Efficacy and Safety of Direct Oral Anticoagulants Versus Warfarin in Saudi Patients With Atrial Fibrillation.

INTRODUCTION: Atrial fibrillation (AF) significantly heightens stroke risk, which can be mitigated through anticoagulation therapy. Although warfarin was traditionally employed for this purpose, the use of direct-acting oral anticoagulants (DOACs) is on the rise. METHODS: This retrospective study, which spanned from June 2016 to January 2018, focused on adult patients diagnosed with AF. Their treatments, either via warfarin or DOACs (apixaban, rivaroxaban, and dabigatran), were evaluated. Data analysis was done using Statistical Product and Service Solutions (SPSS, version 21; IBM SPSS Statistics for Windows, Armonk, NY). This study aims to evaluate the safety and effectiveness of DOACs versus warfarin in preventing thromboembolic complications among Saudi patients with AF. RESULTS: A total of 396 patients with AF, averaging 66 ± 14 years of age, were part of the study. Among them, there were slightly more female patients (205 or 51.8%). The majority of patients (223 or 56.3%) were treated with a DOAC, while the rest (173 or 43.7%) received warfarin. Furthermore, 93 patients (23.5%) were taking anti-platelet drugs. Statistically, the rate of ischemic stroke was significantly higher among patients treated with DOACs than with warfarin (p=0.005), but bleeding rates were similar in both groups. Specifically, the DOACs apixaban and rivaroxaban showed a significant association with the occurrence of stroke when compared to warfarin (p=0.012 and p=007, respectively). CONCLUSION: Overall, both DOACs and warfarin presented similar results regarding hemorrhagic complications when treating AF patients. However, the DOACs apixaban and rivaroxaban displayed higher risks of ischemic stroke compared to warfarin.

Outcomes and complications of patients with cerebral venous thrombosis: a retrospective study.

OBJECTIVES: To assess outcomes and complications of patients with cerebral venous thrombosis (CVT). METHODS: This multicenter retrospective study was conducted at 2 health care centers in Saudi Arabia and Oman. Adult patients diagnosed with CVT in radiological imaging between 2006 and 2020 were included. Data were collected from medical records and analyzed using the software IBM® SPSS version 22. Neurological disability occurring after CVT was graded according to the modified Rankin scale (mRS). RESULTS: The study included 103 patients, of which the majority (68%) were female. The mean age was 39.12±12.96 years. Two-thirds of patients received low-molecular-weight heparin (LMWH) in acute treatment, while 76% of discharged patients used warfarin. The majority of patients had no or mild neurological disability during follow-up, and 6 patients had an mRS score ≥3, implying significant neurological disability. There were 55 patients (52.3%) who had complications from CVT, including seizures in 17 (16.5%) patients and one mortality. Follow-up imaging of 55 patients showed complete thrombus resolution in 20 patients (36%). CONCLUSION: Anticoagulation is the mainstay treatment for CVT patients. Approximately half of patients experience complications. Prospective studies are needed to assess the long-term neurological outcomes in such patients.

Diagnostic approach and use of CTPA in patients with suspected pulmonary embolism in an emergency department in Saudi Arabia.

Background: In patients with suspected pulmonary embolism (PE), the literature suggests the overuse of computerized tomography pulmonary angiography (CTPA) and underuse of clinical decision rules before imaging request. This study determined the potential for avoidable CTPA using the modified Wells score (mWS) and D-dimer assay in patients with suspected PE. Methods: This hospital-based retrospective study analyzed the clinical data of 661 consecutive patients with suspected PE who underwent CTPA in the emergency department of a tertiary hospital for the use of a clinical prediction rule (mWS) and D-dimer assay. The score was calculated retrospectively from the available data in the files of patients who did not have a documented clinical prediction rule. Overuse (avoidable) CTPA was defined as D-dimer negativity and PE unlikely for this study. Results: Of 661 patients' data examined, clinical prediction rules were documented in 15 (2.3%). In total, 422 patients (63.8%) had required information on modified Wells criteria and D-dimer assays and were included for further analysis. PE on CTPA was present in 22 (5.21%) of PE unlikely (mWS ≤4) and 1 (0.24%) of D-dimer negative patients. Thirty patients (7.11%) met the avoidable CTPA (DD negative+PE unlikely) criteria, and it was significantly associated with dyspnea. The value of sensitivity of avoidable CTPA was 100%, whereas the positive predictive value was 90.3%. Conclusion: Underutilization of clinical prediction rules before prescribing CTPA is common in emergency departments. Therefore, a mandatory policy should be implemented regarding the evaluation of avoidable CTPA imaging to reduce CTPA overuse.

High rate of bleeding and arterial thrombosis in COVID-19: Saudi multicenter study.

BACKGROUND: Several observational studies have reported the rate of venous and arterial thrombotic events in patients infected with COVID-19, with conflicting results. The aim of this study was to estimate the rate of thrombotic and bleeding events in hospitalized patients diagnosed with Coronavirus disease 2019 (COVID-19). METHODS: This was a multicenter study of 636 patients admitted between 20 March 2020 and 31 May 2020 with confirmed COVID-19 in four hospitals. RESULTS: Over a median length of stay in the non-ICU group of 7 days and of 19 days in the ICU group, twelve patients were diagnosed with Venous thromboembolism (VTE) (1.8 %) (95 % CI, 1.1-3). The rate in the non-ICU group was 0.19 % (95 % CI, 0.04-0.84), and that in the ICU group was 10.3 % (95 % CI, 6.4-16.2). The overall rate of arterial event is 2.2 % (95 % CI, 1.4-3.3). The rates in the non-ICU and ICU groups were 0.94 % (95 % CI, 0.46-0.1.9) and 8.4 % (95 % CI, 5.0-14.0). The overall composite event rate was 2.9 % (95 % CI, 2.0-4.3). The composite event rates in the non-ICU and ICU groups were 0.94 % (95 % CI, 0.46-0.1.9) and 13.2 % (95 % CI, 8.7-19.5). The overall rate of bleeding is 1.7 % (95 % CI, 1.0-2.8). The bleeding rate in the non-ICU group was 0.19 % (95 % CI, 0.04-0.84), and that in the ICU group was 9.4 % (95 % CI, 5.7-15.1). The baseline D-dimer level was a significant risk factor for developing VTE (OR 1.31, 95 % CI, 1.08-1.57, p = 0.005) and composite events (OR 1.32, 95 % CI, 1.12-1.55, p = 0.0007). CONCLUSIONS: In this study, we found that the VTE rates in hospitalized patients with COVID-19 might not be higher than expected. In contrast to the risk of VTE, we found a high rate of arterial and bleeding complications in patients admitted to the ICU. An elevated D-dimer level at baseline could predict thrombotic complications in COVID-19 patients and may assist in the identification of these patients. Given the high rate of bleeding, the current study suggests that the intensification of anticoagulation therapy in COVID-19 patients beyond the standard of care be pursued with caution and would best be evaluated in a randomized controlled study.

Thromboprophylaxis after bariatric surgery.

BACKGROUND: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known cause of morbidity and mortality after bariatric surgery. However, the data concerning appropriate thromboprophylaxis after bariatric surgery is uncertain. The objective of this study was to evaluate the efficacy and safety of extended duration thromboprophylaxis in post-bariatric surgery patients. METHODS: We conducted a retrospective study of consecutive patients who underwent bariatric surgery from November 2014 to October 2018 at King Fahad General Hospital in Jeddah, Saudi Arabia. All included patients were treated with extended duration thromboprophylaxis. RESULTS: We identified 374 patients who underwent bariatric surgery during the study period. Of these, 312 patients (83%) were followed for at least 3 months. The most common type of surgery was a laparoscopic sleeve gastrectomy (N=357) and the median weight was 110 kg. The cumulative incidence of symptomatic postoperative VTE at 3 months was 0.64% (95% confidence interval, 0.20-1.52). All events occurred after hospital discharge. The most commonly used pharmacological prophylaxis (91%) for VTE prevention after bariatric surgery was enoxaparin 40 mg subcutaneously twice daily for 10-14 days after hospital discharge. There were no reported cases of bleeding or VTE related mortality after 3 months. CONCLUSION: Extended thromboprophylaxis after bariatric surgery appears to be an effective and safe strategy for VTE prevention. Large prospective studies are needed to evaluate the optimal thromboprophylaxis regimen after bariatric surgery.

Venous thromboembolism after total knee and hip arthroplasty. A retrospective study.

OBJECTIVES: To evaluate the incidence and risk factors of Venous thromboembolism (VTE) among total knee arthroplasty (TKA)  and total hip arthroplasty (THA) patients following surgery. Methods: We conducted a retrospective review of electronic medical records of consecutive patients between January 2010 and January 2015 who underwent TKA or THA at King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia.  Results: The incidence of symptomatic VTE was 1.9% (17 events, 95% CI: 1.1-2.8) in 756 patients who underwent 889 surgeries. All VTE cases developed before hospital discharge. Twelve (1.4%) patients developed pulmonary embolism, and 5 (0.6%) patients developed deep vein thrombosis. The majority of patients (n=557, 62.7%) underwent surgery for single TKA, and 138 (15.5%) patients underwent bilateral arthroplasty. Based on univariate risk analysis, bilateral arthroplasty was the only potential predictor for VTE after surgery.  Conclusion: The rate of symptomatic VTE in a Saudi population following arthroplasty is low and comparable to the international data. However, efforts and more trials are needed to further improve in-hospital thromboprophylaxis measures.

The efficacy and safety of anticoagulation in cerebral vein thrombosis: A systematic review and meta-analysis.

BACKGROUND: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH) is the mainstay for the treatment of patients with acute cerebral vein thrombosis (CVT) with or without intracranial hemorrhage (ICH). AIM: We conducted a systematic review and meta-analysis to determine the efficacy and safety of LMWH compared to UFH for the treatment of acute CVT. METHODS: An electronic search of MEDLINE, Pubmed, CENTRAL and Google Scholar was performed. Randomized controlled trials (RCT) reporting on the efficacy and safety of anticoagulation for acute treatment of CVT were included. Outcomes of interest included mortality, disability, new ICH and pulmonary embolism (PE). RESULTS: Overall, 4 RCTs were included in the meta-analysis. Two trials compared anticoagulation (UFH (N = 1) and LMWH (N = 1)) to placebo. The use of anticoagulation therapy was associated with an odd ratio (OR) for mortality and disability of 0.31 (95% confidence interval (CI) 0.07 to 1.45; p = 0.14) and 0.3 (95% CI 0.09 to 1.01; p = 0.05), respectively. Three new ICHs were observed among patients receiving placebo and no patient had a PE complication. The other two trials compared LMWH to UFH. LMWH was associated with an OR for mortality and disability of 0.21 (95% CI 0.02 to 2.44, p = 0.21) and 0.5 (95% CI 0.11 to 2.23; p = 0.36), respectively. There were no new events of ICH or PE. CONCLUSION: LMWH seems to be safe and effective for the management of acute CVT.

Indications, retrieval rate, and complications of inferior vena cava filters: Single-center experience in Saudi Arabia.

BACKGROUND: Inferior vena cava (IVC) filter is indicated in patients with acute venous thromboembolism (VTE) in whom therapeutic anticoagulation is contraindicated. While prophylactic insertion of an IVC filter may be considered for patients at high risk of VTE, there are significant differences between clinical guidelines on the role of IVC filters. These discrepancies have arisen predominantly because of the paucity of data on the efficacy and safety of IVC filters. We, therefore, evaluated the indications for filter insertion, the rate of filter retrieval and complications in patients who received IVC filters at King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia. METHODS: A descriptive, retrospective review of electronic- and paper-based medical records was performed. Consecutive sampling was used to study all adult patients who received an IVC filter at KAMC between 2007 and 2016 and met the inclusion criteria. RESULTS: A total of 382 IVC filters were inserted. 113 patients (30%) had an acute VTE and a contraindication to anticoagulation while 53 patients (14%) received an IVC filter in the absence of VTE (i.e., prophylactic). Only 124 (32.5%) IVC filters were eventually retrieved. The most common reason for nonretrieval was the need for permanent filtration (155, 60%). Thrombotic complications developed in 72 (19%) patients; nine patients had fatal pulmonary embolism. CONCLUSION: The insertion of IVC filters in this cohort was associated with low retrieval rate and relatively high incidence of thrombotic complications. Follow-up of patients is required to detect IVC filter-related complications and to increase retrieval rate.

Pulmonary embolism in a patient with neuroleptic malignant syndrome.

Venous thromboembolism is one of the complications in patients prescribed antipsychotic medications. Neuroleptic malignant syndrome (NMS) is a rare side effect of antipsychotic medications in this population. In this case, a young patient, who presented with NMS after a recent start of antipsychotic medications, had developed a pulmonary embolism despite standard of care measures of venous thromboprophylaxis and early mobilization. A low threshold of VTE suspicion and effective preventive measures are both required in order to avoid this preventable complication in this population.

Use of direct oral anticoagulants in daily practice.

In recent years, the options for anticoagulant therapy have examined new direct oral anticoagulants (DOACs) comprising direct thrombin inhibitors (dabigatran) and direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). These agents represent further progress towards the ideal anticoagulant drug and thus towards a safe and effective antithrombotic therapy. The ideal anticoagulant is oral and has a wide therapeutic range, predictable pharmacokinetics and pharmacodynamics, a rapid onset of action, an available antidote, minimal side effects, and minimal interactions with other drugs or food. This review addresses the practical considerations for physicians in DOAC use, including indication, dosage, monitoring, pharmacokinetic profile, drug-drug interaction, and reversal of direct anticoagulation effects in case of bleeding.

Reversal of direct oral anticoagulants.

Reversal agents for direct oral anticoagulants (DOACs), including factor X inhibitors and direct thrombin inhibitors, are a major concern in clinical practice. After DOACs were introduced and became widely used as an alternative for vitamin K antagonists in the management of venous thromboembolism and nonvalvular atrial fibrillation, the need for effective reversal agents has increased, particularly for life-threatening bleeding episodes related to DOACs or to reverse medication effects during urgent interventions. In the absence of specific reversal agents, prothrombin complex concentrate (PCC) and activated PCC are reasonable options to reverse bleeding associated with DOACs. However, high-quality clinical evidence is lacking. Idarucizumab is the only agent approved by the US Food and Drug Administration to reverse the effects of dabigatran; andexanet alfa and ciraparantag are also under evaluation as reversal agents for DOACs. This review summarizes the current evidence for nonspecific and specific reversal of DOACs.