Rivaroxaban or vitamin-K antagonists following early endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis

Tim Sebastian; Lawrence O Hakki; David Spirk; Frederic A Baumann; Daniel Périard; Martin Banyai; Rebecca S Spescha; Nils Kucher; Rolf P Engelberger

doi:10.1016/j.thromres.2018.10.027

Rivaroxaban or vitamin-K antagonists following early endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis

Thromb Res. 2018 Dec:172:86-93. doi: 10.1016/j.thromres.2018.10.027. Epub 2018 Oct 26.

Authors

Tim Sebastian¹, Lawrence O Hakki², David Spirk³, Frederic A Baumann¹, Daniel Périard⁴, Martin Banyai¹, Rebecca S Spescha¹, Nils Kucher⁵, Rolf P Engelberger⁶

Affiliations

¹ Clinic for Angiology, University Hospital Zurich, Switzerland.
² Medical Faculty, University of Bern, Switzerland.
³ Institute of Pharmacology, University of Bern, Switzerland.
⁴ Division of Angiology, Cantonal Hospital Fribourg, Fribourg, Switzerland.
⁵ Clinic for Angiology, University Hospital Zurich, Switzerland. Electronic address: nils.kucher@usz.ch.
⁶ Medical Faculty, University of Bern, Switzerland; Division of Angiology, Cantonal Hospital Fribourg, Fribourg, Switzerland.

PMID: 30391776
DOI: 10.1016/j.thromres.2018.10.027

Abstract

Background: The optimal anticoagulant following catheter-based therapy of acute iliofemoral deep vein thrombosis (IFDVT) is unknown.

Methods: From the Swiss Venous Stent registry, an ongoing prospective cohort study, we performed a subgroup analysis of patients with acute IFDVT who underwent catheter-based early thrombus removal followed by nitinol stent placement. Duplex ultrasound and Villalta scores were used to determine patency rates and incidence of the post-thrombotic syndrome (PTS) in patients treated with either rivaroxaban (n = 73) or a vitamin K-antagonist (VKA; n = 38) for a minimum duration of 3 months.

Results: Mean follow-up duration was 24 ± 19 months (range 3 to 77 months). Anticoagulation therapy was time-limited (3 to 12 months) in 56% of patients (47% in the rivaroxaban group and 58% in the VKA group, p = 0.26), with shorter mean duration of anticoagulation in the rivaroxaban group (180 ± 98 days versus 284 ± 199 days, p = 0.01). Overall, primary and secondary patency rates at 24 months were 82% (95%CI, 71-89%) and 95% (95%CI, 87-98%), respectively, with no difference between the rivaroxaban (87% [95%CI, 76-94%] and 95% [95%CI, 85-98%]) and the VKA group (72% [95%CI, 52-86%] and 94% [95%CI, 78-99%]; p > 0.10 for both). Overall, 86 (86%) patients were free from PTS at latest follow-up, with no difference between the rivaroxaban and the VKA groups (57 [85%] versus 29 [88%]; p = 0.76). Two major bleeding complications (1 in each group) occurred in the peri-interventional period, without any major bleeding thereafter.

Conclusions: In patients with acute IFDVT treated with catheter-based early thrombus removal and venous stent placement, the effectiveness and safety of rivaroxaban and VKA appear to be similar.

Clinical trial registration: The study is registered on the National Institutes of Health website (ClinicalTrials.gov; identifier NCT02433054).

Keywords: Anticoagulation; Catheter-directed thrombolysis; Deep vein thrombosis; Post-thrombotic syndrome; Rivaroxaban.

Publication types

Clinical Trial

MeSH terms

Adult
Aged
Anticoagulants / therapeutic use*
Catheterization / methods
Endovascular Procedures* / methods
Factor Xa Inhibitors / therapeutic use
Female
Femoral Vein / pathology
Humans
Iliac Vein / pathology
Male
Middle Aged
Postthrombotic Syndrome / etiology*
Prospective Studies
Rivaroxaban / therapeutic use*
Stents
Thrombolytic Therapy* / methods
Treatment Outcome
Vascular Patency / drug effects
Venous Thrombosis / complications*
Venous Thrombosis / drug therapy
Venous Thrombosis / pathology
Venous Thrombosis / therapy*
Vitamin K / antagonists & inhibitors*

Substances

Anticoagulants
Factor Xa Inhibitors
Vitamin K
Rivaroxaban

Associated data

ClinicalTrials.gov/NCT02433054