Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty.”

10BACKGROUND: We investigated the efficacy of rivaroxaban, an orally active direct factor Xa inhibitor, in preventing venous thrombosis after total knee arthroplasty. METHODS: In this randomized, double-blind trial, 2531 patients who were to undergo total knee arthroplasty received either oral rivaroxaban, 10 mg once daily, beginning 6 to 8 hours after surgery, or subcutaneous enoxaparin, 40 mg once daily, beginning 12 hours before surgery. The primary efficacy outcome was the composite of any deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 13 to 17 days after surgery. Secondary efficacy outcomes included major venous thromboembolism (i.e., proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death related to venous thromboembolism) and symptomatic venous thromboembolism. The primary safety outcome was major bleeding. RESULTS: The primary efficacy outcome occurred in 79 of 824 patients (9.6%) who received rivaroxaban and in 166 of 878 (18.9%) who received enoxaparin (absolute risk reduction, 9.2%; 95% confidence interval [CI], 5.9 to 12.4; P<0.001). Major venous thromboembolism occurred in 9 of 908 patients (1.0%) given rivaroxaban and 24 of 925 (2.6%) given enoxaparin (absolute risk reduction, 1.6%; 95% CI, 0.4 to 2.8; P=0.01). Symptomatic events occurred less frequently with rivaroxaban than with enoxaparin (P=0.005). Major bleeding occurred in 0.6% of patients in the rivaroxaban group and 0.5% of patients in the enoxaparin group. The incidence of drug-related adverse events, mainly gastrointestinal, was 12.0% in the rivaroxaban group and 13.0% in the enoxaparin group. CONCLUSIONS: Rivaroxaban was superior to enoxaparin for thromboprophylaxis after total knee arthroplasty, with similar rates of bleeding.; Autore interno incluso nel Gruppo RECORD3 Investigators. ClinicalTrials.gov number, NCT00361894.reservedmixedLASSEN MR; AGENO W; BORRIS LC; LIEBERMAN JR; ROSENCHER N; BANDEL TJ; MISSELWITZ F; TURPIE AG; DELLA ROCCA G; RECORD INVESTIGATORSLassen, Mr; Ageno, W; Borris, Lc; Lieberman, Jr; Rosencher, N; Bandel, Tj; Misselwitz, F; Turpie, Ag; DELLA ROCCA, Giorgio; Record, Investigator

Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty

BACKGROUND: This phase 3 trial compared the efficacy and safety of rivaroxaban, an oral direct inhibitor of factor Xa, with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. METHODS: In this randomized, double-blind study, we assigned 4541 patients to receive either 10 mg of oral rivaroxaban once daily, beginning after surgery, or 40 mg of enoxaparin subcutaneously once daily, beginning the evening before surgery, plus a placebo tablet or injection. The primary efficacy outcome was the composite of deep-vein thrombosis (either symptomatic or detected by bilateral venography if the patient was asymptomatic), nonfatal pulmonary embolism, or death from any cause at 36 days (range, 30 to 42). The main secondary efficacy outcome was major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism). The primary safety outcome was major bleeding. RESULTS: A total of 3153 patients were included in the superiority analysis (after 1388 exclusions), and 4433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1595 patients (1.1%) in the rivaroxaban group and in 58 of 1558 patients (3.7%) in the enoxaparin group (absolute risk reduction, 2.6%; 95% confidence interval [CI], 1.5 to 3.7; P<0.001). Major venous thromboembolism occurred in 4 of 1686 patients (0.2%) in the rivaroxaban group and in 33 of 1678 patients (2.0%) in the enoxaparin group (absolute risk reduction, 1.7%; 95% CI, 1.0 to 2.5; P<0.001). Major bleeding occurred in 6 of 2209 patients (0.3%) in the rivaroxaban group and in 2 of 2224 patients (0.1%) in the enoxaparin group (P=0.18). CONCLUSIONS: A once-daily, 10-mg oral dose of rivaroxaban was significantly more effective for extended thromboprophylaxis than a once-daily, 40-mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty. The two drugs had similar safety profiles. (ClinicalTrials.gov number, NCT00329628.

Insight into the development of a carbonate platform through a multi-disciplinary approach - A case study from the Upper Devonian slope deposits of Mount Freikofel (Carnic Alps, Austria/Italy)

The development and behavior of Million year-scaled depositional sequences recorded within Palaeozoic carbonate platform has remained poorly examined. Therefore, the understanding of palaeoenvironmental changes that occur in geological past is still limited. We herein undertake a multi-disciplinary approach (sedimentology, conodont biostratigraphy, magnetic susceptibility and geochemistry) of a long-term succession in the Carnic Alps which offers new insights into the peculiar evolution of one of the best example of Palaeozoic carbonate platform in Europe. The Freikofel section, located in the central part of the Carnic Alps represents an outstanding succession in a fore-reef setting, extending from the latest Givetian (indet. falsiovalis conodont Zones) to the early Famennian (Lower crepida conodont Zone). Sedimentological analysis allowed to propose a sedimentary model dominated by distal slope and fore-reef slope deposits. The most distal setting is characterized by an autochthonous pelagic sedimentation showing local occurrence of thin-bedded turbiditic deposits. In the fore-reef slope, in a more proximal setting, there is an accumulation of various autochthonous and allochthonous fine- to coarse-grained sediments originated from the interplay of gravity-flow currents derived from the shallow-water and deeper-water area. The temporal evolution of microfacies in the Freikofel section evolves in two main steps corresponding to the Freikofel (Unit 1) and the Pal (Unit 2) Limestones. Distal slope to fore-reef lithologies and associate changes are from base to top of the section: (U1) thick bedded litho- and bioclastic breccia beds with local fining upward sequence and fine-grained mudstone intercalations corresponding, in the fore-reef setting, to the dismantlement of the Eifelian – Frasnian carbonate platform during the early to late Frasnian time (falsiovalis to rhenana superzones) with one of the causes being the Late Givetian major rift pulse; (U2) occurrence of thin-bedded red nodular and cephalopod-bearing limestones with local lithoclastic grainstone intercalations corresponding to a significant deepening of the area and the progressive withdrawal of sedimentary influxes toward the basin, in relation with late Frasnian sea-level rise. Magnetic susceptibility and geochemical analyses were also performed along the Freikofel section and demonstrate the inherent-parallel link existing between variation in magnetic susceptibility values and proxy for terrestrial input. Interpretation of magnetic susceptibility in term of palaeoenvironmental processes reflect that even though distality remains the major parameter influencing magnetic susceptibility values, carbonate production and water agitation also play an important role.Grants IGCP 580 and NAP0017 (DP, ACDS), the FWF P 23775-B17 (TS and EK