Treatment Of In-stent Restenosis Research Articles

Incidence and Predictors of Outcome in the Treatment of In-Stent Restenosis with Drug-Eluting Balloons, a Real-Life Single-Centre Study.

Objectives To determine the one-year and five-year occurrence and prognosticators of major adverse cardiac events (MACE: composition of all-cause death, myocardial infarction, target vessel revascularization, and vessel thrombosis), mortality, and target lesion revascularization (TLR) in patients with in-stent restenosis (ISR) treated with drug-eluting balloons (DEBs). Background DEBs have become an emerging therapeutic option for ISR. We report the results of a single-center retrospective study on the treatment of ISR with DEB. Methods 94 consecutive patients with ISR treated with the paclitaxel-eluting balloon were retrospectively studied between August 2011 and December 2019. Results The one-year MACE rate was 11.8%, and the five-year MACE rate was 39.8%. The one-year mortality was 5.3%, and the five-year mortality rate was 21.5%. The one-year TLR rate was 4.3%, and the five-year rate was 18.7%. The univariable-Cox proportional hazard models for TLR showed lesion length, and the number of DEBs per vessel is associated with adverse outcomes with H.R. of 1.038 (1.007–1.069) and 4.7 (1.6–13.8), respectively. Conclusion Our data indicate that at one year, DEBs provide an effective alternative to stenting for in-stent restenosis. Our five-year data, representing one of the longest-term follow-ups of DEB use, demonstrate high rates of MACE. The high five-year MACE reflects all-cause mortality in a high-risk population. This is offset by a reasonable five-year rate of TLR, indicating that DEB provides both short-term and long-term benefits in ISR.

Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon

BackgroundTreatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ highly non-compliant balloon (NCB) at high pressure (>30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPN™ NCB in a real-world population. MethodsFrom an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE). ResultsTotally, 208 ISR lesions were treated in 188 patients (mean age 68 ± 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre- and post-dilatation (mean pressure 33 ± 6 atm) with the OPN™ NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died. ConclusionsFor ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials.

Intracoronary Lithotripsy Use for In-Stent Restenosis, Including Multilayer ISR

IntroductionIntravascular lithotripsy (IVL) has been well characterized as a safe and effective method for plaque modification in the treatment of de-novo, calcific coronary artery disease. In-stent restenosis (ISR) remains a major challenge in coronary revascularization, especially “multilayer” ISR. The use of IVL in ISR remains off-label and has been described in case reports and small case series. We report the single-center experience using IVL for the treatment of ISR, including multilayer ISR. Materials and methodsThis was a retrospective single-center study. All intracoronary percutaneous interventions requiring lithotripsy use, between May 2021 and December 2021, were reviewed. We selected only the cases involving IVL use for the treatment of in-stent restenosis. Baseline characteristics of patients were obtained from chart review. Procedural details and outcomes were obtained from reports and from a detailed review of procedural images. ResultsA total of 13 ISR lesions were treated with IVL, of which 5 were in cases of multilayer ISR. Procedural success was observed in 11 lesions. Three patients had recurrent angina during a mean follow-up of 133 days. None of the patients had hard outcomes of myocardial infarction or cardiac death during the follow-up period. ConclusionIVL is feasible and safe for ISR treatment including multilayer ISR. IVL is associated with good immediate procedural success, and a low rate of short-term adverse outcomes.

Identification of differentially expressed genes associated with coronary in-stent restenosis by integrated bioinformatics approaches.

In-stent restenosis (ISR) is a common complication following percutaneous coronary intervention (PCI). Designing ISR-specific therapeutic targets is important for optimizing coronary stenosis therapy. This study aims to find new potential key genes related to ISR and the usefulness of differentially expressed genes (DEGs) as diagnostic biomarkers for ISR. Microarray datasets of peripheral blood was downloaded from the Gene Expression Omnibus (GEO) public database (GSE46560, n=11). The DEGs between the ISR group and the control were obtained through the limma package analysis of the R language. Gene ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses were used to obtain the related signal pathways. STRING database was used to constructed a protein-to-protein interaction network with DEGs. Networkanalyst database was used to predict the target miRNA of the target gene. The area under the curve (AUC) value obtained from receiver operating characteristic (ROC) curve analysis was used to evaluate the diagnostic effectiveness of the hub gene in distinguishing ISR patients from normal individuals. A total of 154 DEGs were identified between ISR group and control group, including 57 up-regulated and 97 down-regulated DEGs. GO enrichment analysis showed that genes were enriched in homeostasis, cell morphology and cell connection. KEGG pathway analysis shows that genes are mainly involved in human papillomavirus infection, salmonella infection, human T-cell leukemia virus type 1 infection, axon guidance and MAPK signaling pathway. CLTA, CAT, STAT5A, CD300A, CA1, NCF2, HBQ1, AHSP, SLC4A1 and EPB42 were identified as 10 hub genes. A total of 151 target miRNAs of 7 DEGs were obtained, and 149 mRNA-miRNA pairs were identified. ROC curve indicates that CA1, STAT5A and HBQ1 have high diagnostic value in ISR. CA1, STAT5A and HBQ1 are identified as specific related genes for ISR patients. These genes may provide new targets for the early identification and treatment of ISR.

Shockwave intracoronary lithotripsy for the treatment of calcium-mediated undilatable in-stent restenosis.

Shockwave intracoronary lithotripsy for the treatment of calcium-mediated undilatable in-stent restenosis.

Outcomes and prognostic factors of patients treated for in-stent restenosis: a retrospective single-center experience

BackgroundThe incidence of in-stent restenosis (ISR) remains relatively common despite the use of drug-eluting stents. Outcomes and prognostic factors following ISR revascularization are still being investigated. We aimed to describe the outcomes following different ISR treatment strategies in order to identify prognostic factors associated with worse outcomes.ResultsIn a retrospective cohort study, we included patients who were admitted to our department and treated for ISR, from January 2017 to December 2018. All patients were followed up for a median period of 24 months. Major cardiac adverse event (MACE) was a composite outcome of the following events: myocardial infarction, target vessel revascularization, target lesion revascularization or cardiovascular death. MACEs were collected during follow-up. Our population consisted of 116 patients. Mean age was 60 years old with a sex ratio of 2.8. During follow-up, 44 patients (37.9%) had at least one MACE. Independent factors identified by multivariate logistic regression were ISR of the proximal left anterior descending artery [Odds ratio (OR) = 1.29; 95% confidence interval (95% CI) 1.16–1.81; p = 0.05], diffuse ISR [OR = 2.16; 95% CI 1.1–3.47; p = 0.022], double or triple vessel disease [OR = 2.97; 95% CI 1.2–6.8; p = 0.008], two or more stents per lesion [OR = 1.82; 95% CI 1.14–2.21, p = 0.031] and absence of post-dilatation in the initial angioplasty [OR = 1.32; 95% CI 1–1.35; p = 0.04].ConclusionsOur study suggested that ISR is related to poor outcomes. Identifying prognostic factors would play a key role in the refinement of interventional techniques.

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.

Utilization of Drug-Coated Balloons for the Treatment of Coronary Lesions in the Elderly Population.

Introduction: The use of drug-coated balloons (DCBs) has become more prevalent in the past few years for the treatment of in-stent restenosis (ISR) and de novo lesions. The absence of foreign polymer implantations potentially shortens the duration of dual anti-platelet therapy (DAPT), which can be beneficial for the elderly population. We aimed to investigate the safety and efficacy of the use of DCBs for the treatment of coronary lesions in elderly patients as compared to the younger population. Materials and methods: A database of 446 consecutive patients who underwent a procedure of DCB inflation in our institution was divided into two groups, below 70 years old and above 80 years old. We compared and analyzed the endpoints of total major adverse cardiovascular events (MACE), cardiovascular (CV) death, and all-cause mortality in both groups. Results: The difference in MACE between the two age groups was non-significant (p = 0.225); the difference in cardiovascular death was also non-significant (p = 0.086). All-cause mortality was significantly different (p < 0.0001) and can be attributed to the age of the patients. Conclusion: The utilization of DCBs for the treatment of coronary lesions may be as safe and effective for the elderly population as for the younger population and may allow a shorter period of DAPT therapy, which can lower the risk of bleeding.

The effectiveness of Salvianolate injection for in-stent restenosis after percutaneous coronary intervention: A protocol for systematic review and meta-analysis.

Background:In-stent restenosis (ISR) caused by vascular remodeling after percutaneous coronary intervention limits the long-term efficacy of this method. Salvianolate injection is now widely used in the clinical treatment of ISR. However, there is no systematic review or meta-analysis to evaluate the effects of Salvianolate injection on ISR.Methods:We will search articles in 8 electronic databases, including the Cochrane Central Register of Controlled Trials, PubMed, Embase, the Web of Science, China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, Wanfang Database, and the Chinese Scientific Journal Database for randomized controlled trials of ISR treated by Salvianolate injection from their inception to February 27, 2022. The primary outcome measure will be the restenosis rate. The data meeting the inclusion criteria were analyzed by RevMan V.5.4 software. Two authors evaluated the study using the Cochrane collaborative risk bias tool. We will use a scoring method to assess the overall evidence supporting the main results.Results:This study will analyze the clinical effectiveness of Salvianolate injection in the treatment of ISR.Conclusion:The findings of this systematic review will provide evidence to evaluate the effectiveness of Salvianolate injection for the treatment of ISR.INPLASY registration number:INPLASY202220117.

Excimer laser atherectomy combined with drug-coated balloon angioplasty for the treatment of femoropopliteal arteriosclerosis obliterans.

It has been reported that excimer laser atherectomy combined with a drug-coated balloon (ELA+DCB) can achieve better results than simple balloon angioplasty, especially for the treatment of femoropopliteal in-stent restenosis. However, reports on the application of ELA+DCB in China for femoropopliteal arteriosclerosis obliterans are lacking. This study focuses on analysing the effectiveness and safety of ELA+DCB. This was a single-centre retrospective study that enrolled patients from November 2016 to January 2019 who had femoropopliteal arteriosclerosis obliterans treated by ELA+DCB. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically. There were 43 patients with an average patient age of 68.0±8.6 years; 79.1% were male. In 30 cases, the lesions were de novo and the others were in-stent restenosis (ISR). During the procedure, flow-limiting dissection (48.8%) was the main adverse event and there were 17 bailout stent implantations due to dissection. Mean (±sd) ankle-brachial index (ABI) in the patients was 0.42±0.31 before the operation and 0.83±0.13 before discharge. The mean (±sd) follow-up time was 29.35±9.71 months. The primary patency rate was 66.8%, 64.3% and 60.9% at 12, 24 and 36 months. Freedom from target lesion revascularisation (TLR) was 85.7%, 80.7% and 75.3% at 12, 24 and 36 months. Rutherford categories also greatly improved during follow-up. Overall mortality was 6.9% (3/48), and no deaths were related to the intervention. The use of ELA+DCB had good clinical benefit for femoropopliteal arteriosclerosis obliterans, which had good primary patency and freedom from TLR, although intraoperative complications still required attention. Multicentre randomised controlled trials with long-term follow-up are needed.

Efficacy and safety of drug-coated balloon in the treatment of acute myocardial infarction: a meta-analysis of randomized controlled trials

Acute myocardial infarction (AMI) is one of the main causes of death in the world, and the incidence of AMI is increasing in the young population. Drug-coated balloon (DCB) has become an effective concept for the treatment of in-stent restenosis, small vessel disease, bifurcation lesions, high blood risk conditions, and even de novo large vessel disease. To ensure whether DCB can play an alternative role in AMI, we conducted a comprehensive meta‐analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of DCB in the treatment of AMI. Electronic databases were searched for RCTs that compared DCB with stent for AMI. The primary outcome was major adverse cardiac events (MACEs), the secondary outcome was late lumen loss (LLL). RevMan 5.3 software and RStudio software were used for data analysis. Five RCTs involving 528 patients with 6–12 months of follow-up were included. There was no significant difference in the incidence of MACEs between DCB group and stent group (RR, 0.85; 95% CI 0.42 to 1.74; P = 0.66). Lower LLL was shown in DCB group (WMD, − 0.29; 95% CI − 0.46 to − 0.12; P < 0.001). This meta-analysis of RCT showed that DCB might provide a promising way on AMI compared with stents. Rigorous patients’ selection and adequate predilation of culprit lesions are necessary to optimize results and prevent bailout stent implantation.PROSPERO registration number: CRD42020214333.

Comparison of 2 Different Paclitaxel-Coated Balloons in CoronaryIn-Stent Restenosis: A Randomized Controlled Trial.

Drug-coated balloons (DCBs) offer an effective treatment for in-stent restenosis (ISR). The Genoss DCB is a novel paclitaxel-coated balloon with a shellac plus vitamin E excipient that enhances drug delivery to the target lesion, minimizing restenosis. This study aimed to investigate the angiographic efficacy, clinical safety, and effectiveness of the novel shellac plus vitamin E-based DCB in a randomized controlled trial designed to enable regulatory approval of this new device in South Korea. This noninferiority trial randomized patients experiencing their first ISR to the novel shellac plus vitamin E-based DCB or the reference SeQuent Please iopromide-based DCB in a 1:1 ratio. All patients underwent planned angiographic and clinical follow-up at 6months. The study was powered for the primary endpoint of 6months in-segment late lumen loss (LLL). A total of 82 patients from 7 centers were randomized to either the novel shellac plus vitamin E-based DCB group (n=41) or the reference iopromide-based DCB group (n=41). The 6-month in-segment LLL was 0.15 ± 0.43mm with the novel DCB compared with 0.24 ± 0.39mm with the reference device. The 1-sided 97.5% upper confidence limit of the difference was 0.13mm, lower than the noninferiority limit of 0.29mm, achieving noninferiority (P for noninferiority=0.001). Major cardiovascular events were comparable between 2 groups at 6months (7.7% for the novel DCB vs 10.3% for the reference DCB; P = 0.692). In this multicenter, head-to-head comparison randomized trial, the novel shellac plus vitamin E-based DCB showed a comparable result to the reference iopromide-based device for the primary endpoint of 6-month in-segment LLL for the treatment of coronary ISR. (Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patient With Coronary In-stent Restenosis; NCT04405063).

Valproic acid decreases vascular smooth muscle cell proliferation via protein phosphatase 2A-mediated p70 S6 kinase inhibition

Valproic acid (VPA) has been used to treat epilepsy and bipolar disorder. Although the abnormal proliferation of vascular smooth muscle cells (VSMCs) is a well-established contributor to the development of various vascular diseases including atherosclerosis, the effect of VPA on VSMC proliferation and its mechanism of action have not been fully revealed. Herein, we investigated the molecular mechanism by which VPA inhibits rat VSMC proliferation. VPA dose-dependently decreased VSMC proliferation, which was accompanied by the dose-dependent decrease in phosphorylation of p70 S6 kinase (p70S6K) at Thr389 (p-p70S6K-Thr389), and overexpression of the p70S6K-T389E mutant gene significantly reversed VPA-inhibited VSMC proliferation. Co-treatment with okadaic acid, a specific protein phosphatase 2A (PP2A) inhibitor, significantly restored p-p70S6K-Thr389. Furthermore, knockdown of PP2Ac gene expression by siRNA significantly reversed VPA-inhibited p-p70S6K-Thr389 and VSMC proliferation. Confocal microscopic analyses and co-immunoprecipitation results clearly showed that the physical binding of p70S6K and PP2Ac was promoted by VPA. Valpromide, a VPA's structural derivative with no histone deacetylase (HDAC) inhibition activity, as well as VPA and sodium butyrate, an HDAC inhibitor similar to VPA, decreased VSMC proliferation and p-p70S6K-Thr389, indicating that HDAC is not involved in VPA-inhibited VSMC proliferation. Finally, the inhibitory effects of VPA on p-p70S6K-Thr389 and VSMC proliferation were reiterated in a platelet-derived growth factor (PDGF)-induced in vitro atherosclerosis model. In conclusion, our results demonstrate that VPA decreased cell proliferation via PP2A-mediated inhibition of p-p70S6K-Thr389 in basal and PDGF-stimulated VSMCs. The results suggest that VPA could be used in the treatment and prevention of atherosclerosis and in-stent restenosis.

Use of rotational atherectomy for treatment of in-stent restenosis with coronary double-mesh stent underexpansion. Case report

Treatment of in-stent restenosis lesions, especially calcified lesions, with stent underexpansion, generally requires more complex techniques, such as rotational atherectomy. The case reported is a male patient with a 99% in-stent focal restenosis lesion at the origin of the first diagonal branch, where two stents were implanted 14 years ago. After failure of balloon angioplasty alone, ablation of the plaque and part of the stent struts was performed using the rotational atherectomy technique, which allowed the implantation of a new stent which was totally expanded.

Intravascular Lithotripsy in Calcified Coronary Lesions: A Single-Center Experience in "Real-World" Patients.

ObjectivesThis study aims to describe the outcome of intravascular lithotripsy (IVL) when used with different indications and to assess the short- and long-term outcomes of IVL-facilitated percutaneous coronary intervention (PCI).BackgroundIntravascular lithotripsy can improve the results of PCI of calcified coronary lesions with a low rate of periprocedural complications.MethodsA total of 105 consecutive patients with 110 calcified lesions underwent IVL. A total of 87 de novo lesions were treated by IVL with the following indications: 25 before attempting other balloon-based devices (primary IVL), 51 after the failure of non-compliant balloon dilatation (secondary IVL), and 11 after stent implantation because of stent under expansion (bailout IVL). In 23 lesions, IVL was used for the treatment of in-stent restenosis (ISR). Effectiveness (angiographic success) and safety [major adverse cardiovascular events (MACEs) and IVL-related procedural complications] endpoints were assessed.ResultsAngiographic success was achieved in 84.6% of lesions. Early MACEs were periprocedural MI only, ranging from 6.7 to 20% depending on MI definition. The flow-limiting dissections rate was 2.7%. A total of five (4.5%) IVL balloons ruptured during treatment with subsequent vessel perforation in 1 case. MACEs at 12 months were 13.3%, with TLR occurring in 8 lesions (12% primary IVL, 0% secondary IVL, 0% bailout IVL, and 21.7% IVL for ISR, p = 0.002).ConclusionTreatment of calcified coronary lesions with IVL in a “real-world” setting can be performed with high success, low rate of procedural complications, and an acceptable MACEs rate. Target lesion failure may be more frequent when IVL is performed for the treatment of ISR due to calcium-mediated stent under expansion.

Treatment of in-stent restenosis with sirolimus-eluting magnesium bioresorbable scaffolds: optical coherence tomography insights.

To assess the value of sirolimus-eluting magnesium bioresorbable scaffolds (MgS) in the treatment of patients with in-stent restenosis (ISR). The better option for the treatment of patients with ISR remains unsettled. Bioresorbable vascular scaffolds represent an interesting strategy in this setting to avoid another permanent metal layer. The novel MgS is an attractive option to treat these challenging patients. We present the results of the first prospective series of consecutive patients with ISR treated with MgS under optical coherence tomography (OCT) guidance. A total of 14 patients (15 lesions) were prospectively included. The mean age was 67 ± 9 years and six patients (40%) presented with an acute coronary syndrome. In 10 patients (67%), underlying neoatherosclerosis was disclosed by OCT. An excellent MgS expansion was obtained in all but two patients who showed persistent suboptimal expansion in heavily calcified vessels. Minor residual malapposition ( n = 5) and angiographically silent minor edge dissections ( n = 8) were readily recognized by OCT. After a median clinical follow-up of 30 (range, 20-54) months, no patient required repeated revascularization, suffered a myocardial infarction or device thrombosis. These preliminary results suggest a potential role for the MgS in selected patients presenting with ISR.

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.

High Dose-rate Brachytherapy For Lower Extremity In-stent Restenosis: A 18-year, Single-center Experience

INTRODUCTION AND OBJECTIVES We present our 18-year experience of endovascular brachytherapy (EVBT), which was previously validated as a treatment for in-stent restenosis (ISR). METHODS We performed a single-center retrospective analysis of outcomes in 158 patients who underwent PTA and EVBT from 2003 to 2020. A dose of 20Gy was given at a depth of 0.5mm beyond the radius of the largest PTA balloon using iridium-192, with at least 2-cm-long margins of radiation coverage proximal and distal to the injured area. Stents were assessed for patency by duplex ultrasound imaging or angiography at 1, 3, 6, 9, 12, and 18 months and then yearly. The primary endpoint was freedom from 50% restenosis in the treated segment at 1 year, and 2 years. Patency data were estimated using the Kaplan-Meier method. Secondary endpoints were early and late thrombotic occlusion. RESULTS Of the 174 consecutive cases of EVBT, 29 (16.7%) were performed in common, external, or internal iliac, 145 (83.3%) in common femoral, superficial femoral, or popliteal arteries, or both. 142 patients (89.9%) had claudication, and 16 (10.1%) had critical limb ischemic symptoms. Preliminary analysis revealed the mean treated length to be 24.1 ± 12.3 cm over a mean duration of 16.5 ± 9.6 minutes. Median post-EVBT follow-up time was 2670 days (range, 1-4154 days). There were six (3.4%) and eighteen (10.3%) cases of early and late thrombotic occlusions, respectively. There were two deaths secondary acute coronary syndrome and stroke. Primary, assisted primary, and secondary patency in the entire cohort was 77.5%, 88.6%, and 90.6%, respectively, at 1 year and 64.8%, 79,2%, and 83.6%, respectively, at 2 years. CONCLUSIONS Our validated PTA with adjunctive EVBT protocol, followed by a consistent surveillance strategy, proves to offer a viable treatment option of ISR in centers that have the capacity to collaborate with Radiation Oncology. We present our 18-year experience of endovascular brachytherapy (EVBT), which was previously validated as a treatment for in-stent restenosis (ISR). We performed a single-center retrospective analysis of outcomes in 158 patients who underwent PTA and EVBT from 2003 to 2020. A dose of 20Gy was given at a depth of 0.5mm beyond the radius of the largest PTA balloon using iridium-192, with at least 2-cm-long margins of radiation coverage proximal and distal to the injured area. Stents were assessed for patency by duplex ultrasound imaging or angiography at 1, 3, 6, 9, 12, and 18 months and then yearly. The primary endpoint was freedom from 50% restenosis in the treated segment at 1 year, and 2 years. Patency data were estimated using the Kaplan-Meier method. Secondary endpoints were early and late thrombotic occlusion. Of the 174 consecutive cases of EVBT, 29 (16.7%) were performed in common, external, or internal iliac, 145 (83.3%) in common femoral, superficial femoral, or popliteal arteries, or both. 142 patients (89.9%) had claudication, and 16 (10.1%) had critical limb ischemic symptoms. Preliminary analysis revealed the mean treated length to be 24.1 ± 12.3 cm over a mean duration of 16.5 ± 9.6 minutes. Median post-EVBT follow-up time was 2670 days (range, 1-4154 days). There were six (3.4%) and eighteen (10.3%) cases of early and late thrombotic occlusions, respectively. There were two deaths secondary acute coronary syndrome and stroke. Primary, assisted primary, and secondary patency in the entire cohort was 77.5%, 88.6%, and 90.6%, respectively, at 1 year and 64.8%, 79,2%, and 83.6%, respectively, at 2 years. Our validated PTA with adjunctive EVBT protocol, followed by a consistent surveillance strategy, proves to offer a viable treatment option of ISR in centers that have the capacity to collaborate with Radiation Oncology.

Short-term efficacy and safety of TurboHawk atherectomy for in-stent restenosis in peripheral artery disease: a single-centre experience.

Information regarding the efficacy of the TurboHawk atherectomy for the treatment of in-stent restenosis (ISR) in patients with peripheral artery disease (PAD) of the lower extremity is scarce. This study was performed to investigate the curative efficacy and safety of the TurboHawk system for ISR in PAD patients over 60 years old. The TurboHawk atherectomy device was used to treat ISR in 28 patients with PAD. The intraoperative, 2-day postoperative, 3-month, and 2-year follow-up data were obtained. Differences in the ankle-brachial index (ABI), Rutherford class and minimum diameter of the femoral-popliteal artery were analysed along with the correlations of the factors associated with patency. Twenty-six patients (92.86%) had successful surgeries. All patients reported alleviation of pain and intermittent claudication after surgery. One patient who had a malignant hepatoma and coronary heart disease received an amputation on the 76th postoperative day and another patient who had atrial fibrillation received a thrombectomy on the 40th postoperative day. TurboHawk atherectomy increased the ABI (from 0.30 to 0.70, P < 0.0001) and minimum diameter (from 0 to 4.93 mm, P < 0.0001) and reduced the Rutherford class (from 4.00 to 2.00, P < 0.0001). During the 3-month follow-up, the median minimum diameter, ABI, and Rutherford class were 4.12, 0.69, and 2.00, respectively. No death happened during the 3-month follow-up. The TurboHawk atherectomy is a safe and effective technique for ISR in PAD patients over 60 years old.

Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry).

IntroductionData regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous.AimTo evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES.Material and methodsOverall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs. > 3 and ≤ 6 vs. > 6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes.ResultsPairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs. > 6 months) before PSM revealed superiority of DES + DAPT > 6 months vs. DEB + DAPT > 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Also, DES + DAPT ≤ 6 months was found to be superior compared to DEB + DAPT ≤ 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Kaplan-Meier estimate analysis confirmed that DAPT > 6 months is related to a higher stroke rate (p = 0.01) when compared to ≤ 6 months.ConclusionsTreatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT > 6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.