Moderate-intensity statin plus ezetimibe vs high-intensity statin according to baseline LDL-C in the treatment of atherosclerotic cardiovascular disease: A post-hoc analysis of the RACING randomized trial.

BACKGROUND AND AIMS: Whether the effect of a combination strategy rather than increasing doses of one drug to lower low-density lipoprotein cholesterol (LDL-C) levels is consistent across baseline LDL-C levels remains uncertain. METHODS: In the RACING trial, which showed a non-inferiority of moderate-intensity statin with ezetimibe (rosuvastatin 10 mg with ezetimibe 10 mg) to high-intensity statin (rosuvastatin 20 mg) for the primary outcome (3-year composite of cardiovascular death, major cardiovascular event, or stroke), the heterogeneity in treatment effect according to baseline LDL-C levels was assessed for the primary and secondary outcomes (clinical efficacy and safety). RESULTS: Of 3780 participants, 2817 participants (74.5%) had LDL-C <100 mg/dL, and 963 participants (25.5%) had LDL-C ≥100 mg/dL. The treatment effect of combination therapy versus high-intensity statin monotherapy was similar among the lower LDL-C subset (8.8% vs. 10.2%; hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.67 to 1.08, p = 0.19) and the higher LDL-C subset (10.8% vs. 9.6 %; HR 1.14, 95% CI 0.76 to 1.7, p = 0.53) without a significant interaction (interaction p = 0.22). Of the secondary outcomes, the 1-, 2-, and 3-year achievement of LDL-C <70 mg/dL was greater in the combination therapy group regardless of baseline LDL-C levels. CONCLUSIONS: Among ASCVD patients, there was no heterogeneity in the effect of moderate-intensity statin plus ezetimibe combination therapy in the higher and lower baseline LDL-C levels for the 3-year composite of cardiovascular outcomes.

Comparison of Antiplatelet Monotherapies After Percutaneous Coronary Intervention According to Clinical, Ischemic, and Bleeding Risks.

BACKGROUND: Clopidogrel was superior to aspirin monotherapy in secondary prevention after percutaneous coronary intervention (PCI). OBJECTIVES: The purpose of this study was to evaluate the benefits of clopidogrel across high-risk subgroups METHODS: This was a post hoc analysis of the HOST-EXAM (Harmonizing Optimal Strategy for Treatment of coronary artery diseases-EXtended Antiplatelet Monotherapy) trial that randomly assigned patients who were event free for 6 to 18 months post-PCI on dual antiplatelet therapy (DAPT) to clopidogrel or aspirin monotherapy. Two clinical risk scores were used for risk stratification: the DAPT score and the Thrombolysis In Myocardial Infarction Risk Score for Secondary Prevention (TRS 2°P) (the sum of age ≥75 years, diabetes, hypertension, current smoking, peripheral artery disease, stroke, coronary artery bypass grafting, heart failure, and renal dysfunction). The primary composite endpoint was a composite of all-cause death, nonfatal myocardial infarction, stroke, readmission because of acute coronary syndrome, and major bleeding (Bleeding Academic Research Consortium type ≥3) at 2 years after randomization. RESULTS: Among 5,403 patients, clopidogrel monotherapy showed a lower rate of the primary composite endpoint than aspirin monotherapy (HR: 0.73; 95% CI: 0.59-0.90). The benefit of clopidogrel over aspirin was consistent regardless of TRS 2°P (high TRS 2°P [≥3] group: HR: 0.65 [95% CI: 0.44-0.96]; and low TRS 2°P [<3] group: HR: 0.77 [95% CI: 0.60-0.99]) (P for interaction = 0.454) and regardless of DAPT score (high DAPT score [≥2] group: HR: 0.68 [95% CI: 0.46-1.00]; and low DAPT score [<2] group: HR: 0.75 [95% CI: 0.59-0.96]) (P for interaction = 0.662). The association was similar for the individual outcomes. CONCLUSIONS: The beneficial effect of clopidogrel over aspirin monotherapy was consistent regardless of clinical risk or relative ischemic and bleeding risks compared with aspirin monotherapy. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy [HOST-EXAM]; NCT02044250).

Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice.

BACKGROUND/AIMS: The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention. METHODS: The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months. RESULTS: A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%. CONCLUSION: In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.

Combination Moderate-Intensity Statin and Ezetimibe Therapy for Elderly Patients With Atherosclerosis.

BACKGROUND: The routine use of high-intensity statins should be considered carefully in elderly patients because of their higher risk of intolerance or adverse events. OBJECTIVES: We evaluated the impact of moderate-intensity statin with ezetimibe combination therapy compared with high-intensity statin monotherapy in elderly patients with atherosclerotic cardiovascular disease (ASCVD). METHODS: In this post hoc analysis of the RACING (RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases) trial, patients were stratified by age (≥75 years and <75 years). The primary endpoint was a 3-year composite of cardiovascular death, major cardiovascular events, or nonfatal stroke. RESULTS: Among the 3,780 enrolled patients, 574 (15.2%) were aged ≥75 years. The rates of the primary endpoint were not different between the moderate-intensity statin with ezetimibe combination therapy group and the high-intensity statin monotherapy group among patients aged ≥75 years (10.6% vs 12.3%; HR: 0.87; 95% CI: 0.54-1.42; P = 0.581) and those <75 years (8.8% vs 9.4%; HR: 0.94; 95% CI: 0.74-1.18; P = 0.570) (P for interaction = 0.797). Moderate-intensity statin with ezetimibe combination therapy was associated with lower rates of intolerance-related drug discontinuation or dose reduction among patients aged ≥75 years (2.3% vs 7.2%; P = 0.010) and those <75 years (5.2% vs 8.4%; P < 0.001) (P for interaction = 0.159). CONCLUSIONS: Moderate-intensity statin with ezetimibe combination therapy showed similar cardiovascular benefits to those of high-intensity statin monotherapy with lower intolerance-related drug discontinuation or dose reduction in elderly patients with ASCVD having a higher risk of intolerance, nonadherence, and discontinuation with high-intensity statin therapy. (RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases [RACING Trial]; NCT03044665).

Estimation of peak oxygen consumption in individuals with spinal cord injury patients using multiple linear regression analysis: a preliminary study.

PURPOSE: This study aims to develop a regression model to estimate peak oxygen consumption (VO2peak) in individuals with spinal cord injury (SCI) by employing different variables. METHODS: In this study, 34 participants were divided into two groups: 19 with cervical injury (CI) and 15 with thoracic injury (TI). Key measurements included VO2peak and related factors such as age, height, weight, body mass index (BMI), fat-free mass, body fat percentage, limb and trunk circumferences, spinal cord independence (SCIM III), Korean activities of daily living (K-ADL), and respiratory functions (forced vital capacity (FVC), peak expiratory flow (PEF), and maximum voluntary ventilation (MVV)). Statistical analyses were conducted using forward selection regression to examine the relationships between these variables. RESULTS: Height, calf circumference, SCIM III score, and PEF were key variables in all patients with SCI (TSCI). For patients with CI, the key variables were height, calf circumference, and MVV, whereas for patients with TI, the key variable was calf circumference. The average explanatory powers of the VO2peak regression model for TSCI were 70.3% (R2) and 66.2% (adjusted R2), with an average standard error of estimate (SEE) of 2.94 ml/kg/min. The average explanatory power for patients with CI was 71.7% (R2) and 66.1% (adjusted R2), with an average SEE of 1.88 ml/kg/min. The average explanatory power for patients with TI was 55.9% (R2) and 52.5% (adjusted R2), with an average SEE of 3.41 ml/kg/min. There was no significant difference between the VO2peak measured and predicted VO2peak for each type of injury. CONCLUSION: The regression model for estimating VO2peak in SCI patients in this preliminary study is as follows: TSCI=39.684-0.144×(Height)-0.513×(Calf)+0.136×(SCIM III)+1.187×(PEF), CI=38.842-0 .158×(Height) - 0.371×(Calf)+0.093×(MVV), TI=42.325-0.813×(Calf).

Comparison Between Corticosteroid Injection Into Coracohumeral Ligament and Inferior Glenohumeral Capsule and Corticosteroid Injection Into Posterior Glenohumeral Recess in Adhesive Capsulitis: A Prospective Randomized Trial.

BACKGROUND: For managing symptoms of adhesive capsulitis (AC), corticosteroid injection is typically conducted under the guidance of ultrasound via posterior glenohumeral recess (PGHR). It has been reported that pathologies such as inflammation and edema are most commonly observed in the coracohumeral ligament (CHL) and anterior and inferior joint capsules. We compared the therapeutic effects of corticosteroid injection into the CHL and inferior glenohumeral capsule (IGHC) with those of corticosteroid injection into PGHR in patients with AC. METHODS: One hundred twenty consecutive patients with AC were included in this study and randomly allocated to either the CHL + IGHC group (n = 60) or the PGHR group (n = 60). Patients in both groups received 3 injections at 2 week intervals. After the first injection, if the patient's shoulder pain showed satisfactory improvement, further injections were not administered. The therapeutic effect was measured at 2 and 4 months after the first injection. Pain intensity was evaluated using the visual analog scale (VAS). Additionally, the passive range of motion (ROM) of the shoulder joint (abduction, external rotation, and internal rotation) was measured. RESULTS: VAS scores and ROM of abduction, external rotation, and internal rotation improved at follow-up evaluation in both groups (P < 0.05) (CHL and IGHC: VAS, pre-treatment = 6.5 ± 0.5, 2 months = 2.1 ± 0.8, 4 months = 1.4 ± 0.6; ROM-abduction, pre-treatment = 131.3° ± 16.4°, 2 months = 162.4° ± 8.2°, 4 months = 176.2° ± 5.6°; ROM-external rotation, pre-treatment = 31.6° ± 16.9°, 2 months = 67.2° ± 11.1°, 4 months = 81.3° ± 12.1°, ROM-internal rotation, pre-treatment = 6.2 ± 2.2, 2 months = 4.0 ± 2.2, 4 months = 2.7 ± 1.2; PGHR: VAS, pre-treatment = 6.5 ± 0.5°, 2 months = 3.9 ± 1.1, 4 months = 2.1 ± 1.1; ROM-abduction, pre-treatment = 132.1° ± 9.5°, 2 months = 145.5° ± 11.7°, 4 months = 167.4° ± 11.2°; ROM-external rotation, pre-treatment = 32.4° ± 13.4°, 2 months = 49.3° ± 13.2°, 4 months = 72.7° ± 18.0°, ROM-internal rotation, pre-treatment = 6.3 ± 1.4, 2 months = 5.4 ± 0.8, 4 months = 3.6 ± 1.0). However, the improvements were greater in patients who received corticosteroid injection into the CHL and IGHC compared to that into the PGHR at 2 and 4 months after the initiation of the treatment (P < 0.05). LIMITATIONS: Long-term therapeutic outcomes were not investigated, and the therapeutic effect of corticosteroid injection into the CHL and IGHC was not compared with placebo injection. CONCLUSION: Corticosteroid injection into the CHL and IGHC might be a better treatment alternative for patients with AC.

Effect of Ultrasound-Guided Partial Release of the Transverse Carpal Ligament with a Needle in Patients with Refractory Carpal Tunnel Syndrome.

BACKGROUND: Neuropathic pain in the hands due to carpal tunnel syndrome (CTS) disturbs sleep and affects the quality of life. OBJECTIVES: We evaluated the effect of ultrasound (US)-guided partial release of the transverse carpal ligament (TCL) using an 18-G needle in patients with refractory CTS. STUDY DESIGN: A prospective outcome study. SETTING: The outpatient clinic of a single academic medical center. METHODS: This study was prospectively conducted. A total of 155 consecutive patients (191 wrists) with refractory chronic CTS (M:F = 28:127; age = 54.7 ± 9.6 years; pain duration = 50.3 ± 36.3 weeks) were enrolled and underwent US-guided partial release of the TCL using a needle. The pain severity was measured using the Numeric Rating Scale (NRS) at 3 and 6 months after the treatment. Successful treatment outcomes were defined as more than 50% reduction in the NRS score at 6 months after the treatment compared with the score at pre-treatment and NRS score < 3 at 6 months after the treatment without any surgical intervention. RESULTS: There were 3 dropouts, and 188 wrists were included in the study. No side effects were reported. A total of 162 wrists (86.2%) showed successful treatment outcomes at 6 months after TCL release. Of the 26 wrists which had unsuccessful treatment outcomes, 6 received surgical treatment. The NRS scores at 3- and 6-month post-treatment were significantly reduced: the average NRS scores were 7.1 ± 0.6 at baseline, 1.9 ± 1.7 at 3 months after the treatment, and 1.7 ± 1.7 at 6 months after the treatment. LIMITATIONS: We conducted our study without a control or a placebo group. CONCLUSION: We believe that US-guided partial release of the TCL using a needle can be an effective and safe technique for treating chronic refractory pain due to CTS. It can potentially be attempted before surgical treatment.

Comparison between ultrasound-guided monopolar and bipolar pulsed radiofrequency treatment for refractory chronic cervical radicular pain: A randomized trial.

BACKGROUND: Many patients complain of chronic cervical radicular pain, and pulsed radiofrequency (PRF) is known to have a positive effect for alleviating neuropathic pain. OBJECTIVES: In the present study, we used ultrasound (US) guidance and compared the effects of monopolar PRF with those of bipolar PRF in patients with chronic cervical radicular pain refractory to repeated transforaminal epidural steroid injections. METHODS: Sixty-six patients with chronic cervical radicular pain were included in this study. Patients were randomly assigned to one of the two groups: monopolar or bipolar PRF group (n= 33 per group). Pain intensity was evaluated using a numeric rating scale (NRS) at pretreatment, and at 1 and 3 months after the treatment. Target stimulation site was the extraforaminal nerve root. RESULTS: Compared to the pretreatment NRS scores, patients in both groups showed a significant decrease in NRS scores at 1 and 3 months after the treatment. Reductions in the NRS scores over time were significantly larger in the bipolar PRF group. Three months after the treatment, 18 patients (54.5%) in the monopolar PRF group and 27 (81.8%) in the bipolar PRF group reported successful pain relief (pain relief of ⩾50%). CONCLUSIONS: US-guided PRF can be an effective interventional technique for the management of chronic refractory cervical radiculopathy. Moreover, bipolar PRF has better treatment outcome than monopolar PRF.

The effects of inclusion of minimal-dose corticosteroid in autologous whole blood and dextrose injection for the treatment of lateral epicondylitis.

BACKGOUND: Lateral epicondylitis (LE) is one of the most common musculoskeletal disorders that causes pain. OBJECTIVES: We evaluated the effect of the inclusion of a minimal dose of corticosteroid in a solution comprising autologous whole blood (AWB), 20% dextrose, and 2% lidocaine for treating LE. METHODS: In this randomized prospective trial LE patients were allocated to the CS+ group (n= 70; solution comprising 1 mL AWB, 1 mL 20% dextrose, 0.4 mL 2% lidocaine, and 0.1 mL (0.4 mg) dexamethasone palmitate; injected into the common wrist extensor tendon) or the CS- group (n= 70; same solution as above but without dexamethasone palmitate). Five injections were administered at monthly intervals. At each visit, pain intensity was evaluated using the numeric rating scale (NRS), and grip strength was measured using a hand-grip dynamometer. RESULTS: In the CS+ and CS- groups, 1 and 10 patients dropped out, respectively. In both groups, the NRS scores at each evaluation were significantly lower than the pretreatment scores. The NRS scores from pretreatment to the second and third visits were significantly lower in the CS+ group than those in the CS- group. However, at the fourth and fifth visits, and 6 months after the last injection (the sixth visit), the degree of pain reduction between the groups was not significantly different. Grip strength increased significantly over time in both groups. At each evaluation, grip strength was significantly higher than that at the pretreatment stage. However, the degree of increase was not significantly different between groups. CONCLUSIONS: The inclusion of a minimal dose of corticosteroid in the AWB and 20% dextrose injection can reduce pain, especially during early treatment.

The Effectiveness of Facet Joint Injection with Steroid and Botulinum Toxin in Severe Lumbar Central Spinal Stenosis: A Randomized Controlled Trial.

Lumbar central spinal stenosis (LCSS) is a common disorder that causes disability and pain in the elderly. It causes pain in the radicular leg. Recently, transforaminal epidural steroid injection (TFESI) has been widely used to control radicular leg pain caused by LCSS. However, in cases of severe LCSS, drugs injected using TFESI cannot spread into the spinal canal and would have less therapeutic effects than in mild LCSS. To compensate for this limitation of TFESI, we injected steroids and botulinum toxin type A into the bilateral facet joints, evaluated their effects, and compared them with those of TFESI. One hundred patients with severe LCSS were included in the study and randomly allocated to either the facet injection (FI) or TFESI group. For 50 patients in the FI group, 30 mg (40 mg/mL) of triamcinolone with 50 IU of botulinum toxin type A mixed with a 1 mL solution of 100 mL of 50% dextrose water and 30 mL of 4% lidocaine were administered into the bilateral facet joints under fluoroscopy. For 50 patients in the TFESI group, 30 mg (40 mg/mL) of triamcinolone with 0.8 mL of 2% lidocaine and 2.5 mL of 50% dextrose water was injected bilaterally under fluoroscopy. Radicular leg pain (measured with a numeric rating scale) and pain-related disability (measured with the modified Oswestry Disability Index) due to severe LCSS were significantly reduced after facet joint injection. The therapeutic effects were greater after facet joint injection than after bilateral TFESI. The injection of a mixed solution of steroids and botulinum toxin type A into the bilateral facet joints would be a beneficial therapeutic option in patients with severe LCSS.

Effectiveness of new nerve blocks method on the articular branches of the suprascapular and subscapular nerves to treat shoulder pain.

To evaluate the effectiveness and safety of performing nerve blocks on the articular branches of the suprascapular and subscapular nerves for the treatment of shoulder pain caused by various pathologies.Fifty-two patients with shoulder pain were included in this study. Suprascapular and subscapular nerve blocks were performed with 2.5 mL anesthetic solution (2 mL of 0.5% bupivacaine and 0.5 mL of 2 mg/mL dexamethasone). The subjects were evaluated before the procedure and 1, 3, and 6 months afterward by means of the numeric rating scale and the shoulder pain and disability index. A post-injection pain reduction of >50% and <50% was considered a positive and negative response to the blocks, respectively.After nerve blocks, the mean numeric rating scale and shoulder pain and disability index scores were significantly reduced from pre-injection values, and this effect persisted for 6 months after injection. The positive and negative response groups consisted of 31 (60%) and 21 (40%) patients, respectively. The positive response group showed significantly better outcomes on the numeric rating scale and shoulder pain and disability index compared with the negative response group. No patients reported adverse effects either during or after the procedure.Performing nerve blocks on the articular branches of the suprascapular and subscapular nerves resulted in positive outcomes for shoulder pain patients. Regardless of shoulder pathology, this new injection method can be safely used in shoulder pain patients.

Prediction of Coronary Artery Calcium Score Using Machine Learning in a Healthy Population.

BACKGROUND: Coronary artery calcium score (CACS) is a reliable predictor for future cardiovascular disease risk. Although deep learning studies using computed tomography (CT) images to predict CACS have been reported, no study has assessed the feasibility of machine learning (ML) algorithms to predict the CACS using clinical variables in a healthy general population. Therefore, we aimed to assess whether ML algorithms other than binary logistic regression (BLR) could predict high CACS in a healthy population with general health examination data. METHODS: This retrospective observational study included participants who had regular health screening including coronary CT angiography. High CACS was defined by the Agatston score ≥ 100. Univariable and multivariable BLR was performed to assess predictors for high CACS in the entire dataset. When performing ML prediction for high CACS, the dataset was randomly divided into a training and test dataset with a 7:3 ratio. BLR, catboost, and xgboost algorithms with 5-fold cross-validation and grid search technique were used to find the best performing classifier. Performance comparison of each ML algorithm was evaluated with the area under the receiver operating characteristic (AUROC) curve. RESULTS: A total of 2133 participants were included in the final analysis. Mean age and proportion of male sex were 55.4 ± 11.3 years and 1483 (69.5%), respectively. In multivariable BLR analysis, age (odds ratio [OR], 1.12; 95% confidence interval [CI], 1.10-1.15, p < 0.001), male sex (OR, 2.91; 95% CI, 1.57-5.38, p < 0.001), systolic blood pressure (OR, 1.02; 95% CI, 1.00-1.03, p = 0.019), and low-density lipoprotein cholesterol (OR, 1.00; 95% CI, 0.99-1.00, p = 0.047) were significant predictors for high CACS. Performance in predicting high CACS of xgboost was AUROC of 0.823, followed by catboost (0.750) and BLR (0.585). The comparison of AUROC between xgboost and BLR was significant (p for AUROC comparison < 0.001). CONCLUSIONS: Xgboost ML algorithm was found to be a more reliable predictor of CACS in healthy participants compared to the BLR algorithm. ML algorithms may be useful for predicting CACS with only laboratory data in healthy participants.

Effectiveness of Ultrasound-Guided Pulsed Radiofrequency Treatment in Patients with Refractory Chronic Cervical Radicular Pain.

BACKGROUND: The effect of pulsed radiofrequency (PRF) stimulation for alleviating cervical radicular pain has been demonstrated in several previous studies. OBJECTIVES: We aimed to evaluate the effectiveness of PRF with ultrasound (US) guidance in patients with chronic cervical radicular pain that was refractory to repeated transforaminal epidural steroid injections (TFESIs). STUDY DESIGN: A prospective outcome study. SETTING: The outpatient clinic of a single academic medical center. METHODS: This study included 49 patients with chronic cervical radicular pain, unresponsive to repeated TFESIs, and who underwent PRF stimulation under US guidance. Using US, a cannula was inserted toward the cervical spinal nerve. The pain intensity was evaluated using the Numeric Rating Scale (NRS-11) for cervical radicular pain at pretreatment and 1, 3, and 6 months posttreatment; and the Neck Disability Index (NDI) was used for evaluating functional disability before treatment and 6 months posttreatment. Successful pain relief was defined as >= 50% reduction in the NRS-11 score as compared with the score before treatment. RESULTS: Cervical radicular pain was significantly reduced at 1, 3, and 6 months post-PRF (P < 0.001). At 6 months post-PRF, functional disability (NDI score) had significantly reduced, and 63.3% of the patients achieved successful pain relief. LIMITATIONS: The small number of included patients and no long-term follow-up. CONCLUSIONS: PRF stimulation under the guidance of US is a potentially effective treatment method for managing refractory chronic cervical radicular pain. KEY WORDS: Ultrasound, pulsed radiofrequency, cervical radicular pain, chronic pain.

Randomized Comparison of Everolimus- and Zotarolimus-Eluting Coronary Stents With Biolimus-Eluting Stents in All-Comer Patients.

BACKGROUND: There is limited data comparing the Xience everolimus-eluting stent (EES) and the Resolute zotarolimus-eluting stent (ZES) with the BioMatrix biolimus-eluting stent (BES). METHODS: This open-label, randomized, noninferiority trial enrolled all-comer patients to be randomly treated with either BES, EES, or ZES in a 1:1:1 ratio in 15 centers across South Korea. The primary end point was a device-oriented composite outcome consisting of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization at 24 months. The BES was compared with the EES and the ZES by intention-to-treat analyses with a noninferiority margin of 3.8%, respectively. RESULTS: Because of slow recruitment and low event rates, this trial was prematurely terminated after enrollment of 1935 (75%) of the intended 2580 patients. Of the 1911 patients randomized to either EES (n=638), BES (n=634), or ZES (n =639), the rate of device-oriented composite outcome was 3.6%, 2.2%, and 3.9%, respectively, at 24 months (BES versus EES: absolute risk difference -1.4% [upper limit of 1-sided 95% CI: -3.2%]; Pfor noninferiority <0.001; BES versus ZES: absolute risk difference -1.7% [upper limit of 1-sided 95% CI: -3.6%]; Pfor noninferiority <0.001). CONCLUSIONS: The BES was noninferior to either the EES or the ZES in all-comer patients for device-oriented composite outcome at the 24-month follow-up. However, caution is advised regarding interpretation of these results due to the premature termination of this study. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01397175.

Effect of inter-arm blood pressure differences on outcomes after percutaneous coronary intervention.

BACKGROUND: We investigated the effect of inter-arm blood pressure differences (IABPD) on the percutaneous coronary intervention (PCI) outcomes of patients with coronary artery diseases. METHODS: We retrospectively reviewed the data of blood pressures measured simultaneously in the bilateral arms of 855 patients (560 males) who underwent PCI with drug-eluting stents for coronary artery diseases. IABPD was defined as the difference of blood pressure in both arms. The primary outcome was the presence of major adverse cardiac events (MACE) consisting of cardiovascular death, myocardial infarction, stroke, and ischemia-driven target vessel revascularization. RESULTS: The mean age of the included patients was 66.2 ± 11.6 years, with a mean follow-up period of 44.5 ± 26.4 months. MACE occurred in 15.2% of patients, showing a higher rate in the higher IABPD group (≥10 mmHg) than in the lower IABPD group (<10 mmHg) (22.5% vs 14.5%, p = 0.081). The difference was induced by a higher rate of ischemia-driven target vessel revascularization (17.5% vs 8.3%, p = 0.011). The Kaplan-Meier survival analysis revealed a greater incidence of MACE in patients with a higher IABPD (log rank p = 0.054). The Cox proportional hazard analysis showed that IABPD was an independent predictor of long-term MACE (hazard ratio, 1.028; 95% confidence interval, 1.002-1.055; p = 0.037), along with age, diabetes mellitus, and number of implanted stents. CONCLUSION: Among patients treated with PCI, the incidence of MACE was significantly higher in those with a higher IABPD (≥10 mmHg) than in those with a lower IABPD (<10 mmHg), which was mainly driven by ischemia-driven target vessel revascularization.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice.

BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent. METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up. RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects. CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.

The Effect of Botulinum Toxin Injection into the Common Extensor Tendon in Patients with Chronic Lateral Epicondylitis: A Randomized Trial.

BACKGROUND: Botulinum toxin (BTX) is widely used for pain control in various musculoskeletal disorders. OBJECTIVES: We evaluated the analgesic effect of botulinum toxin type A (BTX-A) in chronic lateral epicondylitis and compared the effect between 10 and 50 IU of BTX-A. METHODS: Sixty subjects with chronic lateral epicondylitis were included and underwent a BTX-A injection in the common extensor tendon. The subjects were randomly allocated into two groups: the small-dose group (SD group; 30 subjects, 10 IU) and large-dose group (LD group; 30 subjects, 50 IU). Treatment outcomes were evaluated by measuring the pain level using the numeric rating scale (NRS) and measuring grip strength before and one, two, three, four, five, and six months after treatment. RESULTS: Subjects in both groups showed a significant decrease in NRS scores at all evaluation time points after treatment. The reduction in NRS scores was significantly greater in the LD group at one, two, three, and four months after treatment. Six months after treatment, 19 subjects (63.3%) in the SD group and 21 (70%) in the LD group reported successful pain relief (pain relief ≥50%). The rate of successful pain relief was not significantly different between the two groups. Grip strength was more increased in the LD group at one, two, three, four, and six months after treatment. CONCLUSIONS: BTX-A injection into the common extensor tendon can be a good treatment option for chronic lateral epicondylitis. The 50-IU BTX-A injection achieved a better outcome than the 10-IU injection.

A MULTICENTRE SURVEY OF LOCAL DIAGNOSTIC REFERENCE LEVELS AND ACHIEVABLE DOSE FOR CORONARY ANGIOGRAPHY AND PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION PROCEDURES IN KOREA.

Interventional cardiology procedures can involve relatively high radiation doses compared to general radiography. During coronary angiography (CAG) and percutaneous transluminal coronary intervention (PCI), the same area is exposed to radiation for a long period. In this study, radiation exposure data of 1071 examinations in Korean hospitals were collected, and the achievable dose (AD) and diagnostic reference levels (DRLs) in actual medical practice for two types of interventional cardiology procedures in Korea were established. In CAG, 75th percentile DRLs and AD of the total kerma-area product were 47.0 and 33.1 Gy·cm 2, respectively. In PCI, those values were 171.3 and 102.6 Gy·cm2, respectively. This is the first study to introduce the DRLs for cardiovascular interventional procedures in Korea. These results will help optimise the interventional cardiology procedures for Korean cardiac centres.

PI3K-Akt-Wnt Pathway Is Implicated in Exercise-Induced Improvement of Short-term Memory in Cerebral Palsy Rats.

PURPOSE: Maternal lipopolysaccharide (LPS) injection induces neurodevelopmental disorders, such as cerebral palsy. Exercise activates phosphatidylinositol 3-kinase (PI3K)-protein kinase B (Akt) signaling pathway that enhances neurogenesis. Wnt ligands are also implicated in the hippocampal neurogenesis and synaptic plasticity. Glycogen synthase kinase-3ß (GSK-3ß) is a downstream molecule of Akt, and GSK-3ß is known to modulate hippocampal neurogenesis negatively. METHODS: Cerebral palsy was made by maternal LPS-injection. On the 5 weeks after birth, treadmill running was applied to the rat pups of the exercise groups, for 30 minutes, 5 times a week during 6 weeks. RESULTS: Treadmill running alleviated short-term memory impairments of the cerebral palsy rat pups. Hippocampal cell proliferation was increased and hippocampal apoptosis was suppressed by treadmill running in the cerebral palsy rat pups. Hippocampal phosphorylated-PI3K/PI3K ratio, phosphorylated-Akt/Akt ratio, and Wnt expression were enhanced by treadmill running in the cerebral palsy rat pups. In contrast, hippocampal phosphorylated-GSK-3ß/GSK-3ß ratio and ß-catenin expression were suppressed by treadmill running in the cerebral palsy rat pups. CONCLUSION: The results of this study showed that short-term memory improvement due to treadmill running in cerebral palsy occurs via activation of the PI3K-Akt-Wnt pathway.