Masahisa Yamane

A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan

AIMS Theoretically, bioresorbable vascular scaffolds (BVSs) may provide superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown. METHODS AND RESULTS ABSORB Japan was a single-blind, multicentre, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Eligible patients with one or two de novo lesions in different epicardial vessels were randomized at 38 Japanese sites in a 2:1 ratio to Absorb BVS vs. cobalt-chromium everolimus-eluting stents (CoCr-EESs). The primary endpoint was target lesion failure [TLF: a composite of cardiac death, myocardial infarction attributable to target vessel, or ischaemia-driven target lesion revascularization (ID-TLR)] at 12 months, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss (LLL) at 13 months. A total of 400 patients were randomized to BVSs (266 patients and 275 lesions) or CoCr-EESs (134 patients and 137 lesions). TLF through 12 months was 4.2% with BVSs and 3.8% with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.39% (3.95%); Pnon-inferiority < 0.0001]. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5% of the patients with both devices (P = 1.0), and ID-TLR for restenosis was infrequent (1.1% with BVSs and 1.5% with CoCr-EESs, P = 1.0). With 96.0% angiographic follow-up, in-segment LLL at 13 months was 0.13 ± 0.30 mm with BVSs and 0.12 ± 0.32 mm with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.01 (0.07); Pnon-inferiority < 0.0001). CONCLUSION In the ABSORB Japan randomized trial, 12-month clinical and 13-month angiographic outcomes of BVSs were comparable to CoCr-EESs. CLINICAL REGISTRATION ClinicalTrials.gov, number NCT01844284.

Japanese multicenter registry evaluating the retrograde approach for chronic coronary total occlusion.

This registry evaluated the current trends and outcomes associated with retrograde percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).

Contemporary retrograde approach for the recanalisation of coronary chronic total occlusion: on behalf of the Japanese Retrograde Summit Group.

AIMS The retrograde approach to CTO is promising, but questions remain with regard to its wider application and the potential risks. This study evaluated the feasibility and efficacy of retrograde recanalisation of chronic total occlusion (CTO) of the coronary arteries. METHODS AND RESULTS A total of 378 consecutive patients (previously failed PCI 32.0%) who enrolled in 27 institutions in Japan underwent retrograde recanalisation for CTO. We analysed the data on lesion characteristics, procedural materials, technique used, complications and clinical outcomes. Successful retrograde recanalisation was achieved in 70.4% and the overall procedural success was 83.6%. Collateral crossing was achieved via a septal route in 68.9%, epicardial in 27.2% and bypass grafts in 2.6%, respectively. The retrograde approach was completed with implementation of reverse CART in 42.5%, direct wire crossing in 23.1%, bilateral wiring in 22.7%, and CART in 11.7%. Major and minor collateral injuries and coronary perforations were noted in 1.3%, 10.3% and 2.9% of cases, respectively. Stroke occurred in 0.3%, QWMI and emergency PCI in 0.3% of patients with successful recanalisation. CONCLUSIONS Wider application of retrograde CTO PCI achieved a high rate of success in recanalisation with an acceptable rate of complications in Japan.

Appropriateness of percutaneous revascularization of coronary chronic total occlusions: an overview.

Coronary chronic total occlusions (CTOs) are commonly encountered in patients undergoing coronary angiography. Several observational studies have demonstrated that successful CTO revascularization is associated with better cardiovascular outcomes and enhanced quality of life (QOL). However, in the absence of randomized trials, its prognostic benefit for patients remains debated. Over the past decade, the interest of the interventional community in CTO percutaneous coronary intervention (PCI) has exponentially grown due to important developments in dedicated equipment and techniques, resulting in high success and low complication rates. Both European and American guidelines have assigned a class IIa (level of evidence B) recommendation for CTO PCI. In the current review, we focus on the impact of CTO revascularization on clinical outcomes and QOL and on appropriate patient selection, and we provide a critical assessment of the current guidelines and recommendations on CTO PCI.

Comparison of percutaneous coronary intervention for chronic total occlusion outcome according to operator experience from the Japanese retrograde summit registry

This study was performed to evaluate the acute outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) based on operator experience.

Complications during retrograde approach for chronic coronary total occlusion: Sub-analysis of Japanese multicenter registry.

This study was performed to determine the complications occurring during retrograde percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) based on analysis of the multicenter, prospective, nonrandomized Retrograde Summit registry.

Incidence and impact on midterm outcome of intimal versus subintimal tracking with both antegrade and retrograde approaches in patients with successful recanalisation of chronic total occlusions: J-PROCTOR 2 study

AIMS The aim of this study was to assess the incidence and impact on midterm outcomes of intimal versus subintimal tracking with both antegrade and retrograde approaches in patients undergoing successful percutaneous coronary intervention for chronic total occlusion (CTO). METHODS AND RESULTS In 2012, a total of 1,573 CTO cases from 30 hospitals were enrolled in the Japanese CTO registry. Successful guidewire crossing was performed in 1,411 cases (89.7%). Among them, the guidewire penetration position was clearly identified using intravascular ultrasound (IVUS) imaging in 352 cases, and clinical follow-up at 12 months was performed in 323 cases. These 323 cases were enrolled in this retrospective study: 242 cases were treated with the antegrade approach (antegrade group) and 81 cases were treated with the retrograde approach (retrograde group). The endpoint of this study was target vessel revascularisation (TVR) and major adverse cardiac events (MACE) at 12-month follow-up. Subintimal tracking occurred more frequently in the retrograde group (11.6% vs. 30.9%, p<0.01). TVR was more frequent in the subintimal tracking group in the retrograde group (7.1% vs. 16.0%, p=0.03) but not in the antegrade group (2.8% vs. 3.6%, p=0.99). Although the occlusion length was similar, the subintimal tracking group required a longer stent length compared to the intimal tracking group in the retrograde approach (59.7±24.4 mm vs. 74.0±24.4 mm, p<0.01). CONCLUSIONS Subintimal tracking was more frequent in the retrograde approach. Intimal tracking should be recommended in the retrograde approach to reduce stent length and to improve follow-up outcomes.

Clinical and angiographic outcomes of paclitaxel-eluting coronary stent implantation in hemodialysis patients: A prospective multicenter registry: The OUCH-TL study (outcome in hemodialysis of TAXUS Liberte).

BACKGROUND The outcome of percutaneous coronary intervention (PCI) has been reported to be poor in hemodialysis (HD) patients even in the drug-eluting stent era. We have reported relatively poor outcomes after sirolimus-eluting stent implantation in the OUCH study. METHODS The OUCH-TL study is a prospective, non-randomized, single-arm registry designed to assess the results of paclitaxel-eluting stent (PES) in HD patients with follow-up quantitative coronary angiography analysis. The primary endpoint was the occurrence of target-vessel failure (TVF) defined as cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR) at 12 months. RESULTS A total of 119 patients with 154 lesions were enrolled (one withdrawal). Mean age was 65±10 years, male gender was 79%, 89% of cases had stable coronary disease. Diabetic nephropathy was diagnosed in 61% of the patients. American College of Cardiology/American Heart Association type B2/C accounted for 96% of lesions and 22.7% of lesions were treated with Rotablator (Boston Scientific Corporation, Natick, MA, USA). Rates of TVF, death, MI, stent thrombosis and TVR at 12 months were 20.2%, 5.9%, 5.0%, 1.4%, and 12.6%, respectively. TVR was performed in 8.4% of the patients up to 12 months. Late loss in-stent was 0.48±0.61mm, and late loss in-segment was 0.37±0.61mm at 9 months. Binary restenosis in-stent was 10.3% and in-segment was 14.5%. CONCLUSIONS Outcomes of PES implantation in hemodialysis patients appears comparable to those of non-hemodialysis patients.

Independent predictors of retrograde failure in CTO-PCI after successful collateral channel crossing.

To evaluate factors for predicting retrograde CTO‐PCI failure after successful collateral channel crossing. Background: Successful guidewire/catheter collateral channel crossing is important for the retrograde approach in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).

INDEPENDENT PREDICTIVE FACTOR FOR RETROGRADE PROCEDURE FAILURE IN PERCUTANEOUS CORONARY INTERVENTION OF CHRONIC TOTAL OCCLUSION AFTER SUCCESSFUL COLLATERAL CHANNEL CROSSING: SUBANAYSIS OF 1646 CASES FROM JAPANESE MULTICENTER REGISTRY

Methods: Total 1,646 retrograde cases in CTO-PCI were collected from 2009 to 2012 in 44 centers in Japan. Retrograde procedure success was 70.0% and successful collateral channel crossing with wire and any support catheter was achieved in 80.8% (1330) and 76.5% (1260) respectively. Univariate and multivariate analyses were conducted to investigate independent predictors for retrograde procedural failure even after successful collateral channel crossing of any support catheter.