Progression from normal vessel wall to atherosclerotic plaque: lessons from an optical coherence tomography study with follow-up of over 5 years.

The initial process of atherosclerotic development has not been systematically evaluated. This study aimed to observe atherosclerotic progression from normal vessel wall (NVW) to atherosclerotic plaque and examine local factors associated with such progression using > 5-year long-term follow-up data obtained by serial optical coherence tomography (OCT). A total of 49 patients who underwent serial OCT for lesions with NVW over 5 years (average: 6.9 years) were enrolled. NVW was defined as a vessel wall with an OCT-detectable three-layer structure and intimal thickness ≤ 300 µm. Baseline and follow-up OCT images were matched, and OCT cross sections with NVW > 30° were enrolled. Cross sections were diagnosed as "progression" when the NVW in these cross sections was reduced by > 30° at > 5-year follow-up. Atherogenic progression from NVW to atherosclerotic plaque was observed in 40.8% of enrolled cross sections. The incidence of microchannels in an adjacent atherosclerotic plaque within the same cross section (6.7 vs. 3.3%; p = 0.046) and eccentric distribution of atherosclerotic plaque (25.0 vs. 12.6%; p < 0.001) at baseline was significantly higher in cross sections with progression than in those without. Cross sections with progression exhibited significantly higher NVW intimal thickness at baseline than cross sections without progression (200.1 ± 53.7 vs. 180.2 ± 59.6 µm; p < 0.001). Multivariate analysis revealed that the presence of microchannels in an adjacent atherosclerotic plaque, eccentric distribution of atherosclerotic plaque, and greater NVW intimal thickness at baseline were independently associated with progression at follow-up. The presence of microchannels in an adjacent atherosclerotic plaque, eccentric distribution of atherosclerotic plaque, and greater NVW intimal thickness were potentially associated with initial atherosclerotic development from NVW to atherosclerotic plaque.

Prediction of the debulking effect of rotational atherectomy using optical frequency domain imaging.

Whether predicting the rotational atherectomy (RA) effect based on the position of optical frequency domain imaging (OFDI) is accurate remains uncertain. The aim of this study was to evaluate the predictive accuracy of OFDI in identifying RA location and area. Twenty-five patients who underwent RA with OFDI were included. On pre-RA OFDI images, a circle with the dimension of a Rota burr was drawn at the center of the OFDI catheter. The area where the circle overlapped with the vessel wall was defined as the predicted ablation area (P-area), and the actual ablated area (A-area) was measured. The predictive accuracy of OFDI was evaluated as follows: overlapped ablation area (O-area: overlapping P- and A-areas) divided by P-area = %Correct-area, and A-area - O-area divided by A-area = %Error-area. Cross-sections were separated into four categories based on the median values of %Correct- and %Error-area. Among 334 cross-sections, RA effects were confirmed in the predicted location in 87% of them. The median %Correct- and %Error-areas were 43.1% and 64.2%, respectively. Floppy wire, narrow lumen area, OFDI catheter close to the intima, and large arc of calcium were independently associated with good prediction (high %Correct-/low %Error-areas). Non-left anterior descending lesions, OFDI catheter far from the wire, and OFDI catheter and wire far from the intima were associated with irrelevant ablation (low %Correct-/ high %Error-areas). The accuracy of the OFDI-based predictions for RA effects was acceptable with regard to location, but not high with regard to area. Wire types, target vessels, and OFDI catheter and wire positions are important determinants for accurately predicting RA effect using pre-procedural OFDI.

Efficacy of optical frequency domain imaging in detecting peripheral artery disease: the result of a multi-center, open-label, single-arm study.

Optical frequency domain imaging (OFDI) is a high-resolution intracoronary imaging modality with fast automated longitudinal pullback. We aimed to evaluate the ability of performing OFDI from the superficial femoral artery (SFA) to the below-knee (BK) artery. This clinical trial was a multi-center, single-arm, open-label study. The primary endpoint was to obtain a clear image of the intra-vascular lumen from the SFA to the BK artery, specifically > 270° visualization of the blood vessel lumen with > 16/21 cross sections. The proportion of the clear image (≥ 85%) was regarded as confirmatory of the ability of OFDI to visualize the vessel lumen. Overall, 20 patients were enrolled. The proportion of the primary endpoint was 90% (18/20), and the pre-specified criterion was successfully attained. The proportion of the clear image assessed by the operator was 100% (20/20), and an additional statistical analysis for the proportion of the visualization, > 270°, of the blood vessel lumen revealed a significantly higher cut-off value than that for the pre-specified criterion, 85% (p = 0.0315). There were three adverse events not related to OFDI. OFDI achieved acceptable visualization of the vessel lumen without any adverse event related to it. After regulatory approval based on the present study, OFDI will be available as a new option of endovascular imaging for peripheral artery diseases in daily practiceTrial registration: This study was registered in the Japanese Registry of Clinical Trials (jRCT 2052190025, https://jrct.niph.go.jp/latest-detail/jRCT2052190025 ).

Concomitant Use of Rosuvastatin and Eicosapentaenoic Acid Significantly Prevents Native Coronary Atherosclerotic Progression in Patients With In-Stent Neoatherosclerosis.

BACKGROUND: In-stent neoatherosclerosis (NA) is a risk for future cardiovascular events through atherosclerotic progression in non-stented lesions. Using optical coherence tomography, this study assessed the efficacy of intensive therapy with 10 mg/day rosuvastatin plus 1,800 mg/day eicosapentaenoic acid (EPA) vs. standard 2.5 mg/day rosuvastatin therapy on native coronary plaques in patients with NA.Methods and Results:This was a subgroup analysis of the randomized LINK-IT trial, which was designed to compare changes in the lipid index in NA between intensive and standard therapy for 12 months. In all, 42 patients with native coronary plaques and NA were assessed. Compared with standard therapy, intensive therapy resulted in greater decreases in serum low-density lipoprotein cholesterol concentrations and greater increases in serum 18-hydroxyeicosapentaenoic acid concentrations, with significantly greater decreases in the lipid index and macrophage grade in both NA (-24 vs. 217 [P<0.001] and -15 vs. 24 [P<0.001], respectively) and native coronary plaques (-112 vs. 29 [P<0.001] and -17 vs. 1 [P<0.001], respectively) following intensive therapy. Although there was a greater increase in the macrophage grade in NA than in native coronary plaques in the standard therapy group, in the intensive therapy group there were comparable reductions in macrophage grade between NA and native coronary plaques. CONCLUSIONS: Compared with standard therapy, intensive therapy prevented atherosclerotic progression more effectively in native coronary plaques in patients with NA.

Bailout MitraClip therapy for deteriorated systolic anterior motion-related severe mitral regurgitation post-alcohol septal ablation: a case report.

Background: Percutaneous alcohol septal ablation (ASA) is a non-surgical treatment for symptomatic hypertrophic obstructive cardiomyopathy. It has a potential risk for systolic anterior motion (SAM)-related mitral regurgitation (MR) deterioration, leading to acute congestive heart failure. In such clinical scenarios, additional surgical interventions for SAM-MR are risky. Case summary: A 70-year-old man experienced acutely deteriorated heart failure caused by SAM-related MR following ASA, for which venous-arterial extracorporeal membrane oxygenation (ECMO) and a percutaneous left ventricular assist device (Impella CP, Abiomed, MA, USA) were required. Transoesophageal echocardiography showed that an interventricular septal oedematous protrusion led to a large coaptation gap of mitral leaflets with a pseudo-prolapse of the posterior mitral leaflet (PML). Because of his prohibitive surgical risks, we opted for transcatheter edge-to-edge mitral valve repair with MitraClip therapy. After removing the Impella device, an XT clip (Abbott Vascular, CA, USA) was located to cover the pseudo-prolapsed PML, resulting in optimal MR reduction with an acceptable mean transmitral valve-pressure gradient. Thereafter, his heart failure was well controlled, and venous-arterial ECMO was successfully removed on post-MitraClip Day 2. Discussion: This case demonstrated that MitraClip therapy rescued the patient from a rare complication of severe acute heart failure with haemodynamic collapse caused by massive SAM-related MR following ASA. MitraClip therapy can be a feasible, less-invasive interventional therapy for SAM-related MR in cases with acceptable severity of iatrogenic mitral stenosis post-MitraClip implantation.

Comparison of MECHANISM of early and late vascular responses following treatment of ST-elevation acute myocardial infarction with two different everolimus-eluting stents: a randomized controlled trial of biodegradable versus durable polymer stents.

The early and mid-term arterial healing profile of biodegradable polymer-coated everolimus-eluting stents (BP-EES) is unclear, especially in ST-segment elevation myocardial infarction (STEMI) culprit lesions. This study aimed to compare early- and mid-term arterial healing between durable polymer-coated everolimus-eluting stents (DP-EES) and BP-EES in STEMI patients. In a prospective, multicenter, non-inferiority trial, STEMI patients were randomized to receive BP-EES (n = 60) or DP-EES (n = 60). The primary endpoint of this study was the mean percentage of covered struts (%covered struts) on FD-OCT 2 weeks post-PCI. Key secondary endpoints included the percentage of uncovered struts, frequency of abnormal intra-stent tissue, and percentage of malapposed struts by FD-OCT 2 weeks and 12 months post-PCI. They underwent serial frequency-domain optical coherence tomography (FD-OCT) evaluations immediately after percutaneous coronary intervention, and at 2 weeks and at 12 months after the procedure. The primary endpoint of %covered struts at 2 weeks was 71.4% in BP-EES and 72.3% in DP-EES [risk difference - 0.94%, lower limit of one-sided 95% confidence interval (CI) - 5.6; Pnon-inferiority = 0.0756]. At 12 months, the mean percentage of uncovered struts was significantly lower [1.73% (95% CI 0.28-3.17) vs. 4.81% (95% CI 3.52-6.09); p = 0.002], and the average malapposed volume was significantly smaller in the BP-EES group than in the DP-EES group (p = 0.002). At 12 months, BP-EES had a significantly larger average neointimal area with a significantly smaller average intra-stent tissue unevenness score than DP-EES, suggesting more uniform neointimal coverage with BP-EES. Strut coverage was comparable between BP-EES and DP-EES at 2 weeks. Non-inferiority could not be proven because of an insufficient sample size. The significantly better arterial healing with BP-EES at 12 months suggests a safer profile for STEMI culprit lesions.Trial registration: jRCTs022180024 https://jrct.niph.go.jp/en-latest-detail/jRCTs022180024.

Cholesterol uptake capacity: A new measure of high-density lipoprotein functionality as a predictor of subsequent revascularization in patients undergoing percutaneous coronary intervention.

BACKGROUND AND AIMS: High-density lipoprotein (HDL) functionality is an important determinant of coronary artery disease (CAD) development. We recently developed cholesterol-uptake capacity (CUC), a rapid cell-free assay system that directly evaluates the capacity of HDL to accept additional cholesterol. We aimed to evaluate the association between CUC and revascularization in patients who have undergone percutaneous coronary intervention (PCI). METHODS: We retrospectively reviewed patients who underwent PCI with subsequent revascularization or coronary angiography (CAG) without revascularization. The patients who had frozen blood samples for which CUC were measurable at the index PCI and follow-up were enrolled. RESULTS: We finally enrolled 74 patients who underwent subsequent revascularization and 183 patients who underwent follow-up CAG without revascularization. The serum CUC level at the index PCI was significantly lower in the revascularization group than that in the non-revascularization group (84.3 [75.2-98.9] vs. 92.0 [81.6-103.3 A U.]; p = 0.004). Multivariate logistic regression analysis revealed that decreased serum CUC level at the index PCI was independently associated with subsequent revascularization (odds ratio, 0.98; 95% confidence interval, 0.969-1.000). After adjusting for 16 cardiovascular risk factors, the serum CUC level at the index PCI and follow-up and the absolute change in serum CUC level from the index PCI to follow-up were significantly lower in the revascularization group than those in the non-revascularization group. CONCLUSIONS: Serum CUC level at index PCI was independently associated with subsequent revascularization after PCI. Continuous assessment of HDL functionality by CUC might help predict subsequent revascularization after PCI.

Optical Coherence Tomography Fractional Flow Reserve and Cardiovascular Outcomes in Patients With Acute Coronary Syndrome.

BACKGROUND: Optical coherence tomography-derived fractional flow reserve (OCT-FFR) correlates strongly with wire-based FFR; however, its clinical significance remains uncertain. OBJECTIVES: This study sought to investigate the relationship between post-percutaneous coronary intervention (PCI) OCT-FFR and long-term clinical outcomes in acute coronary syndrome (ACS). METHODS: This retrospective, multicenter, observational cohort study included consecutive patients with ACS who underwent OCT-guided emergency PCI. We analyzed post-PCI OCT images and calculated OCT-FFR to identify independent factors associated with target vessel failure (TVF) after PCI. RESULTS: Among 364 enrolled patients, 54 experienced TVF during a median follow-up of 36 (IQR: 26-48) months. Vessel-level OCT-FFR was significantly lower in the TVF group than in the non-TVF group (0.87 vs 0.94; P < 0.001). In the multivariable Cox regression analysis, low vessel-level OCT-FFR (HR per 0.1 increase: 0.38; 95% CI: 0.29-0.49; P < 0.001) and thin-cap fibroatheroma in the nonculprit lesion were independently associated with TVF. The TVF rate of vessels with both low vessel-level OCT-FFR (<0.90) and thin-cap fibroatheroma in the nonculprit lesion was 8.1 times higher than that of all other vessels (69.3% vs 12.4%; HR: 8.13; 95% CI: 4.33-15.25; log-rank P < 0.001). Furthermore, adding vessel-level OCT-FFR to baseline characteristics and post-PCI OCT findings improved discriminatory and reclassification ability in identifying patients with subsequent TVF. CONCLUSIONS: Vessel-level OCT-FFR was an independent factor associated with TVF after PCI in patients with ACS. Adding the OCT-FFR measurement to post-PCI OCT findings may enable better discrimination of patients with subsequent TVF after PCI for ACS. (Relationship between Intracoronary Optical Coherence Tomography Derived Virtual Fractional Flow Reserve and cardiovascular outcome on Acute coronary syndrome; UMIN000043858).

Morphological Plaque Characteristics and Clinical Outcomes in Patients With Acute Coronary Syndrome and a Cancer History.

Background Although patients with a cancer history have a 2 to 3 times higher risk for acute coronary syndrome (ACS), the morphological characteristics of ACS culprit plaque in those patients and their relations with clinical outcomes remain unknown. Methods and Results This retrospective, multicenter, observational cohort study included consecutive patients with ACS who underwent optical coherence tomography-guided emergent percutaneous coronary intervention. Patients were categorized into those without a cancer history, those with a cancer history, and those currently receiving cancer treatment. ACS culprit lesions were classified as plaque rupture, plaque erosion, or calcified nodule using optical coherence tomography. Plaque erosion frequency was significantly higher in culprit lesions of patients with current cancer and patients with cancer history than in those of patients without cancer history (56.3% versus 61.7% versus 36.5%). Calcified nodule incidence was significantly higher in patients without cancer history than in patients with current cancer and patients without cancer history (patients with current cancer: 12.4% versus patients without cancer history: 25.5% versus patients without cancer history: 12.6%, P<0.001). Cancer history was independently associated with nonplaque rupture (plaque erosion or calcified nodule) in ACS culprit lesions (odds ratio, 4.00; P<0.001). Cancer history was independently associated with major adverse cardiovascular events (hazard ratio [HR], 1.98; P=0.002). Nonplaque rupture in ACS culprit lesions was independently associated with major adverse cardiovascular events (HR, 1.60; P=0.011). Conclusions Patients with a cancer history had significantly worse clinical outcomes after ACS than those without a cancer history. Those with a cancer history had significantly higher plaque erosion and calcified nodule incidences in the ACS culprit lesions, which might partly explain their worse clinical outcomes. Registration URL: www.umin.ac.jp/ctr/index.htm. Unique Identifier: UMIN000038442.

Relationship among clinical characteristics, morphological culprit plaque features, and long-term prognosis in patients with acute coronary syndrome.

Culprit lesions of acute coronary syndrome (ACS) could be classified as plaque rupture (PR), erosion, or calcified nodule (CN). We aimed to determine the relationship among clinical characteristics, morphological plaque features, and long-term prognosis in ACS. Patients with ACS, who underwent pre-intervention optical coherence tomography between April 2013 and July 2018 were retrospectively enrolled, and classified into the three groups based on the culprit lesion morphology. In the 436 patients enrolled, incidences of PR, erosion, and CN in ACS culprit lesions were 46.1, 39.9, and 14.0%, respectively. Plaque erosion was more frequent in men aged < 60 years and CN was more frequent in older adults in both sexes (≥ 80 years) (P < 0.001). Patients with CN had a higher incidence of hemodialysis treatment (P < 0.001) and diabetes (P = 0.003). Multivariate analysis revealed that ST elevation myocardial infarction (STEMI) (P = 0.049) and presence of thin-cap fibroatheroma (TCFA) at the culprit lesion were independently associated with PR; in younger patients (< 60 year), preserved left ventricular ejection fraction and lower incidence of TCFA were correlated with plaque erosion; and older age, non-STEMI, or unstable angina pectoris, higher serum brain natriuretic peptide levels, and lower incidence of TCFA were independently associated with CN. Multivariable analysis revealed that CN (odds ratio [OR] 1.990, P = 0.005), male sex (OR 2.012, P = 0.004), and older age (OR 1.036, P < 0.001) were independently associated with future adverse events during a median follow-up of 757 days. Different patient characteristics and morphological features were associated with the type of culprit lesion in patients with ACS.

Feasibility of morphological assessment of coronary artery calcification with electrocardiography-gated non-contrast computed tomography: a comparative study with optical coherence tomography.

To investigate the feasibility of pre-procedural morphological assessment of coronary artery calcification in severely calcified lesions with electrocardiography (ECG)-gated non-contrast computed tomography (CT). Severely calcified coronary arteries in patients who underwent ECG-gated non-contrast CT prior to optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) were studied retrospectively. CT and OCT data were co-registered by marking landmark structures such as side branches and reviewed side by side with cross-sectional images. The maximum calcium angle (MCA) and presence of nodular calcification (NC) were evaluated. A total of 496 cross-sections in 16 lesions were included in this analysis. The Pearson correlation coefficient between CT- and OCT-derived MCA was 0.92 (p < 0.001). Bland-Altman plots of OCT-derived MCA in relation to CT-derived MCA showed a mean bias of 4.8 degrees with 95% limits of agreement of - 69.7 to 79.4 degrees. Sensitivity, specificity, and positive and negative predictive values of CT in identifying MCA > 270 degrees were 90.3%, 79.7%, 92.1%, and 97.4%, respectively. Sensitivity, specificity, and positive and negative predictive values of CT in identifying NC were 73.3%, 97.5%, 47.8%, and 99.2%, respectively. ECG-gated non-contrast coronary CT might be helpful to obtain detailed information of severe coronary artery calcification before PCI.

Association Between Visit-to-Visit Variability in Low-Density Lipoprotein Cholesterol and Plaque Rupture That Leads to Acute Coronary Syndrome.

Background: The effect of intraindividual variability in lipid levels on the onset of acute coronary syndrome (ACS) remains uncertain. We evaluated the relationship between intraindividual variability in lipid levels and culprit lesion morphologies by optical coherence tomography (OCT). Methods and Results: Seventy-four consecutive patients with ACS whose cholesterol levels were assessed ≥3 times during outpatient visits before the onset of ACS were enrolled in the study; 222 patients without significant stenotic lesions were used as a control group. Based on OCT findings of culprit lesions, ACS patients were categorized into a plaque rupture ACS (PR-ACS) group (n=44) or a non-plaque rupture ACS (NPR-ACS) group (erosion or calcified nodule; n=30). Visit-to-visit variability in lipid levels was evaluated using the corrected variability independent of the mean (cVIM). Patients with ACS had significantly higher low-density lipoprotein cholesterol (LDL-C) levels and cVIM in LDL-C than the control group. The PR-ACS group had significantly higher mean LDL-C levels and greater cVIM in LDL-C than the control group. The PR-ACS group had a significantly higher cVIM than the NPR-ACS group, despite similar mean LDL-C levels. Multivariate analysis revealed that higher cVIM of LDL-C was an independent predictor of PR-ACS (odds ratio 1.06; P=0.018). Conclusions: In addition to the LDL-C level, greater visit-to-visit variability in LDL-C levels may be associated with the onset of ACS induced by plaque rupture.

Efficacy of optical frequency-domain imaging in detecting peripheral artery disease: a single-center open-label, single-arm study protocol.

Intravascular optical coherence tomography is a high-resolution intracoronary imaging modality, providing a microscopic image of intravascular features. However, it has lower penetration depth than intravascular ultrasound. Recently, a second-generation optical frequency-domain imaging (OFDI) technique has been developed to provide greater penetration depth and faster pullback speed. However, there is little evidence supporting the efficacy of OFDI in patients with peripheral artery disease (PAD) undergoing endovascular treatment (EVT). We aimed to evaluate the ability of OFDI to visualize vessel walls from the superficial femoral artery (SFA) to the below-knee (BK) arteries, as well as the coronary arteries. This clinical trial is a single-center, single-arm, open-label study to be conducted in Japan. A total of 20 patients will be enrolled in this study. The primary endpoint is to obtain a clear image of the intravascular features of the SFA and BK arteries, specifically the visualization of ≥ 270° of the vessel lumen in ≥ 16 out of 21 cross sections. Obtaining clear images in ≥ 85% of cases will be regarded as confirmation of the ability of OFDI to visualize vessel walls from the SFA to the BK arteries. This is the first clinical trial to be conducted accordance with good clinical practice to expand the indications of OFDI for PAD patients undergoing EVT in Japan. The result of this study will help provide another imaging option during EVT in daily practice.

Correction to: Efficacy of optical frequency­domain imaging in detecting peripheral artery disease: a single­center open­label, single­arm study protocol.

In the original publication of the article, the author group was published without full names and one of the co-authors' name was published incorrectly. The full names of author group and correct co-authors' name are given in this Correction.

Techniques for reducing air bubble intrusion into the left atrium during radiofrequency catheter and cryoballoon ablation procedures: An ex vivo study with a high-resolution camera.

BACKGROUND: Air embolisms are serious complications during catheter ablation procedures. OBJECTIVES: The aims of the present study were to determine when air bubbles enter the left atrium (LA) during catheter ablation procedures and to identify techniques that reduce air bubble intrusion. METHODS: An ex vivo study was performed to monitor air bubbles using a silicone heart model and a high-resolution camera. In total, 280 radiofrequency catheter and cryoballoon ablation processes were tested. RESULTS: Small and large air bubbles were often observed during catheter ablation processes. Many small air bubbles arose during sheath flushing at fast speeds (15 mL/2 s) (median bubble number [quartiles]: 35 [20-53] for SL0, 35 [23-44] for Agilis, and 98 [91-100] for FlexCath) and during initial cryoballoon inflation/freezing/deflation (34 [22-47]). Large (≥1.5 mm) air bubbles were observed during Lasso catheter insertion (1 [0-1]), cryoballoon insertion (2 [1-2]), and initial inflation/freezing/deflation (1 [1-3]). Massive air bubbles were observed during Optima catheter insertion into the sheath using an inserter (10 [2-15]). Sheath flushing at slow speeds (15 mL/5 s) significantly reduced the number of air bubbles. Before cryoballoon insertion, temporary balloon inflation and air bubble removal from the inflated surface were most effective in reducing air bubble intrusions. Optima catheter insertion without an inserter significantly reduced large air bubble intrusion. CONCLUSION: Air bubbles entered the LA at specific times. Techniques such as sheath flushing at slow speeds, temporary cryoballoon inflation before insertion, inserting the Optima catheter without an inserter, and avoidance of negative pressure in the LA could reduce air bubble intrusion.

Efficacy of alirocumab for reducing plaque vulnerability: Study protocol for ALTAIR, a randomized controlled trial in Japanese patients with coronary artery disease receiving rosuvastatin.

BACKGROUND: Although a recent clinical trial demonstrated that alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, significantly reduces the incidence of acute coronary events, the impact of alirocumab on plaque stabilization remains uncertain. The Efficacy of ALirocumab for Thin-cap fibroatheroma in patients with coronary Artery disease estImated by optical coherence tomogRaphy (ALTAIR) study will investigate the effect of alirocumab on thin-cap fibroatheroma (TCFA) in Japanese patients who underwent recent percutaneous coronary intervention (PCI). METHODS AND DESIGN: ALTAIR is a phase IV, open-label, randomized, parallel-group, single-center study involving blinded optical coherence tomography (OCT) image analysis in Japanese adults hospitalized for PCI and having suboptimal control of low-density lipoprotein cholesterol (LDL-C) levels (>70mg/dL) despite statin therapy. Patients will be randomized (1:1) to the alirocumab arm (alirocumab 75mg every 2 weeks added to rosuvastatin 10mg/day) or the standard-of-care arm (rosuvastatin 10mg/day, with initiation and/or dose adjustment of non-statin lipid-lowering to achieve an LDL-C target of <70mg/dL). OCT imaging will be conducted at baseline and at week 36 (post-treatment). The primary objective is to compare the alirocumab and standard-of-care arms regarding the change in TCFA fibrous-cap thickness after 9 months of treatment. CONCLUSION: The outcomes of ALTAIR (ClinicalTrials.gov identifier: NCT03552432) will provide insights into the effect of alirocumab on plaque vulnerability following PCI in patients with suboptimal LDL-C control despite stable statin therapy.

The importance of catheter stability evaluated by Visitag(TM) during pulmonary vein isolation.

BACKGROUND: The recurrence rates of atrial fibrillation (Af) after ablation are still high, and repeat procedures are required in these patients. The main reason for Af recurrence is the recovery of the conduction between the pulmonary veins and left atrium. The importance of catheter stability during the pulmonary vein isolation (PVI) is not well studied. PURPOSE: The purpose of this study was to evaluate the contact force (CF), stable ablation time, and power during conduction blocking lesion formation for PVI. METHODS: Thirty-two consecutive drug-refractory Af patients who underwent an initial PVI using CARTO 3 and Visitag were included. The CF, ablation time, force time integral (FTI), and ablation power were recorded by Visitag. Residual conduction gap points requiring touch-up ablation after an encircling linear ablation (R point), spontaneous reconnection points (S point), and dormant conduction points (D point) were considered as non-conduction blocking lesion points. Each ablation parameter for the non-conduction blocking lesion points was compared with the other lesion points. RESULTS: Twenty-one points in 16 patients were considered non-conduction blocking lesions. Ten were R, eight were S, and three were D points. The CF, ablation time, FTI, and power at the non-conduction blocking lesion points and other points were 12.0 g (7.0-21.5) and 12.0 g (9.0-16.0) (P = 0.9), 7.7 s (5.6-10.1) and 12.5 s (9.4-16.8) (P < 0.05), 103.0 g*s (62.0-174.5) and 149.0 g*s (104.0-213.0) (P < 0.05), and 30.0 W (22.5-30.0) and 30.0 W (30.0-30.0) (P = 0.06), respectively. CONCLUSIONS: Shorter ablation time recorded in Visitag lead to non-conduction blocking lesion.

Optical coherence tomography study of chronic-phase vessel healing after implantation of bare metal and paclitaxel-eluting self-expanding nitinol stents in the superficial femoral artery.

BACKGROUND: This study aimed to assess chronic-phase suppression of neointimal proliferation and arterial healing following paclitaxel-coated (PTX) and bare metal stent (BMS) implantation in the superficial femoral artery using optical coherence tomography (OCT). METHODS: Twenty-five patients with 68 stents underwent an 8-month OCT follow-up. Besides standard OCT variables, neointimal characterization and frequencies of peri-strut low-intensity area (PLIA), macrophage accumulation, and in-stent thrombi were evaluated. RESULTS: The mean neointimal thickness was significantly less with PTX stents (544.9±202.2 µm vs. 865.0±230.6 µm, p<0.0001). The covered and uncovered strut frequencies were significantly smaller and larger, respectively, in the PTX stent group vs. the BMS group (93.7% vs. 99.4%; p<0.0001, 4.0% vs. 0.4%; p<0.0001, respectively). Heterogeneous neointima was only observed in the PTX stent group (12.5% vs. 0%, p=0.017). The frequencies of PLIA and macrophage accumulation were significantly greater in the PTX stent group (87.2% vs. 67.6%, p=0.001 and 46% vs. 9.1%, p=0.003, respectively). CONCLUSION: After 8 months, reduced neointimal proliferation was observed with PTX stent implantation. On the other hand, delayed arterial healing was observed compared with BMS.