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This head-to-head, multicenter, randomized trial investigated the safety and efficacy of Restore (Cardionovum, Bonn, Germany) drug-coated balloon (DCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).A total of 240 patients with coronary DES-ISR were treated with Restore DCB or with SeQuent® Please (Braun, Melsungen, Germany) DCB. This trial used nine-month in-segment late lumen loss (LL) as the primary endpoint. Secondary endpoints included two-year clinical event rates.Patient, lesion, and procedural characteristics in both treatment groups were similar. Nine-month in-segment LL was 0.38 ± 0.50 mm with Restore vs. 0.35 ± 0.47 mm with SeQuent® Please (p for non-inferiority = 0.02). The two-year follow-up rates were 95.8 % (115/120) in the Restore group and 94.2 % (113/120) in the SeQuent® Please group. Both groups had similar one- and two-year target lesion failure (TLF) rates (13.3 % vs. 12.6 %; p = 0.87 at one year, 14.8 % vs. 15.0 %; p = 1.0 at two years). Moreover, the all-cause mortality and myocardial infarction rates were 0 and 3.5 % (4/120) in the Restore group and 0.9 % (1/120) and 3.5 % (4/120) in the SeQuent® Please group, respectively. Additional analyzing of vessel quantitative flow ratio (QFR) did also show noninferior outcomes for one explicit treatment bunch.The two-year follow-up indicated sustained long-term clinical safety and efficacy for both devices on the basis of QFR value.

Intravascular 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.This 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.A 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.IVL 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.

Introduction 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. Methods 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. Results 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. Conclusion 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.

Drug-eluting stents (DES) significantly improved angiographic and clinical outcomes compared with bare-metal stents in patients with diabetes. The clinical effects of BioMime sirolimus-eluting stent (SES) in patients with diabetes have not been evaluated. Therefore, we compared the efficacy of BioMime DES in coronary artery disease (CAD) patients with versus without diabetes.This prospective analytical study compared angiographic in-segment late loss and clinical effectiveness of BioMime SES stents in treating patients with (patients: 77 and lesions: 83) versus without (patients: 154 and lesions: 162) diabetes. The purpose of this study was the comparison of angiographic in-segment late loss at 12 months. Major adverse cardiac events (MACEs) were also monitored as secondary outcomes 24 months after the index procedure.Of 231 patients enrolled in the study, the mean age was 63.3 years and 153 patients were male. Angiographic follow-up rate was 84.8% (patients: 196) and intravascular ultrasound (IVUS) follow-up rate was 67.9% (patients: 157) at 12 months. Diabetic patients were comparable to nondiabetic patients for 12-month in-segment late loss (0.01 ± 0.31 mm for the nondiabetes group versus 0.04 ± 0.11 mm for the diabetes group; P = 0.158; P 0.05). At 24 months, MACEs, including death, myocardial infarction and ischemic-driven target lesion revascularization were not statistically different between the two treatment groups.BioMime SES stents in treating patients with diabetes were comparable in reducing angiographic restenosis at 12 months and MACEs at 24 months compared to nondiabetic patients with CAD.

In-stent restenosis (ISR) remains a potential complication after percutaneous coronary intervention, even in the era of drug-eluting stents, and its treatment remains suboptimal. Neoatherosclerosis is an important component of the pathology of ISR and is accelerated in drug-eluting stents compared with bare-metal stents. Coronary angiography is the gold standard for evaluating the morphology of ISR, although computed tomography angiography is emerging as an alternative noninvasive modality to evaluate the presence of ISR. Drug-coated balloons and stent reimplantation are the current mainstays of treatment for ISR, and the choice of treatment should be based on clinical background and lesion morphology.

International audience; Background: Intravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified coronary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion.Methods: Prospective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as

One strategy to improve the effectiveness of intravascular brachytherapy (IVBT) is to study its failures. Previous investigations described mostly discrete, focal recurrences, typically at the proximal or distal edges of the irradiated segment after plain angioplasty or bare metal stents. We reviewed failure patterns of 30 unselected drug-eluting stent (DES) patients who had follow-up angiograms for recurrence within their IVBT-treated vessel.Records of 53 unselected IVBT patients treated between 2016 and 2021 were reviewed. Thirty of the 53 patients had at least one subsequent percutaneous intervention (PCI) for in-stent restenosis (ISR) after IVBT. Angiographic findings of those 30 patients with ISR within their previously irradiated vessel are reported here.Of the 30 patients, 21 (70%) developed recurrent ISR within the irradiated segment. Six of the 21 patients who failed within the irradiated segment also experienced ISR proximal or distal to the irradiated segment. Only 15 patients (50%) failed exclusively within the irradiated segment. In nine patients (30%), restenosis occurred proximally and/or distally to the irradiated segment, but not inside of the irradiated segment itself.We have shown here that 50% of failures after coronary IVBT for DES ISR occur exclusively within the irradiated segment. An additional 20% of patients had failure within and outside of the irradiated segment. These percentages suggest that a higher radiation dose might improve the long-term patency rates, a conclusion that should be tempered by the lack of universal follow-up.

There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR).To compare the long-term outcomes of patients treated with either a thin-strut drug-eluting stent (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES).A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. The primary outcome was target lesion revascularization (TLR).Out of 311 patients (mean age, 67 years; 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3%, respectively; HR, 0.38; 95% CI, 0.17-0.86; P = 0.01). The risks of device-oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model, the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13-0.84; P = 0.02).In patients with R-ISR implantation of a thin-DES is associated with a lower risk of repeated revascularization compared with angioplasty with a DEB.

Drug-coated balloon (DCB) angioplasty for side branches with main branch stenting is effective for bifurcation lesions and reduces late lumen loss (LLL) in side branches. However, the predictors and clinical implications of LLL after DCB angioplasty are largely unexplored.Among 181 patients undergoing DCB angioplasty for side branches with drug-eluting stent implantation for main branches between 2016 and 2018, we enrolled 138 patients (138 lesions) undergoing follow-up coronary angiography within 1 year. The 1-year cumulative rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE: defined as a composite of all-cause death, myocardial infarction, and TLR) were compared between patients with late lumen gain (LLG) (LLG group) and those with LLL (LLL group).The binary restenosis rate of the side branch was 8.0% (11 lesions), mean LLL was -0.14 ± 0.43 mm, and LLG was observed in 99 lesions (71.7%). The DCB size/reference vessel diameter ratio showed mild discrimination (area under the curve, 0.60; 95% confidence interval, 1.2-65.0; p = 0.03) for predicting the side branch progression. The 1-year cumulative rates of MACE and TLR were not significantly different but numerically lower in the LLG group than in the LLL group (2.0% vs. 7.8%, p = 0.11 and 2.0% vs. 7.7%, p = 0.11, respectively). Lumen regression after DCB angioplasty for side branches are associated with improved clinical outcomes.The DCB size relative to the reference vessel diameter is a predictor of late lumen enlargement in side branches.

Aim Recently, the atherogenic index of plasma (AIP) has been proposed as a novel, reliable plasma atherogenicity marker. This study aimed to investigate the association of AIP with the risk of in-stent restenosis (ISR) in patients with acute coronary syndrome (ACS). Methods This study retrospectively enrolled patients with ACS followed by angiography within 6 to 18 months after successful percutaneous coronary intervention (PCI) with a drug-eluting stent (DES). And the participants were divided into ISR or non-ISR groups based on the angiographic follow-up results. AIP was defined as the base 10 logarithm of the ratio of serum triglyceride (mmol/L) to high-density lipoprotein cholesterol (mmol/L). Results This study recruited 1319 patients with ACS, 199 of which had ISR. Compared with the non-ISR group, patients in the ISR group had higher level of AIP (0.199±0.290 vs 0.131±0.282, p=0.002). In the multiple logistic regression analysis, AIP was an independent risk factor for DES-ISR (OR=2.100, 95% CI 1.134 to 3.891, p=0.018). When we modulated AIP as a categorical variable, the risk of DES-ISR increased in quartile 4 compared to quartile 1 (OR=1.713, 95% CI 1.040 to 2.822, p=0.034). Furthermore, this association remains stable in various subgroups. Unexpectedly, the subgroup analysis suggested AIP and DES-ISR had a stronger positive association in individuals with low-density lipoprotein cholesterol (LDL-C) ＜1.8 mmol/L. Conclusions AIP and the risk of DES-ISR were positively and independently correlated in patients with ACS, especially in those with an LDL-C ＜1.8 mmol/L.

Problem. Investigating the importance of vessel geometry and hemodynamics in intracranial atherosclerotic stenosis (ICAS) might provide a more profound understanding about the underlying mechanisms of in-stent restenosis (ISR). Methods. Severe ICAS patients managed with percutaneous transluminal angioplasty and stenting (PTAS) were included in the retrospective cohort study and were divided into two groups according to whether ISR occurred at follow-up (ISR group and no-ISR group). Computational fluid dynamics models were built based on digital subtraction angiography before and after PTAS to simulate blood flow and quantify hemodynamic parameters. The associations between vessel geometry, hemodynamics, and ISR in ICAS patients were investigated. Results. Among 39 patients, ISR occurred in seven patients (17.95%) after a mean follow-up period of 6.69 ± 3.24 months. Stenting decreased vessel angulation (51.11° [40.07°–67.27°] vs. 15.97° [0.00°–36.16°], P = 0.000 ) and vessel tortuosity (0.09 [0.06–0.13] vs. 0.01 [0.00–0.03], P = 0.000 ). Meanwhile, the translational pressure ratio (PR) dramatically increased (0.07 [0.00–0.31] vs. 0.62 [0.41–0.82], P = 0.000 ) with the wall shear stress ratio decreased (13.93 [8.37–40.30] vs. 2.90 [1.69–4.48], P = 0.000 ). In the multivariate analysis, smaller Δ tortuosity ( P = 0.038 ) was independently associated with the occurrence of ISR, and smaller post-PTAS translesional PR was also a predictive factor of marginal significance ( P = 0.059 ). Conclusion. PTAS decreased vessel angulation, vessel tortuosity, and translesional wall shear stress ratio while it increased translesional pressure ratio (PR) dramatically in ICAS patients. Smaller Δ tortuosity was found to be a risk factor for ISR, and smaller post-PTAS translesional PR was also a predictive factor of marginal significance, indicating that both geometric and hemodynamic parameters played important roles in the occurrence of ISR after PTAS.

Background. In-stent restenosis (ISR) is an important clinical complication that occurs following stent implantation. The application of drug-eluting stents (DES) and even consumption of drugs such as antiplatelet agents and statins are not completely effective in reducing ISR risk. Since the number of these patients continues to rise, it is pivotal to detect patients who are at a higher risk of ISR. In addition, identification of biochemical markers of ISR could give the right perspective on choosing the proper strategy to treat these patients. Several pathophysiological pathways including oxidative stress (OS) are implicated in the progression of ISR. Hence, this study aimed to evaluate the association between oxidative/anti-oxidative markers and ISR. Methods. This was a case-control study which comprised 21 ISR, 26 NISR (non-ISR), and 20 healthy subjects. The serum levels of OS markers including malondialdehyde (MDA), thiol groups (GSH), total antioxidant capacity (TAC), and the activity of serum antioxidant enzymes such as glutathione peroxidase (GPx) and superoxide dismutase (SOD) were assessed by colorimetric methods. The overall oxidative burden was assessed using a pro-oxidant-antioxidant balance (PAB) assay. Results. MDA levels were considerably higher in the ISR group when compared to healthy subjects ( P = 0.004 ). PAB also indicated significantly higher values in both ISR ( P < 0.001 ) and NISR ( P < 0.001 ) groups related to healthy subjects. No significant differences were observed between the studied groups regarding thiol levels, antioxidant enzyme activities, and TAC. Multinomial logistic regression analysis showed that elevated serum levels of MDA (OR: 1.028, 95% CI: 1.008-1.048; P = 0.006 ) and PAB (OR: 1.076, 95% CI: 1.017-1.139; P = 0.011 ) were significantly associated with higher ISR risk; however, increased values of TAC (OR: 0.990, 95% CI: 0.982-0.999; P = 0.030 ) were significantly associated with decreased ISR risk, while after adjustment for confounders, only SOD activity (OR: 0.0, 95% CI: 0.0-0.0; P < 0.001 ) and PAB value (OR: 1.866, 95% CI: 1.856-1.900; P < 0.001 ) showed association with ISR risk. Conclusion. According to the present findings, some oxidative and antioxidative markers like PAB and SOD activity showed the potential in the prediction of ISR risk.

In-stent restenosis (ISR) remains a challenge in the treatment of vertebral artery V1 segment stenosis. The aim of this meta-analysis is to identify the risk factors of ISR.Studies eligible for inclusion criteria were found in PubMed, Embase, and Cochrane Library databases. Data related to risk factors of ISR were extracted from the included studies, and pooled analysis was performed when data of the same factor were available in ≥2 studies. Dichotomous outcomes were analyzed with odds ratios (OR) and continuous outcomes were analyzed with a weighted mean difference (WMD). The Stata 14.0 program was used for the meta-analysis.A total of 11 studies involving 1356 patients were included in our analysis. Pooled analyses showed that younger age (p = 0.01; WMD= -1.958; 95% confidence interval [CI], -3.453 to -0.463) and V1 tortuosity (p = 0.004; OR = 4.145; 95% CI, 1.56-11.012) significantly associated with higher risk of ISR in V1 segment stenting. While bare-metal stents, stent diameter and length, diabetes mellitus, coronary artery disease, and smoking were not found to increase ISR rates.This meta-analysis showed that young age and V1 tortuosity increase the ISR rates after vertebral V1 segment stenting.

BACKGROUND Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy. AIMS The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate. METHODS BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up. RESULTS Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5��5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2��5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31��0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20��0.29 mm. Two target lesion failures occurred (3.1%), one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post procedure for restenosis. No stent thrombosis was reported during the 12-month study duration. CONCLUSIONS The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.

In-stent restenosis is a common complication after percutaneous coronary intervention. The purpose of the current study is to look for associations of genetic variation in adrenergic beta-2 receptor (ADRβ2), and cyclin-dependent kinase inhibitor 1B (CDKN1B) genes in patients diagnosed with in-stent restenosis (ISR) after percutaneous coronary intervention in the Egyptians.Polymorphisms in ADRβ2 and CDKN1B were determined using PCR-restriction fragment length polymorphism in 200 Egyptian patients who underwent coronary angioplasty and stent placement of whom 100 patients developed ISR.We found that the GG genotype of ADRβ2 and CC genotype of CDKN1B were more likely to develop restenosis after stenting (odds ratio = 3.7 and 3.2; P = 0.001, respectively). Our study considered that male sex, diabetes, obesity, bare-metal stents type of implanted stents, longer stents, GG genotype of ADRβ2, and CC genotype of CDK1B were significant independent predictors for ISR.our results indicate that ADRβ2 (rs1042713) and CDKN1B (rs36228499) could be associated with the development of ISR in Egyptians.

Background: The relationship between LDL/HDL ratio and in-stent restenosis in acute coronary syndrome is unknown. Methods: This observational study recruited 256 patients with acute coronary syndrome who were being followed up by angiography after stenting. The patients were divided into in-stent restenosis (59%) and non-in-stent restenosis (41%) groups. Three stepwise multivariate logistic regression models and area under the curve were conducted to determine the role of LDL/HDL ratio in predicting in-stent restenosis. Results: LDL/HDL ratio was significantly associated with risk of in-stent restenosis (odds ratio ≈ 2.00; p

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.

In-stent restenosis (ISR) remains the most common cause of stent failure after percutaneous coronary intervention (PCI). Recent data suggest that ISR-PCI accounts for 5-10% of all PCI procedures performed in current clinical practice. This State-of-the-Art review will primarily focus on the management of ISR but will begin by briefly discussing diagnosis and classification. We then move on to detail the evidence base underpinning the various therapeutic strategies for ISR before finishing with a proposed ISR management algorithm based on current scientific data.

In spite of the remarkable advances in novel drug and revascularization procedure, in-stent restenosis (ISR) remains a major complication of percutaneous coronary intervention (PCI). The aim of this study was to investigate the association between green tea consumption and the incidence of ISR. The study population consisted of 1,509 patients who underwent PCI with drug-eluting stent (DES) implantation from January 2017 to December 2019. Patients were divided into ISR and non-ISR group according to the results of coronary angiography reexamination about 1 y after PCI. Multivariate logistic regression analysis was used to determine the relationship between green tea consumption and the risk of ISR. ISR occurred in 157/1,509 patients (10.4%) by follow-up coronary angiography. After adjusting for other confounding factors, green tea consumption was associated with a reduced risk of ISR (OR 0.653, 95%CI 0.460-0.926, p=0.017). The risk of ISR tended to decline with an increase in the quantity of green tea consumed (adjusted p for trend=0.006). The adjusted ORs for those consuming 125-249 g and ≥250 g of dried green tea leaves per month were 0.579 (95%CI, 0.346-0.970, p=0.038) and 0.501 (95%CI, 0.270-0.932, p=0.029), respectively, compared with non-tea drinkers. Moreover, significant dose-response relationships were also observed for both frequency (adjusted p for trend=0.011) and concentration (adjusted p for trend=0.004) of green tea intake on the risk of ISR. Green tea consumption can protect against the development of ISR in a Chinese population.

Aims Aim of the present study was to investigate the impact of increasing neointimal inhomogeneity and neoatherosclerosis as well as of treatment modality of in-stent restenosis (ISR) on the occurrence of periprocedural myocardial injury (PMI). Methods and results Patients with normal or stable/falling increased baseline high-sensitivity troponin T (hs-cTnT) undergoing intravascular optical coherence tomography (OCT) and subsequent percutaneous coronary intervention (PCI) of ISR by means of drug-coated balloon (DCB) or drug-eluting stent (DES) were included. Overall, 128 patients were subdivided into low (n = 64) and high (n = 64) inhomogeneity groups, based on the median of distribution of non-homogeneous quadrants. No significant between-group differences were detected in terms of hs-cTnT changes (28.0 [12.0–65.8] vs. 25.5 [9.8–65.0] ng/L; p = 0.355), or the incidence of major PMI (31.2 vs. 31.2%; p = 1.000). Similarly, no differences were observed between DCB- and DES-treated groups in terms of hs-cTn changes (27.0 [10.0–64.0] vs. 28.0 [11.0–73.0] ng/L; p = 0.795), or the incidence of major PMI (28.9 vs. 35.6%; p = 0.566). Additionally, no significant interaction was present between optical neointimal characteristics and treatment modality in terms of changes in hs-cTnT (Pint = 0.432). No significant differences in PMI occurrence were observed between low and high neoatherosclerosis subgroups. Conclusions In patients undergoing PCI for ISR, there was no association between increasing neointimal inhomogeneity, or increasing expression of neoatherosclerotic changes and occurrence of PMI. PMI occurrence was not influenced by the treatment modality (DCB vs. DES) of ISR lesions, a finding that supports the safety of DCB treatment for ISR. Graphical abstract

To investigate the value of perioperative cytokine levels in predicting the risk for in-stent restenosis in patients with acute myocardial infarction. 452 patients with acute myocardial infarction admitted to our hospital between June 2018 and June 2020 were prospectively selected as subjects. All patients underwent percutaneous coronary intervention. The baseline data of the patients were collected. Venous blood was taken before, 24 hours, and 3 days after the operation to detect the levels of related cytokines. Follow-up was performed for 1 year. The patients were assigned to restenosis and nonrestenosis groups according to the presence and absence of restenosis. Multivariate logistic analysis was used to explore the influencing factors of the risk for in-stent restenosis in patients with acute myocardial infarction. By July 1, 2021, 449 cases had been followed up. Of them, 44 cases suffered from in-stent restenosis and 405 cases did not affect in-stent restenosis. The incidence of in-stent restenosis was 9.80%. Before, 24 hours, and 3 days after the operation, the lipoprotein-associated phospholipase A2 (Lp-PLA2) level was significantly higher in the restenosis group than that in the nonrestenosis group. At 3 days after the operation, the interleukin 6 (IL-6) level was significantly higher in the restenosis group than that in the nonrestenosis group ( P P

The diagnostic efficacy of coronary computed tomography angiography (CTA) images of coronary arteries in restenosis after coronary stenting based on the combination of the convolutional neural network (CNN) algorithm and the automatic segmentation algorithm for region growth of vascular similarity features was explored to provide a more effective diagnostic method for patients. 130 patients with coronary artery disease were randomly selected as the research objects, and they were averagely classified into the control group (conventional coronary CTA image diagnosis) and the observation group (coronary CTA image diagnosis based on an improved automatic segmentation algorithm). Based on the diagnostic criteria of coronary angiography (CAG), the efficacy of two kinds of coronary CTA images on the postoperative subsequent visit of coronary heart disease (CHD) stenting was evaluated. The results showed that the accuracy of the CNN algorithm was 87.89%, and the average voxel error of the improved algorithm was signally lower than that of the traditional algorithm (1.8921 HU/voxel vs. 7.10091 HU/voxel) ( p p p

Endovascular treatment (EVT) is the main treatment for peripheral artery disease (PAD). Despite advances in device development, the restenosis rate remains high in patients with femoropopliteal lesions (FP). This study aimed to evaluate the effectiveness of exercise training in reducing the 1-year in-stent restenosis rate of bare metal nitinol stents for FPs. This prospective, randomized, open-label, multicenter study was conducted from January 2017 to March 2019. We randomized 44 patients who had claudication with de novo stenosis or occlusion of the FP into an intensive exercise group (n = 22) and non-intensive exercise group (n = 22). Non-intensive exercise was defined as walking for less than 30 min per session, fewer than three times a week. We assessed exercise tolerance using an activity meter at 1, 3, 6, and 12 months, and physiotherapists ensured maintenance of exercise quality every month. The primary endpoint was instant restenosis defined as a peak systolic velocity ratio > 2.5 on duplex ultrasound imaging. Kaplan–Meier analysis was used to evaluate the data. There were no significant differences in background characteristics between the groups. Six patients dropped out of the study within 1 year. In terms of the primary endpoint, intensive exercise significantly improved the patency rate of bare nitinol stents at 12 months. The 1-year freedom from in-stent restenosis rates were 81.3% in the intensive exercise group and 47.6% in the non-intensive exercise group (p = 0.043). No cases of stent fracture were observed in the intensive exercise group. Intensive exercise is safe and reduces in-stent restenosis in FP lesions after endovascular therapy for PAD. Clinical trial registration: University Hospital Medical Information Network Clinical Trials Registry (No. UMIN 000025259).

The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB).There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents.Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4 μg/mmQuantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment LLL was 0.01 ± 0.33 mm in the PCB group versus 0.10 ± 0.32 mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95% CI: -0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P = 0.019). Major adverse cardiovascular events up to 12 months also did not differ between the groups.This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia [SCBDNMAL]; NCT04017364).

Major advances have been made in coronary artery stent technology over the last decades. Drug-eluting stents reduced in-stent restenosis and have shown better outcomes compared with bare metal stents, yet some limitations still exist to their use. Because they delay healing of the vessel wall, longer dual antiplatelet therapy is mandatory to mitigate against stent thrombosis and this limitation is most concerning in subjects at high risk for bleeding. The COBRA PzF nanocoated coronary stent has been associated with accelerated endothelialization relative to drug-eluting stents, reduced inflammation and thromboresistance in preclinical studies, suggesting more flexible dual antiplatelet therapy requirement with potential benefits especially in those at high bleeding risk. Here, we discuss the significance of COBRA PzF in light of recent experimental and clinical studies.Coronary artery disease occurs when the inner walls of the coronary arteries thicken due to plaque build-up. As the plaque develops, the inside of the artery narrows, and blood flow to the heart muscle is restricted. Coronary stents act as a miniature circular scaffolding that flexes to fit the shape of the artery. In the COBRA PzF nanocoated coronary stent, Polyzene F nanocoating (PzF) has been applied to the stent’s surface. Experimental studies have shown that PzF nanocoatings promote healing after stent implantation and reduce the attachment of platelets and inflammatory cells. The principal safety and effectiveness for the COBRA PzF stent has been proven by clinical studies, showing that the COBRA PzF stent was as safe and effective as other approved bare metal coronary stents. Here, we summarize the findings of experimental and clinical studies with the COBRA PzF stent and discuss potential future directions of anti-platelet and anti-coagulant medications following COBRA PzF stent implantation.

In-stent restenosis is a common complication after percutaneous coronary intervention (PCI) for coronary heart disease requiring revascularization. We performed a retrospective analysis to assess the value of inflammatory biomarker albumin to globulin ratio (AGR) in clinical prognosis of PCI. In total, 992 patients with coronary heart disease who underwent the first drug-eluting stent implantation and re-examination angiography in our hospital were enrolled in this study. The AGR was measured. At mean follow-up of 11.2 ± 4 months, the in-stent restenosis (ISR) and revascularization events (including target lesion revascularization, target vessel revascularization, and revascularization of de novo lesions) occurred in 127 and 284 patients, respectively. Compared with the non-ISR or non-event group, AGR was significantly lower in the ISR group and the events group. Beyond that, albumin was significantly lower, whereas urea nitrogen, glucose, and Gensini score, as well as the proportions of a history of diabetes and peripheral vascular diseases were significantly higher in the ISR group and the events group. Age, heart rate, white blood cell, neutrophils, lymphocyte, monocyte, and incidence of ischemic stroke were significantly higher in the events group. Multivariate Cox regression analysis showed that AGR was independently associated with ISR (p = 0.032) and events (p = 0.024). Besides, Kaplan-Meier analysis indicated that the higher quartile of AGR had a lower rate of ISR (p = 0.038) and events (p ≤ 0.001). Finally, the receiver operating characteristic curve for AGR in diagnosing ISR and events indicated that the area under the curve were 0.56 and 0.57, respectively. Therefore, AGR is one of the most important factors that independently associate with the ISR and revascularization events after PCI.

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.

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

Objective To retrospectively investigate the relationship between apolipoprotein E (APOE) gene polymorphism and in-stent restenosis (ISR) after stenting at the beginning of the vertebral artery. Methods The study included 155 patients who successfully underwent stenting at the beginning of the vertebral artery and had postoperative digital subtraction angiography or computed tomography angiography. Based on the follow-up results, they were divided into the restenosis (ISR) group and non-restenosis (non-ISR) group. The clinical information and APOE genotypes of both groups were analyzed. A binary logistic regression model was used to analyze independent risk factors for ISR. Results After 1 year of follow-up, 49 (31.6%) patients had ISR and 106 (68.4%) did not. Binary logistic regression analysis showed that serum low-density lipoprotein cholesterol (LDL-C), serum lipoprotein-related phospholipase A2 (Lp-PLA2), and E3/E4 genotype were independent risk factors for ISR after stenting at the beginning of the vertebral artery. In addition, the LDL-C level of patients with the E3/E4 genotype was higher compared to the E3/E3 genotype group (P Conclusions APOE gene polymorphism is associated with ISR, and the E3/E4 genotype is an independent risk factor for ISR after stenting at the beginning of the vertebral artery. Further genetic studies can identify risk genotypes to facilitate the early prediction and identification of high-risk patients with ISR.

Drug eluting stent (DES) remain several problems, including stent thrombosis, stent fracture and neoatherosclerosis. Stent-less Percutaneous coronary intervention (PCI) using a drug coated balloon (DCB) is a stent-less strategy, and several trials have supported the efficacy of DCB. However, the optimal preparation before using DCB was uncertain. The aim of this study was to investigate the optimal preparation for plaque oppression/debulking before DCB dilatation for de novo coronary artery lesion.A total 936 patients were treated using DCB from 2014 to 2017 at our institution. Among them, we analyzed 247 patients who underwent PCI using DCB alone for de novo lesion. The primary end point of this study was target lesion failure (TLF).The area under the receiver operating characteristic (ROC) curve (AUC) was used to determine the optimal cutoff value of % plaque area to predict TLF. ROC curve analysis revealed plaque area ≥ 58.5% (AUC, 0.81) were associated with TLF. Eligible 188 patients were divided into 2 groups (plaque area ≥ 58.5% [n = 38] and58.5% [n = 150]) according to IVUS data before using DCB. TLF was significantly higher in plaque area ≥ 58.5% group than in58.5% group (P 0.01). Multivariable analysis selected plaque area ≥ 58.5% as an independent predictor of TLF (hazard ratio 7.59, P 0.01).Lesion preparation achieving plaque area 58.5% was important in stent-less PCI using DCB.