Oral factor Xa inhibitors and risk of subdural hematoma

Neurology ◽  
2020 ◽  
Vol 95 (5) ◽  
pp. e480-e487
Author(s):  
Luciana Catanese ◽  
John W. Eikelboom ◽  
Jackie Bosch ◽  
Olga Shestakovska ◽  
Kelvin Ng ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Meta Analysis ◽  
Anticoagulation Therapy ◽  
Factor Xa ◽  
Factor Xa Inhibitors ◽  
Randomized Controlled ◽  
Important Complication ◽  
Increased Risk ◽  
The Mean

ObjectiveSubdural hematomas (SDHs) are an uncommon, but important, complication of anticoagulation therapy. We hypothesized that the risks of SDH would be similar during treatment with oral factor Xa inhibitors compared with aspirin.MethodsWe assessed the frequency and the effects of antithrombotic treatments on SDHs in the recent international Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial comparing aspirin 100 mg daily, rivaroxaban 5 mg twice daily, and rivaroxaban 2.5 mg twice daily plus aspirin. A systematic review/meta-analysis of randomized trials comparing oral factor Xa inhibitors vs aspirin on SDH risk was undertaken.ResultsAmong 27,395 COMPASS participants, 28 patients with SDHs were identified (mean age 72 years). SDH-associated mortality was 7%. Incidence was 0.06 per 100 patient-years (11 SDH/17,492 years observation) during the mean 23-month follow-up among aspirin-assigned patients and did not differ significantly between treatments. Three additional randomized controlled trials including 16,177 participants reported a total of 14 SDHs with an incidence ranging from 0.06 to 0.1 per 100 patient-years. Factor Xa inhibitor use was not associated with an increased risk of SDH compared to aspirin (odds ratio, 0.97; 95% confidence interval, 0.52–1.81; I2 = 0%).ConclusionThe frequency of SDH was similar in all 3 treatment arms of the COMPASS trial. The COMPASS trial results markedly increase the available evidence from randomized comparisons of oral factor Xa inhibitors with aspirin regarding SDH. From available, albeit limited, evidence from 4 randomized trials, therapeutic dosages of factor Xa inhibitors do not appear to increase the risk of SDH compared with aspirin.Clinical trial identifier number:NCT01776424.

scholarly journals Direct Oral Anticoagulants for the Treatment of Acute Venous Thromboembolism Associated with Cancer: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 120 (07) ◽  
pp. 1128-1136 ◽  
Author(s):  
Michela Giustozzi ◽  
Giancarlo Agnelli ◽  
Jorge del Toro-Cervera ◽  
Frederikus A. Klok ◽  
Rachel P. Rosovsky ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Factor Xa Inhibitors ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Recurrent Vte ◽  
Acute Venous Thromboembolism

Abstract Background International guidelines have endorsed the use of edoxaban or rivaroxaban as an alternative to low-molecular-weight heparin (LMWH) for the treatment of acute venous thromboembolism (VTE) in cancer patients. Recently, a large randomized controlled trial of apixaban versus dalteparin in patients with cancer was completed. We performed an updated meta-analysis to assess the efficacy and safety of direct oral anticoagulants (DOACs) versus LMWH in patients with cancer-associated VTE. Methods MEDLINE, EMBASE, and CENTRAL (Cochrane Controlled Trials Registry) were systematically searched up to March 30, 2020 for randomized controlled trials comparing DOACs versus LMWH for the treatment of VTE in patients with cancer. The two coprimary outcomes were recurrent VTE and major bleeding at 6 months. Data were pooled by the Mantel–Haenszel method and compared by relative risk ratios (RRs) and 95% confidence intervals (CIs). Results Four randomized controlled studies (2,894 patients) comparing apixaban, edoxaban, or rivaroxaban with dalteparin were included in the meta-analysis. Recurrent VTE occurred in 75 of 1,446 patients (5.2%) treated with oral factor Xa inhibitors and in 119 of 1,448 patients (8.2%) treated with LMWH (RR 0.62; 95% CI 0.43–0.91; I 2, 30%). Major bleeding occurred in 62 (4.3%) and 48 (3.3%) patients receiving oral factor Xa inhibitors or LMWH, respectively (RR 1.31; 95% CI 0.83–2.08; I 2, 23%). Conclusion In patients with cancer-associated VTE, oral factor Xa inhibitors reduced the risk of recurrent VTE without a significantly higher likelihood of major bleeding at 6 months compared with LMWH.

Low-dose of oral factor Xa inhibitors in patients with a recent acute coronary syndrome: A systematic review and meta-analysis of randomized trials

2013 ◽  
Vol 229 (2) ◽  
pp. 482-488 ◽  
Author(s):  
Karolina Obonska ◽  
Eliano Pio Navarese ◽  
Alexandra Lansky ◽  
Giuseppe Tarantini ◽  
Roberta Rossini ◽  
...  
Keyword(s):  
Systematic Review ◽  
Acute Coronary Syndrome ◽  
Randomized Trials ◽  
Low Dose ◽  
Meta Analysis ◽  
Factor Xa ◽  
Factor Xa Inhibitors ◽  
Coronary Syndrome

scholarly journals Effect of magnification on root coverage surgery

2020 ◽  
Vol 19 ◽  
pp. e201669
Author(s):  
Marcella Goetz Moro ◽  
Maria Luisa Silveira Souto ◽  
Emanuel Silva Rovai ◽  
João Batista Cesar Neto ◽  
Marinella Holzhausen ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Gingival Recession ◽  
Root Coverage ◽  
Randomized Controlled ◽  
Optical Magnification ◽  
Secondary Outcomes ◽  
Exposed Root

Root coverage surgery can be performed in patients with gingival recession to cover the exposed root aiming to control hypersensitivity and promotes better aesthetic. Optical magnification has been proposed as a refinement in this surgical technique to increase root coverage. This approach may lead to enhanced soft tissue stability, less post-operative discomfort, better predictability and esthetic appearance. Aim: This systematic review aimed to evaluate the effectiveness of magnification on root coverage surgery when compared to procedures performed without magnification. Methods: Randomized controlled trials with a follow-up of at least 6 months that compared surgeries for root coverage performed under optic magnification versus conventional (macro) root coverage surgery were screened. The primary outcome was mean root coverage (mm) (MRC) and secondary outcomes were percentage of root coverage (PRC) and complete root coverage (CRC). Results: Of 569 papers relevant to this review, seven were included. Meta-analysis showed that the use of magnification may favor greater PRC (7.38%, 95% CI 3.66-11.09). Conclusion: Magnification can increase PRC in root coverage surgeries. More randomized trials with the use of magnification may be necessary to verify if this benefit is clinically relevant, in order to justify the use of this device.

scholarly journals Effect of Vitamin D Supplementation on Pain: A Systematic Review and Meta-analysis

2016 ◽  
Vol 7;19 (7;9) ◽  
pp. 415-427
Author(s):  
Robert Scragg
Keyword(s):  
Vitamin D ◽  
Pain Score ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean ◽  
Pain Improvement

Background: There is conflicting evidence from previous qualitative reviews on the effect of vitamin D supplementation on pain. Objective: To determine with quantitative methods if vitamin D supplementation lowers pain levels. Study Design: Quantitative meta-analysis of published randomized controlled trials (RCTs). Setting: This meta-analysis examined all studies involving the effect of vitamin D supplementation on pain score. Method: Electronic sources (Medline, Embase, Cochrane Central Register of Controlled Trials, clinical trials website, and Google scholar) were systematically searched for RCTs of vitamin D supplementation and pain from inception of each database to October 2015. Results: Nineteen RCTs with 3,436 participants (1,780 on vitamin D supplementation and 1,656 on placebo) were included in the meta-analysis. For the primary outcome (mean change in pain score from baseline to final follow-up), 8 trials with 1,222 participants on vitamin D and 1,235 on placebo reported a significantly greater mean decrease in pain score for the vitamin D group compared to placebo (mean difference -0.57, 95% CI: -1.00 to -0.15, P = 0.007). The effect from vitamin D was greater in patients recruited with pre-existing pain (P-value for interaction = 0.03). Fourteen studies (1,548 on vitamin D, 1,430 on placebo) reported the mean pain score at final follow-up outcome, and no statistical difference was observed (mean difference -0.06, 95%CI: -0.44 to 0.33, P = 0.78). In 4 studies which reported pain improvement (209 on vitamin D, 146 on placebo), the effect size although not significant, shows participants in the vitamin D supplementation group were more likely to report pain improvement compared with the placebo group (relative risk 1.38, 95%CI: 0.93 to 2.05, P = 0.11). Limitations: Only a few studies reported the mean score change from baseline to final follow-up, and we do not have enough data to determine any modifying effect of baseline vitamin D status and different doses of vitamin D supplementation on pain. Conclusion: A significantly greater mean decrease in pain score (primary outcome) was observed with vitamin D supplementation compared with placebo in people with chronic pain. These results suggest that vitamin D supplementation could have a role in the management of chronic pain. Key words: Meta-analysis, pain, randomized controlled trials, vitamin D supplementation

scholarly journals Impact of anticoagulation therapy on valve haemodynamic deterioration following transcatheter aortic valve replacement

Heart ◽  
2018 ◽  
Vol 104 (10) ◽  
pp. 814-820 ◽  
Author(s):  
María Del Trigo ◽  
Antonio J Muñoz-García ◽  
Azeem Latib ◽  
Vincent Auffret ◽  
Harindra C Wijeysundera ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Vitamin K Antagonists ◽  
Anticoagulation Therapy ◽  
Transcatheter Aortic Valve ◽  
Increased Risk ◽  
The Mean

ObjectiveTo evaluate the changes in transvalvular gradients and the incidence of valve haemodynamic deterioration (VHD) following transcatheter aortic valve replacement (TAVR), according to use of anticoagulation therapy.Methods and resultsThis multicentre study included 2466 patients (46% men; mean age 81±7 years) who underwent TAVR with echocardiography performed at 12-month follow-up. Anticoagulation therapy was used in 707 patients (28.7%) following TAVR (AC group). A total of 663 patients received vitamin K antagonists, and 44 patients received direct oral anticoagulants. A propensity score matching analysis was performed to adjust for intergroup (AC vs non-AC post-TAVR) differences. A total of 622 patients per group were included in the propensity-matched analysis. VHD was defined as a ≥10 mm Hg increase in the mean transprosthetic gradient at follow-up (vs hospital discharge). The mean clinical follow-up was 29±18 months. The mean transvalvular gradient significantly increased at follow-up in the non-AC group within the global cohort (P=0.003), whereas it remained stable over time in the AC group (P=0.323). The incidence of VHD was significantly lower in the AC group (0.6%) compared with the non-AC group (3.7%, P<0.001), and these significant differences remained within the propensity-matched populations (0.6% vs 3.9% in the AC and non-AC groups, respectively, P<0.001). The occurrence of VHD did not associate with an increased risk of all-cause death (P=0.468), cardiovascular death (P=0.539) or stroke (P=0.170) at follow-up.ConclusionsThe lack of anticoagulation therapy post-TAVR was associated with significant increments in transvalvular gradients and a greater risk of VHD. VHD was subclinical in most cases and did not associate with major adverse clinical events. Future randomised trials are needed to determine if systematic anticoagulation therapy post-TAVR would reduce the incidence of VHD.

Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
pp. 152660282110235
Author(s):  
Krystal Dinh ◽  
Alexandra M. Limmer ◽  
Andy Z. L. Chen ◽  
Shannon D. Thomas ◽  
Andrew Holden ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Occlusive Disease ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
All Cause Mortality

Purpose: A late increased mortality risk has been reported in a summary level meta-analysis of patients with femoropopliteal artery occlusive disease treated with paclitaxel-coated angioplasty balloons and stents. However, at the longer follow up timepoints that analysis was limited by small trial numbers and few participants. The aim of this study was to report an updated summary level risk of all-cause mortality after treatment with paclitaxel-coated devices in that same patient group. Materials and Methods: We performed a systematic review and meta-analysis of randomized controlled trials to investigate the mortality outcomes associated with paclitaxel-coated devices used to treat patients with occlusive disease of femoropopliteal arteries (last search date December 10, 2020). The single primary endpoint was all-cause mortality. Results: We identified 34 randomized controlled trials (7654 patients; 84% intermittent claudication). There were 622 deaths among 4147 (15.0%) subjects in the paclitaxel device group and 475 deaths among 3507 (13.5%) subjects in the noncoated control group [relative risk ratio (RR) 1.07, 95% confidence interval (CI) 0.96 to 1.20, p=0.20, I2=0%). All-cause mortality was similar between groups at 12 months (34 studies, 7654 patients; RR 0.99, 95% CI 0.81 to 1.22, p=0.94, I2=0%), 24 months (20 studies, 3799 patients; RR 1.16, 95% CI 0.87 to 1.55, p=0.31, I2=0%), and 60 months (9 studies, 2288 patients; RR 1.19, 95% CI 0.98 to 1.45, p=0.08, I2=0%). Conclusion: This updated meta-analysis with included additional trials and larger patient numbers shows no evidence of increased risk of all-cause mortality in patients treated with paclitaxel-coated devices, compared with uncoated devices for femoropopliteal disease at all time points to 60 months. There is therefore no justification to limit their use, or alter regulatory body follow-up recommendations in this patient population. Systematic Review Registration: CRD42020216140.

scholarly journals Pituitary Apoplexy in the Setting of Oral Anticoagulation Therapy With Apixaban

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A598-A599
Author(s):  
Yadiel Rivera-Nieves ◽  
Janet Marie Colon Castellano ◽  
Nicolle Canales ◽  
Alberto Javier Grana Santini ◽  
Nicole Hernández Cordero ◽  
...  
Keyword(s):  
Pituitary Adenoma ◽  
Pituitary Gland ◽  
Pituitary Apoplexy ◽  
Case Reports ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Factor Xa ◽  
High Dose ◽  
Increased Risk

Abstract Background: Several medical conditions require chronic anticoagulation, but there are potential long-term complications, including intracranial hemorrhages. Pituitary apoplexy (PA), caused by infarction or bleeding into the pituitary gland, is a rare condition that commonly occurs in the setting of a pituitary adenoma. However, several reports have shown an increased risk of PA associated with anticoagulation therapy. Recent case reports have shown that even the newer oral anticoagulants may increase the risk of PA. Typically patients present with an acute headache, visual disturbances and pituitary hormonal deficiencies. Management is controversial and includes either a conservative medical treatment versus a more aggressive surgical approach. We present a case of a PA induced by Apixaban, an orally active factor Xa inhibitor. Clinical Case: This is the case of a 45 years-old male patient with prior medical history of hyperthyroidism treated with radioiodine ablation, systolic heart failure and atrial fibrillation, receiving Apixaban for stroke risk reduction. The patient presented initially to the ER after developing an acute, pulsatile frontal headache, associated with nausea and vomiting. He was treated for a suspected acute gastroenteritis and was discharged home. Two days later the patient returned to the ER, with persistent headaches unresponsive to oral analgesics. This time, the patient also complained of decreased energy, difficulty concentrating, and memory problems. He denied visual changes, galactorrhea, decreased libido or polyuria. Vital signs were unremarkable and there was no orthostatic hypotension. Physical examination showed a male in mild distress due to pain. There were no visual field defects on confrontation, no neurological deficits, and an intact mental status. Brain imaging showed hemorrhage within the pituitary gland with associated edema, compatible with PA. There was no obvious evidence of a pre-existing pituitary adenoma. Laboratory workup did not reveal any hormonal deficiencies. The patient was managed conservatively with close neurological follow up and empiric high dose dexamethasone. Headaches improved significantly after treatment and eventually resolved. After clinical improvement, the patient was discharged home on physiologic replacement of glucocorticoids with outpatient follow up and plans for re-evaluation of hormonal axis. Conclusion: Oral anticoagulants can increase the risk of PA, even in the absence of a pre-existing pituitary adenoma, as other case reports have shown. Management is controversial, and although there are agents for reversal of Apixaban effects (recombinant factor Xa), their use in PA has not been described. This case was managed conservatively with excellent results. Although we cannot exclude a pre-existing pituitary adenoma in this patient, this case shows that Apixaban increases the risk of PA.

Cartilage Restoration of the Knee

2015 ◽  
Vol 44 (7) ◽  
pp. 1888-1895 ◽  
Author(s):  
Raman Mundi ◽  
Asheesh Bedi ◽  
Linda Chow ◽  
Sarah Crouch ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Cartilage Defects ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Standardized Mean Difference

Background: Focal cartilage defects of the knee are a substantial cause of pain and disability in active patients. There has been an emergence of randomized controlled trials evaluating surgical techniques to manage such injuries, including marrow stimulation (MS), autologous chondrocyte implantation (ACI), and osteochondral autograft transfer (OAT). Purpose: A meta-analysis was conducted to determine if any single technique provides superior clinical results at intermediate follow-up. Study Design: Systematic review and meta-analysis of randomized controlled trials. Methods: The MEDLINE, EMBASE, and Cochrane Library databases were systematically searched and supplemented with manual searches of PubMed and reference lists. Eligible studies consisted exclusively of randomized controlled trials comparing MS, ACI, or OAT techniques in patients with focal cartilage defects of the knee. The primary outcome of interest was function (Lysholm score, International Knee Documentation Committee score, Knee Osteoarthritis Outcome Score) and pain at 24 months postoperatively. A meta-analysis using standardized mean differences was performed to provide a pooled estimate of effect comparing treatments. Results: A total of 12 eligible randomized trials with a cumulative sample size of 765 patients (62% males) and a mean (±SD) lesion size of 3.9 ± 1.3 cm2 were included in this review. There were 5 trials comparing ACI with MS, 3 comparing ACI with OAT, and 3 evaluating different generations of ACI. In a pooled analysis comparing ACI with MS, there was no difference in outcomes at 24-month follow-up for function (standardized mean difference, 0.47 [95% CI, –0.19 to 1.13]; P = .16) or pain (standardized mean difference, –0.13 [95% CI, –0.39 to 0.13]; P = .33). The comparisons of ACI to OAT or between different generations of ACI were not amenable to pooled analysis. Overall, 5 of the 6 trials concluded that there was no significant difference in functional outcomes between ACI and OAT or between generations of ACI. Conclusion: There is no significant difference between MS, ACI, and OAT in improving function and pain at intermediate-term follow-up. Further randomized trials with long-term outcomes are warranted.

Sign in / Sign up

Export Citation Format

Share Document