Fibrin Sealant TISSEEL Lyo as a haemostatic agent in vascular surgery: Results of randomized, controlled, patient-blinded, multicentre clinical study in the Russian population.

BACKGROUND: This phase III, controlled, patient-blinded, multicentre study in two parallel, equal-sized treatment groups compared the efficacy and safety of TISSEEL Lyo, fibrin sealant versus Manual Compression (MC) with surgical gauze pads for use as a haemostatic agent in patients who underwent vascular surgery in Russia. METHODS: Adult patients, both genders, who received peripheral vascular expanded polytetrafluoroethylene conduits and had suture line bleeding after surgical haemostasis were enrolled. Patients were randomized to be treated with TISSEEL Lyo or MC. The bleeding needed additional treatment and had to be assessed as grade 1 or 2 bleeding according to the Validated Intraoperative Bleeding scale. The primary efficacy endpoint was the proportion of patients achieving haemostasis at 4 min after treatment application (T4) at the study suture line, which was maintained until the closure of the surgical wound. The secondary efficacy endpoints included the proportion of patients achieving haemostasis at 6 min (T6) and 10 min (T10) after treatment application at the study suture line, which was maintained until closure of the surgical wound, as well as the proportion of patients with intraoperative and postoperative rebleeding. Safety outcomes included incidence of adverse events (AEs), surgical site infections and graft occlusions. RESULTS: A total of 110 patients were screened; 104 patients were randomized: (TISSEEL Lyo: 51 [49%] patients; MC: 53 [51%] patients). T4 haemostasis was achieved in 43 (84.3%) patients in the TISSEEL Lyo group and in 11 (20.8%) patients in the MC group (p < 0.001). Significantly more patients in TISSEEL Lyo group achieved the haemostasis at T6 (relative risk (RR) of achieving haemostasis 1.74 [95% confidence interval (CI) 1.37; 2.35]) and T10 (RR 1.18 [95% CI 1.05; 1.38]) versus MC. No one had intraoperative rebleeding. Postoperative rebleeding was reported only in one patient in the MC group. No treatment-emergent serious AEs (TESAEs) related to TISSEEL Lyo/MC, TESAEs leading to withdrawal and TESAEs leading to death were reported in patients during the study. CONCLUSIONS: Data demonstrated TISSEEL Lyo had clinically and statistically significant superiority to MC as a haemostatic agent in vascular surgery at all measured time points including 4, 6 and 10 min and had proven to be safe.

Correction to: Sulodexide in the Treatment of Chronic Venous Insufficiency: Results of the All-Russian Multicenter ACVEDUCT Program.

In the original article, the "Duration, Types of Therapy and Dynamics of Improvements" topic published incorrectly.

Correction to: Sulodexide in the Treatment of Chronic Venous Insufficiency: Results of the All-Russian Multicenter ACVEDUCT Program.

In the original article, there is some error in the Table 2. The correct Table 2 is given below.

Sulodexide in the Treatment of Chronic Venous Insufficiency: Results of the All-Russian Multicenter ACVEDUCT Program.

INTRODUCTION: Pharmacotherapy is a mainstay of treatment for lower limb chronic venous disease (CVD) and its complications. However, therapeutic agents with evidence-based efficacy for the treatment of CVD are limited. Sulodexide (registered as Vessel Due F in Russia) has confirmed therapeutic efficacy in patients with moderately severe or late-stage CVD, but real-world evidence of its use in Russian patients with initial manifestations of chronic venous insufficiency (CVI) remains scarce. METHODS: Data concerning the use of sulodexide in Russian patients with CVD in routine clinical practice were collected and assessed within the framework of the ACVEDUCT program. This observational, prospective, non-controlled multicenter program included patients routinely prescribed sulodexide, as a solution for injections and/or soft capsules, by their physician in accordance with the registered Russian Federation instructions for use. RESULTS: In total, 2263 patients took part in the program. The majority of patients were diagnosed as having CEAP class C3 (38.4%) or class C4 (35.6%) CVD. Sulodexide was associated with decreased symptom severity in 56.4% of patients and a decreased number of symptoms in 42.8%. Thus, improvements were observed in 99.2% overall, with the drug effects being apparent as early as 15-20 days after starting treatment. The highest rate of CVD symptom regression was observed in patients aged 30-40 years. There was a significant positive correlation between sulodexide efficacy and treatment duration and the use of capsules during follow-up. A negative correlation was found between treatment efficacy and patient age at diagnosis, CEAP class, the total number of symptoms, and a combination of risk factors. CONCLUSIONS: Sulodexide was an effective, safe, well-tolerated, and pathogenetically substantiated pharmacologic agent for the treatment of patients with lower limb CVD, and therefore should be recommended in patients with early-stage CVD. Patients with venous trophic ulcers require higher doses and prolonged administration of the drug.