Nobuhiko Ogata

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. Between May and October 2011, 3,235 patients were randomly assigned to receive either BES (n = 1,617) or EES (n = 1,618). RESULTS At 1 year, the primary efficacy endpoint of TLR occurred in 67 patients (4.2%) in the BES group, and in 66 patients (4.2%) in the EES group, demonstrating noninferiority of BES relative to EES (p for noninferiority <0.0001, and p for superiority = 0.93). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.25% vs. 0.06%, p = 0.18). An angiographic substudy enrolling 528 patients (BES: n = 263, and EES: n = 265) demonstrated noninferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03 ± 0.39 mm vs. 0.06 ± 0.45 mm, p for noninferiority <0.0001, and p for superiority = 0.52) at 266 ± 43 days after stent implantation. CONCLUSIONS One-year clinical and angiographic outcome after BES implantation was noninferior to and not different from that after EES implantation in a mostly stable coronary artery disease population. One-year clinical outcome after both BES and EES use was excellent, with a low rate of TLR and extremely low rate of stent thrombosis.

Plaque Protrusion Detected by Intravascular Ultrasound during Carotid Artery Stenting

BACKGROUND Stroke is a major complication of carotid artery stenting (CAS) that can occur during the procedure and for up to 30 days after the procedure in the late phase. Although the cause of late stroke after CAS is unknown, plaque protrusion may be one of the potential causes. This study aims to assess the rate of plaque protrusion during CAS by intravascular ultrasound (IVUS). METHODS We performed 77 consecutive CAS procedures using IVUS between May 2008 and December 2012. The rate of plaque protrusion was assessed at the end of the procedure using IVUS and angiography. RESULTS Mean age of patients was 72.5 ± 7.5 years. Sixty-eight patients were male and 42 had diabetes mellitus. In all, 65 PRECISE stents and 12 Carotid Wall stents were used. All cases were distally protected with filter devices. Six plaque protrusions (7.8%) through the stent struts were detected by IVUS but only 2 (2.6%) by angiography. A predictor of plaque protrusion was preprocedural severe stenosis with flow delay. Additional postdilations (n = 6) and stent-in-stent implantations (n = 4) were performed to correct the plaque protrusions. No remaining plaque protrusion was observed in the final IVUS. Overall stroke rate was 2.6% (major 0%, minor 2.6%), and these occurred in the catheterization laboratory, but no late stroke was observed at 30 days after procedure. CONCLUSIONS IVUS can detect plaque protrusion better than angiography. Because adequate management of plaque protrusion may reduce stroke complications, IVUS usage is worth considering.

Coronary Angiographic Characteristics That Influence Fractional Flow Reserve

BACKGROUND Percutaneous coronary intervention (PCI) guided with fractional flow reserve (FFR) has been shown to improve clinical outcome. Although coronary angiography is the standard method for PCI guidance, the visual severity of stenosis is not always correlated with functional severity, suggesting that there are additional angiographic factors that affect functional ischemia. METHODS AND RESULTS To evaluate angiographic predictors of positive FFR in stenotic lesions, angiographic characteristics of 260 consecutive patients (362 lesions) who underwent FFR testing from April 2009 to September 2012 were analyzed. A scoring system (STABLED score) using these predictors was developed and compared with quantitative coronary angiography (QCA). %Diameter stenosis >50% (OR, 8.43; P<0.0001), tandem lesion (OR, 4.00; P<0.0001), true bifurcation (OR, 2.42; P=0.028), lesion length >20 mm (OR, 5.40; P=0.0002), and distance from ostium <20 mm (OR, 1.94; P=0.028) were determined as independent predictors of positive FFR. Area under the ROC curve for probability of positive FFR using the STABLED score (Stenosis 2 points, TAndem lesion 1 point, Bifurcation 1 point, LEsion length 1 point, Distance from ostium 1 point) was 0.85, higher than that for QCA stenosis alone (0.76). STABLED score ≥3 had 72.3% sensitivity and 83.6% specificity for predicting positive FFR, and PPV was 76.7%. CONCLUSIONS Specific angiographic features are applicable for predicting functional ischemia. STABLED score correlates well with FFR.

Initial Results of Transradial Iliac Artery Stenting

Aims: Iliac artery stenting is commonly performed via the ipsilateral or contralateral femoral artery. However, transradial intervention is less invasive than the transfemoral approach. We evaluated initial results of transradial iliac artery stenting. Methods and Results: We implanted stents in 32 iliac arteries of 30 patients via the radial artery. Transradial intervention was attempted at the discretion of the operator. Clinical data were analyzed retrospectively. Patients were excluded using a scheduled bidirectional approach. Twenty-one patients were male. In all, 8, 20, 16, and 9 patients had diabetes mellitus, hypertension, dyslipidemia, and smoking habit, respectively. In all, 30 lesions were stenosed and only 2 were occluded. A total of 39 stents were inserted, of which 36 were E-Luminexx stents and the other 3 were SMART control stents. All lesions were successfully treated with a good final angiographic result via a 6F radial access system. Ankle brachial index significantly improved from 0.68 ± 0.13 to 0.92 ± 0.15 (P < .01). Hospital stay was 2.09 ± 1.12 days. None of the patients had any procedural or access site-related complications (hematoma, major bleeding, blood transfusion, stroke, cholesterol embolism, aortic dissection, or arterial perforation). Conclusions: Transradial iliac artery stenting is a feasible and safe alternative in carefully selected patients.

Impact of transport pathways on the time from symptom onset of ST-segment elevation myocardial infarction to door of coronary intervention facility

BACKGROUND Reducing total ischemic time is important in achieving better outcome in ST-segment elevation myocardial infarction (STEMI). Although the onset-to-door (OTD) time accounts for a large portion of the total ischemic time, factors affecting prolongation of the OTD time are not established. PURPOSE The purpose of this study was to determine the impact of transport pathways on OTD time in patients with STEMI. METHODS AND SUBJECTS We retrospectively studied 416 STEMI patients who were divided into 4 groups according to their transport pathways; Group 1 (n = 41): self-transportation to percutaneous coronary intervention (PCI) facility; Group 2 (n = 215): emergency medical service (EMS) transportation to PCI facility; Group 3 (n = 103): self-transportation to non-PCI facility; and Group 4 (n = 57): EMS transportation to non-PCI facility. OTD time was compared among the 4 groups. ESSENTIAL RESULTS Median OTD time for all groups combined was 113 (63-228.8)min [Group 1, 145 (70-256.5); Group 2, 71 (49-108); Group 3, 260 (142-433); and Group 4, 184 (130-256)min]. OTD time for EMS users (Groups 2 and 4) was 138 min shorter than non-EMS users (Groups 1 and 3). Inter-hospital transportation (Groups 3 and 4) prolonged OTD by a median of 132 min compared with direct transportation to PCI facility (Groups 1 and 2). Older age, history of myocardial infarction, prior PCI, shock at onset, high Killip classification, and high GRACE Risk Score were significantly more frequent in EMS users. PRINCIPAL CONCLUSIONS Self-transportation without EMS and inter-hospital transportation were significant factors causing prolongation of the OTD time. Approximately 35% of STEMI patients did not use EMS and 21% of patients were transported to non-PCI facilities even though they called EMS. Awareness in the community as well as among medical professionals to reduce total ischemic time of STEMI is necessary; this involves educating the general public and EMS crews.

Transradial intervention for patients with ST elevation myocardial infarction with or without cardiogenic shock

To compare clinical outcomes between transradial (TRI) and transfemoral intervention (TFI) in primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI) with or without shock.

Delayed plaque protrusion after carotid artery stenting for the patient with symptomatic bi-lateral carotid artery stenosis

Carotid artery stenting (CAS) has been developed as an alternative therapeutic strategy for carotid endarterectomy (CEA) for the past several decades. One of the remaining issues of CAS is the relatively higher incidence of ipsi-lateral stroke after the procedure compared with CEA. Ischemic stroke after CAS sometimes occurred after catheterization, and a major cause of delayed stroke has been hypothesized to be stent-thrombosis. In this report, we present a case of a delayed plaque protrusion observed by contrast enhanced computed tomography and intravascular ultrasound, which could be the cause of the delayed recurrence of ischemic symptom. The lesion required an additional endovascular treatment to relieve the patient of the recurrence. This phenomenon might be a possible reason for the delayed ischemic stroke after CAS.

Transcatheter closure of atrial septal defect protects from pulmonary edema: septal occluder device gradually reduces LR shunt.

A 56-year-old woman was diagnosed as atrial septal defect (ASD) with pulmonary hypertension; pulmonary blood flow/systemic blood flow (Qp/Qs) of 2.3, pulmonary artery pressure (PAP) of 71/23(39) mmHg and diastolic dysfunction of left ventricle. PAP was improved after medical therapy; therefore, transcatheter ASD closure was performed. Seven days later, left-sided heart failure occurred, however, the improvement of Qp/Qs (1.7) and PAP of 51/21(32) was confirmed. Diuretic therapy was introduced which led to further decrease of PAP 40/12(25) and Qp/Qs (1.1). Because of gradual decrease of Qp/Qs, this patient appeared to be protected from acute pulmonary edema.

Potential cause of delayed strokes following carotid artery stenting

Carotid artery stenting (CAS) has been developed as an alternative therapeutic strategy of carotid endarterectomy (CEA) both for symptomatic and asymptomatic extra-cranial carotid artery stenosis. Some randomized clinical trial has been successfully proven the non-inferiority of CAS compared to CEA in terms of efficacy and safety regarding freedom from major adverse event (MAE). One of the remaining problems in CAS is a non-significant but relatively higher incidence of ipsi-lateral minor stroke related to the procedure, both during and soon after the procedure. We routinely examine intravascular ultrasound (IVUS) imaging during the CAS procedure, and found some informative findings. We hereby report the representative IVUS finding, which might suggest the possible cause for delayed stroke after CAS.