Drug-coated balloon angioplasty for the treatment of edge stenosis after self-expanding covered stent placement for superficial femoral artery occlusive disease

Vascular ◽  
2020 ◽  
pp. 170853812094331
Author(s):  
Iris PS van Wijck ◽  
Suzanne Holewijn ◽  
Laurens A van Walraven ◽  
Michel MPJ Reijnen
Keyword(s):  
Median Time ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Stent Placement ◽  
Covered Stent ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Secondary Patency ◽  
One Year ◽  
Drug Coated Balloon

Background Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis. Purpose The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease. Method We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR). Results A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months). Conclusion The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.

scholarly journals Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease

2017 ◽  
Vol 25 (1) ◽  
pp. 92-99 ◽  
Author(s):  
Konstantinos Stavroulakis ◽  
Arne Schwindt ◽  
Giovanni Torsello ◽  
Efthymios Beropoulis ◽  
Arne Stachmann ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Common Femoral Artery ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Success Rates ◽  
Technical Success ◽  
Chronic Total Occlusions ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

Effectiveness of combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass: A paradigm shift in surgical open bypass for chronic limb-threatening ischemia

Vascular ◽  
2020 ◽  
pp. 170853812098122
Author(s):  
Taira Kobayashi ◽  
Masaki Hamamoto ◽  
Takanobu Okazaki ◽  
Misa Hasegawa ◽  
Takashi Fujiwara ◽  
...  
Keyword(s):  
Wound Healing ◽  
Limb Salvage ◽  
Endovascular Therapy ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Popliteal Artery ◽  
Primary Patency ◽  
Drug Eluting Stent ◽  
Secondary Patency ◽  
Nitinol Stent

Objectives The purpose of this study was to evaluate the results of combining superficial femoral artery endovascular therapy with distal bypass originating from the popliteal artery as a method of lower extremity revascularization in patients with chronic limb-threatening ischemia. Methods The records of patients undergoing combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass for chronic limb-threatening ischemia from January 2014 to April 2020 at a single institution were retrospectively reviewed. The patients’ background, operative details, and long-term outcomes were analyzed. Results Fifty-two popliteal-to-distal bypasses with superficial femoral artery endovascular therapy were performed in 49 patients (33 men; mean age, 76 ± 9 years; diabetes mellitus, 80%; end-stage renal disease with hemodialysis, 47%). The Trans-Atlantic Inter-Society Consensus II classification of superficial femoral artery–popliteal lesion was “A” in 8 (15%) patients, “B” in 14 (27%) patients, “C” in 24 (46%) patients, and “D” in 6 (12%) patients. The intervention for superficial femoral artery lesions was plain old balloon angioplasty in 4 patients, self-expandable nitinol stent in 15 patients, drug-coated balloon in 18 patients, drug-eluting stent in 4 patients, stent graft in 10 patients, and interwoven nitinol stent in 1 patient. Distal bypass originated from the above-knee popliteal artery in 9 (17%) limbs and the below-knee popliteal artery in 43 (83%) limbs. The most common outflow artery was the posterior tibial artery (44%). The mean follow-up period was 17 ± 17 months. The primary and secondary patency of the graft was 44% and 72%, respectively, at 1 year and 39% and 72%, respectively, at 3 years. Primary patency and freedom from clinical-driven target lesion revascularization of superficial femoral artery endovascular therapy lesions were 85% and 90%, respectively, at 1 year and 63% and 75%, respectively, at 3 years. Limb salvage was 97% at 1 year and 92% at 3 years. Wound healing was 67% at 6 months and 83% at 12 months. Conclusions Combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass may be a promising approach for patients with chronic limb-threatening ischemia because of durable patency, acceptable wound healing, and good limb salvage.

scholarly journals Better treatment option in chronic superficial femoral artery occlusive disease: comparison of methods (meta-analysis)

2019 ◽  
Vol 11 (3) ◽  
pp. 224-229
Author(s):  
Vladimir Starodubtsev ◽  
Andrey Karpenko ◽  
Evgeniy Lenko ◽  
Pavel Ignatenko
Keyword(s):  
Treatment Option ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Occlusive Disease ◽  
Qualitative Synthesis ◽  
Effective Treatment Option ◽  
One Year

Introduction: The objective is to evaluate the frequency of primary obstruction events (PrO) during one-year follow-up after performing excisional atherectomy with the SilverHawk/TurboHawk atherectomy device (S/TH) or remote superficial femoral artery endarterectomy (RSFAE) in patients with the chronic superficial femoral artery occlusive disease (СSFAOD). Methods: We included all randomized clinical trials (RCTs) and not-RCTs concerning the treatment of patients with СSFAOD after S/TH and RSFAE without duration. Results: Twenty-nine items (1990-2017) were discovered; 27 articles on the levels of evidence were included in qualitative synthesis; 9 studies (meta-analysis) were included in quantitative synthesis. The results of 2762 patients’ treatment were summed up in our analysis (1422 patients S/TH; 1340 patients RSFAE). All included reports were at low risk of bias. According to the criterion "frequency of PrO" during one-year follow-up, the pooled Hazard Ratios indicate significant favours of S/TH if compared it with RSFAE (HR= 0.66 (0.57 to 0.76, P < 0.00001), I2 = 9%). Conclusion: Our study showed that S/TH with the SpiderFX device (distal embolic protection) are safe and effective treatment option for short lesion (<15 cm) in patients with СSFAOD. The usage of S/TH methods significantly reduced number of PrO if compared it with RSFAE. In long-segment lesion (>15 cm) in patients with СSFAOD, RSFAE may be considered better than an endovascular procedure. But still it is necessary to conduct well-planned randomized studies to determine effectiveness and safety of the compared methods (S/TH and RSFAE) in patients with long-segment lesion (>15 cm).

Edge Stenosis After Covered Stenting for Long Superficial Femoral Artery Occlusive Disease: Risk Factor Analysis and Prevention With Drug-Coated Balloon Angioplasty

2018 ◽  
Vol 25 (3) ◽  
pp. 313-319 ◽  
Author(s):  
Ting-Chao Lin ◽  
Chun-Yang Huang ◽  
Po-Lin Chen ◽  
Chiu-Yang Lee ◽  
Chun-Che Shih ◽  
...  
Keyword(s):  
Risk Factors ◽  
Stent Graft ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Disease Risk ◽  
Target Lesion ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Lesion Length ◽  
Distal Edge

Purpose: To report a retrospective analysis of risk factors for edge restenosis after Viabahn stent-graft treatment of superficial femoral artery (SFA) occlusive disease and determine any protective effect of drug-coated balloons (DCBs) used at the time of stent-graft implantation. Methods: Between October 2011 and July 2016, 110 patients (mean age 73.3±7.6 years; 78 men) were treated with the Viabahn stent-graft for long SFA occlusions. Thirty-eight (34.5%) patients had DCB reinforcement at the distal edge of the stent-graft. For analysis, the population was divided into groups of no edge stenosis patients (n=88; mean lesion length 22.4±4.2 cm) and edge stenosis patients (n=22; mean lesion length 23.5±5.7 cm). The clinical outcomes, ankle-brachial indices, computed tomography angiography findings, and patency were compared at a minimum of 12 months. Logistic regression analysis was employed to determine risk factors for edge stenosis; the results are presented as the odds ratio (OR) and 95% confidence interval. Results: No differences in clinical or procedural characteristics were identified except the higher incidence of diabetes (p=0.008) and greater need for retrograde access (p=0.033) in the edge stenosis group. DCB reinforcement reduced the incidence of edge stenosis (p=0.021) and target lesion revascularization (TLR; p=0.010) and resulted in a significantly higher 1-year primary patency rate (92.1% vs 76.4%, p=0.042). However, multivariate analysis revealed only poor distal runoff (OR 0.31, 95% CI 0.11 to 0.83, p=0.020) as a predictor of edge stenosis. Conclusion: The risk of edge stenosis after Viabahn implantation was higher in patients with poor distal runoff. DCB reinforcement over the distal edge reduced edge stenosis, decreased 1-year TLR, and improved 1-year primary patency.

Long-term Results with the Palmaz Stent in the Superficial Femoral Artery

1995 ◽  
Vol 2 (2) ◽  
pp. 161-167 ◽  
Author(s):  
Patrice Bergeron ◽  
Jean J. Pinot ◽  
Vincent Poyen ◽  
Huber Benichou ◽  
Patrick Khanoyan ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Primary Patency ◽  
Long Term Results ◽  
Secondary Patency ◽  
Critical Ischemia

Purpose: Femoral stenting has demonstrated inconsistent and often disappointing long-term results. To compare our experience, we retrospectively analyzed a series of patients who had Palmaz balloon-expandable stents placed exclusively for superficial femoral artery (SFA) lesions. Methods: From January 1990 to November 1993, 39 patients were evaluated for claudication (79%) or critical ischemia in 42 limbs. The culprit lesions were confined to the SFA: 24 (57%) occlusions and 18 (43%) stenoses, including 3 restenotic lesions. Stenting was elective in 12 (29%) cases: the 3 restenoses and 9 chronic, calcified occlusions. The remaining stents were applied for postangioplasty residual stenosis or angioscopic findings of thrombogenic luminal irregularities. A total of 55 prostheses were successfully implanted. All patients were maintained on ticlopidine and followed by routine duplex scanning. Follow-up angiography was performed in 28 (72%) patients between 4 and 45 months. Results: In the postprocedural period, two acute thromboses (4.8%) occurred within 48 hours in patients who had long occlusions and poor runoff; no other major complications were encountered, for a clinical success rate of 95%. Follow-up evaluation ranged from 4 months to 4 years with a mean of 25 months. The restenosis rate was 19% (34% in occlusions; 10% in stenotic lesions, p = NS). At 24 months, cumulative primary patency was 77% and secondary patency 89%. Conclusions: Palmaz stents performed well in the SFA, demonstrating a low acute thrombosis rate and good long-term patency. The incidence of restenosis is likely to be greater in occlusions than in stenoses.

scholarly journals First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease

Vascular ◽  
2017 ◽  
Vol 26 (1) ◽  
pp. 3-11 ◽  
Author(s):  
Bibombe Patrice Mwipatayi ◽  
Kalpa Perera ◽  
Ali Daneshmand ◽  
Rhys Daniel ◽  
Jackie Wong ◽  
...  
Keyword(s):  
Target Lesion ◽  
Bare Metal Stent ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Secondary Patency ◽  
Target Lesion Revascularisation ◽  
Metal Stent ◽  
The Mean ◽  
Drug Coated Balloon

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09–208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37–1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9–98.1) and 88% (95% CI = 75.7–94.5), respectively. The assisted primary was 94% (95% CI = 82.9–98.1) and secondary patency was 96% (95% CI = 85.2–99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83–98%) at 12-month follow-up and 88% (95% CI = 76–94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

scholarly journals Healing of femoral artery dissection after drug-coated balloon angioplasty: A case report with intravascular ultrasonography and angioscopy images

2019 ◽  
Vol 7 ◽  
pp. 2050313X1983415
Author(s):  
Taketsugu Tsuchiya ◽  
Minako Oda ◽  
Takaaki Takamura ◽  
Katsuhide Kitagawa ◽  
Koji Kajinami ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Balloon Angioplasty ◽  
Iliac Artery ◽  
Superficial Femoral Artery ◽  
External Iliac Artery ◽  
Artery Dissection ◽  
Intravascular Ultrasonography ◽  
Stent Deployment ◽  
Atherosclerotic Stenosis ◽  
Drug Coated Balloon

Early 80s male with intermitted claudication underwent endovascular therapy for atherosclerotic stenosis at left external iliac artery and middle of superficial femoral artery. Patient also had chronic atrial fibrillation, diabetes mellitus, and hypertension. After stent deployment for external iliac artery lesion, a short superficial femoral artery lesion was performed with angioplasty using drug-coated balloon. The drug-coated balloon angioplasty resulted in 50% residual stenosis with linear dissection; however, provisional stenting was not performed as decent ante-grade blood flow allowed 10 extra minutes. Medication involved ongoing use of aspirin 100 mg and rivaroxaban 15 mg. Angiography post 3 months from index procedure showed external iliac artery and superficial femoral artery patency and healing of intimal dissection at superficial femoral artery lesion was estimated by intravascular ultrasonography. In angioscopy findings, red thrombus was seen in dissection cavity.

scholarly journals One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study)

2016 ◽  
Vol 63 (2) ◽  
pp. 370-376.e1 ◽  
Author(s):  
Takao Ohki ◽  
John F. Angle ◽  
Hiroyoshi Yokoi ◽  
Michael R. Jaff ◽  
Jeffrey Popma ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Artery Disease ◽  
One Year ◽  
The U.S
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