[Clinical study of efficacy and safety of Aducil in patients with chronic lower limb ischaemia]. / Klinicheskoe issledovanie éffektivnosti i bezopasnosti Adutsila pri khronicheskoi ishemii nizhnikh konechnostei.

AIM: The study was aimed at assessing efficacy and safety of treatment with Aducil® (cilostazol) compared with Trental® 400 in patients with moderate-to-severe intermittent claudication due to peripheral atherosclerosis. PATIENTS AND METHODS: The study included a total of one hundred and forty-five 36-to-75-year-old patients. The participants were distributed into 2 groups according to the inclusion/exclusion criteria in a 2 to 1 proportion: patients in group 1 received Aducil® 100 mg BID, in group 2 - Trental® 400 TID for 12 weeks. 142 subjects completed the protocol. RESULTS: Analysis of the effectiveness of treatment according to the primary criterion showed a better effectiveness of Aducil® as compared with Trental® 400. Subjects who received Aducil® had a higher increase in the absolute maximum walking distance after 12 weeks of treatment as compared with those taking Trental® 400: 126±110 m versus 45±39 m, respectively (р<0.001). Subjects who received Aducil® had a statistically significant improvement in quality of life parameters such as physical and mental health components according to the SF-36 questionnaire after 12 weeks of treatment (р≤0.01). Subjects in Aducil® group had better quality of life with an increase from 34 to 40 points according to the physical component score, while patients in Trental® 400 group demonstrated minor positive changes (from 35 to 37 points); mean mental component score increased from 45 to 48 points in Aducil® group as compared with an increase from 45 to 47 points in Trental® 400 group. While self-reported physical health status was similar between the groups at baseline, subjects in Aducil® group reported better physical functioning after treatment (р=0.016). Two adverse events were registered in two subjects in Aducil® group. CONCLUSION: Analysis of the study endpoints demonstrated that Aducil® had better treatment effectiveness in patients with chronic lower limb ischemia stage IIB according to the classification of A.V. Pokrovsky-Fontaine as compared with Trental® 400, while the safety profile and drug tolerance were similar between the two.

[Administration of the generic prostaglandin E1 VAP 20® in patients with lower limb critical ischaemia: a prospective study].

OBJECTIVE: The study was aimed at assessing efficacy and safety of administering the generic alprostadil VAP in patients presenting with lower limb critical ischaemia. MATERIAL AND METHODS: We carried out a prospective study including a total of 30 patients with lower limb critical ischaemia. The patients' mean age was 67.7±7.8 years, with men predominating - 60%. Trophic ulcers were observed in 40% of patients. The proximal level of the lesion was localized in the arteries below the inguinal ligament in 19 (63.3%) patients, in the aortofemoral segment - in 9 (30%) patients, and in the popliteal-crural-plantar segment - in 2 (6.6%) subjects. The average ankle-brachial index amounted to 0.49±0.4. The studied agent was used at a dose of 40 mcg once a day in patients with stage III ischaemia and a dose of 40 mcg twice daily in patients with stage IV ischaemia. The drug was administered for 14 days followed by a 14-day follow-up period. RESULTS: The pain syndrome score over the 14 days of treatment decreased twofold from 6.1±2.5 to 3.5±2.6 and within the subsequent 14 days it did not increase - 2.4±3.1 (p< 0.05). The number of patients in whom the pain syndrome decreased by 50% amounted to 19 (63.3%). The consumption of analgesic agents decreased from 60% (at the beginning of treatment) to 12 (40%) (14 days after treatment) and to 8 (26.6%) (at the end of the follow-up period). In patients with trophic ulcers, the average size of the ulcers during treatment decreased from 3.3±3.7 cm to 2.8±3.8 after 14 days, and at the end of the follow-up period the size of the ulcers amounted to 2.1±2.8 cm (p >0.05). The number of patients responding to treatment amounted to 22 (77.3%). The ABI during treatment did not change, being 0.49 ± 0.4 at the beginning of treatment, 0.53±0.4 after 14 days of treatment, and 0.47±0.3 at the end of the follow-up period. There were no amputations either during treatment or within the follow-up period. Only one lethal outcome occurred which was related to acute coronary insufficiency. The "response to treatment" was significantly influenced only by the level of the proximal lesion and age (p<0.05). CONCLUSION: VAP 20® demonstrated good efficacy and tolerability comparable to those of the original preparations.

[Own experience endovascular prosthetic repair of abdominal aortic aneurysms].

Endovascular prosthetic repair has increasingly been used over the last several decades. This type of intervention is indicated for patients running a high surgical and anaesthesiological risk of an open surgical procedure. The experience gained in endovascular prosthetic repair of abdominal aortic aneurysms makes it possible to extend the indications for its practical application. The authors describe herein their experience gained in a total of 20 procedures of endovascular prosthetic repair of abdominal aortic aneurysms using the Gore Excluder endograft device in patients running a high risk of an open surgical intervention. There were neither short -nor long-term lethal outcomes. Three patients after endovascular prosthetic repair were found to have type 1 endoleak and two appeared to have type 2 endoleak. Type 1 endoleaks were coped with intraoperationally. Dynamic follow-up (at 1, 6, 12 months after surgery) of patients including computed tomography showed no complications whatsoever (i. e., no endoleaks, endograft migration, nor increase in the aneurysm's diameter). After endografting of abdominal aortic aneurysms there were neither cardiac nor respiratory complications in the immediate postoperative period. Hence, endografting of an abdominal aortic aneurysm is a method of choice for high-risk patients.

[Simultaneous reconstruction of visceral aortic branches and renal arteries].

The paper presents a case report of simultaneous reconstruction of visceral aortic branches and renal arteries. The case is interesting because of special operative particularities, that occurred in 54-year-old patient who received previously radiotherapy for abdominal lymphogranulomatosis. Follow-up investigation 4 years after vascular intervention has shown that the patient remained in a satisfactory condition. The paper includes brief literature review concerning the strategy of reconstructive volume choice for this disease.

Successful percutaneous endovascular treatment of a ruptured femoral aneurysm.

Popliteal and femoral aneurysms account for about 70% of the incidence of peripheral aneurysms. Only 4% of aneurysms run their course with the clinical evidence of rupture. The ruptured aneurysm is dangerous because of a potential limb loss as well as due to the threat of lethal outcome in patients at a high surgical risk. Presented herein is a successful experience (first in this country) gained with the treatment of a ruptured femoral aneurysm by means of endoprosthetics using a new stent graft with PTFB coating in a patient at a high risk for traditional surgical treatment.

Combined operations for multilevel lesions of the aortoiliac and femoropopliteal segments.

This paper describes the results of the treatment of 53 patients with combined arterial lesions of the iliofemoral and femoro-popliteal segments. Altogether 56 primary one-step operations were performed. The initial success was achieved in 53 (94.6%) cases. The long-term results were followed up in 43 (81.1%) patients, in the long-term period, repeated endovascular interventions were accomplished in 6 (1.8%) patients with re-stenoses of the iliac arteries. The best long-term results were obtained in the groups of patients who had undergone balloon angioplasty and stenting of the iliac arteries.

Results of primary reconstructions in patients with lesion of the tibial arteries.

An analysis was made of 146 primary reconstructions performed in 141 patients with occlusion of the arteries of the femoropopliteal segment and leg. At the hospital stage an improvement of the clinical status was attained after primary operations in 98% of cases. The five-year cumulative bypass patency after operations.accounted for 43.5% while the limbs could be saved in 91.5% of cases. The results obtained in patients with stage 2B chronic arterial ischemia (according to the A.V.Pokrovsky classification, 1979) coincided with the results of bypass grafts of the popliteal artery (the 5-year patency was 56.9% with the limbs saved in - 81.2% of cases), whereas the results of in situ vein bypass were marked by a significantly better cumulative patency in the long-term period.