Choosing wisely: The impact of patient selection on efficacy and safety outcomes in the EINSTEIN-DVT/PE and AMPLIFY trials.

Abstract:

BACKGROUND:The results of the EINSTEIN-DVT/PE and AMPLIFY trials, which compared rivaroxaban and apixaban with conventional anticoagulation therapy for acute venous thromboembolism (VTE), respectively, are often compared. However, the trials differed in duration of therapy (3-12 and 6months, respectively) and in patient selection (few exclusion criteria and more stringent exclusion criteria, respectively). METHODS:To determine the effect of these methodological differences on outcomes, the patients enrolled in EINSTEIN-DVT/PE were divided into 2 cohorts; the 5253 patients that matched the exclusion criteria for AMPLIFY and were treated for at least 6months (cohort 1) and the 2368 patients who would have been ineligible for AMPLIFY (cohort 2). RESULTS:Compared with patients in cohort 2, those in cohort 1 were older and more often male and there were more with unprovoked VTE, prior VTE, cancer and known thrombophilia. In cohort 1, rivaroxaban would have significantly reduced recurrent VTE (relative risk [RR], 0.64; 95% confidence interval [CI], 0.43-0.95) and major bleeding (RR, 0.50; 95% CI, 0.30-0.82) compared with conventional therapy, whereas the two treatments would have had similar effects on recurrent VTE (RR, 1.08; 95% CI, 0.65-1.79) and major bleeding (RR, 1.03; 95% CI, 0.48-2.18) in cohort 2. CONCLUSIONS:This analysis illustrates the influence of patient selection and treatments duration on outcome results and highlights the limitations of cross-trial comparisons.

journal_name

Thromb Res

journal_title

Thrombosis research

authors

Beyer-Westendorf J,Lensing AW,Arya R,Bounameaux H,Cohen AT,Wells PS,Middeldorp S,Verhamme P,Hughes R,Kucher N,Pap AF,Trajanovic M,Prins MH,Prandoni P,Weitz JI

doi

10.1016/j.thromres.2016.11.014

subject

Has Abstract

pub_date

2017-01-01 00:00:00

pages

29-37

eissn

0049-3848

issn

1879-2472

pii

S0049-3848(16)30626-0

journal_volume

149

pub_type

临床试验,杂志文章
  • A two-step approach (Enzyme-linked immunosorbent assay and confirmation assay) to detect antibodies against von Willebrand factor in patients with Acquired von Willebrand Syndrome.

    abstract:BACKGROUND:Acquired von Willebrand Syndrome is a rare bleeding disorder, which arises in individuals with no personal or family history of bleeding, associated with lymphoproliferative and myeloproliferative disorders or other diseases. AIM:To develop a two-step approach assay to detect autoantibodies against VWF and ...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2014.09.020

    authors: Franchi F,Biguzzi E,Stufano F,Siboni SM,Baronciani L,Peyvandi F

    更新日期:2014-12-01 00:00:00

  • Effectiveness of and risk associated with aspirin therapy in hemodialysis patients with a background of antiplatelet factor 4/heparin complex antibody detection.

    abstract:BACKGROUND:The optimal prevention measures against hemodialysis (HD)-associated complications, including all-cause thrombotic events and death, are unclear. METHODS:This prospective study was designed to assess the effect of aspirin on prevention of HD-associated complications. Patients were divided into four groups a...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2015.04.023

    authors: Yang Y,Wang C,Jin L,Chen G,Li C,Qi K,Kong D,Wang Y,Song M,Ma L

    更新日期:2015-07-01 00:00:00

  • Urinary procoagulant behaves as tissue factor by promoting factor VIIa-catalyzed activation of factor X.

    abstract::We purified the urinary procoagulant from frozen human urine by introducing phenyl-Sepharose hydrophobic chromatography. By this method, the apoprotein of the procoagulant and the lipid-like substance were separately recovered. Upon reassociation with the lipid-like substance or exogenous crude phospholipids, the apop...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(84)90114-2

    authors: Kurosawa S,Matsuda M,Aoki N

    更新日期:1984-03-15 00:00:00

  • Protease activation of calcium-independent phospholipase A2 leads to neutrophil recruitment to coronary artery endothelial cells.

    abstract:INTRODUCTION:Thrombin or tryptase cleavage of protease-activated receptors (PAR) on human coronary artery endothelial cells (HCAEC) results in activation of a membrane-associated, calcium-independent phospholipase A2 (iPLA2) that selectively hydrolyzes plasmalogen phospholipids. Atherosclerotic plaque rupture results i...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2006.11.007

    authors: White MC,McHowat J

    更新日期:2007-01-01 00:00:00

  • Effect of aspirin and clopidogrel on platelet-dependent tissue factor expression in endothelial cells.

    abstract::Tissue factor is an ubiquitous membrane-anchored glycoprotein that initiates blood coagulation by forming a complex with circulating factors VII and VIIa. Under normal circumstances, endothelial cells do not express tissue factor but, in some pathological situations, when the endothelium or the monocytes are exposed t...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(94)90086-8

    authors: Savi P,Bernat A,Dumas A,Aït-Chek L,Herbert JM

    更新日期:1994-01-15 00:00:00

  • Determination of plasminogen activator inhibitor (PAI) activity of human plasma after dilution in a PAI-depleted plasma.

    abstract::A simple and discriminating assay for the determination of the fast-acting plasminogen activator inhibitor (PAI) activity in human plasma is described. The method is based on the inhibition of purified tissue plasminogen activator (tPA) by plasma diluted with a PAI-depleted plasma and the subsequent measurement of res...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(89)90250-8

    authors: Contant G,Martinoli JL

    更新日期:1989-11-01 00:00:00

  • A novel anti-platelet peptide (Z4A5) potential for glycoprotein IIb/IIIa inhibits platelet aggregation.

    abstract:INTRODUCTION:Z4A5 is a novel peptide that inhibits platelet aggregation and formation of platelet thrombi, but the mechanism of its anti-platelet effects remains unknown. This study explores the anti-platelet effect and mechanism of Z4A5. METHODS:We investigated the anti-platelet activity of Z4A5 on platelet aggregati...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2012.02.047

    authors: Li YX,Sun Q,Zhang H,Ren ST,Liao YR,Wang Y,Shen XL,Wang B

    更新日期:2012-05-01 00:00:00

  • High levels of endothelial and platelet microvesicles in patients with type 1 diabetes irrespective of microvascular complications.

    abstract:INTRODUCTION:Patients with type 1 diabetes have high risk of developing microvascular complications, and microangiopathy contributes to premature cardiovascular disease in this population. The role that microvesicles (MVs) may play in the development of microangiopathy in type 1 diabetes remains unclear. MATERIALS AND...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2020.08.012

    authors: Bergen K,Mobarrez F,Jörneskog G,Wallén H,Tehrani S

    更新日期:2020-12-01 00:00:00

  • Human platelets deficient in dense granules contain normal amounts of pp60c-src.

    abstract::We have determined that pp60c-src, a protein tyrosine kinase abundant in normal platelets, is present at comparable levels in platelets that are deficient in dense granules (Hermansky-Pudlak syndrome). Relative quantitation of pp60c-src was performed by immunoblot analysis after protein separation by sodium dodecyl su...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(92)90227-2

    authors: Sorisky A,Lages B,Weiss HJ,Rittenhouse SE

    更新日期:1992-01-01 00:00:00

  • Factor XIII improves platelet adhesion to fibrinogen by protein disulfide isomerase-mediated activity.

    abstract:BACKGROUND:Factor XIII (FXIII), a plasma pro-transglutaminase, consists of two A subunits and two B subunits (FXIIIA2B2). Following activation by thrombin, it cross-links fibrin chains at the final step of coagulation. We previously reported that FXIII subunit A (FXIIIA) serves as a protein disulfide isomerase (PDI), a...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2012.12.003

    authors: Lahav J,Tvito A,Bagoly Z,Dardik R,Inbal A

    更新日期:2013-04-01 00:00:00

  • Knockdown of liver-derived factor XII by GalNAc-siRNA ALN-F12 prevents thrombosis in mice without impacting hemostatic function.

    abstract:BACKGROUND:Plasma coagulation Factor XII (FXII) plays a crucial role in contact activation, ultimately regulating both the kinin-kallikrein system and the intrinsic pathway of coagulation. A growing body of evidence suggests that inhibition of FXII can prevent thrombosis. Given FXII does not appear to modulate hemostas...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2020.08.040

    authors: Liu J,Cooley BC,Akinc A,Butler J,Borodovsky A

    更新日期:2020-12-01 00:00:00

  • Aprotinin inhibits urokinase but not tissue-type plasminogen activator.

    abstract::The protease inhibitor, aprotinin, has been examined for its ability to inhibit urokinase and tissue-type plasminogen activators at pH 7.4 in assays utilizing pyroGlu-Gly-Arg-p-nitroanilide and H-D-Ile-Pro-Arg-p-nitroanilide as substrates, respectively. Aprotinin inhibited both two-chain low molecular weight urokinase...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(88)90252-6

    authors: Lottenberg R,Sjak-Shie N,Fazleabas AT,Roberts RM

    更新日期:1988-03-15 00:00:00

  • A comparison of the effects of factor XII deficiency and prekallikrein deficiency on thrombus formation.

    abstract::Studies with animal models implicate the plasma proteases factor XIIa (FXIIa) and α-kallikrein in arterial and venous thrombosis. As congenital deficiencies of factor XII (FXII) or prekallikrein (PK), the zymogens of FXIIa and α-kallikrein respectively, do not cause bleeding disorders, inhibition of these enzymes may ...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2016.02.020

    authors: Kokoye Y,Ivanov I,Cheng Q,Matafonov A,Dickeson SK,Mason S,Sexton DJ,Renné T,McCrae K,Feener EP,Gailani D

    更新日期:2016-04-01 00:00:00

  • A new variant of von Willebrand disease (type II I) with a normal degree of proteolytic cleavage of von Willebrand factor.

    abstract::A variant of type II von Willebrand disease (vWd) is described in a young woman and her mother with severe lifelong bleeding histories. On electrophoresis with low-resolution agarose gels the plasma of the proband lacked large and intermediate-size multimers of von Willebrand factor (vWF) but the platelet multimeric s...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(92)90165-7

    authors: Castaman G,Rodeghiero F,Lattuada A,Mannucci PM

    更新日期:1992-02-01 00:00:00

  • Properties and catabolism of heat treated antithrombin III concentrate.

    abstract::Heat treatment is employed to diminish the transmission of hepatitis when blood products are administered. It is possible that such a procedure could reduce the biological activity of the proteins and induce changes in structure and aggregation state. We have therefore made in vitro and pharmacokinetic studies of heat...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(87)90435-x

    authors: Tengborn L,Frohm B,Nilsson LE,Johansson L,Andersson LO

    更新日期:1987-12-15 00:00:00

  • Obligatory role of lipid mediators in platelet-neutrophil adhesion.

    abstract::Platelet-neutrophil interactions play an important role in thrombotic and inflammatory responses. Although it is well known that adhesion of platelets to neutrophils requires interactions of adhesion molecules on platelets such as P-selectin, or GPIIb/IIIa with their counterparts on neutrophils, little is known on the...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/s0049-3848(03)00413-4

    authors: Chlopicki S,Lomnicka M,Gryglewski RJ

    更新日期:2003-06-15 00:00:00

  • Anticoagulant and antithrombotic actions of a semisynthetic beta-1,3-glucan sulfate.

    abstract::Sulfation of the natural polysaccharide curdlan results in anticoagulantly active beta-1,3-glucan sulfates whose activity depends on various structural parameters. In this study the anticoagulant and antithrombotic effects of one of these beta-1,3-glucan sulfates (GS) were compared with those of a porcine mucosal hepa...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(95)00049-w

    authors: Alban S,Jeske W,Welzel D,Franz G,Fareed J

    更新日期:1995-05-01 00:00:00

  • The treatment of venous thromboembolism in special populations.

    abstract::Anticoagulant therapy for the typical venous thromboembolism patient is straightforward with predictably favorable outcomes. However, for certain patients with venous thromboembolism, there remains uncertainty and controversy about optimal treatment. These controversial areas include venous thromboembolism patients wi...

    journal_title:Thrombosis research

    pub_type: 杂志文章,评审

    doi:10.1016/j.thromres.2006.05.015

    authors: Rondina MT,Pendleton RC,Wheeler M,Rodgers GM

    更新日期:2007-01-01 00:00:00

  • Association between red cell distribution width and risk of venous thromboembolism.

    abstract:BACKGROUND:An association between high red cell distribution width (RDW) and venous thromboembolism (VTE) has been observed. However, it is not known whether this association differs within various manifestations of VTE, nor if there is an interaction between RDW and thrombophilia abnormalities on the risk of VTE. AIM...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2015.07.020

    authors: Bucciarelli P,Maino A,Felicetta I,Abbattista M,Passamonti SM,Artoni A,Martinelli I

    更新日期:2015-09-01 00:00:00

  • Thromboprophylaxis patterns, risk factors, and outcomes of care in the medically ill patient population.

    abstract:INTRODUCTION:Medically ill, hospitalized patients are at increased risk for venous thromboembolism (VTE) after discharge. This study aimed to examine thromboprophylaxis patterns, risk factors, and post-discharge outcomes. METHODS:This was a retrospective claims analysis involving administrative claims data and in-pati...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2013.08.013

    authors: Mahan CE,Fisher MD,Mills RM,Fields LE,Stephenson JJ,Fu AC,Spyropoulos AC

    更新日期:2013-11-01 00:00:00

  • Current insights into thrombotic microangiopathies: Thrombotic thrombocytopenic purpura and pregnancy.

    abstract::The complex relation between thrombotic thrombocytopenic purpura (TTP) and pregnancy is concisely reviewed. Pregnancy is a very strong trigger for acute disease manifestation in patients with hereditary TTP caused by double heterozygous or homozygous mutations of ADAMTS13 (ADisintegrin And Metalloprotease with Thrombo...

    journal_title:Thrombosis research

    pub_type: 杂志文章,评审

    doi:10.1016/S0049-3848(15)50437-4

    authors: von Auer C,von Krogh AS,Kremer Hovinga JA,Lämmle B

    更新日期:2015-02-01 00:00:00

  • Platelet activity is negatively modulated by tumor necrosis factor alpha through reductions of cytosolic calcium levels and integrin alphaIIbbeta3 phosphorylation.

    abstract:INTRODUCTION:Tumor necrosis factor-alpha (TNF-α) exerts a critical role in inflammatory events through two distinct receptors, TNFR1 and TNFR2. Platelets have been recognized as important inflammatory cells, but little is known about the effects of TNF-α on the platelet activity. OBJECTIVES:In the present study we hav...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2018.10.008

    authors: Bonfitto PHL,Naime ACA,Lopes-Pires ME,Goulart G,Mendes-Silverio CB,Bueno PI,Castilho RF,Antunes E,Marcondes S

    更新日期:2018-12-01 00:00:00

  • KIDCLOT: the importance of validated educational intervention for optimal long term warfarin management in children.

    abstract:BACKGROUND:Advances in medical and surgical therapy in children have resulted in increased survival in children with primary illnesses. However, thrombosis is a serious complication of this success and results in mortality and morbidity. Prevention or treatment of thrombosis using warfarin is challenging in children du...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2008.07.012

    authors: Bauman ME,Black K,Kuhle S,Wang L,Legge L,Callen-Wicks D,Mitchell L,Bajzar L,Massicotte MP,Western Canadian Children's Heart Network WCCHN.

    更新日期:2009-03-01 00:00:00

  • The treatment of deep vein thrombosis with continuous intravenous low-molecular-weight dermatan sulphate (Desmin). A pilot study.

    abstract::Eight patients with femoro-popliteal or sural DVT, confirmed by phlebography, were treated with intravenous Desmin (LMW-dermatan sulphate): on the first day, after an initial i.v. injection of 400 mg, all patients received an infusion of 800 mg in 500 ml of saline, during 24 hours; this infusion was repeated in each o...

    journal_title:Thrombosis research

    pub_type: 临床试验,杂志文章

    doi:10.1016/s0049-3848(96)00207-1

    authors: Kretz JG,Chakfe N,Wiesel ML,Grunebaum L,Zamboni V,Palazzini E,Cazenave JP

    更新日期:1996-12-15 00:00:00

  • Excessive expressions of T cell activation markers in pediatric immune thrombocytopenia.

    abstract:BACKGROUND:Immune thrombocytopenia (ITP) is an immune-mediated bleeding disorder in children. Activated T cells have been shown to play important roles in ITP. The aims of this study were to evaluate whether these T cell activation markers could be used as indicators to differentiate ITP patients from controls, and to ...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2019.05.010

    authors: Chen Y,Zhou Y,Chen P,Zhang P,Jia M,Tang Y

    更新日期:2019-08-01 00:00:00

  • Variants in chondroitin sulfate metabolism genes in thrombotic storm.

    abstract:INTRODUCTION:Thrombotic storm (TS) presents as a severe, acute thrombotic phenotype, characterized by multiple clotting events and frequently affecting younger adults. Understanding the extensive hypercoagulation of an extreme phenotype as TS will also provide insight into the pathogenesis of a wider spectrum of thromb...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2017.11.016

    authors: Nuytemans K,Ortel TL,Gomez L,Hofmann N,Alves N,Dueker N,Beecham A,Whitehead P,Hahn Estabrooks S,Kitchens CS,Erkan D,Brandão LR,James AH,Kulkarni R,Manco-Johnson MJ,Pericak-Vance MA,Vance JM

    更新日期:2018-01-01 00:00:00

  • Further studies on the role of red blood cells in spontaneous platelet aggregation.

    abstract::The influence of red blood cells on platelet aggregation has recently been a subject of considerable interest. We have studied the effect of red cells on spontaneously formed platelet aggregates in rotating vials at 37 degrees C. Platelet aggregation was quantified by measuring the fall in number of single platelets w...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(85)90150-1

    authors: Saniabadi AR,Lowe GD,Barbenel JC,Forbes CD

    更新日期:1985-05-01 00:00:00

  • Novel astaxanthin prodrug (CDX-085) attenuates thrombosis in a mouse model.

    abstract:BACKGROUND:Cardiovascular disease remains the leading cause of morbidity and premature mortality in most industrialized countries as well as in developing nations. A pro-oxidative state appears to promote and/or exacerbate vascular disease complications. Furthermore, a state of low-grade chronic inflammation can promot...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2010.07.003

    authors: Khan SK,Malinski T,Mason RP,Kubant R,Jacob RF,Fujioka K,Denstaedt SJ,King TJ,Jackson HL,Hieber AD,Lockwood SF,Goodin TH,Pashkow FJ,Bodary PF

    更新日期:2010-10-01 00:00:00

  • Effect of dietary canola and reference oils upon serum lipids and platelet aggregation.

    abstract::To compare Canola a terrestrial (n-3) oil with fish oil (n-3) and common vegetable oil (n-6) in decreasing serum lipids and platelet aggregation, various oils were included in Chow-based diets and fed to rats in an eight-weeks feeding trial. The Chow diet contained 2% cholesterol along with either Canola, menhaden, sa...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/0049-3848(90)90420-h

    authors: Watkins T,Lenz P,Bierenbaum M

    更新日期:1990-08-01 00:00:00

  • Effect of rivaroxaban on prothrombin fragment 1+2 compared with warfarin in patients with acute cardioembolic stroke: Insight from its serial measurement.

    abstract:INTRODUCTION:Patients with intracerebral hemorrhage during rivaroxaban treatment have small hematoma and favorable outcomes compared with those with warfarin. We investigated its possible mechanism, focusing on prothrombin fragment 1+2 (F1+2), a marker of thrombin generation. MATERIALS AND METHODS:In 65 patients with ...

    journal_title:Thrombosis research

    pub_type: 杂志文章

    doi:10.1016/j.thromres.2016.10.011

    authors: Hagii J,Tomita H,Metoki N,Tamai Y,Saito S,Shiroto H,Hitomi H,Kamada T,Seino S,Takahashi K,Sasaki S,Yasujima M,Okumura K

    更新日期:2016-12-01 00:00:00