Residual rates of reflux and obstruction and their correlation to post-thrombotic syndrome in a randomized study on catheter-directed thrombolysis for deep vein thrombosis

Haig, Ylva; Enden, Tone; Slagsvold, Carl-Erik; Sandvik, Leiv; Sandset, Per Morten; Kløw, Nils Einar

doi:10.1016/j.jvsv.2013.10.054

Cited by 40 publications

(46 citation statements)

References 31 publications

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“…Besides patency, the preservation of venous valve function is of importance to avoid venous hypertension and PTS [5]. We detected femoro-popliteal venous reflux in only one-third of patients, whereas 65% of CDT patients (vs. 77% in the conservative management group) in the CaVenT study had femoro-popliteal reflux after 6 months, with similar rates after 2 and 5 years follow-up [4,5]. In contrast, Baekgaard et al found patent veins without reflux in 82% of limbs treated with CDT (venous stenting in 55%) after 6 years follow-up [6].…”

Section: Discussionmentioning

confidence: 99%

Ultrasound‐assisted versus conventional catheter‐directed thrombolysis for acute iliofemoral deep vein thrombosis: 1‐year follow‐up data of a randomized‐controlled trial

Engelberger

Stuck

Spirk

et al. 2017

Journal of Thrombosis and Haemostasis

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Background In patients with acute iliofemoral deep vein thrombosis (IFDVT), catheter-directed thrombolysis (CDT) aims to prevent the postthrombotic syndrome (PTS). Adding intravascular high-frequency, low-power ultrasound energy to CDT does not seem to improve the immediate thrombolysis results but its impact on clinical outcomes at 12 months is not known. Patients/Methods In this randomized-controlled trial, 48 patients (mean age 50 ± 21 years; 52% women) with acute IFDVT were randomized to conventional CDT (n = 24) or ultrasound-assisted CDT (USAT; n = 24). In both groups, a fixed-dose thrombolysis regimen (20 mg r-tPA over 15 h) was used, followed by routine stenting of residual venous obstruction. At 12 months, PTS and venous disease severity (Villalta score and revised Venous Clinical Severity Score [rVCSS]), disease-specific quality of live (QOL; CIVIQ-20) and duplex-sonographic outcomes were assessed. Results Among the 45 surviving patients, 40 (89%; 95% confidence interval [CI] 76-96%) patients were free from PTS (defined as Villalta score < 5 points; 83%, 95% CI 61-95% in the USAT and 96%, 95% CI 77-100% in the CDT group), with a similar mean total Villalta score of 2.3 ± 2.9 vs. 1.7 ± 1.6, and a mean total rVCSS of 3.0 ± 3.5 vs. 2.7 ± 2.9 in the USAT and the CDT groups, respectively. Both groups had good disease-specific QOL with a CIVIQ-20 score of 29.4 ± 11.8 vs. 26.1 ± 7.8, respectively. Primary (100% vs. 92%) and secondary (100% vs. 96%) iliofemoral patency rates and presence of femoro-popliteal venous reflux (39% vs. 33%) were similar in both groups. Conclusion The addition of intravascular ultrasound energy to conventional CDT for the treatment of acute IFDVT did not have any impact on relevant clinical or duplex sonographic outcomes, which were favorable in both study groups. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier:NCT01482273.

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Section: Discussionmentioning

confidence: 99%

Ultrasound‐assisted versus conventional catheter‐directed thrombolysis for acute iliofemoral deep vein thrombosis: 1‐year follow‐up data of a randomized‐controlled trial

Engelberger

Stuck

Spirk

et al. 2017

Journal of Thrombosis and Haemostasis

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“…catheter-directed thrombolysis (CDT) or pharmacomechanical thrombectomy (PMT), reduces the risk of moderate or severe PTS by removing the occluding thrombus and by preventing secondary venous valve damage. [8][9][10] Up to 80% of patients with IFDVT have an underlying obstructive iliac vein lesion, [11,12] which can be treated by stent placement once the acute thrombus has been removed. [13] Venous patency rates 6-24 months after catheterbased thrombus removal with or without stent placement in patients with IFDVT ranged between 72% and 100%.…”

Section: Introductionmentioning

confidence: 99%

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

Sebastian

Hakki

Spirk

et al. 2018

Thrombosis Research

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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.

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“…This concept laid the foundation for the adjunctive use of thrombolytic therapy in acute DVT to prevent PTS. In early studies exploring rates of venous patency and valvular reflux after acute DVT, addition of CDT provided superior results over anticoagulation alone, [10][11][12] suggesting its potential role in prevention or mitigation of PTS. …”

Section: Rationale For Thrombolytic Therapy In Dvtmentioning

confidence: 99%

The case for catheter-directed thrombolysis in selected patients with acute proximal deep vein thrombosis

Chiasakul

Cuker

2018

Blood Advances

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This article has a companion Counterpoint by Poston and Garcia.Lower extremity deep vein thrombosis (DVT) is a common disorder associated with disabling symptoms and significant clinical sequelae. 1 In the acute phase, clot extension and embolization may result in limb ischemia and pulmonary embolism, whereas recurrent venous thromboembolism and postthrombotic syndrome (PTS) are frequent long-term consequences.PTS is a heterogeneous condition ranging in severity from mild discomfort to chronic leg pain, intractable edema, stasis dermatitis, and skin ulceration. The Villalta scale is a validated tool for defining the presence and grading the severity of PTS.2 Moderate to severe PTS results in disability, impaired quality of life (QOL) and high economic burden.3,4 Up to 50% of DVT patients develop PTS despite anticoagulation and compression therapy; 5% to 10% of cases are severe, suggesting that additional strategies are needed to prevent this potentially debilitating complication.3 Patients with iliofemoral DVT (IFDVT), defined as DVT involving any part of the iliac vein and/or the common femoral vein, with or without involvement of the more distal veins, are at especially high risk due to a lack of collateral drainage. Catheter-directed thrombolysis (CDT) allows direct delivery of a fibrinolytic drug to the thrombus site. By means of more rapid and effective clot clearance, CDT has the potential to reduce the risk of PTS. To date, the role of CDT in acute IFDVT remains controversial given conflicting data from published clinical trials. In this article, we describe the rationale for CDT as a means of preventing PTS, summarize CDT techniques, review recent evidence on clinical outcomes, argue for consideration of CDT in selected patients, and summarize factors involved in identifying appropriate candidates for CDT. Rationale for thrombolytic therapy in DVTIn the most extreme form of acute DVT, phlegmasia cerulea dolens, acute thrombosis in the proximal deep vein(s) causes total or near-total occlusion of venous drainage from the lower extremity. The resultant venous congestion leads to compromised circulation, jeopardizing viability of the affected limb. In such cases, it is well-accepted that immediate clot degradation, either by thrombectomy or thrombolysis, is necessary to restore venous patency and avoid limb gangrene and amputation. 6 Thrombolysis is also indicated in less extreme instances in which DVT is not limb-threatening, but results in severe symptoms that are persistent or progressive despite initial treatment with anticoagulation.The role of routine thrombolytic therapy in unselected cases of DVT, in contrast, is controversial. Rather than limb salvage, the desired goal in this setting is prevention of PTS. PTS results from venous hypertension, which is a consequence of incomplete clot lysis, residual venous obstruction, and venous valvular reflux.7-9 Anticoagulation prevents thrombus formation and propagation, effectively reducing the risk of pulmonary embolism and recurrent venous thromboembolism....

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Residual rates of reflux and obstruction and their correlation to post-thrombotic syndrome in a randomized study on catheter-directed thrombolysis for deep vein thrombosis

Cited by 40 publications

References 31 publications

Ultrasound‐assisted versus conventional catheter‐directed thrombolysis for acute iliofemoral deep vein thrombosis: 1‐year follow‐up data of a randomized‐controlled trial

Ultrasound‐assisted versus conventional catheter‐directed thrombolysis for acute iliofemoral deep vein thrombosis: 1‐year follow‐up data of a randomized‐controlled trial

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

The case for catheter-directed thrombolysis in selected patients with acute proximal deep vein thrombosis

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