Literature DB >> 27222638

Erratum to: 'Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program'.

Norikazu Yamada1, Atsushi Hirayama2, Hideaki Maeda3, Satoru Sakagami4, Hiroo Shikata5, Martin H Prins6, Anthonie W A Lensing7, Masaharu Kato8, Junichi Onuma8, Yuki Miyamoto8, Kazuma Iekushi8, Mariko Kajikawa8.   

Abstract

[This corrects the article DOI: 10.1186/s12959-015-0035-3.].

Entities:  

Year:  2016        PMID: 27222638      PMCID: PMC4877730          DOI: 10.1186/s12959-016-0085-1

Source DB:  PubMed          Journal:  Thromb J        ISSN: 1477-9560


Unfortunately, the original version of this article [1] contained errors. The errors have been addressed point by point in full detail below. Correction 1 Regarding primary efficacy endpoint (symptomatic recurrent VTE) and composite outcome of symptomatic recurrent VTE or asymptomatic deterioration in rivaroxaban group, we’ve found “1.3 %” (1 patient in 78 population), is correct instead of current “1.4 %”, it should be replaced in Page 1, Line 16 in the abstract section, and on the right side of Page 5, Line 1. However, it is not necessary to replace the number “1.4%” in Table 3 because it was calculated by another definition. Therefore we also would like to add a description of the excluded population, “patients assessed as “not evaluable” were excluded from these analyses”, in footnotes of Table 2 and Table 3. Correction 2 Due to changes made in correction 1, we need to recalculate absolute risk differences and 95 % Confidence Interval of composite outcome of symptomatic recurrent VTE or asymptomatic deterioration, and we consider these numbers also need to be corrected. And to clarify this “difference” means rivaroxaban reduces risk compared to control, we would like to choose the absolute risk “reduction” instead of “difference”. Absolute risk “reduction” was 4.0 % compared to control, and 95 % CI was (-2.9 to 24.0). We should change these numbers in Page 1, Line 17 in the abstract section, in the right side of Page 5, Line 2 and in the right side of Page 6, Line 6. Correction 3 There was a trivial miscalculation of percentage in the Table 3. Rivaroxaban combined result in DVT and PE patients, 2 patients in 71 was evaluated as “unchanged”, therefore percentage is “2.8 %” instead of current “2.9 %”.
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AbstractPage 1Line 15 to 17The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.4 %) rivaroxaban patient and in 1 (5.3 %) UFH/warfarin patient (absolute risk difference, 3.9 % [95 % confidence interval, -3.4–23.8]).The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.3 %) rivaroxaban patient and in 1 (5.3 %) UFH/warfarin patient (absolute risk reduction, 4.0 % [95 % confidence interval, -2.9-24.0]).
MethodRight sidePage 3Line 23 to 25Crude percentages and absolute differences and their 95 % confidence intervals were calculated.Crude percentages and absolute reduction and their 95 % confidence intervals were calculated.
ResultLeft sidePage 5Line 2 to 4A single patient in the rivaroxaban group (1/78; 1.4 %) developed symptomatic recurrent VTE compared with none of the 19 patients allocated to control treatment.A single patient in the rivaroxaban group (1/78; 1.3 %) developed symptomatic recurrent VTE compared with none of the 19 patients allocated to control treatment.
ResultLeft sidePage 5Line 9 to 12VTE and asymptomatic deterioration at the end of intended treatment occurred in 1 (1.4 %) rivaroxaban patient and in 1 (5.3 %) control patient, with an absolute risk difference of 3.9 % (95 % confidence interval −3.4 to 23.8).VTE and asymptomatic deterioration at the end of intended treatment occurred in 1 (1.3 %) rivaroxaban patient and in 1 (5.3 %) control patient, with an absolute risk reduction of 4.0 % (95 % confidence interval −2.9 to 24.0) compared to control.
ResultRight sidePage 5Line 5 to 8At day 22, the combined venous ultrasound and lung imaging result in patients with DVT and/or PE showed normalization in 20 (26.7 %) of the 75 rivaroxaban recipients and in 3 (15.8 %) of the 19 control patients.At day 22, the combined venous ultrasound and lung imaging result in evaluable patients with DVT and/or PE showed normalization in 20 (26.7 %) of the 75 rivaroxaban recipients and in 3 (15.8 %) of the 19 control patients.
ResultPage 5Table 2Footnotebid, twice daily, DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism; UFH, unfractionated heparin; VTE, venous thromboembolism.*Symptomatic recurrent VTE during first 22 days.bid, twice daily, DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism; UFH, unfractionated heparin; VTE, venous thromboembolism. Patients assessed as "not evaluable" were excluded from these analyses. *Symptomatic recurrent VTE during first 22 days.
ResultPage 6,Table 3Line 212 (2.9)2 (2.8)
ResultPage 6Table 3Footnotebid, twice daily, DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism; UFH, unfractionated heparin; VTE, venous thromboembolism.*Symptomatic recurrent VTE during the entire intended treatment period.bid, twice daily, DVT, deep vein thrombosis; od, once daily; PE, pulmonary embolism; UFH, unfractionated heparin; VTE, venous thromboembolism. Patients assessed as "not evaluable" were excluded from these analyses. *Symptomatic recurrent VTE during the entire intended treatment period.
DiscussionPage 6Left sideLine 9 to 12The lower limit of the confidence interval (i.e. –3.4 %) around the absolute difference in the composite efficacy outcome suggests that an important deterioration in treatment effect can be excluded for rivaroxaban.The lower limit of the confidence interval (i.e. –2.9 %) around the absolute reduction in the composite efficacy outcome suggests that an important deterioration in treatment effect can be excluded for rivaroxaban.
  1 in total

1.  Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program.

Authors:  Norikazu Yamada; Atsushi Hirayama; Hideaki Maeda; Satoru Sakagami; Hiroo Shikata; Martin H Prins; Anthonie Wa Lensing; Masaharu Kato; Junichi Onuma; Yuki Miyamoto; Kazuma Iekushi; Mariko Kajikawa
Journal:  Thromb J       Date:  2015-01-17
  1 in total
  1 in total

1.  Diabetes mellitus is associated with increased bleeding in pulmonary embolism receiving conventional anticoagulant therapy: findings from a "real-world" study.

Authors:  Zhu Zhang; Zhenguo Zhai; Yuanhua Yang; Jun Wan; Wanmu Xie; Jianguo Zhu; Ying H Shen; Chen Wang
Journal:  J Thromb Thrombolysis       Date:  2017-05       Impact factor: 2.300

  1 in total

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