6-month Restenosis Research Articles

A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial

BackgroundSirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising. ObjectivesThe authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population. MethodsThis multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data. ResultsThe mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13). ConclusionsThe SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.

Carotid artery revascularization using second generation stents versus surgery: a meta-analysis of clinical outcomes.

Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).

Correlation between C-reactive protein to albumin ratio and restenosis after femoral popliteal stenting in patients with lower extremity arteriosclerotic obliterans

Objective: To investigate the study of the correlation between C-reactive protein to albumin ratio (CAR) and restenosis after stenting in patients with lower extremity atherosclerotic occlusive disease(LEASO). Methods: The clinical data of 95 patients with LEASO admitted to the Department of Vascular Surgery of Nanjing Drum Tower Hospital from June 2020 to December 2022 were retrospectively analyzed. There were 67 males and 28 females,aged (73.1±9.4) years (range:51 to 92 years). The patients were classified into the restenosis group (n=61) and the patency group (n=34) according to the CT angiography results. Independent sample t test,Mann-Whitney U test and χ2 test were used to compare the data between two groups. Risk factors for restenosis after femoropopliteal artery stenting in patients with LEASO were analyzed using multivariate Cox regression. The relationship between preoperative CAR level and restenosis after stent placement was analyzed. Subject operating characteristic(ROC) curves of CAR were plotted to assess the predictive value of CAR for restenosis after stenting,and the results were expressed as area under the curve (AUC). Results: The aortoiliac calcification grade,number of stents,length of stents,C-reactive protein and CAR levels in restenosis group were higher than those in the patency group,and the serum albumin level was lower than that in the patency group(all P<0.05). And the results of multifactorial Cox regression analysis showed that higher pre-procedure CAR level and lower ABI value was an independent risk factor for in-stent restenosis. The AUC of the ROC curve for restenosis was 0.737(95%CI:0.617 to 0.856),the AUC of the ROC curve for 12-month restenosis was 0.709(95%CI:0.602 to 0.815), and the AUC of the ROC curve for 24-month restenosis was 0.702(95%CI:0.594 to 0.811). Conclusion: Higher pre-procedural CAR levels in patients with LEASO is risk factor for in-stent restenosis,and CAR has a predictive value for restenosis after lower extremity arterial stent dilatation and angioplasty.

Clinical Impact of Additional Cilostazol Treatment on Restenosis Risk following Heparin-Bonded Stent Graft Implantation: Sub-Analysis from the Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study.

The present study investigated the effects of additional cilostazol administration on the 12-month risk of restenosis after femoropopliteal heparin-bonded stent graft implantation. This study was a sub-analysis of the Viabahn stent graft placement for femoropopliteal disease reQUIring endovaScular tHerapy (VANQUISH) study, which was a prospective multicenter study investigating patients who received Viabahn stent graft (W.L. Gore & Associates, Flagstaff, AZ, USA) and dual-antiplatelet therapy with aspirin and a thienopyridine. The comparison of clinical outcomes between subgroups with and without cilostazol treatment were performed using the propensity score-matching method to minimize the intergroup differences in baseline characteristics. Cilostazol-treated patients had a lower 12-month proportion of restenosis than cilostazol-free patients (8.2% vs 27.3%). The odds ratio of cilostazol for the 12-month restenosis was 0.27 [95% CI, 0.08 to 0.97] (p=0.045). Furthermore, the cumulative incidence rates of surgical reconstruction, target lesion revascularization and acute thrombotic occlusion (p values by the log-rank test) were 2.6% versus 1.8% (P=0.43), 5.3% versus 20.5% (P=0.067), and 0.0% versus 11.8% (P=0.0499), respectively. The rates of surgical reconstruction and target lesion revascularization (TLR) were not significantly different between both groups. Our study revealed the clinical impact of additional cilostazol treatment on the risk of restenosis and acute thrombotic occlusion following heparin-bonded stent graft implantation, while TLR and surgical reconstruction were not significantly different.

Application of high-resolution magnetic resonance vessel wall image in the treatment of M1 segment stenosis of middle cerebral artery

To investigate the application of high-resolution magnetic resonance vessel wall image (HRMR-VWI) in treating middle cerebral artery (MCA) M1 segment stenosis. We retrospectively analyzed preoperative clinical data, imaging data, preoperative evaluation, stent procedure, and postoperative complications in 35 patients with atherosclerotic stenosis of the MCA M1 segment. And the 30-day postoperative mortality and disability and the 12-month restenosis were followed up. There were 21 males and 14 females, with a median age of 55 and a median duration of 1 month from onset to stenting. DSA confirmed that the stenosis locates in the M1 segment, with a stenosis degree of (75.00±17.15) %, a stenosis length of (4.34±1.51) mm, and a blood vessel diameter of (2.25±0.42) mm. After the operation, there was 1 case of death after a craniotomy to remove hematoma+decompression due to reperfusion hemorrhage. There were two technical complications during the procedure (1 case of asymptomatic occlusion of the A1 segment due to the covering of stent at the initial part of A1, 1 case of intraparenchymal hematoma in the temporal lobe due to penetrating distal small blood vessel with guide wire). HRMR-VWI is of great value in observing plaques' location, morphology, and stability. It can improve the safety and effectiveness of stenting treatment of MCA M1 segment stenosis.

Carotid Plaque Features and Inflammatory Biomarkers as Predictors of Restenosis and Mortality Following Carotid Endarterectomy.

Carotid endarterectomy (CEA) is the first-line surgical intervention for cases of severe carotid stenoses. Unfortunately, the restenosis rate is high after CEA. This study aims to demonstrate the predictive role of carotid plaque features and inflammatory biomarkers (monocyte-to-lymphocyte ratio (MLR), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic inflammatory index (SII), Systemic Inflammation Response Index (SIRI), and Aggregate Index of Systemic Inflammation (AISI)) in carotid restenosis and mortality at 12 months following CEA. The present study was designed as an observational, analytical, retrospective cohort study and included all patients over 18 years of age with a minimum of 70% carotid stenosis and surgical indications for CEA admitted to the Vascular Surgery Clinic, Emergency County Hospital of Targu Mures, Romania between 2018 and 2021. According to our results, the high pre-operative values of inflammatory biomarkers-MLR (OR: 10.37 and OR: 6.11; p < 0.001), NLR (OR: 34.22 and OR: 37.62; p < 0.001), PLR (OR: 12.02 and OR: 16.06; p < 0.001), SII (OR: 18.11 and OR: 31.70; p < 0.001), SIRI (OR: 16.64 and OR: 9.89; p < 0.001), and AISI (OR: 16.80 and OR: 8.24; p < 0.001)-are strong independent factors predicting the risk of 12-month restenosis and mortality following CEA. Moreover, unstable plaque (OR: 2.83, p < 0.001 and OR: 2.40, p = 0.04) and MI (OR: 3.16, p < 0.001 and OR: 2.83, p = 0.005) were independent predictors of all outcomes. Furthermore, AH (OR: 2.30; p = 0.006), AF (OR: 1.74; p = 0.02), tobacco (OR: 2.25; p < 0.001), obesity (OR: 1.90; p = 0.02), and thrombotic plaques (OR: 2.77; p < 0.001) were all independent predictors of restenosis, but not for mortality in all patients. In contrast, antiplatelet (OR: 0.46; p = 0.004), statin (OR: 0.59; p = 0.04), and ezetimibe (OR:0.45; p = 0.03) therapy were protective factors against restenosis, but not for mortality. Our data revealed that higher preoperative inflammatory biomarker values highly predict 12-month restenosis and mortality following CEA. Furthermore, age above 70, unstable plaque, cardiovascular disease, and dyslipidemia were risk factors for all outcomes. Additionally, AH, AF, smoking, and obesity were all independent predictors of restenosis but not of mortality in all patients. Antiplatelet and statin medication, on the other hand, were protective against restenosis but not against mortality.

Clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter EAGLE study

BackgroundSeveral studies have reported the efficacy of drug-coated balloons (DCB) for simple femoropopliteal (FP) lesions. However, the effectiveness of DCB for FP chronic total occlusive lesions (CTO) is controversial. The present study investigated the clinical outcomes of DCB for FP-CTO.Materials and methodsWe retrospectively analyzed 359 limbs of 318 patients who underwent endovascular therapy with DCB for FP-CTO between July 2017 and February 2021 at seven cardiovascular centers. The primary endpoint was 12-month primary patency. The secondary endpoints were the 12-month rates of freedom from: (1) clinically-driven target lesion revascularization (CD-TLR), and (2) re-occlusion. The association of baseline characteristics with the 12-month restenosis risk was investigated using the Cox proportional hazards regression model.ResultsThe 12-month rate of primary patency was 79.8% (95% confidence interval [95%CI], 75.1% to 84.8%), whereas the corresponding rates of freedom from CD-TLR and re-occlusion were 86.4% (95%CI: 82.6% to 90.4%) and 88.5% (95%CI: 84.7% to 92.4%), respectively. The bailout stent rate was 8.9%. Independent risk factors for restenosis were hemodialysis (adjusted hazard ratio, 2.18 [1.39 to 3.45]; P = 0.001), chronic limb-threatening ischemia (CLTI) (2.02 [1.33 to 3.07]; P = 0.001), and restenosis lesion (2.02 [1.32 to 3.08]; P = 0.001). Use of dual antiplatelet therapy (DAPT) was identified as a protective factor for restenosis (0.54 [0.35 to 0.82]; P = 0.003).ConclusionsDespite the low rate of bailout stent, DCB treatment for FP-CTO was effective in real-world clinical practice. Hemodialysis, CLTI, and restenosis lesion were independent risk factors for 12-month restenosis, and the use of DAPT significantly attenuated the risk of 12-month restenosis.

Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries

PurposeTo evaluate temporal trends, practice variation, and associated outcomes with the use of intravascular ultrasound (US) during deep venous stent placement among Medicare beneficiaries. Materials and MethodsAll lower extremity deep venous stent placement procedures performed between January 1, 2017, and December 31, 2019 among Medicare beneficiaries were included. Temporal trends in intravascular US use were stratified by procedural setting and physician specialty. The primary outcome was a composite of 12-month all-cause mortality, all-cause hospitalization, or repeat target vessel intervention. The secondary outcome was a composite of 12-month stent thrombosis, embolization, or restenosis. ResultsAmong the 20,984 deep venous interventions performed during the study period, 15,184 (72.4%) utilized intravascular US. Moderate growth in intravascular US use was observed during the study period in all clinical settings. There was a variation in the use of intravascular US among all operators (median, 77.3% of cases; interquartile range, 20.0%–99.2%). In weighted analyses, intravascular US use during deep venous stent placement was associated with a lower risk of both the primary (adjusted hazard ratio, 0.72; 95% confidence interval [CI], 0.69–0.76; P < .001) and secondary (adjusted hazard ratio, 0.32; 95% CI, 0.27–0.39; P < .001) composite end points. ConclusionsIntravascular US is frequently used during deep venous stent placement among Medicare beneficiaries, with further increase in use from 2017 to 2019. The utilization of intravascular US as part of a procedural strategy was associated with a lower cumulative incidence of adverse outcomes after the procedure, including venous stent thrombosis and embolization.

Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis.

Background: Single-cohort studies suggest that second-generation stents (SGS; “mesh stents”) may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a “mesh stent” class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials.

The efficacy of balloon dilatation in clinical improving period for patients who suffered from actively caseating endobronchial tuberculosis and central airway stenosis

Objective: To investigate the efficacy of balloon dilatation performed for patients who suffered from actively caseating endobronchial tuberculosis (EBTB) and central airway stenosis in clinical improving period who's bronchus has not formed mature scar tissue. Methods: A total of 152 tuberculous unilateral main bronchus stenosis patients (23 male and 129 female) who received treatment in Hunan Chest Hospital from January 1st 2014 to December 31st 2018 were included in this retrospective analysis. The age was 15-66 (33.3±11.9) years old. All patients received routine anti-tuberculosis chemotherapy. Sixty-four of them who suffered from actively caseating EBTB and unilateral main bronchus stenosis received cryotherapy and endobronchial isoniazid (INH) administration till the caseating necrosis in stenotic bronchus was disappeared and ulcers were recovered, and then received balloon dilatation combined with cryotherapy, were test group. Eighty-eight of them who suffered from fibrostenotic EBTB received balloon dilatation combined with cryotherapy were control group. We analyzed the efficacy and complications after treatments. Results: The lung re-expansion rate after treatment in test group was higher than the control group, and the differences were statistically significant [74.0%(37/50) vs. 37.9%(22/58), χ²=14.094, P<0.001]. The 6-month re-stenosis rate in test group was lower than control group, and the differences were statistically significant [10.9%(7/64) vs. 30.7% (27/88), χ²=8.318, P=0.004]. The differences of diameter and diameter variation after balloon dilatation, immediate effective rates, average times of balloon dilatation and procedure-related bleeding (<10 ml) rates, chest pain rates had no statistical signification in two groups. Severe complications including fatal bleeding (>100 ml) and mediastinal emphysema did not occur during our procedures. Conclusions: Performing balloon dilatation for patients who suffered from actively caseating EBTB and central airway stenosis in the clinical improvement period, when caseous necrosis tissue disappeared and ulcers were recovered, not only helps to perform interventional procedures on distal bronchus in time, increase the rate of lung re-expansion, can also reduce the rate of re-stenosis after 6 months, so it is effective and safe.

A Novel Angiographic Risk Score for Femoropopliteal Interventions

Purpose To present a novel angiographic scoring system that stratifies the risk of restenosis after endovascular therapy (EVT) to inform the decision to use paclitaxel-eluting devices in the femoropopliteal segment. Materials and Methods A prospective, multicenter registry including 1799 limbs of 1578 patients (mean age 74±9 years; 1090 men) with symptomatic peripheral artery disease undergoing intravascular ultrasound–supported femoropopliteal EVT was used as the basis for developing the angiographic score. Multivariable analysis identified baseline patient and limb characteristics associated with restenosis at 12 months. These risk factors for 12-month restenosis were explored using a generalized linear mixed model with a logit-link function in which the inter-institutional and inter-subject variability were treated as random effects. The multiple imputation method was adopted to address missing data. Results of the regression analysis are presented as the odds ratio (OR) with 95% confidence interval (CI). Results Twelve-month primary patency was estimated to be 65.1% (95% CI 62.7% to 67.5%). After multivariable analysis, distal reference vessel diameter per 1 mm (OR 0.71, 95% CI 0.62 to 0.81, p<0.001), lesion length per 10 cm (OR 1.39, 95% CI 1.19 to 1.62, p<0.001), and chronic total occlusion (OR 1.56, 95% CI 1.15 to 2.10, p=0.004) were independently associated with the 12-month restenosis risk, whereas baseline patient risk factors were not. Compared to bare nitinol stent implantation, plain angioplasty (OR 2.31, 95% CI 1.67 to 3.18, p<0.001) was independently associated with a higher risk of 12-month restenosis, while drug-eluting stents (OR 0.65, 95% CI 0.43 to 0.99, p=0.045) and stent-grafts (OR 0.24, 95% CI 0.12 to 0.50, p<0.001) were independently associated with a lower risk of 12-month restenosis. The angiographic score, which was developed by using the 3 angiographic factors but not the TransAtlantic Society Consensus II (TASC) class, was significantly and independently associated with 12-month restenosis. Conclusion The current study demonstrated a novel angiographic score for 12-month restenosis after femoropopliteal EVT in a real-world clinical practice. The developed score was significantly and independently associated with the 12-month restenosis risk, but the TASC class was not.

Intravascular Ultrasound Imaging During Aortoiliac Stenting: No Impact on Outcomes at 1 Year

Purpose To investigate the effect of intravascular ultrasound (IVUS) imaging use on clinical outcomes after aortoiliac stenting in patients with peripheral artery disease (PAD). Materials and Methods Subjects for this retrospective analysis were derived from the OMOTENASHI registry database, which contained 803 symptomatic PAD patients (Rutherford categories 2–4) who were treated with self-expanding stent implantation for aortoiliac atherosclerotic lesions at 61 centers in Japan between January 2014 and April 2016. Of the 803 patients, 545 (67.9%) patients (mean age 73±9 years; 453 men) underwent IVUS-supported stent implantation and were compared with the 258 patients (mean age 73±8 years; 217 men) treated without IVUS. A propensity score analysis of 138 matched pairs was conducted to compare treatment strategies and clinical outcomes between patients having IVUS-supported endovascular therapy and those treated without IVUS. Results Endovascular strategies and postoperative medications were not significantly different between the IVUS and no-IVUS groups. A procedure time under 1 hour was less frequent in the IVUS group, which had a longer fluoroscopy time. The 12-month restenosis rate was not significantly different between the 2 groups [10.2% (95% CI 6.9 to 14.9%) vs 10.3% (95% CI 5.4 to 18.6%), p=0.99]. There was no interaction between baseline characteristics and the association of IVUS use with restenosis risk. Conclusion Propensity score matching analysis revealed that duration and fluoroscopy time during IVUS-supported procedures were significantly longer than in cases without IVUS use, whereas the 12-month restenosis rate was not significantly different between the groups. IVUS use in aortoiliac lesions may be unnecessary.

Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty

PurposeThe post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty.MethodsIn the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months.ResultsA total of 171 patients (69 ± 8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI − 0.04 to 1.3], p = 0.06 and − 0.3 per 10 years [95% CI − 0.5 to 0.01], p = 0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p = 0.01 and OR 0.1 [95% CI 0.01 to 0.6], p = 0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B: − 0.1 per 10 mm [95% CI − 0.1 to − 0.03], p = 0.001 and − 0.1 [95% CI − 1.7 to − 0.1], p = 0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04).ConclusionDCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.

Correlation of pre-operative circulating inflammatory cytokines with restenosis and rapid angiographic stenotic progression risk in coronary artery disease patients underwent percutaneous coronary intervention with drug-eluting stents.

BackgroundThis study aimed to explore the associations of common inflammatory cytokine levels with restenosis and rapid angiographic stenotic progression (RASP) risk in coronary artery disease (CAD) patients underwent percutaneous coronary intervention (PCI) with drug‐eluting stents (DES).MethodsTwo hundred and ten CAD patients underwent PCI with DES were consecutively recruited, then pre‐operative serum levels of TNF‐α, IL‐1β, IL‐4, IL‐6, IL‐8, IL‐10, IL‐17A, IL‐21, and IL‐23 were determined by ELISA. The 12‐month in‐stent restenosis and RASP of non‐intervened lesion were assessed by quantitative coronary angiography analysis.ResultsThe pre‐operative TNF‐α, IL‐6, IL‐17A, and IL‐23 expressions were increased while IL‐4 expression was decreased in restenosis patients compared with non‐restenosis patients. Further analysis revealed that IL‐6, IL‐8, hypercholesteremia, diabetes mellitus, and HsCRP could independently predict restenosis risk, and subsequent ROC curve revealed that their combination was able to differentiate restenosis patients from non‐restenosis patients with an AUC of 0.951 (95%CI: 0.925‐0.978). Meanwhile, the pre‐operative TNF‐α, IL‐6, IL‐17A, IL‐21, and IL‐23 expressions were increased whereas IL‐4 level was decreased in RASP patients compared with non‐RASP patients. Further analysis revealed that TNF‐α, IL‐6, IL‐23, hypercholesteremia, SUA, HsCRP, and multivessel artery lesions could independently predict RASP risk, and subsequent ROC curve disclosed that their combination could discriminate RASP patients from non‐RASP patients with an AUC of 0.886 (95%CI: 0.841‐0.931).ConclusionsThis study unveils the potentiality of pre‐operative circulating inflammatory cytokines as markers for predicting restenosis and RASP risk in CAD patients underwent PCI with DES.

P4704The efficacy of intravascular ultrasound for patients with peripheral artery diseases presenting aorto-iliac artery disease

Abstract Background The use of intravascular ultrasound (IVUS) promotes better clinical outcomes for intervention in complex lesions. However, the data demonstrating whether use of IVUS improves primary patency following stenting for aorto-iliac lesions in patients with peripheral artery disease (PAD) are limited. Purpose The purpose of the current study was to investigate the impact of IVUS use on primary patency 12 months after stent implantation for aorto-iliac lesions. Methods We analyzed a clinical database of the OMOTENASHI registry (Observational prospective Multicenter registry study on Outcomes of peripheral arTErial disease patieNts treated by AngioplaSty tHerapy in aortoIliac artery), registering symptomatic PAD patients (Rutherford category 2, 3, or 4) undergoing endovascular therapy for aorto-iliac lesions between January 2014 and April 2016 in Japan. The current study analyzed 803 patients who underwent self-expandable stent implantation at 61 centers with the institutional volume known. The primary endpoint was 12-month restenosis, defined as ≥50% stenosis on computed tomography or angiography, or a peak systolic velocity ratio ≥2.5 on duplex ultrasound. When treatment strategies, endovascular procedures and clinical outcomes were compared between the patients treated with IVUS use and those treated without IVUS use, the propensity score matching was performed to minimize the inter-group difference in baseline characteristics. Results A total of 545 patients (67.9%) underwent IVUS-supported stent implantation. Patients treated with IVUS use had a lower prevalence of regular dialysis, whereas they had a higher prevalence of TASC II class D and chronic total occlusion. In patients treated with IVUS use, carbon dioxide contrast agent were more often used, and 0.035-inch guidewire was less frequently selected. Implanted stents in these patients were longer and smaller in diameter. The propensity score matching extracted 138 pairs, with no remarkable intergroup difference in baseline characteristics. Procedure time ≤1 hour was less frequent in patients treated with IVUS use; their radiation time was longer. Endovascular strategies, as well as postoperative medication were not significantly different between patients with and without IVUS use. The 12-month restenosis risk was not significantly different between patients with and without IVUS use (10.2% [6.9 to 14.9%] versus 10.3% [5.4 to 18.6%], P=0.99). Conclusion IVUS use in aorto-iliac stenting for patients with PAD was not associated with primary patency at 12 months. Acknowledgement/Funding None

Effectiveness of Tongguan capsules on restenosis after coronary stent implantation: a randomised controlled trial

BackgroundAlthough percutaneous coronary intervention (PCI) has become a widely used therapeutic procedure for coronary artery disease, stent restenosis limits the benefits of this revascularisation. The question of how to prevent such events remains unresolved. Empirical evidence suggests that Tongguan capsules, a patented Chinese Medicine, can decrease frequency and duration of angina pectoris attacks; however, evidence supporting its efficacy on restenosis remains inadequate. We aimed to determine whether Tongguan capsules could reduce restenosis incidence in patients after successful stent implantation. MethodsIn this single-centre, open-label randomised controlled trial, patients undergoing percutaneous coronary stent deployment who were aged 18–80 years were enrolled from Guangdong Provincial Hospital of Chinese Medicine and randomly assigned (1:1) to receive either Tongguan capsules for 3 months (4·5 g/day; Tongguan group) or nothing (control group). All patients received standard anti-platelet, anti-coagulation, and lipid-decreasing treatments, concurrently. The Clinical Research Centre from Guangzhou University of Chinese Medicine generated separate randomisation schedules using a random number generator. All attending physicians, investigators, and the biostatisticians performing the analysis were masked to treatment assignment. The primary clinical endpoint was the 12-month incidence of any major adverse cardiovascular event (defined as cardiac death, myocardial infarction, or recurrence of symptoms requiring additional revascularisation). The primary angiographic endpoint was restenosis incidence at 6 months. The Clinical Research Ethical Committee at Guangdong Provincial Hospital of Chinese Medicine approved the research protocol (Z2017008-01). This trial was registered in ChiCTR (ChiCTR-IIR-17011407). All participants provided written informed consent before enrolment. FindingsWe enrolled 326 patients between Aug 1, 2014, and Dec 1, 2015. Of these patients, 163 were randomly assigned to the Tongguan group and 163 to the control group. Four patients were excluded leaving 322 patients (160 in the Tongguan group and 162 in the control group) for analysis. Compared with the control group, 12-month incidence of major adverse cardiovascular events was reduced in patients treated with Tongguan capsules (12·5% [20 of 160] vs 23·5% [38 of 162], p<0·0001); 6-month restenosis incidence did not differ between groups (3·1% [five of 160] in the Tongguan group vs 4·3% [seven of 162] in the control group, p=0·779). InterpretationAlthough not significant, there was a trend towards a reduction in restenosis and therefore more research is needed to establish whether Tongguan capsules can improve clinical outcomes. Further higher quality and more rigorous randomised trials with larger sample size are needed to attain more robust clinical evidences of Tongguan capsules. FundingNational Science Foundation (81473471, 81202782, 81573708).

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial

ObjectivesAtherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted. BackgroundSo far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued. MethodsIn this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death. ResultsSix hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications. ConclusionsThe treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174)

Five-Year Outcomes After Paclitaxel-Coated Balloon Angioplasty for Drug-Eluting Stent Restenosis

The long-term outcomes of patients who underwent paclitaxel-coated balloon (PCB) angioplasty for drug-eluting stent restenosis (DES-ISR) remain unclear. We investigated the 5-year safety and efficacy outcomes of PCB angioplasty for DES-ISR. The study included 185 patients with 216 DES-ISR lesions who underwent PCB angioplasty from September 2008 to December 2010. Two serial angiographic follow-ups were routinely scheduled at 6 and 18months after the index procedure. Five-year clinical outcomes were investigated. The mean duration of follow-up was 2,052 ± 352.5days, and 94.1% of the patients completed the 5-year follow-up. Recurrent restenosis was observed in 48 lesions (22.2%) at the 6-month follow-up and late restenosis was observed in 22 lesions (14.3%) at the 18-month follow-up. Very late restenosis was observed in 6 lesions (6.8%), and target lesion revascularization (TLR) was performed for 8 lesions (13.6%) beyond 24months after the procedure. The cumulative rates of TLR at 1, 2, and 5years were 16.4%, 28.9%, and 34.1%, respectively. In patients who underwent TLR, 87% (52 of 60 patients) underwent TLR within the first 2years after the index procedure. Multivariable analysis revealed that in-stent occlusion lesion (odds ratio [OR] 2.21; 95% confidence interval [CI] 1.09 to 4.47; p= 0.03), postprocedural percent diameter stenosis >35% (OR 3.19; 95% CI 1.54 to 6.68; p= 0.001), and right coronary artery ostial lesions (OR 5.56; 95% CI 1.40 to 24.9; p= 0.01) were independent predictors of recurrent restenosis. In conclusion, our results suggest that long-term outcomes after PCB angioplasty are acceptable; however, close follow-up during the first 2years following this procedure may be necessary.

Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients: the Belgian diabetic IN.PACT Trial

Several trials have shown that drug coated balloon (DCB) angioplasty reduce the rates of restenosis in the femoropopliteal artery. This controlled, prospective, multicenter study was designed to demonstrate the efficacy of DCB to inhibit restenosis of the infrainguinal arteries in an exclusive diabetic population. Between 2012 and 2014, 106 diabetic patients with symptomatic peripheral arterial disease (PAD) were enrolled at 11 sites in Belgium, 54 treated with DCB angioplasty and 52 treated with plain old balloon angioplasty (POBA). The primary endpoint of the study are the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 6 months without re-intervention in the interim. The 6-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (29±36% vs. 46±35%, P=0.032) and the binary (≥50% diameter stenosis) restenosis rate was signicantly lower in DCB patients compared with the POBA's (27% vs. 49%, P=0.03). The primary patency was significantly better in the paclitaxel coated balloon group (73% vs. 51%, P=0.03). The 6-month adverse effects rates were 5.5% in the POBA and 5.7% in the DCB arm. The treatment of diabetic PAD of the infra-inguinal arteries with the DCB provides a bettter primary patency rate compared with the plain old balloon angioplasty. The use of DCB did not increase the number of major adverse clinical events when compared with those seen with the use of the uncoated balloons.

Primary stenting for TASC C and D femoropopliteal lesions: one-year results from a multicentric trial on 203 patients.

Recent advances in endovascular techniques have made it a seductive choice in the management of TASC C and D lesions. Currently, this tendency remains controversial, despite high success rates. The aim of the study was to regroup and harmonize the results of three surgical teams in 5 centers in order to obtain the largest series ever published on TASC C and D femoro-popliteal lesions primary stenting. Two hundred and three patients and 209 lower limbs were included from March 2008 to October 2013. Each patient underwent primary stenting for TASC C or D femoro-popliteal lesions. Mean age was 70±10; 71.4% were male with a 39.8% rate of coronary heart disease, 20.1% of renal insufficiency and 35.9% of diabetes; 57,4% suffered from claudication and 42.6% from critical limb ischemia (CLI); 61.8% of the 144 limbs analyzed for run-off presented with 3 patent infra-popliteal arteries. Four hundred and three stents were implanted in the 209 limbs included. Median stented length was 252 mm. Associated procedures were performed in 35 patients (17.0%) including 4.3% minor amputations. The 30-day mortality rate was 1.4% (3 patients). Major complications occurred in 19 patients (9.3%) including 7 patients (3.4%) presented with early in-stent thrombosis. Median follow-up duration was 12 months (range 9.5-17.2 months). The 12-month mortality rate was 11.8% (24 patients). The 3, 6 and 12 months primary patency rates according to Kaplan Meier estimates were 98.1±0.9, 85.2±2.5 and 67.0±3.3% respectively. Secondary patency rates were 96.1±1.9, 89.3±3.0 and 75.7±4.2% respectively. A subgroup analysis reported significantly higher patency rates for TASC C lesions compared to TASC D lesions (82.1% vs. 44% respectively, P=0.009). The 12-month in-stent thrombosis and restenosis rates were 19.6% and 13.9% respectively. A subgroup analysis showed higher rates of in-stent restenosis for TASC D lesions compared to TASC C lesions (35% vs. 10% respectively, P=0.005). The stent fracture rate was equal to 10.2% (30 stents). Occurrence of in-stent thrombosis and restenosis were associated with 3 and 5 cases of stent fracture (type II to IV) respectively. Freedom from TLR was 70.5%. Rutherford class decreased from 3.7 to 0.9 (3.52±1.06 to 0.75±1.24) (P<0.0001). At 12 months 61.3% were asymptomatic, 33.3% suffered from claudication (21.3% Rutherford 1) and 5.4% suffered from CLI. Healing rates were 63.9% with a limb salvage rate of 95.5% and a major amputation rate of 3.8%. This is the largest series of TASC C and D femoro-popliteal lesions primary stenting to our knowledge. The results are encouraging with acceptable primary patency and clinical improvement at 12 months. Results from mid- to long-term follow-up are awaited.