The Absorb GT1 Bioresorbable Vascular Scaffold System　- 5-Year Post-Market Surveillance Study in Japan.

BACKGROUND: The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available. METHODS AND RESULTS: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. CONCLUSIONS: Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.

One-Month Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy After Biodegradable Polymer Drug-Eluting Stent Implantation　- The REIWA Region-Wide Registry.

BACKGROUND: The safety and feasibility of using 1-month dual antiplatelet therapy (DAPT) followed by P2Y12inhibitor monotherapy for patients after percutaneous coronary intervention (PCI) with thin-strut biodegradable polymer drug-eluting stents (BP-DES) in daily clinical practice remain uncertain. METHODS AND RESULTS: The REIWA region-wide registry is a prospective study conducted in 1 PCI center and 9 local hospitals in northern Japan. A total of 1,202 patients who successfully underwent final PCI using BP-DES (Synergy: n=400; Ultimaster: n=401; Orsiro: n=401), were enrolled in the registry, and received 1-month DAPT followed by P2Y12inhibitor (prasugrel 3.75 mg/day or clopidogrel 75 mg/day) monotherapy. The primary endpoint was a composite of cardiovascular and bleeding events at 12 months, including cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), ischemic or hemorrhagic stroke, and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. Based on the results of a previous study, we set the performance goal at 5.0%. Over the 1-year follow-up, the primary endpoint occurred in 3.08% of patients, which was lower than the predefined performance goal (Pnon-inferiority<0.0001). Notably, definite ST occurred in only 1 patient (0.08%) within 1 year (at 258 days). No differences were observed in the primary endpoint between stent types. CONCLUSIONS: The REIWA region-wide registry suggests that 1-month DAPT followed by P2Y12inhibitor monotherapy is safe and feasible for Japanese patients with BP-DES.

The vacuolar amino acid transport system is a novel, direct target of GATA transcription factors.

In Saccharomyces cerevisiae, Avt4 exports neutral and basic amino acids from vacuoles. Previous studies have suggested that the GATA transcription factors, Gln3 and Gat1, which are key regulators that adapt cells in response to changes in amino acid status, are involved in the AVT4 transcription. Here, we show that mutations in the putative GATA-binding sites of the AVT4 promoter reduced AVT4 expression. Consistently, a chromatin immunoprecipitation (ChIP) assay revealed that Gat1-Myc13 binds to the AVT4 promoter. Previous microarray results were confirmed that gln3∆gat1∆ cells showed a decrease in expression of AVT1 and AVT7, which also encode vacuolar amino acid transporters. Additionally, ChIP analysis revealed that the AVT6 encoding vacuolar acidic amino acid exporter represents a new direct target of the GATA transcription factor. The broad effect of the GATA transcription factors on the expression of AVT transporters suggests that vacuolar amino acid transport is integrated into cellular amino acid homeostasis.

Monotherapy With Prasugrel After Dual-Antiplatelet Therapy for Japanese Percutaneous Coronary Intervention Patients With High Bleeding Risk　- A Prospective Cohort Study (PENDULUM mono Study).

BACKGROUND: The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI.Methods and Results:The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB. CONCLUSIONS: Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.

Comparison of Archival Angiographic Findings in Patients Later Developing Acute Coronary Syndrome or Stable Angina.

Acute coronary syndrome (ACS) can develop in patients with mildly to moderately stenotic lesions. However, the angiographic characteristics of lesions in patients who will later develop ACS have not been systematically investigated. For this reason, we examined the earlier angiographic findings of such patients in a retrospective study.The study population consisted of 45 consecutive ACS and 45 stable angina (SA) patients who require revascularization. All of them had received cardiac catheterization within 5 years prior to onset, for different reasons. The detailed parameters of the earlier coronary angiographies at the culprit site the whole culprit vessel, and all three vessels were compared between the two groups.Mild-to-moderate stenosis was present exclusively at the culprit site in the earlier angiographies, both in ACS and SA patients. Lesions associated with ACS progression were significantly shorter in length than those associated with SA progression (11.5 ± 5.5 versus 16.1 ± 10.5 mm, P = 0.02) and were more eccentric (eccentricity index: 0.5 ± 0.3 versus 0.7 ± 0.3, P = 0.04). Percent diameter stenosis was similar (42.2 ± 14.5 versus 44.0 ± 13.8%, P = 0.5). The mean grading scores for plaque extension and size (1-3) were significantly lower in ACS than in SA (1.4 ± 0.6 versus 1.8 ± 0.6, P = 0.01, and 1.3 ± 0.6 versus 1.7 ± 0.7, P = 0.01, respectively). Residual SYNTAX scores were significantly lower in ACS (12.5 ± 7.4 versus 16.4 ± 8.6, P = 0.03).Despite equivalent degrees of stenosis in previous angiographies, ACS occurred more frequently in patients with more focal and eccentric lesions but with less diseased coronary arteries than SA.

Assessment of bioresorbable scaffold with a novel high-definition 60 MHz IVUS imaging system: Comparison with 40-MHz IVUS referenced to optical coherence tomography.

BACKGROUND: In vivo assessment of bioresorbable scaffold (BRS) is of growing clinical interest. The novel 60MHz high-definition intravascular ultrasound (HD-IVUS) has been developed to overcome the limitations of conventional 40 MHz IVUS. This study aimed to evaluate the performance and limitations of 60 MHz HD-IVUS compared with 40 MHz IVUS with respect to polymeric-strut visualization, quantitative and qualitative analysis, and feasibility of high-speed pullback in the assessment of BRS. METHODS AND RESULTS: In a bench-test model, 361 struts were analyzed to evaluate the influence of ultrasound-beam angles and proximity of adjacent struts on IVUS visualization of BRS struts. Various settings were created by deforming the BRS and positioning the transducer offcenter. In an in vivo swine coronary model, scaffold and lumen areas, degree of visible external elastic membrane, incomplete strut apposition, and strut fracture were evaluated in 59 matched cross-sections obtained at conventional (0.5 mm/sec) and high speed (10 mm/sec) pullbacks. Both studies utilized optical coherence tomography (OCT) as reference. Overall, 60 MHz HD-IVUS demonstrated significantly improved visualization of polymeric struts compared with 40 MHz IVUS (well-visualized: 84.5% vs 62.3%, not visible: 4.4% vs 13.9%, respectively. P < 0.001), which was less affected by the beam angle and adjacent strut proximity. In the in vivo model, 60-MHz HD-IVUS showed better agreement of area measurements and strut abnormalities with OCT than 40 MHz IVUS. These findings were also confirmed on high-speed pullback images of 60 MHz HD-IVUS. CONCLUSION: As referenced to OCT, this study showed superiority of 60 MHz HD-IVUS over 40 MHz IVUS in the assessment of BRS with feasibility of high-speed pullback imaging.

Myocardial Bridges on Coronary Computed Tomography Angiography　- Correlation With Intravascular Ultrasound and Fractional Flow Reserve.

BACKGROUND: Myocardial bridges (MB) are commonly seen on coronary CT angiography (CCTA) in asymptomatic individuals, but in patients with recurrent typical angina symptoms, yet no obstructive coronary artery disease (CAD), evaluation of their potential hemodynamic significance is clinically relevant. The aim of this study was to compare CCTA to invasive coronary angiography (ICA), including intravascular ultrasound (IVUS), to confirm MB morphology and estimate their functional significance in symptomatic patients.Methods and Results:We retrospectively identified 59 patients from our clinical databases between 2009 and 2014 in whom the suspicion for MB was raised by symptoms of recurrent typical angina in the absence of significant obstructive CAD on ICA. All patients underwent CCTA, ICA and IVUS. MB length and depth by CCTA agreed well with length (0.6±23.7 mm) and depth (CT coverage) as seen on IVUS. The product of CT length and depth (CT coverage), (MB muscle index (MMI)), ≥31 predicted an abnormal diastolic fractional flow reserve (dFFR) ≤0.76 with a sensitivity and specificity of 74% and 62% respectively (area under the curve=0.722). CONCLUSIONS: In patients with recurrent symptoms of typical angina yet no obstructive CAD, clinicians should consider dynamic ischemia from an MB in the differential diagnosis. The product of length and depth (i.e., MMI) by CCTA may provide some non-invasive insight into the hemodynamic significance of a myocardial bridge, as compared with invasive assessment with dFFR.

Intravascular Ultrasound-Derived Stent Dimensions as Predictors of Angiographic Restenosis Following Nitinol Stent Implantation in the Superficial Femoral Artery.

PURPOSE: To identify intravascular ultrasound (IVUS) measurements that can predict angiographic in-stent restenosis (ISR) following nitinol stent implantation in superficial femoral artery (SFA) lesions. METHODS: A retrospective review was conducted of 97 patients (mean age 72.9±8.9 years; 63 men) who underwent IVUS examination during endovascular treatment of 112 de novo SFA lesions between July 2012 and December 2014. Self-expanding bare stents were implanted in 46 lesions and paclitaxel-eluting stents in 39 lesions. Six months after stenting, follow-up angiography was conducted to assess stent patency. The primary endpoint was angiographic ISR determined by quantitative vascular angiography analysis at the 6-month follow-up. Variables associated with restenosis were sought in multivariate analysis; the results are presented as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: At follow-up, 27 (31.8%) angiographic ISR lesions were recorded. The lesions treated with uncoated stents were more prevalent in the ISR group compared with the no restenosis group (74.1% vs 44.8%, p=0.02). Lesion length was longer (154.4±79.5 vs 109.0±89.3 mm, p=0.03) and postprocedure minimum stent area (MSA) measured by IVUS was smaller (13.9±2.8 vs 16.3±1.6 mm(2), p<0.001) in the ISR group. Multivariate analysis revealed that bare stent use (OR 7.11, 95% CI 1.70 to 29.80, p<0.01) and longer lesion length (OR 1.08, 95% CI 1.01 to 1.16, p=0.04) were predictors of ISR, while increasing postprocedure MSA (OR 0.58, 95% CI 0.41 to 0.82, p<0.01) was associated with lower risk of ISR. Receiver operating characteristic analysis identified a MSA of 15.5 mm(2) as the optimal cutpoint below which the incidence of restenosis increased (area under the curve 0.769). CONCLUSION: Postprocedure MSA can predict ISR in SFA lesions, which suggests that adequate stent enlargement during angioplasty might be required for superior patency.

Detailed Lipid Profiles and Lipid-related Residual Risk after 12-week 10 mg Rosuvastatin Treatment for Acute Myocardial Infarction.

Objective We aimed to reveal detailed on-treatment lipid profiles, lipid-related surrogate markers, and factors predicting failure to achieve the guideline-recommended lipid management goal following guideline-recommended statin treatment in Japanese patients with acute myocardial infarction (AMI). Methods and Results Sixty AMI patients who underwent coronary intervention and had received rosuvastatin 10 mg/day since the start of their hospitalization were assessed for on-treatment lipid-related profiles, including high-sensitivity C-reactive protein, small dense low-density lipoprotein cholesterol (sd LDL-C), and lipoprotein (a), at the 12-week follow-up. Patients who failed to achieve the guideline-recommended lipid management at 12 weeks were defined as the "unachieved group." Univariate and multivariate logistic regression analyses were performed to evaluate the predictors of inclusion in the unachieved group after high-dose statin treatment. Despite the use of high-dose rosuvastatin, 61.7% of the enrolled AMI patients were included in the unachieved group. In addition, the unachieved group had higher sd LDL-C and lipoprotein (a) levels than the achieved group. Logistic regression analyses demonstrated that low baseline high-density lipoprotein cholesterol (HDL-C) levels and the absence of diabetes were predictors of inclusion in the unachieved group. Conclusion More than half of the Japanese AMI patients treated with rosuvastatin 10 mg/day did not achieve the guideline-recommended goal of lipid management and still had lipid-related residual risk at 12 weeks. Particular attention should be paid to patients with low baseline HDL-C levels and those without diabetes with regard to their on-treatment lipid profiles.

Evaluation of the thickness of coronary calcium by 60-MHz intravascular ultrasound: head-to-head comparison with optical frequency domain imaging.

The region behind the coronary calcium could not be visualized by intravascular ultrasound (IVUS) because of acoustic shadow. However, some pathological studies have shown that IVUS delineated the vessel border behind thin coronary calcium sheets. This study aimed to reveal whether recent IVUS can visualize the region behind thin coronary calcium sheets. Using 534 cross-sectional optical frequency domain images (OFDI), including severe calcified coronary lesions, calcium sheet thickness was measured by every 1°. Accordingly, the visibility of the vessel border behind the coronary calcium sheet was evaluated using 60-MHz IVUS images, which were longitudinally linked with OFDI ones. After carefully coordinating with the axial position, the association between the IVUS-derived permeability of the coronary calcium sheet and calcium thickness was evaluated. The maximum and mean calcium thickness by OFDI was 0.88 ± 0.39 and 0.62 ± 0.30 mm, respectively. By 60-MHz IVUS, 12.1% of the coronary calcium sheets had permeable segments. Comparing between OFDI and IVUS images, 48.6% of the coronary calcium sheets with maximum thickness ≤ 0.3 mm were sometimes permeable by 60-MHz IVUS, whereas most > 0.5 mm thick calcium sheets were impermeable. In the receiver operating characteristic curve analysis, the best cutoff values for the maximum and mean thickness of permeable calcium were 0.48 and 0.31 mm, respectively. Thus, 60-MHz IVUS can occasionally visualize the region behind a thin coronary calcium sheet. When using 60-MHz IVUS, this finding may be a predictive marker of calcium sheet with a thickness of < 0.5 mm.

Safety and feasibility of intravascular ultrasound-guided robotic percutaneous coronary intervention.

OBJECTIVE: Previous studies have demonstrated the benefit of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) for preventing longitudinal geographic miss (LGM). However, it is yet unclear whether IVUS guidance is useful for robotic-PCI (robotic-assisted perctaneous coronary intervention [R-PCI]). METHODS: A total of 58 consecutive patients with stable angina who underwent IVUS-guided R-PCI were enrolled. The stent landing position was angiographically marked using a balloon marker before stenting, followed by measurements of the expected stent length using balloon pullback. Subsequently, prestenting IVUS was performed to determine stent landing. All pre-PCI IVUS images were assessed for lesion length and percent plaque volume (%PV) using both IVUS and angiographic marking. LGM was defined as a residual %PV >50% at either the distal or proximal stent edge, any stent edge dissection, or additional stent deployment immediately after stenting. RESULTS: The included patients had an average age of 67.1 ± 10.1 years. IVUS guidance had significantly longer lesion lengths compared with angiographic marking. Based on IVUS-guided stent deployment, nine cases exhibited LGM immediately after stenting. IVUS-marked landing points had a significantly smaller %PV and significantly larger lumen area compared with those for angiography. CONCLUSION: IVUS-guided R-PCI was well-tolerated and may be better at preventing LGM compared with angiography-guided R-PCI.

Periprocedural and 30-day outcomes of robotic-assisted percutaneous coronary intervention used in the intravascular imaging guidance.

In recent years, there have been several reports on robotic-assisted percutaneous coronary intervention (R-PCI), but few studies have been conducted on R-PCI performed under intravascular imaging guidance. To elucidate the periprocedural and postoperative 30-day outcomes of intravascular imaging-guided R-PCI, we performed a retrospective observational study on all patients in 102 consecutive cases who underwent R-PCI under intravascular imaging guidance at a single center in Japan from June 12, 2019 to February 18, 2021. The primary end point was 30-day survival, and the secondary end point was the incidence of complications. Intravascular imaging-guided R-PCI was performed 110 times in total on 125 lesions. The medians of procedural time, fluoroscopy time, contrast volume, patient entrance skin dose, and radiation exposure to the main operator were 49 min, 16 min, 67 mL, 0.62 Gy, and 0 µSv, respectively. Furthermore, 60.0% of target lesion branches were American College of Cardiology Foundation/American Heart Association classification type B2 or type C. However, in all cases, lesion dilatation was successful, and the final Thrombolysis in Myocardial Infarction flow grade was 3. The combination of manual operation was required in 12.7% of all cases, but 30-day survival was confirmed in all cases. There were two problems at the puncture site. One small distal branch artery dissection occurred due to manual operation, but no cardiovascular events (myocardial infarction, stroke) occurred and no target lesion restenosis was observed within 30 days of R-PCI. Hence, R-PCI using intravascular imaging demonstrated highly satisfactory treatment outcomes, and no complication caused by robotic operation was observed.

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.

High-definition intravascular ultrasound versus optical frequency domain imaging for the detection of calcium modification and fracture in heavily calcified coronary lesion.

While optical frequency domain imaging (OFDI) can delineate calcium modification and fracture, the capability of high-definition intravascular ultrasound (HD-IVUS) for detecting these remains unclear. This study evaluated diagnostic accuracy of HD-IVUS for assessing calcium modification and fracture as compared to OFDI. HD-IVUS and OFDI were used during orbital or rotational atherectomy procedures conducted for 21 heavily calcified coronary lesions in 19 patients. With OFDI assessment used as the gold standard, diagnostic accuracies of HD-IVUS for calcium modification and fracture were compared every 1 mm to the matched pre-stenting images (n = 1129). Calcium modification, as assessed by OFDI, was defined as polished and concave-shaped calcium. For HD-IVUS, calcium modification was defined as the presence of reverberation with concave-shaped calcium. In both assessments, the definition of calcium fracture was defined as a slit or complete break in the calcium plate. Calcified plaque was found in 86.4% of analyzed OFDI images. Calcium modification and fracture were detected in 20.6% and 11.0% of detected calcified plaques. Sensitivity, specificity, positive and negative predictive values of HD-IVUS detection for calcium modification and fracture were 54.4%, 97.8%, 86.7%, 89.1% and 86.0%, 94.5%, 58.2%, 96.8%, respectively. Discordance cases between both assessments demonstrated that heterogeneous calcium visualized by OFDI, separated calcium, and guide wire artifact can be misdiagnosed. Diagnostic accuracies of HD-IVUS for assessing calcium modification and fracture were acceptable as compared to OFDI. Such findings can be of utility during imaging guided interventional procedures with atherectomy.

Incidence and natural history of coronary evagination after implanted biodegradable polymer sirolimus-eluting stent.

Aims: The incidence and temporal change in coronary evagination (CE) after first-generation drug-eluting stent implantation is well established, whereas that after biodegradable polymer sirolimus-eluting stent (BP-SES) implantation has not yet been evaluated. The aim of this study is to assess the incidence and natural history of CE after BP-SES implantation. Methods and results: In this multicenter registry, stable coronary lesions treated by Ultimaster BP-SES were evaluated by serial optical frequency domain imaging (OFDI) (at 0-1-12 or 0-3-12 months) and the incidence of CE was assessed. Coronary evagination was defined as the presence of an outward bulge in luminal vessel contour between apposed struts according to the following criteria: (i) evagination depth ≥10% of nominal stent diameter and (ii) evagination length ≥3.0 mm. Optical frequency domain imaging was obtained in 98, 47, 49, and 87 lesions at 0, 1, 3, and 12 months, respectively. Coronary evagination was observed in 20 (42.6%) and 12 (24.5%) lesions at 1 and 3 months, respectively, and all but one CE had resolved at 12 months. At 12 months, the mean CE area was almost zero and the mean malapposed stent area was also decreased. Comparison of the serial OFDI images indicated that CEs originated mostly from acute stent malapposition or coronary dissection behind the implanted stent. Conclusions: In stable lesions, CE was occasionally observed with Ultimaster BP-SES at 1-3 months but mostly resolved within 12 months, without late-acquired stent malapposition. These findings suggest the safety and feasibility of biodegradable polymer coating on DES.

A serial optical frequency-domain imaging study of early and late vascular responses to bioresorbable-polymer sirolimus-eluting stents for the treatment of acute myocardial infarction and stable coronary artery disease patients: results of the MECHANISM-ULTIMASTER study.

The purpose of this study was to assess early and late vascular healing in response to bioresorbable-polymer sirolimus-eluting stents (BP-SESs) for the treatment of patients with ST-elevation myocardial infarction (STEMI) and stable coronary artery disease (CAD). A total of 106 patients with STEMI and 101 patients with stable-CAD were enrolled. Optical frequency-domain images were acquired at baseline, at 1- or 3-month follow-up, and at 12-month follow-up. In the STEMI and CAD cohorts, the percentage of uncovered struts (%US) was significantly and remarkably decreased during early two points and at 12-month (the STEMI cohort: 1-month: 18.75 ± 0.78%, 3-month: 10.19 ± 0.77%, 12-month: 1.80 ± 0.72%; p < 0.001, the CAD cohort: 1-month: 9.44 ± 0.78%, 3-month: 7.78 ± 0.78%, 12-month: 1.07 ± 0.73%; p < 0.001 respectively). The average peri-strut low-intensity area (PLIA) score in the STEMI cohort was significantly decreased during follow-up period (1.90 ± 1.14, 1.18 ± 1.25, and 1.01 ± 0.72; p ≤ 0.001), whereas the one in the CAD cohort was not significantly changed (0.89 ± 1.24, 0.67 ± 1.07, and 0.64 ± 0.72; p = 0.59). In comparison with both groups, differences of %US and PLIA score at early two points were almost disappeared or close at 12 months. The strut-coverage and healing processes in the early phase after BP-SES implantation were significantly improved in both cohorts, especially markedly in STEMI patients. At 1 year, qualitatively and quantitatively consistent neointimal coverage was achieved in both pathogenetic groups.

Morphological and quantitative analysis of vascular wall and neointimal hyperplasia after coronary stenting: comparison of bare-metal and sirolimus-eluting stents using optical coherence tomography.

BACKGROUND: It has been suggested that sirolimus-eluting stents (SES) provoke a more sustained inflammatory response (IR) in neointimal hyperplasia (NIH). The purpose of this study was to compare morphological vessel characteristics, including post-stent IR in NIH, between patients with SES and bare metal stents (BMS) using optical coherence tomography (OCT). METHODS AND RESULTS: Thirty-seven patients underwent OCT at their post-stent follow-up. OCT signal-intensity deviation (normalized standard-deviation; OCT-NSD) values in NIH were compared between the 2 groups. In addition, the serum concentration of high-sensitivity C-reactive protein (hs-CRP) was measured. Stent-malapposition rate (1.78% vs. 0.7%; P = 0.016), uncovered stent-strut rate (16% vs. 3.7%; P = 0.0002), peri-stent ulcer like appearance (PSUA; 50% vs. 0%; P = 0.006) were all significantly higher in the SES group than in the BMS group, respectively. The OCT-NSD value was also significantly higher in the SES group than in the BMS group (0.213 ± 0.005 vs. 0.198 ± 0.005; P < 0.001), as was the hs-CRP level (2.54 ± 1.89 vs. 0.64 ± 0.3 mg/L; P = 0.0006). In addition, a significant positive correlation was found between hs-CRP and OCT-NSD (r = 0.471; P = 0.0025). CONCLUSIONS: PSUA-morphology was specific in the SES group, and higher levels of OCT-NSD and hs-CRP after SES implantation suggest sustained IR in NIH compared with following BMS implantation. These different characteristics may be some of the background that promotes thrombus formation as a late-stage post-stent complication of SES.

Prevalence, clinical characteristics, and impact of active cancer in patients with acute myocardial infarction: data from an all-comer registry.

BACKGROUND: Although a history of cancer is a poor prognostic factor in patients with acute myocardial infarction (AMI), the clinical importance of coexisting active cancer remains unclear. METHODS: In this single-center retrospective study, we reviewed an AMI registry and assessed the prevalence and predictors of active cancer, 1-year incidence of cardiac death or major bleeding events (defined as a Bleeding Academy Research Consortium type 3 or 5), and the impact of coexisting active cancer on clinical outcomes. Active cancer was defined as either an already-diagnosed or undiagnosed occult cancer. RESULTS: Between January 2012 and December 2017, 1140 AMI patients (median age, 69 years; male, 76.0%) were enrolled. Active and historical cancers were diagnosed in 63 patients (5.5%) and 50 patients (4.4%), respectively. The most common location was the urinary tract (n=21). In the Kaplan-Meier analysis, the active cancer group had a higher incidence of 1-year cardiac death (17.5% vs. 5.3%, p < 0.001) and major bleeding events (19.0% vs. 5.6%, p < 0.001) than the non-cancer group. In the multivariate Cox proportional hazards regression models, active cancer was an independent predictor of both cardiac death and major bleeding at 1 year. Specifically, gastrointestinal tract and advanced-stage cancers had the poorest outcomes. Compared to the non-cancer group, the 1-year major bleeding rate was higher for all cancer types and stages. In contrast, early-stage cancers had a weaker impact on the 1-year cardiac mortality compared to advanced-stage cancers. Similarly, cardiac death during 1-year also occurred less frequently in occult cancers than in already-known cancers. CONCLUSIONS: In patients with AMI, coexisting active cancer was rare, but it significantly impacted cardiac death and major bleeding events.