Independent Risk Factor For Restenosis Research Articles

Pulmonary Vein Intervention for Severe Pulmonary Vein Stenosis After Atrial Fibrillation Ablation - A Retrospective Cohort Study.

Pulmonary vein (PV) stenosis (PVS) is a serious complication of atrial fibrillation (AF) ablation. The objective of this study was to describe interventional treatments for PVS after AF ablation and long-term outcomes in Japanese patients.Methods and Results: This multicenter retrospective observational study enrolled 30 patients (26 [87%] male; median age 55 years) with 56 severe PVS lesions from 43 PV interventional procedures. Twenty-seven (90%) patients had symptomatic PVS and 19 (63%) had a history of a single AF ablation. Of the 56 lesions, 41 (73%) were de novo lesions and 15 (27%) were retreated. Thirty-three (59%) lesions were treated with bare metal stents, 14 (25%) were treated with plain balloons, and 9 (16%) were treated with drug-coated balloons. All lesions were successfully treated without any systemic embolic event. Over a median follow-up of 584 days (interquartile range 265-1,165 days), restenosis rates at 1 and 2 years were 35% and 47%, respectively. Multivariate Cox regression analysis revealed devices <7 mm in diameter (hazard ratio [HR] 2.52; 95% confidence interval [CI] 1.04-6.0; P=0.040) and totally occluded lesions (HR 3.33; 95% CI 1.21-9.15; P=0.020) were independent risk factors for restenosis. All PVS lesions were successfully enlarged by the PV intervention; however, restenosis developed in approximately half the lesions within 2 years.

Analysis of risk factors for stenosis after laparoscopic pyeloplasty in the treatment of ureteropelvic junction obstruction.

Laparoscopic ureteroplasty is an effective method for managing ureteropelvic junction obstruction. Despite its high success rate, there remains a subset of patients who do not experience improvement in the hydrops. The study retrospectively analyzed the data of 143 patients with ureteropelvic junction obstruction (UPJO) who underwent laparoscopic pyeloplasty (LP) in our hospital from January 2015 to May 2022. Logistic regression was used to analyze the risk factors of recurrence stenosis after UPJO. Out of these patients, 119 had complete clinical data and follow-up records. Among these patients, restenosis occurred in nine cases after the operation. There was a significant statistical difference in blood loss (P < 0.05). Univariate and multivariate logistic regression analysis revealed that the preoperative separation degree of the renal pelvis, cystatin C, and intraoperative blood loss were potential risk factors for recurrent stenosis after primary LP. When divided by split renal function (SRF), the odds ratio (OR) was 7.850 (P = 0.044), indicating that it was an independent risk factor for postoperative restenosis. Similarly, the OR for stenotic segment length was 0.025 (P = 0.011), also indicating it as an independent risk factor for restenosis. The areas under the receiver operating characteristic curve for stenotic segment length and SRF were 0.9056 and 0.7697, respectively. In our study, we identified that preoperative renal pelvis separation, cystatin C, and intraoperative blood loss were potential risk factors for postoperative restenosis. SRF and stenosis segment length were independent risk factors for postoperative restenosis.

Effects of plaque characteristics and artery hemodynamics on the residual stenosis after carotid artery stenting

ObjectiveCarotid artery stenting (CAS) has become an alternative strategy to carotid endarterectomy for carotid artery stenosis. Residual stenosis was an independent risk factor for restenosis, with the latter affecting the long-term outcomes of CAS. This multicenter study aimed to evaluate the echogenicity of plaques and hemodynamic alteration by color duplex ultrasound (CDU) examination and investigate their effects on the residual stenosis after CAS. MethodsFrom June 2018 to June 2020, 454 patients (386 males and 68 females) with a mean age of 67.2 ± 7.9 years, who underwent CAS from 11 advanced stroke centers in China were enrolled. One week before recanalization, CDU was used to evaluate the responsible plaques, including the morphology (regular or irregular), echogenicity of the plaques (iso-, hypo-, or hyperechoic) and calcification characteristics (without calcification, superficial calcification, inner calcification, and basal calcification). One week after CAS, the alteration of diameter and hemodynamic parameters were evaluated by CDU, and the occurrence and degree of residual stenosis were determined. In addition, magnetic resonance imaging was performed before and during the 30-day postprocedural period to identify new ischemic cerebral lesions. ResultsThe rate of composite complications, including cerebral hemorrhage, symptomatic new ischemic cerebral lesions, and death after CAS, was 1.54% (7/454 cases). The rate of residual stenosis after CAS was 16.3% (74/454 cases). After CAS, both the diameter and peak systolic velocity (PSV) improved in the preprocedural 50% to 69% and 70% to 99% stenosis groups (P < .05). Compared with the groups without residual stenosis and with <50% residual stenosis, the PSV of all three segments of stent in the 50% to 69% residual stenosis group were the highest, and the difference in the midsegment of stent PSV was the largest (P < .05). Logistic regression analysis showed that preprocedural severe (70% to 99%) stenosis (odds ratio [OR], 9.421; P = .032), hyperechoic plaques (OR, 3.060; P = .006) and plaques with basal calcification (OR, 1.885; P = .049) were independent risk factors for residual stenosis after CAS. ConclusionsPatients with hyperechoic and calcified plaques of the carotid stenosis are at a high risk of residual stenosis after CAS. CDU is an optimal, simple and noninvasive imaging method to evaluate plaque echogenicity and hemodynamic alterations during the perioperative period of CAS, which can help surgeons to select the optimal strategies and prevent the occurrence of residual stenosis.

Lesion Characteristics Associated with Loss of Primary Patency After Endovascular Therapy for Common Femoral Artery Lesions

PurposeTo identify lesion characteristics associated with restenosis after endovascular therapy (EVT) for common femoral artery (CFA) lesions in patients with peripheral artery disease (PAD) in real-world practice.Materials and MethodsWe included 751 Japanese patients with PAD who underwent CFA EVT. Data were from a large-scale retrospective multicenter registry study. The association of lesion characteristics with the risk of restenosis was investigated with the Cox proportional hazards regression model.ResultsLesions extended to the external iliac artery in 10.0% of patients, were isolated in the CFA in 59.9%, and involved the bifurcation in 30.1%. Chronic total occlusion was noted in 21.1%, and 99% stenosis, in 19.9%. Among the limbs with CFA lesions, 16.4% had a history of CFA EVT. Mean total lesion length was 32 ± 15 mm, and reference vessel diameter, 7.3 ± 1.4 mm. Plain old balloon angioplasty, drug-coated balloon angioplasty, and stent implantation were performed in 56.3, 23.2, and 20.5% of patients, respectively. The mean follow-up period was 10.4 ± 9.5 months. Rates of freedom from restenosis and reintervention at 1 year were 78.2 and 86.6%, respectively. Lesion characteristics independently associated with restenosis were history of CFA EVT, reference vessel diameter less than 6 mm, and lesion length greater than or equal to 50 mm; adjusted hazard ratios were 1.63 (P = 0.007), 1.93 (P = 0.006), and 1.71 (P = 0.018), respectively.ConclusionHistory of CFA EVT, smaller reference vessel diameter, and longer lesion length are independent risk factors for restenosis after CFA EVT.Level of EvidenceLevel 3.

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.

Shockwave intravascular lithotripsy (IVL) for calcified coronary lesions; a real world multicentre European study with long term follow up

Abstract Background The presence of calcium in atherosclerotic plaques is a challenge for successful angioplasty and is an independent risk factor for restenosis and stent thrombosis. Despite conventional tools (non-compliant, scoring and cutting balloons and rotational atherectomy), cracking calcium can still be challenging and incomplete. Intra-vascular lithotripsy (IVL) has shown promising results, although long-term data on safety and efficacy from real-world is lacking. Purpose This study was undertaken to report long-term outcomes following use of IVL from a European multi-centre experience. Methods This was a multicentre, retrospective observational study in which we enrolled all patients treated with shockwave lithotripsy from November 2018 to June 2021. Procedural success, complications and in hospital events were evaluated. The clinical outcomes during follow-up included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR), and major adverse cardiac event (MACE) (composite of cardiac death, TVMI, and TVR). Result A total of 272 patients were treated with IVL, with a mean age of 72 9.1 years and 78.5% (n=216) were male. Forty percent (n=110) were diabetic while 16% (n=45) had chronic kidney disease. Acute coronary syndrome was the presentation in 36% (n=99) while 51% (n=141) had stable angina. De novo lesions accounted for 78% (n=215) of the cases and the remainder were in-stent restenosis (21%; n=58). The LAD was the commonest artery treated 50% (n=139) followed by RCA 24% (n=68). Intracoronary imaging was performed in 33% of cases. Upfront IVL strategy was adopted in 37% (n=101) while 63% (n=171) were bail out procedures due to inadequate pre dilatation. Adjuvant rotational atherectomy was used on 31 (11.4%) cases. Procedural success was achieved in 96% (260) cases with major complications in 8 cases (perforation requiring covered stent in 3 patients) but there was no in-hospital mortality. Clinical outcomes over the median follow up of 641 days are shown in the table. Conclusion This is the largest multicentre registry with long term follow up. It has demonstrated that IVL appears to be safe with high success rates, low rates of complication and no in-hospital mortality. The long-term follow-up show promising results with low rates of hard-endpoints and revascularization rates. Funding Acknowledgement Type of funding sources: None.

Risk Factors for Residual Stenosis After Carotid Artery Stenting.

Background and purpose: Stent residual stenosis is an independent risk factor for restenosis after stenting. This study aimed to analyze the factors influencing residual stenosis after carotid artery stenting (CAS).Methods: A total of 570 patients who underwent CAS with 159 closed-loop stents (CLS) and 411 open-loop stents (OLS) from January 2013 to January 2016 were retrospectively enrolled in this study. Carotid stenosis location in the common carotid artery or in internal carotid artery, plaque size, and features (regular or irregular morphology; with or without calcification), degree of carotid artery stenosis, and stent expansion rate were detected by carotid duplex ultrasonography. Residual stenosis was defined as a stenosis rate ≥30% after CAS, as detected by digital subtraction angiography. A logistic regression analysis was used to analyze residual stenosis risk factors.Results: The overall incidence of residual stenosis was 22.8% (130/570 stents). The incidence of residual stenosis in the CLS group was higher than that in the OLS group (29.5 vs. 20.2%, χ2 = 5.71, P = 0.017). The logistic regression analysis showed that CLS [odds ratio (OR), 1.933; 95% confidence interval (CI), 1.009–3.702], irregular plaques (OR, 4.237; 95% CI, 2.391–7.742), and plaques with calcification (OR, 2.370; 95% CI, 1.337–4.199) were independent risk factors for residual stenosis after CAS. In addition, a high radial expansion rate of stent was a protective factor for residual stenosis (OR, 0.171; 95% CI, 0.123–0.238). The stenosis location and stent length did not impact the occurrence of residual stenosis. After 1-year follow-up, the incidence of restenosis in the residual stenosis group was higher than that in the group without residual stenosis (13.1 vs. 2.0%, χ2 = 28.05, P < 0.001).Conclusions: The findings of this study suggest that plaque morphology, echo characteristics (with calcification), and stents type influence residual stenosis.

Endovascular treatment of cerebrovascular stenosis with stent for patients with ischemic cerebrovascular disease.

This study aimed to investigate the therapeutic effect of cerebrovascular stent implantation in southwest Chinese patients with ischemic cerebrovascular disease and underlying risk factors for stent restenosis.We made a retrospectively analysis of occurring risk, cerebrovascular lesion, stent implantation, complication treatment, and prognosis of 54 patients with ischemic cerebrovascular disease in our department.A total of 85 stents were implanted into 54 patients, involving 44 of the internal carotid artery system, 34 of the vertebral-basal artery system and 7 of the subclavian artery system. All patients with stenosis were reduced by >70%, with all stenosis complete reduction in 5 (9%) patients and reduction of over 90% in 25 (46%) patients. A total of 50 patients were followed up for 28.5 (21–35) months. The stents in 42 patients exhibited satisfactory shape and location while restenosis occurred in 8 patients. Univariate analysis revealed that hyperlipidemia, hyperuricemia, surgery duration, and total length of hospital stay are significantly correlated with stent restenosis, and hyperlipidemia and hyperuricemia were proven to be independent risk factors for restenosis using logistic regression analysis.Cerebrovascular stent implantation and balloon inflation surgery can assist in abating angiostenosis and improving blood supplement effectively in patients with ischemic cerebrovascular disease. Besides, an overall evaluation, strict care, and regular check-up in perioperative period may reduce the occurrence of complications. Finally, several clinical parameters may need to be highly focused on in surgery for better prognosis.

Echolucent carotid plaque is associated with restenosis after carotid endarterectomy.

The mechanism of carotid endarterectomy (CEA) restenosis remains unclear. Our research aimed to investigate the relationship between the carotid plaque grayscale median (GSM) value and restenosis after CEA. Between January 2010 and January 2018, 1280 consecutive patients underwent CEA at our institution; 32 patients were diagnosed with restenosis by ultrasound at 1 year after CEA. The correlations between plaque GSM, plaque echogenicity, clinical manifestations, shunting, and restenosis were analyzed. In total, 829 patients were ultimately enrolled; 32 (4%) presented diagnoses of restenosis (mean age 67.3 ± 8.0 years, 81.2% men). The GSM value was lower in the restenosis group (68.1 ± 19.9 vs 59.9 ± 14.7, p = 0.02). After multiple logistic regression analysis, the GSM value was found to be an independent risk factor for restenosis (OR 0.976, 95% CI 0.957-0.995). Shunting was another significant independent risk factor for restenosis (OR 2.39, 95% CI 1.07-5.34). The GSM cutoff value for predicting restenosis was 75 (sensitivity 0.38, specificity 0.84, area under the curve 0.62). We separated the patients into 2 groups by GSM (GSM ≤ 75 and GSM > 75 subgroups). Comparison of the 2 groups indicated that symptomatic manifestation was related to restenosis in the subgroup with GSM ≤ 75, indicating predominantly echolucent plaques, but not in the subgroup with GSM > 75, indicating predominantly echogenic plaques. Predominantly echolucent carotid plaques, as measured by GSM, had a higher restenosis risk at 1 year than echogenic plaques.

Independent predictors of loss of primary patency at 1 year after aortoiliac stent implantation.

To identify the risk factors for restenosis at 1year after aortoiliac stenting for symptomatic peripheral artery disease in real-world practice. We performed subgroup analysis of a large-scale prospective multicenter registry study enrolling Japanese patients with peripheral arterial disease who underwent aortoiliac endovascular therapy from April 2014 to April 2016. The subgroup comprised 880 patients (1108 limbs) who received iliac stenting. The Rutherford class was 2, 3, and 4 in 42%, 51%, and 7% of the patients, respectively. TASC II class D disease was noted in 18% of the patients and 35% had chronic total occlusion. Mean total stent length was 82.1 ± 48.5 mm and minimum stent diameter was 9.0 ± 1.3 mm. Balloon-expandable stents were used in 8% of the limbs. Concomitant femoropopliteal lesions were present in 36% of the limbs with aortoiliac lesions. In the overall patient population, the risk of restenosis at 1 year after stenting was 11.4%. Femoropopliteal lesions and the minimum stent diameter were identified as independent risk factors for restenosis at 1 year. When the study population was stratified according to these two risk factors, the restenosis rate at 1 year was 27.1% in the patients with a minimum stent diameter < 8 mm and femoropopliteal lesions, whereas it was only 5.3% in those with a minimum stent diameter ≥ 10mm and no femoropopliteal lesions. Femoropopliteal lesions and a smaller stent diameter were independent risk factors for restenosis at 1 year after aortoiliac stenting.

Increased plasma olfactomedin 2 after interventional therapy is a predictor for restenosis in lower extremity arteriosclerosis obliterans patients

Animal studies have indicated that olfactomedin 2 (OLFM2) is involved in the process of vascular remolding. The aim of the present study was to investigate circulating OLFM2 levels in lower extremity arteriosclerosis obliterans (LEASO) patients and the association of OLFM2 with postoperative restenosis in patients. A total of 203 LEASO patients were enrolled in the present study. Plasma OLFM2 was measured before and 6 h after interventional therapy. After 6 months, patients were divided into a restenosis group and a non-restenosis group. Inter-group and intra-group differences in plasma OLFM2 were compared. The correlation between plasma OLFM2 and the severity of restenosis was analyzed by Spearman’s correlation analysis. An receiver operating characteristic (ROC) curve was used to evaluate the predictive efficacy of plasma OLFM2 on restenosis. Logistic regression was used to determine the risk factors for restenosis. Postoperative OLFM2 in the restenosis group was significantly higher compared with the non-restenosis group (34.07 ± 5.76 ng/mL vs. 19.53 ± 2.99 ng/mL). No significant difference in preoperative plasma OLFM2 levels was identified between the two groups (10.92 ± 2.49 ng/mL vs. 11.54 ± 3.18 ng/mL). Postoperative OLFM2 levels were positively correlated with the severity of restenosis (r = 0.728, p < .001). The area under the ROC curve was 0.902 (95% confidence interval (CI): 0.874–0.965), with a cutoff value of 26.91 ng/mL (95% CI: 26.16–28.32). Plasma OLFM2 was an independent risk factor for restenosis. Our results suggest that plasma OLFM2 is a potential biomarker for restenosis and may be a novel target for the treatment of restenosis.

Outcomes and prognostic factors for postsurgical pulmonary vein stenosis in the current era

BackgroundThe optimal management and prognostic factors of postsurgical pulmonary vein stenosis remain controversial. We sought to determine current postsurgical pulmonary vein stenosis outcomes and prognostic factors in a multicentric study in the current era. MethodsSeventy-five patients with postsurgical pulmonary vein stenosis who underwent 103 procedures in 14 European/North American centers (2000-2012) were included retrospectively. A specific pulmonary vein stenosis severity score was developed on the basis of the assessment of each pulmonary vein. End points were death, pulmonary vein reintervention, and restenosis. A univariate and multivariate risk analysis was performed. ResultsSome 76% of postsurgical pulmonary vein stenosis occurred after repair of a total anomalous pulmonary venous return. Sutureless repair was used in 42 of 103 procedures (41%), patch veinoplasty was used in 28 procedures (27%), and endarterectomy was used in 16 procedures (16%). Overall pulmonary vein restenosis, reintervention, and mortality occurred in 56% (n = 58/103), 49% (n = 50/103), and 27% (n = 20/75), respectively. Sutureless repair was associated with less restenosis (40% vs 67%; P = .007) and less reintervention (31% vs 61%; P = .003). Mortality after sutureless repair (20%; 7/35) tends to be lower than after nonsutureless repair (33%; 13/40) (P = .22). A high postoperative residual pulmonary vein stenosis score at the time of hospital discharge was an independent risk factor for restenosis (hazard ratio [HR], 1.55; P < 10−4), reintervention (HR, 1.33; P < 10−4), and mortality (HR, 1.37; P < 10−4). The sutureless technique was an independent protective factor against restenosis (HR, 0.27; P = .006). ConclusionsPostsurgical pulmonary vein stenosis still has a guarded prognosis in the current era. The sutureless technique is an independent protective factor against restenosis. The severity of the residual disease evaluated by a new severity score is an independent risk factor for poor outcomes regardless of surgical technique.

Primary Pulmonary Vein Stenosis: Outcomes, Risk Factors, and Severity Score in a Multicentric Study

Primary pulmonary vein stenosis (PPVS) still carries a poor prognosis, and prognostic factors remain controversial. The aim of this study was to determine outcomes and prognostic factors after PPVS repair in the current era. Thirty patients with PPVS and a normal pulmonary vein (PV) connection operated on in 10 European/North American centers (2000-2012) were included retrospectively. A specific PVS severity score was developed based on the assessment of each PV. Studied end points were death, PV reoperation, and restenosis. A univariate and multivariate risk analysis was performed. The mean number of affected PVs per patient was 2.7 ± 1.1. Sutureless repair was used in 21 patients (70%), endovenectomy was used in 5 patients, and patch venoplasty was used in 4 patients. Overall PV restenosis, reoperation, and mortality occurred in 50%, 40%, and 30% of patients respectively. Freedom from mortality, reoperation, and restenosis at 8 years of follow-up was 70% ± 8%, 62% ± 8%, and 47% ± 9%, respectively. Restenosis and mortality rates after sutureless repair versus nonsutureless repair were 57% (n= 12 of 21) versus 33% (n= 3 of 9) (p= 0.42) for restenosis and 38% (n= 8 of 21) versus 11% (n= 1 of 9) (p= 0.21) for mortality. Patients selected for a sutureless technique were younger and smaller and had more severe disease before operation. A postoperative high PVS score and pulmonary hypertension 1 month after the operation were independent risk factors for restenosis (hazard ratio [HR], 1.34; p= 0.002 and HR, 6.81; p= 0.02, respectively), reoperation (HR, 1.24; p= 0.01 and HR, 7.60; p= 0.02), and mortality (HR, 1.39; p= 0.01 and HR, 39.5; p= 0.008). Primary PVS still has a guarded prognosis in the current era despite adoption of the sutureless technique. Postoperative pulmonary hypertension and severity of disease evaluated by a new severity score are independent prognostic factors regardless of surgical technique.

Correlation between high perfusion syndrome and stent restenosis after stent implantation.

The present study was conducted to determine the correlation between high perfusion syndrome and stent restenosis after cerebral vascular stent implantation. A total of 146 patients diagnosed with cerebral vascular stenosis and stent implantation were selected. A total of 55 cases (37.67%) of cerebral hyperperfusion syndrome patients were diagnosed by xenon-enhanced computer tomography (Xe-CT) examination and clinical symptoms within 3 days after surgery and were chosen as the observation group. A total of 91 cases were selected as the control group. After treatment, blood flow of the anterior cerebral artery, middle cerebral artery, posterior cerebral artery, anterior border zone, posterior border zone and the inner border zone of the two groups increased, with values in the observation group increasing more significantly, and the differences were statistically significant (P<0.05). The rate of restenosis and target lesion diameter one month and one year after operation in the observation group were significantly higher than those in the control group (P<0.05). Multivariate logistic regression analysis showed that the mean systolic blood pressure (mSBP), mean diastolic blood pressure (mDBP), stenosis rate of cerebral vascular diameter and high perfusion syndrome were independent risk factors for restenosis (P<0.05). The application of Xe-CT examination is important for early diagnosis of hyperperfusion syndrome. Hyperperfusion syndrome and the occurrence of stent restenosis are closely related. mSBP, mDBP, cerebral blood vessel diameter stenosis rate and high perfusion comprehensive syndrome are the independent risk factors of restenosis.

Impact of Insulin Resistance on Neointimal Tissue Proliferation after 2nd-Generation Drug-Eluting Stent Implantation.

Percutaneous coronary intervention is established as an effective treatment for patients with ischemic heart disease; in particular, drug-eluting stent implantation is known to suppress in-stent restenosis. Diabetes mellitus is an independent risk factor for restenosis, so reducing insulin resistance is being studied as a new treatment approach. In this prospective study, we sought to clarify the factors associated with in-stent restenosis after percutaneous coronary intervention, and we evaluated the homeostasis model assessment of insulin resistance (HOMA-IR) index as a predictor of restenosis. We enrolled 136 consecutive patients who underwent elective percutaneous coronary intervention at our hospital from February 2010 through April 2013. All were implanted with a 2nd-generation drug-eluting stent. We distributed the patients in accordance with their HOMA-IR index values into insulin-resistant Group P (HOMA-IR, ≥2.5; n=77) and noninsulin-resistant Group N (HOMA-IR, <2.5; n=59). Before and immediately after stenting, we measured reference diameter, minimal lumen diameter, and percentage of stenosis, and after 8 months we measured the last 2 factors and late lumen loss, all by means of quantitative coronary angiography. After 8 months, the mean minimal lumen diameter was smaller in Group P than that in Group N (1.85 ± 1.02 vs 2.37 ± 0.66 mm; P=0.037), and the mean late lumen loss was larger (0.4 ± 0.48 vs 0.16 ± 0.21 mm; P=0.025). These results suggest that insulin resistance affects neointimal tissue proliferation after 2nd-generation drug-eluting stent implantation.

1-Year Results of the ZEPHYR Registry (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery): Predictors of Restenosis.

This study sought to assess the rate and predictors of 1-year restenosis after drug-eluting stent implantation for femoropopliteal (FP) lesions in patients with peripheral arterial disease. Zilver PTX, a paclitaxel-eluting stent for FP lesions, provides superior outcomes to angioplasty and bare-metal stents in clinical trials. However, its real-world outcomes and the associated features remain unclear. This was a prospective multicenter study enrolling 831 FP lesions (797 limbs, 690 patients) treated by Zilver PTX implantation. The primary endpoint was 1-year restenosis. Secondary endpoints included major adverse limb event and stent thrombosis. Mean lesion length was 17 ± 10 cm. One-year restenosis, major adverse limb event, and stent thrombosis rates were 37%, 22%, and 2%, respectively. The generalized linear mixed model showed that lesion length ≥16 cm assessed by angiography and distal external elastic membrane area ≤27 mm(2) and minimum stent area ≤12 mm(2) assessed by intravascular ultrasound were independent risk factors for restenosis. One-year restenosis rates were 15% in cases with none of these risk factors and 50% in those with ≥2 risk factors. The current study demonstrated 1-year real-world outcomes after drug-eluting stent treatment for FP lesions, including challenging ones in clinical practice. Lesion length, external elastic membrane area, and minimum stent area were independent predictors for restenosis. (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery-Prospective Multicenter Registry [ZEPHYR]; UMIN000008433).

Gender-Related Long-term Outcome of Primary Femoropopliteal Stent Placement for Peripheral Artery Disease

Purpose: To evaluate gender-related long-term outcomes in patients undergoing stent treatment of femoropopliteal peripheral artery disease. Methods: Between September 2006 and August 2010, all 517 patients (333 men and 184 women; mean age 70.6 years) undergoing primary stent placement in femoropopliteal atherosclerotic lesions at 2 European vascular centers were prospectively enrolled in the study. The main study outcome was primary stent patency. Secondary outcomes included secondary patency, limb salvage, and all-cause mortality. Results: Women had a higher incidence of critical limb ischemia (32.1% vs. 16.9%, p<0.001). Lesion characteristics according to the TransAtlantic Inter-Society Consensus (TASC) classification were comparable in both genders (p=0.52), although total occlusions and popliteal involvement were observed more frequently in female patients (p=0.043 and p=0.001, respectively). Both genders showed similar 5-year primary patency rates (64.3% men vs. 58.1% women, p=0.11). A statistically significant difference was observed concerning the secondary patency rates in favor of men (71.9% vs. 66.8% at 5 years, p=0.005). Limb salvage rates did not vary between the groups (p=0.83). Survival rates were comparable at 5 years (83.3% and 82.6% for men and women, respectively; p=0.63), although female patients were older at their presentation (68.5 vs. 74.3 years, p<0.001). Female gender was an independent risk factor for restenosis for TASC C/D lesions (primary patency rate 39.8% in women vs. 62.0% in men; p=0.002). Finally, critical limb ischemia was an independent risk factor for restenosis in women (odds ratio 1.5). Conclusion: Female gender was associated with a higher prevalence of critical limb ischemia, poorer secondary patency, and more frequent restenosis in TASC C/D lesions. Endovascular treatment of femoropopliteal lesions provides equal results between genders in terms of primary stent patency in the long term.

Identification of independent risk factors for restenosis following bare-metal stent implantation: Role of bare-metal stents in the era of drug-eluting stents

In the era of drug-eluting stents (DESs), the ability of clinicians to predict which patients have a low risk of coronary restenosis following bare-metal stent (BMS) implantion is likely to be of benefit. The study population consisted of 2,711 patients who underwent BMS implantation in 3,770 lesions between 1995 and 2004. With clinical and 6 month follow-up angiographic data, we retrospectively sought to identify the independent risk predictors of restenosis, applied a previously proposed prediction model and assessed the characteristics of patients with a low likelihood of coronary restenosis within 6 months of BMS implantation. A 6-month follow-up coronary angiography was performed in 65.0% of the patients who had undergone the BMS implantation and the rate of restenosis was 26.6%. Using multivariate analysis, diabetes [odds ratio (OR), 1.294; 95% confidence interval (CI), 1.094–1.483; P=0.005], current smoking (OR, 1.294; 95% CI, 1.094–1.483; P=0.002), a reference vessel diameter of <3.25 mm (OR, 1.238; 95% CI, 1.021–1.501; P<0.001), a lesion length of >30 mm (OR, 1.645; 95% CI, 1.336–2.026; P<0.001), ostial lesion (OR, 1.858; 95% CI, 1.437–2.402; P<0.001), post-stenting minimal luminal diameter (OR, 0.576; 95% CI, 0.484–0.685; P<0.001) and bifurcation lesion (OR, 1.353; 95% CI, 1.070–1.711; P=0.012) were identified as significant independent predictors of restenosis. However, the accuracy of the prediction obtained with the current model, which used the clinical and angiographic variables correlated with the risk of restenosis, was poor. Various clinical and angiographic independent risk variables were revealed to be correlated with the risk of restenosis following BMS implantation in the present large dataset. Certain groups of patients with a relatively low risk of restenosis may be considered for BMS implantation as an alternative to DESs. However, the prediction models used at present are incomplete and further studies are required.

ASSA13-15-2 Relationship of Interleukin-6 –572C/G Promoter Polymorphism and Serum Levels to Post-PCI Restenosis

Background and Objective It has recently been reported that inflammatory mechanisms play an important role in in-stent restenosis (ISR) processes. Inflammatory factors after percutaneous coronary intervention (PCI) for dynamic monitoring can probably predictive ISR. Functional polymorphisms in the promoter region of genes coding for inflammatory factors might be important for determining the magnitude of the inflammatory response. Thus, in the present study, we aim to investigate the serial changes in serum interleukin-6 (IL-6) levels before and after PCI and the relationship between the –572C/G polymorphism in the promoter region of the IL-6 gene and ISR. We will also discuss genetic polymorphisms in the inflammatory response to PCI. Methods 437 patients who successfully underwent bare metal stent (BMS) implantation with a follow-up angiography were divided into an ISR group (166) and a non-ISR (NISR) group (271). The IL-6 gene promoter polymorphism at position –572 was determined by restricted fragment length polymorphism using the polymerase chain reaction (PCR-RFLP) method. The serum IL-6 levels before and one day, five days, and 180 days after PCI were determined by the radioimmunoassay method. Results (1) ISR patients showed higher IL-6 serum levels than NISR patients before PCI (324.42 ± 28.14 ng/L vs. 283.22 ± 47.30 ng/L, PP Increased IL-6 after PCI persisted at a statistically significant level throughout the study in ISR patients, whereas IL-6 levels had normalised 5 days after the procedure in NISR patients. (2) One day post-PCI serum IL-6 levels were the most accurate diagnosis of ISR, the area under the ROC curve was 0.927 (95% CI : 0.878–0.977). The cut-off value for IL-6 to predict ISR was over 355.50ng/L, with a sensitivity of 0.968 and a specificity of 0.865. (3) There were no significant differences in frequencies of –572 genotype and allele between the two groups ( P > 0.05). (4) One day post-PCI IL-6 serum levels in patients with the G allele was significantly higher than in patients without the G allele (366.99 ± 49.37ng/L vs. 347.20 ± 55.30ng/L, P the G allele (405.67 ± 26.56ng/L vs.375.69 ± 38.81ng/L, P. Conclusions (1) IL-6 is an early post-PCI inflammatory cytokine, the day one post-PCI serum IL-6 level is an independent risk factor for restenosis. (2) The frequencies of IL-6 gene –572 genotype and allele are not differ between patients with and without ISR in a Chinese Tianjin Han population, but carrying the IL-6 –572G allele is likely to increase an individual’s susceptibility to ISR by promoting serum IL-6 levels.

Relationship of interleukin-6-572C/G promoter polymorphism and serum levels to post-percutaneous coronary intervention restenosis

Background It has been recently reported that inflammatory mechanisms play an important role in in-stent restenosis (ISR) processes. Inflammatory factors after percutaneous coronary intervention (PCI) for dynamic monitoring can probably predict ISR. Functional polymorphisms in the promoter region of genes coding for inflammatory factors might be important for determining the magnitude of the inflammatory response. Thus, in the present study, we aimed to investigate the serial changes in serum interleukin-6 (IL-6) levels before and after PCI and the relationship between the -572C/G polymorphism in the promoter region of the IL-6 gene and ISR. We also discussed genetic polymorphisms in the inflammatory response to PCI. Methods A total of 437 patients who successfully underwent bare metal stent (BMS) implantation with a follow-up angiography were divided into an ISR group (n=166) and a non-ISR (NISR) group (n=271). The IL-6 gene promoter polymorphism at position -572 was determined by restricted fragment length polymorphism using the polymerase chain reaction (PCR-RFLP) method. The serum IL-6 levels before and one day, five days and 180 days after PCI were determined by the radioimmunoassay method. Results ISR patients showed higher IL-6 serum levels than NISR patients before PCI ((324.42±28.14) ng/L vs. (283.22±47.30) ng/L, P &lt;0.001), and one day post-PCI IL-6 serum levels in the ISR group also showed a significantly higher level than in the NISR group (P &lt;0.001). Increased IL-6 after PCI persisted at a statistically significant level throughout the study in ISR patients, whereas IL-6 levels had normalized five days after the procedure in NISR patients. One day post-PCI serum IL-6 level was the most accurate marker for diagnosis of ISR, the area under the ROC curve being 0.927 (95% CI 0.878-0.977). The cut-off value for IL-6 to predict ISR was over 355.50 ng/L, with a sensitivity of 0.968 and a specificity of 0.865. There were no significant differences in frequencies of -572 genotype and allele between the two groups (P &gt;0.05). One day post-PCI IL-6 serum levels in patients with the G allele was significantly higher than in patients without the G allele ((366.99±49.37) ng/L vs. (347.20±55.30) ng/L, P &lt;0.05). In the ISR group, one day post-PCI serum levels of IL-6 in patients with the G allele was also significantly higher than that in patients without the G allele ((405.67±26.56) ng/L vs. (375.69±38.81) ng/L, P &lt;0.05). Multivariate Logistic regression analysis revealed positive correlations between male gender, one day post-PCI serum levels of IL-6, the pre-PCI degree of stenosis, the length of the target lesion stenosis, and restenosis; and there were negative correlations between the stent diameter, the diameter of the reference vessel before stent implantation and restenosis. Conclusions IL-6 is an early post-PCI inflammatory cytokine, and one day post-PCI serum IL-6 level is an independent risk factor for restenosis. The frequencies of IL-6 gene -572 genotype and allele are not different between patients with and without ISR in a Chinese Tianjin Han population, but carrying the IL-6 -572G allele is likely to increase an individual's susceptibility to ISR by promoting serum IL-6 levels.