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Randomized Controlled Trial
. 2018 Apr 10;2(7):788-796.
doi: 10.1182/bloodadvances.2018017160.

Risk of recurrent venous thromboembolism according to baseline risk factor profiles

Martin H Prins  1 , Anthonie W A Lensing  2 , Paolo Prandoni  3 , Philip S Wells  4 , Peter Verhamme  5 , Jan Beyer-Westendorf  6   7 , Rupert Bauersachs  8   9 , Henri Bounameaux  10 , Timothy A Brighton  11 , Alexander T Cohen  12 , Bruce L Davidson  13 , Hervé Decousus  14 , Ajay K Kakkar  15 , Bonno van Bellen  16 , Akos F Pap  2 , Martin Homering  2 , Miriam Tamm  2 , Jeffrey I Weitz  17
Affiliations
Randomized Controlled Trial

Risk of recurrent venous thromboembolism according to baseline risk factor profiles

Martin H Prins et al. Blood Adv. .

Abstract

The optimal duration of anticoagulation for venous thromboembolism (VTE) is uncertain. In this prespecified analysis, we used data from 2 randomized trials, which compared once-daily rivaroxaban (20 mg or 10 mg) with aspirin (100 mg) or placebo for extended VTE treatment to estimate the risk of recurrence according to baseline risk factor profiles. Index VTE events were centrally classified as unprovoked, or provoked by major transient or persistent, or minor transient or persistent risk factors, and rates of recurrence at 1 year were calculated. A total of 2832 patients received rivaroxaban; 1131 received aspirin, and 590 received placebo. With unprovoked VTE, rates of recurrence in the 1173 patients given rivaroxaban, the 468 given aspirin, and the 243 given placebo were 2.0%, 5.9%, and 10.0%, respectively. There were no recurrences in patients with VTE provoked by major transient risk factors. With VTE provoked by minor persistent risk factors, recurrence rates in the 1184 patients given rivaroxaban, the 466 given aspirin, and the 248 given placebo were 2.4%, 4.5%, and 10.7%, respectively. For patients with minor transient risk factors, recurrence rates were 0.4% in the 268 patients given rivaroxaban, 4.2% in the 121 given aspirin, and 7.1% in the 56 given placebo. Recurrence rates in patients with VTE provoked by minor persistent or minor transient risk factors were not significantly lower than that with unprovoked VTE (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.56-1.16; and HR, 0.68; 95% CI, 0.32-1.30, respectively). Therefore, such patients may also benefit from extended anticoagulation therapy.

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Conflict of interest statement

Conflict-of-interest disclosure: M.H.P. receives consulting fees from Pfizer and Daiichi Sankyo. A.W.A.L., A.F.P., M.H., and M.T. are employees of Bayer. P.P. receives consulting and lecture fees from Bayer, Sanofi, Daiichi Sankyo, and Pfizer. P.S.W. receives grant support, lecture fees, and fees for serving on advisory boards from Bayer; fees for serving on a writing committee from Itreas; consulting fees from Janssen Scientific Affairs; grant support from Bristol-Myers Squibb and Pfizer; and lecture fees from Daiichi Sankyo. P.V. receives grant support, lecture fees, and fees for serving on advisory boards from Boehringer Ingelheim and LEO Pharma; lecture fees from Pfizer and Bristol-Myers Squibb; grant support from Sanofi; lecture fees and fees for serving on advisory boards from Daiichi Sankyo; and fees for serving on an advisory board from Portola Pharmaceuticals. J.B.-W. receives grant support, lecture fees, and fees for serving on advisory boards from Boehringer Ingelheim, Daiichi Sankyo, and Pfizer. R.B. receives consulting and lecture fees from Boehringer Ingelheim, Bristol-Myers Squibb, and Daiichi Sankyo. H.B. receives grant support and fees for serving on the Thrombosis Research Institute Garfield Registry steering committee; consulting fees from Amgen; and fees for serving on advisory boards from Bayer, Pfizer, and Sanofi Aventis. T.A.B. receives lecture fees from Bayer, Novo Nordisk, and GlaxoSmithKline. A.T.C. receives fees for serving on a committee for Boehringer Ingelheim; grant support and fees for serving on committees from Bristol-Myers Squibb and Daiichi Sankyo; consulting fees and fees for serving on steering committees from Johnson & Johnson and Portola; grant support, consulting fees, and fees for serving on committees from Pfizer; and consulting fees from Sanofi, Janssen, and Ono Pharmaceuticals. B.L.D. receives consulting fees from Janssen and Portola. H.D. receives fees for attending symposia from Aspen; fees for serving on advisory boards from Pfizer and Bristol-Myers Squibb; and grant support and fees for board membership from Daiichi Sankyo and Bayer. A.K.K. receives grant support, consulting fees, and lecture fees from Bayer; and consulting and lecture fees from Sanofi, Janssen, Boehringer Ingelheim, and Daiichi Sankyo. B.v.B. receives lecture fees and fees for serving on an advisory board from Bayer and Daiichi Sankyo; and for serving on an advisory board from Bristol-Myers Squibb. J.I.W. receives consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Ionis Pharmaceuticals, Janssen, Johnson & Johnson, Novartis, Portola, Pfizer, and Servier.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Randomization and follow-up.
See this image and copyright information in PMC

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