PO-41 - Rivaroxaban is effective therapy for high risk cancer patients with venous thromboembolic disease.

INTRODUCTION: The standard of care for cancer associated venous thromboembolism (VTE) is generally accepted to be at least six months of therapeutic doses of low molecular weight heparin (LMWH). After six months it is recommended that therapy be continued but no studies have evaluated treatment in this period. Rivaroxaban is a potentially effective therapy given cancer patients were enrolled in the EINSTEIN trial with acceptable safety and efficacy but details on these patients is lacking. AIM: To determine the safety and efficacy of rivaroxaban for the treatment of cancer associated VTE. MATERIALS AND METHODS: We performed a retrospective chart review of all cancer patients seen in our thrombosis program and enrolled patients seen between January 2012 and April 2015. Complete patient identification was accomplished through our hospital data warehouse. We recorded all relevant demographics. Initial diagnoses were all confirmed with objective imaging tests according to standard definitions. Major bleeds, using the ISTH definition, and recurrent VTE events were adjudicated by at least two observers. RESULTS: 237 active cancer patients received treatment with rivaroxaban; 65 (27%) were initiated on rivaroxaban, 30 (12.6%) started between day 8 and 2 months, 75 (32%) started therapy between day 8 and the 6 month point and 97 (41%) started therapy at 6 months or beyond. 26 patients were put on rivaroxaban after failing LMWH. The average duration of rivaroxaban therapy was 297 days; The average age of patients was 61 (SD±13); 41% of patients were male, 59% were female. 47% of patients had metastatic cancer. Of the 65 patients who were initiated on rivaroxaban 24 (37%) had metastatic cancer. Overall 3.8% of patients recurred while on rivaroxaban therapy with no deaths due to PE, and 3 patients had major hemorrhage with 2 deaths. Of the 9 patients who recurred on rivaroxaban, 3 of them were initiated on rivaroxaban, 3 of them were started 8 days-6 months, and 3 of them started after 6 months. The median number of days from initiation of rivaroxaban to VTE recurrence was 113. 26 patients received rivaroxaban after a recurrent event on therapeutic doses of LMWH, none recurred. Of the 65 patients who were initiated on rivaroxaban 3 recurred and of the 97 patients who were started on rivaroxaban after 6 months three recurred 0.580). All patients were treated on an outpatient basis. CONCLUSIONS: Recurrence and major bleeding events on rivaroxaban were low despite the fact almost half the patients had metastatic disease. Rivaroxaban can be considered acceptable therapy for the treatment of cancer associated with venous thromboembolic disease.

Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion.

BACKGROUND: Public concerns regarding the safety of transfused blood have prompted re-consideration of the indications for the transfusion of allogeneic red cells (blood from an unrelated donor), and a range of techniques designed to minimise transfusion requirements. OBJECTIVES: To examine the evidence for the efficacy of pre-operative autologous blood donation (PAD) in reducing the need for peri-operative allogeneic red blood cell (RBC) transfusion. SEARCH STRATEGY: Articles were identified by: computer searches of OVID MEDLINE, EMBASE, and Current Contents (to March 2001) and web sites of international health technology assessment agencies (to January 2001). References in the identified trials were checked and authors contacted to identify additional studies. SELECTION CRITERIA: Randomised controlled trials with a concurrent control group in which adult patients, scheduled for non-urgent surgery, were randomised to PAD, or to a control group who did not receive the intervention. DATA COLLECTION AND ANALYSIS: Trial quality was assessed using criteria proposed by Schulz et al (1995) and Jadad et al (1996). The principle outcomes were: the number of patients exposed to allogeneic red blood cells, and the amount of blood transfused. Other clinical outcomes are detailed in the review. MAIN RESULTS: Overall PAD reduced the risk of receiving an allogeneic blood transfusion by a relative 63% (RR=0.37: 95%CI:0.26,0.54). The absolute reduction in risk of allogeneic transfusion was 43.8% (RD=-0.438: 95%CI: -0.607,-0.268). In contrast the results show that the risk of receiving any blood transfusion (allogeneic and/or autologous) is actually increased by pre-operative autologous blood donation (RR=1.29: 95%CI: 1.12,1.48). Trials were unblinded and allocation concealment was not described in 87.5% of the trials. REVIEWER'S CONCLUSIONS: Although the trials of PAD showed a reduction in the need for allogeneic blood the methodological quality of the trials was poor and the overall transfusion rates (allogeneic and/or autologous) in these trials were high, and were increased by recruitment into the PAD arms of the trials. This raises questions about the true benefit of PAD. In the absence of large, high quality trials using clinical endpoints, it is not possible to say whether the benefits of PAD outweigh the harms.

Expanding eligibility for outpatient treatment of deep venous thrombosis and pulmonary embolism with low-molecular-weight heparin: a comparison of patient self-injection with homecare injection.

BACKGROUND: The outpatient treatment of patients with deep vein thrombosis and pulmonary embolism using low-molecular-weight heparin has the potential to reduce health care costs, but it is unclear if most patients with deep vein thrombosis and pulmonary embolism can be treated as outpatients. In the published studies, more than 50% of patients were excluded from outpatient treatment for reasons such as comorbid conditions, short life expectancy, concomitant pulmonary embolism, and previous deep vein thrombosis, and many patients were not treated entirely at home. We sought to determine if expanding patient eligibility for the outpatient treatment of deep vein thrombosis and pulmonary embolism affects the safety and effectiveness of the treatment, and to determine if patient self-injection compared with injections administered by a homecare nurse affected these outcomes. PATIENTS AND METHODS: We treated as outpatients all patients with deep vein thrombosis and pulmonary embolism, except for those with massive pulmonary embolism, high risk for major bleeding or an active bleed, phlegmasia, and patients hospitalized for reasons that prevented discharge. We compared 2 models of outpatient care to determine feasibility, safety, and efficacy. Both models involved nurse managers who provided daily patient contact and ongoing treatment; however, in one model the patients were taught to inject themselves and in the other model homecare nurses administered the injections. We expanded the population of patients eligible for outpatient treatment by including many patients not treated at home in previous studies. Most patients in our study were treated with dalteparin sodium, 200 U/kg every 24 hours, for a minimum of 5 days. Therapy with warfarin sodium was started on the day of diagnosis or the following day. Patients were followed up for 3 months to determine rates of recurrent venous thromboembolism, bleeding, and death. RESULTS: In this study, 194 (83%) of 233 consecutive patients were deemed eligible and treated as outpatients. Of the 39 patients who did not receive home therapy, 20 had concomitant medical problems responsible for their admission or were already inpatients, 6 had massive pulmonary embolism, 6 refused to pay for the dalteparin therapy, 4 had active bleeding, and 3 had phlegmasia cerulea dolens, which required treatment with intravenous narcotics for pain control. More than 184 (95%) of the 194 patients were treated entirely at home. There was no significant difference (P>.99) in the rate of recurrent venous thromboembolic events between the patients who were injected by homecare nurses (3/95 [3.2%]) and those who injected themselves (4/99 [4.0%]). Combining the 2 models, the overall recurrent event rate was 3.6% (95% confidence interval, 1.5%-7.4%). Similarly, there were no significant differences in rates of major hemorrhage (2/95 vs 2/99; P>.99), minor hemorrhage (8/95 vs 2/99; P = .06), and death (6/95 vs 8/99; P = .63). The overall rate of major hemorrhage was 2.0% (95% confidence interval, 0.6%-5.2%). CONCLUSIONS: We demonstrate that more than 80% of patients at our tertiary care hospital could be treated at home using 1 of the 2 models of care we describe. Our results demonstrate that patients can safely and effectively perform home self-injection under the supervision of a hospital-based nurse. Injections at home by a homecare nurse are similarly effective. Our overall rates of recurrent venous thromboembolism, bleeding, and death are at least as favorable as those previously reported despite using 1 dose per day of dalteparin for most patients.

Preoperative autologous donation decreases allogeneic transfusion but increases exposure to all red blood cell transfusion: results of a meta-analysis. International Study of Perioperative Transfusion (ISPOT) Investigators.

BACKGROUND: Concern about risks associated with allogeneic red blood cell transfusion has led to interest in methods of decreasing patient exposure to perioperative transfusion. OBJECTIVE: To perform a meta-analysis to determine the degree to which predonation of autologous blood reduces patients' exposure to allogeneic blood and all transfusions of red blood cells (allogeneic or autologous). METHODS: We searched MEDLINE, EMBASE, bibliographies, annual reports, press releases, newsletters from organizations with interests in the blood system, and personal files for randomized studies and concurrent control cohort studies in which the control groups were patients excluded for nonmedical reasons. RESULTS: Patients who predonated autologous blood were less likely to receive allogeneic blood in the 6 randomized studies (n = 933) (odds ratio [OR], 0.17; 95% confidence interval [CI], 0.08-0.32) and in the 9 cohort studies (n = 2351) (OR, 0.19; 95% CI, 0.14-0.26). However, autologous donors were more likely to undergo transfusion with allogeneic and/or autologous blood (for randomized studies: OR, 3.03; 95% CI, 1.70-5.39 and for cohort studies: OR, 12.32; 95% CI, 5.90-25.40). Studies that reported use of transfusion protocols found less benefit with preoperative autologous donation, although the difference was not statistically significant. CONCLUSIONS: Preoperative autologous donation of blood decreases exposure to allogeneic blood but increases exposure to any transfusion (allogeneic and/or autologous). There is a direct relationship between the transfusion rate in the control group and the benefit derived from preoperative autologous donation. This suggests that other methods of decreasing blood transfusion, such as surgical technique and transfusion protocols, may be as important as preoperative autologous donation of blood.

Diagnosis of deep vein thrombosis.

Deep vein thrombosis (DVT) is an important, treatable disease that can be diagnosed by noninvasive imaging procedures. Ultrasound is the most accurate and readily available of these modalities but it still has limitations. False positive results occur in up 6% of patients, and calf DVT is not readily detected; thus serial ultrasonography is recommended in order to detect extension of a calf DVT. However, this results in many patients needlessly returning for a repeat assessment. A recently developed clinical model has the potential to identify false positive ultrasound results and to select patients who do not require serial testing. Certain rapidly performed D-dimer assays have similar potential but have not been evaluated in management strategies. In the subgroup of patients with suspected recurrent DVT and asymptomatic patients at high risk for DVT, ultrasonography and impedance plethysmography are less accurate, however, the clinical implications of this are unknown.

Practical applications of the Quantimet 720, an image analysing computer, in the field of investigative dermatology.

Image analysing computers can perform quantitative measurements of epidermal thickness, sebaceous gland volume, and labelling indices of epidermis easily, rapidly and automatically. All these parameters are extremely important in investigative dermatology and this paper describes how they are measured using the Quantimet 720.