Treatment Of In-stent Restenosis Research Articles

One-Year Outcomes After Treatment of Ostial In-Stent Restenosis in Left Circumflex Versus Left Anterior Descending or Right Coronary Artery

The prognosis of left circumflex (LC) versus non-LC in-stent restenosis (ISR) ostial lesions following treatment has not been assessed. We aimed to assess this prognosis. Anecdotally, treatment of ostial LC ISR has been associated with high recurrence rates. We performed a retrospective analysis of patients from our institution who underwent coronary intervention of an ostial ISR lesion between 2003 and 2018. The primary endpoint was target lesion revascularization (TLR) and major adverse cardiovascular events (MACE). Overall, 563 patients underwent ostial ISR lesion intervention, 144 for an ostial LC ISR lesion. Compared to patients with ostial ISR in non-LC lesions, patients with ostial LC ISR were older, had higher rates of diabetes mellitus and previous coronary bypass surgery. At 1-year follow-up, TLR-MACE rates were 26.6% in the LC group versus 18.4% in the non-LC group (p = 0.036). The TLR rate was also higher in the LC group compared to the non-LC group (p = 0.0498). Univariate and multivariate analyses demonstrated a higher TLR-MACE rate for LC versus non-LC ostial ISR lesions. In conclusion, our study shows increased event rates after treatment of LC versus non-LC ISR lesions. Further studies should be done to assess the optimal treatment approach for ostial LC ISR.

Non-Invasive Treatment for Coronary In-Stent Restenosis via Wireless Revascularization With Nitinol Active Stent.

This paper reports a novel shape memory alloy (SMA) nitinol type active stent for non-invasive restenosis treatment, which operates using a radiofrequency (RF) electro-thermo-mechanical actuation technique for wireless revascularization. The developed stent is equipped with a capacitive pressure sensor for in-artery blood pressure measurement and can provide multiple expansion to restore the blood pressure flow. The device design, working principle, fabrication, and characterization of the nitinol active stent are reported in this work. The wireless monitoring feature is achieved via peak shifting in the reflection coefficient of the S11 parameter. The active stent with initial diameter and resonant frequency of 2 mm and 315 MHz, respectively, is expanded uniformly in stages up to 4.2 mm in diameter when excited with an RF power of ∼30 W for 320 s. The active stent is delivered and deployed ex vivo inside the left coronary artery of a cervine heart. The stented cervine heart before and after wireless actuation is inspected via penetration of X-rays. Endoscopic images reveal the expansion of the stent strut profile within the lumen of the stented artery. The active stent expands in stages up to 3.7 mm in diameter to scaffold the cervine coronary artery after excited with an RF power of 46.7 W. The achievable wireless revascularization capability eradicates the necessity of reintervention and repeat stenting procedure, whereas real-time wireless monitoring provides rapid indication of in-artery re-narrowing occurrence.

Magnesium alloy stents: A friend or foe of coronary in-stent restenosis?

Coronary artery disease (CAD) is regarded as the principal cause of cardiovascular diseases and one of the leading causes of mortality. In order to alleviate the risk of CAD, percutaneous coronary intervention (PCI) and stent implantation have recently been applied. In particular, Mg alloy (Mg-alloy) stents (MAS) have been used as clinical routine for the treatment of CAD. However, emerging evidence suggests that this treatment strategy is substantially associated with coronary in-stent restenosis (ISR), which remains the main cause of unintentional and repeat drug-eluting stent (DES) interventions in the United States. In this regard, understanding of MAS as friend or foe of ISR treatment is needed to establish the exact mechanism underlying this condition. This mini review therefore aimed to provide an integrated view on the existing findings of the relationship between MAS and ISR. The understanding of MAS as either a friend or foe is crucial for the management of ISR, which is reported to be very challenging amidst lack of effective therapeutic options.

Intracoronary brachytherapy for the treatment of recurrent drug-eluting stent in-stent restenosis: A systematic review and meta-analysis.

BACKGROUNDWe performed a meta-analysis on observational studies since randomized control trials are not available. We studied intracoronary brachytherapy (ICBT) and recurrent drug eluting stent in-stent restenosis (DES-ISR) to evaluate the procedural success, target lesion revascularization (TLR), incidence of myocardial infarction (MI) and all-cause mortality at 2 years follow-up.AIMTo perform meta-analysis for patients undergoing ICBT for recurrent DES-ISR.METHODSWe performed a systematic search of the PubMed/MEDLINE, Cochrane and DARE databases to identify relevant articles. Studies were excluded if intra-coronary brachytherapy was used as a treatment modality for initial ISR and studies with bare metal stents. We used a random-effect model with DerSimonian & Laird method to calculate summary estimates. Heterogeneity was assessed using I2 statistics.RESULTSA total of 6 observational studies were included in the final analysis. Procedural angiographic success following intra-coronary brachytherapy was 99.8%. Incidence of MI at 1-year was 2% and 4.1% at 2-years, respectively. The incidence of TLR 14.1% at 1-year and 22.7% at 2-years, respectively. All-cause mortality at 1- and 2-year follow-up was 3% and 7.5%, respectively.CONCLUSIONGiven the observational nature of the studies included in the analysis, heterogeneity was significantly higher for outcomes. While there are no randomized controlled trials or definitive guidelines available for recurrent ISR associated with DES, this analysis suggests that brachytherapy might be the alternative approach for recurrent DES-ISR. Randomized controlled trials are required to confirm results from this study.

POS-405 SINGLE KIDNEY WITH RENAL ARTERY STENOSIS CAUSING PICKERING SYNDROME

Pickering syndrome, defined as recurrent 'flash' pulmonary oedema in patients with renal artery stenosis (RAS), is associated with a high mortality. Our case highlights the importance of careful patient selection for percutaneous renal artery stenting (PRAS) to ensure the benefits of revascularisation. A 51-year-old female, with a single functioning kidney secondary to reflux nephropathy, known hypertension, ischaemic heart disease, and a 10 pack-year smoking history, presented to the emergency department with a two week history of dyspnoea, 'flash' pulmonary oedema, a progressive pericardial effusion, acute kidney injury and severe hypertension despite treatment with frusemide and four anti-hypertensive agents. Her blood pressure (BP) remained poorly controlled with systolic readings between 170 and 190 mmHg and diastolic levels between 90 and 110 mmHg. She subsequently developed acute respiratory failure requiring ventilator support. Computed tomographic (CT) angiography revealed severe ostial left RAS and near-occlusive distal aortic atheromatous disease (Figure 1). Following extensive multidisciplinary discussion, a catheter-based selective renal angiogram and stenting were performed, with access from the brachial artery. This resulted in marked improvement in renal perfusion, BP control and diuresis (5-6 litres per day for a week). She was extubated within 48 hours and her kidney function normalised. Percutaneous stenting for the treatment of atherosclerotic RAS continues to be a controversial topic because of variable results from several randomised clinical trials (including ASTRAL, DRASTIC, STAR and CORAL). The primary patency of an optimally sized and deployed bare-metal renal stent exceeds 80% at 5 years. Once placed, periodic kidney function and BP monitoring are required, as is annual renal artery Doppler ultrasonography for surveillance of in-stent restenosis (ISR). There is no consensus on the optimal treatment for ISR; however, drug-coated balloon angioplasty, which delivers anti-proliferative drugs such as paclitaxel directly to the endothelial surface, has recently emerged as a promising therapeutic option.

Role of laser ablation in recalcitrant instent restenosis post iliofemoral venous stenting.

Instent restenosis (ISR) represents the most common reason for recurrent symptoms requiring reintervention in patients who have undergone venous stenting for chronic iliofemoral venous obstruction. Treatment of ISR requires stent angioplasty typically using angioplasty balloons equal to or larger than the rated diameter of the stent. At times this does not yield the required result, and in these patients, utilization of a laser catheter supported by an angled sheath is helpful to ablate the ISR or make it more amenable to repeat balloon angioplasty. The authors report their experience with this technique for 18 patients with recurrent symptoms impacting quality of life as a result of recalcitrant ISR in this retrospective review of contemporaneously entered electronic medical record data. 12 (67%) limbs underwent laser ablation only, while 6 (33%) limbs underwent additional angioplasty post laser ablation. Post intervention for ISR, at 12 months, the venous clinical severity score improved from 5 to 3.5 (P = .0005) and the VAS pain score went from 7 to 5 (P = .0005). At 10 months, primary patency was 87% and primary assisted patency was 100%. There were no stent occlusions. Laser ablation of recalcitrant instent restenosis in patients presenting with recurrent chronic iliac venous obstruction post iliofemoral venous stenting is a safe and effective option. Corroboration from larger studies is warranted.

Drug-coated balloons in the treatment of acute myocardial infarction (Review).

Drug-eluting stents are the standard revascularization strategy for the treatment of symptomatic coronary artery disease. However, in-stent restenosis (ISR), stent thrombosis and reinfarction of target lesions following stent implantation present challenges. Drug-coated balloons (DCBs), which deliver antiproliferative drugs into the vessel wall without stent implantation, are a novel treatment option for percutaneous coronary intervention and have been proven to act as a promising strategy in the treatment of ISR and coronary small vessel disease. However, their role in acute myocardial infarction (AMI) remains unclear. The present review discusses current evidence for the treatment of AMI with DCBs.

Endovascular management of symptomatic stenosis of supra-aortic arteries in patients with Takayasu arteritis.

Endovascular management is used to treat Takayasu arteritis (TA) involving the supra-aortic branches. However, the long-term outcome of this treatment remains unclear. Here, technical safety, outcomes, and restenosis management of supra-aortic arteries in TA patients receiving endovascular treatment were evaluated. TA patients with symptomatic supra-aortic stenosis who underwent percutaneous angioplasty and stenting between 2008 and 2018 at our institute were enrolled in this study. Pre- and post-procedural magnetic resonance imaging (MRI) evaluations, including high-resolution vessel wall imaging (HR-VWI), were performed. Technical efficacy, peri-procedural complications, early post-procedural MRI results, and stent patency were examined. All six patients successfully received stent placement or percutaneous transluminal angioplasty in a total of 22 treated arteries without neurologic complications. During follow-up (mean, 56.3 ± 41.1 months), no recurrent stroke occurred, yet significant restenosis developed in 12 of 22 (54.5%) of the treated arteries. Three of the patients underwent HR-VWI before surgery. Concentric wall thickening and enhancement of the left common carotid artery was detected in one patient, indicating acute inflammation. Angioplasty with drug-eluting balloon (DEB) successfully treated a case of refractory restenosis. Among 10 early post-procedure MRI performed, only two asymptomatic new lesions were detected with diffusion-weighted imaging. Endovascular treatment of supra-aortic arteries of TA patients was safe and effective, yet was associated with a high restenosis rate. Thus, close follow-up is needed. HR-VWI is helpful for pre-procedural selection of patients for percutaneous angioplasty and stenting and drug-eluting balloon angioplasty appears to be a promising treatment for refractory in-stent restenosis.

Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study.

Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).

Intravascular Ultrasound-Guided Coronary Lithotripsy Treatment of In-Stent Restenosis in Saphenous Venous Graft.

To the best of our knowledge, this is the first description of intravascular-ultrasound guided coronary lithotripsy on saphenous vein graft because of severely calcific in-stent restenosis, showing good result without procedural complications.

Rotational Atherectomy for the Management of Undilatable In-Stent Restenosis with Single or Multiple Stent Layers

BackgroundThere is no consensus on the best treatment of undilatable coronary in-stent restenosis (ISR) regardless of the number of stent layers. We aimed to evaluate the procedural and clinical outcomes of rotational atherectomy (RA) to treat undilatable coronary ISR with single or multiple stent layers. MethodsWe retrospectively evaluated consecutive patients treated with RA for undilatable ISR with single or multiple stent layers in the Mount Sinai catheterization laboratory between January 2016 and September 2018. Procedural success was defined as angiographic success without in-hospital major adverse cardiac events (MACE): a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Clinical outcomes were assessed at one-year post-procedure. ResultsA total of 26 patients were included in the study, in which 18 (69.2%) patients were with multiple stent layers. After RA, 9 (34.6%) were received a new drug-eluting stent, and 6 (23.1%) were treated with intravascular brachytherapy. Angiographic success was achieved in 24 (92.3%) patients, and procedural success was achieved in 22 (84.6%) patients. In-hospital MACE occurred in 4 (15.4%) patients, all due to periprocedural non-Q wave MI. Within one year, MACE occurred in 9 (34.6%) patients with 5 (19.2%) TLR. ConclusionsRA for undilatable ISR with single or multiple stent layers was performed with favorable procedural outcomes and a relatively high MACE rate driven by TLR within one year.

Intravascular Lithotripsy for the Treatment of Calcium-Mediated Coronary In-Stent Restenoses.

Coronary intravascular lithotripsy (IVL) has recently been evaluated for the treatment of severely calcified native coronary lesions. Evidence for its use in in-stent restenosis is sparse and is still an off-label indication. Therefore, we aimed to evaluate the feasibility, safety, and acute and mid-term angiographic outcomes after IVL for the treatment of calcium-mediated coronary in-stent restenosis. A retrospective, single-center analysis was performed for 6 cases with undilatable instent restenosis due to calcium-mediated stent underexpansion and/ or calcified neointima from January to November 2019. Lesions were treated with IVL (Shockwave Medical) and subsequent drug-eluting stent or drug-coated balloon. Angiographic success was defined as residual lumen stenosis <20% and Thrombolysis in Myocardial Infarction 3 flow. Follow-up angiography was performed at a median of 141.5 days. Six patients presented with symptomatic in-stent restenoses (65.8% to 87.9%) at 11 to 175 months after implantation. Intravascular and angiographic imaging detected calcium-mediated stent underexpansion (n = 2), calcified neointima (n = 2), or a combination of both (n = 2) as cause of restenosis. In-stent IVL, subsequent high-pressure balloon dilation, and drug-eluting stent or drug-coated balloon implantation were performed successfully in all cases. Acute angiographic success and angina relief were achieved in 5 of 6 cases and sustained during follow-up. No major acute cardiovascular events occurred. The application of IVL for the treatment of calcium-mediated coronary in-stent restenosis was feasible and safe, and yielded promising short- and mid-term results in the majority of cases.

Should paclitaxel be considered an old generation DCB? The limus era.

Since their introduction Drug Coated Balloons (DCBs) have slowly gained their spot into everyday cath-lab practice, first for treatment of in-stent restenosis (ISR), more recently for small vessels disease; today a growing body of evidence start supporting their use in more complex lesions, from bifurcations, to large vessels, to acute lesions. Although the new generation of DCBs showed a better performance and safety than the older one, the drug of choice has always been the Paclitaxel; last year some concerns were raised on the safety of Paclitaxel devices, in particular the balloons mining their use. Recently Sirolimus ventured in the DCBs world, making its appearance on cath-lab shelves and becoming a good alternative to Paclitaxel (DCB).

Recent advances in cardiovascular stent for treatment of in-stent restenosis: Mechanisms and strategies

Treatments of atherogenesis, one of the most common cardiovascular diseases (CVD), are continuously being made thanks to innovation and an increasingly in-depth knowledge of percutaneous transluminal coronary angioplasty (PTCA), the most revolutionary medical procedure used for vascular restoration. Combined with an expanding balloon, vascular stents used at stricture sites enable the long-time restoration of vascular permeability. However, complication after stenting, in-stent restenosis (ISR), hinders the advancement of vascular stents and are associated with high medical costs for patients for decades years. Thus, the development of a high biocompatibility stent with improved safety and efficiency is urgently needed. This review provides an overview of current advances and potential technologies for the modification of stents for better treatment and prevention of ISR. In particular, the mechanisms of in-stent restenosis are investigated and summarized with the aim to comprehensively understanding the pathogenesis of stent complications. Then, according to different therapeutic functions, the current stent modification strategies are reviewed, including polymeric drug eluting stents, biological friendly stents, pro-healing stents, and gene stents. Finally, the review provides an outlook of the challenges in the design of stents with optimal properties. Therefore, this review is a valuable and practical guideline for the development of cardiovascular stents.

Treatment of Patients With Recurrent Coronary In-stent Restenosis With Failed Intravascular Brachytherapy

Intravascular brachytherapy (VBT) is an effective and safe treatment option for recurrent drug-eluting stent (DES) in-stent restenosis (ISR). However, the optimal therapy for patients with failed VBT is not well-defined. In this study, we sought to evaluate the optimal treatment strategy for patients after a failed VBT. Patients with recurrent ISR after an initial unsuccessful VBT were identified from our percutaneous coronary intervention database. Patients were divided into 2 cohorts (standard treatment with DES or balloon angioplasty versus repeat VBT). Baseline characteristics and clinical outcomes during follow-up were extracted. A total of 279 patients underwent PCI after an initial unsuccessful VBT at our institution. Of those, 215 (77%) patients underwent standard treatment with balloon angioplasty with or without DES, and 64 (33%) underwent balloon angioplasty followed by repeat VBT. The mean age of the cohort was 64±11 years. Overall, 71% were men, 47% had diabetes, and 22% had heart failure. The majority (64%) presented with unstable angina. The groups had similar baseline characteristics. The rate of major adverse cardiovascular events (defined as all-cause mortality, myocardial infarction, or target vessel revascularization) was significantly lower in the repeat VBT group at 1 year (31% vs 14%, p = 0.03), 2 years (51% vs 31%, p = 0.03), and 3 years (57% vs 41%, p = 0.08). Target lesion revascularization and target vessel revascularization were consistently lower in the repeat VBT group at all follow-up intervals than in the standard treatment group. Treatment of recalcitrant ISR following an initial failed VBT is associated with a high MACE rate at 3-year follow-up. Repeat VBT is safe and effective and should be considered as the preferred strategy.

Hybrid Recanalization for the Treatment of Carotid/Vertebral In-stent Restenosis or Occlusion: Pilot Surgery Experiences From One Single Center.

Background : The hybrid recanalization of internal carotid artery (ICA) and vertebral artery (VA) in-stent restenosis or occlusion using a combination of endarterectomy and endovascular intervention has achieved technical success. We present our surgical experiences to further evaluate the safety and efficacy of the hybrid technique for the treatment of in-stent restenosis and occlusion.Methods : A cohort of 12 refractory patients with in-stent restenosis or occlusion who underwent hybrid recanalization, a combination of endarterectomy and endovascular intervention, were retrospectively analyzed. Medical records, including presenting symptoms, comorbidities, contralateral ICA/VA findings, use of antiplatelet drugs, postoperative complications, and angiographic outcomes, were collected.Results : Among 415 consecutive patients with ICA, common carotid artery, and V1 segment lesions, 12 refractory patients (2.89%) with 13 cases were enrolled in our study (1 female and 11 male). All patients underwent successful hybrid recanalization. There were no cases of postoperative stroke or death. Only two patients sustained hoarseness, but it resolved within 2 weeks after surgery. Three patients were treated with dual antiplatelet (aspirin and clopidogrel), seven with single antiplatelet (aspirin), one with single antiplatelet (clopidogrel), and one with single antiplatelet (ticagrelor). All patients were followed up in the outpatient department according to the protocol, with a mean follow-up period of 13 months (range, 6–24 months). No death or recurrent symptoms occurred during the regular follow-up period.Conclusion : The hybrid technique maybe a safe and feasible treatment option to recanalize in-stent restenosis or occlusion with acceptable complications.

Abstract 15570: Pathology of In-stent Neointima in Atherosclerotic Porcine Peripheral Artery Treated by Drug-coated Balloon

Introduction: The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal scaffold. Clinical non-inferiority of DCB for treatment of in-stent restenosis (ISR) has been demonstrated compared to drug eluting stents (DES) implantation. However, pathology of neointima treated by DCB remains unclear. Aim: Pathological study of neointima after DCB treatment for ISR has not been reported. This study aimed to examine the tissue response after DCB treatment and plain old balloon angioplasty (POBA) for ISR pathologically, by using atherosclerotic femoral artery of porcine model. Methods: Using micromini pigs fed high-cholesterol, high-fat diet for 3 months, we stented bare metal stents in femoral arteries. After one month of stenting, dilatation of in-stent region by using DCB, and non-compliance balloon (NCB) as POBA were performed. Optimal coherence tomography and angioscopy showed drug adhesion on luminal surface. One month after the balloon expansion, treated arteries were dissected and stent segments were fixed with 10% buffered formalin and embedded in plastic. Stents were segmented at 3mm intervals and histologic sections were prepared. The neointimal area and blood vessel area were morphometrically evaluated, and the ratio of neointimal area per blood vessel area was calculated. Additionally, number of cells per 1mm 2 neointimal area was counted with digital morphometry. Results: We compared the histology between DCB (n=3, 18 histological sections) and POBA (n=3, 18 histological sections) lesions. The ratio of neointimal area per blood vessel area treated by DCB was 0.17 ± 0.01, while that of POBA was 0.21 ± 0.01 (P value = 0.02) respectively. Additionally, the number of cells per 1mm 2 neointimal area was significantly less in the neointima dilated by DCB (1940.9 ± 150.9), compared to that dilated by NCB (2599.8 ± 190.3) (P value = 0.01). These results suggest that DCB treatment after ISR prevents neointimal thickening by inhibiting proliferation of smooth muscle cells. Conclusions: We examined the pathology of in-stent neointima dilated by DCB in peripheral artery of atherosclerotic porcine model. Pathological analysis showed suppressed neointimal proliferation after DCB compared to POBA.

Bioresorbable scaffold versus drug coated balloon for treatment of in-stent-restenosis – long-term outcomes of the randomized ABSORB-ISR trial

Abstract Background Observational studies showed promising results after treatment of coronary instent-restenosis (ISR) using the everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb®. Purpose We compared long-term outcomes after treatment of ISR with BVS versus the paclitaxel-eluting drug coated balloon (PE-DCB) SeQuent® Please, which is commonly used for treatment of ISR. Methods This was randomized-controlled trial of Absorb® BVS versus SeQuent® Please PE-DCB in an all-comers population with clinically relevant ISR. The patients were randomized in a 1:1 fashion. The angiographic primary endpoint was late lumen loss (LLL) at 9 months. Clinical follow-ups (FU) up to 48 months were conducted. Results Totally, 53 patients and lesions were enrolled. The mean age was 66.7±9.8 years, 23 (43.4%) had an acute coronary syndrome (ACS) and 16 (30.2%) were diabetic. PCI was successful in all patients. After 9 months, the mean LLL did not significantly differ between patients treated with BVS versus PE-DCB (median 0.41 (interquartile range (IQR) 0.15; 1.23)mm versus 0.27 (IQR 0.13; 0.66)mm, p=0.86). Moreover, mean lumen area on optical coherence tomography (OCT) did not significantly differ (median 5.47 (IQR 4.44; 7.69)mm2 versus 6.70 (IQR 5.00; 7.82)mm2, p=0.24). Rates of significant ISR (angiographic stenosis &amp;gt;70%) were similar with BVS versus PE-DCB (7 (30.4%) versus 6 (27.3%), p=0.81). The target vessel revascularization rates were 9 (33.3%) versus 9 (34.6%) using the BVS versus PE-DCB (p=0.72), also highlighted in the Figure below). No stent/ scaffold thrombosis occurred during FU. The study was prematurely stopped due to withdrawal of the Absorb® BVS in September 2017. Conclusions In this randomized pilot study, we found no significant difference in angiographic, OCT and clinical endpoints after treatment of ISR lesions using the Absorb BVS versus SeQuent® Please PE-DCB during long-term follow-up (≥48months). However, rates of target vessel revascularization were very high in both groups (&amp;gt;30%). TVR and TLF with BVS or PE-DCB for ISR Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott Vascular

Evidence for treatment of lower limb in-stent restenosis with drug eluting balloons

Restenosis by myointimal hyperplasia after peripheral arterial angioplasty or stenting often limits long term patency. Drug-eluting balloons (DEBs) which inhibit the proliferation of neo-intimal growth of vascular smooth muscle cells may prevent restenosis. The aim of this paper was to examine the evidence in published literature on the use of DEBs in the treatment of peripheral arterial in-stent restenosis (ISR). A systematic literature review was undertaken of all published literature on the treatment of peripheral ISR with drug eluting balloon using Medline and cross-referenced. All published papers on the use of DEBs in peripheral arterial disease (PAD) were used. Cochrane Central Register of Controlled Trials and electronic databases were also searched for on-going studies. There were no level 1 or 2 evidence published on this subject. The number of high-quality publications is few, and consequently a sufficient analysis is not possible. Recently data from non-randomized cohort studies showed encouraging results with DEB as treatment modality for ISR, whether used alone or as combined strategies. Evidence from the published literature suggests that DEBs are safe in preventing peripheral ISR. Despite strong corporate pressure for the use of DEBs, there is only circumstantial evidence that this is a useful modality for ISR. Results from on-going studies may allow further meta-analysis for efficiency and cost-effectiveness.

Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial.

This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. The primary effectiveness endpoint of the study is the primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (PSVR≤2.5) and without target lesion revascularization (TLR) within 12 months. The primary safety endpoint is the proportion of subjects who experience serious device-related adverse events within 30 days postprocedure. A total of 83 patients meeting inclusion and exclusion criteria have been enrolled in this prospective, randomized, multicenter, controlled study in 7 sites between June 2010 and February 2012. Patients with an in-stent restenosis lesion in the femoropopliteal region and a Rutherford classification from 2 to 5 could be enrolled. After screening, the patient was randomized to either treatment with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface or treatment with a standard PTA balloon. After the index procedure, follow-up visits at 1 month, 6 months, 12 months and 24 months were required. A color flow Doppler ultrasound was performed on all follow-up visits and a quantitative vascular angiography at the 12-month follow-up visit. In the VIABAHN® group, 39 patients (74.4% male; mean age 67.69±9.77 years) were enrolled and in the PTA group, 44 patients (72.7% male; mean age 68.98±9.71 years) were enrolled, which is comparable for both treatment groups. In the VIABAHN® group, 34 (87.2%) patients presented with claudication (Rutherford 2 and 3) and 5 (12.8%) patients had critical limb ischemia (Rutherford 4 and 5). In the PTA group, 36 (81.8%) patients were claudicants (Rutherford 2 and 3) and 8 (18.2%) presented with critical limb ischemia (Rutherford 4 and 5). The 12-month primary patency rates were 74.8% for the VIABAHN® group and 28.0% for the PTA group (P<0.001). No patients were reported to have device-related serious adverse events within 30 days postprocedure. The primary patency rate for the 24-month follow-up was 58.40% in the Viabahn group and 11.60% in the PTA group (P<0.001). The treatment of femoropopliteal in-stent restenosis with a VIABAHN® Endoprosthesis shows significantly better results than the treatment with a standard PTA balloon. This demonstrates that the use of the VIABAHN® Endoprosthesis is a very promising tool for the treatment of complex in-stent restenosis.