Change in management k=2 before-and-after case series No comparative studies Risk of bias: 0 Inconsistency: –1 Indirectness: –1 Imprecision: –1 Publication bias: 0 71.5% of patients had a change in management after LGE-CMR (change in invasive procedure in 24.2%). 3/9 CABGs were averted due to non-viability, and overall 13% had a change in surgical management plan. LGE-CMR was found to influence what treatment patients received, but it is unknown how this differs from what they would have received due to the comparators. Very low ⨁⨀⨀⨀ a GRADE Working Group grades of evidence () ⨁⨁⨁⨁ High quality: We are very confident that the true effect lies close to that of the estimate of effect. ⨁⨁⨁⨀ Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. ⨁⨁⨀⨀ Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. ⨁⨀⨀⨀ Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. AE = adverse event; CABG = coronary artery bypass; CT-DCE = computed tomography perfusion with delayed contrast enhancement; DbE = low-dose dobutamine Echo; Echo = echocardiography; k = number of studies; LGE-CMR = late gadolinium enhancement with cardiac magnetic resonance imaging; RCT = randomised controlled trial; SPECT = emission computed tomography; Tl = thallium-201; Tm = technetium-99m
(IHE 8/12) Mean age: 62 ± 8 years n=35/103 women (34%) 66% had intermediate or high PTP for CAD using the modified score CAD risk factors: hypertension 73% hypercholesterolaemia 80% smoker 14% diabetes 39% family history 20% disease; pregnancy; atrial fibrillation; renal insufficiency (creatinine clearance ≤60 mL/minute); and standard contraindications to CMR, adenosine and gadolinium Bruder et al. () Europe Level IV: A case series with either post-test or outcomes Low risk of bias (IHE 8/12) N=27,301 consecutive patients undergoing CMR according to the ACCF/ACR/SCCT/SCMR/ASNC/NASCI/ SCAI/SIR 2006 consensus appropriateness criteria for CMR imaging from 57 participating centres Mean age: 60 years (range 47–70) Women: 35% Primary indication of suspected CAD or ischaemia in known CAD: 34.2% Exclusion criteria: Not reported CMR used according to the ACCF/ACR/SCCT/ SCMR/ASNC/NASCI/ SCAI/SIR 2006 consensus appropriateness criteria Bunce et al. () UK Level IV: A case series with either post-test or outcomes Moderate risk of bias (IHE 6.5/12) N=35 consecutive patients undergoing diagnostic ICA for the investigation of angina Mean age: 56 ± 12 years (range 34–81) n=8/35 women (23%) Mean LVEF: 61 ± 12% CAD risk factors: hypertension 34% smoker 46% Exclusion criteria: An inability or unwillingness to give informed consent; unstable angina or recent MI; the presence of an implanted permanent pacemaker, defibrillator or intracranial clips; significant claustrophobia; bronchial asthma; or previous CABG surgery Adenosine SP-CMR
Moderate risk of bias (IHE 6/12) Prior PCI: 21% CAD risk factors: hypertension 39% hypercholesterolaemia 56% smoker 35% diabetes 15% family history 16% Groothuis et al. () The Netherlands Level IV A case series with either post-test or outcomes Low risk of bias (IHE 8/12) N=198 patients with low or intermediate PTP of having CAD 104 patients had no obstructive CAD on CTCA or CMR and did not have ICA and FFR Mean age, 56 ± 10 years n=96 women (50%) PTP according to the combined Diamond/Forrester and CASS scale: low PTP 45% intermediate PTP 33% high PTP 22% CAD risk factors: hypertension 38% hyperlipidaemia 20% smoker 27% diabetes 12% family history 41% Inclusion criteria: Chest pain and low or intermediate PTP of having CAD according to the Diamond/Forrester and CASS scales. Exclusion criteria: Any prior history of CAD (prior documented myocardial ischaemia, MI, PCI or cardiac surgery), significant arrhythmia, pregnancy, renal insufficiency, known allergy to iodinated contrast material, any absolute contra-indication for CMR (e.g. cerebral clips), claustrophobia, and asthma. Adenosine SP-CMR + LGE
family history 53% Klem et al. () USA Level IV A case series with either post-test or outcomes Low risk of bias (IHE 8/12) N=100 consecutive patients with suspected CAD scheduled for ICA Mean age: 58 ± 11.5 years n=47/92 women (51%) Angina according to Rose chest pain questionnaire: 34% CAD risk factors: hypertension 64% hypercholesterolaemia 54% smoker 39% diabetes 23% family history 52% Exclusion criteria: Patients with known CAD including those with prior MI or revascularisation procedures; and contraindications to CMR (e.g. pacemaker) or adenosine (e.g. high-grade AV-block) Adenosine SP-CMR + LGE Korosoglou et al. () Germany Level IV: A case series with either post-test or outcomes Some risk of bias (IHE 7.5/12) N=1,493 consecutive patients with suspected or known CAD underwent dobutamine SP-CMR Mean age: 65 ± 13 years n=383 women (26%) CAD risk factors: hypertension 71% hyperlipidaemia 53% smoker 18% diabetes 19% family history 22% Exclusion criteria: Non-sinus rhythm; unstable angina; severe arterial hypertension (200/120 mm Hg), moderate or severe valvular disease; and general contraindications to CMR (e.g. implanted pacemakers or defibrillators) Dobutamine SP-CMR, using a standard protocol in a 1.5-T magnetic resonance scanner
Lockie et al. () UK Level IV A case series with either post-test or outcomes Low risk of bias (IHE 8/12) N=44 patients with known or suspected CAD Mean age: 57 ± 10 years n=9 women (21%) Previous PCI: 19% CAD risk factors: smoker 21% diabetes 19% family history 26% Exclusion criteria: Contraindications for CMR or gadolinium-contrast agents; previous MI, CABG, ACS; impaired LVEF (<40%); and obstructive pulmonary disease Adenosine SP-CMR + LGE Ma et al. () China Level IV A case series with either post-test or outcomes Low risk of bias (IHE 8/12) N=50 consecutive patients with suspected CAD who were scheduled for primary diagnostic ICA Mean age: 56 ± 16 years n=22/50 women (44%) n=28/50 men (56%) CAD risk factors: hypertension 36% hypercholesterolaemia 54% smoker 46% diabetes 18% family history 32% Exclusion criteria: Medical instability; known CAD; any contraindications to CMR (i.e. metallic implants such as pacemakers, defibrillators, cerebral aneurysm clips, ocular metallic deposits; severe claustrophobia); or contraindications to adenosine (e.g., 2nd- or 3rd- degree AV block, history of asthma); and renal insufficiency Adenosine SP-CMR + LGE Merkle et al. () Germany Level IV A case series with either post-test or outcomes Low risk of bias (IHE 8/12) N=256 consecutive patients with known or suspected CAD and a time interval of less than 4 weeks between CMR and ICA n=32/73 women (44%) Mean age: 63.4 ± 11.7 years CAD risk factors: hypertension 78% hypercholesterolaemia 71% smoker 16% Exclusion criteria: Acute MI; previous CABG; severe claustrophobia; implants; a heart rate not well controlled; and pulmonary disease requiring treatment with methyl xanthine derivatives. Adenosine SP-CMR
hypertension 68% hypercholesterolaemia 70% smoker 57% diabetes 14% Plein et al. () UK Level IV A case series with either post-test or outcomes Moderate risk of bias (IHE 6.5/12) N=92 patients who were suspected of having or known to have CAD and were scheduled to undergo conventional ICA owing to clinical referral Mean age, 58 ± 11 years n=24 women (26%) Previous MI 21% CAD risk factors: hypertension 33% hypercholesterolaemia 59% smoker 38% diabetes 9% family history 43% Exclusion criteria: Obstructive airway disease; cardiac arrhythmias; and contraindications to cardiac CMR Adenosine SP-CMR Regenfus et al. () Germany Level IV A case series with either post-test or outcomes Moderate risk of bias (IHE 6/12) N=427 CA segments from 61 patients referred for diagnostic ICA due to clinically suspected CAD Mean age, 63 ± 6 years n=9 women (15%) Exclusion criteria: Patients with arrhythmias; in unstable clinical condition; or with contraindications to CMR imaging (e. g. cardiac pacemakers, other ferromagnetic implants or claustrophobia) Nitroglycerin SP-CMR Sakuma et al. () Japan Level IV A case series with either post-test or outcomes Moderate risk of bias (IHE 5/12) N=40 patients with suspected CAD Mean age, 64.6 ± 9.0 years n=12 women (30%) Inclusion criteria: Underwent stress first-pass contrast-enhanced CMR, stress thallium-201 SPECT and ICA within 4 weeks Exclusion criteria: Previous MI; abnormal Q-wave on ECG; chest pain at rest; abnormal myocardial wall motion; severe arrhythmia; and coronary Dipyridamole SP-CMR + LGE
patients Quality: high risk of bias Patient selection Index test Reference standard Flow and timing n=33/60 women (55%) CAD risk factors: hypertension 60% hypercholesterolaemia 37% smoker 17% diabetes 13% family history 35% older than 30 years or a woman older than 40 years. Risk factors included hypertension, hyperlipidaemia, diabetes mellitus, current smoker, and a family history of MI before age 55 years. Exclusion criteria: Atypical chest pain; those with a very low or high PTP of having CAD; aortic stenosis with a mean gradient of 40 mm Hg of more; 2nd-degree or higher AV block; pregnancy; haemodynamic or clinical instability; non-cardiac medical problems that could lead to hospital admission; and standard contraindications to CMR imaging. Stress agent: Adenosine Contrast agent: Gadolinium LGE: Yes (5-minute delay) Sequence: Stress/rest/LGE Image analysis: Perfusion + LGE algorithm to detect ischaemia events during follow-up. Husser et al. () Spain Level III-1: A comparison against independent, blinded reference standard among non-consecutive patients Quality: low risk of bias Patient selection Index test Reference standard Flow and timing N=166 patients with chest pain of possible coronary origin who underwent dipyridamole stress CMR and ICA within 3 months Mean age 65 ± 11 years n=51 women (31%) Mean LVEF: 60 ± 13% Previous MI: 27% Previous PCI: 16% CAD risk factors: hypertension 66% hypercholesterolaemia 54% smoker 21% Inclusion criteria: Retrospective selection of women who underwent both CMR and ICA within 3 months Exclusion criteria: Patients who had undergone a coronary revascularisation; had had an MI within 3 months before the CMR study; or any contraindication for dipyridamole Scanner: 1.5-T scanner with a body surface coil Perfusion sequence: First-pass with a notched saturation pulse Image acquisition: During breath-holds Stress agent: Dipyridamole Contrast agent: Gadopentetate dimeglumine LGE: Yes (10-minute delay) Sequence: Rest/stress/LGE Image analysis: Perfusion and LGE Angiographic data was evaluated by an experienced cardiologist on a standard digital imaging system array
Reference standard Flow and timing smoker 43% diabetes 19% family history 26% n=10 without CAD Mean age, 50 ± 12 years 5/10 women (50%) Mean LVEF: 73 ± 4 CAD risk factors: hypertension 60% hypercholesterolaemia 100% smoker 80% diabetes 0% family history 50% bismethylamide LGE: No Sequence: Stress Stolzmann et al. () Switzerland Level II: A comparison against independent, blinded reference standard among consecutive patients Quality: low risk of bias Patient selection Index test Reference standard Flow and timing N=60 consecutive patients referred to CA who all had an intermediate risk of having CAD based on the Diamond and criteria Mean age, 64 ± 10 years n=8 women (13%) CAD risk factors: hypertension 77% hyperlipidaemia 72% smoker 33% diabetes 15% family history 18% Exclusion criteria: Contraindications for adenosine (e.g. 2nd or 3rd AV block, sick sinus syndrome, symptomatic bradycardia, severe asthma or obstructive pulmonary disease) or to CMR (e.g. implanted electronic devices, metallic foreign bodies in the eye, severe claustrophobia, and others according to local regulations and manufacturer’s recommendations) Scanner: 1.5-T scanner with cardiac phased-array receiver coils Perfusion sequence: First-pass with a saturation recovery gradient echo pulse Image acquisition: During breath-holds Stress agent: Adenosine Contrast agent: Gadobutrolum LGE: Yes (10-minute delay) Sequence: Stress/rest/LGE Image analysis: Either perfusion or LGE defects scored positive Angiograms were obtained in at least two orthogonal projections according to standard techniques. Coronary angiograms of the target vessels were evaluated by consensus of two readers. Takase et al. () Japan Level III-2 A comparison with reference standard (not blinded or blinding not N=57 consecutive patients with suspected CAD Mean age, 66 ± 10 years n=17 women (17%) Inclusion criteria: Referred to the National Defense Medical College Hospital and who agreed to undergo the dipyridamole stress perfusion Scanner: 1.5-T scanner with a phased array cardiac coil Perfusion sequence: First-pass Image acquisition: During breath-holds ICA was performed using the standard Judkins technique and the presence of significant stenosis (>50%) was
with MPI without addressing the diagnostic accuracy of coronary artery stenosis or occlusion, and studies including patients treated with coronary stents or bypass grafts Beanlands et al. () Canada 18% (2/11) Poor quality with a high risk of bias To define Canadian recommendations for the clinical use of advanced imaging modalities Searches were divided into 4 categories: CAD and/or ischemia detection and diagnosis; CAD prognostication; myocardial viability detection; and viability prognostication Analysis at patient and segment level Search period: Up to June 2005 Databases searched: Medline, EMBASE, Cochrane library, and other evidence-based medicine Web sites, such as that of the Agency for Healthcare Research and Quality Inclusion criteria: A systematic search of the literature, using validated British Medical Journal filters for diagnosis and prognosis, was used to identify the best evidence for use of CTCA and CMR. Exclusion criteria: None reported Multidetector CTCA 16-slice: k=19 64slice: k=4 Dobutamine k=11 PET: k=14 ICA: DS cut-off at 50% or above Chen et al. () China 55% (6/11) Moderate quality with a moderate risk of bias To use direct comparative studies or RCTs to compare the accuracy of CMR and SPECT for the detection of obstructive CAD Adult patients with CAD or suspected of having CAD Analysis at patient and coronary artery level Search period: Publication date no later than June 2013 Databases searched: PubMed, EMBASE, Web of Science and the Cochrane Library Inclusion criteria: Direct comparative studies or randomised controlled trials. The data reported in the primary studies were sufficient for the calculation of true-positive, false-positive, true-negative or false-negative values. Exclusion criteria: Review articles, letters, comments, case reports and unpublished articles were excluded. Both SP-CMR and SPECT evaluated in the same patient population: k=6 ICA: DS cut-off at 50% or above CMR:
having CAD Analysis at patient and segment level calcium score categories Exclusion criteria: Laboratory or phantom studies; concerned a review or case report; included examinations of stented or bypassed CAs; or used <16-slice CTCA Desai and Jha () USA 45% (5/11) Moderate quality with a moderate risk of bias To determine the test characteristics of SP-CMR in the diagnosis of flow-limiting obstructive CAD using FFR at ICA as the reference standard Patients with known or suspected CAD Analysis at patient and coronary artery level Search period: January 2000 to August 2012 Databases searched: Medline, PubMed, Cochrane Database and EMBASE Inclusion criteria: The use of a magnet of strength of at least 1.5-T; provision of sensitivity and specificity and NPV and PPV or information enabling such calculation; stable CAD Exclusion criteria: Studies with less than 20 patients; overlapping or duplicate data; that used phantoms; on patients with suspected ACS; and published in non-English journals SP-CMR: in women: k=12 in men: k=8 FFR: diagnostic cut-off at 0.75 or above Dolor et al. () USA 64% (7/11) Good quality with low risk of bias What is the accuracy of one non-invasive technology (NIT) in diagnosing obstructive and CAD when compared with another NIT or with ICA in women with symptoms suspicious for CAD? Adult women who presented symptoms suspicious for CAD Search period: Published in English from 1 January 2000 to 12 September 2011 Databases searched: PubMed, EMBASE, the Cochrane Database of Systematic Reviews and the Cochrane Central Registry of Controlled Trials Grey literature databases included Clinicaltrials.gov; metaRegister of Controlled Trials; ClinicalStudyResults.org; WHO: International Clinical Trials Registry Platform Search Portal; CSA Conference Papers Index; and Scopus. Inclusion criteria: RCTs; prospective or retrospective observational studies with original data; related methodology paper of an included article Exercise ECG: k=41 Exercise/stress Echo with or without a contrast agent: k=22 Exercise/stress SPECT: k=30 SP-CMR: k=6 CTCA: k=8 ICA: DS cut-off at 50% or above
of bias Pooled meta-analyses of studies included in 11 SRs Analysis at patient level PubMed and the Cochrane Library Inclusion criteria: Meta-analyses on the diagnostic performance of non-invasive imaging tests for the diagnosis of CAD with ICA as the reference standard; the absolute numbers of true positives, false negatives, true negatives and false positives of the source studies were available or derivable from the meta-analyses, or from the authors Exclusion criteria: Meta-analyses published before 1990 Stress SPECT: k=103 Iskandar et al. () USA 64% (7/11) Good quality with low risk of bias To perform an SR and bivariate meta-analysis to compare the diagnostic accuracy of SPECT MPI between men and women Patients with known or suspected CAD Analysis at patient level Search period: From inception to January 2012 Databases searched: Medline and EMBASE, bibliographies of review articles and relevant chapters of central cardiology textbooks Inclusion criteria: English-language literature; prospective studies that provided patient level; true and false positives and negatives of at least 20 patients Exclusion criteria: Studies that explicitly stated they were retrospective or reported data of <20 patients of one gender; in case of overlapping publication of study cohorts, only largest study was included SPECT MPI: In women: k=17 In men: k=13 ICA: DS cut-off at 50% Jaarsma et al. () The Netherlands and UK 36% (4/11) Moderate quality with a moderate risk of bias To determine the diagnostic accuracy of the most commonly used myocardial perfusion imaging modalities, for the diagnosis of obstructive CAD Search period: January 1990 to February 2010 Databases searched: PubMed Inclusion criteria: Stress perfusion: SPECT: k=105 SP-CMR: k=27 ICA: DS cut-off at 50% or above invasive
risk of bias patients Patients with suspected or known CAD Analysis at patient level Databases searched: OVID Medline, Medline In-Process and Other Non-Indexed Citations, EMBASE, Cinahl, the Cochrane Library and INAHTA Inclusion criteria: English- or French-language HTAs, English-language SRs, RCTs and clinical trials and observational studies with symptomatic adult patients at intermediate PTP of CAD Exclusion criteria: Non-English studies; studies with paediatric patients; patients with low or high PTP of CAD or non-IHD Medical Advisory Secretariat () Canada 36% (4/11) Moderate quality with a moderate risk of bias To compare Echo performed with microsphere contrast agents to Echo performed without contrast and to SPECT Patients with suspected or known CAD Analysis at patient level Search period: 1 January 2004 until 30 June 2009 Databases searched: OVID Medline, Medline In-Process and Other Non-Indexed Citations, EMBASE, the Cochrane Library and INAHTA Inclusion criteria: HTAs, SRs, RCTs and observational studies with ≥20 adult patients for the diagnosis of CAD Exclusion criteria: Non-systematic reviews, case reports and grey literature (e.g. conference abstracts) Stress contrast Echo: k=10 ICA: DS cut-off at 50% or above Medical Advisory Secretariat () Canada 36% (4/11) Moderate quality with a moderate What is the diagnostic accuracy of SPECT for the diagnosis of CAD compared with the reference standard of ICA? Search period: Update of SR by Heijenbrok-Kal et al. () 1 January 2002 to 30 October 2009 Databases searched: Stress SPECT: vs ≥50% DS: k=51 vs ≥70% DS: k=12 ICA: DS cut-off at 50% or above
contraindication to CMR Objective: To determine whether the addition of regadenoson stress CMR to a clinical risk model can be used for reclassification of cardiovascular risk Continuous NRI Bingham & Hachamovitch () USA Level IV: CS Quality: 8.5/12 Moderate risk of bias N=932 patients referred to stress CMR of whom 908 (98%) were included in the final analysis Age, median (25th, 75th percentiles): 65 years (55, 74) Male: 59% Ethnicity: NR Inclusion criteria: Referred for stress CMR Exclusion criteria: Moderate to severe valvular disease Objective: To assess the incremental prognostic power of myocardial viability, vasodilator stress perfusion, and ventricular wall motion and volumes over patient clinical and historical data alone for the prediction of adverse cardiac events Setting: Outpatient clinic MRI machine: 1.5-T scanner Stress agent: Adenosine Protocol for CMR: Adenosine stress perfusion, myocardial delayed enhancement, LV volumes and function and aortic blood flow Follow-up: Median (25th, 75th percentiles): 948 days (639, 1,263) NA Early referral to revascularisation Cardiovascular risk reclassification with the addition of LGE and stress perfusion models to model of baseline patient characteristics
Prospective multicentre cohort study Age (viability testing): <45 years: 5.3%, 45–59 years: 17.0%, 60–74 years: 19.2%, >74 years: 22.4% Mean age (IQR): 60 years (range 47–70) Male: 65.5% Ethnicity: NR Follow-up: Mean 400 days (IQR 367–419 days) consensus appropriateness criteria for CMR imaging, in centres included in the EuroCMR registry Exclusion criteria: NR Objective: Evaluate indications, image quality, safety and impact on patient management of routine CMR imaging on a European level Therapeutic consequences: Changes in medication Invasive procedure Hospital discharge Hospital admission Taylor et al. () Australia Prospective cohort study Level IV: Quality: 9.5/12 Low risk of bias N=92/732 patients referred for CMR for whom viability testing was done Age (viability testing), mean: 55.9 ± 15.0 years Male: 83% Ethnicity: NR Follow-up: 6 months Inclusion criteria: All patients referred to the Alfred Hospital in Melbourne for clinical CMR scanning Exclusion criteria: Patients undergoing scans for research purposes or non-funded indications Objective: Evaluate the impact of CMR imaging on cardiac device and surgical therapy Setting: Hospital MRI machine: 1.5-T scanner using a cardiac coil and ECG Protocol for LGE-CMR: Inversion recovery gradient echo sequences 10 minutes after intravenous administration of contrast agent (0.2 mmol/kg Gd-DTPA) to demonstrate myocardial delayed enhancement were performed NA % of patients who had a change in surgical management plan CMR = cardiac magnetic resonance imaging; Gd-DTPA = gadolinium diethylenetriaminepentaacetic acid; IQR = inter-quartile range; LGE = late gadolinium enhancement; MRI = magnetic resonance imaging; NR = not reported; NA = not applicable; T = tesla Table 152 Study characteristics of therapeutic effectiveness studies (population 2) Study Country Study design Quality appraisal Study population Inclusion/exclusion criteria Intervention and outcomes
Allman et al. () USA SR Level III-2 Quality: 2/11 Poor quality k=24 studies N=3,088 patients 35% underwent revascularisation 65% underwent medical therapy Age mean: 61.4 years (range 55–69) Male: 70.1% (range 38%–91%) Ethnicity: NR Follow-up: mean 24.7 months (range 12–47) Inclusion criteria: NR Exclusion criteria: Studies not reporting deaths or where deaths could not be apportioned to patients with versus without viability were excluded. Intervention: Revascularisation Comparator: Medical therapy Outcomes: Survival Bonow et al. () USA RCT Level III-1 Quality: 23/26 Good quality N=601 patients undergoing assessment for myocardial viability 298 patients randomised to medical therapy + CABG 303 randomised to medical therapy alone. Mean age: 60.7 ± 9.4 years Male: 87% Ethnicity: NR Follow-up: median 5.1 years Inclusion criteria: Patients with angiographic documentation of CAD amenable to surgical revascularisation and with LVD (LVEF <35%) Exclusion criteria: Left main coronary artery stenosis of >50%; cardiogenic shock; MI within 3 months; need for aortic valve surgery Intervention: CABG + medical therapy Comparator: Medical therapy alone Outcomes: Mortality rates; hazard ratios
Germany (IHE 8/12) (exclusion criteria included contraindications to CMR) 105 patients experienced angina pectoris during adenosine stress. No serious adverse side effects of adenosine like anaphylaxis, bronchospasm or serious ventricular arrhythmias occurred during pharmacological stress. Jogiya et al. () UK Level IV Low risk of bias (IHE 9/12) N=55 consecutive patients with known or suspected CAD. (exclusion criteria included contraindications to CMR or stress agent) SP-CMR + LGE 1 patient had claustrophobia. 46 patients experienced typical symptoms during adenosine stress. - Plein et al. () UK and Switzerland Level IV Low risk of bias (IHE 9/12) N= 51 patients with known or suspected CAD (exclusion criteria included contraindications to CMR or stress agent) SP-CMR +LGE - 40 patients experienced side effects during the adenosine infusion (e.g. breathlessness, flushing, headache), but no clinically relevant complications occurred. - Lockie et al. () UK Level IV Low risk of bias (IHE 8/12) N=44 patients with known or suspected CAD. (exclusion criteria included contraindications to CMR or contrast agent) SP-CMR +LGE 1 patient had claustrophobia. 42 patients showed mild symptoms consistent with adenosine stress but there were no serious complications. - Gebker et al. () Germany Level IV Low risk of bias (IHE 8/12) N=43 consecutive patients with known or suspected CAD (exclusion criteria included contraindications to CMR or stress agent) SP-CMR - 1 patient could not complete CMR due to bronchospasm during adenosine stress. 31 patients had minimal side effects (e.g. flush and dyspnoea). No serious AEs occurred. - Pilz et al. () Germany Level IV Moderate risk of bias N=176 consecutive patients referred with known or suspected CAD (exclusion criteria included SP-CMR + LGE 3 patients had claustrophobia 2 patients had adenosine-induced bronchospasm. 171 patients underwent ICA without major complications.
Kitagawa et al. () Japan Level IV Moderate risk of bias (IHE 7/12) N=50 patients with known or suspected CAD (exclusion criteria included contraindications to CMR, contrast medium or stress agent) SP-CMR + LGE - No serious AE was reported during adenosine stress. - Bernhardt et al. () Germany Level IV Moderate risk of bias (IHE 6/12) N=34 patients with stable angina and suspected or known CAD referred for ICA SP-CMR - CMR was completed without complications in all patients. ICA was completed without complications in all patients. Thiele et al. () Germany and UK Level IV Moderate risk of bias (IHE 7/12) N=32 patients with suspected or known CAD (exclusion criteria included contraindications to CMR or stress agent) SP-CMR All 32 patients tolerated the imaging procedure and contrast agent well. All 32 patients tolerated adenosine administration well. All 32 patients tolerated the tetrofosmin for SPECT well. - - - - - Adenosine or dobutamine - Bruder et al. () 15 European countries Level IV Low risk of bias (IHE 8/12) N=10,228 patients on the EuroCMR registry who underwent stress CMR testing for suspected or known CAD Stress CMR 5% of mild cases were allergic reactions after injection of contrast (e.g. mild urticarial or exanthema). 745 (7.3%) patients had mild complications. 75% of events (e.g. dyspnoea, chest pain, extra systoles) occurred during dobutamine or adenosine infusion. 7 (0.1%) patients had severe complications. 2 had non-sustained VT and 1 had ventricular fibrillation during dobutamine infusion 2 had overt heart failure, 1 had unstable angina and 1 had an anaphylactic shock during adenosine stress. - - - - - - Dobutamine -
USA (IHE 8/12) (exclusion criteria included contraindications to CMR or stress agent) In 1 patient intravenous access could not be obtained. stopping adenosine. Klem et al. () USA and Germany Level IV Low risk of bias (IHE 9/12) N=100 women with symptoms suggestive of CAD who were not included in the Klem et al. () study (exclusion criteria included contraindications to CMR or stress agent) SP-CMR + LGE 1 patient had discomfort during CMR and discontinued. In 2 patients intravenous access could not be obtained. 1 patient had severe adenosine-induced dyspnoea, which quickly resolved after stopping adenosine. - Nagel et al. () Germany Level IV Low risk of bias (IHE 8/12) N=90 patients with moderate PTP for CAD (exclusion criteria included contraindications to CMR or stress agent) SP-CMR 3 patients had claustrophobia. 1 patient was too obese (>150 kg) for scan. Most patients had minimal side effects (e.g. flush, warmth, headache). 6 patients had angina (1 with severe symptoms). 1 patient had breathing difficulties. 1 patient had AV block III that resolved within 30 seconds after stopping the adenosine infusion. - Heitner et al. () USA Level IV Low risk of bias (IHE 8/12) N=68 patients with acute chest discomfort and an intermediate PTP of CAD (exclusion criteria included contraindications to CMR or stress agent) SP-CMR + LGE 1 patient had claustrophobia. 2 patients had body circumference too large to fit in CMR scanner. There were no AEs or complications associated with adenosine administration. - Arnold et al. () UK Level IV Low risk of bias (IHE 8/12) N=65 patients for investigation of exertional chest pain (exclusion criteria included contraindications to CMR, contrast medium or stress agent) SP-CMR + LGE 2 patients had claustrophobia. No significant AEs occurred during the scan. - Cheng et al. () Level IV Low risk of bias N=65 patients with suspected CAD SP-CMR 2 patients had claustrophobia. 1 patient had adenosine intolerance. 1 patient had ICA cancelled for
UK (IHE 8/12) (exclusion criteria included contraindications to CMR or stress agent) clinical reasons. Walcher et al. () Germany Level IV Low risk of bias (IHE 8/12) N=57 patients with suspected CAD (exclusion criteria included contraindications to CMR, contrast medium or stress agent) SP-CMR + LGE 2 patients were claustrophobic. 3 patients refused a second CMR scan. - - Klein et al. () Germany Level IV Low risk of bias (IHE 8/12) N=55 patients with suspected CAD (exclusion criteria included contraindications to CMR or stress agent) SP-CMR + LGE - 1 patient had severe dyspnoea during adenosine. - Ma et al. () China Level IV Low risk of bias (IHE 8/12) N=50 patients with suspected CAD (exclusion criteria included contraindications to CMR, contrast medium or stress agent) SP-CMR + LGE - 45 patients experienced mild AEs during adenosine stress (e.g. breathlessness, flushing, headache), but no clinically relevant complications occurred. - Pereira et al. () Portugal Level IV Moderate risk of bias (IHE 7.5/12) N=121 patients with suspected CAD (exclusion criteria included contraindications to CMR, contrast medium or stress agent) SP-CMR + LGE 4 patients had unknown claustrophobia. - 4 patients refused catheterisation so ICA was not performed. Watkins et al. () Ireland Level IV Moderate risk of bias (IHE 7/12) N=103 patients with suspected angina (exclusion criteria included contraindications to CMR, contrast medium or stress agent) SP-CMR + LGE 3 patients felt claustrophobic. 1 patient suffered anxiety. - - Meyer et al. () Germany Level IV Moderate risk of N=60 patients with suspected occlusive CAD SP-CMR +LGE - 38 patients had mild side effects such as headache, flushing, warmth or mild -
(IHE 6.5/12) obesity and contraindications to CMR or contrast medium) undergo CMR. 2 patients had intolerable side-effects, cause not reported. - - - - - Dipyridamole - Al-Saadi et al. () Germany Level IV Moderate risk of bias (IHE 7.5/12) N=40 patients referred for ICA because of new chest pain or progressive symptoms (exclusion criteria included contraindications to CMR) SP-CMR 3 patients had claustrophobia. ECG triggering was insufficient because of frequent premature ventricular complexes in 2 patients, and 1 patient developed atrial fibrillation at the beginning of the CMR scan. Neither the dipyridamole infusion nor the placement of the central venous catheter caused any serious AEs requiring active treatment; however, the usual side effects of dipyridamole were observed. - Sakuma et al. () Japan Level IV Moderate risk of bias (IHE 5/12) N=40 patients with suspected CAD SP-CMR + LGE - No patient experienced life-threatening or serious adverse reactions during pharmacologic stress. - - - - - - Nitroglycerin - Regenfus et al. () Germany Level IV Moderate risk of bias (IHE 6/12) N=61 patients with clinically suspected CAD (exclusion criteria included contraindications to CMR or stress agent) SP-CMR None of the patients experienced nausea or any other adverse reaction to the contrast agent. - - AE = adverse event; AV block = atrioventricular block; CAD = coronary artery disease; CMR = cardiac magnetic resonance imaging; CTCA = computed tomography coronary angiography; ECG = electrocardiogram; FFR = fractional flow rate; ICA = coronary angiography; IHE = Institute of Health Economics; LBBB = left bundle branch block; LGE = late gadolinium enhancement; PTP = pre-test probability; SP-CMR = stress perfusion CMR
FFR <0.75 FFR ≤0.80 110 118 11 3 11 26 168 153 pattern of CAD in 84 (83.2%) scans. Regenfus et al. () Germany Level III-1 Low risk of bias N=61 patients N=427 segments SP-CMR Per segment ICA ≥50% DS NR 58 25 10 235 99 segments could not be evaluated. Cohen Interobserver agreement for CMR: kappa = 0.85 Interobserver agreement for ICA: kappa = 0.95 Schwitter et al. () Switzerland Level III-1 Low risk of bias N=47/48 patients with suspected CAD SP-CMR ICA ≥50% DS 79% 32 1 5 9 One CMR result was excluded from analysis for technical reasons. Intraobserver variability of slopeendo: mean difference = –0.3% (95%CI –18.3, 17.7); and slopetrans: mean difference = –2.5% (95%CI –14.3, 19.4) Interobserver variability of slopeendo: mean difference = 5.6% (95%CI –15.3, 26.5); and slopetrans: mean difference = 4.7% (95%CI –14.7, 24.1) de Mello et al. () Brazil Level III-1 Low risk of bias N=38 patients with suspected CAD N=114 segments SP-CMR + LGE Per artery ICA ≥70% DS NR 41 8 6 59 - Al-Saadi et al. () Germany Level III-1 Low risk of bias N=34/40 patients referred for ICA because of new chest pain or SP-CMR MPR ≤1.5 Per segment ICA ≥75% DS NR 54 7 6 35 No CMR results due to: Claustrophobia: 3/40 patients ECG triggering insufficient: 3/40
patients. Meyer et al. () Germany and USA Level III-2 Low risk of bias N=60 patients with suspected occlusive CAD N=180 vessels SP-CMR or LGE ICA ≥50% DS Per patient Per segment 60% 32 47 5 16 4 15 19 102 - Merkle et al. () Germany Level III-2 Low risk of bias N=59 patients with suspected CAD SP-CMR ICA ≥70% DS ICA ≥50% DS 22% 31% 13 15 9 7 0 3 37 34 An increase in heart rate >10% during adenosine infusion was achieved in 204/228 (89.5%) patients. Transient AV block grade III occurred in 14/228 patients (6.1%) and resulted in trigger dropouts. All patients included in ITT analysis Takase et al. () Japan Level III-2 Low risk of bias N=57 patients with suspected CAD SP-CMR or LGE ICA ≥50% DS 54% 28 4 3 22 - Falcao et al. () Brazil Level III-2 Low risk of bias N=42/57 patients with suspected CAD SP-CMR ICA ≥50% DS 60% 23 3 2 14 10/57 patients did not undergo CMR 2/57 had claustrophobia 2/57 had inadequate CMR images 1/57 patients had PCI. Kirschbaum et al. () The Netherlands Level III-2 Unclear risk of bias N=75 vessels from patients with stable angina and suspected CAD with normal LVEF SP-CMR MPR <1.8 MPR <1.9 MPR <2.0 Per artery FFR <0.8 NR 27 31 31 14 17 19 5 1 1 29 26 24 -
Good In women In men Pharm stress SPECT Tech 99m SPECT vs ICA ≥50% DS 17 13 8 10 84% [79, 87] 89% [84, 93] 86% [74, 93] 85% [77, 90] 79% [70, 85] 71% [61, 80] 83% [68, 91] 78% [63, 89] Lapado et al. () Poor Perfusion SPECT vs ICA ≥50%–75% DS NR 30 85% [81, 88] 69% [61, 78] - - - de Jong et al. () Moderate Stress perfusion SPECT In suspected CAD vs ICA ≥50% DS vs ICA ≥70% DS 52% 13 (all) 4 8 6 83% [73, 89] 83% [70, 91] 81% [72, 87] 85% [76, 91] 77% [64, 86] 79% [66, 87] 81% [72, 87] 66% [54, 77] - - - Jaarsma et al. () Moderate Stress perfusion SPECT In suspected CAD vs ICA ≥50% DS vs ICA ≥70% DS 70% 105 56 88 17 88% [88, 89] 85% [84, 86] 87% [86, 87] 93% [92, 94] 61% [59, 62] 69% [67, 71] 69% [67, 71] 43% [41, 46] 45 Artery-based 69% [68, 70] 79% [78, 80] Dolor et al. () Good Stress SPECT Suspected CAD–women Known or suspected vs ICA ≥50%–75% DS 42% 14 30 81% [76, 86] 82% [77, 87] 78% [69, 84] 81% [74, 86] - - - Mc Ardle et al. () Moderate Perfusion SPECT vs ICA ≥50%–75% DS 50% 8 85% [82, 87] 85% [82, 87] - - - Al Moudi et al. () Poor Perfusion SPECT vs ICA ≥50% DS NR 15 82% [76, 88] 76% [70, 82]
Medical Advisory Secretariat () Moderate Stress SPECT Pharm stress SPECT Exercise stress SPECT vs ICA ≥50%–70% DS 65% 63 33 20 87% [85, 89] 86% [82, 89] 86% [82, 90] 70% [66, 75] 76% [70, 82] 68% [59, 76] - - - Hacioglu et al. () Poor SPECT MPI vs ICA ≥50%–75% DS NR 8 82% (75–94) 67% (36–100) - - - Heijenbrok-Kal et al. () Poor Stress SPECT Exercise stress SPECT vs ICA ≥50%–70% DS NR 103 48 88% [87, 90] 88% [86, 90] 73% [69, 77] 69% [63, 75] - - - CAD = coronary artery disease; DS = diameter stenosis; FFR = fractional flow rate; ICA = invasive coronary angiography; MPI = myocardial perfusion imaging; NR = not reported; SPECT = single-photon emission computed tomography; SR = systematic review Table 166 Diagnostic accuracy reported in SRs of Echo compared with ICA in patients with suspected or known CAD SR Comparison Prevalence of CAD Number of studies Sensitivity per patient Specificity per patient Number of studies Sensitivity per coronary artery Specificity per coronary artery Lapado et al. () Moderate Stress Echo vs ICA ≥50%–75% DS NR 15 84% [80, 89] 77% [69, 86] - - - de Jong et al. () Moderate Stress contrast Echo In suspected CAD vs ICA ≥50% DS vs ICA ≥70% DS 66% 10 (all) 1 7 3 87% [81, 91] 88% [60, 97] 86% [79, 92] 90% [80, 96] 72% [56, 83] 89% [58, 98] 74% [63, 82] 65% [46, 80] - - - Dolor et al. () Good Stress Echo Suspected CAD–women Known or suspected vs ICA ≥50%–75% DS 43% 14 22 79% [74, 83] 78% [73, 83] 83% [74, 89] 86% [79, 91] - - -
Medical Advisory Secretariat () Moderate Stress contrast Echo Perfusion analysis Wall motion analysis vs ICA ≥50%–70% DS 48% 10 6 6 87% [83, 91] 88% [84, 90] 69% [65, 73] 86% [82, 89] 65% [59, 70] 79% [72, 85] - - - Heijenbrok-Kal et al. () Poor Stress Echo Exercise Echo vs ICA ≥50%–70% DS NR 226 55 79% [78, 81] 83% [80, 85] 87% [86, 89] 84% [80, 88] - - - Geleijnse et al. () Poor Dobutamine Stress Echo in women in men vs ICA ≥50%–70% DS 41% 73% 14 8 72% (weighted mean) 77% (weighted mean) 88% (weighted mean) 77% (weighted mean) - - - CAD = coronary artery disease; DS = diameter stenosis; Echo = echocardiography; ICA = invasive coronary angiography; NR = not reported; SR = systematic review Table 167 Diagnostic accuracy reported in SRs of Exercise ECG compared with ICA in patients with suspected or known CAD SR Comparison Prevalence of CAD Number of studies Sensitivity per patient Specificity per patient Number of studies Sensitivity per coronary artery Specificity per coronary artery Nielsen et al. () Good Exercise ECG vs ICA ≥50%–70% DS NR 7 67% [54, 78] 46% [30, 64] - - - Dolor et al. () Good Exercise ECG Suspected CAD–women Known or suspected vs ICA ≥50%–75% DS 41% 29 41 62% [55, 68] 61% [54, 67] 68% [63, 73] 65% [58, 72] - - - Kwok et al. () Poor Exercise ECG Suspected CAD–women Known or suspected 38% 19 61% (54, 68) 70% (64, 75)
Lithuania of bias segments 0% HE) (35 ± 6 months) Gutberlet et al. () Germany Level III-1 Low risk of bias N=240 LGE-CMR (cut-off value 50% HE) Functional recovery after revascularisation 204 4 2 30 - Kim et al. () US Level II Low risk of bias N=804 dysfunctional segments LGE-CMR (cut-off value 25% and 50% HE) Improvement in regional contractility at follow-up (79 ± 36 days after revascularisation) <25% HE 365 <50% HE 411 147 211 60 14 232 168 - Kuhl et al. () Germany Level II Low risk of bias N=187 severely dysfunctional segments LGE-CMR (cut-off value 50% HE) & PET/SPECT Regional functional recovery after revascularisation LGE-CMR 94 PET/SPECT 83 27 24 2 13 64 67 - Oh et al. () Korea Level III-1 Low risk of bias N=373 dysfunctional segments LGE-CMR (cut-off value 25% and 50% HE) Improvement of segmental wall motion at follow-up (24.1 ± 17.6 months) <25% HE 171 <50% HE 209 61 78 98 60 43 26 - Pegg et al. () UK Level III-1 Low risk of bias N=957 dysfunctional segments LGE-CMR (cut-off value 25% and 50% HE) Improved segmental contractility (at 6 months <25% HE 297 <50% HE 381 126 228 435 16 100 332 -
Regenfus et al. () Germany Level II Low risk of bias N=350 dysfunctional segments LGE-CMR (cut-off 25% HE) & SPECT Regional functional improvement after vascularisation (8 months) LGE-CMR 158 SPECT 148 22 78 14 24 156 100 - Sandstede et al. () Germany Level III-2 Some risk of bias N=73 segments with WMAs LGE-CMR (cut-off NR) Mechanical improvement / contractile recovery 39 8 1 25 - Schvartzman et al. () US Level II Low risk of bias N=207 segments with abnormal contraction before revascularisation LGE-CMR (cut-off 25% or 50% HE) Recovery of function after vascularisation <25% HE 82 <50% HE 95 57 79 19 6 49 27 - Selvanayagam et al. () UK Level III-1 Low risk of bias N=612 dysfunctional segments LGE-CMR (cut-off 25% or 50% HE) Regional functional recovery after vascularisation (>6 months) <25% HE 266 <50% HE 326 96 192 77 17 173 77 - Sharma and Katz () US Level II Low risk of bias N=97 dysfunctional segments LGE-CMR (cut-off 50% HE) & SPECT Recovery of regional function after 3 months LGE-CMR 52 SPECT 43 32 28 3 12 10 14 - Van Hoe and Vanderheyden () Level III-2 Low risk of bias N=117 dysfunctional segments LGE-CMR (cut-off 75% HE) Improved contractile function after vascularisation 56 5 16 40 -
follow-up: 54 >3 months follow-up: 62 follow-up: 35 >3 months follow-up: 92 follow-up: 10 >3 months follow-up: 15 follow-up: 22 >3 months follow-up: 82 Schvartzman et al. ()) US Level II Low risk of bias N=444 segments LGE-CMR cut-off = any scarring Echo (normal vs mild/severe hypokinesia, akinesia or dyskinesia) Echo: 37 Echo: 67 Echo: 28 Echo: 312 464 segments were assessed prior to CABG, but 104 were excluded from further analysis due to poor visualisation (16) or resection (88) Solar et al. () Czech Republic Level III-2 Low risk of bias N=1,360 segments (40 patients) LGE-CMR cut-off = 50% HE Tl-SPECT = 50% of the maximum activity) SPECT: 936 SPECT: 129 SPECT: 96 SPECT: 129 Wu et al. () Taiwan Level II Low risk of bias N=680 segments with N=170 stress DbE LGE-CMR cut-off = 50% HE Tl-SPECT not reported) & stress DbE SPECT: 411 DbE: 91 SPECT: 93 DbE: 38 SPECT: 33 DbE: 5 SPECT: 109 DbE: 26 CABG = coronary artery bypass graft; CAD = coronary artery disease; DbE = dobutamine Echo; Echo = echocardiography; HE = hyper-enhancement; LGE-CMR = late gadolinium enhancement cardiac magnetic resonance imaging; LVD = left ventricular dysfunction; SPECT = single-photon emission computed tomography; TI = thallium-201.
False positives Cross-sectional (cohort type accuracy study) 136 85 24 (102–178) (64–111) (18–31) - ICA cut-off 70% DS - - - - - 44% - True positives False negatives N=190 patients k=6 studies Cross-sectional (cohort type accuracy study) Not serious Not serious Not serious Not serious None 134 392 757 (124–140) (365–409) (705–791) 16 48 93 (10–26) (31–75) (59–145) High ⊕⊕⊕⊕ True negatives False positives N=241 patients k=6 studies Cross-sectional (cohort type accuracy study) Not serious Serious (substantial heterogeneity; I2 = Not serious Not serious None 705 465 125 (612–774) (403–510) (108–137) 145 95 25 (76–238) (50–157) (13–42) Moderate ⊕⊕⊕⨀ - All studies - - - - - 45% - True positives False negatives N=486 patients k=16 studies Cross-sectional (cohort type accuracy study) Not serious Not serious Not serious Not serious None 128 383 722 (123–132) (369–396) (697–748) 22 67 128 (18–27) (54–81) (102–153) High ⊕⊕⊕⊕ True negatives False positives N=604 patients k=16 studies Cross-sectional (cohort type accuracy study) Not serious Not serious Not serious Not serious None 722 468 128 (689–748) (446–484) (122–132) 128 82 22 (102–161) (66–104) (18–28) High ⊕⊕⊕⊕
CAD = coronary artery disease; DS = diameter stenosis; ICA = invasive coronary angiography; LGE = late gadolinium enhancement; PTP = pre-test probability; QoE= quality of evidence; = stress perfusion cardiac magnetic resonance imaging Table 180 Evidence profile for the accuracy of SP-CMR & LGE compared with ICA by coronary artery or segment in patients suspected of having CAD Outcome No. of participants, No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Effect per 1,000 patients/year PTP study PTP 15% prevalence 85% QoE Importance - ICA cut-off 70% DS - - - - - 44% - True positives False negatives N=190 patients k=6 studies Cross-sectional (cohort type accuracy study) Not serious Serious (substantial heterogeneity; I2 = Not serious Not serious None 134 392 757 (124–140) (365–409) (705–791) 16 48 93 (10–26) (31–75) (59–145) Moderate ⊕⊕⊕⨀ True negatives False positives N=241 patients k=6 studies Cross-sectional (cohort type accuracy study) Not serious Serious (substantial heterogeneity; I2 = Not serious Not serious None 705 465 125 (612–774) (403–510) (108–137) 145 95 25 (76–238) (50–157) (13–42) Moderate ⊕⊕⊕⨀ - All studies - - - - - 45% - True positives False negatives N=486 patients k=16 studies Cross-sectional (cohort type accuracy study) Not serious Serious (substantial heterogeneity; I2 = Not serious Not serious None 128 383 722 (123–132) (369–396) (697–748) 22 67 128 (18–27) (54–81) (102–153) Moderate ⊕⊕⊕⨀ True negatives False positives N=604 patients k=16 studies Cross-sectional (cohort type accuracy study) Not serious Not serious Not serious Not serious None 722 468 128 (689–748) (446–484) (122–132) 128 82 22 (102–161) (66–104) (18–28) High ⊕⊕⊕⊕
- SP-CMR + LGE – all - - - - - 42% - True positives False negatives N=261 patients k=12 studies Cross-sectional (cohort type accuracy study) Not serious Serious (substantial heterogeneity; I2 = Not serious Not serious None 128 357 722 (122–132) (340–370) (689–748) 22 63 128 (18–28) (50–80) (102–161) Moderate ⊕⊕⊕⨀ True negatives False positives N=469 patients k=12 studies Cross-sectional (cohort type accuracy study) Not serious Not serious Not serious Not serious None 731 499 129 (680–765) (464–522) (120–135) 119 81 21 (85–170) (58–116) (15–30) High ⊕⊕⊕⊕ SP-CMR & LGE versus: ICA cut-off 70% DS pooled sensitivity = 89% (95%CI 83, 93) and pooled specificity = 83% (95%CI 72, 91); ICA (all studies) pooled sensitivity = 85% (95%CI 82, 88) and pooled specificity = 85% (95%CI 81, 88); SP-CMR + LGE versus ICA (all studies) pooled sensitivity = 85% (95%CI 81, 88) and pooled specificity = 86% (95%CI 80, 90) CAD = coronary artery disease; DS = diameter stenosis; ICA = invasive coronary angiography; LGE = late gadolinium enhancement; PTP = pre-test probability; QoE= quality of evidence; = stress perfusion cardiac magnetic resonance imaging
positives (59–272) (31–141) (10–48) - LGE - - - - - 45% - True positives False negatives N=449 patients k=5 studies Cross-sectional (cohort type accuracy study) Not serious Not serious Not serious Not serious None 61 185 349 (53–69) (158–207) (298–391) 89 265 501 (81–97) (243–292) (459–552) High ⊕⊕⊕⊕ True negatives False positives N=548 patients k=5 studies Cross-sectional (cohort type accuracy study) Not serious Serious (substantial heterogeneity; I2 = Not serious Not serious None 816 528 144 (774–842) (501–545) (137–149) 34 22 6 (8–76) (5–49) (1–13) Moderate ⊕⊕⊕⨀ SP-CMR & LGE pooled sensitivity = 84% (95%CI 78, 89) and pooled specificity = 88% (95%CI 82, 92); SP-CMR pooled sensitivity = 90% (95%CI 77, 96) and pooled specificity = 84% (95%CI 68, 93); LGE pooled sensitivity = 40% (95%CI 34, 47) and pooled specificity = 96% (95%CI 88, 99) CAD = coronary artery disease; ICA = invasive coronary angiography; LGE = late gadolinium enhancement; PTP = pre-test probability; QoE= quality of evidence; SP-CMR = stress perfusion cardiac magnetic resonance imaging Table 184 GRADE assessment of body of evidence for diagnostic accuracy of LGE-CMR in patients diagnosed with CAD and LVD to predict segmental recovery Outcome No. of participants, No. of studies Study design Risk of bias Indirectness Inconsistency Imprecision Other considerations Effect per 1000 patients/year PTP: 56% QoE Importance - LGE-CMR (high cut-off) - - - - - 56% - True positives False N=3,438 segments k=15 studies Cross-sectional (cohort type accuracy study) Not serious Not serious Very serious (considerable heterogeneity; I2 = >95%) Not serious None 521 (504–538) Low ⨁⨁⨀⨀
negatives 39 (22–56) True negatives False positives N=2,815 segments k=15 studies Cross-sectional (cohort type accuracy study) Not serious Not serious Very serious (considerable heterogeneity; I2 = >95%) Not serious None 198 (132–268) 242 (172–308) Low ⨁⨁⨀⨀ - LGE-CMR (low cut-off) - - - - - - - True positives False negatives N=3,257 segments k=10 Cross-sectional (cohort type accuracy study) Not serious Not serious Very serious (considerable heterogeneity; I2 = >95%) Not serious None 382 (294–447) 163 (98–251) Low ⨁⨁⨀⨀ True negatives False positives N=2,153 segments k=10 Cross-sectional (cohort type accuracy study) Not serious Not serious Very serious (considerable heterogeneity; I2 = >95%) Not serious None 309 (255–355) 146 (100–200) Low ⨁⨁⨀⨀ LGE-CMR (low cut-off) pooled sensitivity = 70% (95%CI 54, 82) and pooled specificity = 68% (95%CI 56, 78); LGE-CMR (high cut-off) pooled sensitivity = 93% (95%CI 90, 96) and pooled specificity = 45% (95%CI 30, 61) CAD = coronary artery disease; LGE-CMR = late gadolinium enhancement cardiac magnetic resonance imaging; LVD = left ventricular dysfunction; PTP = pre-test probability; QoE= quality of evidence
Plein et al. () - - - - - Included patients with known CAD Sakuma et al. () - - - - - - Cury et al. () - - - - - - Klem et al. () - - - - - - Pilz et al. () - - - - - - Included patients with known CAD Rieber et al. () - - - - - - Included patients with known CAD Antonio et al. () - - - - - - - - - - - Bernhardt et al. () - - - - - - - - - - - Cheng et al. () - - - - - - - Costa et al. () - - - - - - - Gebker et al. () - - - - - - - - Included patients with known CAD Kuhl et al. () - - - - - - - Included patients with known CAD Merkle et al. () - - - - - - - - Sharples et al. () - - - - - - - - - - Included patients with known CAD Gebker et al. () - - - - - - - - - - Included patients with known CAD Gebker et al. () - - - - - - - - Included patients with known CAD Kitagawa et al. () - - - - - - - - - Included patients with known CAD Klein et al. () - - - - - - - Klem et al. () - - - - - - - - Meyer et al. () - - - - - - - Pingitore et al. () - - - - - - - - - - Included patients with known CAD