Distal Radial Access for Coronary Procedures in a Large Prospective Multicenter Registry: The KODRA Trial.

BACKGROUND: Distal radial access (DRA) as an alternative access route lacks evidence, despite its recent reputation. OBJECTIVES: The aim of this study was to evaluate the safety and feasibility of DRA on the basis of daily practice. METHODS: The KODRA (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach) trial was a prospective multicenter registry conducted at 14 hospitals between September 2019 and September 2021. The primary endpoints were the success rates of coronary angiography (CAG) and percutaneous coronary intervention (PCI). The secondary endpoints included successful distal radial artery puncture, access-site crossover, access site-related complications, bleeding events, and predictors of puncture failure. RESULTS: A total of 4,977 among 5,712 screened patients were recruited after the exclusion of 735 patients. The primary endpoints, the success rates of CAG and PCI via DRA, were 100% and 98.8%, respectively, among successful punctures of the distal radial artery (94.4%). Access-site crossover occurred in 333 patients (6.7%). The rates of distal radial artery occlusion and radial artery occlusion by palpation were 0.8% (36 of 4,340) and 0.8% (33 of 4,340) at 1-month follow-up. DRA-related bleeding events were observed in 3.3% of patients, without serious hematoma. Multilevel logistic regression analysis identified weak pulse (OR: 9.994; 95% CI: 7.252-13.774) and DRA experience <100 cases (OR: 2.187; 95% CI: 1.383-3.456) as predictors of puncture failure. CONCLUSIONS: In this large-scale prospective multicenter registry, DRA demonstrated high success rates of CAG and PCI, with a high rate of puncture success but low rates of distal radial artery occlusion, radial artery occlusion, bleeding events, and procedure-related complications. Weak pulse and DRA experience <100 cases were predictors of puncture failure. (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach [KODRA]; NCT04080700).

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).

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 Left Atrial Function after Device Closure and Surgical Closure in Adult Patients with Atrial Septal Defect.

BACKGROUND: Studies comparing left atrial (LA) function after surgical closure or percutaneous closure in patients with an atrial septal defect (ASD) are lacking. METHODS: Between 1 and 3 years after ASD treatment, we retrospectively analyzed the medical records and transthoracic echocardiographic images of patients who had been diagnosed with an ASD after 20 years of age and who had undergone surgical closure (ASD-S) or percutaneous device closure (ASD-D). We measured LA peak systolic, early diastolic, and late diastolic strain values using 2-dimensional (2D) speckle tracking echocardiography (STE) and calculated reservoir, conduit, and contraction strain. RESULTS: The reservoir strain value of the ASD-D groups was 25.2% ± 7.4%, which was lower compared to the control group (33.6% ± 5.5%) (p = 0.004). The LA conduit strain and the LA contraction values of the ASD-D group were also lower compared to the control group (-13.8% ± 5.8% vs. -20.4% ± 4.7%, p = 0.034; -11.3% ± 4.2% vs. -13.2% ± 2.5%, p = 0.037, respectively). The reservoir, conduit, and contraction strains of the ASD-S group were 27.8% ± 8.8%, -15.3% ± 6.4%, and -12.5% ± 5.8%, respectively, and were not different from those of the control group or the ASD-D group. CONCLUSIONS: The 2D STE is a suitable method for evaluating LA function after ASD closure. Our results demonstrate that 1 year after device closure, the LA reservoir, conduit and contraction function were reduced in ASD-D group compared to healthy controls, while there was no difference between the ASD-S and ASD-D groups.

The Relationship Between Coronary Calcification and the Natural History of Coronary Artery Disease.

OBJECTIVES: The aim of the current study was to explore the impact of plaque calcification in terms of absolute calcified plaque volume (CPV) and in the context of its percentage of the total plaque volume at a lesion and patient level on the progression of coronary artery disease. BACKGROUND: Coronary artery calcification is an established marker of risk of future cardiovascular events. Despite this, plaque calcification is also considered a marker of plaque stability, and it increases in response to medical therapy. METHODS: This analysis included 925 patients with 2,568 lesions from the PARADIGM (Progression of Atherosclerotic Plaque Determined by Computed Tomographic Angiography Imaging) registry, in which patients underwent clinically indicated serial coronary computed tomography angiography. Plaque calcification was examined by using CPV and percent CPV (PCPV), calculated as (CPV/plaque volume) × 100 at a per-plaque and per-patient level (summation of all individual plaques). RESULTS: CPV was strongly correlated with plaque volume (r = 0.780; p < 0.001) at baseline and with plaque progression (r = 0.297; p < 0.001); however, this association was reversed after accounting for plaque volume at baseline (r = -0.146; p < 0.001). In contrast, PCPV was an independent predictor of a reduction in plaque volume (r = -0.11; p < 0.001) in univariable and multivariable linear regression analyses. Patient-level analysis showed that high CPV was associated with incident major adverse cardiac events (hazard ratio: 3.01: 95% confidence interval: 1.58 to 5.72), whereas high PCPV was inversely associated with major adverse cardiac events (hazard ratio: 0.529; 95% confidence interval: 0.229 to 0.968) in multivariable analysis. CONCLUSIONS: Calcified plaque is a marker for risk of adverse events and disease progression due to its strong association with the total plaque burden. When considered as a percentage of the total plaque volume, increasing PCPV is a marker of plaque stability and reduced risk at both a lesion and patient level. (Progression of Atherosclerotic Plaque Determined by Computed Tomographic Angiography Imaging [PARADIGM]; NCT02803411).

Erratum: Diagnostic Performance of Intravascular Ultrasound-Derived Minimal Lumen Area to Predict Functionally Significant Non-Left Main Coronary Artery Disease: a Meta-Analysis.

[This corrects the article on p. 622 in vol. 46, PMID: 27721852.].

Local Atrial/Ventricular Ratio as an Adjuvant Marker for Catheter Ablation of Atrioventricular Accessory Pathways.

BACKGROUND AND OBJECTIVES: The earliest atrial (A)/ventricular (V) activation potential, or accessory pathway (AP) potential are commonly used as ablation targets for atrioventricular (AV) APs. However, these targets are sometimes ambiguous. SUBJECTS AND METHODS: We reviewed 119 catheter ablation cases in 112 patients diagnosed with orthodromic atrioventricular reentrant tachycardia (AVRT) or Wolff-Parkinson-White (WPW) syndrome. Local A/V amplitude potentials with the earliest activation or AP potential were measured shortly before achieving antegrade AP conduction block, ventriculoatrial block during right ventricle (RV) pacing, or AVRT termination with no AP conduction. RESULTS: APs were located in the left lateral (55.5%), left posterior (17.6%), left posteroseptal (10.1%), midseptal (1.7%), right posteroseptal (7.6%), right posterior (1.7%), and right lateral (5.9%) regions. The mean earliest activation time was 16.7±15.5 ms, mean A/V potential was 1.1±0.9/1.0±0.9 mV, and mean A/V ratio was 1.7±2.0. There was no statistically significant difference between the activation methods (antegrade vs. RV pacing vs. orthodromic AVRT) or AP locations (left vs. right atrium). However, when the local A/V ratio was divided into 3 groups (≤0.6, 1.0±0.3, and ≥1.4), the antegrade approach resulted in an A/V ratio greater than 1.0±0.3 (86.7%, p=0.007), and the orthodromic AVRT state resulted in a ratio of less than 1.0±0.3 (87.5%, p<0.001). CONCLUSION: The mean local A/V potential and ratio did not differ by activation method or AP location. However, a different A/V ratio based on activation method (≥1.0±0.3, antegrade approach; and ≤1.0±0.3, orthodromic AVRT state) could be a good adjuvant marker for targeting AV APs.

Combined Use of Neutrophil to Lymphocyte Ratio and C-Reactive Protein Level to Predict Clinical Outcomes in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND AND OBJECTIVES: Both neutrophil to lymphocyte ratio (NLR) and C-reactive protein (CRP) are biomarkers associated with poor prognosis of patients with acute myocardial infarction (AMI). However, the combined usefulness of NLR and CRP in predicting adverse outcomes has not been investigated. SUBJECTS AND METHODS: We analyzed 381 consecutive AMI patients who underwent percutaneous coronary intervention (PCI) from January 2012 to January 2014. The endpoints were all-cause mortality, recurrent myocardial infarction (MI), stent thrombosis, repeat revascularization, stroke, and major adverse cardiac and cerebrovascular events (MACCE) at 2-year follow-up. Included patients were divided into 4 groups according to the optimal cut-off values for NLR and CRP on receiver operating characteristic analysis predicting mortality. RESULTS: Patients with both high NLR (>6.30) and high CRP (>0.76) had significantly greater risk of all-cause death and MACCE at 24 months, with no significant increase in the risk of recurrent MI, stent thrombosis, or stroke compared with patients with either low NLR or low CRP, as well as those with low NLR and low CRP. Kaplan-Meier analysis revealed significantly lower survival in patients with high NLR-CRP. On Cox multivariate analysis, high NLR-CRP (hazard ratio 23.172, 95% confidence interval 6.575 to 81.671, p<0.001) was an independent predictor of all-cause death. CONCLUSION: Elevated levels of both NLR and CRP are associated with increased risk of long-term mortality in AMI patients who have undergone PCI.

Extension of catheter ablation and outcome for ventricular tachycardia or premature ventricular contractions from the right ventricular outflow tract.

Objective We aimed to determine whether the extension of ablation could influence the ablation outcome for ventricular tachycardia (VT)/premature ventricular contractions (PVCs) from the right ventricular outflow tract (RVOT). Methods and results The radiofrequency catheter ablation results of 33 VT/6 frequent PVCs from the RVOT were analysed. The ablation extension was divided into 3 categories from the final successful ablation point with the earliest activation: (I) focal ablation (15 cases); ablation at 1 or 2 points; (II) focal with extended ablation (12 cases); focal and surrounding area ablation (maximum ≤1 cm) after elimination of clinical VT/PVCs; and (III) broad ablation (12 cases); continued broad ablation (maximum >1 cm) after elimination of clinical VT/PVCs. Acute termination was defined as the complete elimination and non-inducibility of clinical VT/PVCs during the procedure. For the mean follow-up of 12.8 months, the recurrence rate was not significantly different among the groups (P = 0.49). The mean procedure time was longer in group II, but ablation times and complication rates were not different among the groups. When acute termination was achieved, the overall recurrence rate was 7.6%. However, when confirming absence of the clinical VT/PVCs using 24-hour Holter monitoring immediately after the procedure, the recurrence rate was 2.7%. Conclusions Ablation extension did not affect ablation outcome of VT/PVCs from the RVOT. Confirmation of absence of clinical VT/PVCs using 24-hour Holter monitoring immediately after the procedure could guarantee long-term success.

Comparison of the Antiplatelet Effects of Once and Twice Daily Low-Dose Ticagrelor and Clopidogrel After Percutaneous Coronary Intervention.

Although Asian people are believed to be more susceptible to bleeding on currently recommended dose of ticagrelor, there is limited evidence supporting low-dose ticagrelor. We prospectively randomized patients receiving dual antiplatelet therapy with aspirin and clopidogrel into 3 groups; aspirin plus clopidogrel 75 mg versus aspirin plus ticagrelor 90 mg once daily versus aspirin plus ticagrelor 45 mg twice daily. Platelet function assessments were conducted using VerifyNow P2Y12 assay at baseline and 28 days after randomization. No differences in baseline P2Y12 reaction unit (PRU) values were observed among the 3 groups. PRU values at the end of the treatment periods were significantly lower in low-dose ticagrelor (90 mg QD group, 98.6 ± 73.4 and 45 mg BID group, 65.5 ± 58.8) compared with clopidogrel (221.2 ± 50.1, both p <0.001). There was no significant difference in PRU values between 2 groups of low-dose ticagrelor (p = 0.208). The rates of high on-treatment platelet reactivity were significantly lower in low-dose ticagrelor compared with clopidogrel, whereas clopidogrel showed higher rate of optimal on-treatment platelet reactivity than ticagrelor 45 mg BID. However, similar rate of optimal on-treatment platelet reactivity was observed in clopidogrel and ticagrelor 90 mg QD. In conclusion, low-dose ticagrelor treatment, either with 90 mg QD or 45 mg BID, was associated with a more potent antiplatelet effect compared with clopidogrel treatment and once daily dose provided similar antiplatelet effect but favorable effect on optimal platelet inhibition compared with twice daily dose.

The Relationships between Body Mass Index and Left Ventricular Diastolic Function in a Structurally Normal Heart with Normal Ejection Fraction.

BACKGROUND: We conducted research to determine the effect of the weight on left ventricular (LV) diastolic function in Asians, who are at greater risk of cardiovascular events compared to individuals from Western countries with similar body mass indices (BMIs). METHODS: We studied 543 participants with structurally normal hearts and normal ejection fractions. Participants were classified as normal-weight (BMI < 23.0 kg/m2), overweight (BMI 23.0-27.4 kg/m2), or obese (BMI ≥ 27.5 kg/m2). Peak E velocity, peak A velocity, and E' velocity were measured and E/E' was calculated. RESULTS: Overweight participants had lower E than normal-weight participants (p = 0.001). E' velocities in overweight and obese participants were less than those in normal weight participants (both p < 0.001). The E/E' ratio in obese participants was higher compared to the value in normal-weight participants (p < 0.001) and overweight participants (p = 0.025). BMI was associated with E (R = -0.108), A (R = 0.123), E' (R = -0.229), and E/E' ratio (R = 0.138) (all p < 0.05). In multivariate analyses, BMI was independently associated with higher A, lower E', and higher E/E'. The risk of diastolic dysfunction was significantly higher among overweight [adjusted odds ratio: 2.088; 95% confidence interval (CI): 1.348-3.235; p = 0.001] and obese participants (adjusted odds ratio: 5.910; 95% CI: 2.871-12.162; p < 0.001) compared to normal-weight participants. CONCLUSION: Obesity and overweight independently predicted diastolic dysfunction. An optimal body weight lower than the universal cut-off is reasonable for preventing LV heart failure in Asians.

Combination Therapy of Rosuvastatin and Ezetimibe in Patients with High Cardiovascular Risk.

PURPOSE: The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk. METHODS: This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed. FINDINGS: The percentage change of LDL-C ranged from -45% to -56% (mean, -51%) in the monotherapy groups and from -58% to -63% (mean, -60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups. IMPLICATIONS: Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.

Diagnostic Performance of Intravascular Ultrasound-Derived Minimal Lumen Area to Predict Functionally Significant Non-Left Main Coronary Artery Disease: a Meta-Analysis.

BACKGROUND AND OBJECTIVES: Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention frequently results in unnecessary stenting due to the low positive predictive value of IVUS-derived minimal lumen area (MLA) for identification of functionally significant coronary stenosis. We appraised the diagnostic accuracy of IVUS-derived MLA compared with the fractional flow reserve (FFR) to assess intermediate coronary stenosis. SUBJECTS AND METHODS: We searched MEDLINE and Cochrane databases for studies using IVUS and FFR methods to establish the best MLA cut-off values to predict significant non-left main coronary artery stenosis. Summary estimates were obtained using a random-effects model. RESULTS: The 17 studies used in our analysis enrolled 3920 patients with 4267 lesions. The weighted overall mean MLA cut-off value was 2.58 mm2. The pooled MLA sensitivity that predicted functionally significant coronary stenosis was 0.75 (confidence interval [CI]: 0.72 to 0.77) and the specificity was 0.66 (CI: 0.64 to 0.68). The positive likelihood ratio (LR) was 2.33 (CI: 2.06 to 2.63) and LR (-) was 0.33 (CI: 0.26 to 0.42). The pooled diagnostic odds ratio (DOR) was 7.53 (CI: 5.26 to 10.76) and the area under the summary receiver operating characteristic curve for all the trials was 0.782 with a Q point of 0.720. Meta-regression analysis demonstrated that an FFR cut-off point of 0.75 was associated with a four times higher diagnostic accuracy compared to that of 0.80 (relative DOR: 3.92; 95% CI: 1.25 to 12.34). CONCLUSION: IVUS-derived MLA has limited diagnostic accuracy and needs careful interpretation to correlate with functionally significant non-left main coronary artery stenosis.

Initial Total Bilirubin and Clinical Outcome in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention With Drug-Eluting Stents.

BACKGROUND: Total bilirubin (TB) concentration is inversely associated with stable coronary artery disease, but there have been few studies on initial TB in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: A total of 1,111 consecutive patients with STEMI undergoing primary percutaneous coronary intervention (PCI) with drug-eluting stents (DES) were divided into a high TB group (n=295) and a low TB group (n=816) according to the optimal cut-off 0.79 mg/dl. The high TB group had a higher rate of in-hospital major adverse cardiac events (MACE), a composite of cardiac death, non-fatal MI, and definite/probable stent thrombosis (14.2% vs. 4.2%, P<0.001) and cardiac death (13.9% vs. 3.9%, P<0.001) compared with the low TB group. The 30-day MACE-free survival rate was also significantly different between the groups (P<0.001, log-rank test). On multivariate Cox regression, initial high TB was a significant predictor of in-hospital MACE (HR, 2.69; 95% CI: 1.67-4.34, P=0.010) and of cardiac death (HR 2.72, 95% CI: 1.67-4.44, P=0.012). Adding initial TB to TIMI risk score significantly improved prediction for in-hospital MACE according to net reclassification improvement (NRI=5.2%, P=0.040) and integrated discrimination improvement (IDI=0.027, P=0.006). CONCLUSIONS: Initial TB is a powerful prognostic marker, and inclusion of this can improve prediction of in-hospital MACE in patients with STEMI undergoing primary PCI with DES. (Circ J 2016; 80: 1437-1444).

Efficacy and Safety of DP-R202 in Patients with Chronic Artery Occlusive Disease: Multicenter Randomized Double-blind Active-controlled Parallel Group Phase III Clinical Study.

PURPOSE: Sarpogrelate hydrochloride, a selective 5-hydroxytryptamine 2A antagonist, is a widely used antiplatelet agent for the treatment of peripheral arterial disease (PAD). DP-R202 is a new sarpogrelate hydrochloride product with an improved dosage regimen compared with the agent in current use. The aim of this study was to compare the efficacy and safety profile of DP-R202 and Anplag(⁎) Tab in patients with PAD. METHODS: This study was a 12-week, multicenter, randomized, double-blinded, active-controlled, parallel group comparative Phase III clinical trial. One hundred fifty-one volunteer patients with PAD were randomized to receive DP-R202 300 mg once daily or Anplag Table 100 mg TID for 12 weeks. The primary end point was a change in patient assessment of lower leg pain intensity with the use of a visual analog scale (VAS) after 12 weeks of treatment. Results after 4, 8, and 12 weeks of treatment were compared with baseline and between treatment groups, and all patients were assessed for adverse events (AEs), clinical laboratory data, and vital signs. FINDINGS: Two hundred thirty-one patients from 25 medical centers were assessed, and 151 were enrolled and randomly assigned to 1 of 2 treatment groups. Seventy-five patients received DP-R202 300 mg once daily and 76 patients received Anplag Table 100 mg TID for 12 weeks. Analysis of the change in lower leg pain intensity as determined by VAS score between baseline and week 12 (mean [SD], 20.72 [20.06] mm vs 15.55 [21.44] mm) suggested that DP-R202 was not inferior to Anplag Tab, and no significant differences were found in the secondary end points. No significant between-group differences were observed in the prevalence of drug-related clinical- or laboratory-determined AEs. For tolerability, no specific issue was found during the treatment period. IMPLICATION: The results of this study suggest that DP-R202 was not inferior to Anplag Tab for efficacy in patients with PAD and indicated a good safety profile.

Impact of Carvedilol versus ß1-selective ß blockers (bisoprolol, metoprolol, and nebivolol) in patients with acute myocardial infarction undergoing percutaneous coronary intervention.

Although ß blocker (BB) has constituted one of the mainstays of evidence-based therapy for patients with acute myocardial infarction (AMI), the comparative efficacy of different BBs remains uncertain. We sought to determine the comparative effectiveness of nonselective BB carvedilol and the most frequently prescribed ß1-selective BBs (bisoprolol, metoprolol, and nebivolol) in patients with AMI undergoing percutaneous coronary intervention (PCI). A total of 7,863 patients were selected from the prospective national AMI registry, and patients were divided into carvedilol group (n = 6,231) and ß1-selective BB group (n = 1,632) at hospital discharge. The primary end point was all-cause death or MI during follow-up. During a mean follow-up of 243 ± 144 days, all-cause death or MI occurred in 94 patients (1.5%) in the carvedilol group versus 31 patients (1.9%) in the ß1-selective BB group (adjusted hazard ratio 0.81, 95% confidence interval 0.54 to 1.22, p = 0.32). This result was consistent across various risk subgroups. The risks of all-cause death, cardiac death, and MI were also similar between the groups. After propensity-score matching, no difference was observed in the rate of all-cause death or MI (1.7% in the carvedilol vs 1.9% in the ß1-selective BB group, adjusted hazard ratio 0.84, 95% confidence interval 0.49 to 1.46, p = 0.55). In conclusion, no differences in the risk of all-cause death or MI were observed between the carvedilol and ß1-selective BB groups in contemporary practice of the treatment for AMI.

Meta-analysis of multivessel versus culprit-only percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndrome and multivessel coronary disease.

Even in the era of contemporary drug-eluting stents, it is not clear whether percutaneous coronary intervention (PCI) for nonculprit lesions can improve long-term outcomes in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) with multivessel coronary disease. Relevant studies published through August 2014 were searched and identified in the electronic databases. Summary estimates were obtained using a random-effects model. From 368 initial citations, 8 observational studies with 8,425 patients (3,227 multivessel and 5,198 culprit-only PCI) were included. Mean follow-up duration was 18 months. There were no significant differences in all-cause mortality (odds ratios [ORs] 0.85, 95% confidence interval [CI] 0.70 to 1.04) and myocardial infarction (OR 0.86, 95% CI 0.55 to 1.35). However, multivessel PCI was associated with a significantly lower rate of repeat revascularization (OR 0.75, 95% CI 0.56 to 1.00). Comparison of multivessel versus culprit-only PCI disclosed OR for major adverse cardiac events of 0.74 (95% CI 0.57 to 0.97). In conclusion, multivessel PCI reduced repeat revascularization without significant benefits in terms of mortality or myocardial infarction at the long-term follow-up in patients with NSTE-ACS and multivessel coronary disease. Future randomized studies that examine the safety and efficacy of multivessel PCI in NSTE-ACS are warranted.

Preventive versus culprit-only percutaneous coronary intervention in ST-elevation myocardial infarction patients with multivessel disease: a meta-analysis.

BACKGROUND: Although previous studies have suggested clinical benefits of complete revascularization in patients with multivessel coronary artery disease, it is still controversial whether preventive percutaneous coronary intervention (PCI) leads to better clinical outcomes in the clinical setting of ST-segment elevation myocardial infarction (STEMI). METHODS: Relevant studies through September 2014 were searched and identified in the electronic databases.Primary endpoint was all-cause mortality at the longest follow-up. Secondary endpoints included myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE). RESULTS: From 836 initial citations, 7 randomized trials, and 23 observational studies with 44,256 patients (8,087 preventive and 36,169 culprit-only) were included in this study. Preventive PCI was associated with a significant reduction in repeat revascularization (odds ratios [OR]: 0.71; 95% CI: 0.51­0.99) with no differences in all-cause mortality (OR: 0.99; 95% CI: 0.76­1.29) or MI (OR: 1.08; 95% CI: 0.62­1.87) as compared with culprit-only PCI.Comparison of preventive PCI to the culprit-only PCI group revealed OR for MACE of 0.80 (95% CI: 0.57­1.12).Stratified analysis according to revascularization strategy demonstrated a significant survival benefit of culprit-only PCI over multivessel PCI during the index procedure and a significantly lower incidence of all-cause mortality with staged PCI as compared with culprit-only or multivessel PCI during the index procedure. CONCLUSIONS: Preventive PCI strategy appears to be effective in reducing the risk of repeat revascularization without significant benefits for mortality or MI when compared with culprit-only revascularization in STEMI patients with multivessel disease.

Randomized Comparison of the Platelet Inhibitory Efficacy between Low Dose Prasugrel and Standard Dose Clopidogrel in Patients Who Underwent Percutaneous Coronary Intervention.

BACKGROUND AND OBJECTIVES: Increased bleeding rates with standard dose prasugrel have led to increased questions about the effectiveness and safety of the lower maintenance dose. We compared platelet inhibitory efficacy between low dose prasugrel and standard dose clopidogrel in patients on maintenance dose dual antiplatelet therapy. SUBJECTS AND METHODS: Forty-three patients who underwent percutaneous coronary intervention were randomized to receive 75 mg clopidogrel (n=23) or 5 mg prasugrel (n=20). Another 20 patients were allocated to 10 mg prasugrel as a reference comparison group. All patients (weight, ≥60 kg; age, <75 years) had been receiving 100 mg aspirin and 75 mg clopidogrel daily. The platelet function test was performed at baseline and 30 days after randomization. The primary endpoint was P2Y12 reaction unit (PRU) at 30 days between 5 mg prasugrel and 75 mg clopidogrel. RESULTS: No differences in baseline PRU values were observed among the three groups. The prasugrel (5 mg) group had a significantly lower PRU value compared with that of 75 mg clopidogrel (174.6±60.2 vs. 223.4±72.9, p=0.022) group at 30 days, whereas the 10 mg prasugrel group showed a lower PRU value (71.9±34.4) compared with that of the 5 mg prasugrel (p<0.001). The rate of high on-treatment platelet reactivity (PRU >235) was significant lower in the 5 mg prasugrel group than that in the 75 mg clopidogrel group (15.0% vs. 56.5%, p=0.010). CONCLUSION: Prasugrel (5 mg) is more potent antiplatelet therapy than 75 mg clopidogrel in non-low body weight and non-elderly patients on a maintenance dose dual antiplatelet therapy.

Intravascular ultrasound-guided implantation of drug-eluting stents to improve outcome: a meta-analysis.

OBJECTIVES: The aim of this study was to systematically review and perform a meta-analysis of randomized trials and observational studies of intravascular ultrasound (IVUS)-guided versus angiography-guided implantation of drug-eluting stents (DES). BACKGROUND: Although studies in the bare-metal stents era suggested that there were clinical benefits to IVUS guidance, it is still controversial whether percutaneous coronary intervention (PCI) with DES guided by IVUS leads to better clinical outcomes. METHODS: Relevant studies published through March 31, 2013, were searched for and identified in the electronic databases. Summary estimates were obtained using a random-effects model. RESULTS: From 138 initial citations, 3 randomized trials and 12 observational studies with 24,849 patients (11,793 IVUS-guided and 13,056 angiography-guided) were included in this study. Comparison of IVUS- versus angiography-guided PCI disclosed odds ratios (ORs) for major adverse cardiac events of 0.79 (95% confidence interval [CI]: 0.69 to 0.91; p = 0.001). IVUS-guided PCI was also associated with significantly lower rates of all-cause mortality (OR: 0.64; 95% CI: 0.51 to 0.81; p < 0.001), myocardial infarction (OR: 0.57; 95% CI: 0.42 to 0.78; p < 0.001), target vessel revascularization (OR: 0.81; 95% CI: 0.68 to 0.95; p = 0.01), and stent thrombosis (OR: 0.59; 95% CI: 0.42 to 0.82; p = 0.002). A meta-analysis of propensity-matched studies demonstrated similar results in terms of clinical outcomes, but not repeat revascularization. CONCLUSIONS: IVUS-guided DES implantation is associated with significantly lower rates of adverse clinical events compared with angiography guidance. Further study is needed to clarify which subgroups of subjects with IVUS guidance will have greater benefit.