Prospective investigation of calcium score in optical coherence tomography-guided revascularization to identify lesions with low risk for stent under expansion: the CORAL study.

The optical coherence tomography (OCT)-based calcium scoring system was developed to guide optimal lesion preparation strategies for percutaneous coronary intervention (PCI) of calcified lesions. However, the score was derived retrospectively, and a prospective investigation is lacking. The CORAL (UMIN000053266) study was a single-arm, prospective, multicenter study that included patients with calcified lesions with OCT-calcium score of 1-2 to investigate whether these lesions could be optimally treated with a balloon-only preparation strategy using a non-compliant/scoring/cutting balloon.

One-year safety and effectiveness of the Agent paclitaxel-coated balloon for the treatment of small vessel disease and in-stent restenosis.

The Agent device consists of a semi-compliant balloon catheter, which is coated with a therapeutic low-dose formulation of paclitaxel (2 µg/mm) blended with an inactive excipient acetyl-tri-n-butyl citrate (ATBC). AGENT Japan SV is a randomized controlled study that enrolled 150 patients from 14 Japanese sites treated with Agent or SeQuent Please paclitaxel-coated balloon. This study also includes a single-arm substudy evaluating the safety and effectiveness of Agent in patients with in-stent restenosis (ISR).

Impact of COVID-19 pandemic on emergency medical system and management strategies in patients with acute coronary syndrome.

The global coronavirus disease-2019 (COVID-19) pandemic is associated with reduced rate of percutaneous coronary intervention (PCI). However, there were a few data showing how emergency medical system (EMS) and management strategies for acute coronary syndrome (ACS) changed during the pandemic. We sought to clarify changes on characteristics, treatments, and in-hospital mortality of patients with ACS transported via EMS between pre- and post-pandemic.

Drug-Coated Balloon for the Treatment of Small Vessel Coronary Artery Disease - A Randomized Non-Inferiority Trial.

Background: Drug-coated balloons (DCB) have shown promising results for the treatment of in-stent restenosis (ISR) and small vessel disease (SVD). However, data comparing the treatment efficacy of different DCBs are limited.

Methods and results: AGENT Japan is a prospective randomized controlled trial that compares the Agent balloon coated with a low-dose formulation of paclitaxel (2 μg/mm) to the SeQuent Please paclitaxel-coated balloon (3 μg/mm) for the treatment of SVD.

Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement - Japanese Disrupt CAD IV Study 1-Year Results.

Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance, and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification and demonstrated low 30-day major adverse cardiovascular events (MACE) and high procedural success following IVL with no final serious angiographic complications. To date, long-term outcomes have not been reported.

Revisiting the Aortic Valve Calcium Score in Evaluating the Severity of Aortic Stenosis in Japanese Patients - A Single-Center Study.

In patients with aortic stenosis (AS), measurement of aortic valve calcification (AVC) using computed tomography (CT) is recommended in cases where echocardiographic measurements are inconclusive. However, sex-specific AVC thresholds proposed in the guidelines for predicting severe AS (women: 1,200 arbitrary units [AU]; men: 2,000 AU) are based on studies from Western countries. We retrospectively included 512 Japanese patients with at least moderate AS who underwent transthoracic echocardiography and CT.

Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study.

Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance and optimize stent deployment. The objective of this study was to assess the safety and effectiveness of IVL treatment of de novo stenoses involving severely calcified coronary vessels in a Japanese population.

Methods and results: Disrupt CAD IV (NCT04151628) was a prospective, multicenter study designed for Japanese regulatory approval of coronary IVL (SWM-1234).

Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study.

Background: Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown.

Methods And Results: This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent.

Instantaneous Wave-Free Ratio for the Assessment of Intermediate Coronary Artery Stenosis in Patients With Severe Aortic Valve Stenosis: Comparison With Myocardial Perfusion Scintigraphy.

Objectives: This study investigated the diagnostic performance of instantaneous wave-free ratio (iFR) in patients with aortic valve stenosis (AS).

Background: The iFR was introduced as a new, nonpharmacologic stress index of coronary stenosis severity. However, the diagnostic performance of iFR has not been sufficiently explored in patients with severe AS.

Impact of sheath size and hemostasis time on radial artery patency after transradial coronary angiography and intervention in Japanese and non-Japanese patients: A substudy from RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) randomized multicenter trial.

Background: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients.

Methods And Results: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan).

Comparison of a new slender 6 Fr sheath with a standard 5 Fr sheath for transradial coronary angiography and intervention: RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT), a randomised multicentre trial.

Aims: The 6 Fr Glidesheath Slender (GSS6Fr) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6 Fr sheaths. The purpose of this trial was to clarify whether the use of this new slender sheath would result in similar rates of RAO to a standard 5 Fr sheath in unselected patients undergoing transradial (TR) coronary angiography and/or intervention, and to assess the relative importance of sheath size and haemostasis protocol on the rate of RAO.

Methods And Results: We conducted a randomised, multicentre, non-inferiority trial comparing the GSS6Fr against the standard GS5Fr in patients undergoing TR coronary angiography and/or intervention.

Comparison of frequency of radial artery occlusion after 4Fr versus 6Fr transradial coronary intervention (from the Novel Angioplasty USIng Coronary Accessor Trial).

The frequency of radial artery occlusion was compared between patients receiving 4Fr versus 6Fr transradial coronary interventions (TRIs) in an open-label randomized trial (ClinicalTrials.gov identifier: NCT00815997). The primary outcome measure was radial artery occlusion on the day after TRI.

Prediction of progression of coronary artery disease and clinical outcomes using vascular profiling of endothelial shear stress and arterial plaque characteristics: the PREDICTION Study.

Background: Atherosclerotic plaques progress in a highly individual manner. The purposes of the Prediction of Progression of Coronary Artery Disease and Clinical Outcome Using Vascular Profiling of Shear Stress and Wall Morphology (PREDICTION) Study were to determine the role of local hemodynamic and vascular characteristics in coronary plaque progression and to relate plaque changes to clinical events.

Methods And Results: Vascular profiling, using coronary angiography and intravascular ultrasound, was used to reconstruct each artery and calculate endothelial shear stress and plaque/remodeling characteristics in vivo.

Mother-and-child technique using 4-Fr inner catheter for stent delivery during provisional stenting.

Provisional stenting is the most common strategy in the treatment of bifurcated lesions. However, such a situation as the failure in additional stent deployment to the side branch through the stent strut is occasionally encountered. In this paper, we report on two cases, in which we managed to successfully cross an additional stent to the angulated side branch through the stent strut using the four-in-six system after failed attempts using conventional techniques.

Estimation with Tc-99m tetrofosmin SPECT of salvaged myocardial mass after emergent reperfusion therapy in acute myocardial infarction.

Objectives: The purpose of this study was to validate a new quantitative index of salvaged myocardial mass calculated from Tc-99m tetrofosmin SPECT for evaluating the therapeutic effect of emergent reperfusion therapy in acute myocardial infarction (AMI).

Methods: Tc-99m tetrofosmin SPECT was performed before and after emergent percutaneous transluminal coronary angioplasty (PTCA) in eight patients with AMI. In the pre-PTCA study, Tc-99m tetrofosmin was injected before emergent PTCA.