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  1. Bleeding events and associated factors in a cohort of adult patients taking warfarin in Sarawak, Malaysia
    Edwards F, Arkell P, Fong, Roberts LM, Gendy D, Wong CS, et al.
    J Thromb Thrombolysis, 2014;38(2):226-34.
    PMID: 24233388
    Evidence is emerging that rates of adverse events in patients taking warfarin may vary with ethnicity. This study investigated the rates of bleeds and thromboembolic events, the international normalised ratio (INR) status and the relationship between INR and bleeding events in Malaysia. Patients attending INR clinic at the Heart Centre, Sarawak General Hospital were enrolled on an ad hoc basis from May 2010 and followed up for 1 year. At each routine visit, INR was recorded and screening for bleeding or thromboembolism occurred. Variables relating to INR control were used as predictors of bleeds in logistic regression models. 125 patients contributed to 140 person-years of follow-up. The rates of major bleed, thromboembolic event and minor bleed per 100 person-years of follow-up were 1.4, 0.75 and 34.3. The median time at target range calculated using the Rosendaal method was 61.6% (IQR 44.6–74.1%). Of the out-of-range readings, 30.0% were below range and 15.4% were above. INR variability, (standard deviation of individuals’ mean INR), was the best predictor of bleeding events, with an odds ratio of 3.21 (95% CI 1.10–9.38). Low rates of both major bleeds and thromboembolic events were recorded, in addition to a substantial number of INR readings under the recommended target range. This may suggest that the recommended INR ranges may not represent the optimal warfarin intensity for this population and that a lower intensity of therapy, as observed in this cohort, could be beneficial in preventing adverse events.

    Study site: INR clinic at the Heart Centre, Sarawak General Hospital
  2. A single centre experience of the efficacy and safety of dabigatran etexilate used for stroke prevention in atrial fibrillation
    Yap LB, Rusani BI, Umadevan D, Muhammad Z, Hussin A, Kaur S, et al.
    J Thromb Thrombolysis, 2014 Jul;38(1):39-44.
    PMID: 24197653 DOI: 10.1007/s11239-013-1020-y
    The use of novel anticoagulants such as dabigatran are increasing. Despite increased risks of intracerebral haemorrhage with warfarin among Asians, there is little published data on dabigatran to assess 'real world' efficacy and safety of dabigatran therapy in Asia. This was a retrospective observational study of patients prescribed dabigatran between 2010 and 2013. Data was available for 510 patients: median age 68 years (range 20-91), median CHA2DS2-VASc score was 2 and median HAS-BLED score was 2. The average follow-up duration of 315 days (range: 1-1,096). The overall discontinuation rate was 16% after a median 252 days of treatment with dabigatran. There were 17 (3.3%) patients with minor bleeding, 2 (0.4%) had major bleeding episodes. 20 patients (3.9%) developed dyspepsia which was the most common side effect. The rate of occurrences of adverse effects and bleeding were lower than those seen in the RE-LY trial. None of the patients had an ischaemic stroke, 1 (0.2%) patient had a haemorrhagic stroke. Out of 510 patients, 158 patients (31%) were switched to dabigatran from warfarin. This showed that patients frequently preferred the dabigatran due to convenience when given a choice to switch from warfarin. We report one of the largest registry of Asian patients. Reassuringly, we found that our cohort had a low rate of rate of ischaemic stroke, low rates of side effects and bleeding with the drug.
  3. ATRA-induced cerebral sinus thrombosis
    Lee KR, Subrayan V, Win MM, Fadhilah Mohamad N, Patel D
    J Thromb Thrombolysis, 2014 Jul;38(1):87-9.
    PMID: 24046068 DOI: 10.1007/s11239-013-0988-7
    All-trans retinoic acid (ATRA) and Idarubicin are part of the AIDA protocol employed for the treatment of Acute promyelocytic leaukaemia (APML) and has been associated with marked improvement in the prognosis. However, it is known to worsen the haematological picture during the course of induction of therapy. Herein, we present a case of an APML patient who developed a rare documented incidence of cerebral sinus thrombosis, first noticed as an ophthalmology referral. This 22 year old lady, a known APML patient was then started on chemotherapy based on AIDA protocol but 17 days into the initiation of therapy, she began to complain of blurred vision on the right eye. Anterior segments were normal but both fundi showed papilloedema with peripapillary haemorrhages. A contrast MRI that was then ordered showed multiple filling defects in numerous venous sinuses. She was started on anticoagulant treatment and the findings resolved. Though a rare case of its side-effects, ATRA usage in APML has a multitude of presentations since its primary pathology lies in the inherent pro-coagulant potential.
  4. Purtscher retinopathy as an initial presentation of thrombotic thrombocytopenic purpura
    Tajunisah I, Patel DK, Subrayan V
    J Thromb Thrombolysis, 2010 Jul;30(1):112-3.
    PMID: 19834784 DOI: 10.1007/s11239-009-0399-y
  5. Fulltext Venous thromboembolism in critically ill COVID-19 patients receiving prophylactic or therapeutic anticoagulation: a systematic review and meta-analysis
    Hasan SS, Radford S, Kow CS, Zaidi STR
    J Thromb Thrombolysis, 2020 Nov;50(4):814-821.
    PMID: 32748122 DOI: 10.1007/s11239-020-02235-z
    Many aspects of care such as management of hypercoagulable state in COVID-19 patients, especially those admitted to intensive care units is challenging in the rapidly evolving pandemic of novel coronavirus disease 2019 (COVID-19). We seek to systematically review the available evidence regarding the anticoagulation approach to prevent venous thromboembolism (VTE) among COVID-19 patients admitted to intensive care units. Electronic databases were searched for studies reporting venous thromboembolic events in patients admitted to the intensive care unit receiving any type of anticoagulation (prophylactic or therapeutic). The pooled prevalence (and 95% confidence interval [CI]) of VTE among patients receiving anticoagulant were calculated using the random-effects model. Subgroup pooled analyses were performed with studies reported prophylactic anticoagulation alone and with studies reported mixed prophylactic and therapeutic anticoagulation. We included twelve studies (8 Europe; 2 UK; 1 each from the US and China) in our systematic review and meta-analysis. All studies utilized LMWH or unfractionated heparin as their pharmacologic thromboprophylaxis, either prophylactic doses or therapeutic doses. Seven studies reported on the proportion of patients with the previous history of VTE (range 0-10%). The pooled prevalence of VTE among ICU patients receiving prophylactic or therapeutic anticoagulation across all studies was 31% (95% CI 20-43%). Subgroup pooled analysis limited to studies reported prophylactic anticoagulation alone and mixed (therapeutic and prophylactic anticoagulation) reported pooled prevalences of VTE of 38% (95% CI 10-70%) and 27% (95% CI 17-40%) respectively. With a high prevalence of thromboprophylaxis failure among COVID-19 patients admitted to intensive care units, individualised rather than protocolised VTE thromboprophylaxis would appear prudent at interim.
  6. Safety and effectiveness of dabigatran in routine clinical practice: the RE-COVERY DVT/PE study
    Goldhaber SZ, Ageno W, Casella IB, Chee KH, Schellong S, Singer DE, et al.
    J Thromb Thrombolysis, 2021 Aug 28.
    PMID: 34453675 DOI: 10.1007/s11239-021-02463-x
    RE-COVERY DVT/PE is a two-phase, international, observational study of anticoagulant therapy in patients with deep vein thrombosis and/or pulmonary embolism (DVT/PE). The objective of the second phase was to compare the safety and effectiveness of dabigatran versus a vitamin K antagonist (VKA) over 1 year of follow-up. Primary safety and effectiveness outcomes were major or clinically relevant nonmajor bleeding events (MBE/CRNMBEs) and symptomatic recurrent venous thromboembolism (VTE) (including deaths related to recurrent VTE). To minimize bias due to unbalanced patient characteristics, only patients in an overlapping range of estimated propensity scores were included (analytic set), and propensity score weighting was applied to compare outcomes. Outcome analysis used an as-treated approach, censoring patients after they stopped or switched their initial anticoagulant. Overall, 3009 patients enrolled from 2016 to 2018 were eligible: 60% were diagnosed with DVT alone, 21% with PE alone, and 19% with DVT plus PE. The analytic set consisted of 2969 patients. The incidence rate in %/year (95% confidence interval [CI]) of MBE/CRNMBEs was 2.63 (1.79-3.74) with dabigatran versus 4.48 (3.23-6.06) with warfarin; hazard ratio 0.63 (95% CI 0.32-1.25). For symptomatic recurrent nonfatal or fatal VTE the incidence rate was 1.53 (0.91-2.42) with dabigatran versus 2.01 (1.21-3.14) with VKAs; hazard ratio 0.78 (95% CI 0.30-2.02). In conclusion, we found lower annualized rates of MBE/CRNMBEs with dabigatran than VKA, although the difference was not statistically significant. Annualized rates of symptomatic VTE or related mortality were similar with dabigatran and VKA. These observational results with 1 year of follow-up reflect those of the randomized clinical trials. Trial registration: ClinicalTrials.gov identifier NCT02596230, first registered November 4, 2015.
  7. Fulltext Profile of patients diagnosed with acute venous thromboembolism in routine practice according to age and renal function: RE-COVERY DVT/PE study
    Ageno W, Casella IB, Chee KH, Schellong S, Schulman S, Singer DE, et al.
    J Thromb Thrombolysis, 2021 Apr;51(3):561-570.
    PMID: 32851572 DOI: 10.1007/s11239-020-02239-9
    In randomized clinical trials (RCTs) of nonvitamin K antagonist oral anticoagulants (NOACs) for acute venous thromboembolism (VTE), ~ 12-13% of patients were elderly and ~ 26% had mild-to-moderate renal impairment. Observational studies are not restricted by the selection and treatment criteria of RCTs. In this ancillary analysis of the RE-COVERY DVT/PE global observational study, we aimed to describe patient characteristics, comorbidities, and anticoagulant therapy for subgroups of age (
  8. A cost-utility analysis of dabigatran, enoxaparin, and usual care for venous thromboprophylaxis after hip or knee replacement surgery in Thailand
    Kotirum S, Chongmelaxme B, Chaiyakunapruk N
    J Thromb Thrombolysis, 2017 Feb;43(2):252-262.
    PMID: 27704332 DOI: 10.1007/s11239-016-1433-5
    To analyze the cost-utility of oral dabigatran etexilate, enoxaparin sodium injection, and no intervention for venous thromboembolism (VTE) prophylaxis after total hip or knee replacement (THR/TKR) surgery among Thai patients. A cost-utility analysis using a decision tree model was conducted using societal and healthcare payers' perspectives to simulate relevant costs and health outcomes covering a 3-month time horizon. Costs were adjusted to year 2014. The willingness-to-pay threshold of THB 160,000 (USD 4926) was used. One-way sensitivity and probabilistic sensitivity analyses using a Monte Carlo simulation were performed. Compared with no VTE prophylaxis, dabigatran and enoxaparin after THR and TKR surgery incurred higher costs and increased quality adjusted life years (QALYs). However, their incremental cost-effectiveness ratios were high above the willingness to pay. Compared with enoxaparin, dabigatran for THR/TKR lowered VTE complications but increased bleeding cases; dabigatran was cost-saving by reducing the costs [by THB 3809.96 (USD 117.30) for THR] and producing more QALYs gained (by 0.00013 for THR). Dabigatran (vs. enoxaparin) had a 98 % likelihood of being cost effective. Dabigatran is cost-saving compared to enoxaparin for VTE prophylaxis after THR or TKR under the Thai context. However, both medications are not cost-effective compared to no thromboprophylaxis.
  9. Comparison of rivaroxaban concentrations between Asians and Caucasians and their correlation with PT/INR
    Ng Tsai HO, Goh JJN, Aw JWX, Lin Y, Fong AYY, Tiong LL, et al.
    J Thromb Thrombolysis, 2018 Nov;46(4):541-548.
    PMID: 30155672 DOI: 10.1007/s11239-018-1726-y
    The objectives of this study are to compare steady-state trough (Cmin,ss) and peak (Cmax,ss) concentrations of rivaroxaban between Asians and Caucasians and to evaluate the relationship between rivaroxaban concentrations and prothrombin time/international normalized ratio (PT/INR). Recruited patients were advised on the time to take rivaroxaban. Cmin,ss and PT/INR were taken when patients arrived. Cmax,ss and PT/INR were drawn between 2 and 4 h later after the patient took rivaroxaban with food. Thirty patients were included in the analyses: 57% (n = 17) males and 43% (n = 13) females, 77% (n = 23) on 20 mg and 23% (n = 7) on 15 mg. Median PTtrough and PTpeak are moderately correlated with Cmin,ss (r2 = 0.43) and Cmax,ss (r2 = 0.49), respectively. Patients on 15 mg have lower Cmin,ss and Cmax,ss versus Caucasians [12 ng/ml vs. 57 ng/ml (Cmin,ss); 87 ng/ml vs. 229 ng/ml (Cmax,ss), p 
  10. Gender differences with short-term vs 12 months dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-years follow-up results of the REDUCE trial
    Verdoia M, Suryapranata H, Damen S, Camaro C, Benit E, Barbieri L, et al.
    J Thromb Thrombolysis, 2021 Oct;52(3):797-807.
    PMID: 33847862 DOI: 10.1007/s11239-021-02439-x
    BACKGROUND: Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study.

    METHODS: REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months.

    RESULTS: From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow 

  11. The outcomes of three-factor prothrombin complex concentrate (3F-PCC) in warfarin anticoagulation reversal: a prospective, single-arm, open-label, multicentre study
    Koh HP, Jagan N, George D, Mazlan-Kepli W, Mohamed S, Lim HT, et al.
    J Thromb Thrombolysis, 2021 Oct;52(3):836-847.
    PMID: 33748900 DOI: 10.1007/s11239-021-02426-2
    There is a wide variation on the efficacy of three-factor Prothrombin Complex Concentrate (3F-PCC) in warfarin reversal. We aimed to determine the efficacy and safety of 3F-PCC in warfarin reversal. This multicentre prospective study analysed data from adult patients on warfarin who received 3F-PCC (Prothrombinex-VF®) for anticoagulation reversal between June 2019 to October 2020. Purposive sampling was used in this study. Study endpoints included target INR achievement, adverse drug reactions (ADRs), and in-hospital all-cause mortality. Logistic regression analyses were used to assess independent predictors of study endpoints. One-hundred thirty-seven patients with a median age of 68 (59-76) years were recruited, who were predominantly male (59.9%, n = 82). A total of 102 patients required 3F-PCC for life-threatening (40.9%, n = 56) and clinically significant bleeding (33.6%, n = 46). Initial INRs ranged from 1.55 to undetectable high (> 26). All patients had INR reduction, of which 62% (n = 85) achieved target INR, whereas 12.4% (n = 17) achieved INR below the target range. Median INR was reduced from 4.76 (3.14-8.32) to 1.54 (1.27-1.88) post-3F-PCC (p 
  12. Fulltext Pharmacologic therapeutic options for thromboprophylaxis in COVID-19
    Kow CS, Hasan SS
    J Thromb Thrombolysis, 2021 Jan;51(1):29-30.
    PMID: 32596786 DOI: 10.1007/s11239-020-02200-w
  13. Fulltext Use of antiplatelet drugs and the risk of mortality in patients with COVID-19: a meta-analysis
    Kow CS, Hasan SS
    J Thromb Thrombolysis, 2021 Jul;52(1):124-129.
    PMID: 33813716 DOI: 10.1007/s11239-021-02436-0
  14. Cost-effectiveness analysis of patient self-testing therapy of oral anticoagulation
    Kantito S, Saokaew S, Yamwong S, Vathesatogkit P, Katekao W, Sritara P, et al.
    J Thromb Thrombolysis, 2018 Feb;45(2):281-290.
    PMID: 29181693 DOI: 10.1007/s11239-017-1588-8
    Patient Self-testing (PST) could be an option for present anticoagulation therapy monitoring, but current evidence on its cost-effectiveness is limited. This study aims to estimate the cost-effectiveness of PST to other different care approaches for anticoagulation therapy in Thailand, a low-to-middle income country (LMIC). A Markov model was used to compare lifetime costs and quality-adjusted life years (QALYs) accrued to patients receiving warfarin through PST or either anticoagulation clinic (AC) or usual care (UC). The model was populated with relevant information from literature, network meta-analysis, and database analyses. Incremental cost-effectiveness ratios (ICERs) were presented as the year 2015 values. A base-case analysis was performed for patients at age 45-year-old. Sensitivity analyses including one-way and probabilistic sensitivity analyses (PSA) were constructed to determine the robustness of the findings. From societal perspective, PST increased QALY by 0.87 and costs by 112,461 THB compared with UC. Compared with AC, PST increased QALY by 0.161 and costs by 21,019 THB. The ICER with PST was 128,697 (3625 USD) and 130,493 THB (3676 USD) per QALY gained compared with UC and AC, respectively. The probability of PST being cost-effective is 74.1% and 51.9%, compared to UC and AC, respectively, in Thai context. Results were sensitive to the efficacy of PST, age and frequency of hospital visit or self-testing. This analysis suggested that PST is highly cost-effective compared with usual care and less cost-effective against anticoagulation clinic. Patient self-testing strategy appears to be economically valuable to include into healthcare system within the LMIC context.
  15. Bleeding related hospitalizations and mortality in England 2014-2019
    Creeper KJ, Stafford AC, Choudhuri S, Tumian R, Breen K, Cohen AT
    J Thromb Thrombolysis, 2023 Aug;56(2):233-240.
    PMID: 37338712 DOI: 10.1007/s11239-023-02849-z
    Acute bleeding is common and associated with increased morbidity and mortality. Epidemiological studies evaluating trends in bleeding-related hospitalisations and mortality are important as they have potential to guide resource allocation and service provision, however, despite this literature evaluating the national burden and annual trends are lacking. Our objective was to report the national burden and incidence of bleeding-related hospitalisation and mortality.This was a population-based review of all people in England between 2014 and 2019 either admitted to an acute care ward of a National Health Service (NHS) English hospital, or who died. Admissions and deaths were required to have a primary diagnosis of significant bleeding.There was a total of 3,238,427 hospitalisations with a mean of 539,738 ± 6033 per year and 81,264 deaths with a mean of 13,544 ± 331 per year attributable to bleeding. The mean annual incident rate for bleeding-related hospitalisations was 975 per 100,000 patient years and for mortality was 24.45. Over the study period there was a significant 8.2% reduction in bleeding related deaths (χ2 test for trend 91.4, p 
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