Treatment Of Restenosis Research Articles

Two-year outcomes of drug-coated balloon only strategy for de novo lesions in large coronary vessels

Abstract Background Drug-coated balloons (DCB) are effective for the treatment of in-stent restenosis and de novo lesions in small coronary vessels (reference vessel diameter: RVD < 3.0 mm). Recently, several studies have reported acceptable results of DCB for de novo lesions in large coronary vessels (RVD ≧ 3.0 mm). However, previous studies were limited, we investigated the clinical outcomes of the DCB only strategy for de novo lesions in large coronary vessels. Methods We retrospectively analyzed 97 patients with 107 de novo lesions (RVD ≧ 3.0 mm) who underwent DCB only angioplasty from January 2016 to December 2021. We scheduled angiographic follow-up at 6 months after procedure and analyzed quantitative coronary angiography (QCA) data. Results The mean duration of follow-up was 737.8 ± 512.6 days. Patients who met the high bleeding risk (HBR) criteria was 56 (57.7%). Procedure success rate was 97.2% (3 lesions needed bailout drug eluting stent implantation) and acute coronary occlusion was not observed. The 2-year cumulative incidences of all-cause death was 7.1%, cardiac death was 1.6%. Target vessel revascularization was 9.2%, target lesion revascularization was 4.2%, respectively. Two patients had major bleeding events (BARC type 3 or 5) within 3 months after treatment and during the DAPT period. No major bleeding events were observed during the SAPT period. Conclusion The clinical outcomes of the DCB only strategy for de novo lesions in large coronary vessels were safe and acceptable. Especially in HBR patients, DCB only strategy could be an alternative treatment option.

Treatment of coronary artery disease with sirolimus- versus paclitaxel-coated balloons

Abstract Background Percutaneous coronary interventions (PCI) with paclitaxel-coated balloons (PCB) represent an established treatment for in-stent restenosis (ISR) and small coronary arteries. Lately sirolimus-coated balloons (SCB) have been introduced. Yet, studies comparing SCBs to PCBs are lacking. Purpose We sought to assess clinical outcomes at 12 months of an all-comer population presenting with acute or chronic coronary artery disease (CAD) treated with either a novel SCB or an established PCB. Methods We analyzed consecutive patients from the ongoing prospective SIROOP registry (NCT:04988685). Outcomes of interest included, target lesion failure (TLF), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiac-death (cv-death). All angiograms and outcomes were independently adjudicated. Results A total of 359 patients were included in this analysis, 220 (61%) and 139 (39%) patients were treated with SCBs and PCBs, respectively. Diabetes was present in 108 (30%) of patients and 145 (40%) patients presented with an acute coronary syndrome. The mean Syntax score of the overall population was 17.8±11, 95 (26%) of the lesions were ISR, 30 (8.4%) chronic total occlusions (CTOs) and 211 (59%) had moderate to severe calcifications. All lesions were treated with a DCB-only approach in both groups. Mean DCB diameter was 2.8±0.56 mm and the maximal mean dilatation pressure was 8.1±4.7 atm. We encountered no relevant coronary artery perforations or acute vessel closures. Further baseline and procedural characteristics can be found in Figure 1. At 1-year follow-up, there was no statistically significant difference in the TLF rate between patients treated with SCBs versus PCBs (14 (7.4%) versus 12 (10%), respectively, (p=0.5)), with TLR being the leading cause for TLF (13 (6.8%) in the SCB and 10 (8.8%) in the PCB group, p=0.7). Figure 2 depicts the Kaplan-Meier curve of TLF over time. The leading TLF cause appeared to be lesion recoil/ collapse in both groups. Comparing ISR lesions treated with SCBs versus PCBs, there was also no significant difference with regards to the TLF rate (3 (9.1%) versus 4 (8.2%), respectively, p=1.00). Conclusions To our best knowledge, this is one of the first studies comparing SCBs to PCBs for treatment of CAD. At 1-year follow-up, there was no significant difference in outcomes between the two groups. Moreover, there was a numerically lower number of adverse events among patients treated with SCBs. These findings warrant further investigation in a dedicated randomized trial.Baseline and procedural characteristicsKaplan-Meier curve of TLF

Ultrasound-mediated delivery of Pik3cb shRNA using magnetic nanoparticles for the treatment of in-stent restenosis in a rat balloon-injured model.

The aim of the present work was to examine the effect of polyethylene glycol (PEG)-coated superparamagnetic iron oxide (SPIO) nanoparticles carrying Pik3cb short hairpin RNA (shRNA) in the prevention of restenosis with the aid of ultrasound and a magnetic field. SPIO is a type of contrast agent used in medical imaging to enhance the visibility of specific tissues or organs. It consists of tiny iron oxide nanoparticles that can be targeted to specific areas of interest in the body. PEG-coated SPIO nanoparticles carrying Pik3cb shRNA (SPIO-shPik3cb) were prepared, and the particle size and zeta potential of PEG-coated SPIO nanoparticles with and without Pik3cb shRNA were examined. After a right common artery balloon-injured rat model was established, the rats were randomly divided into four groups, and the injured arteries were transfected with SPIO-shPik3cb, saline, SPIO-shcontrol and naked shRNA Pik3cb. During the treatment, each group was placed under a magnetic field and was transfected with the aid of ultrasound. Rats were sacrificed, and the tissue was harvested for analysis after 14days. The results suggested that the mean particle size and zeta potential of SPIO-shPik3cbs were 151.45 ± 11nm and 10mV, respectively. SPIO-shPik3cb showed higher transfection efficiency and significantly inhibited the intimal thickening compared with naked Pik3cb shRNA in vascular smooth muscle cells (VSMCs) (*P < 0.05). Moreover, SPIO-shPik3cb could also significantly downregulate the expression of pAkt protein compared with naked Pik3cb shRNA. According to the results, SPIO-shPik3cb can remarkably inhibit the intimal thickening under a combination of magnetic field exposure and ultrasound.

Recurrent Revascularization at 10 Years After Percutaneous Treatment of Drug-Eluting Stent Restenosis

BackgroundTreatment of patients with recurrence of in-stent restenosis (ISR) remains particularly challenging, with data and guideline recommendations for repeat percutaneous coronary intervention being scant. ObjectivesThe aim of this study was to investigate the long-term incidence of recurrent revascularization events after percutaneous treatment of drug-eluting stent (DES) ISR. MethodsIn this post hoc analysis, 402 patients (500 lesions) assigned to plain balloon (PB), drug-coated balloon (DCB), or DES treatment in the randomized ISAR-DESIRE 3 (Efficacy Study of Paclitaxel-Eluting Balloon, -Stent vs. Plain Angioplasty for Drug-Eluting Stent Restenosis) trial were followed up over a median of 10.3 years. The primary endpoint was total repeat target lesion revascularization (R-TLR) including all, first and recurrent, events. ResultsAt the end of follow-up, first R-TLR was required in 204 lesions, 82 in the PB group, 70 in the DCB group, and 52 in the DES group. The total number of R-TLRs was 373: 162 in the PB group, 124 in the DCB group, and 87 in the DES group. During the first year of follow-up, the risk for total R-TLR was reduced by DCB (HR: 0.36; 95% CI: 0.24-0.54) and DES (HR: 0.23; 95% CI: 0.14-0.38) treatment compared with PB treatment. After 1 year, the risk for total R-TLR was nonsignificantly reduced by DCB treatment (HR: 0.77; 95% CI: 0.51-1.16) and significantly reduced by DES treatment (HR: 0.61; 95% CI: 0.39-0.95) compared with PB treatment. Risk in the DCB and DES groups was similar during (HR: 1.54; 95% CI: 0.89-2.69) and after (HR: 1.26; 95% CI: 0.82-1.92) 1 year. ConclusionsThe total number of R-TLRs over 10 years after treatment of patients with DES ISR was high. DCBs and particularly DES were able to reduce the need for both first and recurrent revascularization compared with PB treatment.

Exosomes from umbilical cord-derived mesenchymal stem cells combined with gelatin methacryloyl inhibit vein graft restenosis by enhancing endothelial functions

BackgroundThe prevalence of coronary artery disease is increasing. As a common treatment method, coronary artery bypass transplantation surgery can improve heart problems while also causing corresponding complications. Venous graft restenosis is one of the most critical and intractable complications. Stem cell-derived exosomes could have therapeutic promise and value. However, as exosomes alone are prone to inactivation and easy removal, this therapeutic method has not been widely used in clinical practice. Methacrylated gelatin (GelMA) is a polymer with a loose porous structure that maintains the biological activity of the exosome and can control its slow release in vivo. In this study, we combined human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) and GelMA to explore their effects and underlying mechanisms in inhibiting venous graft restenosis.ResultsHuman umbilical cord mesenchymal stem cells (hUCMSCs) were appraised using flow cytometry. hUCMSC-Exos were evaluated via transmission electron microscopy and western blotting. hUCMSC-Exos embedded in a photosensitive GelMA hydrogel (GelMA-Exos) were applied topically around venous grafts in a rat model of cervical arteriovenous transplantation, and their effects on graft reendothelialization and restenosis were evaluated through ultrasonic, histological, and immunofluorescence examinations. Additionally, we analyzed the material properties, cellular reactions, and biocompatibility of the hydrogels. We further demonstrated that the topical application of GelMA-Exos could accelerate reendothelialization after autologous vein transplantation and reduce restenosis in the rat model. Notably, GelMA-Exos caused neither damage to major organs in mice nor excessive immune rejection. The uptake of GelMA-Exos by endothelial cells stimulated cell proliferation and migration in vitro. A bioinformatic analysis of existing databases revealed that various cell proliferation and apoptosis pathways, including the mammalian target of rapamycin (mTOR)–phosphoinositide 3-kinase (PI3K)–AKT signaling pathways, might participate in the underlying regulatory mechanism.ConclusionsCompared with the tail vein injection of hUCMSC-Exos, the local application of a mixture of hUCMSC-Exos and GelMA was more effective in promoting endothelial repair of the vein graft and inhibiting restenosis. Therefore, the proposed biomaterial-based therapeutic approach is a promising treatment for venous graft restenosis.

EFFICACY AND SAFETY OF DRUG-ELUTING BALLOON VS DRUG-ELUTING STENTS IN THE TREATMENT OF IN-STENT RESTENOSIS

The in-stent restenosis (ISR) treatment remains related to the higher recurrence rate. This comparative study aimed to compare the effectiveness and safety of drug-eluting balloon (DEB) vs drug-eluting stents (DES) in the in-stent restenosis treatment. Sixty-four patients who underwent PCI for ISR in the Department of Cardiology, Peshawar Institute of Cardiology, Peshawar, from October 2022 to March 2023 were enrolled. Patients were distributed as Group-I patients treated with drug-eluting balloons (n=28, 43.8%) and Group-II patients treated with drug-eluting stents (n=36, 56.2%). Clinical outcomes were recorded. Target lesion revascularization (TLR), myocardial infarction, and cardiac death were different endpoints of major adverse cardiac events (MACE). The overall mean age was 64.12±4.65 years. The incidence of MACEs in groups I and II was 14.3% (n=4) and 16.7% (n=6) respectively. Group I and II had insignificant associations regarding baseline characteristics except for MI's prior history. TLR was more frequent in the DEB group (7.1%, n=2) than in the DES group (2.8%, n=1). The incidence of diabetes, hypertension, current smokers, and previous myocardial infarction in Group I vs. Group II was 42.9% vs. 38.9%, 64.3% vs. 47.2%, 14.3% vs. 22.2%, and 17.9% vs. 47.2%, respectively. Drug-eluting balloons showed effective results for PCI, a viable alternative to placing drug-eluting stents for the coronary in-stent restenosis treatment.

TCT-60 Long-Term Outcomes Following Drug-Coated Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis in Chronic Coronary Syndrome (CCS Dragon-Registry)

TCT-60 Long-Term Outcomes Following Drug-Coated Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis in Chronic Coronary Syndrome (CCS Dragon-Registry)

TCT-431 Comparison of the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: The TIS-2 Study.

TCT-431 Comparison of the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: The TIS-2 Study.

TCT-184 Treatment of Side Branch Restenosis After 1-Stent Crossover Stenting for Left Main Bifurcation Lesions

TCT-184 Treatment of Side Branch Restenosis After 1-Stent Crossover Stenting for Left Main Bifurcation Lesions

Exploring the Mechanism of Buyang Huanwu Decoction Alleviating Restenosis by Regulating VSMC Phenotype Switching and Proliferation by Network Pharmacology and Molecular Docking.

Buyang Huanwu Decoction (BHD) is used to regulate blood circulation and clear collaterals and is widely used in coronary heart disease. However, the active compounds and the mechanism of BHD used to treat restenosis are less understood. The study aimed to explore the potential mechanism of Buyang Huanwu decoction BHD for the treatment of restenosis using network pharmacology and molecular docking experiments. The bioactive components of BHD and their corresponding targets were retrieved from the Traditional Chinese Medicine Systems Pharmacology (TCMSP) and Encyclopaedia of Traditional Chinese Medicine (ETCM) databases as well as literature. Restenosisassociated therapeutic genes were identified from the OMIM, Drugbank, GEO, and Dis- GeNET databases. Genes related to the vascular smooth muscle cell (VSMC) phenotype were obtained from the gene ontology (GO) database and literature. The core target genes for the drug-disease-VSMC phenotype were identified using the Venn tool and Cytoscape software. Moreover, the "drug-component-target-pathway" network was constructed and analyzed, and pathway enrichment analysis was performed. The connection between the main active components and core targets was analyzed using the AutoDock tool, and PyMOL was used to visualize the results. The "compound-target-disease" network included 80 active ingredients and 599 overlapping targets. Among the bioactive components, quercetin, ligustrazine, ligustilide, hydroxysafflor yellow A, and dihydrocapsaicin had high degree values, and the core targets included TP53, MYC, APP, UBC, JUN, EP300, TGFB1, UBB, SP1, MAPK1, SMAD2, CTNNB1, FOXO3, PIN1, EGR1, TCF4, FOS, SMAD3, and CREBBP. A total of 365 items were obtained from the GO functional enrichment analysis (p < 0.05), whereas the enrichment analysis of the KEGG pathway identified 30 signaling pathways (p < 0.05), which involved the TGF-β signaling pathway, Wnt signaling pathway, TRAF6-mediated induction of NF-κB and MAPK pathway, TLR7/8 cascade, and others. The molecular docking results revealed quercetin, luteolin, and ligustilide to have good affinity with the core targets MYC and TP53. The active ingredients in BHD might act on TP53, MYC, APP, UBC, JUN, and other targets through its active components (such as quercetin, ligustrazine, ligustilide, hydroxysafflor yellow A, and dihydrocapsaicin). This action of BHD may be transmitted via the involvement of multiple signaling pathways, including the TGF-β signaling pathway, Wnt signaling pathway, TRAF6-mediated induction of NF-κB and MAPK pathway, and TLR7/8 cascade, to treat restenosis by inhibiting the phenotype switching and proliferation of VSMC.

Race and Treatment of Femoral-popliteal Artery In-stent Restenosis with Paclitaxel Angioplasty

Race and Treatment of Femoral-popliteal Artery In-stent Restenosis with Paclitaxel Angioplasty

Treatment of In-stent Restenosis of the Internal Carotid Artery Using Drug-eluting Balloons.

In-stent restenosis (ISR) following internal carotid artery (ICA) stenting is relatively common with an estimated incidence of 5%. Treatment options include repeat angioplasty with conventional or drug-eluting balloons (DEB), repeat stent angioplasty and surgical intervention. Application of DEB in ISR of the coronary and peripheral arteries is an established method; however, data on DEB treatment of ICA ISR are sparse. In this work, results from aretrospective cohort of 45patients harboring 46ICA ISR lesions treated with DEB angioplasty are presented. Clinical, procedural and imaging data from DEB angioplasty treatment of 46high-grade ICA ISR lesions in 45patients, performed between 2013 and 2021 were collected. Asingle type of DEB (Elutax, Aachen Resonance, Aachen, Germany) was used in all procedures. Imaging follow-up was performed by regular Doppler ultrasound (DUS), verified by computed tomography angiography (CTA) in cases suspicious for arecurrent ISR. Technical success was 100%. Intraprocedural and postprocedural complications were not encountered. Clinical follow-up was obtained in all patients. Recurrent stroke in the affected territory was not encountered. Arecurrent ISR following DEB treatment was confirmed by DUS and CTA in 4/46(8.7%) of the lesions and were retreated with DEB. Athird recurrent ISR occurred in asingle case (2%) and following asecond DEB retreatment there were no signs of afourth recurrence after 36months follow-up. The use of DEB angioplasty is asafe and effective treatment of ICA ISR lesions, yielding significantly better results compared to other modalities. Randomized multicenter studies are warranted.

Omentin-1 enhances the inhibitory effect of endothelial progenitor cells on neointimal hyperplasia by inhibiting the p38 MAPK/CREB pathway

AimsEndothelial progenitor cells (EPCs) play an important role in vascular repair. However, they are dysfunctional in the inflammatory microenvironment during restenosis. In this study, we investigated whether omentin-1, an anti-inflammatory factor, could reduce neointima formation after carotid artery injury (CAI) in rats by improving EPC functions that were damaged by inflammation and the underlying mechanisms. Main methodsEPCs were transfected with adenoviral vectors expressing human omentin-1 or green fluorescent protein (GFP). Then, the rats received 2 × 106 EPCs expressing omentin-1 or GFP by tail vein injection directly after CAI and again 24 h later. Hematoxylin-eosin staining and immunohistochemistry were used for analyzing neointimal hyperplasia. Besides, EPCs were treated with omentin-1 and TNF-α to examine the underlying mechanism. Key findingsOur results showed that omentin-1 could significantly improve EPC functions, including proliferation, apoptosis and tube formation. Meanwhile, EPCs overexpressed with omentin-1 could significantly reduce neointimal hyperplasia and tumor necrosis factor-α (TNF-α) expression after CAI in rats. TNF-α could notably induce EPC dysfunction, which could be markedly reversed by omentin-1 through the inhibition of the p38 MAPK/CREB pathway. Furthermore, a p38 MAPK agonist (anisomycin) significantly abrogated the protective effects of omentin-1 on EPCs damaged by TNF-α. SignificanceOur results indicated that genetically modifying EPC with omentin-1 could be an alternative strategy for the treatment of restenosis.

Mechanistic exploration of Yiqi Liangxue Shengji prescription on restenosis after balloon injury by integrating metabolomics with network pharmacology

Context Yiqi Liangxue Shengji prescription (YQLXSJ) is a traditional Chinese medicine (TCM) formula that has long been used for treatment after percutaneous coronary intervention (PCI). Objective To investigate the putative pharmacological mechanism of YQLXSJ on restenosis through an integrated approach utilizing metabolomics and network pharmacology. Materials and methods Forty male Sprague–Dawley rats were divided into sham, model, YQLXSJ, and positive groups. YQLXSJ group received the treatment of YQLXSJ (6 g/kg/d, i.g.) and the positive group was treated with atorvastatin (2 mg/kg/d, i.g.). After 4 weeks, the improvement in intimal hyperplasia was evaluated by ultrasound, H&E staining, and immunofluorescence. UPLC–MS/MS technology was utilized to screen the differential metabolites. Network pharmacology was conducted using TCMSP, GeneCards, and Metascape, etc., in combination with metabolomics. Eventually, the core targets were acquired and validated. Results Compared to models, YQLXSJ exhibited decreased intima-media thickness on ultrasound (0.23 ± 0.02 mm vs. 0.20 ± 0.01 mm, p < 0.01) and reduced intima thickness by H&E (30.12 ± 6.05 μm vs. 14.32 ± 1.37 μm, p < 0.01). We identified 18 differential metabolites and 5 core targets such as inducible nitric oxide synthase (NOS2), endothelial nitric oxide synthase (NOS3), vascular endothelial growth factor-A (VEGFA), ornithine decarboxylase-1 (ODC1) and group IIA secretory phospholipase A2 (PLA2G2A). These targets were further confirmed by molecular docking and ELISA. Discussion and conclusions This study confirms the effects of YQLXSJ on restenosis and reveals some biomarkers. TCM has great potential in the prevention and treatment of restenosis by improving metabolic disorders.

Lifetime management of severely calcified coronary lesions: the treatment algorithm focused on the shape of calcification.

The concept of lifetime management has not been discussed in the field of percutaneous coronary intervention (PCI), because the durability of drug-eluting stent (DES) is considered to be long enough for most patients. Furthermore, even if in-stent restenosis occurs, the treatment for in-stent restenosis is simple in most cases. On the other hand, the long-term clinical outcomes after DES implantation are worse in severely calcified coronary lesions than in non-calcified lesions. Moreover, the treatment for in-stent calcified restenosis or restenosis due to stent underexpansion is not simple. The concept of lifetime management of severely calcified lesions may be necessary like that of aortic stenosis. Recently, several algorithms have been published in PCI to severely calcified lesions, partly because of the emergence of IVL. These algorithms focus on the selection of cracking and debulking devices for the preparation of stenting. However, the optimal stent expansion does not guarantee the long-term patency, when the target lesion includes calcified nodules. Stent restenosis due to calcified nodules is difficult to manage. In this review article, we propose the algorithm for severely calcified lesions focused on the shape of calcification. We do not need to hesitate stenting when multiple cracks on circumferential calcification are observed by intravascular imaging devices. However, DCB may be an option as final device in some situations, when lifetime management of severely calcified lesions is considered.

Diffuse coronary artery disease management with drug-coated balloons

Drug-coated balloons (DCB) have emerged as a valid alternative for drug-eluting stents in the treatment of in-stent restenosis and de-novo lesions in small vessels. In the past years, a significant effort has been made to investigate the role of this strategy in larger vessel disease, with promising preliminary results being reported for several clinical scenarios, including complex lesions, such as bifurcations, chronic total occlusions and diffuse, long lesions. A DCB strategy appears to be of significant interest in diffuse coronary disease, as the total stent length represents an independent predictor for target-vessel failure and a surgical approach does not seem to improve mid- and long-term results compared to optimal medical treatment. Several studies have investigated the safety and efficacy of a non-stent-based approach in this complex setting, and as promising results have been reported, it is fair to assume that reducing the amount of implanted metal in diffusely affected vessels could become the standard of care for these patients if a full or blended therapy with DCB is adopted. However, long-term results from large-scale studies are awaited to confirm these preliminary and intriguing results.

Modern approaches in the treatment of occlusive restenosis of the arteries of the lower extremities. Case report

Chronic lower limb ischemia is becoming increasingly common among patients worldwide. This is a comorbid condition, which is accompanied by chronic pain, trophic ulcers and gangrene, as well as a decrease in the quality of life. Despite the chronic nature of ischemia, the absence of treatment is accompanied by a high rate of limb amputation and mortality. It has been proven that in patients with peripheral arterial disease of the lower extremities, the risk of cardiovascular events and mortality increases. The publication proposes to consider the tactics of minimally invasive arterial revascularization in a patient with occlusive restenosis of the right superficial femoral artery. The correct choice of minimally invasive surgical treatment in combination with a complex of both non-drug (walking) and drug methods made it possible to restore viability and preserve the lower limb without unfavorable consequences for the patient’s health.

Design and rationale of a prospective, randomized, non-inferiority trial to determine the safety and efficacy of the Biolimus A9™ drug coated balloon for the treatment of in-stent restenosis: First-in-man trial (REFORM)

BackgroundDrug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Biolimus A9™ (BA9), a sirolimus analogue with enhanced lipophilicity, may facilitate enhanced local drug delivery into vascular tissue. A novel DCB coated with Biolimus A9™ represents an alternative to traditional paclitaxel- and sirolimus-coated devices. Hence, we sought to investigate the safety and efficacy of this novel DCB in the treatment of coronary ISR. Methods and designREFORM (NCT04079192) is a prospective, multicenter, single blind, randomized controlled trial comparing the BA9-DCB (Biosensors Europe SA, Morges, Switzerland) to the paclitaxel-coated SeQuent® Please DCB (Braun Melsungen AG, Germany) in the treatment of coronary ISR. A total of 201 patients with coronary artery disease and an indication for interventional treatment of ISR in a bare-metal stent (BMS) or drug-eluting stent (DES) have been randomized 2:1 to receive treatment with the BA9- or the paclitaxel-DCB comparator. Patients were enrolled across 24 investigational centers in Europe and Asia. The primary endpoint is percent diameter stenosis (%DS) of the target segment as assessed by quantitative coronary angiography (QCA) at 6 months. Key secondary endpoints are in-stent late lumen loss, binary restenosis, target lesion failure, target vessel failure, myocardial infarction and death at 6 months. Subjects will be followed for 24 months from enrolment. ImplicationsThe REFORM trial will seek to prove that the BA9-DCB is non-inferior to the standard paclitaxel-DCB comparator in the treatment of coronary ISR with respect to %DS at 6 months and has similar safety characteristics.

An observational study assessing the use of Sirolimus-eluting balloons for side-branch treatment in the provisional stenting of coronary bifurcations

BackgroundDrug eluting balloons (DEB) are a feasible method of rapid delivery of drug to a coronary vessel wall. Their efficacy has been established for the treatment of in-stent restenosis and small vessel disease but there is limited data for their use in bifurcation lesions. ObjectiveThe aim of this study was to assess the effectiveness of provisional upfront side-branch DEB use in bifurcation lesions compared to a simple balloon (POBA) or upfront 2 stent bifurcation strategy. MethodsWe conducted an observational study of 625 patients undergoing PCI to bifurcation lesions. All the patients had a DES deployed in the main vessel (MV). Decision on revascularization option for the side branch (SB) was made by the operator. The primary endpoint was target vessel failure. Secondary endpoints were target vessel myocardial infarction and all-cause mortality. Results311 patients had upfront DEB to the SB whilst the remaining were treated with either DES (188) or POBA (126). Baseline characteristics were similar aside from history of previous MI, which were higher in patients treated with DES or POBA, p = 0.009 whereas patients with previous CABG were likely to undergo DEB treatment (p = 0.004). TVF was more likely to occur in the POBA group (7.5 %) compared to the DEB (3.3 %) and DES (3.3 %) groups (p = 0.0019). There was no significant difference in TV-MI (p = 0.62) or death (p = 0.98) between the groups. ConclusionThis study suggests that provisional bifurcation stenting with upfront Sirolimus DEB use in the SB is an effective treatment for non-LMS bifurcation PCI.

Covalent grafting of zwitterion polymer and REDV peptide onto NiTi alloy surface for anticoagulation and proendothelialization

AbstractAlthough stent implantation is an effective treatment for cardiovascular diseases, restenosis and thrombosis still remain great challenges clinically. To address these problems, modifying the stent surface with the bifunctions of anticoagulation and proendothelialization is considered as a promising strategy. Herein, zwitterion polymer poly (α‐methacrylic acid‐co‐2‐methylacryloxyethyl phosphorylcholine) (PMAMPC) and endothelial cells (ECs)‐selective adhesion peptide REDV were co‐modified onto the surface of NiTi stent by chemical graft to obtain NiTi‐PMAMPC/REDV stent. The introduction of PMAMPC and REDV peptide equip NiTi‐PMAMPC/REDV stent with satisfactory anticoagulation performance and enhanced endothelialization, respectively. The in vitro studies showed that NiTi‐PMAMPC/REDV surface had excellent blood compatibility, and could effectively promote the adhesion, proliferation and migration of human umbilical vein endothelial cells (HUVECs). Additionally, NiTi‐PMAMPC/REDV surface were capable of decreasing the adhesion of smooth muscle cells (SMCs). In vivo studies demonstrated that the NiTi‐PMAMPC/REDV stent could maintain good blood patency and form a relatively complete endothelial layer on the surface after 30 days in the rat aorta model. This bifunctional surface might hold great potential in relieving thrombosis and restenosis in the field of stent implantation.