1. Rivaroxaban is safe and effective for venous thromboembolism (VTE) prophylaxis post-bariatric surgery.
2. Similar efficacy and safety profiles were observed with 10 mg rivaroxaban daily for either 7 or 28 days.
Evidence Rating Level: 1 (Excellent)
Individuals undergoing bariatric surgery are considered to be at moderate risk for venous thromboembolic (VTE) events, due to the combination of risks factors such as obesity, surgery, and immobilization. However, guidelines for duration of VTE prophylaxis for bariatric surgery patients vary widely, ranging from 7 days to 4 weeks depending on the country. Furthermore, there are generally no guidelines for the use of direct anticoagulants (DOACs) in bariatric surgery patients, and there is a paucity of clinical trials evaluating their use in this population. Therefore, this multi-centre randomized controlled trial evaluated the efficacy and safety of rivaroxaban post-bariatric surgery, by comparing outcomes in patients on a 7 day versus 28 day regimen for VTE prophylaxis. The primary outcome was a composite of deep vein thrombosis (DVT) detected on ultrasound and pulmonary embolism (PE). Patients were assessed around 28 days post-op with bilateral leg ultrasound to detect DVT, and PE was assessed based on the patient’s symptoms followed by appropriate imaging as indicated. In total, there were 269 patients randomized 1:1 to either cohort. There was only 1 thromboembolic event in the study (0.4%, 95% CI 0.02-2.2%), which was an asymptomatic DVT in the 28-day cohort. There were 5 major bleeding events (1.9%), with 2 in the 7-day cohort and 3 in the 28-day cohort. As well, there were 12 individuals (16.7%) altogether who discontinued their medication due to adverse events, with more in the 28-day cohort (9 vs 3 patients), though this was not statistically significant (p = 0.50). Overall, this study demonstrated that a 7 or 28 day course of rivaroxaban post-bariatric surgery are safe and effective at preventing VTE, with similar outcomes observed between both durations.
1. For critically ill patients hospitalized for COVID-19, P2Y12 inhibitors did not improve organ support-free days or survival to discharge compared to usual care.Â
Evidence Rating Level: 1 (Excellent)
Antiplatelet therapy has been proposed in the management of critically ill COVID-19 patients, as platelets play a prothrombotic and proinflammatory role, in patients who are already at high risk of vasculopathy and thrombotic events. Prior studies suggested that antiplatelet therapy did not decrease the risk of requiring organ support, and had no benefit in noncritically ill COVID-19 patients. Therefore, this international controlled platform randomized controlled trial evaluated the impact of P2Y12 inhibitors on morbidity and mortality in critically ill COVID-19 patients, compared to care as usual. In this study, critically ill referred to patients that required intensive care. Patients were randomized 1:1 to receive a P2Y12 inhibitor, either ticagrelor or clopidogrel, or to usual care with no P2Y12 inhibitor. The duration of therapy was the earliest of either 14 days or discharge. The primary outcome was the organ support-free days, which was a composite of survival to discharge and number of days without cardiac or respiratory organ support up to day 21 of hospitalization. In total, there were 479 patients in the P2Y12 inhibitor group and 470 in usual care. The results showed a median (IQR) organ support-free days of 12 (-1 to 17) and 11 (-1 to 18) in the P2Y12 inhibitor and usual care groups respectively (adjusted odds ratio 1.07, 95% CrI 0.85-1.33, posterior probability of superiority 72.9%). Additionally, 74.5% and 72.4% of patients survived to discharge in the P2Y12 inhibitor and usual care groups respectively. There was also no difference in major thrombotic events or death in-hospital, at 28.2% for the P2Y12 inhibitor cohort versus 25.7% in usual care (aOR 1.10, 95% CI 0.81-1.50). Lastly, the rate of major bleeding was also similar between the cohorts, affecting 1.0% in the P2Y12 inhibitor and 0.4% of the usual care groups respectively (aOR 2.33, 95% CI 0.45-12.2). Overall, this study showed that P2Y12 inhibitor therapy did not improve organ support-free days or survival to discharge, for critically ill COVID-19 patients.
1. For patients with relapsing-remitting multiple sclerosis (RRMS), rituximab demonstrated greater effectiveness at halting disease progression and was more cost-effective than natalizumab.
2. Ocrelizumab used as a 2nd line therapy after failure of natalizumab showed the least clinical effectiveness at halting disease progression, and was the most expensive therapy compared to rituximab and natalizumab.
Evidence Rating Level: 2 (Good)
There are numerous disease-modifying therapies (DMTs) available for slowing the progression of multiple sclerosis (MS). In particular, monoclonal antibodies (mAbs) have been shown to be superior to other DMTs, including interferons and fingolimod. Examples of mAbs used for MS include rituximab and natalizumab, with ocrelizumab used as 2nd line therapy following the failure of natalizumab. However, mAbs are costly therapies and may have differing rates of efficacy. Therefore, this retrospective cohort study based in Saudi Arabia aimed to examine the efficacy and cost-effectiveness of the aforementioned mAbs in patients with relapsing remitting MS (RRMS). Patients were included if they were treated with mAbs for 6 or more months between 2015 and 2022, and who were biologic-naïve prior to starting mAb treatment (for rituximab and natalizumab patients). Effectiveness was evaluated with the NEDA-3 criteria, which includes the absence of disability progression, clinical relapse, and new lesions on MRI. In total, there were 93 patients included, with 54% on natalizumab, 28% on rituximab, and 18% on ocrelizumab. The mean effectiveness overall was 70.96% (95% CI 61.56-80.36%): The effectiveness rates for individual mAb therapies were 72.00% (95% CI 59.11-84.88%) for natalizumab, 76.92% (95% CI 59.57-94.27%) for rituximab, and 58.83% (95% CI 32.74-84.91%) for ocrelizumab. Furthermore, the mean annual cost for each mAb therapy was $20,110.74 for natalizumab, $7,672.61 for rituximab, and $36,698.90 for ocrelizumab. Therefore, natalizumab cost $35,383 (95% CI $25,401.09-$49,717.92) more than rituximab, with a 4.92% lower rate of effectiveness (95% CI -30 to 27.5) compared to rituximab. Overall, this study demonstrated that rituximab is more clinically effective at halting the progression of RRMS and is more cost-effective than natalizumab, whereas ocrelizumab was the least effective clinically and cost-wise.
1. Surgical removal of the tonsils and adenoids was associated with slightly increased risk of subsequent cancer development, even at 20 or more years after surgery.
Evidence Rating Level: 2 (Good)
Tonsils and adenoids are immune system organs that are routinely removed surgically, for indications such as sleep apnea and recurrent infections. However, there is unclear evidence supporting an association between tonsillectomy and adenoidectomy with risk of cancer broadly, with studies reporting an increased risk or decreased risk, even for the same type of cancer. In general, previous work did not appear to examine all types of cancer in one study. Therefore, this population-based cohort study based in Sweden aimed to elucidate the association between tonsil or adenoid removal and any type of malignancy. In the population-based cohort, there were 589,229 patients with surgical tonsil or adenoid removal, and 4,364,354 individuals without surgical removal, to comprise the comparison cohort. Furthermore, a sibling comparison was done to control for familial confounders: These cohorts were comprised of 107,910 individuals with surgical removal, and 186,093 of their full siblings without surgical removal. The results showed a mildly increased risk of any cancer in the population-based cohort individuals with surgical removal (adjusted hazards ratio 1.10, 95% CI 1.07-1.12). Specific types of cancer with significant associations included cancer of the pancreas (HR 1.23, 95% CI 1.05-1.44), breast (HR 1.06, 95% CI 1.01–1.10), prostate (HR 1.15, 95% CI 1.09–1.22), kidney (HR 1.33, 95% CI 1.16–1.52), thyroid (HR 1.18, 95%CI 1.00–1.38), non-melanoma skin cancer (HR 1.14, 95% CI 1.01-1.29), other endocrine (HR 1.15, 95% CI 1.02-1.29), lymphoma (HR 1.11, 95% CI 1.00-1.23), and leukemia (HR 1.22, 95% CI 1.08-1.37). Additionally, the sibling comparison found an association between surgical removal and overall cancer (HR 1.15, 95% CI 1.10-1.20), and specific associations with cancer of the esophagus (HR 2.09, 95% CI 1.02–4.31), breast (HR 1.16, 95% CI 1.02–1.32), prostate (HR 1.24, 95% CI 1.05–1.48), thyroid (HR 1.63, 95% CI 1.11–2.40), and lymphoma (HR 1.28, 95%CI 1.03–1.61). There were no differences based on the type of surgery or indication, and the associations with cancer were present beyond 20 years after surgery. Overall, this study demonstrated a slightly increased risk of developing several forms of cancer, following tonsil or adenoid surgical removal.
1. Patients with chronic upper limb spasticity post-stroke randomized to radial extracorporeal shock wave therapy (rESWT) had greater symptomatic and functional improvement than patients randomized to transcutaneous electrical nerve stimulation (TENS).Â
Evidence Rating Level: 1 (Excellent)
It is estimated that 43% of patients who survive a stroke experience upper limb spasticity, which can be functionally impairing. Transcutaneous electrical nerve stimulation (TENS) has been the standard treatment for this, while radial extracorporeal shock wave therapy (rESWT) has also been shown to treat spasticity. This single-centre randomized controlled trial based in Sri Lanka aimed to compare the efficacy of rESWT and TENS for treating patients with chronic upper limb spasticity post-stroke. Participants included must have had their first stroke 6 months prior to enrollment, resulting in hemiplegia. The treatments were administered one session a week for four weeks, with follow-up assessments after the first and last sessions. The outcomes measured included: Spasticity as defined on the 4-point modified Ashworth scale, voluntary control grading (VCG), and hand function as defined through the Fugl-Meyer Assessment of Upper Limb (FMA-UL). In total, there were 106 patients randomized equally to rESWT and TENS. Both cohorts demonstrated decreased spasticity, but the difference was greater in the rESWT group compared to TENS, with a 4.8 times (95% CI 1.956-2.195) reduction in spasticity after 4 weeks. VCG and FMA-UL scores also improved in both, but moreso in the rESWT patients, with 3.9 times (95% CI 2.314-2.667) improvement in VCG and 3.8 times (95% CI 19.549-22.602) improvement in FMA-UL hand function score. Overall, this study showed that both rESWT and TENS are effective treatments for chronic upper limb spasticity post-stroke, with rESWT potentially being a superior modality.
Image: PD
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