coronary heart disease
evidence based medicine
health technology assessment
meta-analysis as topic
review literature as topic
Public aspects of medicine
Medical philosophy. Medical ethics
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AbstractScientific background: Various diagnostic tests including conventional invasive coronary angiography and non-invasive computed tomography (CT) coronary angiography are used in the diagnosis of coronary heart disease (CHD). Research questions: The present report aims to evaluate the clinical efficacy, diagnostic accuracy, prognostic value cost-effectiveness as well as the ethical, social and legal implications of CT coronary angiography versus invasive coronary angiography in the diagnosis of CHD. Methods: A systematic literature search was conducted in electronic data bases (MEDLINE, EMBASE etc.) in October 2010 and was completed with a manual search. The literature search was restricted to articles published from 2006 in German or English. Two independent reviewers were involved in the selection of the relevant publications. The medical evaluation was based on systematic reviews of diagnostic studies with invasive coronary angiography as the reference standard and on diagnostic studies with intracoronary pressure measurement as the reference standard. Study results were combined in a meta-analysis with 95 % confidence intervals (CI). Additionally, data on radiation doses from current non-systematic reviews were taken into account. A health economic evaluation was performed by modelling from the social perspective with clinical assumptions derived from the meta-analysis and economic assumptions derived from contemporary German sources. Data on special indications (bypass or in-stent-restenosis) were not included in the evaluation. Only data obtained using CT scanners with at least 64 slices were considered. Results: No studies were found regarding the clinical efficacy or prognostic value of CT coronary angiography versus conventional invasive coronary angiography in the diagnosis of CHD. Overall, 15 systematic reviews with data from 44 diagnostic studies using invasive coronary angiography as the reference standard (identification of obstructive stenoses) and two diagnostic studies using intracoronary pressure measurement as the reference standard (identification of functionally relevant stenoses) were included in the medical evaluation. Meta-analysis of the nine studies of higher methodological quality showed that, CT coronary angiography with invasive coronary angiography as the reference standard, had a sensitivity of 96 % (95 % CI: 93 % to 98 %), specificity of 86 % (95 % CI: 83 % to 89 %), positive likelihood ratio of 6.38 (95 % CI: 5.18 to 7.87) and negative likelihood ratio of 0.06 (95 % CI: 0.03 to 0.10). However, due to non-diagnostic CT images approximately 3.6 % of the examined patients required a subsequent invasive coronary angiography. Using intracoronary pressure measurement as the reference standard, CT coronary angiography compared to invasive coronary angiography had a sensitivity of 80 % (95 % CI: 61 % to 92 %) versus 67 % (95 % CI: 51 % to 78 %), a specificity of 67 % (95 % CI: 47 % to 83 %) versus 75 % (95 % CI: 60 % to 86 %), an average positive likelihood ratio of 2.3 versus 2.6, and an average negative likelihood ratio 0.3 versus 0.4, respectively. Compared to invasive coronary angiography, the average effective radiation dose of CT coronary angiography was higher with retrospective electrocardiogram (ECG) gating and relatively similar with prospective ECG gating. The health economic model using invasive coronary angiography as the reference standard showed that at a pretest probability of CHD of 50 % or lower, CT coronary angiography resulted in lower cost per patient with true positive diagnosis. At a pretest probability of CHD of 70 % or higher, invasive coronary angiography was associated with lower cost per patient with true positive diagnosis. Using intracoronary pressure measurement as the reference standard, both types of coronary angiographies resulted in substantially higher cost per patient with true positive diagnosis. Two publications dealing explicitly with ethical aspects were identified. The first addressed ethical aspects regarding the principles of beneficence, autonomy and justice, and the second addressed those regarding radiation exposition, especially when used within studies.Discussion: The discriminatory power of CT coronary angiography to identify patients with obstructive (above 50 %) coronary stenoses should be regarded as “high diagnostic evidence”, to identify patients without coronary stenoses as “persuasive diagnostic evidence”. The discriminatory power of both types of coronary angiography to identify patients with or without functionally relevant coronary stenoses should be regarded as “weak diagnostic evidence”. It can be assumed that patients with a high pretest probability of CHD will need invasive coronary angiography and patients with a low pretest probability of CHD will not need subsequent revascularisation. Therefore, CT coronary angiography may be used before performing invasive coronary angiography in patients with an intermediate pretest probability of CHD. For identifying or excluding of obstructive coronary stenosis, CT coronary angiography was shown to be more cost-saving at a pretest probability of CHD of 50 % or lower, and invasive coronary angiography at a pretest probability of CHD of 70 % or higher. The use of both types of coronary angiography to identify or to exclude functionally relevant coronary stenoses should be regarded as highly cost-consuming. With regard to ethical, social or legal aspects, the following possible implications were identified: under-provision or over-provision of health care, unnecessary complications, anxiety, social stigmatisation, restriction of self-determination, unequal access to health care, unfair resource distribution and legal disputes.Conclusion: From a medical point of view, CT coronary angiography using scanners with at least 64 slices should be recommended as a test to rule out obstructive coronary stenoses in order to avoid inappropriate invasive coronary angiography in patients with an intermediate pretest probability of CHD. From a health economic point of view, this recommendation should be limited to patients with a pretest probability of CHD of 50 % or lower. From a medical and health economic point of view, neither CT coronary angiography using scanners with at least 64 slices nor invasive coronary angiography may be recommended as a single diagnostic test for identifying or ruling out functionally relevant coronary stenoses. To minimise any potential negative ethical, social and legal implications, the general ethical and moral principles of benefit, autonomy and justice should be considered.
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The pre-test risk stratified cost-effectiveness of 64-slice computed tomography coronary angiography in the detection of significant obstructive coronary artery disease in patients otherwise referred to invasive coronary angiographyKreisz, F.; Merlin, T.; Moss, J.; Atherton, J.; Hiller, J.; Gericke, C. (Blackwell Publishing Asia, 2009)Background This study evaluates the cost-effectiveness of 64-slice computed tomography coronary angiography (CTCA) as an alternative to invasive diagnostic coronary angiography (CA) in an elective outpatient setting for patients otherwise referred to invasive diagnostic coronary angiography. Methods Taking the perspective of the Australian health system we used a decision analytic model to integrate data on test accuracy along with complication rates, health state preference weights and health care costs. The analysis is pre-test risk stratified based on Bayes’ theorem of conditional probability. Incremental cost-effectiveness ratios (ICER) are the study endpoints expressed as incremental costs per quality adjusted life year (QALY) gained. Results The results indicate that CTCA is a cost-saving strategy offering a higher health related quality of life up to approximately 65% pre-test risk of coronary artery disease (CAD). Above that threshold the model predicts a cost-utility trade-off with every gain in health related quality of life through the use of CTCA as a rule-out test being associated with additional costs when compared to invasive diagnostic CA. Conclusion This health economic analysis predicts computed tomography coronary angiography to be a cost-effective rule-out strategy in symptomatic patients at low to intermediate risk of significant obstructive coronary artery disease otherwise referred to invasive diagnostic CA.
Cardiac MDCT, beyond coronary angiography : support to learn about extra coronary anomalies on cardiac MDCT except the coronary anomalies.Université de Picardie; TEXIER, Agnès; RENARD, Cédric (2010)L imagerie cardiaque a beaucoup évolué ces dernières années. Bien que l échographie cardiaque demeure l examen de première intention pour l étude de la fonction et de la morphologie cardiaque, d autres techniques telles que l imagerie par résonance magnétique (IRM) et le scanner sont devenues utiles voire indispensables au diagnostic et à la décision thérapeutique. Le scanner cardiaque s inscrit à la fois comme une technique complémentaire et une alternative à l échographie cardiaque dans certaines pathologies. Bien que moins performant que l IRM en terme de caractérisation tissulaire et de résolution temporelle et parfois d utilisation limitée en raison de son caractère irradiant, le scanner présente certains avantages, notamment sa disponibilité, sa très bonne résolution spatiale et le caractère volumique de son exploration. Ces caractéristiques en font l examen de choix pour l étude non invasive des artères coronaires. Par contre, il reste encore sous-exploité pour l étude des pathologies touchant le myocarde, le péricarde et les cavités cardiaques, souvent mal connues des radiologues. Ce CD-Rom a pour objectif de fournir une base de données et un enseignement didactique des anomalies cardiaques extra-coronaires que l on peut retrouver lors d une exploration cardiaque ou thoracique par scanner multi-détecteur. Cet outil a pour ambition de familiariser les radiologues et les cardiologues à la lecture du scanner cardiaque dans sa globalité afin de ne pas limiter son analyse à celle des artères coronaires.
Assessment of coronary flow reserve by Doppler flow wIre in patients with acute coronary syndrome undergoing percutaneous coronary intervention: differences between the LoAding dose of Ticagrelor versus prasugrEl (DILATE): study protocol for a randomized controlled trialMarianna Cicenia; Andrea Ceccacci; Simone Calcagno; Viviana Maestrini; Nicolò Salvi; Alessandra Cinque; Rocco E Stio; Maurizio Pulcini; Gennaro Sardella; Massimo Mancone; et al. (Wolters Kluwer Medknow Publications, 2016-01-01)Background: Percutaneous coronary intervention (PCI) is the main treatment in patients with acute coronary syndromes (ACS). Current guidelines recommend the administration of a loading dose of clopidogrel, ticagrelor or prasugrel during the procedure. Ticagrelor and prasugrel have proven to overcome some limitation related to clopidrogrel administration as of pharmacological resistance. P2Y12 antagonists increase adenosine concentration by inhibiting red blood cells reuptake and induces adenosine triphosphate release from human red blood cells, which is further degraded to adenosine. Ticagrelor has been demonstrated to increase the coronary blood flow velocity more than prasugrel, as assessed by transthoracic Doppler echocardiography after incremental doses of adenosine administration. Currently, no data are available on comparison between prasugrel and clopidrogrel in term of vasodilation effect evaluated invasively. Methods/Design: This prospective, single-center, investigator-initiated, randomized controlled trial will compare the adenosine induced coronary dilatation after the treatment with ticagrelor (180 mg) versus prasugrel (60 mg) in patients with ACS undergoing PCI. A total of 90 patients, aged ≥ 18 and ≤ 75 years, admitted with ACS, treated by PCI with stent implantation and with a second intermediate non-culprit lesion will be included and randomized 1:1 to prasugrel (60 mg) or ticagrelor (180 mg). Coronary flow reserve (CFR), the study endpoint, will be recorded before the stent implantation on the intermediate lesion, then immediately after the stent implantation and during the adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 μg/kg/min with 2-minute interval between infusions. Discussion: Our clinical trial, for the first time, will evaluate the supposed adenosine induced effect of the ticagrelor in terms of coronary vasodilatation calculated by CFR. Currently, CFR represents the gold standard to assess the ability of the myocardium to increase blood flow in response to maximal exercise. Furthermore, this trial will be the first to compare the effects of ticagrelor versus prasugrel on patients ACS. This trial will allow to better understand the physiological pathway of coronary vasodilatiation induced by ticagrelor versus prasugrel using invasive methods. Trial registration: ClinicalTrials.gov identifier: NCT02032303; registered on December 18, 2013. Ethics: The study was approved by the Ethics Committee of Policlinico Umberto I Rome Hospital (approval No. 2322/15) and will be performed in accordance with the ethical standards of the responsible committee on human experimentation and the Declaration of Helsinki. Informed consent: A signed informed consent will be given by each patient with ACS before undergoing angiography.