The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study.

BACKGROUND: Percutaneous coronary intervention (PCI) is one of the most performed well-succeeded therapeutic procedures worldwide, reducing symptoms and improving quality of life. Neutrophil Gelatinase-associated Lipocalin (NGAL) is a biomarker of acute kidney injury (AKI) produced early after an ischemic renal insult. Osmotic diuresis and the vasoconstriction of the afferent arteriole promoted by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) generate a concern regarding the possibility of dehydration and consequent AKI. There is no consensus on the maintenance or discontinuation of SGTL2i in patients who will undergo PCI. This study aimed to evaluate the safety of empagliflozin in diabetic patients submitted to elective PCI regarding kidney function. METHODS: SAFE-PCI trial is a prospective, open-label, randomized (1:1), single-center pilot study and a follow-up of 30 days. The SGLT2i empagliflozin 25 mg daily was initiated at least 15 days before PCI in the intervention group and maintained until the end of the follow-up period. Serum NGAL was collected 6 h after PCI and creatinine before PCI, 24 h, and 48 h after the procedure. As per protocol, both groups received optimal medical treatment and standard protocol of nephroprotection. RESULTS: A total of 42 patients were randomized (22 patients in the iSGLT-2 group and 20 patients in the control group). There was no difference between-group baseline data. The primary outcome (NGAL and creatinine values post PCI) did not differ in both groups: the mean NGAL value was 199 ng/dL in the empagliflozin group and 150 ng/dL in the control group (p = 0.249). Although there was an initial increase in creatinine in the SGLT-2i group compared to the control group between baseline creatinine and pre-PCI and 24 h post-PCI creatinine, no difference was detected in creatinine 48 h post-PCI (p = 0.065). The incidence of CI-AKI, determined by KDIGO criteria, in the iSGLT2-group was 13.6% and 10.0% in the control group without statistical difference. CONCLUSION: The present study showed that the use of empagliflozin is safe regarding kidney function during elective PCI in patients with T2D when compared with no use of SGLT2i. Trial registration Our clinical study is registered on ClinicalTrials.gov with the following number: NCT05037695.

Impact of endothelial shear stress on absorption process of resorbable magnesium scaffold: A BIOSOLVE-II substudy

BACKGROUND/PURPOSE: Local hemodynamic forces such as endothelial shear stress (ESS) may have an influence on appropriate neointimal healing, vessel remodeling, and struts absorption process following second-generation drug-eluting resorbable magnesium scaffold (RMS, Magmaris, Biotronik AG, Buelach, Switzerland) placement. The aim of this study was to investigate the impact of ESS assessed by optical coherence tomography (OCT)- based computational fluid dynamic (CFD) simulations on absorption process and coronary lumen dimension after Magmaris implantation. METHODS AND RESULTS: A total of 22 patients who were enrolled in the BIOSOLVE-II trial and underwent serial OCT assessment immediately after Magmaris implantation and at 6- and 12-month follow-up were included. We evaluated qualitative OCT findings frame by frame, and CFD simulations were performed to calculate the ESS at 3-dimensional (3D) reconstructed arteries. For quantitative calculation, the average ESS within each 1-mm section was classified into three groups: low (2.5 Pa). A significant difference of percentage remnants of scaffold was observed among the 3 groups at 12-month follow-up (P = 0.001) but not at 6-month follow-up. Low-ESS segment at baseline resulted in a greater lumen change of −1.857 ± 1.902 mm2 at 1 year compared to −1.277 ± 1.562 mm2 in the intermediate-ESS segment (P = 0.017) and − 0.709 ± 1.213 mm2 in the high-ESS segment (P = 0.001). CONCLUSION: After Magmaris implantation, the presence of higher ESS might be associated with slower strut absorption process but less luminal loss. SUMMARY FOR TABLE OF CONTENTS: The authors analyzed 22 patients from the BIOSOLVE-II trial who underwent optical coherence tomography assessment immediately after receiving a Magmaris second-generation drug-eluting resorbable magnesium scaffold. The analysis found that after Magmaris implantation, the presence of higher endothelial shear stress (ESS) might be associated with slower strut absorption process but less luminal loss. This study is the first demonstrating the impact of ESS assessed by OCT on absorption process and coronary lumen dimension after Magmaris implantation.

Impact of Endothelial Shear Stress on Absorption Process of Resorbable Magnesium Scaffold: A BIOSOLVE-II Substudy.

BACKGROUND/PURPOSE: Local hemodynamic forces such as endothelial shear stress (ESS) may have an influence on appropriate neointimal healing, vessel remodeling, and struts' absorption process following second-generation drug-eluting resorbable magnesium scaffold (RMS, Magmaris, Biotronik AG, Buelach, Switzerland) placement. The aim of this study was to investigate the impact of ESS assessed by optical coherence tomography (OCT)-based computational fluid dynamic (CFD) simulations on absorption process and coronary lumen dimension after Magmaris implantation. METHODS AND RESULTS: A total of 22 patients who were enrolled in the BIOSOLVE-II trial and underwent serial OCT assessment immediately after Magmaris implantation and at 6- and 12-month follow-up were included. We evaluated qualitative OCT findings frame by frame, and CFD simulations were performed to calculate the ESS at 3-dimensional (3D) reconstructed arteries. For quantitative calculation, the average ESS within each 1-mm section was classified into three groups: low (<1.0 Pa), intermediate (1.0-2.5 Pa), or high (>2.5 Pa). A significant difference of percentage remnants of scaffold was observed among the 3 groups at 12-month follow-up (P = 0.001) but not at 6-month follow-up. Low-ESS segment at baseline resulted in a greater lumen change of -1.857 ± 1.902 mm2 at 1 year compared to -1.277 ± 1.562 mm2 in the intermediate-ESS segment (P = 0.017) and - 0.709 ± 1.213 mm2 in the high-ESS segment (P = 0.001). CONCLUSION: After Magmaris implantation, the presence of higher ESS might be associated with slower strut absorption process but less luminal loss.

Natural History of Adapted Leaman Score Assessing Coronary Artery Disease Progression by Computed Tomography Angiography: A 7-Year Follow-Up Report.

BACKGROUND: Coronary computed tomographic angiography (CCTA) provides a non-invasive assessment of the coronary artery tree. Computed Tomography - adapted Leaman Score (CT-LeSc) has been shown to be an independent predictor of cardiac events in coronary artery disease (CAD) patients with a score greater than 5 (high). PURPOSE: To investigate the relationship between CT-LeSc and the progression of CAD and to provide vessel- and segment-level CAD qualification and quantification at baseline and 7-year follow-up. METHODS: Patients with multivessel CAD and CCTA assessments at baseline and follow-up were included. The CT-LeSc analysis was performed in a paired fashion. The patient-level scores and the differences between each phase were assessed by 2 analysts in an independent core laboratory. RESULTS: This study analyzed 248 coronary segments from 17 patients with a mean follow-up interval of 7.5 ± 0.6 years. The mean CT-LeSc at baseline and follow-up were 14.6 ± 4.2 and 16.9 ± 1.5, respectively, with an absolute increase of 2.3 ± 1.8. The mean cumulative increase of new lesions was 0.2 ± 0.2 per year. Over time, 14.6% of the non-obstructive lesions became obstructive, and 15.0% of the non-calcified plaques became calcified. There were 29 new lesions found at follow-up, and out of these, 16 were obstructive and 19 were non-calcified. CONCLUSION: In patients at high risk for cardiac events, as determined by CT-LeSc, there was an increase in CT-LeSc, obstructive lesions, and calcified plaques over the 7-year follow-up period. Most of the new lesions were obstructive and non-calcified. This is the first report showing long-term serial imaging CCTA changes in a high-risk population.

Comparison of Patterns of Coronary Artery Disease in Patients With Heart Failure by Cardiac Amyloidosis Status.

BACKGROUND/PURPOSE: The aim of this study is to characterize the pattern and the severity of coronary artery lesions in cardiac amyloidosis. METHODS: We retrospectively compared patients with heart failure who tested positive (i.e., biopsy or gene tests - HF/CA+) against those who tested negative (HF/CA-) for cardiac amyloidosis. Groups were compared demographically and angiographically for qualitative and quantitative variables to determine patterns of involvement in the major epicardial coronary vessels. RESULTS: The study included 110 heart failure patients, of whom 55 patients (88 lesions) were in the HF/CA+ group, and 55 patients (66 lesions) were HF/CA-. Despite the advanced age of HF/CA+ patients (74.5 ± 11.0 years vs. 54.1 ± 15.0 years; p = 0.05), no severe calcification was found in the HF/CA+ group (0.0% vs. 4.5%; p = 0.018). The HF/CA+ group also had fewer ostial lesions (3.4% vs. 15.1%; p = 0.0095) and a higher, albeit not significant, Thrombolysis in Myocardial Infarction frame count (30.4 ± 12.6 vs. 26.6 ± 11 frames; p = 0.06). In the HF/CA+ group, men had a significant number of tandem lesions compared to women (14.5% vs 0.0%, p = 0.02). CONCLUSIONS: Overall, heart failure patients with cardiac amyloidosis were older but were found to have less calcified lesions, less ostial involvement, and a reduced anterograde coronary blood flow. This is the first report examining coronary lesions in heart failure patients with cardiac amyloidosis.

Correlation between computed tomography adapted leaman score and computed tomography liver and spleen attenuation parameters for non-alcoholic fatty liver disease as well as respective inflammatory mediators.

Metabolic syndrome is a primary driver of vascular inflammation, plaque development, and atherosclerotic disease. The Computed Tomography-adapted Leaman Score (CT-LeSc) has been shown to be an independent predictor of cardiac events in coronary artery disease (CAD) patients but has never been studied for broader applicability. Non-alcoholic fatty liver disease (NAFLD) is associated with similar systemic inflammatory processes as CAD, and its presence as assessed by Computed Tomography Liver and Spleen Attenuation (CT-LSA) may impact on the extension of the CT-LeSc. The purpose of this study was to investigate the association between the CT-LeSc and NAFLD and to characterize and compare the inflammatory processes of each disease state. This was an exploratory study in which patients with known multivessel CAD who were scheduled to undergo percutaneous coronary intervention were included. CT-LeSc were graded on pre-existing criteria by two independent CoreLab analysts. CT-LSA parameters analyzed included the liver absolute attenuation value, liver and spleen attenuation difference and liver-to-spleen attenuation ratio and were scored by two independent CoreLab analysts as well. Inflammatory mediator analysis included routine laboratory draws for a variety of known signal molecules. The overall liver absolute attenuation value did not correlate significantly with the CT-LeSc, but the subgroup 50 to 65 HU showed moderately negative correlation (R = - 0.629; p = 0.008). The overall liver and spleen attenuation difference did not correlate significantly with the CT-LeSc, but the subgroup 1 to 18 HU showed moderately positive correlation (R = 0.513; p = 0.017). The overall and subgroup liver-to-spleen attenuation ratio did not correlate with the CT-LeSc. The eosinophil and leukocyte ratio showed weakly negative correlation with the overall CT-LeSc (R = - 0.4602; p = 0.008), and VCAM-1 showed moderately negative correlation with CT-LeSc < 16.0 (R = - 0.5678; p = 0.022). Some CT-LSA parameters correlate with high risk CT-LeSc and may both provide complementary information for cardiovascular risk stratification. The significant metrics of liver absolute attenuation value and liver and spleen attenuation difference can be quickly completed in the clinical setting and may support a suspicion of CAD.

Comprehensive assessment of coronary computed tomography angiography by using Leaman and Leiden score in overweight and obese patients.

Coronary computed tomography angiography (CCTA) is a non-invasive modality used to assess for coronary artery disease. The CT Leaman and Leiden scores utilize coronary plaque location, composition and severity of stenosis to risk stratify patients for cardiovascular events with remarkable precision. This study compares the CCTA Leaman and Leiden score between overweight and obese populations in addition to their associated baseline characteristics. All patients who underwent CCTA within the last 1 year from a single institution were included for initial analysis. Body mass index (BMI) was used to classify patients who were overweight (25.0 to < 30 kg/m2) or obese (≥ 30 kg/m2). Patients with a BMI of < 25 kg/m2 were excluded from further analysis. Patients were divided into overweight and obese groups. CT Leaman and Leiden scores, in addition to baseline characteristics were subsequently compared between the two groups. Overall, a strong correlation between CT Leaman and Leiden scores was found (R2 = 0.9831). Patients classified as obese have more coronary lesions 0.71 ± 0.12 vs 0.31 ± 0.50 in overweight patients (p = 0.02) and tended to have a higher positive CT Leiden (5.47 ± 4.10 vs 3.90 ± 1.36, p = 0.2) and Leaman (3.45 ± 2.58 vs 2.35 ± 0.90, p = 0.1). Furthermore, obese patients with a Leiden score > 5 had significantly higher scores compared to overweight patients (10.22 ± 2.54 vs 5.87 ± 0.64, p = 0.016). Obese patients had similar average CT Leaman and Leiden scores compared to overweight individuals but were more likely to have higher CT Leiden scores > 5 which may indicate a higher risk for adverse cardiovascular outcomes.

Periprocedural Myocardial Injury: Pathophysiology, Prognosis, and Prevention.

The definition and clinical implications of myocardial infarction occurring in the setting of percutaneous coronary intervention have been the subject of unresolved controversy. The definitions of periprocedural myocardial infarction (PMI) are many and have evolved over recent years. Additionally, the recent advancement of different imaging modalities has provided useful information on a patients' pre-procedural risk of myocardial infarction. Nonetheless, questions on the benefit of different approaches to prevent PMI and their practical implementation remain open. This review aims to address these questions and to provide a current and contemporary perspective.

Novel Indices of Coronary Physiology: Do We Need Alternatives to Fractional Flow Reserve?

Fractional flow reserve is the current invasive gold standard for assessing the ischemic potential of an angiographically intermediate coronary stenosis. Procedural cost and time, the need for coronary vessel instrumentation, and the need to administer adenosine to achieve maximal hyperemia remain integral components of invasive fractional flow reserve. The number of new alternatives to fractional flow reserve has proliferated over the last ten years using techniques ranging from alternative pressure wire metrics to anatomic simulation via angiography or intravascular imaging. This review article provides a critical description of the currently available or under-development alternatives to fractional flow reserve with a special focus on the available evidence, pros, and cons for each with a view towards their clinical application in the near future for the functional assessment of coronary artery disease.

Coronary Artery Disease Assessed by Computed Tomography-Based Leaman Score in Patients With Low-Risk Transcatheter Aortic Valve Implantation.

We aimed to evaluate the burden of coronary artery disease (CAD) using the computed tomography (CT) Leaman score in low-risk transcatheter aortic valve implantation (TAVI) patients. The extent of CAD in low-risk patients with aortic stenosis who are candidates for TAVI has not been accurately quantified. The CT Leaman score was developed to quantify coronary CT angiography (CCTA) atherosclerotic burden and has been validated to evaluate the extent of CAD. CT Leaman score >5 has been associated with an increase in major adverse cardiac events over long-term follow-up. The study population included patients enrolled in the Low Risk TAVI trial who underwent CCTA before the procedure. For the CT Leaman score, we used 3 sets of weighting factors: (1) location of coronary plaques, (2) type of plaque, and (3) degree of stenosis. A total of 200 patients were enrolled in the Low Risk TAVI trial. Excluded were 31 patients who had no analyzable CCTA imaging. For the remaining 169 patients, the mean CT Leaman score was 6.27 ± 0.27, of whom 102 (60.4%) had CT Leaman score >5. Nearly all analyzed patients (97%) had coronary plaques. Furthermore, 33 patients (19.5%) had potentially obstructive coronary plaques (>50% stenosis by CCTA) in proximal segments. Most low-risk TAVI patients have significant CAD burden by CCTA. It should be a priority for future TAVI devices to guarantee unimpeded access to the coronary arteries for selective angiography and interventions.

Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality.

Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial disease.

Comparison of quantitative flow ratio value of left anterior descending and circumflex coronary artery in patients with Takotsubo syndrome.

Takotsubo syndrome (TTS) is an acute cardiac event without epicardial coronary obstruction but often with reversible ventricular motion abnormalities. Quantitative flow ratio (QFR) is a novel approach to evaluate the coronary stenosis significance on the basis of 3-dimensional quantitative coronary angiography (3D-QCA) and contrast flow by Thrombolysis in Myocardial Infarction frame count. This study aimed to evaluate and compare the QFR value in the left anterior descending artery (LAD) and the left circumflex artery (LCx) in patients with TTS. This retrospective and observational study enrolled 30 patients with TTS who underwent coronary angiography. We evaluated the QFR data using the 3D-QCA analysis and compared the QFR data in the LAD and the LCx. No significant differences were observed in terms of flow velocity, percent diameter stenosis, minimum lumen diameter, and reference diameter between LAD and LCx. However, vessel QFR in the LAD was significantly reduced compared with that in the LCx (0.98 [0.94 to 0.99] vs. 1.00 [0.99 to 1.00], P < 0.001). Ejection fraction at baseline and initial troponin-I levels were not correlated with the vessel QFR both in the LAD and the LCx. The QFR value in the LAD was significantly reduced compared to that in the LCx in patients with TTS.

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials.

BACKGROUND: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. METHODS: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. RESULTS: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ±â€¯10.8 and 62.7 ±â€¯10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. CONCLUSION: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

Second-Generation Drug-Eluting Resorbable Magnesium Scaffold: Review of the Clinical Evidence.

Since October 8, 2013, the second-generation drug-eluting resorbable magnesium scaffold (RMS) has been used to treat coronary lesions. At present, the second-generation drug-eluting RMS is clinically available in Europe, some South American countries, and some Asian and African countries. Furthermore, patients are currently being enrolled in ongoing post-marketing trials. This device has the potential to be an alternative to drug-eluting stents in the future, but there is not yet sufficient evidence. This review provides the latest available evidence, comparison with other bioresorbable scaffolds, future perspectives, and discussion of clinical case reports with second-generation drug-eluting RMS. SUMMARY: Favorable outcomes have been reported after second-generation drug-eluting RMS implantation. More long-term clinical outcomes for this novel device are still required in the future.

Feasibility of a Porcine Arteriovenous Shunt Model for Assessment of Acute Thrombogenicity in Bifurcation Stenting Technique By Optical Coherence Tomography.

BACKGROUND: Double kissing (DK) crush stenting has been reported as a superior bifurcation stenting strategy compared to culotte stenting. However, the mechanism associated with the reduction of clinical events by DK crush stenting remains unclear. We therefore investigated the thrombogenicity of DK crush stenting and culotte stenting with both bare-metal stents (BMS) and drug-eluting stents (DES) and the feasibility of a novel porcine arteriovenous shunt model. METHODS: High-resolution intracoronary imaging with optical coherence tomography (OCT) evaluated the bifurcation stenting models for thrombogenicity. RESULTS: All porcine models retained continuous circulation without blood leakage. Thrombus was macroscopically demonstrated around the bifurcation in all settings. The volume of thrombus (mm3) with BMS using DK crush/culotte and DES using DK crush/culotte were 1.38/1.19 and 0.09/0.15, respectively. Culotte stenting had more thrombus in the proximal main branch, and DK crush stenting had more at the bifurcation. Unlike DK crush stenting, culotte stenting showed malapposition in the proximal main branch and bifurcation segments. CONCLUSION: The feasibility of a porcine arteriovenous shunt model to assess thrombogenicity by OCT in bifurcation stenting technique was confirmed. OCT detected less thrombogenicity in DES when used in the bifurcation model when compared to BMS.

Impact of periprocedural biomarker elevation on mortality in stable angina pectoris patients undergoing elective coronary intervention: a systematic review and meta-analysis including 24 666 patients.

BACKGROUND: Uncertainty remains regarding the exact prognostic impact of biomarker elevation following percutaneous coronary intervention in patients with stable angina pectoris and the subsequent risk of death. We sought, therefore, to evaluate the effect of periprocedural myocardial infarction on the subsequent mortality risk following percutaneous coronary intervention in patients with stable angina pectoris and normal preprocedural cardiac biomarkers level. METHODS: After a systematic literature search was done in PubMed and EMBASE, we performed a meta-analysis of studies with post-procedural cardiac biomarkers data. All-cause mortality and cardiac death were evaluated in subjects with stable angina pectoris who underwent an elective coronary intervention. RESULTS: Fourteen studies with 24 666 patients were included. The mean age was 64.2 years ± 9.8 with about 3-quarters (74.9%) of these patients being men. The mean duration of follow-up was 18.1 months ± 14.3. Periprocedural myocardial infarction, based on study-specific biomarker criteria, occurred in 14.3% of the patients. Periprocedural myocardial infarction conferred a statistically significant increase in the risk of all-cause mortality (odds ratio, 1.62; 95% confidence interval, 1.30-2.01; P < 0.0001; I = 0%); where reported separately, cardiac death was also significantly increase (odds ratio, 2.77; 95% confidence interval, 1.60-4.80; P = 0.0003; I = 0%). CONCLUSION: The occurrence of periprocedural myocardial infarction after an elective percutaneous coronary intervention in patients with stable angina pectoris is associated with a statistically significant increase in subsequent all-cause mortality and cardiac mortality.

Impact of procedural characteristics on coronary vessel wall healing following implantation of second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary artery lesions: an optical coherence tomography analysis

AIMS : Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is an alternative novel device for treating coronary lesions. However, the relationship between in-scaffold dimensions after implantation of DREAMS 2G and vessel healing and luminal results at follow-up is unknown. The aim of this study is, therefore, to investigate whether the expansion index after implantation of DREAMS 2G as assessed by optical coherence tomography (OCT) impacts late luminal status and healing of the vessel wall. METHODS AND RESULTS : This study comprises of a total 65 out of 123 patients who were enrolled in the BIOSOLVE-II trial. We assessed both qualitative and quantitative OCT findings and the expansion index of DREAMS 2G after implantation frame by frame using OCT. Expansion index was defined as minimum scaffold area/mean reference lumen area. The over-expansion group was also defined with expansion index >1.0. The total number of analyzed frames at post-procedure and 6-month follow-up was 8243 and 8263 frames, respectively. At 6-month follow-up, in-scaffold healing was documented by the reduction of 82% in dissections, 93% in attached intra-luminal mass (ILM), 65% in non-attached ILM, and 76% in jailed side branch. The over-expansion group had significantly greater in-scaffold luminal volume loss (LVL) compared with the non-over-expansion group [over-expansion: 35.0 (18.5-52.1) mm3 vs. non-over-expansion: 21.0 (11.6-37.9) mm3, P = 0.039]. CONCLUSION : Excellent in vivo healing process after implantation of DREAMS 2G was observed at 6 months. We found that higher expansion indices were associated with higher in-scaffold LVL at 6 months assessed by OCT. (AU)

Impact of two formulas to calculate percentage diameter stenosis of coronary lesions: from stenosis models (phantom lesion model) to actual clinical lesions.

Percentage diameter stenosis (%DS) by angiography is still commonly used to determine luminal obstruction of coronary artery disease (CAD) lesions. While visual estimation of %DS is widespread, because of high inter-operator variability, quantitative coronary arteriography (QCA) analysis is the gold standard. There are two %DS formulas: %DS1 averages the proximal and distal reference vessel diameter (RVD); %DS2 interpolates the RVD. This study aims to evaluate the difference between %DS assessed by QCA in two datasets, phantom lesion models and CAD patients. Ten phantom lesion models (PLMs) and 354 CAD lesions from the FIRST trial were assessed by QCA. In the latter, two scenarios were assessed: Scenario A (worst view), the most common approach in the clinical setting; and Scenario B (average of two complementary views), the standard core-laboratory analysis. In the PLMs, %DS1 and %DS2 mean ± standard deviation (median) was 58.5 ± 21.7 (61.6) and 58.7 ± 21.6 (61.8), respectively, with a signed difference of - 0.2% ± 0.3% (- 0.1%). In Scenario A, the mean %DS1 was 43.8 ± 9.1 (43.3) and 44.0 ± 9.1 (42 .9) in %DS2. In Scenario B, the mean %DS1 was 45.3 ± 8.8 (45.1) and 45.5 ± 9.0 (45.1) in %DS2. The signed difference was - 0.2% ± 2.4% (0.0%) and - 0.2% ± 2.1% (0.0%) in Scenario A and B, respectively. These differences between formulas ranged from - 1.2 to 0.5% for the phantom cases compared to - 17.7% to 7.7% in Scenario A and to - 15.5% to 7.1% in Scenario B. Although the overall means of the formulas provide similar results, significant lesion-level differences are observed. The use of the worst view versus the average of two views provided similar results.