Double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing PCI: The BLADE-PCI trial.

BACKGROUND: Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM. METHODS: Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography. RESULTS: From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups. CONCLUSIONS: Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.

A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial.

BACKGROUND: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. AIMS: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. METHODS: Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001). RESULTS: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group. CONCLUSIONS: The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.

A head-to-head comparison of wall motion score index, force, strain, and ejection fraction for the prediction of SYNTAX and Gensini coronary scores by dobutamine stress echocardiography.

BACKGROUND: Predicting the severity of coronary artery disease (CAD) may be possible during dobutamine stress echocardiography (DSE) with various indices of left ventricular function. AIMS: We assessed the relative value of ejection fraction (EF), force, global longitudinal strain (GLS), and wall motion score index (WMSI) in predicting SYNTAX and Gensini scores in patients with known or suspected CAD. METHODS: We prospectively enrolled 223 patients (120 men; mean [SD] age, 62 [9] years) and assessed the following indices: 1) EF (with triplane imaging); 2) force, calculated as the ratio of systolic blood pressure to left ventricular end­systolic volume; 3) GLS; 4) WMSI. All patients underwent coronary angiography within 12 weeks with SYNTAX and Gensini scores evaluation. RESULTS: The correlation of SYNTAX and Gensini scores was highest with peak WMSI (SYNTAX, rho = 0.591; Gensini, rho = 0.612; P <0.001), intermediate with peak force (SYNTAX, rho = -0.346; Gensini, rho = -0.377; P <0.001) and GLS (SYNTAX, rho = -0.205; P = 0.002 and Gensini rho = -0.216; P = 0.001), and the weakest for EF (SYNTAX, rho = -0.149; P = 0.03 and Gensini, rho = -0.191; P = 0.006). The similar hierarchy of variables was detected for changes during DSE. In the subgroup after myocardial infarction (n = 66 [27%]), GLS outperformed the force. CONCLUSIONS: In patients with CAD at DSE peak, theWMSI and force were better predictors of the coronary SYNTAX and Gensini scores and CAD severity than GLS or EF. However, in patients after myocardial infarction, the GLS correlation with coronary scores improved and got closer to the visual assessment.

Prevalence of hepatitis C virus infection in patients hospitalised for ischemic heart disease versus controls - PRO-CARDIO-C study.

AIM OF THE STUDY: Ongoing national screening programmes suggest that the prevalence of chronic hepatitis C (CHC) in Poland ranges between 0.5% and 1%. It has been recently noted that patients with confirmed coronary artery disease may be at higher risk for hepatitis C virus (HCV) infection. MATERIAL AND METHODS: Testing for the presence of anti-HCV antibodies was performed in a group of patients admitted to the Cardiology Department with symptomatic ischemic heart disease (IHD) and in patients hospitalised in the Dermatology Department. RESULTS: A total of 1171 patients underwent anti-HCV testing: 672 patients in the Cardiology Department (K group) and 499 patients in the Dermatology Department (D group). Twenty-eight (2.4%) positive anti-HCV results were detected. The prevalence of positive anti-HCV antibodies in groups K and D was 2.23% and 2.61%, respectively (p > 0.05). Presence of HCV RNA was confirmed in 15 cases (1.28%) - 7 patients in group K and 8 patients in group D (1.04% and 1.6%, respectively; p > 0.05). CONCLUSIONS: Our findings suggest that this patient cohort has increased risk of HCV infection, which may influence screening strategies.

Relative value of serum pregnancy-associated plasma protein A (PAPP-A) and GRACE score for a 1-year prognostication: A complement to calculation in patients with suspected acute coronary syndrome.

BACKGROUND: The Global Registry of Acute Coronary Events (GRACE) study produced a scale for risk stratification in acute coronary syndromes (ACSs). Pregnancy-associated plasma protein A (PAPP-A) serum concentration was implicated as a marker of unstable atherosclerotic plaques. OBJECTIVES: We hypothesized that the measurement of the concentration of PAPP-A on admission may improve the stratification of cardiovascular risk in suspected ACS patients. MATERIAL AND METHODS: We studied 70 patients with chest pain suggesting ACS diagnosis on admission. Serum cardiac biomarkers and PAPP-A were measured on top of the standard biochemical panel, and the GRACE risk score was calculated. A 12-month follow-up was completed to major adverse cardiac events (MACE): death, myocardial infarction (MI), need for percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG), unplanned cardiovascular hospitalization. RESULTS: In hospital/6-month GRACE, low risk was found in 35 patients (50%)/37 patients (53%), intermediate risk in 23 patients (33%)/21 patients (30%) and high risk in 12 patients (17%)/12 patients (17%). Mean PAPP-A was 39.64 mlU/L (standard deviation - SD 24.2), and median PAPP-A values for in hospital/6-month GRACE were 21.49 mlU/L (quartile 1st; 3rd - 13.41; 32.65) and 22.61 mlU/L (14.03; 34.1) for low risk patients, 51.76 mlU/L (35.18; 59.99) and 51.76 mlU/L (28.9; 62.1) for intermediate risk patients, and 68.82 mlU/L (58.54; 83.76) for high risk patients. The PAAP-A concentration with specific cut-off points had 66.7% positive predictive value (PPV) and 95.5% negative predictive value (NPV) for death, 33.3% PPV and 80.6% NPV for MI, 71.4% PPV and 57.1% NPV for any event. Intermediate and high in hospital/6-months GRACE had 14.3%/15.2% PPV and 100%/100% NPV for death, 34.3%/33.3% PPV and 94.3%/91.9% NPV for MI, 74.3%/72.7% PPV and 65.7%/62.2% NPV for any event. CONCLUSIONS: The PAPP-A serum concentration represents a promising prognostic biomarker with significantly improved PPV. The GRACE score is superior to stratification based on PAPP-A with regard to combined cut-off point for 1-year mortality.

Conscious sedation for transcatheter implantation of atrial septal occluders with two- and three-dimensional transoesophageal echocardiography guidance - a feasibility and safety study.

BACKGROUND: General anaesthesia may have negative impact on patient mortality and morbidity, as well as overall procedure costs, in atrial septal occluder (ASO) implantation. AIM: We sought to evaluate the safety, efficacy, and feasibility of conscious sedation for transcatheter implantation of ASOs. METHODS: A total of 122 patients referred for transcatheter implantation of ASO were included. Mean patient age was 51 ± 15 years, and 43 (35%) patients were male. The initial dose of midazolam was 2 mg and fentanyl dose was 25 µg. Additional doses of midazolam and fentanyl were administered, if necessary. Patient responsiveness was assessed every 10 min, and the sedatives doses were titrated in order not to exceed grade 3 sedation in the Ramsey scale. RESULTS: Atrial septal occluders were successfully implanted in the majority of patients (98.4%). In two (1.6%) cases the proce-dure failed because of too small patent foramen ovale (PFO) diameter (n = 1, 0.8%) or device instability (n = 1, 0.8%). The mean duration of procedure was 47.6 ± 28.4 min and was similar for ASD and PFO closure (p = 0.522). The overall mean dose of midazolam was 4.7 ± 2.2 mg (63.9 ± 32.5 µg/kg) and fentanyl was 30.0 ± 11.9 µg (0.43 ± 0.17 µg/kg). Median entrance dose of radiation at the patient plane was 25 (interquartile range: 16-57) mGy, and did not differ between ASD and PFO procedures (p = 0.614). The majority of patients were free of complications (91.0%). The following early complications were observed: transient ischaemic attack (n = 2, 1.6%), supraventricular arrhythmias (n = 4, 3.3%), left atrial thrombus formation (n = 1, 0.8%), symptomatic bradycardia (n = 1, 0.8%), and femoral venous bleeding (n = 5, 4.1%). After mean follow-up of 386 days residual shunt was observed in eight (6.6%) patients. CONCLUSIONS: Conscious sedation for transcatheter implantation of ASO is a feasible, safe, and efficient technique, allowing successful PFO and ASD closure in the majority of patients.

The role of selected adipokines and ghrelin in the prognosis after myocardial infarction in a 12-month follow-up in the presence of metabolic syndrome.

INTRODUCTION: The aim of this study was to evaluate the predictive value of selected adipokines in the improvement in the ejection fraction and in the development of adverse cardiac remodeling during 12 months of follow-up among patients with an ST-segment elevation acute myocardial infarction (STEMI) in the presence of metabolic syndrome (MeS). MATERIAL AND METHODS: The study population consisted of 69 patients (49 male; mean age: 59 ±10 years) with a first STEMI that was treated with a primary percutaneous coronary intervention (pPCI). In this group, 36 patients (18 male; mean age: 60 ±15 years) had MeS according to the definition of the International Diabetes Federation. The baseline clinical evaluation included a clinical examination and evaluation of the blood levels of C-reactive protein, ghrelin, resistin, and fasting glucose. Within 72 h after the STEMI, an echocardiographic examination was performed. A complete clinical evaluation was repeated after 12 months. Adverse cardiac remodeling was defined as an increase in the left ventricular end-diastolic volume of ≥ 8%. An improvement of the ejection fraction (EF) was defined as an increase of more than 5% in the EF. RESULTS: A concentration of ghrelin ≤ 160.46 pg/ml (AUC = 0.71, p = 0.032) had a good predictive value for the occurrence of adverse left ventricular remodeling but only in the patients without MeS. Among the patients with MeS, a concentration of resistin ≤ 5196 pg/ml (AUC = 0.073, p = 0.024) had a good predictive value for the occurrence of left ventricular remodeling. A concentration of leptin > 52.18 pg/ml (AUC = 0.81, p < 0.0001) and resistin > 4419.27 ng/ml (AUC = 0.67, p = 0.049) had a good predictive value for improvement of the LVEF in the patients without MeS. CONCLUSIONS: The selected adipokines had a good predictive value for the development of adverse cardiac remodeling and for improvement of the ejection fraction among patients after a STEMI in the presence of metabolic syndrome.

Comparison of shortened gated myocardial perfusion imaging processed with "Myovation Evolution" with full time study.

BACKGROUND: The work compares the results of shortened gated myocardial perfusion imaging (MPI), processed with "Myovation Evolution" software, with a study performed in a standard way. MATERIAL AND METHODS: A retrospective study was conducted in a group of 95 patients (56 males and 39 females, age 62 ± 9 years, BMI 28 ± 4) with known or suspected CAD, without clinical history or any signs of a previous myocardial infarction. All patients underwent coronary angiography (CA) within 3 months of MPI. CA was used as a reference for diagnostic performance of MPI. Patients underwent a stress/rest 2-day MPI. Both studies were performed twice, with normal (25s) and shortened (13s) time per projection. Studies were processed using Myovation protocol (OSEM with 2 iterations and 10 subsets) for full time (FT) studies and a Myovation Evolution protocol dedicated to half time (HT) studies (OSEM with 12 iterations, 10 subsets). Reconstructed images, with and without attenuation correction (AC), were evaluated by 2 experienced nuclear medicine specialists (a consensus), with regard to image quality and perfusion, evaluated using a visual semi-quantitative method, applying a standard division of myocardium into 17 segments. Perfusion was assessed in every segment using a standard 5 grade scale. Summed stress scores were calculated for every patient and threshold values for detection of CAD were selected based on ROC analysis with CA treated as a reference method. After 2 months FT images were interpreted again by the same specialists. RESULTS: The quality of images obtained from shortened and normal studies was equally good. All correlation coefficients between segmental scorings of FT and HT studies were high and statistically significant. Correlation coefficients between corresponding segments in FTAC and HTAC (i.e. with AC) studies were systematically higher than without AC. The agreement between FT and HT study results was equal to 81% for FT and HT studies and to 86% for FTAC and HTAC studies (p = 0.40). The repeatability of FTAC study assessments was equal to 94%. 95-percent confidence intervals calculated for agreement between FTAC and HTAC studies and the repeatability of FTAC study overlapped considerably. Correlation coefficients for EDV, ESV and EF values between FT and HT were high: 0.93, 0.96 and 0.88, respectively. CONCLUSION: Myovation Evolution protocol used for reconstruction of myocardial perfusion studies with reduced number of counts requires AC. The agreement between the results of visual assessment of normal and reduced count studies is high and not worse than the agreement between repeat assessment of a full time study.

Reduced-time myocardial perfusion study processed with "Myovation Evolution" - assessment of diagnostic efficacy.

BACKGROUND: While assessing images using standard segmental method, we felt that some defects were either underscored or missed. So this work is intended to compare results of low count myocardial perfusion studies (MPS) processed with "Myovation Evolution", applying complete evaluation of all available slices, with full count studies and assess impact of reduction of counts on diagnostic efficacy of the study. MATERIAL AND METHODS: A retrospective study was conducted in a group of 95 patients (56 males, age 62 ± 9 years, BMI 28 ± 4) with known or suspected CAD, without clinical history or any signs of a previous myocardial infarction. All patients underwent coronary angiography (CA) within 3 months of MPS. CA was used as a reference method for diagnostic performance of MPS. Patients underwent a stress/rest 2-day MPS. Both studies were performed twice, with normal (25 s) and shortened (13 s) time/projection. Studies were processed using Myovation protocol (OSEM, 2 iterations, 10 subsets) for full time (FT) studies and a Myovation Evolution protocol for half time (HT) studies (OSEM, 12 iterations, 10 subsets, Resolution Recovery). Reconstructed images, with and without attenuation correction (AC), were evaluated by 2 experienced nuclear medicine specialists (a consensus) visually, taking into account all available slices, in a 5-grade scale (normal, probably normal, equivocal, probably abnormal and abnormal). Study results were additionally dichotomized as normal or abnormal. Perfusion defects were assigned to coronary arteries. RESULTS: An exact agreement between FT and HT study assessment, without AC, amounted to 66%, with AC it grew to 79%, p = 0.05. In studies without AC 10 perfusion defects were found only in HT studies in RCA area in male patients. A higher percentage of studies with perfusion defects in RCA area visible only in HT studies was found among discordant (7/25, 28%) than concordant results (3/70, 4%), p = 0.003. AC reduced this difference. HT study provided lower accuracy in detection of CAD than FT study (58% vs. 68%, p = 0.034). AC reduced this difference considerably. Dichotomized assessment agreed in 81% of studies without AC and in 87% with AC. CONCLUSIONS: Myovation Evolution protocol requires application of AC otherwise perfusion defects in RCA area in male patients are falsely detected. Shortened studies reconstructed with "Myovation Evolution" package without AC reveal a tendency toward reduction of accuracy of the study in detection of CAD. AC makes up for this reduction.

Outcomes of percutaneous coronary intervention in patients after previous coronary artery bypass surgery.

BACKGROUND: Patients after previous coronary artery bypass grafting (CABG) often require repeat percutaneous revascularisation due to poor patency rates of saphenous vein grafts (SVG) and higher risk of re-CABG. Few data are available to evaluate different percutaneous revascularisation strategies in patients after previous CABG. AIM: To evaluate outcomes of percutaneous coronary intervention (PCI) in patients after previous CABG, including the effect of treatment on the quality of life and symptoms, and secondly to assess the relation between angiographic factors and treatment outcomes METHODS: This was a prospective observational study which included 78 patients after previous CABG. Following coronary angiography, the patients were assigned to one of three groups: group A (n = 20), PCI of a SVG (PCI SVG); group B (n = 29), PCI of a native coronary artery (PCI NA); group C (n = 29), control group that received medical treatment (MT) only. Duration of follow-up was 12 months. RESULTS: Compared to MT patients, patients treated with PCI had significantly higher Canadian Cardiovascular Society (CCS) class (2.75 vs. 2.41, p = 0.03) and more frequently had coronary angiography performed due to unstable angina (57% vs. 31%, p = 0.04). Patients in the PCI SVG group had significantly older SVG conduits compared to the PCI NA group (13.4 years vs. 8.2 years, p = 0.005). At 12 months of follow-up, we found a significant improvement in the EQ-5D index of the quality of life, and a significant reduction in CCS class in the PCI SVG group (0.66 vs. 0.7, p = 0.0003, and 2.75 vs. 1.9, p < 0.001, respectively) and in the PCI NA group (0.65 vs. 0.72, p < 0.001, and 2.75 vs. 2.17, p < 0.001, respectively), but no improvement in the MT group. Treatment outcomes did not differ significantly between the three groups (combined endpoint rate 20% vs. 13% vs. 27.5%, p = 0.37). In multivariate analysis, SVG age > 11 years was identified as a significant predictor of poor outcomes in patients treated with PCI after previous CABG. CONCLUSIONS: PCI in patients after previous CABG does not improve prognosis but significantly improves the quality of life and reduces symptom severity.

Diagnostic performance of myocardial perfusion single-photon emission computed tomography with attenuation correction.

BACKGROUND: Myocardial perfusion single-photon emission computed tomography (SPECT) is one of the basic tools used for the purpose of diagnosis of coronary artery disease (CAD), prognosis of its unfavourable consequences, and evaluation of therapy effectiveness. However, its efficacy is compromised by a relatively low specificity of detection of perfusion defects, which is attributed to attenuation of gamma rays inside the patient's body, causing artefacts erroneously taken for perfusion defects. It is expected that attenuation correction (AC) could eliminate such artefacts. AIM: To evaluate whether visual, semi-quantitative analysis of attenuation-corrected myocardial perfusion imaging provides an advantage over a non-corrected study. METHODS: A retrospective study applying AC was performed in 107 patients who had coronary angiography within three months. Patients underwent a stress/rest Tc-99m methoxyisobutylisonitrile (MIBI, POLATOM) double day SPECT/CT myocardial perfusion imaging. Images were analysed by two experienced nuclear medicine specialists (a consensus) applying a visual semiquantitative method. Coronary angiography findings were used as a reference for the analysis of diagnostic performance of myocardial perfusion study protocols. RESULTS: AC increased the specificity of detection of CAD in the whole group of patients from 63% to 86% (p = 0.0005), with a slight reduction in sensitivity (from 83% to 79%). The improved specificity was also noted in subgroups of male and female patients. Accuracy in the whole group of patients increased from 71% to 83% (p = 0.01). AC improved the specificity and accuracy of the method in the detection of perfusion defects in the right coronary artery (RCA) area from 73% to 88% (p = 0.005) and from 74% to 83% (p = 0.04), respectively, and the accuracy of the method in the left anterior descending (LAD) artery area from 79% to 87% (p = 0.043). It also reduced the number of ambiguous results of the study. CONCLUSIONS: AC improved the diagnostic performance of myocardial perfusion study in the detection of CAD and identification of critically stenosed LAD and RCA vessels, with enhanced comfort of study interpretation.

Usefulness of the Left Anterior Descending Coronary Artery Wrapping Around the Left Ventricular Apex to Predict Adverse Clinical Outcomes in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction Trial).

The association between anatomic features of the left anterior descending artery (LAD) and outcomes in patients with anterior ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. We sought to clarify the impact of an LAD coronary artery wrapping around the left ventricular (LV) apex on clinical outcomes in patients with anterior STEMI. Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction enrolled patients with STEMI presenting <12 hours after symptom onset who underwent primary percutaneous coronary intervention. Patients with a culprit lesion in the LAD were categorized as (1) LAD wrapping around the LV apex (wrap-around LAD, n = 871) versus (2) LAD not wrapping around the LV apex (non-wrap-around LAD, n = 224). Killip class ≥II, dysrhythmia, and LV mural thrombi were more frequently observed in the wrap-around LAD group; LV ejection fraction was worse in the wrap-around LAD group (54.5% vs 58.7%, p = 0.006). At 3 years of follow-up, major adverse cardiac events (death, stroke, or stent thrombosis, 12.7% vs 5.4%, p = 0.002), death (6.6% vs 3.2%, p = 0.052), stroke (1.9% vs 0.5%, p = 0.12), stent thrombosis (5.6% vs 2.3%, p = 0.047), and severe heart failure (4.5% vs 1.4%, p = 0.03) were more common in patients with a wrap-around LAD versus those with a non-wrap-around LAD. Multivariate analysis indicated that a wrap-around LAD independently and significantly predicted major adverse cardiac events (hazard ratio 2.18, p = 0.02) and severe heart failure (odds ratio 3.31, p = 0.049) in patients with an anterior STEMI. In conclusion, a wrap-around LAD predicted adverse clinical outcomes at 3 years in patients with anterior STEMI who underwent primary percutaneous coronary intervention.