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Thrombosis Journal Apr 2024Currently published studies have not observed consistent results on the efficacy and safety of direct oral anticoagulants (DOACs) use in patients with chronic kidney... (Review)
Review
BACKGROUND
Currently published studies have not observed consistent results on the efficacy and safety of direct oral anticoagulants (DOACs) use in patients with chronic kidney disease (CKD) combined with atrial fibrillation (AF). Therefore, this study conducted a meta-analysis of the efficacy and safety of DOACs for patients with AF complicated with CKD.
METHODS
Database literature was searched up to May 30, 2023, to include randomized controlled trials (RCT) involving patients with AF complicated with CKD DOACs and vitamin K antagonists (VKAs). Stroke, systemic embolism (SE), and all-cause mortality were used as effectiveness indicators, and major bleeding, intracranial hemorrhage (ICH), fatal bleeding, gastrointestinal bleeding (GIB), and clinically relevant non-major bleeding (CRNMB) were used as safety outcomes.
RESULTS
Nine RCT studies were included for analysis according to the inclusion criteria. Results of the efficacy analysis showed that compared with VKAs, DOACs reduced the incidence of stroke/SE (OR = 0.75, 95% CI 0.67-0.84) and all-cause deaths (OR = 0.84, 95% CI 0.75-0.93) in patients with AF who had comorbid CKD. Safety analyses showed that compared with VKAs, DOACs improved safety by reducing the risk of major bleeding (OR = 0.76, 95%CI 0.65-0.90), ICH (OR = 0.46, 95%CI 0.38-0.56), and fatal bleeding (OR = 0.75, 95%CI 0.65-0.87), but did not reduce the incidence of GIB and CRNMB.
CONCLUSION
Compared with VKAs, DOACs may increase efficacy and improve safety in AF patients with CKD (90 ml/min> Crcl≥15 ml/min), and shows at least similar efficacy and safety in AF patients with Kidney failure (Crcl<15 ml/min).
PubMed: 38679736
DOI: 10.1186/s12959-024-00608-5 -
Journal of Global Health Apr 2024Several reviews have been conducted on thromboprophylaxis in non-hospitalised patients with coronavirus disease 2019 (COVID-19). In this systematic review and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Several reviews have been conducted on thromboprophylaxis in non-hospitalised patients with coronavirus disease 2019 (COVID-19). In this systematic review and meta-analysis, we sought to investigate the impact of prophylactic-dose direct oral anticoagulants (DOACs) in this population.
METHODS
We searched PubMed, Web of Science, EMBASE and Cochrane Library for randomised controlled trials (RCTs) comparing prophylactic-dose DOACs with placebo or no treatment in non-hospitalised patients with COVID-19 until September 2023. The primary efficacy outcome was a composite of all-cause mortality and thromboembolic events, while major bleeding events were the primary safety outcome. We expressed continuous outcome data as mean differences (MDs) with 95% confidence intervals (CIs) and dichotomous outcome data as risk ratios (RRs) with 95% CIs.
RESULTS
We included six RCTs involving 4307 patients. Prophylactic-dose DOAC therapy compared with placebo or no treatment was associated with significantly decreased risks of the composite outcome of all-cause mortality and thromboembolic events (1.43% vs 2.67% (RR = 0.53; 95% CI = 0.34-0.82, P = 0.004, I = 3%)). Major bleeding events were infrequent, and we detected no significant differences between patients assigned to prophylactic-dose DOACs vs placebo or no treatment (0.19% vs 0.05% (RR = 2.50; 95% CI = 0.49-12.87, P = 0.27, I = 0%)). The use of prophylactic-dose DOACs was also associated with a reduction in venous thromboembolism, with no difference in all-cause mortality, arterial thromboembolism, hospitalisations, and clinically relevant nonmajor bleeding between two groups. Sensitivity analyses with the leave-one-out method for the primary efficacy and safety outcome did not change the effect estimate substantially.
CONCLUSIONS
We found that prophylaxis-dose DOACs could significantly improve clinical outcomes and reduce venous thrombotic events without increasing the risk of major bleeding events compared with placebo or no treatment in non-hospitalised patients with COVID-19.
REGISTRATION
PROSPERO: CRD42023466889.
Topics: Humans; COVID-19; Randomized Controlled Trials as Topic; Anticoagulants; Administration, Oral; SARS-CoV-2; COVID-19 Drug Treatment; Thromboembolism; Hemorrhage
PubMed: 38665058
DOI: 10.7189/jogh.14.05015 -
Catheterization and Cardiovascular... May 2024Among different coronary stents implanted in High Bleeding Risk (HBR) patients with an indication for short antiplatelet therapy, no comparisons in terms of efficacy... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Among different coronary stents implanted in High Bleeding Risk (HBR) patients with an indication for short antiplatelet therapy, no comparisons in terms of efficacy have been provided.
METHODS
A Network Meta Analysis was performed including all randomized controlled trials comparing different coronary stents evaluated in HBR patients. Major Adverse Cardiovascular Events (MACEs) as defined by each included trial were the primary end point, whereas TLR (target lesion revascularization), TVR (target vessel revascularization), stent thrombosis and total and major (BARC3-5) bleedings were the secondary ones.
RESULTS
A total of four studies (ONYX ONE, LEADERS FREE, SENIOR and HBR in BIO-RESORT) including 6637 patients were analyzed with different kind of stents and dual antiplatelet therapy (DAPT) length (1 or 6 months) on 12 months follow-up. About one-third of these patients were defined HBR due to indication for oral anticoagulation. All drug eluting stents (DESs) reduced risk of MACE compared to Bare Metal Stents (BMSs) when followed by a 1-month DAPT. At SUCRA analysis, Orsiro was the device with the highest probability of performing best. Rates of TLR and TVR were significantly lower when using Resolute Onyx, Synergy and BioFreedom stents in comparison to BMS when followed by 1-month DAPT, with Synergy ranking best. Synergy also showed a significantly lower number of stent thrombosis compared to BMS (RR 0.28, 95% CI 0.06-0.93), while Orsiro and Resolute Integrity showed the highest probability of performing best.
CONCLUSION
In HBRs patients, all DESs were superior to BMSs in terms of efficacy and safety. Among DESs, Orsiro was the one with the highest ranking in terms of MACE, mainly driven by a reduced incidence of repeated revascularization and stent thrombosis.
Topics: Humans; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Hemorrhage; Network Meta-Analysis; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome
PubMed: 38639169
DOI: 10.1002/ccd.31047 -
BMC Oral Health Apr 2024Oral leukoplakia (OLK) is a prevalent precancerous lesion with limited non-pharmacological treatment options. Surgery and various lasers are the mainstay of treatment;... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Oral leukoplakia (OLK) is a prevalent precancerous lesion with limited non-pharmacological treatment options. Surgery and various lasers are the mainstay of treatment; however, their relative efficacy and optimal choice remain unclear. This first network meta-analysis compared the effects of different lasers and surgical excision on post-treatment recurrence and comfort in OLK patients.
METHODS
We searched four databases for relevant randomized controlled trials (RCTs) up to April 2023. The primary outcome was post-treatment recurrence, and secondary outcomes included intraoperative hemorrhage and postoperative pain scores. The Cochrane Risk of Bias tool was used to assess the study quality. Meta-analysis and network meta-analysis were employed to determine efficacy and identify the optimal intervention.
RESULTS
A total of 11 RCTs including 917 patients and 1138 lesions were included. Er,Cr:YSGG laser treatment showed significantly lower recurrence rates compared to CO laser (OR: 0.04; 95% CI: 0.01-0.18), CO laser with margin extension (OR: 0.06; 95% CI: 0.01-0.60), Er:YAG laser (OR: 0.10; 95% CI: 0.03-0.37), electrocautery (OR: 0.03; 95% CI: 0.00-0.18), and standard care (OR: 0.08; 95% CI: 0.02-0.33). Er,Cr:YSGG laser also ranked the best for reducing recurrence, followed by standard care and CO laser combined with photodynamic therapy (PDT). Er:YAG and Er:Cr:YSGG lasers minimized bleeding and pain, respectively. None of the interventions caused severe adverse effects.
CONCLUSION
For non-homogeneous OLK, Er:YAG, Er:Cr:YSGG, and CO laser combined with PDT offer promising alternatives to surgical excision, potentially reducing recurrence and improving patient comfort. Further high-quality RCTs are necessary to confirm these findings and determine the optimal laser-PDT combination for OLK treatment.
Topics: Humans; Network Meta-Analysis; Carbon Dioxide; Patient Comfort; Laser Therapy; Leukoplakia, Oral; Lasers, Solid-State
PubMed: 38632580
DOI: 10.1186/s12903-024-04179-9 -
Journal of the American Heart... Apr 2024Concomitant atrial fibrillation and end-stage renal disease is common and associated with an unfavorable prognosis. Although oral anticoagulants have been well... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Concomitant atrial fibrillation and end-stage renal disease is common and associated with an unfavorable prognosis. Although oral anticoagulants have been well established to prevent thromboembolism, the applicability in patients under long-term dialysis remains debatable. The study aimed to determine the efficacy and safety of anticoagulation in the dialysis-dependent population.
METHODS AND RESULTS
An updated network meta-analysis based on MEDLINE, EMBASE, and the Cochrane Library was performed. Studies published up to December 2022 were included. Direct oral anticoagulants (DOACs, dabigatran, rivaroxaban, apixaban 2.5/5 mg twice daily), vitamin K antagonists (VKAs), and no anticoagulation were compared on safety and efficacy outcomes. The outcomes of interest were major bleeding, thromboembolism, and all-cause death. A total of 42 studies, including 3 randomized controlled trials, with 185 864 subjects were pooled. VKAs were associated with a significantly higher risk of major bleeding than either no anticoagulation (hazard ratio [HR], 1.47; 95% CI, 1.34-1.61) or DOACs (DOACs versus VKAs; HR, 0.74 [95% CI, 0.64-0.84]). For the prevention of thromboembolism, the efficacies of VKAs, DOACs, and no anticoagulation were equivalent. Nevertheless, dabigatran and rivaroxaban were associated with fewer embolic events. There were no differences in all-cause death with the administration of VKAs, DOACs, or no anticoagulation.
CONCLUSIONS
For dialysis-dependent populations, dabigatran and rivaroxaban were associated with better efficacy, while dabigatran and apixaban demonstrated better safety. No anticoagulation was a noninferior alterative, and VKAs were associated with the worst outcomes.
Topics: Humans; Atrial Fibrillation; Rivaroxaban; Dabigatran; Stroke; Network Meta-Analysis; Anticoagulants; Hemorrhage; Fibrinolytic Agents; Administration, Oral; Kidney Failure, Chronic; Thromboembolism; Randomized Controlled Trials as Topic
PubMed: 38606775
DOI: 10.1161/JAHA.123.034176 -
The British Journal of Oral &... May 2024Cleft palate repair is a common reconstructive procedure that can involve significant blood loss. Tranexamic acid (TXA) has been proposed to minimise blood loss during... (Meta-Analysis)
Meta-Analysis Review
Cleft palate repair is a common reconstructive procedure that can involve significant blood loss. Tranexamic acid (TXA) has been proposed to minimise blood loss during various surgical procedures, but its effectiveness in cleft palate repair remains unclear. This systematic review and meta-analysis aimed to assess the effectiveness of TXA to reduce postoperative blood loss. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a comprehensive search across multiple databases, including PubMed, Cochrane, and Web of Science, to identify relevant studies published up to September 2023. Only randomised controlled trials (RCTs) were included. Primary outcomes measured were total blood loss, transfusion rates, and postoperative complications. We identified four relevant RCTs, which included 275 cleft palate patients with a mean (range) age of 28.7 (6-65) months. The pooled analysis found no significant difference in duration of surgery (MD -18.40 minutes, p = 0.09), preoperative haemoglobin (MD 0.46 g/dl, p = 0.27), or postoperative haemoglobin (MD 0.07 g/dl, p = 0.86) between TXA and control groups. Intraoperative blood loss was lower with TXA, but with TXA, the difference was not statistically significant (MD -16.63 ml, p = 0.15). TXA significantly improved surgical field visibility (p = 0.004). No adverse events occurred with its use. While no significant differences were found in surgical outcomes with TXA, surgical field visibility significantly improved, and TXA showed a promising safety profile. Larger and higher-quality RCTs are still needed to validate these preliminary findings before TXA can be considered as a standard treatment.
Topics: Tranexamic Acid; Humans; Cleft Palate; Blood Loss, Surgical; Antifibrinolytic Agents; Postoperative Hemorrhage; Blood Transfusion
PubMed: 38508902
DOI: 10.1016/j.bjoms.2023.12.019 -
JAMA Cardiology May 2024Among patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether the treatment efficacy of P2Y12 inhibitor monotherapy after a short course... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Among patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether the treatment efficacy of P2Y12 inhibitor monotherapy after a short course of dual antiplatelet therapy (DAPT) depends on the type of P2Y12 inhibitor.
OBJECTIVE
To assess the risks and benefits of ticagrelor monotherapy or clopidogrel monotherapy compared with standard DAPT after PCI.
DATA SOURCES
MEDLINE, Embase, TCTMD, and the European Society of Cardiology website were searched from inception to September 10, 2023, without language restriction.
STUDY SELECTION
Included studies were randomized clinical trials comparing P2Y12 inhibitor monotherapy with DAPT on adjudicated end points in patients without indication to oral anticoagulation undergoing PCI.
DATA EXTRACTION AND SYNTHESIS
Patient-level data provided by each trial were synthesized into a pooled dataset and analyzed using a 1-step mixed-effects model. The study is reported following the Preferred Reporting Items for Systematic Review and Meta-Analyses of Individual Participant Data.
MAIN OUTCOMES AND MEASURES
The primary objective was to determine noninferiority of ticagrelor or clopidogrel monotherapy vs DAPT on the composite of death, myocardial infarction (MI), or stroke in the per-protocol analysis with a 1.15 margin for the hazard ratio (HR). Key secondary end points were major bleeding and net adverse clinical events (NACE), including the primary end point and major bleeding.
RESULTS
Analyses included 6 randomized trials including 25 960 patients undergoing PCI, of whom 24 394 patients (12 403 patients receiving DAPT; 8292 patients receiving ticagrelor monotherapy; 3654 patients receiving clopidogrel monotherapy; 45 patients receiving prasugrel monotherapy) were retained in the per-protocol analysis. Trials of ticagrelor monotherapy were conducted in Asia, Europe, and North America; trials of clopidogrel monotherapy were all conducted in Asia. Ticagrelor was noninferior to DAPT for the primary end point (HR, 0.89; 95% CI, 0.74-1.06; P for noninferiority = .004), but clopidogrel was not noninferior (HR, 1.37; 95% CI, 1.01-1.87; P for noninferiority > .99), with this finding driven by noncardiovascular death. The risk of major bleeding was lower with both ticagrelor (HR, 0.47; 95% CI, 0.36-0.62; P < .001) and clopidogrel monotherapy (HR, 0.49; 95% CI, 0.30-0.81; P = .006; P for interaction = 0.88). NACE were lower with ticagrelor (HR, 0.74; 95% CI, 0.64-0.86, P < .001) but not with clopidogrel monotherapy (HR, 1.00; 95% CI, 0.78-1.28; P = .99; P for interaction = .04).
CONCLUSIONS AND RELEVANCE
This systematic review and meta-analysis found that ticagrelor monotherapy was noninferior to DAPT for all-cause death, MI, or stroke and superior for major bleeding and NACE. Clopidogrel monotherapy was similarly associated with reduced bleeding but was not noninferior to DAPT for all-cause death, MI, or stroke, largely because of risk observed in 1 trial that exclusively included East Asian patients and a hazard that was driven by an excess of noncardiovascular death.
Topics: Ticagrelor; Percutaneous Coronary Intervention; Humans; Clopidogrel; Platelet Aggregation Inhibitors; Dual Anti-Platelet Therapy; Purinergic P2Y Receptor Antagonists; Hemorrhage
PubMed: 38506796
DOI: 10.1001/jamacardio.2024.0133 -
Pediatric Dentistry Jan 2024The purpose of this study was to present an evidence-based guideline for primary teeth with deep caries or trauma requiring vital pulp therapies (VPT). A systematic... (Meta-Analysis)
Meta-Analysis
The purpose of this study was to present an evidence-based guideline for primary teeth with deep caries or trauma requiring vital pulp therapies (VPT). A systematic review/meta-analysis on vital primary teeth resulting from trauma or caries was conducted using GRADE to assess the certainty of evidence for clinical recommendations. A decision tree was provided for choosing VPTs. No articles on trauma VPT were found. For VPT in primary teeth with deep caries, indirect pulp treatment (IPT) or pulpotomy using the calcium silicate cement (mineral trioxide aggregate [MTA] or Biodentine) show increased success over using direct pulp capping (DPC) and other pulpotomies. Different liners do not affect IPT success (high certainty) or DPC capping agents' success (very low certainty) after 24 months. It is strongly recommended, with high certainty from 24-month data, that calcium silicate cement pulpotomy is preferred over formocresol, ferric sulfate, zinc oxide eugenol pulpotomy, and other pulpotomies. Using selective caries removal and IPT for deep caries is strongly recommended with moderate certainty over complete and stepwise removal. Statistically, this results in significantly fewer pulp exposures. No caries removal and Hall technique crown may be used when indicated (moderate certainty at 24 months). For vital primary incisors with deep caries, pulpotomy was significantly better statistically than pulpectomy. Teeth diagnosed with/without reversible pulpitis pain showed comparable success after 12 months of treatment by IPT or calcium silicate cement pulpotomy. The following had little or no significant effect on MTA pulpotomy success: coronal pulp removal methods; irrigation solution; method to control hemorrhage; base over MTA; treatment in one or two visits; anterior or posterior teeth. Indirect pulp treatment or calcium silicate cement pulpotomy is likely to increase vital pulp therapy success over other VPTs such as direct pulp capping and other pulpotomies after 24 months (moderate certainty).
Topics: Humans; Dental Care; Pulpotomy; Dental Pulp; Calcium; Dental Cements; Glass Ionomer Cements; Tooth, Deciduous; Calcium Compounds; Silicates
PubMed: 38449041
DOI: No ID Found -
Journal of Thrombosis and Thrombolysis Apr 2024Direct oral anticoagulants (DOACs) are the mainstay of treatment for venous thromboembolism (VTE) and non-valvular atrial fibrillation (AF), with or without an...
BACKGROUND
Direct oral anticoagulants (DOACs) are the mainstay of treatment for venous thromboembolism (VTE) and non-valvular atrial fibrillation (AF), with or without an underlying cancer. Patients with cancer have a 2-3-fold increase in risk for bleeding complications compared to non-cancer patients taking anticoagulant therapy, however the incidence of bleeding for urogenital and gynecological cancers on DOACs are uncertain.
AIMS
To assess the bleeding risk associated with the use of DOACs in patients with urogenital and/or gynecological cancers.
METHOD
We conducted a systematic review of randomized controlled trials (RCTs) and prospective cohort studies to address the safety of DOACs for VTE and AF when used in patients with urogenital and/or gynecological malignancy. The primary outcomes assessed were major and clinically relevant non-major (CRNMB) bleeding, with minor bleeding considered as a secondary outcome. MEDLINE, EMBASE and COCHRANE Central Registry of Controlled Trials were searched up to and including Oct 28, 2022. The study protocol was registered in PROSPERO (CRD42022370981). Studies were independently assessed for inclusion and data extracted in duplicate.
RESULT
Seven studies met our inclusion criteria (Fig. 1): 2 RCTs and 5 prospective cohort studies. A total of 676 patients treated with DOACs were included, 628 (92.8%) had VTE and 48 (7.1%) had AF. In patients with VTE treated with DOACs, the pooled major bleeding rate was 2.1%, 95% confidence intervals (CI) 0.9-3.3% (Fig. 2). Pooled estimates could not be determined for AF patients given small event and patient numbers.
CONCLUSION
Major bleeding rates in urogenital and/or gynecological cancer patients treated with DOACs are similar to that of the general cancer population.
Topics: Humans; Anticoagulants; Venous Thromboembolism; Incidence; Hemorrhage; Neoplasms; Administration, Oral
PubMed: 38429468
DOI: 10.1007/s11239-024-02956-5 -
World Journal of Surgical Oncology Feb 2024Direct oral anticoagulants (DOACs) used as an alternative to low-molecular-weight heparin (LMWH) for thromboprophylaxis after cancer surgery for venous thromboembolic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Direct oral anticoagulants (DOACs) used as an alternative to low-molecular-weight heparin (LMWH) for thromboprophylaxis after cancer surgery for venous thromboembolic events (VTE) remains unclear. This study aimed to investigate the efficacy and safety of DOACs versus LMWH in these patients.
MATERIALS AND METHODS
A search of EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science was carried out and included all randomized controlled trials (RCTs) and observational studies that directly compared DOACs with LMWH for thromboprophylaxis in patients after cancer surgery through July 25, 2023. The primary efficacy and safety outcomes were VTE, major bleeding, and clinically relevant non-major bleeding (CRNMB) within 30 days of surgery. The risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB2) tool for RCTs and ROBINS-I tool for non-randomized studies. This study was registered in PROSPERO (CRD42023445386).
RESULTS
We retrieved 5149articles, selected 27 for eligibility, and included 10 studies (three RCTs and seven observational studies) encompassing 3054 patients who underwent postoperative thromboprophylaxis with DOACs (41%) or LMWH (59%). Compared to LMWH thromboprophylaxis, DOACs had a comparable risk of VTE (RR:0.69[95% CI:0.46-1.02], I = 0%), major bleeding (RR:1.55 [95% CI:0.82-2.93], I = 2%), and CRNMB (RR, 0.89 [95% CI, 0.4-1.98], I = 31%) during the 30-day postoperative period. Subgroup analysis of VTE and major bleeding suggested no differences according to study type, extended thromboprophylaxis, tumor types, or different types of DOAC.
CONCLUSION
DOACs are potentially effective alternatives to LMWH for thromboprophylaxis in patients undergoing cancer surgery, without increasing the risk of major bleeding events.
Topics: Humans; Heparin, Low-Molecular-Weight; Anticoagulants; Venous Thromboembolism; Hemorrhage; Neoplasms
PubMed: 38403630
DOI: 10.1186/s12957-024-03341-5