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Plastic and Reconstructive Surgery.... May 2024Antithrombotic agents are used after free-flap surgery to prevent thrombus formation and improve flap outcomes. However, the reports vary. Therefore, this meta-analysis...
BACKGROUND
Antithrombotic agents are used after free-flap surgery to prevent thrombus formation and improve flap outcomes. However, the reports vary. Therefore, this meta-analysis aimed to elucidate the need for antithrombotic agents in this context.
METHODS
We searched for studies that compared the outcomes of patients undergoing free-flap surgery with or without postoperative antithrombotic agents in the PubMed, Cochrane, and ClinicalTrials.gov databases. The primary outcome was total flap failure, with secondary outcomes including partial flap failure, pedicle thrombosis, and bleeding/hematoma. The relative risks (RRs) of outcomes with or without antithrombotic use were evaluated.
RESULTS
Fifteen studies (n = 6755 cases) were included. Antithrombotic agents did not reduce flap failure or pedicle thrombosis risks but increased bleeding and hematoma risks (RR, 1.535). Subgroup analyses by antiplatelet and anticoagulant use demonstrated results similar to those of antithrombotic use. The RR of bleeding/hematoma was 1.761 and 2.740 in the antiplatelet and anticoagulant groups, respectively. Postoperative dextran-40 administration reduced the risk of partial flap failure, with an RR of 0.535.
CONCLUSIONS
Postoperative antithrombotic, antiplatelet, or anticoagulant use did not change the risk of total/partial flap failure or pedicle thrombosis but increased the risk of hematoma/bleeding. Postoperative use of dextran-40 reduced the risk of partial flap failure. Increased intraflap blood flow may decrease the risk of partial flap failure. However, dextran-40 may cause severe pulmonary distress. Further prospective studies are required to evaluate the effects of these agents on thrombus formation, intraflap blood flow, and partial flap failure risk.
PubMed: 38752217
DOI: 10.1097/GOX.0000000000005812 -
BMC Gastroenterology May 2024To systematically analyze risk factors for delayed postpolypectomy bleeding (DPPB) in colorectum. (Meta-Analysis)
Meta-Analysis
BACKGROUND
To systematically analyze risk factors for delayed postpolypectomy bleeding (DPPB) in colorectum.
METHODS
We searched seven large databases from inception to July 2022 to identify studies that investigated risk factors for DPPB. The effect sizes were expressed by relative risk (RR) and 95% confidence interval (95% CI). The heterogeneity was analyzed by calculating I values and performing sensitivity analyses.
RESULTS
A total of 15 articles involving 24,074 subjects were included in the study. The incidence of DPPB was found to be 0.02% (95% CI, 0.01-0.03), with an I value of 98%. Our analysis revealed that male sex (RR = 1.64), history of hypertension (RR = 1.54), anticoagulation (RR = 4.04), polyp size (RR = 1.19), polyp size ≥ 10 mm (RR = 2.43), polyp size > 10 mm (RR = 3.83), polyps located in the right semicolon (RR = 2.48) and endoscopic mucosal resection (RR = 2.99) were risk factors for DPPB.
CONCLUSIONS
Male sex, hypertension, anticoagulation, polyp size, polyp size ≥ 10 mm, polyps located in the right semicolon, and endoscopic mucosal resection were the risk factors for DPPB. Based on our findings, we recommend that endoscopists should fully consider and implement effective intervention measures to minimize the risk of DPPB.
Topics: Humans; Risk Factors; Colonic Polyps; Postoperative Hemorrhage; Hypertension; Sex Factors; Male; Anticoagulants; Endoscopic Mucosal Resection; Colonoscopy; Female; Incidence
PubMed: 38745130
DOI: 10.1186/s12876-024-03251-6 -
Journal of Critical Care May 2024Despite the advancements in extracorporeal membrane oxygenation (ECMO) technology, balancing the prevention of thrombosis and the risk of bleeding in patients on ECMO is...
BACKGROUND
Despite the advancements in extracorporeal membrane oxygenation (ECMO) technology, balancing the prevention of thrombosis and the risk of bleeding in patients on ECMO is still a significant challenge for physicians. This systematic review and meta-analysis aimed to assess the efficacy and safety of viscoelastic point-of-care (POC)-guided coagulation management in adult patients on ECMO.
METHODS
PubMed Medline, Embase, Scopus, Web of Science, and Cochrane Library databases were searched. After quality assessment, meta-analysis was carried out using random effects model, heterogeneity using I and publication bias using Doi and Funnel plots.
RESULTS
A total of 1718 records were retrieved from the searches. Fifteen studies that enrolled a total of 583 participants met the inclusion criteria. Of those, 3 studies enrolling 181 subjects were eligible for meta-analysis. In patients managed with POC-guided algorithms, the odds were coherently lower for bleeding (OR 0.71, 95%CI 0.36-1.42), thrombosis (OR 0.91, 95%CI 0.32-2.60), and in-hospital mortality (OR 0.54, 95%CI 0.29-1.03), but not for circuit change or failure (OR 1.50, 95%CI 0.59-3.83). However, the differences were not statistically significant due to wide 95%CIs.
CONCLUSION
Viscoelastic POC monitoring demonstrates potential benefits for coagulation management in ECMO patients. Future research should focus on standardizing evidence to improve clinical decision-making.
REGISTRATION
The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) with registration ID CRD42023486294.
PubMed: 38744017
DOI: 10.1016/j.jcrc.2024.154830 -
European Stroke Journal May 2024There is a longstanding clinical uncertainty regarding the optimal timing of initiating oral anticoagulants (OAC) for non-valvular atrial fibrillation following acute...
INTRODUCTION
There is a longstanding clinical uncertainty regarding the optimal timing of initiating oral anticoagulants (OAC) for non-valvular atrial fibrillation following acute ischemic stroke. Current international recommendations are based on expert opinions, while significant diversity among clinicians is noted in everyday practice.
METHODS
We conducted an updated systematic review and meta-analysis including all available randomized-controlled clinical trials (RCTs) and observational cohort studies that investigated early versus later OAC-initiation for atrial fibrillation after acute ischemic stroke. The primary outcome was defined as the composite of ischemic and hemorrhagic events and mortality at follow-up. Secondary outcomes included the components of the composite outcome (ischemic stroke recurrence, intracranial hemorrhage, major bleeding, and all-cause mortality). Pooled estimates were calculated with random-effects model.
RESULTS
Nine studies (two RCTs and seven observational) were included comprising a total of 4946 patients with early OAC-initiation versus 4573 patients with later OAC-initiation following acute ischemic stroke. Early OAC-initiation was associated with reduced risk of the composite outcome (RR = 0.74; 95% CI:0.56-0.98; = 46%) and ischemic stroke recurrence (RR = 0.64; 95% CI:0.43-0.95; = 60%) compared to late OAC-initiation. Regarding safety outcomes, similar rates of intracranial hemorrhage (RR = 0.98; 95% CI:0.57-1.69; = 21%), major bleeding (RR = 0.78; 95% CI:0.40-1.51; = 0%), and mortality (RR = 0.94; 95% CI:0.61-1.45; = 0%) were observed. There were no subgroup differences, when RCTs and observational studies were separately evaluated.
CONCLUSIONS
Early OAC-initiation in acute ischemic stroke patients with non-valvular atrial fibrillation appears to have better efficacy and a similar safety profile compared to later OAC-initiation.
PubMed: 38742375
DOI: 10.1177/23969873241251931 -
JAMA Neurology Jun 2024Cervical artery dissection is the most common cause of stroke in younger adults. To date, there is no conclusive evidence on which antithrombotic therapy should be used... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Cervical artery dissection is the most common cause of stroke in younger adults. To date, there is no conclusive evidence on which antithrombotic therapy should be used to treat patients.
OBJECTIVE
To perform an individual patient data meta-analysis of randomized clinical trials comparing anticoagulants and antiplatelets in prevention of stroke after cervical artery dissection.
DATA SOURCES
PubMed.gov, Cochrane database, Embase, and ClinicalTrials.gov were searched from inception to August 1, 2023.
STUDY SELECTION
Randomized clinical trials that investigated the effectiveness and safety of antithrombotic treatment (antiplatelets vs anticoagulation) in patients with cervical artery dissection were included in the meta-analysis. The primary end point was required to include a composite of (1) any stroke, (2) death, or (3) major bleeding (extracranial or intracranial) at 90 days of follow-up.
DATA EXTRACTION/SYNTHESIS
Two independent investigators performed a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and inconsistencies were resolved by a principal investigator.
MAIN OUTCOMES AND MEASURES
The primary outcome was a composite of (1) ischemic stroke, (2) death, or (3) major bleeding (extracranial or intracranial) at 90 days of follow-up. The components of the composite outcome were also secondary outcomes. Subgroup analyses based on baseline characteristics with a putative association with the outcome were performed. Logistic regression was performed using the maximum penalized likelihood method including interaction in the subgroup analyses.
RESULTS
Two randomized clinical trials, Cervical Artery Dissection in Stroke Study and Cervical Artery Dissection in Stroke Study and the Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection, were identified, of which all participants were eligible. A total of 444 patients were included in the intention-to-treat population and 370 patients were included in the per-protocol population. Baseline characteristics were balanced. There were fewer primary end points in those randomized to anticoagulation vs antiplatelet therapy (3 of 218 [1.4%] vs 10 of 226 [4.4%]; odds ratio [OR], 0.33 [95% CI, 0.08-1.05]; P = .06), but the finding was not statistically significant. In comparison with aspirin, anticoagulation was associated with fewer strokes (1 of 218 [0.5%] vs 10 of 226 [4.0%]; OR, 0.14 [95% CI, 0.02-0.61]; P = .01) and more bleeding events (2 vs 0).
CONCLUSIONS AND RELEVANCE
This individual patient data meta-analysis of 2 currently available randomized clinical trial data found no significant difference between anticoagulants and antiplatelets in preventing early recurrent events.
Topics: Humans; Vertebral Artery Dissection; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Anticoagulants; Randomized Controlled Trials as Topic; Stroke; Carotid Artery, Internal, Dissection
PubMed: 38739383
DOI: 10.1001/jamaneurol.2024.1141 -
Pharmacotherapy May 2024Previous meta-analyses assessed andexanet alfa (AA) or prothrombin complex concentrate (PCC) products for the treatment of Factor Xa inhibitor (FXaI)-associated major... (Meta-Analysis)
Meta-Analysis Review Comparative Study
Previous meta-analyses assessed andexanet alfa (AA) or prothrombin complex concentrate (PCC) products for the treatment of Factor Xa inhibitor (FXaI)-associated major bleeding. However, they did not include recent studies or assess the impact of the risk of bias. We conducted a systematic review with meta-analysis on the effectiveness of AA versus PCC products for FXaI-associated major bleeding, inclusive of the studies' risk of bias. PubMed and Embase were searched for comparative studies assessing major bleeding in patients using FXaI who received AA or PCC. We used the Methodological Index for NOn-Randomized Studies (MINORS) checklist and one question from the Joanna Briggs Institute (JBI) Critical Appraisal of Case Series tool to assess the risk of bias. Random-effects meta-analyses were performed to provide a pooled estimate for the effect of AA versus PCC products on hemostatic efficacy, in-hospital mortality, 30-day mortality, and thrombotic events. Low-moderate risk of bias studies were meta-analyzed separately, as well as combined with high risk of bias studies. Eighteen comparative evaluations of AA versus PCC were identified. Twenty-eight percent of the studies (n = 5) had low-moderate risk and 72% (n = 13) had a high risk of bias. Studies with low-moderate risk of bias suggested improvements in hemostatic efficacy [Odds Ratio (OR) 2.72 (95% Confidence Interval (CI): 1.15-6.44); one study], lower in-hospital mortality [OR 0.48 (95% CI: 0.38-0.61); three studies], and reduced 30-day mortality [OR 0.49 (95% CI: 0.30-0.80); two studies] when AA was used versus PCC products. When studies were included regardless of the risk of bias, pooled effects showed improvements in hemostatic efficacy [OR 1.36 (95% CI: 1.01-1.84); 12 studies] and reductions in 30-day mortality [OR 0.53 (95% CI: 0.37-0.76); six studies] for AA versus PCC. The difference in thrombotic events with AA versus PCC was not statistically significant in the low-moderate, high, or combined risk of bias groups. The evidence from low-moderate quality real-world studies suggests that AA is superior to PCC in enhancing hemostatic efficacy and reducing in-hospital and 30-day mortality. When studies are assessed regardless of the risk of bias, the pooled hemostatic efficacy and 30-day mortality risk remain significantly better with AA versus PCC.
Topics: Humans; Factor Xa Inhibitors; Hemorrhage; Factor Xa; Blood Coagulation Factors; Recombinant Proteins; Hospital Mortality
PubMed: 38721837
DOI: 10.1002/phar.2925 -
Clinical and Translational Science May 2024Cannabis-drug interactions have caused significant concerns, mainly due to their role in the cytochrome P450 (CYP) enzyme-mediated metabolic pathway of numerous...
Cannabis-drug interactions have caused significant concerns, mainly due to their role in the cytochrome P450 (CYP) enzyme-mediated metabolic pathway of numerous medications. A systematic review was conducted to gain an overview of the potential interactions of cannabis with different drug classes by extracting pertinent information from published study data. From the inception of the study to October 1, 2023, we performed a systematic search of PubMed, Scopus, clinicaltrials.gov, and Web of Science. We included 54 out of 464 articles, and a total of 20 drug classes were identified to have interactions with medicinal cannabis. The cannabis-drug interactions were assessed and classified according to their probability and severity. The analysis revealed that antiepileptics had the most evidence of interaction with cannabis, followed by clobazam (CLB), warfarin, and tacrolimus. Generally, cannabis-drug interactions result in pharmacokinetic (PK) or pharmacodynamic (PD) changes. Therefore, careful monitoring should be performed to detect any unusual elevations in plasma levels. In addition, dose titrations or treatment withdrawal could help mitigate the adverse effects attributed to cannabis-drug interactions. Nevertheless, novel drugs are constantly emerging, and more research is needed to further identify potential interactions with cannabis.
Topics: Humans; Anticonvulsants; Clobazam; Drug Interactions; Medical Marijuana; Warfarin
PubMed: 38720531
DOI: 10.1111/cts.13812 -
Clinical Genitourinary Cancer Jun 2024Several phase II trials have investigated neoadjuvant novel androgen receptor signaling inhibitors (ARSIs) in combination with androgen deprivation therapy (ADT)... (Meta-Analysis)
Meta-Analysis Review
Cardiovascular and Thromboembolic Events in Patients With Localized Prostate Cancer Receiving Intensified Neoadjuvant Androgen Deprivation: A Systematic Review and Meta-Analysis.
Several phase II trials have investigated neoadjuvant novel androgen receptor signaling inhibitors (ARSIs) in combination with androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) in prostate cancer (PC) patients. However, data regarding complications of intense hormone therapy and surgical complications are scarce. Our objective was to evaluate the occurrence of cardiovascular (CV) and thromboembolic (TE) adverse events (AE) in patients with localized PC who have received intense neoadjuvant ADT followed by prostatectomy. A comprehensive search in MEDLINE, Embase, Scopus and conference abstracts was performed. The strategies were developed and applied for each electronic database on March 7th, 2023. Eligible studies included randomized and single-arm trials testing ARSIs prior to prostatectomy that adequately reported safety data regarding CV and TE AE, peri-operative complications, and mortality during therapy. Pooled incidence (PI) of AE with 95% confidence interval (95% CI) was estimated using a random effects model. Quality assessment and reporting followed Cochrane Collaboration Handbook and PRISMA guidelines. PROSPERO: CRD42022344104. Nine randomized controlled trials and three single-arm phase II trials were included, comprising 702 patients (702 patients for CV AE and 522 for perioperative complications). The neoadjuvant regimen was classified as monotherapy with ARSI (100 patients), combination therapy with ADT + ARSI (383 patients), or ADT + ARSI + ARSI (219 patients). The PI of TE within the perioperative interval was 4.2% (95% CI = 2.6%-6.6%, I2 = 0.0%, P = .65), and the PI for CV AE was 4.6% (95% CI = 3.1%-6.7%, I2 = 0.0%, P = .71). Seven deaths were reported, resulting in a PI of 2.2% (95% CI = 1.3%-3.8%, I2 = 0.0%, P = .99), of which two were considered treatment-related and occurred within the perioperative period. The PI of hypertension grade 3-5 was 7.3% (95% CI = 4.8%-11.0%, I2 = 38.8%, P = .04). CV and TE AE associated with intense neoadjuvant hormone therapy in patients with localized PC can occur in up to 4.6% of cases. Our data warns for further assessment of thrombotic risk and prophylactic anticoagulation in this setting.
Topics: Humans; Male; Prostatic Neoplasms; Neoadjuvant Therapy; Thromboembolism; Prostatectomy; Androgen Antagonists; Cardiovascular Diseases; Randomized Controlled Trials as Topic; Clinical Trials, Phase II as Topic; Postoperative Complications
PubMed: 38718699
DOI: 10.1016/j.clgc.2024.102088 -
Thrombosis Research Jun 2024Thromboembolic events are common complications of COVID-19. Clinical study results on safety and efficacy of anticoagulation in COVID-19 are controversial. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Thromboembolic events are common complications of COVID-19. Clinical study results on safety and efficacy of anticoagulation in COVID-19 are controversial.
MATERIAL AND METHODS
This report is the second update of our systematic review with meta-analysis on randomized controlled trials (RCTs) comparing standard thromboprophylaxis, intermediate or therapeutic dose anticoagulation or no anticoagulation in COVID-19 in- and outpatients. We searched eligible studies up to 5 October 2023. Certainty of evidence was assessed using GRADE.
RESULTS
For this update we included fourteen new RCTs and a total of 27 RCTs with 16,789 patients. Certainty of evidence ranged from very low to high depending on outcome and comparison. Standard thromboprophylaxis with low dose anticoagulation may have little or no effect for COVID-19 outpatients compared to no anticoagulation. In inpatients with moderate or severe COVID-19, intermediate dose anticoagulation may decrease any thrombotic events or death, but may increase major bleeding compared to standard thromboprophylaxis. Therapeutic dose anticoagulation decreases thrombotic events or deaths in inpatients with moderate COVID-19, but probably has little or no effect in patients with severe COVID-19 compared to standard thromboprophylaxis with low or intermediate dose anticoagulation. With therapeutic dose anticoagulation, the risk of major bleeding probably increases regardless of COVID-19 severity. We are uncertain on the effect of thromboprophylaxis with low dose anticoagulation compared to no anticoagulation in the post-discharge setting.
CONCLUSIONS
Hospitalized, moderately-ill COVID-19 patients may benefit from intermediate or therapeutic dose anticoagulation, while critically ill patients may not. Risk of major bleeding must be considered.
Topics: Humans; Anticoagulants; COVID-19; SARS-CoV-2; Hemorrhage; COVID-19 Drug Treatment; Randomized Controlled Trials as Topic; Thromboembolism
PubMed: 38718472
DOI: 10.1016/j.thromres.2024.04.007 -
Annals of Hematology May 2024Rivaroxaban is a new direct oral anticoagulant, and the same dose is recommended for older and young patients. However, recent real-world studies show that older... (Review)
Review
Rivaroxaban is a new direct oral anticoagulant, and the same dose is recommended for older and young patients. However, recent real-world studies show that older patients may need dose adjustment to prevent major bleeding. At present, the evidence for dose adjustment in older patients is extremely limited with only a few reports on older atrial fibrillation patients. The aim of this study was to review the morbidity data of adverse events and bleeding events across all indications for older and young patients treated with the same dose of rivaroxaban to provide some support for dosage adjustment in older patients. The PubMed, EMBASE, ClinicalTrials, Cochrane and Web of Science databases were searched for randomized controlled trials (RCTs) published between January 1, 2005, and October 10, 2023. The primary outcomes were the morbidity of bleeding events and efficacy-related adverse events. Summary estimates were calculated using a random effects model. Eighteen RCTs were included in the qualitative analysis. The overall morbidity of primary efficacy endpoints was higher in older patients compared to the young patients (3.37% vs. 2.60%, χ = 5.24, p = 0.022). Similarly, a higher morbidity of bleeding was observed in older patients compared to the young patients (4.42% vs. 6.03%, χ = 13.22, p < 0.001). Among all indications, deep vein thrombosis, pulmonary embolism and atrial fibrillation were associated with the highest incidence of bleeding in older patients, suggesting that these patients may be most need dose adjustment. Patients older than 75 years may require extra attention to prevent bleeding. The same dose of rivaroxaban resulted in higher bleeding morbidity and morbidity of efficacy-related adverse events in older patients compared to the young patients. An individualized dose adjustment may be preferred for older patients rather than a fixed dose that fits all.
PubMed: 38710878
DOI: 10.1007/s00277-024-05767-z