Rate Of Recurrent Bleeding Research Articles

Rate of Rebleed and Retreatment of Previously Treated Intracranial Aneurysms

Intracranial aneurysms (IAs) can be treated through endovascular treatment (EVT) or microsurgery (MS). Treated IAs can recanalize, which can lead to rupture or retreatment. The aim of our study was to evaluate the natural history of previously treated IA, by evaluating the risk of rupture and the risk of retreatment. All patients treated for an IA between 2007 and 2017 in 4 hospitals were included. The rate of (recurrent) hemorrhage and the rate of prophylactic retreatment were retrospectively evaluated. Kaplan-Meier survival analysis with log-rank tests was used to compare the rates of rupture or retreatment. Patients with ruptured and unruptured aneurysms were separated, and we compared the risk of retreatment between EVT and the surgical treatment. A total of 4997 IAs were included in the study, corresponding to 20,489 patient-years. Overall, 28 (0.6%) aneurysms that had been previously treated demonstrated hemorrhage. Moreover, 237 (4.7%) aneurysms were retreated for recanalization without hemorrhage. The rate of retreatment was higher in the EVT-treated IAs as compared with the MS-treated IAs (LogRank: P < 0.0001) and higher in the previously ruptured IAs versus unruptured IAs (LogRank: P < 0.0001). However, the rate of posttreatment hemorrhage/IA rupture was similar for both groups. The rate of IA retreatment is low; however, the rate of hemorrhage/rupture from treated IAs is even lower. A higher rate of retreatment was noted in EVT-treated IAs versus MS-treated IAs and in ruptured IAs versus unruptured IAs; however, the rate of hemorrhage or rerupture was comparable between the groups.

Laparoscopic splenectomy and esophagogastric devascularization combined with fast-track principles offers greater benefit for patients with portal hypertension.

IntroductionLaparoscopic splenectomy and esophagogastric devascularization (LSED) is becoming increasingly popular in the treatment of esophageal-fundic variceal bleeding with portal hypertension (PHT) in China, and its high safety and minimal trauma have been proven. Fast-track (FT) surgery improves patient recovery and decreases postoperative complications.AimTo determine whether LSED with fast-track principles can provide better outcomes than traditional treatment for patients with PHT.Material and methodsA total of 140 patients who underwent LSED with either traditional treatment or fast-track principles in our department were retrospectively analyzed. The postoperative outcomes, complications, inflammatory mediators, portal vein thrombosis (PVT) and recurrent esophagogastric variceal bleeding rate were recorded.ResultsNo significant differences were found in the patients’ preoperative characteristics. The FT group had better outcomes than the non-FT group with respect to gastrointestinal function recovery, resumption of oral intake, and postoperative hospitalization. The incidence of postoperative complications, including pneumonia, severe ascites, and urinary tract infection, were significantly lower in the FT than the non-FT group. The C-reactive protein and interleukin 6 concentrations and the incidence of PVT were significantly lower in the FT than the non-FT group. The overall recurrent bleeding rate is 11.5% and no significant difference was found between the two groups in the follow-up period.ConclusionsLSED with fast-track principles was superior to LSED with traditional treatment in terms of postoperative outcomes, complications, postoperative inflammatory reactions, and the incidence of PVT. This strategy is safe and effective for the treatment of PHT.

High-Dose Proton Pump Inhibitors Are Superior to Standard-Dose Proton Pump Inhibitors in High-Risk Patients With Bleeding Ulcers and High-Risk Stigmata After Endoscopic Hemostasis.

INTRODUCTION:To define the best cutoff of the Glasgow-Blatchford score (GBS) for identifying high- and low-risk rebleeding patients with bleeding ulcers and high-risk stigmata after endoscopic hemostasis and compare the efficacy of high-dose and standard-dose intravenous proton pump inhibitors (HD-IVPs and SD-IVPs, respectively) in this patient population.METHODS:We retrospectively reviewed the data of 346 patients with bleeding ulcers and high-risk stigmata who underwent endoscopic hemostasis between March 2014 and September 2018 in our center and were divided into an HD-IVP group and an SD-IVP group. Propensity score–matching analysis was performed to control for selection bias and other potential confounders. Recurrent bleeding rates were calculated according to the GBS.RESULTS:Overall, 346 patients meeting the inclusion criteria were enrolled, with 89 patients in the SD-IVP group and 89 patients in the HD-IVP group after matching with all baseline characteristics balanced (P > 0.05). GBS = 8 was the best cutoff for identifying high-risk rebleeding patients (GBS ≥ 8) with a significant difference (P = 0.015) in recurrence rate between the SD-IVP (17/61, 27.9%) and HD-IVP (7/65, 10.8%) groups and low-risk rebleeding patients (GBS < 8) with no difference (P = 1) in recurrence rate between the SD-IVP (2/28, 7.1%) and HD-IVP (2/24, 8.3%) groups.DISCUSSION:The best cutoff for identifying high-risk and low-risk rebleeding patients with bleeding ulcers and high-risk stigmata after endoscopic hemostasis was GBS = 8. Although HD-IVP is more effective than SD-IVP in high-risk patients, they are equally effective in low-risk patients.

Impact of no, distal, and proximal deep vein thrombosis on clinical outcomes in patients with acute pulmonary embolism: From the COMMAND VTE registry

BackgroundThe majority of acute pulmonary embolism (PE) is caused by thrombus developed from leg veins. However, impact of concomitant deep venous thrombosis (DVT) on clinical outcomes has not been fully evaluated in patients with acute PE. MethodsThe COMMAND VTE Registry is a multicenter registry enrolling consecutive 3027 patients with acute symptomatic venous thromboembolism (VTE) in Japan. The current study population consisted of 655 acute PE patients who underwent lower extremities ultrasound examination at diagnosis for the assessment of concomitant DVT status. ResultsThere were 424 patients with proximal DVT (64.7%), 162 patients with distal DVT (24.7%), and 69 patients with no DVT (10.5%). The cumulative 90-day incidence of all-cause death was higher in proximal DVT patients than in distal DVT and no DVT patients (7.9%, 2.5%, and 1.4%, p = 0.01). Regarding the causes of death, the cumulative 90-day incidence of PE-related death was low, and not significantly different across the 3 groups (1.4%, 0.6%, and 1.7%, p = 0.62). The most frequent cause of death was cancer in proximal and distal DVT patients. There were no significant differences in 90-day rates of recurrent VTE and major bleeding, regardless of the status of concomitant DVT (2.9%, 3.2%, and 2.2%, p = 0.79, and 1.5%, 4.4%, and 4.9%, p = 0.46, respectively). ConclusionsAcute PE with proximal DVT at diagnosis was associated with a higher risk for short-term mortality than in patients without DVT, while the risk for short-term mortality was not significantly different between distal DVT patients and patients without DVT.

Risk of Recurrent Venous Thromboembolism and Bleeding in Patients with Cancer Associated Thrombosis

Background: The treatment paradigm for cancer associated thrombosis (CAT) has evolved over recent years from using low molecular weight heparin (LMWH) to direct oral anticoagulants (DOACs). Some randomized trials suggest decreased rates of recurrent venous thromboembolism (VTE) in CAT patients treated with DOACs compared to LMWH but also reported increased rates of bleeding. The Cleveland Clinic Taussig Cancer Center has been treating cancer thrombosis in a centralized CAT clinic since 2014. Here we report our rates of bleeding and recurrent VTE in cancer patients treated with anticoagulation. Methods: We prospectively followed cancer patients referred to our clinic from 8/2014-10/2019. A total of 1548 patients were referred to the clinic, of whom 462 were diagnosed with an acute VTE. VTE events, including deep venous thrombosis, pulmonary embolism, and visceral thrombosis, were noted. The comparison of bleeding rates (defined using ISTH criteria for major and clinically relevant non major bleeding, CRNMB) among treatment groups (LMWH vs DOACs) was examined using chi-square test. Rate of recurrent VTE was analyzed using a competing model in which death was treated as a competing risk. Results: The study population comprised 462 patients with acute VTE with a mean age of 62.67±12.23 and 51.8 % males. Of these, 234 (52.9%) received LMWH, 161(36.4%) received DOACs, and 47 (10.6%) received other agents including warfarin for initial anticoagulation. Overall, the 6-month, 1 year, and 2-year VTE recurrence rate was 5.9%, 6.6%, 7.9%, respectively. Recurrent VTE rates were similar for LMWHs, DOACs and other agents (P&amp;gt;0.05). Of 368 patients for whom follow-up data was available, 74 (16.7%) had bleeding event , of which 25 (33.8%) had major bleeding and 49 (66.4%) had CRNMB at 6 month follow-up with no difference across three treatment groups (p=0.56). Conclusion: In this real-world practice setting, rates of recurrent VTE and bleeding were similar for DOACs and LMWH suggesting that with careful patient selection the concern for higher bleeding with DOACs in cancer patients can be safely overcome. Disclosures McCrae: Momenta Pharmaceuticals: Consultancy; Novartis: Honoraria; Rigel: Consultancy; Dova: Consultancy. Khorana:Merck: Research Funding; Medscape: Honoraria; Leo Pharma: Honoraria; Seattle Genetics: Honoraria; Pharmacyte: Honoraria; Pharmacyclics: Honoraria; Array: Other: Research funding (to institution); Janssen: Honoraria; Bayer: Honoraria; Pfizer: Honoraria; Sanofi: Honoraria; BMS: Honoraria, Research Funding; Leap: Research Funding.

Empiric cone-beam CT-guided embolization in acute lower gastrointestinal bleeding.

To evaluate the clinical effect and safety of cone-beam CT (CBCT)-guided empirical embolization for acute lower gastrointestinal bleeding (LGIB) in patients with a positive CT angiography (CTA) but subsequent negative digital subtraction angiography (DSA). A retrospective study of consecutive LGIB patients with a positive CTA who received a DSA within 24h from January 2008 to July 2019. Patients with a positive DSA were treated with targeted embolization (TE group). Patients with a negative DSA underwent an empiric CBCT-guided embolization of the assumed ruptured vas rectum (EE group) or no embolization (NE group). Recurrent bleeding, major ischemic complications, and in-hospital mortality were compared by means of Fisher's exact test. Further subgroup analysis was performed on hemodynamic instability. Eighty-five patients (67.6years ± 15.7, 52 men) were included (TE group, n = 47; EE group, n = 19; NE group, n= 19). If DSA was positive, technical success of targeted embolization was 100% (47/47). If DSA was negative and the intention to treat by empiric CBCT-guided embolization, technical success was 100% (19/19). Recurrent bleeding rates in the TE group, EE group, and NE group were 17.0% (8/47), 21.1% (4/19), and 52.6% (10/19) respectively. Empiric CBCT-guided embolization reduced rebleeding significantly in patients with a negative DSA and hemodynamic instability (EE group, 3/10 vs NE group, 10/12, p = .027). Major ischemic complications occurred in one patient (TE group). Overall, the in-hospital mortality rate was 7.1% (6/85). Empiric cone-beam CT-guided embolization proved to be a feasible, effective, and safe treatment strategy to reduce rebleeding and improve clinical success in hemodynamically unstable patients with acute LGIB, positive CTA but negative DSA. • A novel transarterial embolization technique guided by cone-beam CT could be developed extending the "empiric" embolization strategy to lower gastrointestinal bleeding. • By implementing the empiric treatment strategy, nearly all patients with an active lower gastrointestinal bleeding on CTA will be eligible for a superselective empiric embolization, even if subsequent catheter angiography is negative. • In patients with a negative catheter angiography, empiric embolization reduces the rebleeding rate and, particularly in hemodynamically unstable patients, improves clinical success compared with a conservative "wait-and-see" management.

HCF-ANMCO/AICPR/GIEC/ITAHFA/SICOA/SICP/SIMG/SIT Cardiological Societies Council Consensus document: Anticoagulant therapy in venous thromboembolism and atrial fibrillation of the patient with cancer. Current knowledge and new evidence

Venous thromboembolism (VTE), including pulmonary embolism and deep venous thrombosis, either symptomatic or incidental, is a common complication in the history of cancer disease. The risk of VTE is 4-7-fold higher in oncology patients, and it represents the second leading cause of death, after cancer itself. In cancer patients, compared with the general population, VTE therapy is associated with higher rates of recurrent thrombosis and/or major bleeding. The need for treatment of VTE in patients with cancer is a challenge for the clinician because of the multiplicity of types of cancer, the disease stage and the imbricated cancer treatment. Historically, in cancer patients, low molecular weight heparins have been preferred for treatment of VTE. More recently, in large randomized clinical trials, direct oral anticoagulants (DOACs) demonstrated to reduce the risk of VTE. However, in the "real life", uncertainties remain on the use of DOACs, especially for the bleeding risk in patients with gastrointestinal cancers and the potential drug-to-drug interactions with specific anticancer therapies.In cancer patients, atrial fibrillation can arise as a perioperative complication or for the side effect of some chemotherapy agents, as well as a consequence of some associated risk factors, including cancer itself. The current clinical scores for predicting thrombotic events (CHA2DS2-VASc) or for predicting bleeding (HAS-BLED), used to guide antithrombotic therapy in the general population, have not yet been validated in cancer patients. Encouraging data for DOAC prescription in patients with atrial fibrillation and cancer are emerging: recent post-hoc analysis showed safety and efficacy of DOACs for the prevention of embolic events compared to warfarin in cancer patients. Currently, anticoagulant therapy of cancer patients should be individualized with multidisciplinary follow-up and frequent reassessment. This consensus document represents an advanced state of the art on the subject and provides useful notes on clinical practice.

Transjugular Intrahepatic Portosystemic Shunts Reduce Variceal Bleeding and Improve Survival in Patients with Cirrhosis: A Population-Based Analysis

PurposeTo investigate from a population health perspective the effects of transjugular intrahepatic portosystemic shunt (TIPS) creation on recurrent variceal bleeding and survival in patients with cirrhosis. Materials and MethodsPatients with cirrhosis who presented to outpatient and acute-care hospitals in California (2005–2011) and Florida (2005–2014) with variceal bleeding comprised the study cohort. Patients entered the study cohort at their first presentation for variceal bleeding; all subsequent hospital encounters were then evaluated to determine subsequent interventions, complications, and mortality data. ResultsA total of 655,577 patients with cirrhosis were identified, of whom 42,708 (6.5%) had at least 1 episode of variceal bleeding and comprised the study cohort. The median follow-up time was 2.61 years. A TIPS was created in 4,201 (9.8%) of these patients. There were significantly greater incidences of coagulopathy (83.9% vs 72.8%; P < .001), diabetes (45.5% vs 38.8%; P < .001), and hepatorenal syndrome (15.3% vs 12.5%; P < .001) in TIPS recipients vs those without a TIPS. Following propensity-score matching, TIPS recipients were found to have improved overall survival (82% vs 77% at 12 mo; P < .001) and a lower rate of recurrent variceal bleeding (88% vs 83% recurrent bleeding–free survival at 12 months,; P < .001) than patients without a TIPS. Patients with a TIPS had a significant increase in encounters for hepatic encephalopathy vs those without (1.01 vs 0.49 per year; P < .001). ConclusionsTIPS improves recurrent variceal bleeding rates and survival in patients with cirrhosis complicated by variceal bleeding. However, TIPS creation is also associated with a significant increase in hepatic encephalopathy.

Clinical Outcome of Pars Plana Vitrectomy With Or Without Intravitreal Bevacizumab As A Pretreatment in Advanced Diabetic Eye Disease

Purpose: To find out the clinical outcome of Pars Plana Vitrectomy with and without Intravitreal Bevacizumab as a pretreatment in advanced diabetic eye disease.&#x0D; Place and Duration of Study: Ophthalmology department of holy family hospital Rawalpindi, from January 2018 to December 2018.&#x0D; Methods: Sixty patients with advanced proliferative diabeticretinopathy wereincluded. Patients were divided into two groups. In group A, patients had pars plana vitrectomy with pre procedure injection of intravitreal Bevacizumab and group B had vitrectomy without pre procedure intravitreal Bevacizumab. Amount of bleeding during vitrectomy, surgical time and rate of iatrogenic tears were noted in both groups. Outcome measures were post operative best corrected visual acuity at 6 months and post operative recurrent vitreous hemorrhage.&#x0D; Results: Patients had a mean age of 63.83 ± 7.314. In group A, mild bleeding was seen in 33%, moderate in 6.7% and severe in 0%. In group B, mild bleeding was seen in 13.3%, moderate in 46.7%, and severe bleeding in 40%. After 6 months, 27 (90%) patients in group A showed improvement in best corrected visual acuity while it was seen in 12 (40%) patients in group B. Iatrogenic tearswere seen in 10% in group A and 36% in group B. Mean time of surgery in group A was 59.27 ± 6.823 minutes and in group B was 77.87 ± 9.637 minutes. Rate of recurrent vitreous hemorrhage after vitrectomy was 6.7% in group A and 40% in group B.&#x0D; Conclusion: Intravitreal injection of Bevacizumab is helpful in reducing surgical time and also decreases intraoperative and post operative bleeding.&#x0D; Key Words: Bevacizumab, Vitrectomy, Proliferative Diabetic Retinopathy.

Venous thromboembolism in palliative care patients: what do we know?

Despite a breadth of data on the management of cancer-associated thrombosis, all the studies informing clinical guidelines excluded patients receiving palliative care. Patients with advanced cancer have a higher rate of recurrent venous thromboembolism (VTE) and bleeding, making them one of the most challenging populations to treat. The dearth of population-specific research leaves clinicians with few options but to extrapolate data from clinical trials conducted on a healthier population. Recent observational studies have challenged the utility of doing this, suggesting the natural history of VTE in the advanced cancer patient may differ to our first beliefs and that a less aggressive approach to anticoagulation is warranted particularly near the end of life. This paper highlights what we know so far.

Superselective transcatheter arterial embolization for acute small bowel bleeding: clinical outcomes and prognostic factors for ischemic complications.

Small bowel bleeding (SBB) accounts for 5%-10% of all cases of acute gastrointestinal bleeding. Transcatheter arterial embolization (TAE) plays an important role in the treatment of SBB. To evaluate the safety and efficacy of superselective TAE exclusively for SBB and to assess factors associated with clinical outcomes. From January 2006 to April 2017, 919 patients were admitted with signs and symptoms of gastrointestinal bleeding; 74 patients (mean age = 57.5 years; age range = 14-82 years) with positive angiographic findings for SBB were retrospectively analyzed. The technical success of TAE and clinical outcomes, including recurrent bleeding, major complications, and in-hospital mortality were evaluated. The associations of various clinical and technical factors with clinical outcomes were analyzed. The bleeding foci were in the ileum in 48 (65%) patients and the jejunum in 26 (35%). Technical success was achieved in 72 (97%) patients. The rates of recurrent bleeding, major complications, and in-hospital mortality were 12% (7/57), 21% (15/71), and 25% (18/72), respectively. Superselective embolization was a significant prognostic factor associated with fewer major complications (OR = 0.069; P = 0.003). The increased number of embolized vasa recta was significantly associated with a higher probability of major complications (OR = 2.64; P < 0.001). The use of N-butyl cyanoacrylate was associated with lower rates of major complication (OR = 0.257; P = 0.027). TAE is a safe and effective treatment modality for SBB. In addition, whenever possible, TAE should be performed in a superselective manner to minimize ischemic complications.

Histoacryl glue injection without lipiodol dilution and post sclerotherapy bleeding; prevalence among patients with upper GIT bleed.

Objectives: To determine role of histoacryl injection in preventing upper acute upper gastrointestinal bleeding. Study Design: Prospective Study. Setting: Gastroenterology ward of DHQ Teaching Hospital Gujranwala. Period: One year from 1st September 2017 to 31st August 2018. Material &amp; Methods: Patients presented to the study hospital having upper gastrointestinal bleeding of acute onset due to gastric varices bleeding were included in this study. All other cases having upper GIT bleeding due to other causes like peptic ulcer disease, Mallory weise syndrome, gastritis or esophageal varices were not included in this study. Both male and female patients were included irrespective of their age. Hemostasis in these cases was achieved by endoscopic sclerotherapy using histoacryl glue (N-butyl-2-cyanoacrylate) injection without lipoidal dilution. After first session of injection patients were called on follow up after 5 days and they were assessed for recurrent GIT bleeding and treatment failure. All data was documented on a predesigned performa. Frequencies and percentage were calculated and results were expressed in tabular form and graphs. Results: Total 80 cases were studied including 56% male and 44% female cases. Endoscopic sclerotherapy using histoacryl injection proved successful in 87.5% cases and recurrent bleeding occurred in 12.5% cases. Minimum age of patients was 25 years and maximum age 70 years with mean age of 45 years. Total 450 cases presented in study institution with Upper GIT bleeding during study period and causes among them were liver cirrhosis in 92% cases, peptic ulcer disease in 4% cases, Malloryweise Syndrome in 2.5% and gastritis in 1.5% cases. In our study group cause of gastric varices was liver cirrhosis due to viral hepatitis in 73% cases and alcoholic hepatitis in 27% cases. After single session of endoscopic histoacryl glue injection to 80 cases, no bleeding occurred after 5 days in 71(88.7%) cases, recurrent bleeding occurred within 5 days in 9(11.2%) cases. Two cases died due to massive recurrent bleeding and mortality rate was 2.5%. Conclusion: Endoscopic sclerotherapy using Histoacryl injection is very successful treatment for acute upper gastrointestinal bleeding with very low recurrence rate of bleeding and low mortality rate.

497 WHAT TREATMENT TO USE FOR SEVERE NON-VARICEAL UGI HEMORRHAGE: STANDARD ENDOSCOPIC HEMOSTASIS, DOPPLER GUIDED HEMOSTASIS, OR OVER-THE-SCOPE-CLIP (OTSC)?

Non-variceal UGI hemorrhage (NVUGIH) is common but 26-28% of high risk patients with bleeding peptic ulcers (PUB’s) or Dieulafoy’s lesions (DL) rebled after standard, visually guided endoscopic hemostasis in 2 recently reported randomized controlled trials (RCT’s). See references in Table. These were separate comparisons of Doppler probe assisted hemostasis (DEP) or OTSC with STANDARD endoscopic hemostasis, but the 3 have never been compared in a head-to-head study before. Our purposes were to compare rates of recurrent bleeding and other 30 day clinical outcomes after endoscopic treatment with DEP, OTSC or STANDARD hemostasis of patients with severe NVUGIH. Individual patient data from 2 successive RCT’s were analyzed. Only patients with PUB’s & DL’s were included in 3 treatment groups: 69 DEP, 24 OTSC, & 101 STANDARD patients. We utilized SAS for data management & a biostatistician for the statistical analyses (JG). Patients were randomized if they had either major stigmata of hemorrhage – SRH (spurting arterial bleeding, non-bleeding visible vessel, or adherent clot) or lesser SRH (oozing bleeding or flat spot). In all treatments of spurting arterial bleeding or adherent clots, epinephrine injection was used prior to hemostasis with hemoclips (HC) &/or multipolar electrocoagulation (MPEC), or OTSC. DEP patients had visually guided hemostasis & if still positive for residual blood flow, more MPEC or HC’s was applied to obliterate underlying arterial blood flow, if feasible & safe. All patients received high dose proton pump infusions – PPI’s - X 72 hours & then BID PPI’s. Patients & their healthcare teams were blinded to endoscopic treatments & made all decisions after randomization about transfusions, further intervention for rebleeding, & level of care. Patients in the 3 treatment groups had similar baseline risk factors. However, there were significantly higher rates of 30 day rebleeding for STANDARD vs. DEP or OTSC (25.7% vs. 10.1% vs. 4.2%). The numbers needed to treat (NNT) for OTSC vs. STANDARD are 4.6 & for DEP vs. STANDARD are 6.4. Severe complications, number of RBC’s after randomization & number of bleeding episodes were also significantly higher in the STANDARD group – See Table & Kaplan-Meier Curves (p = 0.0141 for overall difference). For patients with severe UGIH from PUB’s or Dieulafoy’s lesions treated by the same investigators in 2 consecutive RCT’s: 1. STANDARD hemostasis resulted in significantly higher rates of further bleeding than DEP assisted hemostasis or OTSC. 2. Post-randomization rates of severe complications, units of RBC transfused, & number of bleeds were also significantly higher in the STANDARD treatment group. Either DEP assisted or OTSC are recommended as the new initial treatments of choice for severe NVUGIH from PUB’s or DL’s.Legend: Kaplan-Meier curves of time to first rebleed. Overall p = 0.0141 by log rank test.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

A retrospective single-center evaluation of the safety and efficacy of direct oral anticoagulants versus low molecular weight heparin in patients with cancer-associated thrombosis.

e24102 Background: Over the past decade, there has been an increase in the use of direct oral anticoagulants (DOACs) in the cancer population despite limited data comparing its use against low molecular weight heparin (LMWH), the standard of care in cancer patients. Increasing data supporting DOACs in cancer-associated thrombosis has emerged over the past few years. Nonetheless, this study will evaluate the relative safety and efficacy of DOACs versus LMWH in cancer-associated thrombosis within an urban setting associated with low socioeconomic status. Methods: This is a retrospective chart review of medical records from patients treated at an urban academic medical center from October 2010 through October 2018. Patients met study inclusion if they had a diagnosis of venous thromboembolism occurring after the date of diagnosis of active cancer and were prescribed a direct oral anticoagulant (rivaroxaban, apixaban, dabigatran, edoxaban) or a low molecular weight heparin (dalteparin, enoxaparin, or fondaparinux) as monotherapy for the treatment of venous thromboembolic disease. Patients were excluded if they had less than 6 months of follow up data for reasons other than death. The primary outcomes were recurrent venous thromboembolism, major bleeding and death. Results: Of the 914 patients who met inclusion criteria, 286 were excluded due to lack of follow up data. The remaining patients included 472 in the LMWH arm and 156 in the DOAC arm. At 6 months, recurrent thromboembolism occurred in 5 of the 472 patients (1.1%) in the LMWH group as compared with 4 of the 156 patients (2.6%) in the DOAC group (p = 0.170). Major bleeding occurred in 36 patients (7.6%) in the LMWH group and 11 patients (7.0%) in the DOAC group (p = 0.813). Death within 6 months of starting anticoagulation occurred in 76 patients (16.1%) in the LMWH group and 16 patients (9.6%) in the DOAC group (p = 0.046). Discontinuation before 6 months of treatment occurred in 241 patients (51.2%) in the LMWH group and 46 patients (29.5%) in the DOAC group. Conclusions: The LMWH and DOAC groups had similar rates of recurrent thromboembolism and major bleeding. The mortality rate within 6 months of starting anticoagulation was significantly higher in the LMWH group and this difference requires further evaluation. These results help support the continued use of DOACs for the treatment of cancer-associated thrombosis and demonstrate that DOACs are as safe and effective as LMWH in this patient population.

Low rate of recurrent bleeding after double-balloon endoscopy-guided therapy in patients with overt obscure gastrointestinal bleeding.

Double-balloon endoscopy (DBE) provides both diagnosis and treatment in overt obscure gastrointestinal bleeding (OGIB). The aim of this study was to evaluate the rebleeding rate after DBE. This retrospective review was conducted between January 2006 and July 2018, 166 patients with overt OGIB who underwent DBE were enrolled. Therapeutic intervention was defined as endoscopic treatment, embolization, or surgery. Primary outcome was rebleeding rate after DBE. The patients were divided into 3 groups based on their DBE; (1) positive DBE requiring therapeutic intervention (G1), (2) positive DBE without therapeutic intervention required (G2) and (3) negative DBE (G3). Cumulative incidence of rebleeding was estimated using the Kaplan-Meier method. Cox regression was used to assess the association of DBE with rebleeding risk. This study was approved by our Institutional Review Board. Sixty-eight patients (41%) were categorized in G1, 34 patients (20%) in G2 and 64 patients (39%) in G3. Overall rebleeding occurred in 24 patients (15%). The cumulative incidence of rebleeding for G1 was the lowest. The 1-year and 2-year cumulative probability of developing rebleeding after DBE in G1 were 3.5% and 3.5%, 8.2% and 14.0% in G2, and 18.2% and 20.6% in G3, respectively (p = 0.02). After adjusting for bleeding severity and comorbidities, patients with positive DBE requiring therapeutic intervention had a significantly lower rate of rebleeding when compared with patients who did not receive intervention (hazard ratio 0.17; 95% CI 0.03-0.90). DBE-guided therapeutic intervention was associated with a lower risk of rebleeding when compared with those with negative and positive DBE without therapeutic intervention. One-fifth of patients with overt OGIB had false negative after DBE.

Comparative effectiveness of oral anticoagulants in venous thromboembolism: GARFIELD-VTE

IntroductionRandomized controlled trials have shown that direct oral anticoagulants (DOACs) are a safe and effective alternative to vitamin K antagonists (VKAs) for the treatment of venous thromboembolism (VTE). However, there are limited post-marketing data describing the effectiveness and safety of the DOACs in the community setting. We aimed to compare the effectiveness of DOACs and VKAs on 12-month outcomes in a real-world VTE patient population. MethodsThe Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE is an observational study designed to document real-world treatment practices. This intention-to-treat analysis included 7987 VTE patients initiated on either DOACs (N = 4791) or VKAs (N = 3196) with or without pre-treatment with parenteral anticoagulants. Treatment groups were balanced according to baseline characteristics, using overlapping propensity score weights. ResultsAfter adjustment for baseline characteristics, all-cause mortality was significantly lower with DOAC than with VKAs (hazard ratio [HR]: 0.73; 95% confidence interval [CI] 0.56–0.95. Patients receiving VKAs were more likely than those receiving DOACs to die of complications of VTE (4.7% vs 2.7%) or from bleeding (4.2% vs. 1.3%). There was no significant difference in recurrent VTE (HR: 0.91, 95% CI 0.71–1.18), major bleeding (HR 1.03, 95% CI 0.69–1.54), or overall bleeding (HR 0.96, 95% CI 0.81–1.14) with DOACs or VKAs. ConclusionsIn this real-world analysis of VTE treatment, DOACs were associated with reduced all-cause mortality compared with VKAs, and similar rates of recurrent VTE and bleeding.

Are Patients with Active Cancer and Those with History of Cancer Carrying the Same Risks of Recurrent VTE and Bleeding While on Anticoagulants?

Direct oral anticoagulants (DOAC) are now recommended for the treatment of cancer-associated thrombosis (CAT) based on the results of dedicated trials demonstrating that DOAC are non-inferior to low molecular weight heparins in preventing recurrent venous thromboembolism (VTE) in this population. The definition of “cancer patient” differs substantially among studies. Whether patients with active cancer and those with a history of cancer (HOC) carry the same risks of recurrent VTE and bleeding remains unclear. Few studies reported data on the efficacy and safety of anticoagulants according to active cancer or HOC categories. While in subgroup analyses of EINSTEIN and HOKUSAI the rates of recurrent VTE and bleeding did not differ between these categories, results from a subgroup analysis of AMPLIFY, from HOKUSAI-Cancer, and from the COMMAND cohort suggest that HOC patients might have a lower bleeding risk than active cancer patients. Whether the inclusion of HOC patients in CAT studies might introduce some bias by decreasing the rates of both recurrent VTE and bleeding remains an unanswered issue since no dedicated prospective study addressed this question. A strict definition of active cancer should be used in further trials.

Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial

BackgroundTo compare efficacy and safety of intravitreal aflibercept (IVA) injection with panretinal photocoagulation (PRP) versus early vitrectomy for diabetic vitreous hemorrhage (VH).MethodsProspective, randomized study that included 34 eyes with diabetic VH. They were divided into two groups, Group Ι (17 eyes) received three successive IVA injections followed by PRP and group ΙΙ (17 eyes) for whom early vitrectomy was done. Follow up was carried out after one, two, three, six and nine months. The primary outcome measure was change in the mean best corrected visual acuity (BCVA) after nine months, secondary outcome measures were mean duration of clearance of VH and rate of recurrent hemorrhage with any additional treatment in both groups. Complications were reported.ResultsThere was no statistically significant difference regarding initial demographic criteria between both groups. The mean final log MAR BCVA was statistically better than the initial BCVA in both groups (0.51 ± 0.20, 1.17 ± 0.48 for group I and 0.48 ± 0.18, 1.44 ± 0.44 for group II, P < 0.001). There was no statistically significant difference between both groups regarding the mean final Log Mar BCVA (0.51 ± 0.20 for group I, 0.48 ± 0.18 for group II, p ≥ 0.05), the mean duration of clearance of VH was 7.8 ± 1.8 weeks, 5 days for group I and II respectively. PRP was completely done for all eyes in group I after three months. The difference in the recurrence rate between group I (29.4%) and group II (11.8%) was statistically significant (p < 0.05). Vitrectomy was done for three eyes (17.6%) due to recurrent non-resolving VH in group I. late recurrent VH occurred in two eyes (11.8%) in group II, IVA was given with complete clearance of the hemorrhage. No vision threatening complications were reported in both groups.ConclusionBoth intravitreal injection of aflibercept followed by PRP and early vitrectomy are effective and safe modalities for treatment of diabetic vitreous hemorrhage. Early vitrectomy leads to faster vision gain with less incidence of recurrence than intravitreal injection.Trial registrationRandomized clinical trial under the number of NCT04153253 on November 6, 2019 “Retrospectively registered”.

A Meta-Analysis of Case Fatality Rates of Recurrent Venous Thromboembolism and Major Bleeding in Patients with Cancer.

Knowing the case fatality rates of recurrent venous thromboembolism (VTE) and major bleeding is important for weighing the relative risks and benefits of anticoagulation and deciding on the duration of anticoagulant therapy, but these rates are uncertain in patients with cancer-associated thrombosis. We performed a systematic review and a meta-analysis to determine the incidence of recurrent VTE and major bleeding and their respective case fatality rates in patients with cancer-associated VTE. Our analysis included 29 studies (15 prospective cohort studies and 14 randomized controlled trials) from 1980 to January 2019. Data from 8,000 cancer patients with 4,786 patient-years of follow-up were summarized. Rates of recurrent VTE and fatal recurrent VTE were 23.7 (95% confidence interval [CI]: 20.1-27.8) and 1.9 (95% CI: 0.8-4.0) per 100 patient-years of follow-up, respectively, with a case fatality rate of 14.8% (95% CI: 6.6-30.1%). The rates of major bleeding and fatal major bleeding events were 13.1 (95% CI: 10.3-16.7) and 0.8 (95% CI: 0.3-2.1) per 100 patient-years of follow-up, respectively, with a case fatality rate of 8.9% (95% CI: 3.5-21.1%). While the estimates of case fatality vary by anticoagulation regimen and study design, the differences between them were not statistically significant. In cancer patients receiving anticoagulation, the case fatality rate of recurrent VTE is higher than the case fatality rate of major bleeding. These findings may help to inform decisions regarding the management of anticoagulation in patients with active cancer and VTE.

Optimal Timing of Feeding After Endoscopic Hemostasis in Patients With Peptic Ulcer Bleeding: A Randomized, Noninferiority Trial (CRIS KCT0001019).

The optimal duration of fasting after endoscopic hemostasis in patients with peptic ulcer bleeding has not yet been determined. We investigated the appropriate timing of feeding after endoscopic hemostasis in patients with high-risk peptic ulcer bleeding. This study was a randomized, single center, noninferiority trial. Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding were randomized to resume feeding either 24 or 48 hours after successful endoscopic hemostasis. A total of 209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis. The primary outcome measure was recurrent bleeding within 7 days of hemostasis. Noninferiority testing was performed in the PP population, and the noninferiority margin was set at 10%. Secondary outcomes included 30-day rebleeding and mortality, transfusion requirements, and length of hospital stay. Recurrent bleeding rates at 7 days were 7.9% in the 24-hour group and 4.0% in the 48-hour group in the PP analysis; tests for noninferiority did not reach statistical significance (difference: 3.9%, 95% confidence interval [CI]: -2.7 to 10.5, P value for noninferiority = 0.034). The recurrent bleeding rates within 30 days were 10.9% and 4.0% in the 24- and 48-hour groups (difference: 6.9%, 95% CI: -0.5 to 14.2), and the 30-day mortality rates were 5.9% and 14.1%, respectively (difference: -8.2%, 95% CI: -16.5 to 0.1) in the PP analysis. The transfusion requirement and the length of hospital stay were similar between the 2 groups. Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding. Our results do not allow a recommendation of refeeding at 24 hours, rather than later refeeding in this population.