Long-Term Clinical Outcomes After Filter Protection During Percutaneous Coronary Intervention in Patients With Attenuated Plaque - 1-Year Follow up of the VAMPIRE 3 (Vacuum Aspiration Thrombus Reemoval 3) Trial.

Background: Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.

Methods and results: Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial.

Prognostic impact of nutritional status and physical capacity in elderly patients with acute decompensated heart failure.

Aims: Nutritional status as well as physical capacity is related to prognosis in patients with heart failure. The purpose of this study was to explore a simple prognostic indicator in patients with acute decompensated heart failure (ADHF) by including both nutritional status and physical capacity.

Methods And Results: Patients hospitalized with ADHF (N = 203; mean age, 81 years) were enrolled.

Diagnostic performance of coronary angiography utilizing intraprocedural 320-row computed tomography with minimal contrast medium.

Recently developed coronary angiography with intraprocedural 320-row computed tomography can be performed in a catheterization laboratory (XACT) by injecting contrast medium from a place close to the coronary arteries, thereby requiring a minimal amount of contrast medium. However, its clinical application has not yet been established. This study aimed to evaluate the diagnostic accuracy of XACT angiography with a minimal volume of contrast medium in patients with suspected coronary artery disease (CAD).

Impact of Residual Stenosis on the Angiographic Edge Restenosis of a Second-Generation Drug-Eluting Stent.

Edge restenosis has gained attention as a main cause of restenosis after first-generation drug-eluting stent (DES) implantation. The aim of this study was to assess the incidence of edge restenosis and identify the predictors of edge restenosis after second-generation DES implantation. Data were obtained from several postmarketing surveillance (PMS) studies on a cobalt-chromium everolimus-eluting stent (CoCr-EES; Xience V/PROMUS, Xience Prime, Xience Prime SV, and Xience Expedition SV), a second-generation DES, in Japan.

Relation of Chronic Total Occlusion to In-Hospital Mortality in the Patients With Sudden Cardiac Arrest Due to Acute Coronary Syndrome.

Although the presence of chronic total occlusion (CTO) has been associated with long-term mortality in the patients with ST-segment elevation myocardial infarction, the influence of having CTO on in-hospital mortality in sudden cardiac arrest (SCA)-acute coronary syndrome (ACS) patients has not been reported. Therefore, we examined the association between the presence of CTO and in-hospital mortality in those patients. Consecutive 106 SCA-ACS patients who received coronary angiography were retrospectively included.

A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound.

Objectives: The aim of this study was to evaluate the utility of distal protection during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes at high risk for distal embolization.

Background: The results of previous clinical trials indicated that the routine use of distal protection in patients with ST-segment elevation myocardial infarction did not improve clinical outcomes. However, selective use of distal protection by means of a filter-based distal protection system has not been evaluated.

Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan.

The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years.

Satisfactory arterial repair 1 year after ultrathin strut biodegradable polymer sirolimus-eluting stent implantation: an angioscopic observation.

The ultrathin strut biodegradable polymer sirolimus-eluting stent (Orsiro, O-SES) exhibits satisfactory clinical outcomes. However, no report to date has documented the intravascular status of artery repair after O-SES implantation. We examined 5 O-SES placed in 4 patients (age 65 ± 12 years, male 75%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries.

The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results of a XIENCE V/PROMUS post-marketing surveillance study.

Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography.

Ideal Guiding Catheter Position During Bilaterally Engaged Percutaneous Coronary Intervention.

Using a novel combined angiography computed tomography (CT) system, we evaluated the impact of the intra-aortic root position of a right coronary artery (RCA) catheter on its coaxiality. We retrospectively enrolled 19 patients who underwent CT scans during bilaterally engaged percutaneous coronary intervention. Coaxiality was defined as the angle between the RCA and the RCA catheter.

Comparison of early-phase arterial repair following cobalt-chrome everolimus-eluting stent and slow-release zotarolimus-eluting stent: an angioscopic study.

Whether arterial repair following implantation of drug-eluting stents (DES) of the second generation differs among stent types remains unknown. We examined 41 DES placed in 28 patients (age 72 ± 7 years, male 89%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed 4 ± 1 months after stent implantation.

Efficient distal tip size of primary guidewire for antegrade percutaneous coronary intervention in chronic total occlusion: The G-FORCE study.

Background: Although several new techniques have been introduced for CTO such as the retrograde approach, the fundamental question of what type of guidewire is the most appropriate as a primary guidewire in the antegrade approach has not been answered.

Methods: The G-FORCE study was designed as a prospective multicenter randomized controlled trial to determine the efficient primary guidewire in antegrade approach for chronic total occlusion (CTO). The first guidewire was randomly assigned to a regular size distal tip group (0.

Effect of Optimal Medical Therapy Before Procedures on Outcomes in Coronary Patients Treated With Drug-Eluting Stents.

It has not been established whether the achievement of optimal medical therapy (OMT) before implantation of a drug-eluting stent has a clinical benefit for patients with stable coronary artery disease (CAD). This study included 3,004 patients with CAD treated with drug-eluting stent from 123 Japanese participating centers. The achievement of OMT was defined as control of blood pressure <130/80 mm Hg, hemoglobin A1c <7.

Three-year follow-up outcomes of SES and PES in a randomized controlled study stratified by the presence of diabetes mellitus: J-DEsSERT trial.

Background: Three-year clinical follow-up of patients with diabetes mellitus (DM) in the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT) using 2 different drug eluting stents (DES). A recent study demonstrated that efficacy of sirolimus eluting stents (SES) attenuated over time in diabetic patients.

Methods: In the largest trial of its kind, 1724 DM patients out of 3533 enrolled patients were randomized to either SES or paclitaxel eluting stents (PES).

Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan.

Background: The Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) Post-marketing Surveillance (PMS) is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan.

Methods and results: We enrolled 2,010 consecutive patients (2,649 lesions) who underwent PCI using CoCr-EES. Clinical outcomes were evaluated for up to 3 years.

Reproducibility and clinical potential of myocardial mass at risk calculated by a novel software utilizing cardiac computed tomography information.

To select the best revascularization strategy a correct understanding of the ischemic territory and the coronary anatomy is crucial. Stress myocardial perfusion single photon emission computed tomography (SPECT) is the gold standard to assess ischemia, however, SPECT has important limitations such as lack of coronary anatomical information or false negative results due to balanced ischemia in multi-vessel disease. Angiographic scores are based on anatomical characteristics of coronary arteries but they lack information on the extent of jeopardized myocardium.

Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial.

Background: There is a paucity of data reporting the clinical outcomes of biodegradable polymer biolimus-eluting stent (BP-BES) compared with durable polymer everolimus-eluting stent (DP-EES) beyond 1 year after stent implantation when the polymer is fully degraded.

Methods And Results: The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT) is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BP-BES with DP-EES in patients scheduled for percutaneous coronary intervention using drug-eluting stent (DES) without any exclusion criteria among 98 participating centers in Japan. The trial was designed to evaluate noninferiority of BP-BES relative to DP-EES in terms of any target-lesion revascularization at 1 year and death or myocardial infarction at 3 years.

Extensive arterial repair one year after paclitaxel-coated nitinol drug-eluting stent vs. bare-metal stent implantation in the superficial femoral artery.

Arterial repair differences between paclitaxel-coated nitinol drug-eluting stent (DES) vs. bare-metal stent (BMS) up to 1 year after implantation in the superficial femoral artery (SFA) have not been well characterized. We compared angioscopic findings 1 year after implantation in the SFA of 22 DES in 18 patients and 12 BMS in 9 patients (follow-up period 354 ± 49 vs.

Outcomes of the largest multi-center trial stratified by the presence of diabetes mellitus comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT).

The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT) was conducted to compare the effectiveness of 2 different drug-eluting stents (DES). It remains uncertain which is more efficacious in diabetic patients, sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). In this trial, the largest of its kind, 3,533 patients including 1,724 diabetes mellitus (DM) patients were randomized to either SES or PES.

Angioscopic assessment of peri-stent contrast staining following drug-eluting stent implantation.

Background: Peri-stent contrast staining (PSS) has been recognized as a predictor of late stent thrombosis following drug-eluting stent (DES) implantation. However, the intravascular conditions at PSS sites remain unclear.

Methods And Results: We evaluated 10 patients (median age 72 years, 80% male) with stable angina pectoris by coronary angioscopy.

Angioscopically apparent large thrombus and uncovered stent struts 6 months after late stent thrombosis of a paclitaxel-coated nitinol drug-eluting stent implanted in the superficial femoral artery.

A 74-year-old woman complained of claudication due to in-stent restenosis of bare-metal stents in the right superficial femoral artery, and two Zilver PTXs were deployed. However, hemarthrosis developed, and aspirin and clopidogrel were discontinued. Thirty-six days later, she suddenly felt rest pain in her right leg.

Integrity of stent polymer layer after drug-eluting stent implantation: in vivo comparison of sirolimus-, paclitaxel-, zotarolimus- and everolimus-eluting stents.

Few data exist with regard to the polymer integrity of drug-eluting stents (DES) in vivo. This study aims to investigate the integrity of the polymer layer of 4 polymer-coated DES in vivo. We assessed the morphology of the polymer layer of sirolimus-eluting stent (SES; Cypher Select™), paclitaxel-eluting stent (PES; Taxus Liberté™), zotarolimus-eluting stent (ZES; Endeavour RX™) and everolimus-eluting stent (EES; Xience V™) by scanning electron microscopy after balloon expansion at nominal and high pressures in the coronary arteries of 3 pigs.

Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial.

Objectives: NEXT (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial) was designed for evaluating the noninferiority of a biolimus-eluting stent (BES) relative to an everolimus-eluting stent (EES) in terms of target lesion revascularization (TLR) at 1 year.

Background: Efficacy and safety data comparing biodegradable polymer BES with durable polymer cobalt-chromium EES are currently limited.

Methods: The NEXT trial is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BES with EES.