Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis

Attract Trial Investigators

doi:10.1016/j.jvsv.2019.03.023

Abstract

BackgroundAfter deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT. MethodsThe Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups. ResultsOf 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups. ConclusionsAmong patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

Highlights

Despite treatment with anticoagulation and compression stockings, 30–50% of patients with proximal deep vein thrombosis (DVT) develop the post-thrombotic syndrome (PTS), a chronic, burdensome complication.[1, 2] PTS is characterised by limb pain, heaviness, swelling and skin changes, including, in severe cases, venous ulceration
In the ATTRACT randomized trial, among patients with proximal deep vein thrombosis (DVT), early use of pharmacomechanical catheter-directed thrombolysis had a beneficial effect on quality of life (QOL) during the first 6 months post-treatment
In patients with iliofemoral DVT, this QOL benefit was apparent over 24 months post-treatment

Summary

Introduction

Despite treatment with anticoagulation and compression stockings, 30–50% of patients with proximal deep vein thrombosis (DVT) develop the post-thrombotic syndrome (PTS), a chronic, burdensome complication.[1, 2] PTS is characterised by limb pain, heaviness, swelling and skin changes, including, in severe cases, venous ulceration. QOL is impaired in the acute phase of DVT3, 4, and development of PTS reduces QOL in the months to years following DVT.[5] In the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) Trial, we showed that pharmacomechanical catheter-directed thrombolysis (PCDT) did not reduce the occurrence of PTS during 24 months follow-up but reduced the severity of PTS and accelerated resolution of acute symptoms.[6] In the current analysis, we assessed the effect of PCDT on short-term and long-term QOL in all patients in ATTRACT and in predefined subgroups with (iliofemoral DVT) or without (femoral-popliteal DVT) involvement of the iliac or common femoral vein, and assessed if this effect differed over time. After deep vein thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess if pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and if QOL is related to extent of DVT

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