Search

Background The Pulmonary Embolism Severity Index (PESI) has been validated in the setting of standard treatment of pulmonary embolism with initial low molecular weight heparin followed by vitamin K antagonists. We evaluated the proposed simplified PESI in a large, phase III randomized trial involving patients with symptomatic pulmonary embolism with or without deep vein thrombosis, who were treated with rivaroxaban or standard therapy. Methods The EINSTEIN PE study was an open-label, randomized, phase III study that compared oral rivaroxaban alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with subcutaneous enoxaparin overlapping with and followed by a vitamin K antagonist (warfarin or acenocoumarol, target international normalized ratio 2.0–3.0) for 3, 6, or 12 months in patients with acute, symptomatic pulmonary embolism. At baseline, the simplified PESI score was assessed, with 1 point each assigned for age >80 years, history of cancer, chronic cardiopulmonary disease, heart beat ≥110 beats per minute, systolic blood pressure Results It was possible to calculate the simplified PESI score in 4831 of the 4832 included patients, of whom 2589 (53.6%) had a PESI score of 0; 1775 (36.7%) had a score of 1; and 467 (9.7%) had a score of 2 or 3. No patient had a simplified PESI score greater than 3. Incidences of outcomes in relation to time period, simplified PESI score and treatment are presented in the following table. Conclusions Among patients with a simplified PESI score of 0 or 1, major clinical outcome events were rare during the first 30 days of treatment and were similar in patients treated with rivaroxaban or standard therapy. Patients with a simplified PESI score of 2 or more in both treatment groups had more frequent adverse outcomes both initially and in the long term. Disclosures: Fermann: Novartis: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Radiometer: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Cubist: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Cardiorentis: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Pfizer: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity’s Board of Directors or advisory committees, Research Funding. Prins:Bayer HealthCare: Consultancy; Sanofi-aventis: Consultancy; Boehringer Ingelheim: Consultancy; GlaxoSmithKline: Consultancy; Daiichi Sankyo: Consultancy; Leo Pharma: Consultancy; Thrombogenics: Consultancy; Pfizer: Consultancy. Wells:BMS/Pfizer: Research Funding; Pfizer: Honoraria; Bayer Schering Pharma: Honoraria; Boehringer Ingelheim: Honoraria; Bayer HealthCare Pharmaceuticals: Honoraria; Biomerieux: Honoraria. Pap:Bayer Pharma AG: Employment. Lensing:Bayer Pharma AG: Employment.

Abstract 3180 Introduction: Pulmonary embolism (PE) is a continuous risk up to 3 months after surgery. Management of anticoagulation can be challenging in those diagnosed with PE after a major surgical procedure. The aim of this study is to evaluate the outcomes and characteristics of patients diagnosed with PE after a major surgery. Methods: A retrospective cohort of consecutive patients with suspected acute PE that underwent computed tomographic pulmonary angiography (CTPA) or lung ventilation/perfusion scans between 1 January 2007 and 31 December 2008 was constructed by two independent investigators by reviewing each patient's diagnostic images. Patients were included in the study if they had a major surgical procedure (admitted to the hospital for more than 24 hours) and developed PE within 12 weeks of the operation. Patients' follow-up for the first 3 months was recorded. Outcomes included major bleeding, as defined by the ISTH guidelines; recurrent venous thromboembolism (VTE), including PE or deep vein thrombosis (DVT); and mortality. The number of days between treatment initiation and major hemorrhage, recurrent VTE, or death, was recorded. Results: Out of the 842 patients diagnosed with PE at the Ottawa Hospital within the timeframe of the study, 160 (19%) were diagnosed during the post-operative period and were eligible for this study. The mean age (SD) in years was 63 (±15.5), 53% were males, 37% had a cancer related surgery, 37% had orthopedic procedures, and 31% had emergency procedures. The mean time (SD) from surgery to PE diagnosis was 13 (±11) days. All patients were followed-up until the end of their treatment; six patients were transferred to end of life care. Initial treatment was low molecular-weight heparin (LMWH) in 124 (78%) patients, unfractionated heparin (UFH) was given intravenously in 27 (17%) patients, and 5 (3%) requiered an inferior vena cava (IVC) filter to be inserted as the initial treatment. During the 90 days of follow up, there were 17 major bleeding events (12%), 6 recurrent VTEs (4%), and 15 deaths (9%). Of the 17 bleeding events, 13 of them (76%) occurred within the first two weeks of initiation of therapy. No bleeding events occurred after the first month. Two patients died (11.7%) from bleeding, one intracranial and one gastrointestinal (GI). Bleeding was from the GI tract in 47% of cases. Of the 5 patients with IVC filters, 3 developed recurrent DVT in the first two weeks after IVC insertion. The other 3 recurrent VTEs occurred on patients receiving anticoagulation. All cause mortality was 8.7% at 3 months. Within the first 14 days, 8 patients died (5%): 3 patients from PE. Outcomes did not vary by type of surgery, initial treatment or by presence of malignancy. Conclusions: Major bleeding is a common and deadly complication in patients diagnosed with PE after a major surgical procedure. The reported rates of bleeding in this population have varied widely in the literature (between 2 to 9%), according to the type of surgery or population. Our results suggest that alternative triaging and treatment strategies may be indicated in these patients. Disclosures: No relevant conflicts of interest to declare.

Abstract 1102 Introduction: The management of saddle pulmonary embolism (PE) is controversial. Evidence about outcomes and management strategies is scarce in the literature due to the small prevalence of saddle PE. Historically it has been recommended that this group of patients should be treated aggressively. Purpose: To determine the prevalence and outcomes of patients diagnosed with saddle PE. Methods: Retrospective cohort study of consecutive patients with saddle PE diagnosed at the Ottawa Hospital between January 2007 and December 2008. Patients were included if a thrombus was present on computed tomographic pulmonary angiography (CTPA) in the main pulmonary arteries spanning the bifurcation of the main pulmonary trunk. These cases were each matched with two non-saddle controls with proximal PE (thromboemboli in the main pulmonary arteries) based on age, sex, systolic blood pressure greater than or less than 90 mmHg, and the presence or absence of cancer. Demographics, prognostic factors, treatment, and outcomes were collected. Patients were followed over a 30 day period following the diagnosis. RESULTS: A total of 32 (5%) of 724 patients with PE had a saddle event. Baseline characteristics are depicted in Table 1. Differences between the saddle case group and non-saddle control group include the presence of right ventricular dilation (59% of saddle cases vs. 22% of controls, p-value: 0.0007) and in the proportion of patients managed as outpatients (7% of saddle cases vs. 33% of controls, p-value: 0.02). At 30 days no differences were found in patients with saddle PE or proximal PE for all cause mortality (6% vs. 10%; OR: 0.64; 95% CI: 0.08–3.2), PE related mortality (0% vs. 6%; OR: 0.52; 95% CI: 0.01–6.1), major bleeding (3% vs. 5%; OR: 0.65; 95% CI: 0.02–6.4), or recurrent venous thromboembolism (6% vs. 10%; OR: 0.64; 95% CI: 0.08–3.2). Conclusions: Patients with saddle PE do not have a worse 30-day prognosis than patients with proximal PE matched by age, sex, systolic blood pressure, and presence of cancer. Disclosures: No relevant conflicts of interest to declare.

Abstract 3186 Background Several clinical decision rules (CDRs) are available for the exclusion of acute pulmonary embolism (PE). This prospective multi-center study compared the safety and clinical utility of four CDRs (Wells rule, revised Geneva score, simplified Wells rule and simplified revised Geneva score) in excluding PE in combination with D-dimer testing. Methods Clinical probability of patients with suspected acute PE was assessed using a computerized based “black box”, which calculated all CDRs and indicated the next diagnostic step. A “PE unlikely” result according to all CDRs in combination with a normal D-dimer result excluded PE, while patients with “PE likely” according to at least one of the CDRs or an abnormal D-dimer result underwent CT-scanning. Patients in whom PE was excluded were followed for three months. Results 807 consecutive patients were included and PE prevalence was 23%. The number of patients categorized as “PE unlikely” ranged from 62% (simplified Wells rule) to 72% (Wells rule). Combined with a normal D-dimer level, the CDRs excluded PE in 22–24% of patients. The total failure rates of the CDR-D-dimer combinations were similar (1 failure, 0.5– 0.6%, upper 95% CI 2.9– 3.1%). Despite 30% of the patients had discordant CDR outcomes, PE was missed in none of the patients with discordant CDRs and a normal D-dimer result. Conclusions All four CDRs show similar safety and clinical utility for exclusion of acute PE in combination with a normal D-dimer level. With this prospective validation, the more straightforward simplified scores are ready for use in clinical practice. Disclosures: No relevant conflicts of interest to declare.