Postural change, gait, and physical function in older adults.

In a more clinical setting, abrupt posture change may be used to determine the presence of orthostatic hypotension, a hemodynamic response with relationships to physical function. Certain gait features and physical function performance are also associated with risk of falling in older adults. However, the extent to which posture change is associated with subsequent gait and physical function has received little attention in the literature. This study aims to determine the effects of posture change on spatiotemporal parameters of gait and Timed Up-and-Go (TUG) performance. METHODS: Forty-two volunteers (age 73.21 ± 6.22 years) participated in the study. A custom Tekscan Strideway (Tekscan, Boston, MA.) gait system was used to measure gait velocity (VEL), cadence (CAD), stride length (SL), and percent of time spent in active propulsion (AP). Dependent t-tests were used to compare TUG time, VEL, CAD, SL and AP after at least 10 mins of seated rest and supine rest. RESULTS: Time to complete the TUG was significantly slower after supine rest compared to seated (11.47 ± 0.51 and 10.01 ± 0.33 s, respectively, p<0.001); VEL was significantly slower after supine rest compared to seated (0.888 ± 0.042 and 1.049 ± 0.033 m/s, respectively, p=0.003); CAD was significantly slower after supine rest compared to seated (111.21 ± 2.87 and 120.97 ± 2.56spm, respectively, p=0.001); and AP was significantly lower after supine rest compared to seated (56.87 ± 4.76 and 70.79 ± 4.05 %, respectively, p<0.001). No significant differences were detected in stride length between conditions. CONCLUSIONS: Among this sample of older adults, standing from a supine posture is associated with spatiotemporal gait parameters consistent with a risk for falling and aging. Additionally, TUG performance worsens significantly after supine rest. Future studies could explore the sensitivity and specificity of falls risk screening after supine rest.

Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial.

BACKGROUND: Current guidelines recommend complete revascularization (CR) in hemodynamically stable patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD). With regard to the timing of percutaneous coronary intervention (PCI) for non-infarct-related artery (non-IRA), recent randomized clinical trials have revealed that immediate CR was non-inferior to staged CR. However, the optimal timing of CR remains uncertain. The OPTION-STEMI trial compared immediate CR and in-hospital staged CR guided by fractional flow reserve (FFR) for intermediate stenosis of the non-IRA. METHODS: The OPTION-STEMI is a multicenter, investigator-initiated, prospective, open-label, non-inferiority randomized clinical trial. The study included patients with at least 1 non-IRA lesion with ≥50% stenosis by visual estimation. Patients fulfilling the inclusion criteria were randomized into 2 groups at a 1:1 ratio: immediate CR (i.e., PCI for the non-IRA performed during primary angioplasty) or in-hospital staged CR. In the in-hospital staged CR group, PCI for non-IRA lesions was performed on another day during the index hospitalization. Non-IRA lesions with 50%-69% stenosis by visual estimation were evaluated by FFR, whereas those with ≥70% stenosis was revascularized without FFR. The primary endpoint was the composite of all-cause death, non-fatal myocardial infarction, and all unplanned revascularization at 1 year after randomization. Enrolment began in December 2019 and was completed in January 2024. The follow-up for the primary endpoint will be completed in January 2025, and primary results will be available in the middle of 2025. CONCLUSIONS: The OPTION-STEMI is a multicenter, non-inferiority, randomized trial that evaluated the timing of in-hospital CR with the aid of FFR in patients with STEMI and MVD. TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT04626882; and URL: https://cris.nih.go.kr. Unique identifier: KCT0004457.

Effect of cinnamon powder on quality attributes and off-flavor in fried chicken drumsticks made from long-term thawed Korean native chicken.

The effect of cinnamon powder on the quality and mitigation of off-flavor in fried chicken drumsticks made from long-term thawed Korean native chicken (Woorimatdag No. 1, WRMD1) was investigated. The WRMD1 drumsticks were categorized into 5 groups: conventional thawing (16 h, CT), long-term thawing (48 h, LT), cinnamon powder added into 'LT' as marinade (0.03%, CM) or incorporated into the batter (1.35%, CB), and long-term thawing with cinnamon powder incorporated both in the marinade and batter (0.03% + 1.35%, CMB). The crude fat content was significantly higher in the CT and CMB than that of the CB. The CM, CB, and CMB showed significantly lower levels of 2-thiobarbituric acid reactive substance compared with the CT and LT. The predominant fatty acids in all treatments were C18:1n9, C18:2n6, and C16:0. The LT displayed lower total unsaturated fatty acid content than the CT (P < 0.05). The CM effectively decreased lipid oxidative volatiles, such as 1-octanol, 1-octen-3-ol, and 2-octen-1-ol, (E), in the LT (P < 0.05). Both the CM and CB showed an inclination to increase specific pyrazines associated with pleasant notes compared with the LT, and showed higher levels of pyrazines, such as pyrazine, 2-ethyl-6-methyl-, and pyrazine, 3-ethyl-2,5-dimethyl-, than those of the CMB (P < 0.05). The CM contained higher levels of 2,3-butanedione when compared with the other groups (P < 0.05). Multivariate analysis demonstrated that cinnamon had an effect in discriminating the treatment groups with cinnamon addition from both the CT and LT, whereas the CM, CB, and CMB formed distinct clusters. The CM and CMB received significantly higher aroma scores from panelists in comparison to the other groups. These findings suggest that the CM (0.03% cinnamon powder) can be used to enhance the aroma in fried WRMD1 drumsticks by reducing or masking the off-flavor volatiles associated with long-term thawing.

Validation of a new risk stratification system-based management for methicillin-resistant Staphylococcus aureus bacteraemia: analysis of a multicentre prospective study.

PURPOSE: Distinguishing between complicated and uncomplicated Staphylococcus aureus bacteraemia (SAB) is therapeutically essential. However, this distinction has limitations in reflecting the heterogeneity of SAB and encouraging targeted diagnostics. Recently, a new risk stratification system for SAB metastatic infection, involving stepwise approaches to diagnosis and treatment, has been suggested. We assessed its applicability in methicillin-resistant SAB (MRSAB) patients. METHODS: We retrospectively analysed data of a 3-year multicentre, prospective cohort of hospitalised patients with MRSAB. We classified the patients into three risk groups: low, indeterminate, and high, based on the new system and compared between-group management and outcomes. RESULTS: Of 380 patients with MRSAB, 6.3% were classified as low-, 7.6% as indeterminate-, and 86.1% as high-risk for metastatic infection. No metastatic infection occurred in the low-, 6.9% in the indeterminate-, and 19.6% in the high-risk groups (P < 0.001). After an in-depth diagnostic work-up, patients were finally diagnosed as 'without metastatic infection (6.3%)', 'with metastatic infection (17.4%)', and 'uncertain for metastatic infection (76.3%)'. 30-day mortality increased as the severity of diagnosis shifted from 'without metastatic infection' to 'uncertain for metastatic infection' and 'with metastatic infection' (P = 0.09). In multivariable analysis, independent factors associated with metastatic complications were suspicion of endocarditis in transthoracic echocardiography, clinical signs of metastatic infection, Pitt bacteraemia score ≥ 4, and persistent bacteraemia. CONCLUSIONS: The new risk stratification system shows promise in predicting metastatic complications and guiding work-up and management of MRSAB. However, reducing the number of cases labelled as 'high-risk' and 'uncertain for metastatic infection' remains an area for improvement.

Physicochemical Features and Volatile Organic Compounds of Horse Loin Subjected to Sous-Vide Cooking.

The purpose of this study was to evaluate the effect of temperature and time of sous-vide cooking method on the characteristics of Thoroughbred horse loin. Sliced portions (200 ± 50 g) were cooked by boiling (control) and sous-vide (65 and 70 °C for 12, 18, and 24 h). The samples were analyzed for proximate composition, pH, color, texture, microstructure, sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), microbiology, volatile organic compounds (VOCs), nucleotide content, and fatty acids composition. The color analysis showed decreased redness at elevated temperatures. Improved tenderness, demonstrated by reduced shear force values (36.36 N at 65 °C for 24 h and 35.70 N at 70 °C for 24 h). The micrographs indicated dense fiber arrangements at 70 °C. The SDS-PAGE revealed muscle protein degradation with extended sous-vide cooking. The VOC analysis identified specific compounds, potentially distinctive markers for sous-vide cooking of horse meat including 1-octen-3-ol, decanal, n-caproic acid vinyl ester, cyclotetrasiloxane, octamethyl, and 3,3-dimethyl-1,2-epoxybutane. This study highlights the cooking time's primary role in sous vide-cooked horse meat tenderness and proposes specific VOCs as potential markers. Further research should explore the exclusivity of these VOCs to sous-vide cooking.

Comparative Analysis of High-Intensity versus Low-to-Moderate Intensity Statin Therapy in Patients Undergoing Rotational Atherectomy for Calcified Coronary Artery Disease.

(1) Background: Moderate-intensity statin therapy, when compared to high-intensity statin therapy in Asian populations, has shown no significant difference in cardiovascular prognosis in small studies. The aim of this study was to compare the prognosis of patients based on statin intensity following rotational atherectomy (RA) during high-complexity percutaneous coronary intervention (PCI). (2) Methods: The ROCK registry, a multicenter retrospective study, included patients who had undergone rotational atherectomy (RA) during percutaneous coronary intervention (PCI) at nine tertiary medical centers in South Korea between January 2010 and October 2019. The patients were divided into high-intensity statin (H-statin) and moderate/low-intensity statin (M/L-statin) therapy groups. The primary endpoint includes outcomes (cardiac death, target vessel myocardial infarction (MI), and target vessel revascularization (TVR)) within an 18-month follow-up period. (3) Results: In this registry, a total of 540 patients with 583 lesions were included. We excluded 39 lesions from the analysis due to the absence of statin usage. The H-statin group had 394 lesions and the M/L-statin group had 150 lesions. There were no significant differences in baseline characteristics, procedural adverse events without heart failure history, triglycerides, or medications between the two groups. The procedural success rate showed a significant difference between the two groups. Multivariate analysis did not show a significant association between M/L-statin therapy and an increased risk of the primary endpoint. In propensity score matching analysis, no significant difference was observed in the primary endpoint either. (4) Conclusions: In high-complex RA PCI, moderate/low-intensity statin therapy is not inferior to high-intensity statin therapy in Korea.

Fish Oil Supplementation with Resistance Exercise Training Enhances Physical Function and Cardiometabolic Health in Postmenopausal Women.

Menopause is a condition associated with an increased risk of dysregulation in cardiovascular and metabolic health among older women. While fish oil (FO) has garnered great attention for its health-enhancing properties, its potential for enhancing cardiometabolic health in this demographic remains to be established. The purpose of this study was to determine the clinical efficacy of an 8 wk administration of FO combined with programmed resistance exercise training (RET) on physical function and risk factors associated with cardiometabolic health in healthy older women. Twenty, healthy, older women were randomly assigned to one of the two experimental groups: resistance training with placebo (RET-PL) or RET with fish oil (RET-FO). Physical function, blood pressure (BP), triglyceride (TG), and systemic inflammation and oxidative stress biomarkers were assessed before and after the intervention. Statistical significance was set at p ≤ 0.05. Physical function was greatly enhanced in both RET and RET-FO. Handgrip strength substantially increased only in RET-FO. RET-FO exhibited significant decreases in BP, TG, inflammatory cytokines (TNF-α and IL-6), and oxidative stress (MDA and 8-OHdG) levels, while no detectable changes were found in RET-PL. Our findings indicate that FO administration during 8 wks of RET appears to enhance muscle function and lower risk factors linked to cardiometabolic disorders in postmenopausal women.

Prognostic Impact of Atrial Fibrillation in Patients with Heavily Calcified Coronary Artery Disease Receiving Rotational Atherectomy.

Background and Objectives: Although both rotational atherectomy (RA) and atrial fibrillation (AF) have a high thrombotic risk, there have been no previous studies on the prognostic impact of AF in patients who undergo percutaneous coronary intervention (PCI) using RA. Thus, the aim of the present study was to determine the prognostic impact of AF in patients undergoing PCI using RA. Materials and Methods: A total of 540 patients who received PCI using RA were enrolled between January 2010 and October 2019. Patients were divided into AF and sinus rhythm groups according to the presence of AF. The primary endpoint was net adverse clinical events (NACEs) defined as a composite outcome of all-cause death, myocardial infarction, target vessel revascularization, cerebrovascular accident, or total bleeding. Results: Although in-hospital adverse events showed no difference between those with AF and those without AF (in-hospital events, 54 (11.0%) vs. 6 (12.2%), p = 0.791), AF was strongly associated with an increased risk of NACE at 3 years (NACE: hazard ratio, 1.880; 95% confidence interval, 1.096-3.227; p = 0.022). Conclusions: AF in patients who underwent PCI using RA was strongly associated with poor clinical outcomes. Thus, more attention should be paid to thrombotic and bleeding risks.

Cancer Cachexia: Underlying Mechanisms and Potential Therapeutic Interventions.

Cancer cachexia, a multifactorial metabolic syndrome developed during malignant tumor growth, is characterized by an accelerated loss of body weight accompanied by the depletion of skeletal muscle mass. This debilitating condition is associated with muscle degradation, impaired immune function, reduced functional capacity, compromised quality of life, and diminished survival in cancer patients. Despite the lack of the known capability of fully reversing or ameliorating this condition, ongoing research is shedding light on promising preclinical approaches that target the disrupted mechanisms in the pathophysiology of cancer cachexia. This comprehensive review delves into critical aspects of cancer cachexia, including its underlying pathophysiological mechanisms, preclinical models for studying the progression of cancer cachexia, methods for clinical assessment, relevant biomarkers, and potential therapeutic strategies. These discussions collectively aim to contribute to the evolving foundation for effective, multifaceted counteractive strategies against this challenging condition.

Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia.

The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, or ATV 20 mg /AML 5 mg. The primary endpoint was the efficacy of the RSV 10.20 mg/AML 5 mg via percentage changes in LDL-C after 8 weeks of treatment, compared with the ATV 20 mg /AML 5 mg. There was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 10 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (full analysis set [FAS]: -7.08%, 95% CI: -11.79 to -2.38, p = .0034, per-protocol analysis set [PPS]: -6.97%, 95% CI: -11.76 to -2.19, p = .0046). Also, there was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 20 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (FAS: -10.13%, 95% CI: -15.41 to -4.84, p = .0002, PPS: -10.96%, 95% CI: -15.98 to -5.93, p < .0001). There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg. In conclusion, while maintaining safety, RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL-C compared with the ATV 20 mg /AML 5 mg (Clinical trial: NCT03951207).

Intravascular Ultrasound Guided Intervention in Calcified Coronary Lesions Showed Good Clinical Outcomes during One Year Follow-Up.

BACKGROUND: Calcified coronary lesions can cause stent under-expansion, malapposition, and polymer degradation, hence increasing the risk of adverse clinical outcomes. Percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS) has been used regularly to improve outcomes. Our primary aim was to evaluate the clinical efficacy of IVUS-guided PCI in calcified coronary lesions. METHODS: From August 2018 to December 2021, we prospectively included 300 patients in the CAPIRO study (CAlcified plaque in patients receiving Resolute Onyx®) at three educational hospitals in Jeonbuk Province. We studied 243 patients (265 lesions) who were followed up for over a year. Based on coronary calcification by IVUS analysis, the patient population was categorized into two groups (Group I: non/mild calcification; Group II: moderate/severe calcification (maximum calcium arc >180° and calcium length > 5 mm)). One-to-one Propensity Score Matching was used to match the baseline characteristics. The stent expansion rate was analyzed by recent criteria. The primary clinical outcome was Major Adverse Cardiac Events (MACE), which included Cardiac death, Myocardial Infarction (MI), and Target Lesion Revascularization (TLR). RESULTS: After follow-up time, the MACE rate in Group I was 1.99%, comparable to Group II's 1.09% (p = 0.594). The components of MACE did not significantly differ between the two groups. Based on absolute MSA or MSA/MVA at MSA site criteria, the stent expansion rate in Group II was lower than that of Group I. Nevertheless, based on recent relative criteria, the stent expansion rate in both groups was comparable. CONCLUSIONS: After more than a year of follow-up, IVUS-guided PCI in moderate/severe calcification lesions was associated with good clinical outcomes, which was comparable with non/mild calcification lesions. Future studies with a larger sample size and a more extended follow-up period are required to clarify our findings.

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 coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: PARADE II study.

Background: The efficacy of spot stenting using drug-eluting stents (DES) for the treatment of long femoropopliteal (FP) lesion is unknown. This study aimed to compare clinical outcomes of long full coverage vs. spot coverage with DES for long FP artery disease. Methods: This multicenter randomized trial compared long DES vs. spot DES for FP lesions longer than 150 mm. All lesions were treated with paclitaxel-eluting stents (Zilver PTX). The primary endpoint was primary patency at 12 months. Results: The study was terminated early after an interim analysis. A total of 103 patients (55 in the long DES group; 48 in the spot DES group) were eligible for analysis. There were no significant differences in baseline and lesion characteristics between groups. Total stent length was longer in the long DES group than in the spot DES group (225.6 ± 67.2 vs. 131.3 ± 48.7 mm, p < 0.001). Technical success was achieved in all patients. There was a trend toward a higher primary patency rate at 12 months in the long DES group than in the spot DES group (87.5% vs. 67.5%, p = 0.120). The rate of survival free from target lesion revascularization was significantly higher in the long DES group than in the spot DES group (91.7% vs. 72.0%, p = 0.044). In multivariate Cox regression analysis, spot DES [hazard ratio (HR) 2.42, 95% confidence interval (CI) 1.14-5.12, p = 0.021] and postdilation (HR 0.27, 95% CI 0.09-0.79, p = 0.018) were identified as independent predictors for loss of patency at 12 months post-procedure. Conclusions: Long DES were more effective than spot DES for treating long FP lesions. Clinical trial registration: Clinicaltrials.gov, identifier: NCT02701881.

Fish oil administration combined with resistance exercise training improves strength, resting metabolic rate, and inflammation in older adults.

BACKGROUND: While fish oil (FO) has attracted great attention due to their health-enhancing properties, its potential to enhance benefits from resistance exercise training (RET) has not been fully elucidated yet. AIMS: The aim of this study was to investigate effects of FO administration during 12 weeks of programmed RET on muscular strength, resting metabolic rate (RMR), and systemic inflammation in healthy older adults. METHODS: Twenty-eight healthy older adults were randomly assigned to three experimental groups: sedentary control (CON), resistance exercise training (RET), or RET combined with FO (RET-FO). A one-repetition (1RM) of maximum muscle strength, RMR, substrate oxidation, and blood inflammatory biomarkers were assessed before and after the intervention. Statistical significance was set at p ≤ 0.05. RESULTS: 1RM muscle strength was significantly increased in RET and RET-FO while substantially decreased in CON. RMR greatly increased in RET and RET-FO with no change in CON. RET-FO exhibited significantly increased fatty acid oxidation, but no change was found in CON and RET. Systemic interleukin 6 (IL-6) and C-reactive protein (CRP) were significantly decreased from baseline in RET-FO while no change was observed in CON and RET. CONCLUSION: Our data indicate chronic RET reversed aging-induced loss of muscle strength and improved RMR, while FO administration combined with RET appears to enhance fat metabolism and mildly reduce some indicators of systemic inflammation.

Impact of Diabetes Duration on Clinical Outcome in Patients Receiving Rotational Atherectomy in Calcified Lesions in Korea-Results from ROCK Registry.

There are limited data regarding the clinical impact of diabetes duration for patients with heavy calcified coronary lesions. We sought to determine the clinical impact of diabetes duration on clinical outcomes in patients with heavily calcified lesions who required rotational atherectomy during percutaneous coronary intervention (PCI). A total of 540 diabetic patients (583 lesions) were enrolled between January 2010 and October 2019. Patients were classified into three subgroups: patients with no diabetes mellitus (non-DM), shorter duration (S-DM), and longer duration (L-DM), of which duration was divided at 10 years. During 18 months of follow-up-duration, diabetes duration was significantly associated with the primary outcome. The incidence rate of target-vessel failure (TVF), the primary outcome, was significantly higher in the L-DM group compared with non-DM or S-DM. Among secondary outcomes, any repeat revascularization (RR) was frequently observed in the L-DM compared with other groups. In multivariate analysis, the risk of TVF and any RR was 1.9 times and 2.4 times higher in L-DM than in non-DM, respectively. This study firstly demonstrated that there is an association between a longer DM duration and poor clinical outcomes in patients with severe calcified CAD after PCI. More careful monitoring for recurrence is needed during follow-up in those patients.

Long-Term Clinical Outcomes of Iliac Artery Endovascular Therapy in the Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA) Registry.

BACKGROUND AND OBJECTIVES: Limited data are available regarding long-term clinical outcomes of iliac artery endovascular therapy (EVT) in real-world practice. This study investigated long-term outcomes according to Trans-Atlantic Inter-Society Consensus (TASC) classifications. METHODS: We analyzed data from 1,705 limbs of 1,364 patients from the retrospective cohort of the multicenter Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease registry. The primary endpoint was target lesion revascularization (TLR)-free survival. RESULTS: TASC A, B, C, and D lesions were present in 19.4%, 26.2%, 28.7%, and 25.7% of the treated limbs, respectively. The technical success rate was 96.2% and did not differ between TASC lesion types. Complications occurred in 6.8% of cases and more occurred in TASC D (11.8%). Iliac artery EVT showed a 5-year TLR-free survival of 89.2%. The TASC D group had the lowest TLR-free rate of 79.3%. TASC D (hazard ratio [HR], 1.75; 95% confidence interval [CI], 1.12-2.73; p=0.014), plain old balloon angioplasty (HR, 4.25; 95% CI, 2.03-8.88; p<0.001), current smoker (HR, 1.89; 95% CI, 1.26-2.83; p=0.002), previous bypass surgery (HR, 3.04; 95% CI, 1.28-7.19; p=0.011), combined femoropopliteal treatment (HR, 4.89; 95% CI, 3.19-7.50; p<0.001), combined below the knee treatment (HR, 2.20; 95% CI, 1.25-3.89; p=0.007), and complications (HR, 1.86; 95% CI, 1.07-3.24; p=0.028) were predictors for TLR. CONCLUSIONS: Iliac artery EVT achieved excellent technical success and 5-year TLR-free survival. TASC D showed a favorable but lower 5-year TLR-free survival rate and higher complication rate compared with other TASC groups. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02748226.

Efficacy and Safety of SID142 in Patients With Peripheral Arterial Disease: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Clinical Trial.

PURPOSE: Renexin® is a combination pill of cilostazol and Ginkgo biloba leaf extract that is used for the improvement of ischemic symptoms associated with peripheral arterial disease (PAD). SID142 is a controlled-release tablet of cilostazol (200 mg) and G biloba leaf extract (160 mg) that was developed to address the limitation of BID administration with Renexin. This study aimed to verify that SID142 was not inferior to Renexin in the treatment of patients with PAD. METHODS: This was a multicenter, randomized, double-blind, active-controlled, parallel-group, Phase III clinical trial. Study subjects were randomized to receive SID142 once daily or Renexin twice a day for 12 weeks. The primary end point was a change in the patient assessment of lower leg pain intensity with the use of a visual analog scale (VAS) after 12 weeks of treatment. If the lower limit of the two-sided 95% CI was greater than -10, the study drug was declared noninferior to the reference drug. Secondary efficacy end points included cold sensation, ankle-brachial index, ankle systolic pressure, maximum walking distance, pain-free walking distance, and investigator's global assessment. Study group results were compared 4, 8, and 12 weeks after treatment. Adverse events were assessed as a safety end point. FINDINGS: In total, 344 subjects from 19 medical centers were screened, and a total of 170 subjects were randomly assigned to either the SID142 (n = 86) or the Renexin (n = 84) group. Analysis of the change in lower extremity pain at 12 weeks compared with baseline revealed that SID142 was not inferior to Renexin (21.44 [19.23] vs 22.30 [17.75]; 95% CI, -7.70 to 5.97; P = 0.5942). No significant differences were found between groups in any secondary efficacy end point. However, the incidence of adverse reactions was significantly lower in the SID142 group (22.35% vs 39.29%; P = 0.0171). IMPLICATIONS: SID142 once daily was not inferior to Renexin twice a day for efficacy in patients with PAD. SID142 had a favorable safety profile. CLINICALTRIALS: gov identifier: NCT03318276.

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.

Poor Prognosis of Contrast-Induced Nephropathy during Long Term Follow Up.

Contrast-induced nephropathy (CIN) is known to associate with poor prognosis. However, there have been few studies for long-term follow up. The purpose of this study was to know the prognosis of CIN during a 10-year follow up. We retrospectively analyzed 528 patients who underwent coronary angiography in Jeonbuk National University Hospital (South Korea, Jeonju) between Jan 2005 to Dec 2006. We excluded the patients who required regular dialysis before study enrollment. We compared adverse events in the no CIN (group I, n=485, 61.9±11.4 years, male 64.1%) and CIN (group II, n=43, 65.7±11.1 years, male 62.8%). Baseline clinical characteristics and cardiovascular risk factors were not different between the two groups except the post-procedure creatinine level (1.04 mg/dL vs 1.84 mg/dL, p=0.0001). The higher rates of all-cause death were observed in group II at 1-year (3.7% vs 13.9%, log-rank, p=0.001), 5-years (17.9% vs 34.9%, log-rank, p=0.003), and 10-years (25.3% vs 48.8%, log-rank, p=0.000). MACE was higher in group II at 1-year (3.9% vs 11.6%, log-rank, p=0.013), 5-years (6.8% vs 20.9%, log-rank, p=0.000) and 10-years (13.4% vs 27.9%, log-rank, p=0.000). In addition, CIN was an independent predictor for 10-year MACE (adjusted HR 3.432, 95% CI 1.314-8.965, p=0.012) after propensity score matching. The worse prognosis of CIN was continuously observed after the 10-year follow-up. Our data suggests that it is worthwhile to prevent the appearance of CIN in order to improve longterm results.