Katsumi Saito

Randomized pilot trial comparing tolvaptan with furosemide on renal and neurohumoral effects in acute heart failure

Loop diuretics are first‐line medications for congestive heart failure (CHF); however, they are associated with serious adverse effects, including decreased renal function, and sympathetic nervous and renin–angiotensin system activation. We tested whether tolvaptan, a vasopressin V2‐receptor antagonist, could reduce unfavourable furosemide‐induced effects during CHF treatment.

Low-density lipoprotein cholesterol targeting with pitavastatin + ezetimibe for patients with acute coronary syndrome and dyslipidaemia: the HIJ-PROPER study, a prospective, open-label, randomized trial

Abstract Aims To elucidate the effects of intensive LDL-C lowering treatment with a standard dose of statin and ezetimibe in patients with dyslipidaemia and high risk of coronary events, targeting LDL-C less than 70 mg/dL (1.8 mmol/L), compared with standard LDL-C lowering lipid monotherapy targeting less than 100 mg/dL (2.6 mmol/L). Methods and results The HIJ-PROPER study is a prospective, randomized, open-label trial to assess whether intensive LDL-C lowering with standard-dose pitavastatin plus ezetimibe reduces cardiovascular events more than standard LDL-C lowering with pitavastatin monotherapy in patients with acute coronary syndrome (ACS) and dyslipidaemia. Patients were randomized to intensive lowering (target LDL-C < 70 mg/dL [1.8 mmol/L]; pitavastatin plus ezetimibe) or standard lowering (target LDL-C 90 mg/dL to 100 mg/dL [2.3–2.6 mmol/L]; pitavastatin monotherapy). The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, and ischaemia-driven revascularization. Between January 2010 and April 2013, 1734 patients were enroled at 19 hospitals in Japan. Patients were followed for at least 36 months. Median follow-up was 3.86 years. Mean follow-up LDL-C was 65.1 mg/dL (1.68 mmol/L) for pitavastatin plus ezetimibe and 84.6 mg/dL (2.19 mmol/L) for pitavastatin monotherapy. LDL-C lowering with statin plus ezetimibe did not reduce primary endpoint occurrence in comparison with standard statin monotherapy (283/864, 32.8% vs. 316/857, 36.9%; HR 0.89, 95% CI 0.76–1.04, P = 0.152). In, ACS patients with higher cholesterol absorption, represented by elevated pre-treatment sitosterol, was associated with significantly lower incidence of the primary endpoint in the statin plus ezetimibe group (HR 0.71, 95% CI 0.56–0.91). Conclusion Although intensive lowering with standard pitavastatin plus ezetimibe showed no more cardiovascular benefit than standard pitavastatin monotherapy in ACS patients with dyslipidaemia, statin plus ezetimibe may be more effective than statin monotherapy in patients with higher cholesterol absorption; further confirmation is needed. Trial No UMIN000002742, registered as an International Standard Randomized Controlled Trial.

Antiischemic effect of intracoronary diltiazem on myocardial ischemia during PTCA

SummaryTo evaluate the effect of intracoronary diltiazem on myocardial ischemia during percutaneous transluminal coronary angioplasty (PTCA), 38 patients were randomly assigned to receive inactive placebo (n = 19; group C) or a low dose (1 mg,n = 10; group D1), or a high dose (2 or 3mg,n = 9; group D2) of diltiazem in a double-blind manner. The agent was administered directly into the coronary artery via a balloon catheter following a control balloon inflation. Chest pain score (maximum, 10) and the magnitude of ischemic ST elevation on standard and intracoronary electrocardiograms (ECGs) during a balloon inflation were assessed in the control and posttreatment periods. After the administration of diltiazem, the chest pain score was significantly decreased in group D1 (control: 5.1 ± 3.6, posttreatment: 3.8 ± 3.1,P < 0.01) and group D2 (3.4 ± 2.5 vs 2.5 ± 2.0,P < 0.01), but not in group C (4.1 ± 3.1 vs 3.7 ± 3.3, difference not significant). The magnitude of ST elevation relative to the control on standard and intracoronary ECGs was significantly smaller in groups D1 and D2 than in group C (standard ECG; D1: 51.8 ± 10.6% of control, D2: 41.6 ± 28.7% vs C: 93.3 ± 15.6% and intracoronary ECG; D1: 47.1 ± 11.7% of control, D2: 27.5 ± 26.9% vs C: 94.6 ± 29.3%, allP < 0.01). Although systolic blood pressure decreased slightly in groups D1 and D2, there was no significant correlation between the change in ST elevation and the change in the rate-pressure product. Pretreatment with a small dose of intracoronary diltiazem attenuated myocardial ischemia during PTCA and this pretreatment may enable us to perform balloon inflation for a longer period.

Efficacy of 24-Hour Blood Pressure Monitoring in Evaluating Response to Percutaneous Transluminal Renal Angioplasty

BACKGROUND Percutaneous transluminal renal angioplasty (PTRA) improves patency in atherosclerotic renal artery stenosis (ARAS), but improvement in clinic blood pressure (BP) is seen in only 20-40% of patients who undergo PTRA. This study investigated the effects of PTRA on BP lowering, assessed on 24-h ambulatory BP monitoring (ABPM), and identified preoperative features predictive of satisfactory BP improvement after PTRA. METHODSANDRESULTS Of 1,753 consecutive patients undergoing coronary angiography, 31 patients with angiographically significant ARAS and translesional pressure gradient (TLPG) >20 mmHg underwent PTRA. ABPM was performed before, at 1 month and at 1 year after PTRA; patients with average systolic ABPM-BP decrease >10 mmHg at 1 month from baseline were categorized as responders. There was no obvious relationship between clinic BP and ABPM-BP at baseline. ABPM-BP was significantly higher in responders at baseline (SBP: 148 vs. 126 mmHg, P<0.01) and was improved 1 month after PTRA. This difference persisted until 1 year after PTRA. Night-time BP improved more than daytime BP in responders. Patients with higher baseline ABPM-BP achieved a larger decrease in ABPM-BP, but the severity of stenosis reflected by TLPG; renal duplex findings; and neurohumoral parameters other than baseline renal function, did not differ between the groups. CONCLUSIONS Clinic BP does not represent daily hemodynamic status, whereas high ABPM-BP is a potent predictor of satisfactory BP response to PTRA. (Circ J 2016; 80: 1922-1930).

Correction to: Good response to tolvaptan shortens hospitalization in patients with congestive heart failure

In the original publication of the article, the values of blood urea nitrogen (BUN) and plasma renin activity (PRA) have been published incorrectly and the corrected values are as follows.

Pilot Cohort Study Assessing the Efficacy of Endovascular Revascularization in the Restoration of Peripheral Sensory Disturbance in Patients With Critical Limb Ischemia

BACKGROUND Sensory disturbance (SD) is a common consequence of peripheral nerve damage associated with diabetes and severe ischemia. Progression of SD places patients at high risk for lower extremity ulcers and amputations. SD has been thought to be progressive and irreversible, and possibly caused by microvascular dysfunction. The aim of this study was to determine whether endovascular revascularization (EVR) induces quantifiable changes in SD in chronic critical limb ischemia (CLI) patients with neuropathy.Methods and Results:In all, 36 legs from 28 chronic CLI patients who underwent elective EVR were prospectively enrolled in this study (64% with diabetes and 54% on maintenance hemodialysis). The current perception threshold (CPT), an established diagnostic parameter for SD, was measured before and 3 months after EVR. Of the target lesions, 11%, 47%, and 81% were in the aortoiliac, femoropopliteal, and below-the-knee arteries, respectively, and 58% were totally occluded. Overall CPT in the target foot had improved significantly 3 months after EVR (from 53 to 30 µA; P=0.010); however, EVR did not change CPT in the non-target foot (from 44 to 33 µA; P=0.33). Patients with improved SD after EVR had a significantly higher 180-day survival rate (94% vs. 63%; P=0.040). CONCLUSIONS EVR improved CPT in target limbs of patients with CLI, and may be a promising option to improve SD associated with peripheral ischemic sensory neuropathy.

Intimal disruption affects drug-eluting cobalt-chromium stent expansion: A randomized trial comparing scoring and conventional balloon predilation

BACKGROUND Stent expansion remains one of the most important predictors of restenosis and subacute thrombosis, even with the use of drug-eluting stents. This study was designed to clarify the impact of lesion preparation on final stent expansion. METHODS Sixty-six consecutive patients were included in this trial, and ultimately 52 enrolled non-calcified de novo lesions were randomly assigned to undergo single predilation with either a semi-compliant scoring balloon or a semi-compliant conventional balloon. Lesions were treated with a single 2.5- to 3.0-mm cobalt-chromium everolimus-eluting stent under optical coherence tomography (OCT) guidance without post-stenting dilation. Stent expansion was defined as the ratio of OCT-measured minimum stent area to the predicted stent area. RESULTS Stent expansion was significantly higher after predilation by a scoring balloon (68.0% vs. 62.1%, p=0.017) with similar stent lumen eccentricity (0.84 vs. 0.80, p=0.18). Intimal disruption was induced significantly more frequently (68.0% vs. 38.4%, p=0.035) and was more extensive in the scoring group (122° vs. 65°, p=0.038). Lesions with intimal disruption after predilation achieved significantly higher stent expansion than that without it (67.7% vs. 61.6%, p=0.023). One case in the conventional group required target lesion revascularization; however, any other adverse clinical events including death, myocardial infarction, and stent thrombosis were not observed up to 9months after PCI in both groups. CONCLUSIONS In this randomized study, pretreatment with a scoring balloon enhanced stent expansion partly through induction of intimal disruption. CLINICAL TRIAL REGISTRATION URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000014176.

THE EFFECTS OF PREDILATION WITH SCORING BALLOON COMPARED TO CONVENTIONAL BALLOON ON COBALT-CHROMIUM STENT EXPANSION ANALYZED WITH OPTICAL COHERENT TOMOGRAPHY

Stent expansion remains one of important predictors of restenosis and subacute thrombosis, even in use of drug-eluting stent. In addition, the bioresorbable vascular scaffold requires sufficient lesion preparation for their appropriate apposition. The aim of this study was to clarify the impact of

TCTAP A-106 Effects of Percutaneous Transluminal Renal Angioplasty on Blood Pressure Evaluated with 24-hour Monitoring

Percutaneous transluminal renal angioplasty (PTRA) improves patency in atherosclerotic renal artery stenosis (ARAS). However, OFFICE blood pressure (BP) improvement as primary purpose was achieved in only 20-40% of patients performed PTRA. The purpose of this study was to clarify the effects of PTRA