective Studies , Fibrinolytic Agents/therapeutic use , Plasma Exchange , ADAMTS13 Protein
19.
Arq Neuropsiquiatr ; 81(3): 217-224, 2023 03.
Article in English | MEDLINE | ID: mdl-37059430

ABSTRACT

BACKGROUND: Seizures after stroke can negatively affect the prognosis of ischemic stroke and cause a decrease in quality of life. The efficacy of intravenous (IV) recombinant tissue plasminogen activator (rt-PA) treatment in acute ischemic stroke has been demonstrated in many studies, and IV rt-PA treatment has been increasingly used around the world. The SeLECT score is a useful score for the prediction of late seizures after stroke and includes the severity of stroke (Se), large artery atherosclerosis (L), early seizure (E), cortical involvement (C), and the territory of the middle cerebral artery (T). However, the specificity and sensitivity of the SeLECT score have not been studied in acute ischemic stroke patients that received IV rt-PA treatment. OBJECTIVE: In the present study, we aimed to validate and develop the SeLECT score in acute ischemic stroke patients receiving IV rt-PA treatment. METHODS: The present study included 157 patients who received IV thrombolytic treatment in our third-stage hospital. The 1-year seizure rates of the patients were detected. SeLECT scores were calculated. RESULTS: In our study, we found that the SeLECT score had low sensitivity but high specificity for predicting the likelihood of late seizure after stroke in patients administered IV rt-PA therapy. In addition to the SeLECT score, we found that the specificity and sensitivity were higher when we evaluated diabetes mellitus (DM) and leukoaraiosis. CONCLUSION: We found that DM was an independent risk factor for late seizures after stroke in a patient group receiving thrombolytic therapy, and late seizures after stroke were less frequent in patients with leukoaraiosis.


ANTECEDENTES: As convulsões após o AVC podem afetar negativamente o prognóstico do AVC isquêmico e causar uma diminuição na qualidade de vida. A eficácia do tratamento com ativador do plasminogênio tecidual recombinante (rt-PA) intravenoso (IV) no AVC isquêmico agudo foi demonstrada em muitos estudos, e o tratamento com rt-PA IV tem sido cada vez mais usado em todo o mundo. A pontuação SeLECT é uma pontuação útil para a previsão de convulsões tardias após AVC e inclui a gravidade do AVC (Se), aterosclerose de grandes artérias (L), convulsão precoce (E), envolvimento cortical (C) e o território do meio artéria cerebral (T). No entanto, a especificidade e a sensibilidade do escore SeLECT não foram estudadas em pacientes com AVC isquêmico agudo que receberam tratamento IV com rt-PA. OBJETIVO: No presente estudo, objetivamos validar e desenvolver o escore SeLECT em pacientes com AVC isquêmico agudo recebendo tratamento IV com rt-PA. MéTODOS: O presente estudo incluiu 157 pacientes que receberam tratamento trombolítico IV em nosso hospital de terceiro estágio. As taxas de convulsão de 1 ano dos pacientes foram detectadas. Os escores SeLECT foram calculados. RESULTADOS: Em nosso estudo, descobrimos que o escore SeLECT apresentou baixa sensibilidade, mas alta especificidade para prever a probabilidade de convulsão tardia após AVC em pacientes que receberam terapia IV com rt-PA. Além do escore SeLECT, descobrimos que a especificidade e a sensibilidade foram maiores quando avaliamos diabetes mellitus (DM) e leucoaraiose. CONCLUSãO: Descobrimos que DM foi um fator de risco independente para convulsões tardias após AVC em um grupo de pacientes recebendo terapia trombolítica, e convulsões tardias após AVC foram menos frequentes em pacientes com leucoaraiose.


Subject(s)
Brain Ischemia , Diabetes Mellitus , Ischemic Stroke , Leukoaraiosis , Stroke , Humans , Tissue Plasminogen Activator/therapeutic use , Leukoaraiosis/complications , Leukoaraiosis/drug therapy , Leukoaraiosis/chemically induced , Quality of Life , Brain Ischemia/therapy , Treatment Outcome , Fibrinolytic Agents/therapeutic use , Stroke/complications , Stroke/drug therapy , Thrombolytic Therapy/adverse effects , Seizures/drug therapy , Seizures/etiology
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