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Background: In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery disease who were receiving routine clinical care with no direct follow-up., Methods: We did a single-blind, all-comer superiority trial in adult patients with chronic stable coronary artery disease or acute coronary syndromes, and at least one target lesion. Patients were treated at one of five percutaneous coronary intervention centres between January, 2006, and August, 2007. Computer-generated block randomisation and a telephone allocation service were used to randomly assign patients to receive the zotarolimus-eluting or the sirolimus-eluting stent. Data for follow-up were obtained from national Danish administrative and health-care registries. The primary endpoint was a composite of major adverse cardiac events within 9 months: cardiac death, myocardial infarction, and target vessel revascularisation. Intention-to-treat analyses were done at 9-month and 18-month follow-up. This trial is registered with ClinicalTrials.gov, number NCT00660478., Findings: 1162 patients (1619 lesions) were assigned to receive the zotarolimus-eluting stent, and 1170 patients (1611 lesions) to receive the sirolimus-eluting stent. 67 patients (72 lesions) had stent failure, and six patients were lost to follow-up. All randomly assigned patients were included in analyses at 9-month follow-up; 2200 patients (94%) had completed 18-month follow-up by the time of our assessment. At 9 months, the primary endpoint had occurred in a higher proportion of patients treated with the zotarolimus-eluting stent than in those treated with the sirolimus-eluting stent (72 [6%] vs 34 [3%]; HR 2.15, 95% CI 1.43-3.23; p=0.0002). At 18-month follow-up, this difference was sustained (113 [10%] vs 53 [5%]; 2.19, 1.58-3.04; p<0.0001). For patients receiving the zotarolimus-eluting stent and those receiving the sirolimus-eluting stent, all cause-mortality was similar at 9-month follow-up (25 [2%] vs 18 [2%]; 1.40, 0.76-2.56; p=0.28), but was significantly different at 18-month follow-up (51 [4%] vs 32 [3%]; 1.61, 1.03-2.50; p=0.035)., Interpretation: The sirolimus-eluting stent is superior to the zotarolimus-eluting stent for patients receiving routine clinical care., Funding: Cordis and Medtronic., (Copyright 2010 Elsevier Ltd. All rights reserved.)

Background: The sirolimus-eluting stent has demonstrated the least amount of late lumen loss among previously released drug-eluting stents, but its safety and efficacy has not been compared head-to-head with the everolimus-eluting stent., Method: The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non-inferiority design, power calculations estimated a needed enrolment of 2,678 patients. The primary endpoint is a composite of cardiac death, myocardial infarction, and stent thrombosis or target vessel revascularization after 9 months. Data on clinical events and mortality for all randomized patients will be obtained from national databases at 9 months. No clinical follow-up examination is scheduled., Conclusion: The SORT OUT IV trial will directly compare clinically relevant differences in efficacy and safety in two drug-eluting stents: a first-generation sirolimus-eluting stent versus a second-generation everolimus-eluting stent. The study makes use of clinical endpoints routinely collected in computerized healthcare registries, allowing complete follow-up of a large, well-defined population without scheduled angiographic examinations., (Copyright 2010 S. Karger AG, Basel.)

Lipid lowering treatment with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statins) may reduce morbidity and mortality in patients with stable ischaemic heart disease. In trials where a statin was used as secondary prevention after an acute coronary syndrome (ACS), the treatment was initiated 3-6 months after the event. A high rate of serious complications occurs in the unstable clinical state after an ACS, including myocardial infarction and death. The incidence rate of serious complications declines after 1 month and then gradually diminishes. It has not been determined whether initiation of treatment with a statin soon after an ACS reduces the occurrence of early coronary events. Statins have effects on the vessel wall other than the lipid lowering effect, and these may partly account for the benefit of statin therapy. Whether these mechanisms are associated with a prognostic effect soon after an ACS has not been clarified.

Purpose: The purpose of the study was to investigate the incidence, cause and probability of re-hospitalization within 30 and 365 days after percutaneous coronary intervention (PCI) in patients with diabetes. Method: Between January 2010 and September 2014, 2763 patients with diabetes were treated with PCI at two Hospitals in Western Denmark. Reasons for readmission within 30 and 365 days were identified. Results: Readmission risks for patients with diabetes were 58% within 365 days and 18% within 30 days. Reason for readmission was ischemic heart disease (IHD) in 725 patients (27%), and non-IHD-related reasons in 826 patients (31%). IHD-related readmission within 365 days was associated with female gender (OR 1.3, 95% CI: 1.1–1.5), and non-ST-segment elevation myocardial infarction, compared to stable angina at the index hospitalization (OR 1.3, 95% CI: 1.1–1.6). Among patients with diabetes, increased risk of readmission due to other reasons were age (OR 1.3, 95% CI: 1.2–1.5) and higher scores of modified Charlson Comorbidity index (CCI): CCI ≥3 (OR 3.6, 95% CI: 2.8–4.6). Conclusion: More than half of the patients with diabetes mellitus undergoing PCI were readmitted within 1 year. Comorbidities were the strongest predictor for non-IHD-related readmission, but did not increase the risk for IHD-related readmissions. [ABSTRACT FROM AUTHOR]

Background: Diabetes patients without obstructive coronary artery disease as assessed by coronary angiography have a low risk of myocardial infarction, but their myocardial infarction risk may still be higher than the general population. We examined the 10-year risks of myocardial infarction, ischemic stroke, and death in diabetes patients without obstructive coronary artery disease according to coronary angiography, compared to risks in a matched general population cohort. Methods: We included all diabetes patients without obstructive coronary artery disease examined by coronary angiography from 2003 to 2016 in Western Denmark. Patients were matched by age and sex with a cohort from the Western Denmark general population without a previous myocardial infarction or coronary revascularization. Outcomes were myocardial infarction, ischemic stroke, and death. Ten-year cumulative incidences were computed. Adjusted hazard ratios (HR) then were computed using stratified Cox regression with the general population as reference. Results: We identified 5734 diabetes patients without obstructive coronary artery disease and 28,670 matched individuals from the general population. Median follow-up was 7 years. Diabetes patients without obstructive coronary artery disease had an almost similar 10-year risk of myocardial infarction (3.2% vs 2.9%, adjusted HR 0.93, 95% CI 0.72–1.20) compared to the general population, but had an increased risk of ischemic stroke (5.2% vs 2.2%, adjusted HR 1.87, 95% CI 1.47-2.38) and death (29.6% vs 17.8%, adjusted HR 1.24, 95% CI 1.13–1.36). Conclusions: Patients with diabetes and no obstructive coronary artery disease have a 10-year risk of myocardial infarction that is similar to that found in the general population. However, they still remain at increased risk of ischemic stroke and death. [ABSTRACT FROM AUTHOR]

Background: Diabetes is considered a risk factor for myocardial infarction. However, we have previously found that diabetes was not a short-term risk factor for myocardial infarction in the absence of obstructive coronary artery disease. Methods: We conducted a cohort study of patients undergoing coronary angiography from 2003 to 2012 and followed them by cross-linking Danish health registries. Patients were stratified according to coronary artery disease and diabetes. Endpoints included myocardial infarction, cardiac death, all-cause death and coronary revascularization. Results: 86,202 patients were included in total (diabetes: n = 12,652). Median follow-up was 8.8 years. Using patients with neither coronary artery disease nor diabetes as reference (cumulative myocardial infarction incidence 2.6%), the risk of myocardial infarction was low and not substantially increased for patients with diabetes alone (3.2%; hazard ratio 1.202, 95% confidence interval 0.996-1.451), was increased for patients with coronary artery disease alone (9.3%; hazard ratio 2.75, 95% confidence interval 2.52-3.01) and was highest for patients with both coronary artery disease and diabetes (12.3%; hazard ratio 3.79, 95% confidence interval 3.43-4.20). Similar associations were observed for cardiac death and coronary revascularization. Conclusion: Diabetes patients without coronary artery disease by coronary angiography have a low risk of myocardial infarction, not substantially increased compared to patients with neither coronary artery disease nor diabetes. In the presence of coronary artery disease, however, diabetes increases the risk of myocardial infarction. [ABSTRACT FROM AUTHOR]

Objective: We examined the risk of myocardial infarction associated with glucose-lowering therapy among diabetes patients with and without obstructive coronary artery disease. Methods: A cohort of patients with type 1 or type 2 diabetes (n = 12,030), who underwent coronary angiography from 2004 to 2012, were stratified by presence of obstructive (any stenosis ⩾50%) coronary artery disease and by type of diabetes treatment: diet, non-insulin treatment and insulin (±oral anti-diabetics). The primary endpoint was myocardial infarction. Adjusted hazard ratios were calculated using diet-treated patients without coronary artery disease as reference. Results: In patients without coronary artery disease, risk of myocardial infarction was similar in patients treated with non-insulin medication (adjusted hazard ratio 0.70, 95% confidence interval 0.27–1.81) and insulin (adjusted hazard ratio 0.76, 95% confidence interval 0.27–2.08) as compared to diet only. In patients with coronary artery disease, the risk of myocardial infarction was higher than in the reference group and an incremental risk was observed being lowest in patients treated with diet (adjusted hazard ratio 3.79, 95% confidence interval 1.61–8.88), followed by non-insulin medication (adjusted hazard ratio 5.42, 95% confidence interval 2.40–12.22), and highest in insulin-treated patients (adjusted hazard ratio 7.91, 95% confidence interval 3.51–17.82). Conclusion: The presence of obstructive coronary artery disease defines the risk of myocardial infarction in diabetes patients. Glucose-lowering therapy, in particular insulin, was associated with risk of myocardial infarction only in the presence of coronary artery disease. [ABSTRACT FROM AUTHOR]

Purpose: We examined risk of myocardial infarction and all-cause death associated with the extent of coronary artery disease ascertained by coronary angiography in patients with diabetes mellitus. We hypothesized that risks of myocardial infarction and death were associated with extent of coronary artery disease in diabetes patients. Patients and methods: We conducted a cohort study of patients with type 1 and type 2 diabetes, who underwent coronary angiography from 2004 to 2012. Patients were stratified according to extent of coronary artery disease: 0-, 1-, 2- or 3-vessel disease or diffuse vessel disease. Endpoints were myocardial infarction, all-cause death, and major adverse cardiovascular events (MACE), defined as the composite of myocardial infarction, cardiac death, or ischemic stroke. Adjusted incidence and mortality rate ratios (IRRsadj) were calculated using patients with 0-vessel disease as the reference group. Median follow-up was 3 years for a total of 45,164 person-years. Results: The study included 12,594 diabetes patients. Of these, 3,147 (25.0%) had 0-vessel disease, 1,195 (9.5%) had diffuse vessel disease, 3,001 (23.8%) had 1-vessel disease, 2,220 (17.6%) had 2-vessel disease, and 3,031 (24.1%) had 3-vessel disease. The myocardial infarction rate was 0.4 per 100 person-years (95% CI: 0.3–0.5) in patients with 0-vessel disease. Using patients with 0-vessel disease as reference, the risk of myocardial infarction increased according to the number of diseased vessels (diffuse vessel disease: 1.4 per 100 person-years, IRRadj 3.87, 95% CI: 2.41–6.23; 1-vessel disease: 1.9 per 100 person-years, IRRadj 4.99, 95% CI: 3.33–7.46; 2-vessel disease: 2.7 per 100 person-years, IRRadj 7.14, 95% CI: 4.78–10.65; and 3-vessel disease: 4.3 per 100 person-years, IRRadj 11.42, 95% CI: 7.76–16.82; ptrend<0.001). Similar associations were observed for all-cause death and MACE. Conclusion: The extent of coronary artery disease is a major risk factor for myocardial infarction and death in patients with diabetes mellitus. [ABSTRACT FROM AUTHOR]

Current guidelines do not recommend coronary computed tomography angiography (CCTA) in patients with high levels of coronary calcium, as severe calcification leads to difficulties in estimating stenosis severity due to blooming artifacts obscuring the vessel lumen. Whether the CCTA-derived fractional flow reserve (FFRCT) improves the diagnostic performance of CCTA in patients with high levels of coronary calcification has not been sufficiently evaluated. We hypothesize that a noninvasive diagnostic strategy using FFRCT will perform comparably to an invasive diagnostic strategy in the detection of hemodynamically significant coronary artery disease (CAD) in clinical stable chest pain patients with high levels of coronary calcium. In this prospective, blinded, multicenter study, patients with suspected stable CAD referred for CCTA and demonstrating an Agatston score >399 will be included. Patients accepting inclusion will, in addition to CCTA, undergo invasive coronary angiography (ICA) and invasive FFR measurement. FFRCT analyses are performed by an external core laboratory blinded to any patient data, and the FFRCT results are blinded to all participating study sites. The primary objective is to evaluate whether FFRCT can identify patients with and without hemodynamically significant CAD, when ICA with FFR is the reference standard. A negative study result would question the clinical usefulness of FFRCT in patients with high levels of coronary calcium. A positive study result, however, would imply a reduction in the number of patients referred for coronary catheterization and, at the same time, increase the proportion of patients with hemodynamically significant CAD at the subsequent invasive examination. [ABSTRACT FROM AUTHOR]

Aims To show non-inferiority of the 67- or 87 mm thick, sirolimus-eluting Orsiro drug eluting stent (DES) to the 122 mm thick, biolimus-eluting Nobori DES regarding size of vessel lumen outside the stent at 13-month follow-up. Methods and results This study was a substudy to the SORT-OUT VII trial, a prospective, 1:1-randomized, comparison of the two stents in patients with stable coronary artery disease or acute coronary syndrome. Optical coherence tomography was acquired after percutaneous coronary intervention and at 13-month follow-up. The substudy was powered to access non-inferiority (D= 0.60mm²) of the Orsiro DES to the Nobori DES for the primary endpoint of mean extra stent lumen (ESL) i.e. vessel lumen outside the stent at 13-month follow-up. We randomized 124 patients to Orsiro (n = 60) or Nobori (n = 64). Due to a difference in the one-sided 95%-confidence interval of 0.26mm², but increased to 0.82 mm² after appropriate log-transformation, it could not be rejected that Orsiro exceeded the non-inferiority limit. Testing for superiority, Orsiro had a significantly larger mean ESL at follow-up (Orsiro: 0.11mm² [0.02;0.30] mm², Nobori: 0.03mm² [0.00;0.17] mm², P = 0.04). Stent strut coverage was, Orsiro: 97.6 % [93.8;99.4]%, and Nobori: 96.3 % [90.5;98,6]% (P = 0.13). Conclusion Orsiro DES had a significantly larger mean ESL at follow-up and it could not be excluded that Orsiro exceeded the limit for non-inferiority. Nobori DES had a more heterogeneous distribution of neointima but stent strut coverage did not differ significantly between the two stents. [ABSTRACT FROM AUTHOR]

Background Patients with acute myocardial infarction are at increased risk of ischaemic stroke. Previous myocardial infarction is an important part of risk assessment for ischaemic stroke. However, there is a lack of information regarding the association between the severity and extent of coronary artery disease and long-term risk of ischaemic stroke. Materials and methods A cohort study of coronary angiographies performed in western Denmark from 1 January 2003 to 31 December 2012. Patients were stratified according to the number of vessels affected by obstructive coronary artery disease (lumen narrowing ≥50%) at the time of angiography: zero-, one-, two- or three-vessel disease and diffuse vessel disease. We followed patients for a maximum of 7 years. Endpoints were all-cause death, cardiac death, myocardial infarction and ischaemic stroke. Cumulative risks and crude and adjusted rate ratios were estimated. Results The study population included 78 195 patients. Of these, 32 061 (41·0%) had zero-vessel disease, 6205 (7·9%) had diffuse vessel disease, 20 202 (25·8%) had one-vessel disease, 10 675 (13·7%) had two-vessel disease, and 9038 (11·6%) had three-vessel disease. Median follow-up was 3·6 years (interquartile range 1·7-6·0 years). Increasing severity of obstructive coronary artery disease was associated with an increasing risk of all-cause death, cardiac death, myocardial infarction ( MI) and ischaemic stroke during follow-up. Conclusions The presence and extent of coronary artery disease was associated with an incremental risk of not only death, cardiac death, myocardial infarction, but also ischaemic stroke over a 7-year period. [ABSTRACT FROM AUTHOR]

Objective: The risk of myocardial infarction (MI) in patients with diabetes is greater than for patients without diabetes. Consequently, prophylactic treatment is recommended for patients with diabetes and risk factors for ischemic heart disease. We aimed to estimate the risk of adverse cardiac events in patients with and without diabetes with and without coronary artery disease (CAD) after coronary angiography (CAG).Research Design and Methods: A population-based cohort of patients registered in the Western Denmark Heart Registry who underwent CAG between 1 January 2003 and 31 December 2012 was stratified according to the presence or absence of obstructive CAD and diabetes. End points were death, cardiac death, and MI. Unadjusted and adjusted rate ratios (RRs) were calculated by using patients without diabetes and without CAD as the reference group.Results: We included 93,866 patients of whom 12,544 (13.4%) had diabetes at the time of CAG. Median follow-up was 4.1 years. Patients with and without diabetes without obstructive CAD had the same adjusted risk of death (RR 1.03 [95% CI 0.92-1.15]), cardiac death (RR 1.21 [95% CI 0.90-1.64]), and MI (RR 0.88 [95% CI 0.65-1.17]). Patients with diabetes without CAD were more often treated with statins (75.3% vs. 46.0%) and aspirin (65.7% vs. 52.7%) than patients without diabetes and CAD.Conclusions: In a real-world population, patients with diabetes with high rates of statin and aspirin treatment had the same risk of cardiovascular events as patients without diabetes in the absence of angiographically significant CAD. [ABSTRACT FROM AUTHOR]

Purpose: CT angiography (CTA) can rule out significant stenoses with a very high reliability, whereas its ability to confirm significant stenoses is suboptimal. In contrast, measurements of myocardial blood flow (MBF) provide information on the haemodynamic consequences of stenoses. Therefore, a combination of the two might improve diagnostic accuracy. We conducted a head-to-head comparison of CTA, measurement of MBF by O-water PET, and hybrid PET/CTA for the detection of significant coronary artery stenoses. Methods: The study group comprised 44 outpatients scheduled for invasive coronary angiography (ICA) with an intermediate pretest likelihood of coronary artery disease. The patients underwent 64-slice CTA and baseline and hyperaemic PET before ICA with quantitative coronary angiography analysis. Results: On a per-patient basis, the negative predictive values (NPV; 95 % confidence intervals in parentheses) were 88 % (64 - 97 %) for CTA, 90 % (71 - 97%) for PET and 92 % (74 - 98%) for PET/CTA, and the positive predictive values (PPV) were 71 % (53 - 85%) for CTA, 87 % (68 - 95%) for PET and 100 % (84 - 100%) for PET/CTA. Similarly, on a per-vessel basis the NPVs (which were generally high) were 97 % (94 - 100%) for CTA, 95 % (90 - 99%) for PET and 97 % (95 - 100%) for PET/CTA, and the PPVs (which were lower, but higher with PET/CTA) were 53 % (39 - 66%) for CTA, 53 % (40 - 66%) for PET and 85 % (73 - 97%) for PET/CTA. In six patients, CTA analysis was hampered by the presence of severe calcifications. However, with the addition of the PET data, all six patients were correctly categorized. Conclusion: Cardiac quantitative hybrid PET/CTA imaging has better diagnostic accuracy than CTA alone and PET alone. CTA has a suboptimal PPV, suggesting that hybrid PET/CTA imaging should be used to assess the significance of coronary stenoses diagnosed by CTA. [ABSTRACT FROM AUTHOR]

The article presents a study which analyzed the temporal implementation of primary percutaneous coronary intervention (PPCI) in Western Denmark, the gradual introduction of field triage for PPCI, and the associated outcome. In order to ensure that majority of patients are triaged directly to a PPCI center with an associated lower mortality, prehospital diagnosis and triage of patients with Segment Elevation Myocardial Infarction (STEMI) can be implemented at a national level.

Objectives. Coronary computed tomography angiography (CTA) has proven clinically useful for non-invasive assessment of coronary pathology. However, coronary calcium can reduce its diagnostic value. The objective of this study was to define a calcium score above which CTA appears less reliable. Design. We prospectively investigated 109 patients referred for elective coronary angiography (CA). With a 64-slice CT-scanner, coronary calcium was determined and expressed in Agatston unit (AU). A significant coronary stenosis was defined as ≥50% luminal diameter reduction. Following blinded interpretation, diagnostic values of CTA at different levels of AU were calculated using quantitative CA as reference. Results. A strong association with stent and the severity of coronary calcium was observed. In patients without stents (n = 91) sensitivity, specificity and positive and negative predictive value for presence of significant stenosis were: 100%, 91%, 74%, and 100% in patients with a calcium score ≤400 AU versus 100%, 17%, 75%, and 100% in patients with a score >400 AU. Conclusions. The diagnostic accuracy of CTA in patients with no or little coronary calcium is excellent. However, in patients with an Agatston score >400 specificity declines and therefore, these patients should not go on to CTA, but be referred to CA instead. [ABSTRACT FROM AUTHOR]

Intravascular ultrasound (IVUS) allows precise measurements of plaque plus media (P+M) volume and neointimal hyperplasia after coronary artery stenting. Conventional IVUS volumetric analysis is performed mostly without electrocardiographically gated acquisition, and the IVUS images are selected at 1-mm intervals, whereas the electrocardiographically gated approach consists of images in end-diastole. The accuracy in the luminal, P+M, and external elastic membrane (EEM) volumes between 2 pullbacks with the electrocardiographically gated and nongated approaches has not previously been compared. In 15 patients, 19 segments were studied with electrocardiographically gated and nongated IVUS systems. Two identical pullbacks were performed with each system using the same IVUS catheter. Volumes of the lumen, EEM, and P+M obtained using the electrocardiographically gated pullback technique did not differ significantly from the corresponding volumes obtained using the nongated pullback technique (lumen: 109.7 ± 47.7 vs 109.2 ± 45.0 mm3, p = NS; EEM: 242.6 ± 109.2 vs 235.0 ± 108.1 mm3, p = NS; P+M: 134.8 ± 67.7 vs 129.8 ± 69.1 mm3, p = NS). No significant differences were seen in changes between 2 electrocardiographically gated and 2 nongated pullbacks (lumen: 0.37 ± 1.76 vs −0.23 ± 2.32 mm3, p = NS; EEM: 0.25 ± 3.22 vs −0.94 ± 4.27 mm3, p = NS; P+M: −0.18 ± 3.42 vs −0.74 ± 3.88 mm3, p = NS). In conclusion, in moderate atherosclerotic or stented coronary arteries, electrocardiographically gated IVUS acquisition is not superior in accuracy to conventional nongated IVUS acquisition. [Copyright &y& Elsevier]

Background: Although intravascular ultrasound (IVUS) can detect plaque rupture, the fibrous cap remnant has not previously been studied in detail. The aim of the present study is to assess the fibrous cap remnants by IVUS in ruptured plaques. Methods: In 53 patients, a ruptured plaque with a fibrous cap remnant was studied by IVUS. Results: In 36 (68%) patients, the rupture of the fibrous cap appeared to have occurred at the shoulder. The absolute length of the fibrous cap remnant was significantly longer in the center rupture site compared with the shoulder rupture site (1.37 +/- 0.56 vs 0.84 +/- 0.34 mm, P = .001); however, the estimated length of the original fibrous cap did not differ between the 2 rupture site groups (2.28 +/- 0.66 vs 2.11 +/- 0.69, P = not significant). In none of the patients did the remnants of the fibrous cap cover the entire mouth of the cavity. The estimated absolute length of the missing part of the fibrous cap correlated significantly with the cavity area (r = 0.517, P < .001), the lesion external elastic membrane area (r = 0.330, P = .016), the lumen area (r = 0.289, P = .036), the maximum plaque thickness (r = 0.364, P = .007), and the length of the estimated original fibrous cap (r = 0.709, P < .001). Conclusion: In general, the postrupture fibrous cap does not cover the entire mouth of the ruptured plaque cavity in its postrupture state. Potential explanations include the following: (1) part of the fibrous cap may be too thin to be visualized with IVUS, (2) part of it may have embolized, or (3) the prerupture fibrous cap may have been stretched and/or there were postrupture changes in lesion geometry. [ABSTRACT FROM AUTHOR]

Abstract: Background: Endothelium-dependent dilation (EDD) has often been studied in patients with hypercholesterolemia without overt coronary atherosclerosis where an improvement after statin treatment has been documented within few weeks. The aim of the study was to assess the short-term effect of diet as well as short- and long-term effect of simvastatin on EDD in patients with hypercholesterolemia and ischemic heart disease. Methods: In 43 male patients with hypercholesterolemia and ischemic heart disease, EDD of the brachial artery was measured at baseline, after 3 months on a lipid-lowering diet, and after another 1, 3 and 12 months on simvastatin at 40 mg/day. Results: Three months changes in EDD were neither influenced by diet nor short-term simvastatin therapy (4.9% vs. 4.9% vs. 4.8%, p =ns). Twelve months simvastatin treatment, however, significantly improved EDD by 32.7% (4.9% vs. 6.5%, p =0.007). By regression analysis an individual adjusted increase in EDD during the simvastatin treatment period was seen (coefficient 0.132 a month, p =0.002). A significant reduction in total cholesterol of 31.0% (6.1±0.8 vs. 4.2±0.7, p <0.001) and LDL cholesterol of 42.6% (4.0±0.8 vs. 2.2±0.6, p <0.001) was observed. Conclusion: EDD is improved after long-term simvastatin therapy; however, neither did 3 months diet or 3 months simvastatin therapy has influence on the EDD. [Copyright &y& Elsevier]

Extent of coronary artery disease (CAD) which may lead to underestimation of the Levels are not part of cardiovascular risk assessment in patients with diabetes since Guidelines on diabetes, pre-diabetes, and cardiovascular diseases. [Extracted from the article]

Background: Coronary Artery Disease in Saudis is reaching epidemic levels. The extent of Coronary Athero-Thrombosis (CAT) is yet to be studied. We present the design and preliminary results of IVUS project intended for centres with IVUS capabilities in Saudi Arabia. We aim at gathering clinical and quantitative IVUS data. Methods: 60 pts. IVUS studies at Prince Salman Heart Center (PSHC), King Fahad Medical City reviewed. 40 of 105 runs analysed for Borderline Lesions 35 pts. Pre-Runs (PR), 67 runs 25 pts. post stenting (PS). Initial analysis done at IVUS Core-Lab Odense University Hospital Odense–Denmark, now available at PSHC. Each 1mm slice, had separate Luminal and External Elastic Membrane (EEM) tracings, obtained 5mm Proximal and Distal to maximal Plaque Burden. Results: 35 pts. (28 males, mean age 54±18). 27 pts. (77%) Diabetics. Forty IVUS borderline lesions runs analysed. 12 pts. (34.29%) with recent ST Elevation Myocardial Infarction (STEMI), 8 (22.86%) Non-STEMI (NSTEMI), and 15 (42.85%) Unstable Angina (UA). Non-Diabetics had larger Luminal, Vessel Diameters, and Plaque Areas (P value: 0.048, 0.008 , 0.0088, 0.020), Diabetics with NSTEMI had larger Plaque Areas and Burden (P value: 0.0003, 0.0033). Vessels volumes non-significantly different. Conclusion: SAUDICAT, is the first national quantitative IVUS study of CAT of Saudi pts. with ACS. Non diabetics had larger vessels, diabetics with STEMI, and NSTEMI had larger plaque areas and burdens. We believe with the completion of this project, a Core-Lab for IVUS studies can be established in Saudi Arabia and the Middle East. [ABSTRACT FROM AUTHOR]

Background: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease.Methods: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis.Results: Because of the COVID-19 pandemic, the data safety and monitoring board recommended to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across 8 countries. Participants assigned to influenza vaccine totaled 1290 and individuals assigned to placebo equaled 1281; of these, 2532 received the study treatment (1272 influenza vaccine and 1260 placebo) and were included in the modified intention to treat analysis. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72 [95% CI, 0.52-0.99]; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59 [95% CI, 0.39-0.89]; P=0.010), rates of cardiovascular death were 2.7% and 4.5%, (hazard ratio, 0.59 [95% CI, 0.39-0.90]; P=0.014), and rates of MI were 2.0% and 2.4% (hazard ratio, 0.86 [95% CI, 0.50-1.46]; P=0.57) in the influenza vaccine and placebo groups, respectively.Conclusions: Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, and a lower risk of all-cause death and cardiovascular death, as well, at 12 months compared with placebo. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02831608. [ABSTRACT FROM AUTHOR]

The diagnostic accuracy of non-invasive diagnostic methods for detecting coronary artery disease has increased in recent years. This study aimed to assess the diagnostic performance of 15O-water positron emission tomography (PET) in terms of stress myocardial blood flow (MBF) and myocardial flow reserve (MFR) in patients with single-vessel disease referred for percutaneous coronary intervention (PCI), using fractional flow reserve (FFR) value of ≤0.80 as the reference for a significant stenosis. We also assessed the influence of the index of microcirculatory resistance (IMR) on the diagnostic performance of PET. 15O-water PET FFR and IMR were measured before PCI in 26 patients with single-vessel disease. Stress MBF < 2.5 ml/min/g (95% confidence interval [CI]) had sensitivity 78% (95% CI: 52%-94%), specificity 50% (95% CI: 16%-84%), positive predictive value (PPV) 78% (95% CI: 63%-88%), negative predictive value (NPV) 50% (95% CI: 25%-75%), and accuracy 69% (95% CI: 48%-86%). MFR < 2.5 had sensitivity 72% (95% CI: 47%-90%), specificity 75% (95% CI: 35%-97%), PPV 87% (95% CI: 65%-96%), NPV 55% (95% CI: 34%-74%), and accuracy 73% (95% CI: 52%-88%). In patients with IMR > 24, stress MBF correlated with FFR (r = 0.651; p = 0.016) whereas stress MBF did not correlate with FFR in patients with IMR < 24. In conclusion, stress MBF and MFR had modest diagnostic performance compared to invasive FFR measurements in patients with single-vessel disease. [ABSTRACT FROM AUTHOR]

Background: Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease.Methods: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651.Findings: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke.Interpretation: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease.Funding: Biosensors, Aarhus University Hospital, and participating sites. [ABSTRACT FROM AUTHOR]

Purpose: Frequency-domain optical coherence tomography (FD-OCT) is a high-resolution imaging tool (~10-15 μm), which enables near-histological in-vivo images of the coronary vessel wall. The use of the technique is increasing, both for research- and clinical purposes. This study sought to investigate the intra- and interobserver reliability, as well as the intra-catheter reproducibility of quantitative FD-OCT-assessment of morphometric stent parameters and qualitative FD-OCT-evaluation of strut coverage in 10 randomly selected 6-month follow-up Nobori® biolimus-eluting stents (N-BESs).Methods: Ten N-BESs (213 cross sectional areas (CSAs) and 1897 struts) imaged with OCT 6 months post-implantation were randomly selected and analyzed by 2 experienced analysts, and the same 10 N-BESs were analyzed by one of the analysts 3 months later. Further, 2 consecutive pullbacks randomly performed in another 10 N-BESs (219 CSAs and 1860 struts) were independently assessed by one of the analysts.Results: The intraobserver variability with regard to relative difference of mean luminal area and mean stent area at the CSA-level was very low: 0.1%±1.4% and 0.5%±3.2%. Interobserver variability also proved to be low: -2.1%±3.3% and 2.1%±4.6%, and moreover, very restricted intra-catheter variation was observed: 0.02%±6.8% and -0.18%±5.2%. The intraobserver-, interobserver- and intra-catheter reliability for the qualitative evaluation of strut coverage was found to be: kappa (κ)=0.91 (95% confidence interval (CI): 0.88-0.93, p<0.01), κ=0.88 (95% CI: 0.85-0.91, p<0.01), and κ=0.73 (95% CI: 0.68-0.78, p<0.01), respectively.Conclusions: FD-OCT is a reproducible and reliable imaging tool for quantitative evaluation of stented coronary segments, and for qualitative assessment of strut coverage. [ABSTRACT FROM AUTHOR]

Abstract: Background: Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombosis. Methods: PubMed was systematically searched for eligible studies from the drug-eluting stent (DES) era (1/2002–12/2010). Studies were selected if including ≥2000 patients undergoing stenting or reporting on ≥25 thromboses. Study features, patient characteristics, and incidence of stent thrombosis were abstracted and pooled, when appropriate, with random-effect methods (point estimate [95% confidence intervals]), and consistency of predictors was formally appraised. Results: A total of 30 studies were identified (221,066 patients, 4276 thromboses), with DES used in 87%. After a median of 22months, definite, probable, or possible stent thrombosis had occurred in 2.4% (2.0%; 2.9%), with acute in 0.4% (0.2%; 0.6%), subacute in 1.1% (1.0%; 1.3%), late in 0.5% (0.4%; 0.6%), and very late in 0.6% (0.4%; 0.8%). Similar figures were computed for studies reporting only on DES. From a total of 47 candidate variables, definite/probable stent thrombosis was more commonly and consistently predicted by early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length, with acute coronary syndrome at admission, diabetes, smoking status, and bifurcation/ostial disease also proving frequent predictors, but less consistently. Conclusions: Despite numerous possible risk factors, the most common and consistent predictors of stent thrombosis are early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length. [Copyright &y& Elsevier]