Superficial Femoral Artery In-stent Restenosis Research Articles

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery

ObjectiveThe aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. MethodsWe conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. ResultsPatients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. ConclusionsThis post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Superficial Femoral Artery in-Stent Restenosis Treated with Paclitaxel-Coated Balloon Angioplasty - Results of Three-Year Follow-Up.

In-stent restenosis remains a common and important complication after endovascular treatment of superficial femoral artery peripheral artery disease. It occurs in 14 to 35% of cases in 1year and there is still no efficient treatment for this condition. Paclitaxel-coated balloons have shown promising results. Investigate the 3year results of superficial femoral artery in-stent restenosis treated with paclitaxel-coated balloon angioplasty, using the Lutonix™ 035 device. We conducted a retrospective observational study with patients with symptomatic (Rutherford 2 to 5) superficial femoral artery in-stent restenosis, that were treated with paclitaxel-coated balloon angioplasty using the Lutonix™ 035 device, in a single center from January 2016 to December 2020. Duplex scan was used to follow the patients. Primary patency was obtained through Kaplan-Meier analysis. Mortality, and amputation rates were also evaluated. 105 patients were included. Two patients had technical failure and required an additional stent, and were thus excluded. 103 patients were analyzed. Primary patency was 91.26, 80.47, and 67.71%, respectively, in the first, second, and third year after the procedure. There were no deaths 30days after the procedure. There were no major amputations during the 3year follow-up. Paclitaxel-coated balloon angioplasty with the Lutonix™ 035 device was a safe and effective treatment to superficial femoral artery in-stent restenoses. The results were maintained along the 3year follow-up.

Outcomes of Endovascular Treatment in Patients with Superficial Femoral Artery In-Stent Restenosis

Outcomes of Endovascular Treatment in Patients with Superficial Femoral Artery In-Stent Restenosis

Combined therapy with rotational atherectomy and drug coated balloon for superficial femoral artery in-stent restenosis: safety, efficacy, and two-year results of a single center experience.

The primary patency rate of superficial femoral artery (SFA) after percutaneous transluminal angioplasty (PTA) has improved with the use of self-expanding stents. However, occurrence of in-stent restenosis (ISR) still represents a frequent problem. Despite different studies have assessed the role of atherectomy and drug coated balloons (DCBs), no long-term data exist about combined use. The aim of this study was to evaluate safety and efficacy of combined treatment with Jetstream (Boston Scientific Corp., Marlborough, MA, USA) atherectomy and DCB for SFA intrastent restenosis (ISR) at 2-year follow-up. 30 patients treated with PTA from November 2018 to September 2019 at Montevergine Clinic (Mercogliano, Avellino, Italy) were included in this analysis. All patients underwent PTA of SFA-ISR with Jetstream Atherectomy System followed by paclitaxel eluting balloon treatment. Patients were evaluated at 30 days, and every 3 months up to 24. Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. No acute and sub-acute(in-hospital) procedure related complications occurred. During follow-up, 1 patient died due to stroke. Primary patency rate at 12 months was 93.4%. Primary patency rate at 24 months was 83.4%. Secondary patency rate at 24 months was 96.7%. One minor amputation, planned before treatment, was performed in the first 30 days. Our data suggest that combined therapy with Rotational Atherectomy and DCBs for SFA-ISR represents a safe and effective procedure with a high rate of primary patency at 2-year follow-up.

Aneurysmal degeneration of fluoropolymer-coated paclitaxel-eluting stent in the superficial femoral artery: a rising concern

BackgroundAlthough several clinical reports demonstrated a durable patency rate after a novel fluoropolymer-coated paclitaxel-eluting stent (Eluvia; Boston Scientific, Marlborough, MA, USA) placement, aneurysmal degeneration after drug-eluting stent (Eluvia) placement has raised clinical concerns. Here, we report a case with progressive aneurysm formation on serial angiography and intravascular ultrasound over 50 months after drug-eluting stent (Eluvia) placement for a superficial femoral artery atheromatous plaque.Case presentationA 79-year-old woman with right leg intermittent claudication at 100 m distance was referred to our hospital. Pre-procedural angiography showed long-segment severe stenosis from the middle-to-distal part of the right superficial femoral artery, and a 7 mm wide drug-eluting stent (Eluvia) was placed. However, the patient had a recurrence of intermittent claudication in the right lower extremity 25 months thereafter. Angiography revealed de novo stenosis in the distal part of the popliteal artery and proximal superficial femoral artery in-stent restenosis. Subsequently, the patient underwent endovascular therapy for these lesions. In addition, intravascular ultrasound at the time of endovascular therapy revealed femoral artery enlargement with a maximum vessel diameter of 10.0 mm at the distal edge of the stent. Intermittent claudication on the right side recurred again 50 months after drug-eluting stent (Eluvia). Angiography demonstrated de novo severe stenosis from the distal part of the superficial femoral artery to the middle part of the popliteal artery. Peri-stent contrast staining was found at the distal part of the drug-eluting stent (Eluvia) site. Intravascular ultrasound showed a further enlargement of maximum vessel diameter to 12.0 mm at the distal edge of the stent.ConclusionsWe report a case with progressive aneurysm degeneration on serial angiography and intravascular ultrasound over 50 months after drug-eluting stent (Eluvia) placement for a superficial femoral artery stenosis.

A risk predictor of restenosis after superficial femoral artery stent implantation: relevance of mean platelet volume

BackgroundTo investigate the relationship between an increase in the pre- and post-operative mean platelet volume (MPV) and superficial femoral artery in-stent restenosis (ISR) rate.Methods and resultsWe recruited patients that underwent superficial femoral artery stenting for lower extremity arteriosclerosis obliterans at our hospital from March 2015 to March 2018. All patients gave venous blood three days before and following implantation. Doppler ultrasound, computed tomography angiography or digital subtraction angiography were used for regular follow-up examination. Logistic regression was used to identify predictors of ISR after superficial femoral artery stenting. We enrolled 173 patients, of which 34 (19.6%) were determined as having ISR for a mean of 8.9 ± 2.7 months (3–12 months). Neutrophil count, neutrophil ratio, lymphocyte ratio and platelet count pre-implantation, and platelet count and MPV after stent implantation, and the pre- and post-operative mean platelet volume difference (MPVD) and mean platelet volume difference ratio (MPVDR) were all statistically different when comparing the ISR and non-restenosis groups (p < 0.05). A positive correlation was found for post-operative MPV and presence of ISR (r = 0.58; P < 0.001). A MPVD not less than 1.5 fL was associated with an odds ratio of 9.17 (95% CI [3.76 to 22.35]; P < 0.001) for presence of ISR. A MPVDR of not less than 17.9% was associated with an odds ratio of 7.68 (95% CI [3.19 to 18.49]; P < 0.001) for occurrence of ISR.ConclusionsAn increase in pre- and post-operative MPV was correlated with the occurrence of superficial femoral artery ISR.

The relationship between neutrophil-lymphocyte ratio and in-stent restenosis in superficial femoral artery.

The present study aimed to investigate the relationship between an increase in the pre- and post-operative neutrophil–lymphocyte ratio (NLR) and superficial femoral artery in-stent restenosis (ISR) rate. We recruited 199 patients that underwent superficial femoral artery stenting for lower extremity arteriosclerosis obliterans at our hospital from March 2015 to July 2018. Patients were divided into two groups according to the occurrence of ISR within 1 year (group 1, ISR and group 2, Non-ISR). The after NLR (NLRafter) and NLR change ratio (NLRratio) (P<0.001) were significantly higher in group 1. A NLRafter > 4.3 was associated with an odds ratio of 1.946 (95% CI [1.51–2.50]; P<0.001) for the presence of ISR. A NLRratio > 37.5% was associated with an odds ratio of 3.6 (95% CI [2.03–6.36]; P<0.001) for occurrence of ISR. A NLRafter level > 4.3 had 75% sensitivity and 76% specificity for the prediction of ISR, as identified by the ROC curve. A NLRratio level > 37.5% predicted ISR with 77% sensitivity and 60% specificity. Multivariate logistic regression analysis demonstrated that NLRratio was the strongest independent predictor of ISR (P<0.001). In conclusions, NLRratio could be used as a prognostic marker in superficial femoral artery stents.

Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis

Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis

Drug-coated balloon in superficial femoral artery in-stent restenosis.

The femoropopliteal artery is one of the commonest sites of involvement in peripheral artery disease (PAD) leading to intermittent claudication and/or critical limb ischemia. Endovascular therapy for superficial femoral artery (SFA) disease has been recognized as a safe and efficient therapy and is recommended by current guidelines as the first-line approach. Although the widespread use of new-generation, self-expanding, nitinol stents in SFA stenosis has reduced the shortcomings associated with plain old balloon angioplasty (POBA), lumen renarrowing at the stented (in-stent restenosis – ISR) level still represents a relevant clinical problem, because of higher risk of recurrent ISR, occlusion and surgical revascularization compared to de-novo lesions. In this setting, different treatment options are available and drug-coated balloons (DCBs) have shown good results in terms of safety and effectiveness. In this review we examine the results of different trials exploring the outcome of using DCBs for the treatment of SFA ISR. The available data demonstrate that SFA ISR can be safely treated with percutaneous transluminal angioplasty with a DCB, with a reduction in recurrent restenosis and target lesion revascularization (TLR) at least at 1 year after POBA. The consistent and positive results of different registries and randomized trials support the use of DCB to reduce SFA ISR recurrence.

Advances in Percutaneous Therapies for Peripheral Artery Disease: Drug-Coated Balloons.

This review paper provides a summary on the use of drug-coated balloons in peripheral artery disease. It covers the main drug-coated balloon (DCB) trials. It is divided into categories of lesions: superficial femoral artery and popliteal lesions, infra-popliteal lesions and in-stent restenosis. It also includes an overview of the future of DCBs, highlighting the main ongoing trials. The latest research on DCB focuses on newer types of DCBs, mainly paclitaxel-coated but with lower doses. Another area of latest DCB research is its use in superficial femoral artery and popliteal artery in-stent restenosis, with superior outcomes. Drug-coated balloons produce better outcomes than percutaneous transluminal angioplasty alone in de novo and in-stent restenosis lesions of superficial femoral artery and popliteal arteries. More data are needed to demonstrate efficacy and safety of DCBs in infrapopliteal disease. Newer DCBs and adjunctive therapy may provide improved outcomes for peripheral artery disease interventions.

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial

Atherectomy for superficial femoral artery in-stent restenosis: can lasers light the way to a better outcome?

Atherectomy for superficial femoral artery in-stent restenosis: can lasers light the way to a better outcome?

Drug-Eluting Balloons for the Treatment of the Superficial Femoral Artery In-Stent Restenosis: 2-Year Follow-Up

The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up. From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months. During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05). The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up.

TCT-533 Drug-Eluting Balloon for treatment of superficial femoral artery in-stent restenosis. Two years results from an Italian registry.

TCT-533 Drug-Eluting Balloon for treatment of superficial femoral artery in-stent restenosis. Two years results from an Italian registry.

Drug-Eluting Balloon for Treatment of Superficial Femoral Artery In-Stent Restenosis

The purpose of this prospective registry was to evaluate the safety and efficacy, at 1 year, of the use of drug-eluting balloons (DEB) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). The use of the self-expanding nitinol stent has improved the patency rate of SFA after percutaneous transluminal angioplasty (PTA). As the population with SFA stenting continues to increase, occurrence of ISR has become a serious problem. The use of DEB has showed promising results in reducing restenosis recurrence in coronary stents. From December 2009 to December 2010, 39 consecutive patients underwent PTA of SFA-ISR in our institution. All patients underwent conventional SFA PTA and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic, Minneapolis, Minnesota). Patients were evaluated up to 12 months. Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. At 1 year, 1 patient died due to heart failure. Primary endpoint, primary patency rate at 12 months, was obtained in 92.1% (35 patients). At 1 year, patients were asymptomatic for claudication, and duplex assessment demonstrated lack of recurrent restenosis (100% rate of Secondary patency). The presence of an occlusive restenosis at the time of treatment was not associated with an increased restenosis rate, when compared with non-occlusive restenosis, at 1 year. The data suggest that adjunctive use of DEB for the treatment of SFA-ISR represents a potentially safe and effective therapeutic strategy. These data should be considered hypothesis-generating to design a randomized trial.

Lipoproteins and the Development of Restenosis After Stent Implantation in the Superficial Femoral Artery in Patients with Peripheral Artery Disease

High levels of apolipoprotein B (apo B) are a risk factor for the development of major vascular events. We evaluated the association between plasma lipoproteins and the development of superficial femoral artery (SFA) in-stent restenosis and reocclusion in patients with peripheral artery disease. We included 139 patients with SFA stenting. Plasma lipoproteins were measured after stent implantation. Stent restenosis was assessed with duplex scan after 3, 6, and 12months. A stenosis grade was considered relevant if >50%. Seventy-two patients experienced recurrence of their atherosclerotic disease, meaning restenosis of >50% within 1year of follow-up. Ten of these patients had a stent occlusion. In the patients who experienced recurrence, the mean apo B level was 105.8 versus 94.9mg/dl in patients without recurrence (P<0.05). Patients without recurrence had higher high-density lipoprotein cholesterol levels than patients with recurrence (39.7 vs. 34.7mg/dl, P<0.05). Comparing patients with a stent occlusion (n=10) and those with a restenosis of 75-99% (n=28), the patients with a stent occlusion had higher levels of plasma cholesterol (234.1 vs. 185.9mg/dl, P<0.05), apo B (135.3 vs. 99.8mg/dl, P<0.05), low-density lipoprotein cholesterol (160.3 vs. 113.6mg/dl, P<0.05), and low-density lipoprotein apo B (115.5 vs. 82.4mg/dl, P<0.001) than the patients with restenosis of 75-99% (n=28). Changes in the lipid profile could be one reason for the development of restenosis and for the development of reocclusion after SFA stenting.