Femoropopliteal Artery In-stent Restenosis Research Articles

Rivaroxaban and Aspirin in Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis: A Retrospective Cohort Study

BackgroundAfter drug-coated balloon (DCB) treatment of the femoropopliteal artery in-stent restenosis (ISR), a certain proportion of patients also experience target lesion restenosis. The purpose of this study was to explore the efficacy and safety of rivaroxaban combined with aspirin in the treatment of ISR after DCB intervention. MethodsPatients who underwent DCB treatment for ISR after femoropopliteal artery intervention at our center from March 2017 to February 2022 were included consecutively. According to the drug treatment after DCB intervention of ISR, the patients were divided into rivaroxaban and aspirin group (RA Group) and dual antiplatelet therapy (DAPT) group. The outcomes of two groups during the 12-month follow-up after DCB intervention were compared. ResultsA total of 92 patients were included in final analysis, with 43 in RA group and 49 in DAPT group. During 12-month follow-up, a total of 15 cases of recurrent ISR were detected, and the recurrence rate of ISR and clinically driven TLR in the RA group were lower than those in the DAPT group (P<0.05). The vascular patency rate in the RA group was higher than that in the DAPT group at 6 and 12 months of follow-up (P<0.05). During the follow-up, there were no adverse events such as death, myocardial infarction, stroke, amputation, or major bleeding, and only a total of 5 cases of minor bleeding occurred. ConclusionCompared with the standard DAPT regimen, rivaroxaban combined with aspirin can safely improve the follow-up outcome after DCB for femoropopliteal ISR.

Outcomes and Comparative Analysis of the Initial Results of Standard Balloon Angioplasty Versus Drug-Coated Balloons Alone Versus in Association With Laser-Excimer Atherectomy in the Treatment of Femoropopliteal Artery In-Stent Restenosis (INTACT).

Despite improved patency with newer-generation nitinol stents, one-half of patients will require secondary interventions for in-stent restenosis (ISR). The best treatment strategy remains unclear. This study aimed to compare drug-coated balloons (DCBs) used alone or in association with excimer laser atherectomy (ELA) to simple percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal-ISR. The INTACT trial is a multicenter, prospective, triple-arm randomized trial conducted across 14 centers from December 2015 to November 2019. Patients Rutherford Class 2-5 with ISR≥70% were followed-up for 18 months. The primary efficacy endpoint was recurrent ISR>70% by duplex ultrasound analysis. The primary safety endpoint was major adverse events (MAEs) defined as death, major amputation, or target lesion revascularization (TLR). Around 134 subjects were randomized to PTA alone (n=41), PTA+DCB (n=43) or PTA+ELA+DCB (n=50). Procedural success was similar (p=.74), as was clinical success (p=.17). The number of recurrent ISR>70% decreased after PTA+ELA+DCB (30.0%; p=.04) and PTA+DCB (30.2%; p=.05) compared to PTA alone (51.2%). Primary patency was higher after PTA+ELA+DCB (log-rank p=.04) and PTA+DCB (log-rank p=.02) compared to PTA alone at 12 months (78.7% and 70.4% vs 61.5%) and 18 months (61.6% and 67.7% vs 37.3%). Freedom from MAEs was lower after PTA+DCB (27.9%) compared to PTA alone (53.7%; p=.02) but did not differ with PTA+ELA+DCB (40.0%). It was primarily driven by TLR; 2 major amputations occurred after PTA+ELA+DCB (4.0%; p=.18). This independent study demonstrated a decrease in recurrent ISR>70% and increase in primary patency up to 18 months after PTA+ELA+DCB and PTA+DCB compared to PTA alone in the treatment of FP-ISR. It did not show an increase in MAEs but could have lacked power. This multicenter, prospective, triple-arm randomized, controlled trial focuses on the results of adjunctive therapies, such as excimer laser atherectomy (ELA) and/or drug-coated balloons (DCBs) in the treatment of in-stent restenosis (ISR) in femoropopliteal lesions in 134 patients. It has the originality of being an independent study funded by a grant from the French Ministry of Health. This study confirms a significant decrease in recurrent ISR >70% and increase in primary patency up to 18 months after the use of ELA+DCB and DCBs compared to simple percutaneous transluminal angioplasty in the treatment of femoropopliteal ISR without an increase in major adverse events.

The Safety and Efficacy of Different Endovascular Treatments for In-Stent Restenosis of the Femoropopliteal Artery: A Network Meta-analysis

Review of the MEDLINE, Embase, Web of Science, and Cochrane databases through February 1, 2021. There were 1348 patients from 14 eligible studies (10 prospective, randomized; 4 retrospective) with femoropopliteal artery in-stent restenosis (FP-ISR) who underwent plain old balloon angioplasty (POBA), drug-coated balloon angioplasty (DCBA), peripheral cutting balloon angioplasty, Viabahn endoprosthesis, directional atherectomy, excimer laser atherectomy, and combination therapy. Technical success rates were significantly higher for Viabahn endoprosthesis than for DCBA and POBA alone. The 1-year primary patency rates were significantly higher for excimer laser atherectomy plus DCBA than excimer laser atherectomy plus POBA and POBA alone. Excimer laser atherectomy plus DCB showed encouraging results regarding one-year primary patency rates for femoropopliteal in-stent restenosis.

The safety and efficacy of different endovascular treatments for in-stent restenosis of the femoropopliteal artery: A network meta-analysis.

Introduction: Femoropopliteal artery in-stent restenosis (ISR) remains a challenging treatment. We performed a network meta-analysis (NWM) for femoropopliteal artery ISR to explore the safety and efficacy of endovascular therapeutic strategies. Methods: The MEDLINE, Embase, Web of Science, and Cochrane databases were used as data sources. The network meta-analysis (NWM) approach used random-effects models based on the frequentist framework. We compared technical success rate, primary patency, target lesion revascularization (TLR), and major amputation at the 12-month follow-up for femoropopliteal artery ISR. Results: In total, 14 eligible studies (10 prospective and four retrospective; 1348 patients; and eight treatment modalities - standard balloon angioplasty (SBA), drug-coated balloon (DCB), peripheral cutting balloon angioplasty (PCBA), Viabahn endoprosthesis (VBE), directional atherectomy (DA), excimer laser atherectomy (ELA), and combinations - were included. The primary patency rates (at 6 months) were significantly higher for DCB and ELA+DCB than for SBA and ELA+SBA. ELA+DCB had higher primary patency rates (at 12 months) than ELA+SBA and SBA. The technical success rates were significantly lower for DCB and SBA than for VBE. The major amputation rates were significantly lower for ELA+DCB than for DCB. Based on the surface values under the cumulative ranking curve (SUCRA), ELA+DCB was considered the best treatment in terms of primary patency at 6 months (SUCRA = 91.1), primary patency at 12 months (SUCRA = 82.3), and TLR (SUCRA = 83.4). Conclusion: ELA+DCB showed positive encouraging results in primary patency (6, 12 months), TLR, and major amputation in femoropopliteal ISR. The efficacy and safety of ELA+DCB are worthy of further investigation. PROSPERO Registration No.: CRD42021246674.

Percutaneous Mechanical Atherectomy Plus Thrombectomy Using the Rotarex®S Device Followed by a Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-stent Restenosis: A Prospective Single-Center, Single-Arm Efficacy Trial (PERMIT-ISR Trial).

Background: Studies investigating debulking devices with drug-coated balloons (DCBs) in the treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) are limited. We aimed to evaluate the safety and midterm outcome of percutaneous mechanical atherectomy plus thrombectomy (MATH) using the Rotarex®S (Straub Medical, Wangs, Switzerland) catheter followed by a DCB in the treatment of FP-ISR.Methods: This study was a single-center single-arm trial. Patients with symptomatic (Rutherford category 2–5) de novo restenosis lesions of FP-ISR were treated with MATH and subsequent DCB. From June 2016 to May 2018, 59 patients with FP-ISR were enrolled. The primary endpoint was target lesion revascularization (TLR) and changes in the Rutherford category of the target limb at 12 months. Secondary endpoints included primary and secondary patency at 12 months, technical success rate, major adverse events, and ankle-brachial index (ABI). Risk factors for TLR were analyzed using Cox proportional hazard model.Results: The average follow-up time was 33 ± 8 months. The rate of technical success was 88.1% (52/59). Nine patients received bailout stenting. The rate of freedom from TLR was 84.7% (50/59) at 1 year, the Rutherford category changed at 12 months were significantly improved from baseline (p < 0.01). The primary patency rates and the secondary patency at the 12-month follow-ups were 82.5 and 92.5%, respectively. The ABI changed at 12 months were significantly improved from baseline (p < 0.01). Global limb anatomic staging system (GLASS) classification III [hazard ratio (HR) 18.44, 95% CI (1.57–215.99), p = 0.020] and postoperative Rutherford classification ≥4 [HR 8.28, 95% CI (1.85–37.06), p = 0.006] were identified as independent predictors of TLR.Conclusion: Our preliminary data suggested that MATH using a Rotarex®S catheter combined with DCB angioplasty is a safe, minimally invasive, and effective treatment for FP-ISR with favorable, immediate, and midterm outcomes.Clinical Trial Registration:http://www.chictr.org.cn, identifier [ChiCTR2000041380].

How does drug-eluting angioplasty compare with uncoated balloon angioplasty for adults with in-stent restenosis of femoropopliteal arteries?

How does drug-eluting angioplasty compare with uncoated balloon angioplasty for adults with in-stent restenosis of femoropopliteal arteries?

Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis.

To assess the efficacy and safety of Orchid drug-coated balloon (DCB) for treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) in Chinese patients. The study is a prospective, single center, single-blinded, randomized controlled trial (RCT) that randomized (1:1) 74 patients to DCB group (N.=38) and PTA group (N.=36). The primary efficacy endpoint was primary patency of the target lesion at 12 months. Second efficacy endpoint included clinically-driven target-lesion revascularization (CD-TLR) and ABI change at 12 months. The primary safety endpoint included peri-operative death at 30 days, all-cause death, major amputation, and other major adverse events (MAEs) at 12 months. The primary functional endpoint included Walking Impairment Questionnaire (WIQ), quality-of-life measures (EQ-5D) and 6-minute walking test (6MWT). The DCB group had higher primary patency (87.9% vs. 51.6%; P=0.001) and lower rates of CD-TLR (6.1% vs. 35.5%; P=0.003) than the PTA group at 12 months. There were no peri-operative deaths, and no major amputations at 12 months in two groups. There were 1(2.6%) in the DCB group and 2 (5.6%) in the PTA group of all-cause deaths (P=0.524). Results from the study showed superior treatment effect with Orchid DCB versus PTA for the treatment of FP ISR, and without an apparent difference in safety.

Combination of Rotarex Thrombectomy and Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-Stent Restenosis

The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR. From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ). Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45±0.14 at baseline and 0.84±0.12 at 12months (P<0.05). The WIQ score was 30.45±21.14 at baseline and 52.68±29.75 at 12months (P<0.05). The Kaplan-Meier estimate of the primary patency rate at 12months was 86.2% (25/29), and freedom from CD-TLR rate at 12months was 89.7% (26/29). The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.

Treatment of Femoropopliteal Artery In-stent Restenosis

Femoropopliteal (FP) artery-in stent restenosis (ISR) is a daunting management problem that we continue to face. FP artery-ISR rates after primary stent implantation are relatively high. Although repeat FP artery-ISR and the need for additional interventions remain all too common, little consensus exists regarding the best treatment algorithm. In this article, we review the limitations of the currently used devices for the endovascular treatment of FP artery-ISR and discuss which strategies are the most effective and safe.

Drug-coated balloon angioplasty for in-stent restenosis of femoropopliteal arteries: a meta-analysis.

Our aim was to perform a meta-analysis to investigate the outcomes of patients undergoing percutaneous revascularisation with drug-coated balloon (DCB) angioplasty because of femoropopliteal in-stent restenosis (ISR). We searched scientific databases for studies of DCB angioplasty for femoropopliteal ISR. The primary outcome was target lesion revascularisation (TLR). The main secondary outcome was recurrent ISR. Other outcomes of interest were Rutherford class (RC) improvement, ankle-brachial index (ABI) and death. A total of 367 patients enrolled in four studies received DCB (n=188) or plain balloon angioplasty (n=179). Median follow-up was 12 months. Patients treated with DCB angioplasty displayed a lower risk for TLR (odds ratio [OR] 0.20, 95% confidence interval [CI]: 0.07-0.55, p=0.002) and recurrent ISR (OR 0.24, 95% CI: 0.09-0.61, p=0.003), and a sustained RC improvement (OR 2.57, 95% CI: 1.40-4.72, p=0.002) with similar ABI and mortality as compared to those patients treated with plain balloon angioplasty. In comparison to plain balloon angioplasty, DCB therapy for femoropopliteal ISR is associated with superior clinical and antirestenotic efficacy. Further randomised trials comparing DCB with therapies alternative to plain balloon, in a larger number of patients, and with extended follow-up are needed to address definitively the role of DCB for femoropopliteal ISR.

Number of Blades-up Runs Using JetStream XC Atherectomy for Optimal Tissue Debulking in Patients with Femoropopliteal Artery In-Stent Restenosis

Rotational atherectomy with the use of the JetStream XC device is indicated for treatment of infrainguinal arterial obstructive disease. The number of blades-up (BU) runs needed for optimal tissue debulking in femoropopliteal in-stent restenosis (ISR) is unknown. In the present series, 6 patients (15 lesions) were treated for femoropopliteal ISR with the JetStream XC device. Minimal luminal diameter or percent stenosis improved significantly from baseline after 2 BU runs, but no further gain was seen between 2 and 4 BU runs (P > .05). However, adjunctive balloon angioplasty reduced percent stenosis significantly following BU runs. In conclusion, the JetStream XC device achieved optimal acute angiographic results in treating femoropopliteal ISR following 2 BU runs and adjunctive balloon angioplasty.

Two Blades-Up Runs Using the JetStream Navitus Atherectomy Device Achieve Optimal Tissue Debulking of Nonocclusive In-Stent Restenosis

Purpose: To determine the number of runs with blades up (BU) using the JetStream Navitus to achieving optimal debulking in a porcine model of femoropopliteal artery in-stent restenosis (ISR). Methods: In this porcine model, 8 limbs were implanted with overlapping nitinol self-expanding stents. ISR was treated initially with 2 blades-down (BD) runs followed by 4 BU runs (BU1 to BU4). Quantitative vascular angiography (QVA) was performed at baseline, after 2 BD runs, and after each BU run. Plaque surface area and percent stenosis within the treated stented segment were measured. Intravascular ultrasound (IVUS) was used to measure minimum lumen area (MLA) and determine IVUS-derived plaque surface area. Results: QVA showed that plaque surface area was significantly reduced between baseline (83.9%±14.8%) and 2 BD (67.7%±17.0%, p=0.005) and BU1 (55.4%±9.0%, p=0.005) runs, and between BU1 and BU2 runs (50.7%±9.7%, p<0.05). Percent stenosis behaved similarly with no further reduction after BU2. There were no further reductions in plaque surface area or percent stenosis with BU 3 and 4 runs (p=0.10). Similarly, IVUS (24 lesions) confirmed optimal results with BU2 runs and no additional gain in MLA or reduction in plaque surface area with BU3 and 4. IVUS confirmed no orbital cutting with JetStream Navitus. There were no stent strut discontinuities on high-resolution radiographs following atherectomy. Conclusion: JetStream Navitus achieved optimal tissue debulking after 2 BD and 2 BU runs with no further statistical gain in debulking after the BU2 run. Operators treating ISR with JetStream Navitus may be advised to limit their debulking to 2 BD and 2 BU runs to achieve optimal debulking.

CRT-90 Safety and One-Year Revascularization Outcome of Excimer Laser Ablation Therapy in Treating In-Stent Restenosis of Femoropopliteal Arteries: A Retrospective Review from a Single Center

Treatment of in-stent restenosis of the femoropopliteal artery is challenging with a high rate of restenosis. Excimer laser atherectomy (ELA) has a theoretical advantage of ablating restenotic tissue and reducing or delaying the need for repeat revascularization. We present a retrospective analysis

Safety and One-Year revascularization outcome of excimer laser ablation therapy in treating in-stent restenosis of femoropopliteal arteries: A retrospective review from a single center

Treatment of in-stent restenosis of the femoropopliteal (FP) arteries is challenging with a high rate of restenosis. Excimer laser atherectomy (ELA) has a theoretical advantage of ablating restenotic tissue and reducing or delaying the need for repeat revascularization. We present a retrospective analysis from our center on the outcomes of ELA in the treatment of in-stent restenosis of the FP arteries. Demographic, clinical, angiographic and procedural data were collected on all patients that underwent ELA for in-stent restenosis from February 2005 to April 2010 at a single medical center. Major adverse events and one-year target lesion revascularization (TLR) and target vessel revascularization (TVR) were obtained by reviewing of medical records. Descriptive analysis was performed on all variables. Kaplan-Meier survival curves for TLR were plotted. 40 consecutive patients (mean age 67.7±9.0years, 57.5% males) were included and followed for 1year. Adjunctive balloon angioplasty was performed in 100% at a mean pressure of 12.4±2.9atm. Acute procedural success (<30% angiographic residual narrowing) occurred in 92.5% of patients. Embolic filter protection (EFP) was used in 57.5% of patients. Bailout stenting was 50.0%. Macrodebris was noted in 65.2% of filters. The following adverse events were reported: distal embolization (DE) requiring treatment 2.5% (1 patient with no EFP); planned minor amputation 2.6%, planned major amputation 2.6%, total death 7.7% (all cardiac related). One perforation occurred treated successfully with stenting and balloon inflation. At one year, TLR and TVR occurred in 48.7% and 48.7% respectively. ELA has an overall favorable acute result in treating in-stent restenosis of the FP arteries. At one year TLR and TVR remain clinically significant. DE also occurs significantly with ELA and is effectively prevented with EFP.

Safety and 1-year revascularization outcome of SilverHawk atherectomy in treating in-stent restenosis of femoropopliteal arteries: A retrospective review from a single center

Treatment of in-stent restenosis of the femoropopliteal arteries with balloon angioplasty carries a high rate of recurrence and requires frequent repeat stenting. In the "Instructions for Use," SilverHawk atherectomy (SA) is contraindicated for in-stent restenosis at a peripheral site. SA, however, has a theoretical advantage of reducing the volume of restenotic tissue and potentially delaying the need for frequent repeat revascularization and additional stenting. We present a retrospective analysis from our center on the safety and outcomes of SA in the treatment of in-stent restenosis of the femoropopliteal arteries. Demographic, clinical, angiographic, and procedural data were collected on all patients who underwent SA for in-stent restenosis from February 2005 to April 2010 at a single medical center. Major adverse events and 1-year target lesion revascularization (TLR) and target vessel revascularization (TVR) were obtained by review of medical records and phone calls. Descriptive analysis was performed on all variables. Kaplan-Meier survival curves for TVR were plotted. A total of 41 consecutive patients (mean age 70.9±9.2 years, 56% males) were included and followed for a mean of 331.63 days. The following variables were noted: mean ankle brachial index (ABI) of treated leg 0.66±0.2; chronic renal failure (creatinine >2.0 at baseline) 14.6%; diabetes 61%; history of smoking 85.4%; number of vessel runoffs of treated limb 1.9±0.9; hypertension 90.2%; lesion length 126.2±79.3mm; lesion severity 90.7±8.2%; vessel diameter 5.8±0.7 mm. All patients received bivalirudin during the procedure and were on aspirin. Ninety-five percent of patients were placed on clopidogrel. Adjunctive balloon angioplasty was performed in 97.6% at a mean pressure of 11.9±3.3atm. Embolic filter protection (EFP) was used in 56.1% of patients. Bailout stenting was 24.4%. Acute procedural success (<30% angiographic residual narrowing) occurred in 100% of patients. Compared to baseline, ABI at 1 month significantly improved to 0.91±0.19 (P<0.05) but was not statistically different at 1 year (0.61±0.28). Debris was noted in 81.9% of filters used; 36.4% were macrodebris. The following adverse events were reported: distal embolization (DE) requiring treatment 7.3%; stent thrombosis 4.9%; planned minor amputation in the nonindex limb 2.4%. No device-related complications occurred. There was no death or amputation. TLR and TVR occurred in 31.7% and 34.1%, respectively. SA has favorable acute results in treating in-stent restenosis of the femoropopliteal arteries. At 1 year, TLR and TVR remain high but compare favorably to published data. DE also occurs significantly with SA and EFP appears to be effective in capturing the debris.

Safety and one-year revascularization outcomes of Silverhawk atherectomy in treating in-stent restenosis of femoropopliteal arteries: a retrospective review from a single center

Safety and one-year revascularization outcomes of Silverhawk atherectomy in treating in-stent restenosis of femoropopliteal arteries: a retrospective review from a single center

Conventional Balloon Angioplasty versus Peripheral Cutting Balloon Angioplasty for Treatment of Femoropopliteal Artery In-Stent Restenosis: Initial Experience

To prospectively determine whether cutting balloon angioplasty, when compared with conventional balloon angioplasty (CBA), improves morphologic and clinical outcome in patients with femoropopliteal in-stent restenosis. Patients with symptomatic femoropopliteal in-stent restenosis were randomly assigned to undergo CBA or peripheral cutting balloon angioplasty (PCBA) for treatment of lesions up to 20 cm in length. Patients were followed up clinically and with duplex ultrasonography (US) at 1, 3, and 6 months for occurrence of a restenosis of 50% or higher. The Fisher exact test and Mann Whitney U test were used for statistical analyses. Forty patients were enrolled; one patient was lost to follow-up. In the remaining patients, CBA was performed in 22 patients; PCBA was used in 17 patients. Average lesion length was 80 mm +/- 68 (standard deviation). Restenosis rates at 6 months were 65% (11 of 17; 95% confidence interval: 42%, 88%) after PCBA versus 73% (16 of 22; 95% confidence interval: 54%, 92%) after CBA (P = .73). Ankle brachial index (0.83 vs 0.75, P = .26) and maximum walking capacity on the treadmill (117 m vs 103 m, P = .97) at 6 months were also not significantly different between the two groups. PCBA failed to prove superiority compared with CBA for treatment of femoropopliteal in-stent restenosis in this pilot study. In restenotic lesions with an average length of approximately 8 cm, both treatment modalities yielded disappointing 6-month patency rates.