One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis.

Background: Prospective single and multicenter studies have shown improved outcomes of patients who underwent carotid artery stenting with the novel CGuard dual-layer mesh stent at 1 year. Objectives: The aim of this study is to conduct a systematic review and meta-analysis of all published studies to assess 1-year efficacy and outcomes of CGuard in patients with carotid stenting. Methods: A systematic search was performed. All studies enrolling at least 20 patients were included in our analysis. The primary endpoints were death (all-cause, cardiovascular and ipsilateral stroke-related death) and stroke rate at 1 year. The secondary endpoint was in-stent restenosis at 1 year. Results: The final analysis included 1709 patients. The one-year all-cause mortality rate was 2.97% (39/1699, 95% CI: 1.26-6.86%, I2 = 67%, t2 = 0.3442, p < 0.01), cardiovascular-related death was 0.92% (10/1616, 95% CI: 0.35-2.39%, I2 = 34%, t2 = 0.2302, p = 0.18), and ipsilateral stroke-related death was 0.3% (1/1649, 95% CI: 0.1-0.87%, I2 = 0%, t2 = 0, p = 0.69). The one-year ipsilateral stroke rate was 1.21% (16/1649, 95% CI: 0.58-2.5%, I2 = 28%, t2 = 0.1433, p = 0.23), transient ischemic attacks (TIAs) rate was 1.78% (19/1149, 95% CI: 1.11-2.84%, I2 = 0%, t2 = 0, p = 0.69), and total composite 1-year stroke/TIA rate was 2.97% (32/1149, 95% CI: 1.84-4.77%, I2 = 0%, t2 = 0, p = 0.41). The in-stent restenosis rate at 1 year was 1.06% (13/1653, 95% CI: 0.48-2.34%, I2 = 28%, t2 = 0.2308, p = 0.22). Conclusions: This meta-analysis shows that CAS with CGuard is safe with minimal neurological adverse events and in-stent restenosis rate at 1 year.

Association Between Serum Uric Acid Levels and Neoatherosclerosis.

Neoatherosclerosis is a major cause of stent failure after percutaneous coronary intervention. Metabolism such as hyperuricemia is associated with in-stent restenosis (ISR). However, the association between serum uric acid (sUA) levels and in-stent neoatherosclerosis (ISNA) has never been validated.A total of 216 patients with 220 ISR lesions who had undergone optical coherence tomography (OCT) of culprit stents were included in this study. According to their sUA levels, eligible patients were divided into two groups [normal-sUA group: sUA < 7 mg/dL, n = 126, and high-sUA group: sUA ≥ 7 mg/dL, n = 90]. OCT findings were analyzed and compared between the normal- and high-sUA groups.The incidence of ISNA (63.0% versus 43.0%, P = 0.004) was significantly higher in the high-sUA group than in the normal-sUA group. Lipid plaques (66.3% versus 43.0%, P < 0.001) and thin-cap fibroatheroma (38.0% versus 18.0%, P = 0.001) were observed more frequently in the restenotic tissue structure in patients in the high-sUA group than in those in the normal-sUA group. Meanwhile, univariate (OR: 1.208, 95% CI: 1.037-1.407; P = 0.015) and multivariate (OR: 1.254, 95% CI: 1.048-1.501; P = 0.013) logistic regression analyses indicated that sUA levels were an independent risk factor for ISNA after adjusting for relevant risk factors.The high-sUA levels were an independent risk factor for the occurrence of neoatherosclerosis in patients with ISR via OCT.

Comparison of Recurrent With First-Time In-Stent Restenosis.

Recurrent in-stent restenosis (Re-ISR) remains a therapeutic challenge. We aimed to investigate the clinical characteristics, treatment, and long-term outcomes in patients with Re-ISR compared with those with first-time ISR (First-ISR). This retrospective study consecutively enrolled patients who underwent percutaneous coronary intervention (PCI) for ISR in Fuwai Hospital between January 2017 and December 2018. Re-ISR was defined as a second event of ISR after a previous successful treatment of the ISR lesion. The primary outcome was defined as a composite of all-cause death, spontaneous myocardial infarction, and repeat revascularization. A total of 2,006 patients (2,154 lesions) with ISR underwent successful PCI were enrolled and categorized into 2 groups: the Re-ISR group (246 patients/259 lesions) and the First-ISR group (1,760 patients/1,895 lesions). During a mean follow-up of 36 months, the primary outcomes occurred in 80 patients (32.5%) in the Re-ISR group and 349 patients (19.3%) in the First-ISR group (p <0.001 by log-rank test), major driven by spontaneous myocardial infarction (4.9% vs 2.7%, p = 0.049) and repeat revascularization (30.1% vs 16.5%, p <0.001). The multivariable Cox regression analysis revealed that Re-ISR was independently associated with a higher rate of major adverse cardiovascular events (adjusted hazard ratio 1.88, 95% confidence interval 1.39 to 2.53, p <0.001) and repeated revascularization (adjusted hazard ratio 2.09, 95% confidence interval 1.53 to 2.84, p <0.001). The relation remained consistent after the propensity score analysis. In conclusion, in the present cohort of patients who underwent PCI for ISR, Re-ISR was significantly associated with a higher risk of long-term outcomes than First-ISR.

Prognostic Nutritional Index as a Novel Predictor of In-Stent Restenosis: A Retrospective Study.

Background and Objectives: In-stent restenosis (ISR) is a major problem in patients undergoing percutaneous coronary intervention. The prognostic nutritional index (PNI) is a nutritional status score used in the literature to determine the prognosis of coronary artery disease. In this study, we aimed to investigate the effect of preprocedural PNI values on the risk of ISR in patients with stable coronary artery disease who underwent successful percutaneous coronary intervention. Materials and Methods: This retrospective study included 809 patients. Stent restenosis was evaluated in the follow-up coronary angiography of the patients due to stable angina pectoris or acute coronary syndrome. The patients were divided into two groups based on those with (n = 236) and without (n = 573) in-stent restenosis, and their nutritional status was compared with PNI. The PNI values before the first angiography of the patients were calculated. Results: The mean PNI score was significantly lower in patients with ISR than in those without ISR (49.5 vs. 52.3, p < 0.001). Concerning the results of the Cox regression hazard model for predictors of ISR, PNI was significantly associated with the development of ISR (HR = 0.932, 95% CI: 0.909-0.956, p < 0.001). In addition, stent type, stent length, and diabetes mellitus were associated with the development of ISR. Conclusions: A low PNI value indicates poor nutritional status, which is thought to accelerate inflammation processes and cause atherosclerosis and ISR.

SGLT-2 inhibitors and in-stent restenosis-related events after acute myocardial infarction: an observational study in patients with type 2 diabetes.

BACKGROUND: No study evaluated the incidence of intra-stent restenosis (ISR)-related events in patients with type 2 diabetes (T2DM) and acute myocardial infarction (AMI) treated or not with sodium/glucose cotransporter 2 inhibitors (SGLT2i). METHODS: We recruited 377 patients with T2DM and AMI undergoing percutaneous coronary intervention (PCI). Among them, 177 T2DM were treated with SGLT2 inhibitors before PCI. The primary outcome was major adverse cardiovascular events (MACE) defined as cardiac death, re-infarction, and heart failure related to ISR. In patients without ISR, minimal lumen area and minimal lumen diameter were assessed by coronary CT-angiography at 1-year follow-up. RESULTS: Glycemic control was similar in SGLT2i-treated patients and never SGLT2i-users. The incidence of ISR-related MACE was higher in never SGLT2i-users compared with SGLT2i-treated patients, an effect independent of glycemic status (HR = 0.418, 95% CI = 0.241-0.725, P = 0.002) and observed also in the subgroup of patients with HbA1c < 7% (HR = 0.393, 95% CI = 0.157-0.984, P = 0.027). In patients without the event, the stent patency was greater in SGLT2i-treated patients compared with never SGLT2i-users at 1-year follow-up. CONCLUSIONS: SGLT2i treatment in T2DM is associated with a reduced incidence of ISR-related events, independently of glycemic control.

Short-term outcome of stenting with Enterprise stents for symptomatic intracranial atherosclerotic disease at a single center.

OBJECTIVE: To evaluate the safety and efficacy of stenting for symptomatic intracranial atherosclerotic severe stenosis or occlusion with Enterprise stents. METHODS: Fifty-three consecutive patients with symptomatic intracranial atherosclerotic severe (70%-99%) stenosis or occlusion who underwent endovascular treatment with Enterprise stents between September 2019 and March 2022 were retrospectively analyzed. Primary outcomes included technical stenting success rates, the incidence of complications within 30 days of the procedure, and the in-stent restenosis rates during the follow-up period. These outcomes were further categorized based on lesion location and operation time. RESULTS: Fifty-seven lesions in 53 patients aged 61.0 ± 10.0 years were treated with Enterprise stents with a technical success rate of 100%. Seven patients (12.3%) had severe complications within 30 days of the procedure: five had a symptomatic ischemic stroke, one had a symptomatic intracerebral hemorrhage, and one had a subarachnoid hemorrhage related to the procedure. No deaths were observed. The rate of in-stent restenosis was 18.2%, with a mean vascular imaging follow-up period of 6.7 months. The 30-day complication and in-stent restenosis rates did not differ significantly between patients with different lesion locations and operation times (P > 0.05). CONCLUSION: This retrospective study suggests that percutaneous transluminal angioplasty and stenting with Enterprise stents is an effective treatment for symptomatic intracranial arterial stenosis or occlusion with a high technical success rate. It also indicates that stenting during the early nonacute stage after stroke may not increase the incidence of perioperative complications for symptomatic intracranial atherosclerotic stenosis when following strict inclusion criteria.

A single-center experience of 30-day perioperative and one year clinical outcomes of transcarotid artery revascularization in 100 consecutive patients.

BACKGROUND: Transcarotid Artery Revascularization (TCAR) using the ENROUTE system (Silk Road) has been proposed as a safe and effective alternative to both carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). Two large registries (ROADSTER 1 and ROADSTER 2) have shown that TCAR has acceptable/low rates of perioperative stroke/death. This study will analyze the 30-day perioperative and 1-year clinical outcomes from a single-center. PATIENT POPULATION AND METHODS: This is a retrospective analysis of prospectively collected data from SVS/VQI TCAR surveillance project (TSP) of 100 consecutive patients (102 TCAR procedures) done in our institution. These procedures were done for high-risk patients for CEA, which included anatomical (previous CEA, high cervical lesion, neck radiation, stoma, arch type, etc.), physiological (CHF, severe coronary artery disease, COPD on O2 therapy, etc.) and combined anatomical/physiological reasons. These procedures were done by vascular surgeons after receiving the appropriate training. The perioperative stroke, death, and MI rates were analyzed. Kaplan Meyer analysis was used to estimate rate of freedom from stroke/death and the incidence of ≥50% and ≥80% in-stent restenosis at 1 year. RESULTS: 100 consecutive high-risk patients for CEA included: 38% anatomical, 44% physiological, and 18% combined anatomical and physiological reasons. The mean age was 72.5 years (range 52-90 years). Indications for TCAR were 34% for symptomatic lesions (TIA/stroke) and 66% for asymptomatic lesions. Mean ipsilateral treated stenosis was 80.4%. Contralateral ≥50% stenosis/occlusion was present in 31% of patients. Technical success rate was 100%. 92% had pre-stenting PTA and 26% had post-stenting PTA. The mean flow reversal time was 8.5 min (range 3-26 min). The 30-day perioperative stroke rate was 2.9% (1/67, 1.5% for asymptomatic patients), the stroke/death rate was 2.9%, and stroke/death and MI rate was 3.9% (4/102). Other perioperative complications included cranial nerve injury 3/102 (2.9%), carotid artery dissection (2%), and major hematoma (necessitated operation evacuation) (5.9%). Freedom from stroke rates and stroke/death rates at 1 year were: 90% and 89%. Freedom from ≥50% and ≥80% in-stent restenosis rates at 1 year were 82% and 90%, respectively. None of these restenosis were symptomatic except two (2/13). Freedom from reintervention rate at 1 year was 98%. CONCLUSION: Although the perioperative events were somewhat higher than what has been reported in previous registries, TCAR for patients who are high-risk for CEA has a low perioperative stroke and stroke/death rates with satisfactory outcome at 1 year. Further long-term data is probably needed to verify long-term outcome.

Resolute onyx stent more effective than wingspan stent at preventing procedural complications and long-term restenosis.

BACKGROUND AND PURPOSE: Angioplasty and stenting is a treatment option for patients with medically refractory symptomatic intracranial atherosclerotic disease (sICAD). Currently the Wingspan Stent System (WSS) is the only FDA approved device for this indication. We find the Resolute (R) Onyx Stent, a drug-eluting balloon mounted stent (DES), a better alternative to the WSS for treatment of sICAD. Herein, we present our findings comparing the two stents based on our single center experience. METHODS: A prospectively maintained neuro-endovascular databased was queried for patients between January 2013 to June 2021. Inclusion criteria for patients included sICAD with failed medical management, and intracranial stenting with either R-Onyx DES or WSS, including patients treated within 7 days of their last stroke. Primary outcomes were assessed via the occurrence of ischemic or hemorrhagic stroke or death within 72 h of the procedure. Secondary outcomes consisted of recurrent stroke or significant in-stent restenosis evaluated by a clinical or angiographic follow-up at 6 months. RESULTS: A total of 184 patients, average age 61.26 (SD = 12.53) (44% women), were eligible for analysis with 58 having R-onyx DES and 126 having WSS. Within 72 h, the primary outcome was observed in 1.7% (n = 1) of patients in the R-onyx DES group and 6.3% (n = 8) of patients in the WSS group (p = 0.089). Among 41 angiographic and clinical follow-ups in the R-onyx DES group, none had a recurrent stroke, while among 101 patients who had follow-up in the WSS group, 8.9% (n = 9) had a stroke (p = 0.024). At a 6-month angiographic follow-up, there was a significantly lower rate of symptomatic in-stent restenosis among the R-onyx DES group with 1.7% (n = 1) compared with 21.4% (n = 27) in the WSS group (p = 0.0003). CONCLUSION: R-onyx DES is more effective than WSS in treating sICAD with low rates of periprocedural complications and long-term strokes and symptomatic in-stent restenosis. Future prospective randomized multicenter trials are needed.

Impact of residual stenosis on clinical outcomes when performing carotid artery stenting without postdilation.

OBJECTIVE: Many centers consider postdilation if the final angiography after carotid artery stenting (CAS) shows residual stenosis of >30% to 40%. Postdilation has been demonstrated to potentially increase the risk of developing neurologic events. This study aimed to investigate the safety of CAS without postdilation regardless of the degree of residual stenosis. METHODS: We retrospectively investigated 191 patients who underwent transfemoral CAS without postdilation intendedly. All cases underwent mild predilation and self-expanding stent implantation. We divided the patients into a residual stenosis of ≥40% group (n = 69 [36.1%]) and a residual stenosis of <40% group (n = 122 [63.9%]) according to their final angiography. We compared the procedural (within 30 days after CAS) and nonprocedural (afterward) adverse cardiovascular events and in-stent restenosis between the two groups. We also investigated the incidence of perioperative hemodynamic depression between the groups and the changes in residual stenosis over the follow-up time. RESULTS: Patients in the residual stenosis of ≥40% group had a higher preoperative stenosis rate and a greater proportion of severely calcified lesions than those in the <40% group. There was one procedural cardiac death (0.5%), five strokes (2.6%), and four myocardial infarctions (2.1%). A total of 2.9% had stroke or death procedurally in the residual stenosis of ≥40% group and 3.2% in the residual stenosis of <40% group (P > .950). The median nonprocedural follow-up time was 22 months, with a total of six deaths and four strokes. The cumulative 2-year death or stroke rate was 6.2%, with 5.9% in the residual stenosis of ≥40% group versus 6.7% in the residual stenosis of <40% group (P = .507). There were two cases of in-stent restenosis in the residual stenosis of ≥40% group and three in the residual stenosis of <40% group (P = .927). The difference in the peak systolic velocity of the target lesion between groups at 3 months after CAS was no longer present, and residual stenosis stabilized at 10% to 20% at 6 months in both groups. The patients showed an association between increasing hemodynamic depression incidence and residual stenosis in a significantly graded response (P = .021). CONCLUSIONS: Residual stenosis after carotid stenting without postdilation is not associated with a risk of postoperative adverse events. This study provides evidence for the feasibility of a no postdilation strategy for CAS.

Impact of cerebral small vessel disease on symptomatic in-stent restenosis in intracranial atherosclerosis.

OBJECTIVE: Cerebral small vessel disease (CSVD) commonly coexists with intracranial atherosclerotic stenosis (ICAS). In-stent restenosis (ISR) affects the nonprocedural outcome of severe symptomatic ICAS after intracranial stenting. However, only 8%-27% of ISR patients are symptomatic, which highlights the importance of the investigation of risk factors associated with symptomatic ISR (SISR) to improve long-term functional outcome. Whether CSVD is associated with SISR remains unclear. The authors tested the hypothesis that CSVD is associated with SISR in ICAS patients after intracranial stenting. METHODS: This retrospective study enrolled 97 patients who were symptomatic due to severe anterior circulation ICAS treated with intracranial stenting. SISR was evaluated with clinical and vascular imaging follow-up. CSVD subtypes, including white matter hyperintensities (WMHs), enlarged perivascular spaces, and chronic lacunar infarctions, were evaluated. Cox regression analysis was used to compare the incidence of SISR between patients with and without CSVD. RESULTS: Of the enrolled patients, 58.8% had CSVD. The 1- and 2-year ISR rates were 24.7% and 37.1%, respectively. Of the CSVD subtypes, SISR was associated with deep WMHs (DWMHs; HR 5.39, 95% CI 1.02-28.44). DWMH Fazekas scale grades 2 (HR 85.54, 95% CI 2.42-3018.93) and 3 (HR 66.24, 95% CI 1.87-2352.32) were associated with SISR, but DWMH Fazekas grades 0 and 1 were not. The proportions of SISR in patients with DWMH Fazekas grades 0, 1, 2, and 3 were 16.7%, 33.3%, 50%, and 100%, respectively. CONCLUSIONS: Patients with CSVD have a higher risk of SISR than those without CSVD. Of the CSVD subtypes, patients with DWMHs are associated with SISR. The DWMH Fazekas scale score is considered to be a predictor for SISR.

A practice audit of short-term outcomes of Wallstents versus Venovo stents for the treatment of nonthrombotic iliac vein outflow stenoses.

OBJECTIVE: The Wallstent (WS; Boston Scientific, Malborough, MA) is currently the standard of care for comparisons of clinical efficacy for new stent devices in the treatment of iliac vein outflow disease. Many vein-specific Nitinol-based stents have been now approved by the Food and Drug Administration for use in the iliofemoral venous system. However, few comparisons of these devices to the current standard have been reported. The purpose of this investigation was to compare the complication and reintervention rates between the WS and Venovo stent (VS; BD, Franklin Lakes, NJ). METHODS: A random sample of 100 WS and 100 VS cases performed from April 2018 through December 2020 were selected for retrospective analysis. The demographics, presenting symptoms, and CEAP (Clinical, Etiology, Anatomy, Pathophysiology) class were assessed. The complication logs and 90-day follow-up data were reviewed for every case to assess the incidence of postoperative deep vein thrombosis, stent thrombosis, in-stent restenosis, bleeding, and transient back pain. RESULTS: WSs had been placed more often in the left common iliac vein segment (52 vs 1), and VSs had been placed more often in the left common iliac vein and external iliac vein segments (36 vs 63; P = .0069). The average diameter and length of the WSs and VSs were 19.7 ± 2.2 mm vs 15 ± 1.4 mm (P = 2.4∗10-44) and 80.8 ± 9 mm vs 117.6 ± 20.4 mm (P = 2.4∗10-38), respectively. The average number of stents per patient was 1.05 for the WSs and 1.03 for the VSs (P = .47). The reintervention rates were similar between the two groups: WS, n = 5; and VS, n = 4 (P = .74). Four of the five WS reinterventions were stent extensions to treat in-stent restenosis and recurrence of symptoms, and one was secondary to occlusion requiring ipsilateral venoplasty and stenting. Two of the four VS reinterventions were venoplasty for in-stent restenosis and two were stent extensions for symptom recurrence. Transient back pain was the most common complication (WS, 37%; VS, 47%; P = 0.28). Insertion site deep vein thrombosis had developed in the three patients in the WS group and four patients in the VS group (P = .71). No patient had experienced bleeding requiring hospitalization, and no stent fractures, stent migration, or deaths had occurred. CONCLUSIONS: The complication and reintervention rates between the WS and VS groups were similar. Both stents demonstrated evidence of in-stent stenosis requiring reintervention. Implanted VSs tended to be smaller in diameter and longer in length and covered the common and external iliac veins more often compared with the WSs. Therefore, one VS can be used to cover two territories compared with the WS for which two stents will be required to cover the same vein territory length.

Hybrid surgery techniques for the treatment of in-stent restenosis after 5 years of femoral artery self-expanding bare-metal stent implantation: A case report.

RATIONALE: Lower extremity arteriosclerosis obliterans (ASO) disease is caused by the formation of atherosclerotic plaque in the femoral artery, which causes the stenosis and occlusion of lower legs, and then leads to chronic limb ischemia. Stent intervention is the most common treatment for ASO in the lower extremities, although there is a risk of overstretching or fracturing the stent, resulting in stent rupture. We provide a unique method for treating stent rupture. PATIENT CONCERNS: A 79-year-old male presented with intermittent claudication of the left lower limb for 6 months. Five years ago, a stent was placed in the lower extremity femoral artery. According to the examination, the stent suffered a modest torsional fracture. DIAGNOSIS: The case was diagnosed with lower extremity ASO. INTERVENTIONS: We performed a combination of femoral endarterectomy and interventional surgery. OUTCOMES: Blood flow was restored after the hybrid operation has been used to treat arterial stenosis in the lower limbs. CONCLUSION: Integrating vascular interventional surgeries can shorten surgical procedures time and increase success rates.

Late Outcomes of Carotid Artery Stenting for Radiation Therapy-Induced Carotid Stenosis.

PURPOSE: Carotid artery stenting (CAS) appears as a promising alternative treatment to carotid endarterectomy for radiation therapy (RT)-induced carotid stenosis. However, this is based on a poor level of evidence studies (small sample size, primarily single institution reports, few long-term data). The purpose of this study was to report the long-term outcomes of a multicentric series of CAS for RT-induced stenosis. METHODS: All CAS for RT-induced stenosis performed in 11 French academic institutions from 2005 to 2017 were collected in this retrospective study. Patient demographics, clinical risk factors, elapsed time from RT, clinical presentation and imaging parameters of carotid stenosis were preoperatively gathered. Long-term outcomes were determined by clinical follow-up and duplex ultrasound. The primary endpoint was the occurrence of cerebrovascular events during follow-up. Secondary endpoints included perioperative morbidity and mortality rate, long-term mortality rate, primary patency, and target lesion revascularization. RESULTS: One hundred and twenty-one CAS procedures were performed in 112 patients. The mean interval between irradiation and CAS was 15 ± 12 years. In 31.4% of cases, the lesion was symptomatic. Mean follow-up was 42.5 ± 32.6 months (range 1-141 months). The mortality rate at 5 years was 23%. The neurologic event-free survival and the in-stent restenosis rates at 5 years were 87.8% and 38.9%, respectively. Diabetes mellitus (p=0.02) and single postoperative antiplatelet therapy (p=0.001) were found to be significant predictors of in-stent restenosis. Freedom from target lesion revascularization was 91.9% at 5 years. CONCLUSION: This study showed that CAS is an effective option for RT-induced stenosis in patients not favorable to carotid endarterectomy. The CAS was associated with a low rate of neurological events and reinterventions at long-term follow-up.

Blood biomarkers of progressive atherosclerosis and restenosis after stenting of symptomatic intracranial artery stenosis.

In-stent restenosis (ISR) represents a major complication after stenting of intracranial artery stenosis (ICAS). Biomarkers derived from routine blood sampling including C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and mean platelet volume (MPV) have been associated with progressive atherosclerosis. We investigated the role of CRP, NLR, PLR and MPV on the development of intracranial ISR and recurrent stroke risk. We retrospectively included all patients who had undergone stenting of symptomatic ICAS at our university hospital between 2005 and 2016. ISR (≥ 50% stenosis) was diagnosed by regular Duplex sonography follow-up studies and confirmed by digital subtraction angiography or computed tomography angiography (mean follow-up duration: 5 years). Laboratory parameters were documented before stenting, at the time of restenosis and at last clinical follow-up. Of 115 patients (mean age: 73 ± 13 years; female: 34%), 38 (33%) developed ISR. The assessed laboratory parameters did not differ between patients with ISR and those without (p > 0.1). While ISR was associated with the occurrence of recurrent ischemic stroke (p = 0.003), CRP, NLR, PLR and MPV were not predictive of such events (p > 0.1). Investigated blood biomarkers of progressive atherosclerosis were not predictive for the occurrence of ISR or recurrent ischemic stroke after ICAS stenting during a 5-year follow-up.

Effect of umbilical cord blood stem cell transplantation on restenosis after endovascular interventional therapy for diabetic hindlimb vascular disease.

This study aimed to investigate the mechanism of human umbilical cord blood stem cell (HUCBSC) transplantation on restenosis after percutaneous transluminal angioplasty (PTA) for diabetic hindlimb vascular disease in rabbits. After successfully preparing a rabbit model of diabetic hindlimb vascular disease, 16 rabbits were randomly assigned to two groups. Of these, 8 rabbits received PTA surgery alone (PTA group), and the other 8 rabbits received PTA and HUCBSC (PTA+HUCBSC group) treatments. Five more healthy rabbits were set as healthy control (HC group). Samples were collected after 4 weeks of treatment. The expressions of regulator of calcineurin 1 (RCAN1) and calcineurin A (CnA) in the diseased artery were detected by immunofluorescence staining. The distribution of HUCBSCs was observed by pathological examination in transplanted artery, distal artery, and liver. Cytology experiments were applied to assess the levels of JAK and STAT3, and the migration and proliferation of human aortic vascular smooth muscle cells (HA-VSMC). In the rabbit model of diabetic vascular lesions in the hindlimbs, we found the stenosis of the femoral artery became more and more serious with time, and the expression level of PCNA positive cells was also gradually increased. The expression levels of RCAN1 and CnA in the PTA+HUCBSC group were significantly lower than those in PTA group. HUCBSC inhibited the migration and proliferation of HA-VSMC via JAK/STAT3 pathway. After HUCBSC local transplantation, HUCBSC had no distal tissue distribution. HUCBSC transplantation may prevent restenosis after PTA of diabetic hindlimb vascular disease through JAK/STAT3 pathway.

Influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con reestenosis en el stent / Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis

Introducción y objetivos La neoateroesclerosis es una de las causas de la reestenosis en el stent (RS). Nuestro objetivo es evaluar la influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con RS. Métodos Se trata de un análisis conjunto de los subestudios de tomografía de coherencia óptica (OCT) de los RIBS IV y V, 2 ensayos clínicos aleatorizados y multicéntricos que comparan el tratamiento con un balón recubierto con paclitaxel frente al stent liberador de everolimus en pacientes con RS. La evaluación con OCT se realizó basalmente y a los 6-9 meses. La neoateroesclerosis se definió en la OCT basal como una neoíntima con contenido calcificado o lipídico. Se evaluaron los resultados angiográficos y por OCT a los 6-9 meses y la aparición de eventos adversos cardiovasculares mayores a los 3 años de seguimiento en pacientes con y sin neoateroesclerosis tratados con balón recubierto con paclitaxel o stent liberador de everolimus. Resultados Se estudió mediante OCT a 64 pacientes en el momento del procedimiento. Se documentó neoateroesclerosis en 23 lesiones (36%). El seguimiento angiográfico a los 6-9 meses no mostró diferencias entre los pacientes con y sin neoateroesclerosis en reestenosis (5 [24%] frente a 6 [15%]; p=0,49), diámetro luminal mínimo (1,79±0,7 frente a 1,94±0,6 mm; p=0,41) o pérdida tardía (0,33±0,7 frente a 0,15±0,5; p=0,34). El seguimiento con OCT confirmó la ausencia de diferencias en los parámetros cuantitativos y las características del tejido de recubrimiento entre los 2 grupos. A los 3 años de seguimiento, la incidencia de eventos fue de 3 (13%) frente a 5 (12%) en los grupos con y sin neoateroesclerosis respectivamente (HR=0,94; IC95%, 0,22-3,93; p=0,93). Conclusiones En este estudio con una pequeña muestra de pacientes aleatorizados a tratamiento con balón recubierto con paclitaxel o stent liberador de everolimus por RS, ... (AU)

Introduction and objectives Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. Methods This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. Results Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). Conclusions In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR. (AU)

Melatonin attenuates restenosis after vascular injury in diabetic rats through activation of the Nrf2 signaling pathway.

Diabetes is a major risk factor for the development of cardiovascular disease. Diabetic patients have a higher incidence of restenosis following endovascular therapy than non-diabetic patients. Melatonin is primarily synthesized and secreted by the pineal gland and plays an important protective anti-inflammatory and antioxidant role in a variety of cardiovascular diseases. However, no studies to date have evaluated the underlying effects and molecular mechanisms of melatonin on diabetes-related restenosis. Herein, we used an in vivo model of diabetes-related restenosis and an in vitro model of high glucose-cultured vascular smooth muscle cells to investigate the anti-restenosis effect and signaling mechanisms induced by melatonin treatment. The present study provides the first evidence that melatonin attenuates restenosis following vascular injury in diabetic rats. We further investigated the underlying molecular mechanisms both in vivo and in vitro. The data suggest that the Nrf2 signaling pathway is an important molecular target for melatonin-mediated inhibition of diabetes-related restenosis after vascular injury. These findings indicate that melatonin may represent a potential candidate for the prevention or treatment of vascular diseases and restenosis following endovascular therapy, especially in diabetic patients.

Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry.

BACKGROUND: Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. METHODS AND RESULTS: We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003-16.761, p=0.509). CONCLUSIONS: In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.

Effects of a Matrix Metalloproteinase Inhibitor-Eluting Stent on In-Stent Restenosis.

BACKGROUND The aim of this study was to compare changes in the extracellular matrix after implantation of a stent that elutes a matrix metalloproteinase (MMP) inhibitor (GM6001); and to determine the effects of the GM6001-eluting stent upon prevention of in-stent restenosis (ISR). MATERIAL AND METHODS We included 48 Guangxi Bama mini-pigs in this study. A GM6001-eluting stent was placed in one iliac artery and a stent that did not elute GM6001 was placed in the contralateral iliac artery. The iliac arteries were removed at 6 hours as well as 1, 7, 14, 56, 84, and 336 days after stent placement. Arteries were analyzed for morphometry, gelatinase content, different phenotypes of vascular smooth muscle cells (VSMCs), collagen content, apoptotic rate, and cell density. RESULTS The vascular lumen areas of the GM6001 group were significantly increased and the neointimal areas were significantly reduced compared with the control group from the 7 days to the 336 days. In the 2 groups, expression of MMP-2 and MMP-9 peaked simultaneously, but GM6001-eluting stents inhibited expression of MMP-2 and MMP-9 in the vascular media and neointima (especially around the struts) significantly. In the GM6001 group, expression of tissue inhibitor of matrix metalloproteinase (TIMP)-1, TIMP-2, myosin heavy chain 10 (MYH-10, marker of the proliferative phenotype of VSMCs), collagen content, percentage of apoptotic cells, and cell density were also decreased significantly compared with those in the control group. CONCLUSIONS Use of GM6001-eluting stents resulted in persistent and potent inhibition of intimal hyperplasia, an increase in luminal area, and no obvious thrombosis in the arteries of the mini-pigs.