Comparative study between ordinary balloon and drug coated balloon in the management of infragenicular arterial diseases

INTRODUCTION

Critical limb ischemia (CLI) is a clinical term that describes chronic, severe limb perfusion impairment that leads to failure to fulfil the body's basic metabolic requirements. Resting pain with or without trophic skin alterations or tissue loss, involving ischemic ulceration and/or ischemia gangrene, for more than two weeks due to circulatory impairment is the most common symptom ^{(1, 2)}. Because of the scarcity of collateral vascular routes beyond such lesions, popliteal and tibial artery occlusions are more typically linked with limb-threatening ischemia. They are generally not the source of IC as isolated lesions, but they are clinically significant in individuals who have tissue loss. Endovascular treatment is often the first option for treating infrainguinal peripheral arterial disease (PAD). Risk factor optimization by lifestyle changes and drugs, as well as operational treatments employing both open and less invasive procedures, like balloon angioplasty, have all been used as therapeutic approaches. For the therapy of this challenging disease process, drug-eluting balloon (DEB) angioplasty has developed as a possible option to uncoated balloon angioplasty ⁽³⁾.

In recent times, the use of DEB for the therapy of femoro-popliteal artery blockages has grown more common. Drug-coated balloons have the potential to decrease restenosis rates by delivering an antiproliferative drug (paclitaxel) directly to the vessel wall without the requirement for a long-term implant ⁽⁴⁾.

The biological alteration of the damage responses following balloon dilatation is the challenging notion underpinning the drug-coated balloon (DCB) idea. The significant benefits of DCBs include the quick drug delivery at uniform concentrations using a single dosage, their efficiency in regions where stents have previously been contraindicated (e.g., bifurcation, ostial lesions), and the absence of a stent scaffold. Because DCBs do not leave any metal behind, reinterventions are simpler ⁽⁵⁾.

The present study aimed to compare DCB and standard PTA for management of infragenicular arterial disease in critical lower limb ischemia and its preliminary results.

PATIENTS AND METHODS

Study design: a prospective single blinded randomized study. Study population: 40 patients complaining of critical limb ischemia due to infragenicular arterial disease. They were divided into two equal groups. Group A was given a drug-eluting balloon, while Group B was given a conventional balloon angioplasty. Study duration: between October 2017 to October 2018 at the Department of Vascular Surgery in Al-Azhar University and at Alexandria armed forces hospital.

Inclusion criteria: All patients were investigated and proven to have no significant lesions in the SFA nor POP A. All of them were diabetic, in addition to infrapopliteal arterial disease. That was confirmed clinically, colored duplex and CTA.

Exclusion criteria: patients with wet gangrene in lower extremity, uncontrolled risk factors or renal insufficiency with abnormal renal functions. Also, patients who are suffering from severe illness such as heart failure or pulmonary edema were excluded

Pre-procedure Workup: Patients involved in this study were informed about all the adopted procedures and provided their written consent to the investigation.

A documented medical history that includes: a history of the presenting symptoms, treatment indications, and the patient's surgical and medical history, allergic history, a list of current drugs, and vascular risk factors. Physical examinations include: a thorough vascular exam, skin lesions, ankle-brachial indexes, segmental pressure measurements, pulse volume recordings, and a comprehensive examination of adequate depth to rule out serious concurrent diseases. Laboratory and radiological assessment were done preoperatively for all patients. Patients were evaluated through follow up clinic visits at 2 weeks, 6 weeks and 3 months post-procedure regarding clinical improvement, Hemodynamic state, and Limb salvage rate.

Statistical analysis: Using Microsoft Excel software, data from the history, basic clinical examinations, laboratory tests, and outcome measurements were coded, processed, and analyzed. The data was then analyzed using the Statistical Package for the Social Sciences (SPSS) version 20.0 software. Numbers and percentages were employed to describe qualitative data. The mean and standard deviation were employed to describe quantitative data. To determine the significance of differences, the following tests were employed: the chi square test (X2) was utilized for the difference and association of qualitative variables. To compare quantitative parametric groups, the t test was employed. For significant findings, the P value has been set at 0.05.

RESULTS

From October 2017 to October 2018, a total of 40 participants have been included in the research and followed up on for up to 3 months. Patients with critical lower limb ischemia were randomly allocated to either DCB angioplasty or standard percutaneous transluminal angioplasty (PTA). The mean age of the study population was 57.43 years (Table 1).

65% of patients were smokers, 67.5 % were hypertensive, 22.5 % were cardiac patients, and 100 % were diabetics (Table 2).

75 % of the cases have no previous surgical intervention while 25% of the cases have as shown below in the (Table 3)

According to the presence of popliteal artery pulse by clinical examination, 62.5% of the cases have popliteal pulse pre operatively while 37.5 % of the cases, their popliteal artery pulsations cannot be assessed clinically due to obesity but had no significant stenosis in angiography. (Table 4).

In 50 % of the cases the Anterior tibial artery was the only distal run off and in the other 50% the posterior tibial artery was the only distal run off (Table 5).

Ordinary balloons were used in 50% of the patients: 25% of them were complaining of rest pain, 17.5 % had toe or toes lesions, 7.5 % had forefoot lesions. In the other 50 % of the patients the DCBs were used as following: 25% were complaining of rest pain, 20 % had toe or toes lesions, 5 % had forefoot lesions (Table 6).

Regarding the 20 patients whom DCB were used the fate was as following: 10 patients were complaining of rest pain improved at the conclusion of the research.  8 patients were complaining of toe or toes lesion and they were debrided postoperatively and their wounds healed or were healing at the conclusion of the research. Two patients were complaining of forefoot lesions, one of them underwent MTA and the other underwent BKA (Table 7).

Regarding the 20 patients whom ordinary balloons were used the fate was as following: 10 patients were complaining of claudications or rest pain improved at the conclusion of the research. 7 patients were complaining of toe or toes lesion and they were debrided postoperatively; 5 of them their wounds healed or were healing at the end of the study and the other two underwent MTA. 3 patients were complaining of forefoot lesions, one of them underwent MTA and the other two underwent BKA (Table 8).

Before intervention, all patients had their ankle brachial pressure index measured, and the mean value of ABI was 0.54 ± 0.13 SD. During the follow up period, the ABI values were recorded after two weeks, six weeks and three months following the procedures with mean values as following:(0.92 ± 0.09 SD), (0.86 ± 0.09 SD), (0.85 ± 0.09 SD).There were no significant changes in the ABI values in the different follow up periods indicating the continuation of the hemodynamic success all through the follow up periods (Table 9).

Twenty patients (50%) were relieved from the rest pain.13 cases (32.5%) had healed ulcers and another 3 cases (7.5%) had major amputations during the three months following the procedure. 19 cases out of 20 who were treated using drug coated balloons were cured,with a cure rate (47.5%) of the total cases.18 out of 20 cases treated with ordinary balloons were cured, with a cure rate of (45%) of the total cases. The total number of recovery cases is 37 out of 40 cases, with a rate of (92.5%) (Table 10).

Two patients (5%) had ecchymosis and small non communicating groin hematoma at puncture site diagnosed by duplex ultrasound. Both patients were conservatively managed successfully. Another patient (2.5%) complained of communicating hematoma and pseudo aneurysm with ecchymosis and edema of the thigh as shown in fig.15. The patient discovered the hematoma 4 days following the procedure at the puncture site but he didn’t seek medical advice till the first follow up visit. He was managed operatively for arterial repair and hematoma evacuation after one week following the procedure. There were no cases of either major bleeding or wire vessel perforation (Table 11).

Case 1

Fifty-four years old female patient, smoker diabetic, hypertensive cardi complaining of left big and 2nd toes dry gangrene. She has intact popliteal artery pulsations and preoperative posterior tibial artery as the distal run off.

Preoperative angiographic lesion was in both PTA and peroneal arteries.

Balloon used: normal balloon

Radiological

Clinically

Case 2

Sixty one years old female patient, smoker diabetic complaining of right big, 2nd and 3rd toes dry gangrene. She hasn’t popliteal artery pulsation and pre-operative CTA was done showing the ATA as the distal run off. 

Preoperative angiographic lesion was in both ATA and peroneal arteries.

Balloon used: drug coated balloon

Radiological

Clinically

Table 1: Distribution of the investigated patients based on demographic data.

Table 2: Distribution of the investigated patients based on risk factors.

Table 3: Distribution of the investigated patients as per surgical history.

Table 4: Distribution of the investigated patients as per popliteal pulse.

Table 5: Distribution of the investigated patients as per distal run off (n = 40).

Table 6: Distribution of the investigated patients as per CTA pre (n = 40).

Table 7: Relation between balloons used and clinical presentations..

Table 8: Relation between clinical presentations and fate post intervention.

Table 9: A descriptive analysis of the investigated patients as per ABI.