Choosing an Access for Endovascular Treatment of Femoral-popliteal Segment Occlusions (ATFA)

The purpose of the study: to compare the complication rate of the shoulder and retrograde femoral access in elderly patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries.

Scientific hypotheses:

1. The shoulder access has a lower number of complications compared to the femoral access
2. The shoulder access has a lower number of complications requiring surgical intervention compared to the femoral access
3. The shoulder access has a comparable % of success of the main intervention with the femoral access Inclusion criteria: arterial diameter at the access site of at least 3 mm, indications for endovascular intervention on the lower extremity arteries, age of 60 years or more, and patient consent to participate in the study.

Exclusion criteria: inability to perform an access due to stenotic lesions of the above-mentioned arteries (common femoral, iliac, axillary, subclavian arteries, brachiocephalic trunk); height more than 180 cm; presence of concomitant pathology limiting the survival of patients; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.), previously performed catheterization through the access artery.

The required sample size was calculated using the M. Blanda method [3] for a study with increased accuracy. The required level of significance (α) was 0.05, and the study's power was 95%. The estimated complication rates in the Femoral and Brachial groups were assumed to be 2% and 9%, respectively. Under these conditions, the estimated sample size was 269 patients. The planned loss rate during the study was 5%. Therefore, the minimum sample size was 283 patients.

The study has an experimental design and follows the CONSORT protocol. A simple method of randomization using a random number generator was selected.

The puncture of the brachial or common femoral artery was performed under ultrasound control. The choice of the type of arterial access was made by randomization using a random number generator, and depending on this choice, the patient was assigned to one of the groups: the Femoral access group or the Brachial access group. The femoral artery was catheterized at a typical location, and the brachial artery was catheterized 2-3 cm above the elbow. The choice of access location was made by randomization using the random number method, and the patient was assigned to one of the groups based on this choice. The following instruments were used to perform the intervention: an 18G angiographic needle 7 cm long, a 0.035-inch diagnostic guide 260 cm, a 6 Fr 90 cm guide introducer (Destination, manufacturer Terumo), 5 Fr diagnostic catheters 125 cm long (Optitorque, manufacturer Terumo or Impress, manufacturer Merit Medical), peripheral conductors 0.035 or 0.018 inches, balloon catheters with a delivery length of 150 cm and 180 cm (Atropos, manufacturer of BrosMed; Pacific Plus, manufacturer of Medtronic) and balloon catheters for peripheral arteries with a drug coating of paclitaxel and a delivery system length of 150 cm (Ranger, manufacturer of Boston Scientific). 5,000 IU of heparin in saline solution was injected into the catheterized artery. Hemostasis was achieved by applying a pressure bandage in the case of a shoulder access or by using a suturing device (AngioSeal, Terumo) in the case of a femoral access.

A control examination of the access site was performed within 3 hours after the end of the intervention, and then, if there were no complaints, the bandage was removed. After the bandage was removed, the patients underwent an ultrasound examination. Complications were recorded within 3 days after the intervention.