Background: In the present study, it was aimed to compare the stent grafts and bare-metal stents in terms of post-procedural patency, clinical recovery and complications in the subjects with symptomatic aorto-iliac arterial disease. Methods: A total of 79 subjects with symptomatic aorto-iliac arterial disease treated with endovascular methods were included in the present study. Forty three subjects received self-expendable bare metal stent (ev3 Protégé stent system, Endovascular Inc., Plymouth, Minnesota, USA) and 36 subjects received PTFE-covered stent graft (Fluency Plus Stent Graft, Bard Peripheral Vascular, Tempe, Arizona). The subjects were compared after and at Months 1, 6, and 12 following the procedure in terms of Rutherford ’ s classification, ankle-arm index (AAI), patency rates, and complications. Results: The subjects receiving bare metal stent and stent graft for aorto-iliac arterial disease were followed for averagely 15 months. For the subjects receiving bare metal stent, primary patency rates at months 1, 6, and 12 were 98%, 81%, and 70%, respectively, while secondary patency rate at month 12 was found to be 84%. For the group of stent graft, primary patency rates were found as 97%, 97%, and 92%, respectively and secondary patency rate at month 12 was found to be 94%. Stent grafts were applied at the same time in 2 patients who had metal bare metal because the rupture occurred during the procedure. In the comparison between two groups, the group of stent graft was found to be statistically superior to the other in terms of patency, clinical and post-procedural complications. Conclusion: In conclusion, it was found that the stent grafts were superior to the bare metal stents in terms of patency and complication rates in the subjects with symptomatic aortoiliac disease.
Prevalence of the peripheral arterial disease (PAD) is 4% in the age of 40 and more and it increases sharply to rise above 14% after age of 70 [
In our clinic, 79 aortoiliac artery patients who underwent endovascular methods between 2014-2016 were included in the study following the approval of university ethics committee. 43 cases were treated with self expendable bare metal stent (BMS), (ev3 Protege stent system, Endovascular Inc., Plymouth, Minnesota, United States) and 36 were treated with PTFE coated stent graft (SG), (FLUENCY Plus Stent Graft, Bard Peripheral Vascular, Tempe, Arizona). The demographic and preoperative data of the cases were presented in
The inclusion criteria were being above 18 years old, cases with TASC-B, C and D aortoiliac artery lesion, BMS or SG endovascular treatment. The exclusion criteria were life expectancy less than 12 months, TASC A iliac lesion, iliac artery aneurysm, hybrid procedure (the cases who underwent surgery following endovascular treatment), pregnancy, antiaggregant use contraindication. Target occlusive lesions were categorized angiographically as 0% - 50% mild, 50% - 79% moderate, 80% - 99% severe and 100% occlusion. Following procedure, surgical team evaluated the cases in 1st, 6th, and the 12th months by ankle/arm index, rutherford clinical stage and doppler ultrasonography. During ABI evaluation, tension was measured on bilateral upper extremity, lower extremity dorsalis pedis and posterior tibial artery systolic pressure, the highest pressures were approximated. The cases with lower ABI values and increased symptoms underwent computed tomographical angiography (BTA) or digital substruction angiography (DSA) in the control visit. Narrowing by 60% and above in the target
BMS | SG | p | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Med. ± s.s./n-% | Med (Min-Max) | Med. ± s.s./n-% | Med (Min-Mak) | ||||||||||||||
Age | 59.8 | ± | 8.8 | 61 | 44 | - | 77 | 60.7 | ± | 7.9 | 60 | 44 | - | 74 | 0.741 | ||
Sex | Male | 38 | 88% | 32 | 89% | 0.943 | |||||||||||
Female | 5 | 12% | 4 | 11% | |||||||||||||
DM | 22 | 51% | 18 | 50% | 0.918 | ||||||||||||
HT | 19 | 44% | 13 | 36% | 0.467 | ||||||||||||
Dyslipidemia | 25 | 58% | 15 | 42% | 0.145 | ||||||||||||
Smoke | 33 | 77% | 27 | 75% | 0.857 | ||||||||||||
CAD | 10 | 23% | 6 | 17% | 0.468 | ||||||||||||
CKD | 2 | 5% | 3 | 8% | 0.503 | ||||||||||||
CVD | 1 | 2% | 3 | 8% | 0.225 | ||||||||||||
Symptom | Cloudication | 21 | 49% | 16 | 44% | 0.697 | |||||||||||
Rest pain | 12 | 28% | 17 | 48% | 0.002 | ||||||||||||
Tissue Lose | 10 | 23% | 3 | 8% | 0.075 | ||||||||||||
TASC | B | 1 | 2% | 1 | 3% | 0.740 | |||||||||||
C | 19 | 44% | 17 | 47% | |||||||||||||
D | 23 | 53% | 18 | 50% | |||||||||||||
Site | Right | 20 | 47% | 26 | 72% | 0.021 | |||||||||||
Left | 23 | 53% | 10 | 28% |
Independent sample, t test/Mann-Whitney u test/Ki-Square test (Fischer test). BMS: Bare Metal Stent, SG: Stent Graft, DM: Diabetes Mellitus, HT: Hypertension, CAD: Coronary artery disease, CKD: Chronic kidney disease, CVD: Cerebrovascular disease.
lesion were considered as restenosis and the intervention was repeated. Primary patency was considered as time from patency lesion to restenosis. Secondary patency was considered as patency time following repeated intervention.
All cases undergoing procedure were treated with 300 mg klopidogrel (Plavix, Sanofi, Hoechst, Germany) load followed by daily 300 mg asetilsalisilic acid and 75 mg klopidogrel. When klopidogrel was used before the procedure, loading was not performed.
Access from iliac artery to target lesion was performed under local anesthesia with the use of shuttle sheath (Cook Medical, Bloomington, Ind) in contralateral femoral artery or brachial artery as antegrad, ipsilateral femoral artery as retrograd. Following sheath replacement, 100 IU/kg dose bolus heparin was administrated. To confirm BTA findings and evaluate distal bed (femoropopliteal angiography) angiographically before the procedure, peripheral angiography was performed. Following the lesional passage by 0.035 or 0.018 hydrophilic guidewire, BMS or SG was replaced. For the decision, the diameters of SG and BMS were measured before the procedure in the lumen BTA of distal side of lesion. Osirix-demo (Pixmeo-Sarl, Bernex, Switzerland) program was used to measure lumen diameters.
Mean, standard deviation, median the lowest, the highest, frequency and percentile values were used for definitive statistics of the data. The distributions of the variables were measured by Kolmogorov Simirnov Test. The quantitative data were analyzed by Mann-Whitney u test and independent sample T test. Wilcoxon was used for the analysis of repeated measurements. The qualitative data were analyzed by Chi-square test, Fischer test was used when Chi-square settings could not be established. Kaplan Meier was used for survival analyses. SPSS 22.0 program was used for analyses.
In our clinic, total of 79 patients who underwent BMS and SG due to symptomatic multi-segment AIAD were included in the study. 43 patients underwent BMS, 36 underwent SG. The patients were followed for approximately 15 months, no significant difference in the follow-up duration was found between two groups (p: 0.252).
No significant difference in terms of age, sex, comorbidity and lesion severity was found between 2 groups; however, the incidence of rupture stent was significantly higher in BMS group as compared to graft group (p < 0.05). Between 2 groups, in terms of clinical complaints, the incidence of resting pain was significantly higher in SG group (p < 0.05). No significant difference in other symptoms was found. The demographical data were presented in
According to TASC classification the cases were classified as follows: in BMS group 42 patients (98%) as TASC C-D, in SG group 35 patients (97%) as TASC C-D. No significant difference in lesion severity was found between 2 groups (p: 0.740).
No significant difference between BMS and SG groups by preoperative and 1st month Rutherford classification. However, intra- and inter-SG group significant decreases were observed in 6 and 12th month control visits (p: 0.036, 0.014). In both groups, post-operative values were significantly lower as compared to preoperative Rutherford classification (p < 0.05). When BMS and SG groups were compared by ABI, no significant difference was found preoperative, 1st. and 6th month, however, there was a significant difference in the 12th month between 2 groups (p: 0.012) (
The rates of primary patency period were as follows at 1, 6, and 12th months: in BMS group 98%, 81% and 70%; in SG group 97%, 97%, and 92%, respectively.
BMS | SG | p | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean. ± s.s./n-% | Med (Min-Mak) | Mean. ± s.s./n-% | Med (Min-Mak) | |||||||||||||||
Rutherford | ||||||||||||||||||
Preop | 3.5 | ± | 0.7 | 3.0 | 3.0 | - | 5.0 | 3.7 | ± | 0.8 | 3.0 | 3.0 | - | 5.0 | 0.539 | |||
1. month | 1.9 | ± | 0.9* | 2.0 | 1.0 | - | 5.0 | 1.9 | ± | 0.7* | 2.0 | 1.0 | - | 3.0 | 0.658 | |||
6. month | 1.8 | ± | 0.9* | 2.0 | 1.0 | - | 4.0 | 1.8 | ± | 0.7* | 2.0 | 1.0 | - | 4.0 | 0.036 | |||
12. month | 1.8 | ± | 1.2* | 2.0 | 1.0 | - | 6.0 | 1.5 | ± | 0.5* | 1.0 | 1.0 | - | 2.0 | 0.014 | |||
ABI | ||||||||||||||||||
Preop | 0.6 | ± | 0.1 | 0.6 | 0.5 | - | 0.8 | 0.7 | ± | 0.1 | 0.7 | 0.6 | - | 0.8 | 0.401 | |||
Post-Procedur | 0.9 | ± | 0.1* | 0.9 | 0.8 | - | 1.0 | 0.9 | ± | 0.1* | 0.9 | 0.8 | - | 1.0 | 0.709 | |||
1. month | 0.9 | ± | 0.1* | 0.9 | 0.8 | - | 1.0 | 0.9 | ± | 0.1* | 0.9 | 0.8 | - | 1.0 | 0.396 | |||
6. month | 0.9 | ± | 0.1* | 0.9 | 0.6 | - | 1.0 | 0.9 | ± | 0.1* | 0.9 | 0.6 | - | 1.0 | 0.643 | |||
12. month | 0.8 | ± | 0.3* | 0.9 | 0.0 | - | 1.0 | 0.9 | ± | 0.1* | 0.9 | 0.8 | - | 1.0 | 0.012 | |||
Primary patency | ||||||||||||||||||
1. month | occlude | 1 | 2% | 1 | 3% | 1.000 | ||||||||||||
patent | 42 | 98% | 35 | 97% | ||||||||||||||
6. month | Occlude | 8 | 19% | 1 | 3% | 0.027 | ||||||||||||
Patent | 35 | 81% | 35 | 97% | ||||||||||||||
12. month | Occlude | 13 | 30% | 3 | 8% | 0.016 | ||||||||||||
patent | 30 | 70% | 33 | 92% | ||||||||||||||
12. monh Sec.Pat. | Occlude | 7 | 16% | 2 | 6% | 0.018 | ||||||||||||
Patent | 36 | 84% | 34 | 94% | ||||||||||||||
Mann-Whitney u test/Wilcoxon test/Ki-square test (Fischer test); *p < 0.05 statical significantly, BMS: Bare Metal Stent, SG: Stent Graft, Sec. Pat: Secondary Patency.
The rates were significantly higher in SG group at 6 and 12th months. (p < 0.05). In BMS group, 13 (30%) cases were re-operated, in SG 3 (8%) cases were reoperated; a significant difference was found between 2 groups (p: 0.002). 12th month secondary patency period was 84% in BMS group, %94 in SG group. In terms of secondary patency period, SG was significantly higher (p: 0.018).
When compared in terms of post-operative complications, no mortality was observed in none of the groups. However, in BMS group, a rupture was observed during balloon dilatation in 2 cases without sufficient patency. SG was treated successfully in both cases. Although these 2 patients were accepted as bare metal stent complications, they were not added to the stent graft group during the study and were left out of the study. The complications during the operation were presented in
Today, the term “endovascular first” has gained a place in medical sense in the
BMS | SG | p | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Med. ± s.s./n-% | Med (Min-Max) | Med. ± s.s./n-% | Med (Min-Max) | |||||||||||||||||
Dissection | 4 | 9% | 3 | 8% | 0.880 | |||||||||||||||
Rupture | 2 | 5% | 0 | 0% | 0.880 | |||||||||||||||
Thrombosis | 7 | 16% | 2 | 5.5% | 0.028 | 0.135 | ||||||||||||||
Mortality | 0 | 0% | 0 | 0% | 0.135 | - | ||||||||||||||
Amputation | 3 | 7% | 0 | 0% | - | 0.246 | ||||||||||||||
Reintervention | 13 | 30% | 3 | 8 % | 0.002 | |||||||||||||||
Stent length | 9.4 | ± | 3.7 | 9.2 | ± | 3.4 | 0.813 | |||||||||||||
Preop-Drug | 1.4 | ± | 1.0 | 1.0 | ± | 0.9 | 0.059 | |||||||||||||
Follow Time (Month) | 14.5 | ± | 5.2 | 15.1 | ± | 4.0 | 0.252 | |||||||||||||
Independent sample, t test/Mann-Whitney u test/Ki-Square test (Fischer test); BMS: Bare Metal Stent, SG: Stent Graft, DM: Diabetes Mellitus, HT: Hypertension, CAD: Coronary artery disease, CKD: Chronic kidney disease, CVD: Cerebrovascular disease.
treatment of the cases with AIAD. While the opening of the abdominal cavity reduces morbidity and mortality, the fact that primary and secondary patency rates are comparable with OBS explains why the endovascular procedures should be chosen as the first choice [
diameter of the SG to be applied should be oversize no more than 10% of the vessel diameter distal to the target lesion. Causing turbulent flow in graft distal, diameter mismatch increases the formation of thrombus and intimal hyperplasia [
In the subjects with aorto-iliac arterial disease, BMS and SG achieved successful results with their patency rates similar to the surgery. The fact that rates of mortality and morbidity of the surgery are higher than endovascular inventions leads the endovascular procedures to be preferred in this group of patients. Additionally, the stent grafts were found to be superior to the bare metal stents in terms of higher patency rates and lower complication rates in the subjects with AIAD.
There is no conflict of interest and the study has not been published anywhere before.
Gur, O., Demet, O.G. and Selami, G. (2018) Which Offers the Best? Stent Graft or Bare Metal Stent for Endovascular Treatment of Aortoiliac Disease. World Journal of Cardiovascular Diseases, 8, 489-497. https://doi.org/10.4236/wjcd.2018.811048