Effect of Cilostazol on Patients With Diabetes Who Underwent Endovascular Treatment for Peripheral Artery Disease.

Background No large-scale study has compared the clinical impact of triple antiplatelet therapy (TAPT: aspirin, clopidogrel, and cilostazol) and dual antiplatelet therapy (DAPT) on adverse limb events in patients with diabetes after endovascular therapy (EVT) for peripheral artery disease. Thus, we investigate the effect of cilostazol added to a DAPT on the clinical outcomes after EVT in patients with diabetes using a nationwide, multicenter, real-world registry. Methods and Results A total of 990 patients with diabetes who underwent EVT were enrolled from the retrospective cohorts of a Korean multicenter EVT registry and were divided according to the antiplatelet regimen (TAPT [n=350; 35.4%] versus DAPT [n=640; 64.6%]). After propensity score matching based on clinical characteristics, a total of 350 pairs were compared for clinical outcomes. The primary end points were major adverse limb events, a composite of major amputation, minor amputation, and reintervention. For the matched study groups, the lesion length was 125.4±102.0 mm, and severe calcification was observed in 47.4%. The technical success rate (96.9% versus 94.0%; P=0.102) and the complication rate (6.9% versus 6.6%; P>0.999) were similar between the TAPT and DAPT groups. At 2-year follow-up, the incidence of major adverse limb events (16.6% versus 19.4%; P=0.260) did not differ between the 2 groups. However, the TAPT group showed less minor amputation than the DAPT group (2.0% versus 6.3%; P=0.004). In multivariate analysis, TAPT was an independent predictor of minor amputation (adjusted hazard ratio, 0.354 [95% CI, 0.158-0.794]; P=0.012). Conclusions In patients with diabetes undergoing EVT for peripheral artery disease, TAPT did not decrease the incidence of major adverse limb events but may be associated with a decreased risk of minor amputation.

Long-term Clinical Outcomes and Prognostic Factors After Endovascular Treatment in Patients With Chronic Limb Threatening Ischemia.

BACKGROUND AND OBJECTIVES: Endovascular therapy (EVT) first strategy has been widely adopted for the treatment of chronic limb threatening ischemia (CLTI) patients in real-world practice. This study aimed to investigate long-term outcomes of CLTI patients who underwent EVT and identify prognostic factors. METHODS: From the retrospective cohorts of a Korean multicenter endovascular therapy registry, 1,036 patients with CLTI (792 men, 68.8 ± 9.5 years) were included. The primary endpoint was amputation-free survival (AFS) defined as the absence of major amputation or death. Secondary endpoints were major adverse limb events (MALE; a composite of major amputation, minor amputation, and reintervention). RESULTS: Five-year AFS and freedom from MALE were 69.8% and 61%, respectively. After multivariate analysis, age (hazard ratio [HR], 1.476; p<0.001), end-stage renal disease (ESRD; HR, 2.340; p<0.001), Rutherford category (RC) 6 (HR, 1.456; p=0.036), and suboptimal EVT (HR, 1.798; p=0.005) were identified as predictors of major amputation or death, whereas smoking (HR, 0.594; p=0.007) was protective. Low body mass index (HR, 1.505; p=0.046), ESRD (HR, 1.648; p=0.001), femoropopliteal lesion (HR, 1.877; p=0.004), RC-6 (HR, 1.471; p=0.008), and suboptimal EVT (HR, 1.847; p=0.001) were predictors of MALE. The highest hazard rates were observed during the first 6 months for both major amputation or death and MALE. After that, the hazard rate decreased and rose again after 3-4 years. CONCLUSIONS: In CLTI patients, long-term outcomes of EVT were acceptable. ESRD, RC-6, and suboptimal EVT were common predictors for poor clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02748226.

Increased risk of coronary heart disease with hysterectomy in young women: A longitudinal follow-up study using a national health screening cohort.

OBJECTIVE: Hysterectomy is one of the most commonly performed gynecological procedures. Several studies have reported an association between hysterectomy and coronary heart disease (CHD), but the conclusions are controversial. This study aimed to evaluate the association between hysterectomy and the occurrence of CHD using a national sample cohort from South Korea. STUDY DESIGN: Using the national cohort from the Korean National Health Insurance Service, we extracted data on patients who had undergone hysterectomy (n = 8,642) and on controls matched at a ratio of 1:4 (n = 34,568) and then analyzed the occurrence of CHD from 2002 to 2013. Patients were matched according to age, income, region of residence, obesity, smoking, alcohol consumption, and medical history. MAIN OUTCOME MEASURES: A Cox proportional hazards model was used to analyze the hazard ratios (HRs) and 95% confidence intervals (CIs). Subgroup analyses were performed based on both age and bilateral salpingo-oophorectomy (BSO) status. The age of the participants was defined as that at the time of hysterectomy. RESULTS: The HR for CHD was 1.05 (95% CI = 0.96-1.16, p = 0.286) in the hysterectomy group. The HRs for CHD according to the different age subgroups were 1.19 (95% CI = 1.03-1.38, p = 0.018) for patients aged < 50 years, 1.05 (95% CI = 0.89-1.25, p = 0.561) for patients aged 50-59 years, and 0.88 (95% CI = 0.73-1.05, p = 0.147) for patients aged ≥ 60 years. CONCLUSION: The incidence of CHD was statistically significantly higher in women who underwent hysterectomy when they were under 50 years of age than in the matched controls.

Influence of preprocedural glycemic control on clinical outcomes of endovascular therapy in diabetic patients with lower extremity artery disease: an analysis from a Korean multicenter retrospective registry cohort.

BACKGROUND: The influence of intensive glucose control in diabetic patients on the macrovascular outcomes is controversial. Thus, this study aimed to elucidate the effect of preprocedural hemoglobin A1c (HbA1c) on clinical outcomes after endovascular therapy for lower extremity artery disease (LEAD) in diabetic patients. METHODS: Diabetic patients were enrolled from the retrospective cohorts of a Korean multicenter endovascular therapy registry and were divided according to the HbA1c level during index admission into the optimal (< 7.0%) or suboptimal (≥ 7.0%) glycemic control groups. The primary endpoints were major adverse limb events (MALE, a composite of major amputation, minor amputation, and reintervention). RESULTS: Of the 1103 patients enrolled (897 men, mean age 68.2 ± 8.9 years), 432 (39.2%) were classified into the optimal glycemic control group and 671 (60.8%) into the suboptimal glycemic control group. In-hospital events and immediate procedural complications were not different between the two groups. The suboptimal group showed a trend towards a higher incidence of MALE than the optimal group (log-rank p = 0.072). Although no significant differences were found between the two groups in terms of overall survival or amputation, the risk of reintervention was significantly higher in the suboptimal group (log-rank p = 0.048). In the multivariate Cox regression model, suboptimal glycemic control was one of the independent predictors for reintervention. When our data were analyzed according to the initial presentation, suboptimal preprocedural HbA1c significantly increased the incidence of MALE compared with optimal preprocedural HbA1c only in patients with intermittent claudication. CONCLUSION: In diabetic patients undergoing endovascular therapy for LEAD, suboptimal preprocedural HbA1c is associated with an increased risk of adverse limb events, especially in patients with intermittent claudication. Further prospective research will be required to validate the role of more intensive glycemic control on the reduction of adverse limb events in diabetic patients undergoing endovascular therapy for LEAD.

The impact of educational attainment on cardiorespiratory fitness and metabolic syndrome in Korean adults.

The aim of this study was to evaluate the relationship between educational attainment and cardiorespiratory fitness (CRF) as a predictor of metabolic syndrome in a Korean population.In this single-center, retrospective cross-sectional study, 988 healthy adults (601 men and 387 women) who underwent regular health check-up in Seoul St. Mary's Hospital were analyzed. Educational attainment was categorized into 3 groups according to their final grade of educational course: middle or high school (≤12 years of education), college or university (12-16 years of education), and postgraduate (≥16 years of education). CRF was assessed by cardiopulmonary exercise testing, biceps strength, hand grip strength, bioelectrical impedance analysis, and echocardiography. Metabolic syndrome was diagnosed according to the 3rd report of the National Cholesterol Education Program.Among the subjects, 357 (36.1%) had metabolic syndrome. The postgraduate group had significantly higher peak oxygen consumption (VO2), biceps strength, hand grip strength, and peak expiratory flow than other groups (all P < .001). This group showed better left ventricular diastolic function, in terms of deceleration time of mitral inflow, maximal tricuspid valve regurgitation velocity, and left atrial volume index than other groups. Peak VO2 (%) was significantly correlated with all the parameters of metabolic syndrome, including insulin resistance (r = -0.106, P = .002), waist circumference (r = -0.387, P < .001), triglyceride (r = -0.109, P = .001), high density lipoprotein-cholesterol (r = 0.219, P < .001), systolic blood pressure (r = -0.143, P < .001), and diastolic blood pressure (r = -0.177, P < .001). And Peak VO2 (%) was found to be a predictor of metabolic syndrome (adjusted ß = .988, P < .001). However, the level of education was not able to predict metabolic syndrome (postgraduate group; ß = .955, P = .801).Although the postgraduate group had better CRF than other groups, the educational attainment could not exclusively predict metabolic syndrome in this study. Further research is needed to reveal the socioeconomic mechanism of developing metabolic syndrome.

Differential efficacy between stenting and plain balloon angioplasty for femoropopliteal disease with or without total occlusion.

BACKGROUND/AIMS: Whether the presence of chronic total occlusion (CTO) affects patency after stenting in femoropopliteal lesions is unknown. We determined the effects of plain balloon angioplasty (POBA) in comparison with those of stenting on patency for femoropopliteal CTO and stenosis (non-CTO). METHODS: We analyzed data from the Korean Vascular Intervention Society Endovascular Therapy in Lower-Limb Artery Diseases Registry, a multicenter cohort of patients with lower extremity peripheral arterial disease. Data from 1,329 patients and 1558 limbs treated with endovascular intervention for at least one femoropopliteal lesion were evaluated. RESULTS: Among the 1,558 limbs, 345, 432, 275, and 506 were in the non-CTO-POBA, non-CTO-stent, CTO-POBA, and CTO-stent groups, respectively. During follow-up, loss of clinical primary patency, a composite of freedom from restenosis or clinically driven target lesion revascularization, occurred in 65 (18.8%), 68 (15.7%), 62 (22.5%), and 113 limbs (22.3%) in the non-CTO-POBA, non-CTO-stent, CTO-POBA, and CTO-stent groups, respectively. The patients in the non-CTO-stent group showed a significantly better clinical primary patency than those in the no-CTO-POBA group, whereas those in the CTO-stent and CTO-POBA groups showed no significant differences. After inverse probability of treatment weighting to balance the differences among covariates between the non-CTO-stent and non-CTO-POBA groups, the non-CTO-stent group still showed superior clinical primary patency as compared with the non-CTO-POBA group. CONCLUSION: In the patients with femoropopliteal stenosis without CTO, stenting resulted in better clinical outcomes than balloon angioplasty. The presence of CTO in the femoropopliteal lesion should be considered when selecting a suitable device for performing endovascular procedures.

Different association between renal dysfunction and clinical outcomes according to the presence of diabetes in patients undergoing endovascular treatment for peripheral artery disease.

OBJECTIVE: Although chronic kidney disease (CKD) and diabetes are important prognostic factors in patients with peripheral artery disease, there are limited data regarding the outcomes of endovascular treatment (EVT) according to the severity of CKD, especially in the presence of diabetes. This study sought to compare clinical outcomes of lower limb EVT between patients with and patients without CKD according to the presence of diabetes. METHODS: Patients were enrolled from the Korean multicenter EVT registry and were divided according to the presence of diabetes, then further stratified by CKD (estimated glomerular filtration rate <60 mL/min/1.73 m2). The primary outcome was major adverse limb events (MALEs; a composite of reintervention for target limb, reintervention for target vessel, and unplanned major amputation) at 2 years. RESULTS: A total of 3045 patients were eligible for analysis: 1277 nondiabetic patients (944 without CKD, 333 with CKD) and 1768 diabetic patients (951 without CKD, 817 with CKD). CKD was associated with a significantly increased risk of MALEs after EVT in diabetic patients (14.4% vs 9.9%; adjusted hazard ratio, 1.60; 95% confidence interval, 1.28-2.01; P < .001) but not in nondiabetic patients (7.6% vs 9.7%; adjusted hazard ratio, 0.78; 95% confidence interval, 0.53-1.14; P = .203; interaction P = .018). In analysis stratified by the severity of CKD among diabetic patients, end-stage renal disease was significantly associated with an increased risk of MALE. CONCLUSIONS: CKD was associated with a significantly higher risk of MALEs after EVT in diabetic patients but not in nondiabetic patients. The increased risk of MALEs was mainly driven by patients with end-stage renal disease.

Vein conduit for end-to-side anastomosis of a calcified vessel in lower extremity free flap reconstruction.

BACKGROUND: As the microsurgical and interventional revascularization techniques are evolving, traditionally amputated limbs are now challenged to salvage. However, a calcified recipient vessel is a common but challenging problem encountered in lower extremity reconstruction. METHODS: An end-to-side anastomosis of a vein graft (1.5-3.5 cm in length) was performed to the recipient vessel when it was difficult to clamp the recipient vessel near the defect because of the inelastic and hard vessel wall. The vascular clamp was applied to the vein graft, and the flap's pedicle was anastomosed to the vein graft. RESULTS: A total of 18 free flaps (10 ALT cases, 4 TDAP cases, 2 PAP cases, and 2 SCIP cases) were anastomosed with a bridge vein graft to the heavily calcified recipient vessels (7 ATA cases, 3 PTA cases, 7 DPA cases, and 1 MPA case). Overall flap survival rate was 83.3%. Limb salvage rate was 93.7%, and anastomosis patency rate was 94.4% CONCLUSION: Vein conduit in an end-to-side anastomosis of severely calcified recipient vessels shows a reasonable limb salvage rate. It acts as a buffer, which makes microscopic vessel manipulation easier. If vessel calcification is the only drawback for a free flap reconstruction, then a vein graft needs to be prepared instead of an amputation. This method may extend the surgical option to more high-risk patients in lower extremity microsurgical reconstruction and increase the limb salvage rate.

Sex Differences in Outcomes Following Endovascular Treatment for Symptomatic Peripheral Artery Disease: An Analysis From the K- VIS ELLA Registry.

Background With advances in peripheral artery disease ( PAD ) treatments such as endovascular treatment ( EVT ), personalized patient assessment is important. Data on sex differences in clinical outcome for PAD patients undergoing EVT have been limited, and studies have produced conflicting results. This study sought to compare midterm clinical outcomes between women and men in a large population of patients with PAD undergoing EVT . Methods and Results The K- VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease) registry is a nationwide, multicenter, observational study that includes 3073 PAD patients undergoing EVT . The study population was divided into men (n=2523) and women (n=550). The primary outcome was a composite of death, myocardial infarction, and major amputation; the secondary outcome included major adverse limb events. Women had more comorbidities and more severe and complex target lesions than men. Women showed higher rates of death, myocardial infarction, or major amputation than men (14.8% versus 9.8%, adjusted hazard ratio 1.350, 95% CI 1.017-1.792, P=0.038), and higher rates of major adverse limb events (19.9% versus 14.5%, adjusted hazard ratio 1.301, 95% CI 1.014-1.670, P=0.039) and procedural complications (10.2% versus 5.9%, P<0.001) based on multivariable analysis. In patients with claudication, the primary outcome incidence was significantly higher in women (hazard ratio 2.088, 95% CI 1.421-3.068, P<0.001). In contrast, there was no significant difference in primary outcome for patients with critical limb ischemia between the 2 groups (hazard ratio 1.164, 95% CI 0.800-1.694, P=0.426). A significant interaction ( P=0.035) between patient presentation and outcome was observed. Conclusions In a large population of patients with PAD undergoing EVT , women had higher rates of death, myocardial infarction, or major amputation than men and higher rates of complex lesions, procedural complications, and limb-specific adverse events.

Comparison of successful percutaneous coronary intervention versus optimal medical therapy in patients with coronary chronic total occlusion.

BACKGROUND: Chronic total occlusion (CTO) is a challenging entity in coronary interventions. With improvements in technology and techniques, success rates for percutaneous coronary intervention (PCI) of CTO continue to improve. However, the clinical benefits of PCI remain unclear. The aim of the study was to determine the effectiveness of successful PCI on clinical outcomes using drug-eluting stents in patients with CTO. METHODS: From 2004 to 2010, we analyzed 898 patients with at least one CTO who underwent successful PCI (n=424, 448 lesions) or only medical treatment (n=474, 519 lesions) from a multicenter registry. The primary outcome was all-cause death. RESULTS: During a median of 2.2 years, incidence rate of all-cause death after successful PCI was lower than that after medical treatment (10.6% and 17.5%, p=0.004). However, the multivariate Cox proportional hazards model showed that successful PCI was not associated with improvement in mortality compared to medical treatment [adjusted hazard ratio (HR) 0.84, 95% confidence interval (CI) 0.57-1.24, p=0.38]. Comparable results were obtained after propensity-score matching. Subgroup analysis of propensity-score matched population demonstrated that patients with age under 65 years benefited from successful PCI (HR 0.25, 95% CI 0.08-0.75, p for interaction=0.005). CONCLUSIONS: In patients considered for CTO intervention, medical treatment appears to be associated with a similar mortality compared to successful PCI. Successful CTO PCI might be associated with survival benefit in younger patients compared to medical treatment.

Thyroid stimulating hormone elevation as a predictor of long-term mortality in patients with acute myocardial infarction.

BACKGROUND: Hypothyroidism has been known to be associated with hyperlipidemia, endothelial dysfunction and atherosclerosis. Elevation of thyroid-stimulation hormone (TSH) is a gold standard to detect these conditions. However, no large studies have investigated the association between TSH elevation and long-term clinical outcomes in patients with acute myocardial infarction (AMI). HYPOTHESIS: Hypothyroidism is associated with higher mortality in patients with AMI. METHODS: A total of 4748 AMI patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents were consecutively enrolled. We analyzed 1977 patients whose thyroid function data available after the exclusion of hyperthyroidism and possible central hypothyroidism. Patients were divided into two groups; euthyroid group (n = 1846) with normal TSH and normal free thyroxine (FT4); hypothyroidism group (n = 131) with elevated TSH and normal or low FT4. The two groups were subsequently compared with their all-cause and cardiac mortalities. RESULTS: Median follow-up duration was 3.5 years. Hypothyroidism group were older, included in more females, and had higher incidences of atrial fibrillation, stroke, and renal dysfunction. Elevated TSH was associated with significantly higher all-cause mortality (26.0% vs 11.7%, P < 0.0001) and cardiac mortality (9.2% vs 4.6%, P = 0.014). The multivariate Cox proportional hazards model identified that TSH elevation was a significant predictor of all-cause mortality (adjusted hazard ratio 1.560, 95% confidence interval 1.017 to 2.392, P = 0.041). CONCLUSIONS: Our data suggest that AMI patients with TSH elevation had worse clinical outcome. Moreover, TSH elevation was a predictor of all-cause mortality in patients with AMI.

Differential Impact of Chronic Kidney Disease on Coronary Calcification and Atherosclerosis in Asymptomatic Individuals with or without Diabetes: Analysis from a Coronary Computed Tomographic Angiography Registry.

AIM: The aim of this study was to assess the combined effects of chronic kidney disease (CKD) and diabetes on the extent and developmental pattern of coronary artery disease (CAD). METHODS: A total of 3,017 self-referred asymptomatic individuals without known CAD who underwent 64-channel dual-source coronary computed tomography angiography between 2006 and 2010 were enrolled. The patients were divided into six groups based on their diabetes status (nondiabetic or diabetic) and estimated glomerular filtration rate (eGFR) (eGFR > 90 mL/min/1.73 m2, normal renal function; eGFR 60-89, mild CKD; or eGFR 30-59, moderate CKD). We compared the coronary artery calcium score (CACS), segment stenosis score (SSS), and ≥50% obstructive CAD among the groups. RESULTS: In nondiabetics, whereas SSS and ≥50% obstructive CAD were not different as renal function deteriorated, after adjusting for cardiovascular risk factors, CACS showed a unique developmental pattern: no CACS increase until mild CKD, but abrupt increase from the stage of moderate CKD (moderate vs. normal renal function, adjusted OR 5.118, 95% CI 1.293-20.262, p = 0.020). In diabetics, patients from the stage of mild CKD were more likely to have ≥50% obstructive CAD (p = 0.004), higher CACS (p = 0.020), and SSS (p = 0.001) in multivariable analysis. CONCLUSIONS: The presence of CKD did not have a significant impact on the development of coronary atherosclerosis, but affected the progression of coronary calcification more markedly from the stage of moderate CKD in nondiabetics. However, in diabetics, the deterioration of renal function was significantly associated with the development of coronary atherosclerosis and calcification from the stage of mild CKD.

Effects of chronic kidney disease on clinical outcomes in patients with peripheral artery disease undergoing endovascular treatment: Analysis from the K-VIS ELLA registry.

OBJECTIVES: Chronic kidney disease (CKD) is a risk factor for peripheral artery disease (PAD), but the impact of CKD in PAD patients who received endovascular treatment (EVT) is not well studied. Aim of this study is to clarify the impact of CKD in patients with PAD in real EVT era. METHODS: Using the Korean Vascular Intervention Society (K-VIS) endovascular therapy in lower limb artery disease registry (ELLA) registry, we analyzed 3434 patients who underwent EVT. Baseline characteristics, in-hospital events, and overall- and major adverse limb events (MALE)-free survival were analyzed. RESULTS: 2739 patients (3548 target limbs) were included. 272 patients featured CKD (9.9%). Limbs in CKD patients had higher Rutherford scores, higher prevalence of critical limb ischemia (CLI). There were no differences in technical success rates in non-CKD vs. CKD group comparison and non-severe CKD vs. severe CKD group comparison (p = 0.050, 0.581, respectively). In-hospital death (p < 0.001) and short-term unexpected amputation (p = 0.028) were more frequent in the CKD group. The short-term outcome differences between severe and non-severe CKD were insignificant. Kaplan-Meier curves favored overall and MALE-free survival in non-CKD patients compared with CKD patients, but there was no difference in overall- or MALE-free survival between non-severe CKD and severe CKD groups. CONCLUSION: PAD patients with CKD showed worse short-term mortality, short-term unexpected amputation outcome, and overall- and MALE-free survival than those without CKD in real EVT era. These findings might provide additive prognostic information for PAD patients with CKD who will be treated with EVT.

Clinical Outcomes of Subintimal vs. Intraluminal Revascularization Approaches for Long Femoropopliteal Occlusions in a Korean Multicenter Retrospective Registry Cohort.

BACKGROUND: There are limited data comparing the outcomes of subintimal vs. intraluminal approach in the treatment of long femoropopliteal artery occlusions. The objective of this study was to investigate the efficacy and safety of the subintimal approach for long femoropopliteal artery occlusions.Methods and Results:From a multicenter retrospective registry cohort, we included a total of 461 patients with 487 femoropopliteal artery occlusions classified as Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II C/D for this analysis. We compared the immediate and mid-term outcomes of subintimal vs. intraluminal approaches. There were 228 patients with 243 limbs in the subintimal group, and 233 patients with 244 limbs in the intraluminal group. Baseline clinical and lesion characteristics were comparable between the 2 groups. The technical success rate was significantly higher in the subintimal group than in the intraluminal group (95.1% vs. 89.8%, P=0.041). The clinical primary patency (67.5% vs. 73.4% at 12 months, 54.0% vs. 61.3% at 24 months; P=0.086) and target lesion revascularization (TLR)-free survival (89.5% vs. 86.3% at 12 months, 77.6% vs. 76.0% at 24 months; P=0.710) did not differ significantly between the subintimal and the intraluminal groups. CONCLUSIONS: In long femoropopliteal occlusions, the subintimal approach achieved a higher technical success rate and similar mid-term primary patency and TLR-free survival compared with intraluminal approach.

Visit-to-visit variability of systolic blood pressure predicts all-cause mortality in patients received percutaneous coronary intervention with drug-eluting stents.

Blood pressure (BP) and its variability are associated with atherosclerotic disease and cardiovascular events. The prognostic implications of outpatient clinic visit-to-visit blood pressure variability (BPV) are unknown in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). A total of 1,463 patients undergoing PCI with DES were consecutively enrolled from January 2009 to December 2013. We analyzed the 1,234 patients, who measured clinic BP more than three times during the first year after PCI. The BPV is determined by standard deviation of systolic and diastolic BP, and coefficient of variation. Median follow-up duration was 905 days (interquartile range 529-1,310 days). All patients were divided into two groups according to the coefficient of variation of systolic BP (CVSBP); high CVSBP group (> 8.78, n = 617) and low CVSBP group (≤ 8.78, n = 617). High CVSBP group had significantly higher all-cause mortality (7.9% versus 3.1%, p < 0.001) and composite of all-cause mortality, myocardial infarction, and stroke (13.1% versus 6.2%, p < 0.001). In multivariate logistic regression analysis for prediction of all-cause mortality, and composite of all-cause mortality, myocardial infarction, and stroke after PCI with DES, hazard ratios of high CVSBP group were 2.441 (95% of confidence interval 1.042-5.718, p = 0.040), and 1.980 (95% of confidence interval 1.125-3.485, p = 0.018). The higher visit-to-visit BPV is associated higher mortality in patients undergoing PCI with DES. The clinic measured visit-to-visit BPV may serve as a predictor of all-cause mortality after PCI with DES.

Clinical and Angiographic Outcomes of the First Korean-made Sirolimus-Eluting Coronary Stent with Abluminal Bioresorbable Polymer.

BACKGROUND AND OBJECTIVES: This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent. METHODS: This study was a prospective, multicenter, randomized trial with a 1:1 ratio of Genoss drug-eluting stent (DES)™ and Promus Element™. Inclusion criteria were the presence of stable angina, unstable angina, or silent ischemia. Angiographic inclusion criteria were de novo coronary stenotic lesion with diameter stenosis >50%, reference vessel diameter of 2.5-4.0 mm, and lesion length ≤40 mm. The primary endpoint was in-stent late lumen loss at 9-month quantitative coronary angiography follow-up. Secondary endpoints were in-segment late lumen loss, binary restenosis rate, death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis during 9 months of follow-up. RESULTS: We enrolled 38 patients for the Genoss DES™ group and 39 patients for the Promus Element™ group. In-stent late lumen loss at 9 months was not significantly different between the 2 groups (0.11±0.25 vs. 0.16±0.43 mm, p=0.567). There was no MI or stent thrombosis in either group. The rates of death (2.6% vs. 0%, p=0.494), TLR (2.6% vs. 2.6%, p=1.000), and TVR (7.9% vs. 2.6%, p=0.358) at 9 months were not significantly different. CONCLUSION: This first-in-patient study of the Genoss DES™ stent showed excellent angiographic outcomes for in-stent late lumen loss and major adverse cardiac events over a 9-month follow-up.

Baseline Characteristics of a Retrospective Patient Cohort in the Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA) Registry.

BACKGROUND AND OBJECTIVES: The Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA) Registry is a multicenter observational study with retrospective and prospective cohorts of patients with lower extremity peripheral artery disease (PAD) undergoing endovascular treatment. In this study, we report the baseline characteristics of this retrospective cohort. SUBJECTS AND METHODS: In the present study we analyzed datasets of 3073 patients with 3972 target limbs from a retrospective cohort treated with endovascular therapy in 31 Korean hospitals. Data regarding patient baseline clinical and lesion characteristics and postintervention medications were collected from electronic medical records. RESULTS: The mean patient age was 68.3±9.4 years. The majority were male (82.1%) with comorbidities such as diabetes mellitus (58.0%), hypertension (73.4%), and coronary artery disease (CAD; 55.3%). Patients more commonly presented with intermittent claudication (66.3%) than with critical limb ischemia (CLI; 33.7%). Femoropopliteal artery (41.2%) was the most common target vessel for endovascular treatment, followed by the aortoiliac (35.6%) and infrapopliteal arteries (23.2%). TransAtlantic Inter-Society Consensus for the Management of Peripheral Artery Disease (TASC II) type C/D aortoiliac (48.0%) or femoropopliteal lesions (60.2%) were frequent targets of endovascular treatment. At hospital discharge, only 73.1% of patients received dual antiplatelet therapy and 69.2% received a statin. CONCLUSION: The majority of Korean patients with PAD exhibited conventional risk factors, such as male sex, older age, diabetes, and hypertension with coexisting CAD. Complex lesions were frequently treated with endovascular therapy. However, the rate of adherence to guidelines regarding post-procedural medical treatment requires improvement.

Computed Tomography Angiography Images of Coronary Artery Stenosis Provide a Better Prediction of Risk Than Traditional Risk Factors in Asymptomatic Individuals With Type 2 Diabetes: A Long-term Study of Clinical Outcomes.

OBJECTIVE: We investigated the efficacy of coronary computed tomography angiography (CCTA) in predicting the long-term risks in asymptomatic patients with type 2 diabetes and compared it with traditional risk factors. RESEARCH DESIGN AND METHODS: We analyzed 933 patients with asymptomatic type 2 diabetes who underwent CCTA. Stenosis was considered obstructive (≥50%) in each coronary artery segment using CCTA. The extent and severity scores for coronary artery disease (CAD) were evaluated. The primary end point was major adverse cardiovascular events (MACE), including all-cause mortality, nonfatal myocardial infarction, and late coronary revascularization during a mean follow-up period of 5.5 ± 2.1 years. RESULTS: Ninety-four patients with MACE exhibited obstructive CAD with a greater extent and higher severity scores (P < 0.001 for all). After adjusting for confounding risk factors, obstructive CAD remained an independent predictor of MACE (hazard ratio 3.11 [95% CI 2.00-4.86]; P < 0.001]). The performance of a risk prediction model based on C-statistics was significantly improved (C-index 0.788 [95% CI 0.747-0.829]; P = 0.0349) upon the addition of a finding of obstructive CAD using CCTA to traditional risk factors, including age, male, hypertension, hyperlipidemia, smoking, estimated glomerular filtration rate, and HbA1c. Both integrated discrimination improvement (IDI) and net reclassification improvement (NRI) analyses further supported this finding (IDI 0.046 [95% CI 0.020-0.072], P < 0.001, and NRI 0.55 [95% CI 0.343-0.757], P < 0.001). In contrast, the risk prediction power of the coronary artery calcium score remained unimproved (C-index 0.740, P = 0.547). CONCLUSIONS: Based on our data, the addition of CCTA-detected obstructive CAD to models that include traditional risk factors improves the predictions of MACE in asymptomatic patients with type 2 diabetes.

Infarcted Myocardium-Primed Dendritic Cells Improve Remodeling and Cardiac Function After Myocardial Infarction by Modulating the Regulatory T Cell and Macrophage Polarization.

BACKGROUND: Inflammatory responses play a critical role in left ventricular remodeling after myocardial infarction (MI). Tolerogenic dendritic cells (tDCs) can modulate immune responses, inducing regulatory T cells in a number of inflammatory diseases. METHODS: We generated tDCs by treating bone marrow-derived dendritic cells with tumor necrosis factor-α and cardiac lysate from MI mice. We injected MI mice, induced by a ligation of the left anterior descending coronary artery in C57BL/6 mice, twice with tDCs within 24 hours and at 7 days after the ligation. RESULTS: In vivo cardiac magnetic resonance imaging and ex vivo histology confirmed the beneficial effect on postinfarct left ventricular remodeling in MI mice treated with tDCs. Subcutaneously administered infarct lysate-primed tDCs near the inguinal lymph node migrated to the regional lymph node and induced infarct tissue-specific regulatory T-cell populations in the inguinal and mediastinal lymph nodes, spleen, and infarcted myocardium, indicating that a local injection of tDCs induces a systemic activation of MI-specific regulatory T cells. These events elicited an inflammatory-to-reparative macrophage shift. The altered immune environment in the infarcted heart resulted in a better wound remodeling, preserved left ventricular systolic function after myocardial tissue damage, and improved survival. CONCLUSIONS: This study showed that tDC therapy in a preclinical model of MI was potentially translatable into an antiremodeling therapy for ischemic tissue repair.