Imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: The MeRes-1 extend trial.

OBJECTIVES: This study explores the safety and efficacy of thin strut MeRes100 sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with de novo coronary artery lesions. BACKGROUND: In interventional cardiology, the emergence of BRS technology is catalyzing the next paradigm shift. METHODS: The MeRes-1 Extend was a multicenter, prospective, single-arm, open-label study enrolling 64 patients in Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE) which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). The imaging efficacy endpoint was mean in-scaffold late lumen loss (LLL) evaluated by quantitative coronary angiography (QCA). Optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. RESULTS: A total of 69 target lesions were identified in 64 enrolled patients (mean age 58.30 ± 9.02 years). Of the treated lesions, 49 (71.01%) lesions were of type B2/C. Procedural and device success was achieved in 64 and 62 patients, respectively. At 2-year follow-up, MACE was reported in one patient (1.61%) in the form of ID-TLR. There was no case of MI, cardiac death or scaffold thrombosis through 2-year. In a subset of 32 patients, paired QCA showed mean in-scaffold LLL of 0.18 ± 0.31 mm at 6-month follow-up. In a subset of 21 patients, OCT revealed 97.95 ± 3.69% strut coverage with mean scaffold area of 7.56 ± 1.79 mm2 and no evidence of strut malapposition. CONCLUSIONS: The clinical and imaging outcomes of MeRes-1 Extend trial demonstrated favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions.

Near-infrared spectroscopy predicts events in men and women: Results from the Lipid Rich Plaque study.

Background: The Lipid Rich Plaque (LRP) study demonstrated that near-infrared spectroscopy imaging of non-obstructive lesions identified patients and segments at higher risk for subsequent non-culprit major adverse cardiac events (NC-MACE). Whether this is true for both men and women is not known. In this post hoc analysis of the LRP study, we sought to investigate whether the maximum 4-mm Lipid Core Burden Index (maxLCBI4mm) was of similar predictive value in men and women for NC-MACE. Methods: Patients with an evaluable maxLCBI4mm were stratified on the basis of sex at birth. A Cox proportional-hazards model was used to assess the predictive value of maxLCBI4mm on future NC-MACE at the patient and plaque levels. The primary endpoint was cumulative incidence of NC-MACE at 24 months. Results: Among 1271 patients, 388 (30.5%) were women. Women were older and had a higher cardiovascular risk profile. Cumulative incidence of NC-MACE at 24 months was 10.3% for women and 7.6% for men (log-rank p = 0.11). When comparing maxLCBI4mm > 400 to maxLCBI4mm ≤ 400, the hazard ratio (HR) for future NC-MACE was not significantly different between sexes: 2.10 (95% confidence interval [CI]: 1.28-3.44; p = 0.003) for men and 2.24 (95% CI: 1.18-4.28; p = 0.014) for women (p = 0.87). At the plaque level, the HR comparing maxLCBI4mm > 400 to maxLCBI4mm ≤ 400 was 3.49 (95% CI: 1.60-7.60, p = 0.002) for men and 4.79 (95% CI: 2.02-11.38, p < 0.001) for women, which was not significantly different (p = 0.57). Conclusions: The maxLCBI4mm was of similar predictive value for NC-MACE within 24 months in men and women.

Six-month clinical follow-up of the Tryton side branch stent for the treatment of bifurcation lesions: a two center registry analysis.

BACKGROUND: Treatment of bifurcation lesions with the Tryton Sidebranch stent has been shown to be feasible with an acceptable clinical outcome and low side branch late loss in the first in man trial. OBJECTIVE: To report acute procedural and six month clinical follow-up after the use of the Tryton Sidebranch stent in an "all comer" registry. METHODS: The first 100 coronary bifurcation lesions assigned for treatment with the Tryton stent were included in a prospective registry. Procedural and angiographic success rates were determined from patient charts and pre- and postprocedural quantitative coronary angiography. RESULTS: Totally, 96 patients with 100 lesions were included in the study. Seventy-two percent presented with stable angina, 25% with unstable angina/NSTEMI, and 3% STEMI. The bifurcation was located in the left main in 8%. Two lesions were chronic total occlusions. Sixty-nine percent were true bifurcation lesions. One failure of stent delivery occurred. Acute gain in SB was 0.76 ± 0.64 mm and three patients had residual stenosis of >30%. Angiographic success rate was 95%; procedural success rate reached 94%. Peri-procedural MI occurred in two and there was one cardiac death during hospitalization. At a median six months follow-up, TLR rate was 4%, MI 3%, and cardiac death 1%. The percentage MACE-free survival at six months was 94%. No cases of definite stent thrombosis occurred. CONCLUSIONS: In a real world the use of the Tryton Sidebranch stent is associated with good procedural safety and angiographic success rate and acceptable outcome at six months of follow-up.

Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial.

BACKGROUND: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. METHODS: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. RESULTS: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. CONCLUSIONS: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.

Adiponectin in Relation to Coronary Plaque Characteristics on Radiofrequency Intravascular Ultrasound and Cardiovascular Outcome.

BACKGROUND: Prospective data on the associations of adiponectin with in-vivo measurements of degree, phenotype and vulnerability of coronary atherosclerosis are currently lacking. OBJECTIVE: To investigate the association of plasma adiponectin with virtual histology intravascular ultrasound (VH-IVUS)-derived measures of atherosclerosis and with major adverse cardiac events (MACE) in patients with established coronary artery disease. METHODS: In 2008-2011, VH-IVUS of a non-culprit non-stenotic coronary segment was performed in 581 patients undergoing coronary angiography for acute coronary syndrome (ACS, n = 318) or stable angina pectoris (SAP, n = 263) from the atherosclerosis-intravascular ultrasound (ATHEROREMO-IVUS) study. Blood was sampled prior to coronary angiography. Coronary plaque burden, tissue composition, high-risk lesions, including VH-IVUS-derived thin-cap fibroatheroma (TCFA), were assessed. All-cause mortality, ACS, unplanned coronary revascularization were registered during a 1-year-follow-up. All statistical tests were two-tailed and p-values < 0.05 were considered statistically significant. RESULTS: In the full cohort, adiponectin levels were not associated with plaque burden, nor with the various VH-tissue types. In SAP patients, adiponectin levels (median[IQR]: 2.9(1.9-3.9) µg/mL) were positively associated with VH-IVUS derived TCFA lesions, (OR[95%CI]: 1.78[1.06-3.00], p = 0.030), and inversely associated with lesions with minimal luminal area (MLA) ≤ 4.0 mm2 (OR[95%CI]: 0.55[0.32-0.92], p = 0.025). In ACS patients, adiponectin levels (median[IQR]: 2.9 [1.8-4.1] µg/mL)were not associated with plaque burden, nor with tissue components. Positive association of adiponectin with death was present in the full cohort (HR[95%CI]: 2.52[1.02-6.23], p = 0.045) and (borderline) in SAP patients (HR[95%CI]: 8.48[0.92-78.0], p = 0.058). In ACS patients, this association lost statistical significance after multivariable adjustment (HR[95%CI]: 1.87[0.67-5.19], p = 0.23). CONCLUSION: In the full cohort, adiponectin levels were associated with death but not with VH-IVUS atherosclerosis measures. In SAP patients, adiponectin levels were associated with VH-IVUS-derived TCFA lesions. Altogether, substantial role for adiponectin in plaque vulnerability remains unconfirmed.

Additional diagnostic value of integrated analysis of cardiac CTA and SPECT MPI using the SMARTVis system in patients with suspected coronary artery disease.

UNLABELLED: CT angiography (CTA) and SPECT myocardial perfusion imaging (MPI) are complementary imaging techniques to assess coronary artery disease (CAD). Spatial integration and combined visualization of SPECT MPI and CTA data may facilitate correlation of myocardial perfusion defects and subtending coronary arteries and thus offer additional diagnostic value over either stand-alone or side-by-side interpretation of the respective datasets from the 2 modalities. In this study, we investigated the additional diagnostic value of a software-based CTA/SPECT MPI image fusion system over conventional side-by-side analysis in patients with suspected CAD. METHODS: Seventeen symptomatic patients who underwent both CTA and SPECT MPI within a 90-d period were included in our study; 7 of them also underwent invasive coronary angiography (ICA). The potential benefits of the synchronized multimodal heart visualization (SMARTVis) system in assessing CAD were investigated through a case study involving 4 experts from 2 medical centers, in which we performed, first, a side-by-side analysis using structured CTA and SPECT reports and, second, an integrated analysis using the SMARTVis system in addition to the reports. RESULTS: The fused interpretation led to a more accurate diagnosis, reflected in an increase in the individual observers' sensitivity and specificity to correctly refer for invasive angiography eventually followed by revascularization. For the first, second, third, and fourth observers, the respective sensitivities improved from 50%, 60%, 80%, and 80% to 70%, 80%, 100%, and 90% and the respective specificities from 100%, 94%, 83%, and 83% to 100%, 100%, 94%, and 83%. Additionally, the interobserver diagnosis agreement increased from 74% to 84%. The improvement was primarily found in patients presenting with CAD in more vessels than the number of reported perfusion defects. CONCLUSION: Integrated analysis of cardiac CTA and SPECT MPI using the SMARTVis system results in an improved diagnostic performance.

Circulating cytokines in relation to the extent and composition of coronary atherosclerosis: results from the ATHEROREMO-IVUS study.

OBJECTIVE: We investigated whether concentrations of TNF-α, TNF-ß, TNF-receptor 2, interferon-γ, IL-6, IL-8, IL-10 and IL-18 are associated with extent and composition of coronary atherosclerosis determined by grayscale and virtual histology (VH)- intravascular ultrasound (IVUS). METHODS: Between 2008 and 2011, IVUS(-VH) imaging of a non-culprit coronary artery was performed in 581 patients (stable angina pectoris (SAP), n = 261; acute coronary syndrome (ACS), n = 309) undergoing coronary angiography from the ATHEROREMO-IVUS study. Plaque burden, presence of VH-IVUS-derived thin-cap fibroatheroma (TCFA) lesions, and presence of VH-TCFA lesions with plaque burden ≥70% were assessed. Blood samples for cytokine measurement were drawn from the arterial sheath prior to the angiography procedure. We applied linear and logistic regression. RESULTS: TNF-α levels were positively associated with plaque burden (beta (ß) [95%CI]: 4.45 [0.99-7.91], for highest vs lowest TNF-α tertile) and presence of VH-TCFA lesions (odds ratio (OR) [95%CI] 2.30 (1.17-4.52), highest vs lowest TNF-α tertile) in SAP patients. Overall, an inverse association was found between IL-10 concentration and plaque burden (ß [95%CI]: -1.52 [-2.49 to -0.55], per Ln (pg/mL) IL-10) as well as IL-10 and VH-TCFA lesions with plaque burden ≥70% (OR: 0.31 [0.12-0.80],highest vs lowest IL-10 tertile). These effects did not reach statistical significance in the separate SAP and ACS groups. CONCLUSION: Higher circulating TNF-α was associated with higher plaque burden and VH-TCFA lesions in SAP patients. Lower circulating IL-10 was associated with higher plaque burden and large VH-TCFA lesions. These in-vivo findings suggest a role for these cytokines in extent and vulnerability of atherosclerosis.

Adiponectin in Relation to Coronary Plaque Characteristics on Radiofrequency Intravascular Ultrasound and Cardiovascular Outcome / Relação da Adiponectina com as Características da Placa Aterosclerótica ao Ultrassom Intravascular com Radiofrequência e Desfechos Cardiovasculares

Abstract Background: Prospective data on the associations of adiponectin with in-vivo measurements of degree, phenotype and vulnerability of coronary atherosclerosis are currently lacking. Objective: To investigate the association of plasma adiponectin with virtual histology intravascular ultrasound (VH-IVUS)-derived measures of atherosclerosis and with major adverse cardiac events (MACE) in patients with established coronary artery disease. Methods: In 2008-2011, VH-IVUS of a non-culprit non-stenotic coronary segment was performed in 581 patients undergoing coronary angiography for acute coronary syndrome (ACS, n = 318) or stable angina pectoris (SAP, n = 263) from the atherosclerosis-intravascular ultrasound (ATHEROREMO-IVUS) study. Blood was sampled prior to coronary angiography. Coronary plaque burden, tissue composition, high-risk lesions, including VH-IVUS-derived thin-cap fibroatheroma (TCFA), were assessed. All-cause mortality, ACS, unplanned coronary revascularization were registered during a 1-year-follow-up. All statistical tests were two-tailed and p-values < 0.05 were considered statistically significant. Results: In the full cohort, adiponectin levels were not associated with plaque burden, nor with the various VH-tissue types. In SAP patients, adiponectin levels (median[IQR]: 2.9(1.9-3.9) µg/mL) were positively associated with VH-IVUS derived TCFA lesions, (OR[95%CI]: 1.78[1.06-3.00], p = 0.030), and inversely associated with lesions with minimal luminal area (MLA) ≤ 4.0 mm2 (OR[95%CI]: 0.55[0.32-0.92], p = 0.025). In ACS patients, adiponectin levels (median[IQR]: 2.9 [1.8-4.1] µg/mL)were not associated with plaque burden, nor with tissue components. Positive association of adiponectin with death was present in the full cohort (HR[95%CI]: 2.52[1.02-6.23], p = 0.045) and (borderline) in SAP patients (HR[95%CI]: 8.48[0.92-78.0], p = 0.058). In ACS patients, this association lost statistical significance after multivariable adjustment (HR[95%CI]: 1.87[0.67-5.19], p = 0.23). Conclusion: In the full cohort, adiponectin levels were associated with death but not with VH-IVUS atherosclerosis measures. In SAP patients, adiponectin levels were associated with VH-IVUS-derived TCFA lesions. Altogether, substantial role for adiponectin in plaque vulnerability remains unconfirmed.

Resumo Fundamento: Faltam dados prospectivos sobre as associações de adiponectina com medidas in-vivo de grau, fenótipo e vulnerabilidade da aterosclerose coronariana. Objetivo: Investigar a associação da adiponectina plasmática com medidas de aterosclerose derivadas de ultrassonografia virtual intravascular (VH-IVUS) e eventos cardíacos adversos importantes (major adverse cardiac events - MACE) em pacientes com doença arterial coronariana estabelecida. Métodos: Em 2008-2011, a VH-IVUS de um segmento coronariano não estenótico não culpado foi realizado em 581 pacientes submetidos à angiografia coronariana para síndrome coronariana aguda (SCA, n = 318) ou angina pectoris estável (APE, n = 263) a partir do estudo de ultrassonografia aterosclerótica-intravascular (ATHEROREMO-IVUS). Sangue foi amostrado antes da angiografia coronária. Foram avaliados a carga de placa coronária, a composição tecidual, as lesões de alto risco, incluindo fibroateroma de capa fina (FCF) derivado de VH-IVUS. Mortalidade por todas as causas, SCA, e revascularização coronária não planejada foram registradas durante um ano de acompanhamento. Todos os testes estatísticos foram bicaudais e os valores de p < 0,05 foram considerados estatisticamente significativos. Resultados: Na coorte completa, os níveis de adiponectina não foram associados à carga de placa, nem a vários tipos de tecido virtual histológico. Entre os pacientes com APE, os níveis de adiponectina (mediana[IIQ]: 2,9(1,9-3,9) µg/mL) foram associados positivamente às lesões FCF derivadas de VH-IVUS, (OR[IC 95%]: 1,78[1,06-3,00], p = 0,030), e inversamente associados a lesões com área luminal mínima (ALM) ≤4,0 mm2 (OR[IC 95%]: 0,55[0,32-0,92], p = 0,025). Em pacientes com SCA, os níveis de adiponectina (mediana[IIQ]: 2,9 [1,8-4,1] µg/mL) não foram associados à carga de placa nem a componentes teciduais. A associação positive de adiponectina ao óbito esteve presente na coorte completa (HR[IC 95%]: 2,52[1,02-6,23], p = 0,045) e (limítrofe) em pacientes com APE (HR[IC 95%]: 8,48[0,92-78,0], p = 0,058). Entre pacientes com SCA, essa associação perdeu significância estatística após ajuste multivariado (HR[IC 95%]: 1,87[0,67-5,19], p = 0,23). Conclusão: Na coorte completa, os níveis de adiponectina foram associados à obito, mas não a medidas de aterosclerose por VH-IVUS. Em pacientes com APE, os níveis de adiponectina foram associados a lesões FCF derivadas de VH-IVUS. Em geral, o papel da adiponectina na vulnerabilidade da placa permanece não confirmado.