An analysis of data from the ATTRACT trial, published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVSVL), has revealed that quality of life (QoL) measures improve after pharmacomechanical catheter-directed thrombolysis (PCDT). According to the findings of the analysis, this is particularly true early on and for iliofemoral deep venous thrombosis (DVT).
It is said that, despite treatment with anticoagulation and compression stockings, up to 50% of patients with proximal DVT develop post-thrombotic syndrome (PTS), which causes patients to experience severe pain and swelling of the limb, as well as increasing the risk of pulmonary embolism (PE).
As Venous News has previously reported, the results of the ATTRACT trial showed that PCDT does not reduce the occurrence of PTS at two years but does lessen its severity, as well as treating acute symptoms faster.
In this analysis, lead investigator Susan Kahn (Jewish General Hospital, Montreal, Canada) and colleagues aimed to assess the effect of PCDT on both short-term and long-term QoL in all of the patients enrolled in the ATTRACT trial—as well as predefined subgroups with (iliofemoral DVT) or without (femoral-popliteal DVT) involvement of the iliac or common femoral vein—before examining whether this effect differed over time.
As part of the investigation, QoL was evaluated in a total of 692 patients between 2009 and 2014, with follow-up taking place at one, six, 12, 18 and 24 months. Randomisation resulted in 337 being allocated to PCDT, and 355 to no PCDT; upon analysis, it was found that VEINES-QOL change scores were greater (and therefore better) in the PCDT cohort vs. no PCDT from baseline to one month (difference, 5.7, p=0.0006), and from baseline to six months (5.1; p=0.0029). For all other intervals, there was no difference.
According to the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS), scores were greater in PCDT vs. no PCDT from baseline to one month (difference, 2.4; p=0.01), but not for other intervals.
However, among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs. no PCDT group, and this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; p<0.0001) and 6 months (8.8; p<0.0001). SF-36 PCS change scores were greater in PCDT vs. no PCDT from baseline to 1 month (difference, 3.2; p=0.0010), but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in both cohorts.
Commenting on these findings, Kahn said: “First, most of the improvement in QoL was in the first six months, and the trial did find that PCDT reduced clot burden and early leg pain and swelling over no PCDT, and was associated with a reduced point prevalence of PTS at six months, but not thereafter. Though PCDT did not prevent PTS, it did reduce its severity.”
Furthermore, a statement from the Society for Vascular Surgery (SVS) noted that the decision to proceed with lytic therapy for patients with iliofemoral DVT can be complicated. “This data supports offering this therapy to selected patients with severe symptoms, low bleeding risk and a willingness to undergo a catheter-based procedure,” it read.