BACKGROUND:Adequate endothelization after drug-eluting stent (DES) implantation is essential to reduce thrombotic risk. Adequate strut coverage (ASC) is defined as ≥40 μm on optical coherence tomography, but its functional significance remains uncertain. Coronary angioscopy can assess neointimal function by detecting thrombus and plaque color. This study evaluated functionally adequate endothelization and contributing factors after DES implantation. METHODS AND RESULTS:Post hoc analyses of the COLLABORATION 1 and 2 studies were performed using serial optical coherence tomography and coronary angioscopy 1 and 12 months after DES implantation. Four DES types were examined: durable polymer everolimus-eluting stent (DP-EES); sirolimus-eluting stent (SES); polymer-free biolimus-coated stent (PF-BCS); and dual-therapy sirolimus-eluting stent (DTS). PF-BCS and DTS were classified as "ingenious" DES, and DP-EES and SES were classified as "fundamental." The correlation between the percentage of struts with ≥40 μm coverage (%ASC) and functional neointima (i.e., no thrombus and white plaque) was assessed. Among 150 patients (177 lesions), thrombus and yellow plaque were inversely correlated with %ASC at 12 months. Cut-off values of %ASC were 67% for thrombus prevention and 90% for plaque stabilization. Multivariable analysis identified the use of ingenious DES, prasugrel therapy, and hypertension as independent predictors of chronic adequate endothelization. CONCLUSIONS:Functional protection against thrombus requires %ASC ≥67%, and plaque stabilization requires ≥90%. The use of ingenious DESs and prasugrel contributes to improved chronic adequate endothelization.
Precise navigation of a guidewire tip to a target within the three-dimensional (3D) structure of a coronary artery—controlled from 140 cm away—requires “3D wiring,” a technique involving wire manipulation based on 3D imaging. Hypothesizing that 3D wiring enables the standardization of wiring techniques for chronic total occlusion (CTO) intervention, we have established a 3D wiring method utilizing fluoroscopy and intravascular ultrasound (IVUS). As a first step to visualize guidewire movement within CTO lesions, we collaborated with Terumo Corporation to develop the Navifocus WR in 2012, a CTO-specific IVUS featuring a small diameter and a short tip. Observing guidewire movement during CTO PCI using this IVUS provided the insights necessary to understand how the shaft and tip must be visualized to facilitate effective 3D wiring. We first established angiography-guided 3D wiring using “3D imaging rules” in 2014. Subsequently, to achieve real-time IVUS-guided 3D wiring, we devised the tip detection (TD) method in 2017 and developed the AnteOwl WR IVUS (Terumo Corporation)—a short-tip, pullback-compatible catheter—in 2019, establishing a strategic approach for TD-intra-plaque tracking. Contrary to the traditional view that IVUS guidance is limited to intra-plaque tracking, our 2021 findings show that re-entry is routinely feasible through TD-guided perpendicular puncture (TD-ADR: Antegrade Dissection and Re-entry). This evolution elevated the TD method into a more robust technique for wire crossing. This review aims to systematically organize the theory of 3D wiring and disseminate this knowledge to the global community.
Background: Below-the-ankle (BTA) disease is increasingly prevalent in chronic limb-threatening ischemia (CLTI), particularly in diabetes and end-stage renal disease, but its determinants and prognostic impact after revascularization remain unclear. Methods and Results: We retrospectively analyzed 185 CLTI limbs with complete pedal angiography undergoing revascularization at 2 vascular centers between 2002 and 2023. Using the Global Limb Anatomic Staging System (GLASS) inframalleolar/pedal artery descriptor (IPD), limbs were classified as BTA (IPD-P2; n=40) or non-BTA (IPD-P0 or P1; n=145). Logistic regression identified factors associated with BTA. Kaplan-Meier compared limb-based patency (LBP), wound healing, limb salvage, and survival. BTA limbs presented with more severe limb status (WIfI stage 4: 72.5% vs. 41.0%; P=0.001), whereas GLASS stage was similar. On multivariable analysis, non-ambulatory status independently predicted BTA disease (adjusted odds ratio 2.65; 95% confidence interval 1.19-5.94; P=0.02). BTA disease was associated with lower 1-year primary/secondary LBP (55.6% and 72.4% vs. 75.2% and 86.1%; P=0.004 and P=0.005), 6-month wound healing (54.0% vs. 83.2%; P=0.0002), 1-year limb salvage (77.3% vs. 97.2%; P<0.0001), and 1-year survival rates (67.9% vs. 85.6%; P=0.003). Conclusions: Non-ambulatory status was independently associated with advanced BTA disease. Despite similar GLASS stage, BTA involvement predicted worse patency, limb outcomes, and survival, suggesting pedal arterial status reflects systemic disease severity.
The objective was to prepare guidelines to perform the current optimum treatment by organizing effective and efficient treatments of hemangiomas and vascular malformations, confirming the safety, and systematizing treatment, employing evidence-based medicine techniques and aimed at improvement of the outcomes. Clinical questions (CQs) were decided based on the important clinical issues. For document retrieval, key words for literature searches were set for each CQ and literature published from 1980 to the end of December 2020 was searched in PubMed, and Japana Centra Revuo Medicina (JCRM). The strengths of evidence and recommendations acquired by systematic reviews were determined following the Medical Information Network Distribution Service (Minds) technique. A total of 38 CQs were used to compile recommendations and the subjects included efficacy of resection, sclerotherapy/embolization, drug therapy, laser therapy, radiotherapy, and other conservative treatment, differences in appropriate treatment due to the location of lesions and among symptoms, appropriate timing of treatment and tests, pathological diagnosis deciding the diagnosis, and causal genes of vascular anomalies. Thus, the Japanese clinical practice guidelines for vascular tumors, vascular malformations, lymphatic malformations, and lymphangiomatosis 2022 have been prepared as the evidence-based guidelines for the management of vascular anomalies.
This multicenter, randomized, double-blind, parallel-group, active-controlled study aimed to demonstrate a superior BP-lowering effect of sacubitril/valsartan (SacVal) and amlodipine (AML) combination therapy vs SacVal monotherapy in Japanese patients with grade Ⅰ/Ⅱ essential hypertension inadequately controlled with SacVal monotherapy. After 4 weeks of single-blind active run-in with SacVal 200 mg monotherapy, patients (n=717) with mean sitting systolic blood pressure (msSBP) of 140 to <180 mmHg were randomized and received SacVal 200 mg monotherapy or SacVal 200 mg in combination with AML (2.5, 5, or 10 mg) for 8 weeks. All SacVal/AML 200 mg/2.5 mg, 200 mg/5 mg, 200 mg/10 mg combinations achieved statistically significant, dose-dependent reductions in msSBP vs SacVal 200 mg monotherapy (treatment difference [mmHg] [95% CI]: -5.63 [ -8.01, -3.25], -12.94 [ -15.22, -10.67], -16.39 [ -19.01, -13.77], respectively; all p < 0.001). Treatment effects of all combinations were also statistically significant in 24-h ambulatory SBP (treatment difference [mmHg] [95% CI] vs SacVal: -6.48 [ - 8.79, -4.18], -14.18 [ -16.63, -11.73], -17.70 [ -20.24, -15.26], respectively; all p < 0.001) and BP control ( < 140/90 mmHg) rates (57.2, 72.5, 79.9%, respectively, vs 35.0% in SacVal with odds ratio [95% CI]: 2.16 [1.40, 3.33], 5.28 [3.31, 8.43], 7.23 [4.41, 11.86], respectively; all p < 0.001). Subgroup and waterfall plot analyses in msSBP demonstrated consistent BP-lowering effects across patient demographic and baseline characteristics. The safety profile of combination therapy was similar to that of SacVal with no new safety findings. These results demonstrated that combination therapy provided superior BP reduction with favorable safety and tolerability in Japanese patients inadequately controlled by SacVal 200 mg monotherapy. In this multicenter, randomized, double-blind, parallel group, active controlled trial, sacubitril/valsartan and amlodipine combination therapy showed dose-dependent reductions in office and 24-hour systolic blood pressure and a favourable safety profile in Japanese patients inadequately controlled on sacubitril/valsartan monotherapy, supporting its efficacy and safety as a treatment option.
