Gruppo di lavoro: Malattie Tromboemboliche

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1 Gruppo di lavoro: Malattie Tromboemboliche

2 2381 Soluble Recombinant Thrombomodulin Ameliorates Hematological Malignancy-Induced Disseminated Intravascular Coagulation More Promptly Than Conventional Anticoagulant Therapy Without Causing Severe Hemorrhagic Events Naoki Kurita, MD, PhD *, Department of Hematology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan BACKGROUND: Since there is not enough evidence of soluble recombinant thrombomodulin (rtm) on DIC associated with hematological malignancy, we retrospectively compared outcome of these conditions treated with rtm or other conventional anticoagulant therapies. PATIENTS AND METHODS: 165 consecutive DIC episodes in 146 patients with hematological malignancies (AML except for APL, 49; APL, 21; ALL, 19; NHL, 31; myeloma, 11; CML, 7; other; 8) were retrospectively analyzed. DIC was induced by hematological malignancy itself (h-dic) or severe infection secondary to hematological malignancy (i-dic) in 108 and 57 episodes, respectively. In 73 episodes, 380 units/kg/day of rtm was administered intravenously from the onset of DIC for median of 6 (range, 2-22) days. Other DIC episodes were treated with conventional anticoagulant therapy (low molecular weight heparin, 65; gabexate mesilate, 17; other anticoagulant, 10). Every anticoagulant therapy was accompanied by treatment for DIC-causing disease. We compared recovery time from DIC (the day when DIC score was decreased to 5 or less), overall survival, and severe hemorrhagic events related to the treatment, between rtm- and conventional anticoagulant-treated groups. RESULTS: 53 DIC episodes were accompanied by bleeding tendency at the onset. 1) In h-dic, recovery from DIC was significantly more prompt in rtm-treated group, with the recovery rates of 55% (95% CI: 40-68) in the rtm-treated group and 33% (95% CI: 21-45) in the conventional therapy group at day 7 after the therapy initiation (P = 0.03, Fig.1). On day 14, the recovery from h-dic was seen in 72% (95% CI: 56-83) and 60% (95% CI: 47-71) with the rtm and conventional therapies, respectively (P = 0.2). 2) By contrast, recovery from i-dic was significantly worse than that from h-dic, and was not influenced by anticoagulant therapies. 3) Severe hemorrhagic events that led to discontinuation of anticoagulant therapy was significantly less in the rtm-treated group (3%; 95% CI, 0.3-9) compared with that in the conventional therapy group (12%; 95% CI: 6-20; P = 0.04). CONCLUSIONS: The recovery from h-dic treated with rtm was more prompt compared to that with conventional anticoagulant therapy without causing adverse hemorrhagic event even in DIC cases with preexisting bleeding tendency. However, the outcome was still significantly worse in i-dic secondary to hematological malignancies even after introduction of rtm.

3 214 Pattern and Management Of Bleeding Complications With Novel Oral Anticoagulants Results Of The Prospective Dresden Noac Registry (NCT ) Kati Förster 1* et al. 1 Vascular Medicine, Dresden University Hospital "Carl Gustav Carus", Dresden, Germany Background: little is known about the distribution pattern, management and outcome of NOAC-related bleeding complications in daily care. Results: 2249 patients were enrolled into the registry 1738 (77.3%) patients received rivaroxaban 356 (15.8%) received dabigatran 155 (6.9%) received apixaban During follow-up ( patient years), 825 patients reported 1137 bleeding complications 59.1% minor 33.9% non-major, clinically relevant (NMCR) mucosal and skin bleeding (67.9%) genitourinary (10.9%) gastrointestinal bleeding (10.9%) 6.9% major bleeding gastrointestinal bleeding (2.8%) genito-urinary bleeding (0.6%). Treatment was not necessary or consisted of conservative treatment (93%) Surgical or interventional treatment was required in 7.0% (0.0% of minor, 13.0% of NMCR and 38.0% of major bleedings). Prothrombin complex concentrate was used in 1.3% (24% of all major bleedings). Bleeding-associated mortality was 0.5% for all and 7.5% for major bleeding. Of the six fatal bleedings observed, three were intracranial bleedings. Conclusions: Overall, only few NOAC-associated bleeding complications in daily care are fatal, indicating that available management strategies are sufficient.

4 2380 Acute Treatment Of Pulmonary Embolism With Rivaroxaban - Real Life Data From The Prospective Dresden Noac Registry (NCT ) Christina Köhler, MD 1*, et al. 1 Vascular Medicine, Dresden University Hospital "Carl Gustav Carus", Dresden, Germany Background and Objectives: In the EINSTEIN PE study rivaroxaban (RX) was found to be as effective as warfarin in the treatment of acute pulmonary embolism (PE) with superior safety. However, study results need to be confirmed in unselected PE patients in daily care. Patients and Methods: 2249 patients were enrolled. Of these, 72 patients received RX for acute PE treatment. The rate of recurrent VTE, other cardiovascular complications and bleeding events in these was evaluated. Results: - Registry patients were older than the EINSTEIN PE population (67.3 vs years). - During follow-up, unplanned rivaroxaban discontinuation rates were low (around 5%). - So far, only one recurrent VTE event occurred (1.7 events per 100 patient years). - One patient experienced non-fatal ischaemic stroke within 4 weeks after PE diagnosis (1.7 events per 100 patient years). - Bleeding complications were frequent but only 2 major bleeding (non-fatal vaginal bleeds) occurred (3.3 events per 100 patient years). - During follow-up three patients died of underlying diseases but none of these deaths were related to VTE or bleeding complications. Conclusions: Acute PE treatment with rivaroxaban in daily care is effective, safe and well tolerated with low rates of unplanned treatment discontinuation. Thromboembolic and major bleeding complications are rare and seem to occur predominantly in the early phase of PE treatment.

5 211 Edoxaban For Long-Term Treatment Of Venous Thromboembolism In Cancer Patients Gary E Raskob, PhD 1, et al. 1 College of Public Health, Univesity of Oklahoma Health Sciences Center, Oklahoma City, OK Background: Cancer patients with venous thromboembolism (VTE) have been mostly excluded from clinical trials comparing new oral anticoagulants with vitamin-k antagonists. Hokusai-VTE was a global randomized, double-blind, noninferiority trial that compared edoxaban with warfarin for long-term therapy in 8,292 patients with acute symptomatic proximal deep-vein thrombosis and/or pulmonary embolism; all patients received initial LMWH treatment for at least 5 days. Patients with a history of cancer or with active cancer were eligible if long-term LMWH treatment was not planned due to availability, physician judgment or patient preference. Methods: The edoxaban dose was 60 mg once daily (30 mg in patients with body weight less than 60 kg or creatinine clearance 30 to 50 ml/min). Warfarin was adjusted to maintain the INR between 2.0 and 3.0. The primary efficacy outcome was recurrent symptomatic VTE. The efficacy analysis included all patients who received at least one dose of study drug, and included all outcomes through 12 months follow-up or study closure, regardless of the duration of treatment. The principal safety outcome was major or clinically relevant non-major bleeding, occurring on treatment or within 3 days of stopping treatment. A total of 771 cancer patients (9.3%) were enrolled (208 with active cancer and 563 with a history of cancer). Results: a) 208 patients with active cancer - recurrent VTE occurred in 4 of 109 patients (3.7%) who received edoxaban and in 7 of 99 patients (7.1%) who received warfarin (hazard ratio 0.55, 95% CI 0.16 to 1.85). - clinically relevant bleeding (major or non-major) occurred in 20 patients (18.3%) given edoxaban (5 patients with major, 4.6%) and 25 patients (25.3%) given warfarin (3 patients with major, 3.0%) (hazard ratio for clinically relevant bleeding 0.72, 95% CI 0.40 to 1.30). b) all 771 cancer patients - recurrent VTE occurred in 14 of 378 patients (3.7%) given edoxaban and in 28 of 393 patients (7.1%) who received warfarin (hazard ratio 0.53, 95% CI 0.28 to 1.00). - clinically relevant bleeding (major or non-major) occurred in 47 patients (12.4%) given edoxaban (10 patients with major, 2.6%) and 74 patients (18.8%) given warfarin (13 patients with major, 3.3%) (hazard ratio for clinically relevant bleeding 0.64, 95% CI 0.45 to 0.92). Conclusions: The results suggest edoxaban is as effective, and possibly more effective, than warfarin in cancer patients with VTE. In such patients, bleeding is appreciable during anticoagulant therapy, and may potentially be reduced by edoxaban therapy.

6 3638 Apixaban Reduces Hospitalization In Patients With Venous Thromboembolism: An Analysis Of The AMPLIFY-EXT Trial Xianchen Liu, MD, PhD 1,2*, 1 Pfizer Inc, New York, NY 2 College of Pharmacy, University of Tennessee, Memphis, TN Introduction: the effects of apixaban therapy versus placebo on medical hospitalization during AMPLIFY-EXT trial (a double-blind placebo-controlled trial with 12 months of treatment, two doses of apixaban (2.5 mg and 5 mg, twice daily) versus placebo) were evaluated. Methods: A total of 2,477 patients who received study drugs were included in the analysis, during a mean follow-up of 12.3 months. Outcomes of interest were rate of hospitalizations and time from randomization to the first hospitalization. Results: There was no significant difference in hospitalizations between the 2 doses of apixaban (5 mg vs. 2.5 mg: HR 0.84, 95%CI , p=0.445). The mean time to first hospitalization was days in the placebo group, days in the apixaban 2.5 mg group, and days in the apixaban 5 mg group. Conclusions: Extended anticoagulation with apixaban at either a dose of 5 mg or 2.5 mg significantly reduced the risk of hospitalization, possibly due to the reduction in VTE recurrence.

7 3640 Indirect Comparison Of Dabigatran, Rivaroxaban and Apixaban For Venous Thromboembolic Disease Simon Mantha, MD, MPH 1 et al. 1 Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 2 New York University School of Medicine, New York, NY Background: Novel anticoagulant agents have not been compared head-to-head for the treatment of acute venous thromboembolism (VTE) and minimal data exist to guide the choice of drug for any given patient Materials and Methods: an indirect comparison with respect to four phase III trials (RE-COVER, EINSTEIN-DVT, EINSTEIN- PE and AMPLIFY) Results: Conclusions: Except for major bleeding (RR of an event was 0.38 for A vs D (95% CI= , p=0.02), there was no significant difference in evaluated outcomes between dabigatran, rivaroxaban and apixaban. A dedicated randomized trial directly comparing the new agents would be required to confirm those results.

8 Gruppo di lavoro: Malattie Tromboemboliche Griglia di valutazione Voto da 1 a 10 Abstract Metodologia Originalità Importanza Totale

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