European Heart Journal Advance Access originally published online on September 23, 2005
European Heart Journal 2006 27(1):29-34; doi:10.1093/eurheartj/ehi503
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Potential impact of myocardial perfusion scintigraphy as gatekeeper for invasive examination and treatment in patients with stable angina pectoris: observational study without post-test referral bias
1Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark
2Department of Statistics, University of Southern Denmark, Odense, Denmark
3Department of Cardiology, Odense University Hospital, Odense, Denmark
Received 11 March 2005; revised 16 July 2005; accepted 1 September 2005; online publish-ahead-of-print 23 September 2005.
* Corresponding author. Tel: +45 65411396; fax: +45 65906192. E-mail address: pfhc{at}ouh.fyns-amt.dk
See page 3 for the editorial comment on this article (doi:10.1093/eurheartj/ehi627)
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Abstract |
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Aims To evaluate the impact of using myocardial perfusion scintigraphy (MPS) as gatekeeper for coronary angiography and revascularization in stable angina pectoris.
Methods and results A prospective series of 507 out of 972 adult patients referred to coronary angiography for known or suspected stable angina pectoris underwent clinical examination followed immediately by MPS, the result of which was not communicated. MPS showed normal perfusion in 258/507 (51%) patients, reversible defects in 201/507 (40%), and fixed defects in 48/507 (9%). Of 168 revascularized patients, 27 (16%) had normal perfusion and 13 (8%) had fixed defects. Coronary angiography was undertaken in 476 patients of whom 252 (53%) had normal findings or insignificant stenoses. The same was the case in 361 (41%) out of the 883 of the 972 consecutive patients, who had this examination. Assuming that the true rate of normal perfusion in the entire series was correspondingly lower, 48% of catheterizations and 19% of revascularizations were superfluous.
Conclusion The use of MPS as gatekeeper appears to make about half of catheterizations and almost one-fifth of revascularizations redundant. Even in high-risk groups, substantial savings are possible, and the risk of overlooking patients with severe disease seems negligible.
Key Words: Angina • Catheterization • Coronary disease • Perfusion • Revascularization • Observational study
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Introduction |
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In patients with stable angina pectoris, coronary angiography has become a screening instrument for ‘significant’ stenoses, the presence of which will often lead to coronary revascularization. However, several reports suggest that primary non-invasive myocardial perfusion scintigraphy (MPS) may be a cost-effective gatekeeper for this invasive intervention strategy and that this is mainly due to a reduction in resource use for patients with a normal test result.1–3 The impact of this approach depends on the fraction of patients with normal myocardial perfusion, because in these, invasive procedures may be safely omitted because of a very favourable prognosis.4 In addition, they may be omitted in the majority of patients with fixed perfusion defects unless significant amounts of viable tissues are demonstrated.4,5
To investigate the impact of an according change in management decision, it was necessary to avoid the so-called post-test referral bias which hampers previous studies. Once a non-invasive test is accepted as clinically effective for diagnosis and risk stratification, its results strongly influence referral to and hence the performance of coronary angiography and revascularization.4,6 Because we were allowed to keep the results of MPS secret, we could evade this source of error. The study aims were to determine prospectively the distribution of the various myocardial perfusion patterns and especially the rate of normal perfusion in patients referred to catheterization for stable angina pectoris and to evaluate the potential savings of using MPS as gatekeeper for catheterization and revascularization.
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Methods |
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Participants
Odense University Hospital serves the entire island of Funen with regard to invasive cardiac procedures. Its 473 000 inhabitants (
1/10 Denmark) are considered as representative for the Danish population. Eligible were all patients referred for catheterization from 19 October 1999 to 29 November 2001 because of known or suspected stable angina pectoris. During this period, 972 patients entered a waiting list for coronary angiography. In principle, we wanted to carry out MPS before angiography in all patients. However, owing to a limited examination capacity, we decided beforehand on a series of exclusion criteria. For practical reasons, residents outside the county (n=29) and patients of foreign language (n=19) were not included. In addition, the following categories were also excluded on the basis of the information given in their referrals: patients >75 years (n=73) and patients with diabetes mellitus (n=59), patients being followed by the cardiologists because of known ischaemic heart disease (n=90), patients who underwent accelerated or acute angiography because their symptoms became unstable (n=60), and patients with myocardial infarction within the last 6 months (n=26) or an MPS study within the last 3 months (n=19). Finally, patients with no complaints of angina (n=19), other cardiac diseases (n=10), or cerebral infarct, rheumatoid arthritis, or acute illness (n=16) were also excluded. Of 552 remaining patients, 516 gave written informed consent to participate in the study, which was approved by the local Ethics Committee and complied with the Declaration of Helsinki. In nine patients, stress MPS was not completed because of bradycardia (n=2), claustrophobia (n=2), medication (n=2), ventricular tachycardia (n=1), carotid stenosis (n=1), or a massive fall in blood pressure (n=1). Thus, the study population comprised 507 patients whose characteristics are shown in Table 1.
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Study programme
Clinical evaluation
Immediately before MPS, all patients were interrogated, examined physically, and classified by a single physician (H.W.C.) into (i) the following types of chest pain in line with Danish Guidelines7 adopted from Diamond:8 typical angina, atypical angina, and non-cardiac or no chest pain within the last fortnight and (ii) four grades of severity given by the Canadian Cardiovascular Society (CCS).9
Stress testing protocol
For stress imaging, 223 patients underwent a standard maximum symptom-limited bicycle exercise test according to national guidelines.10 Pharmacological stress was used in 284 patients unable to perform adequate exercise (274 adenosine, eight dipyridamole, and two dobutamine).
Myocardial perfusion scintigraphy
Gated single-photon emission computed tomography was performed using a same-day rest/stress dual-isotope protocol described by Berman et al.11 Details concerning our use of this protocol were given elsewhere.12 In short, thallium-201 (95 MBq+1 MBq/kg >70 kg) was applied for rest and technetium-99 m sestamibi (925 MBq+10 MBq/kg >70 kg) for stress imaging using a rotating dual head gamma camera, ECG-gated acquisition with eight frames per cycle, and 100% beat acceptance.
Standard procedures for image interpretation included review of all scans by two experienced observers (P.F.H.-C. and A.J.) blinded to each other and to clinical history, physical examination data, stress type, and the result of coronary angiography. Final overall diagnosis was achieved by consensus. A semi-quantitative visual interpretation was made using ungated short axis-, horizontal-, and vertical long axis-myocardial tomograms and a five-grade (0–4) scoring system in a 20-segment model.11,12 In the case of equivocal results, the gated studies were evaluated in cine mode. A study was judged abnormal if the sum of stress scores was 
4 with at least one segment having a score 2. Defects that were present at rest and remained unchanged during stress were considered as fixed. The appearance of new or worsening defects following stress was considered to be defect reversibility. Studies combining fixed and reversible defects were categorized as ‘reversible’. The diagnostic accuracy of the MPS method in those (n=357) of the 507 patients who had unknown coronary disease has been reported elsewhere. The estimated sensitivity and specificity for detecting significant coronary disease were 75% (95% CI 66–82%) and 79% (95% CI 73–84%), respectively.13
Coronary angiography
Selective coronary angiography was performed in 476 out of 507 study patients in median 54 days (interquartile range 36–84) after MPS using standard techniques in multiple views and subjective visual interpretation. In excluded patients, it was carried out in 407. If necessary, the results were corrected at the ‘Heart Conference’ of the cardiology department. For the purpose of this study, significant stenoses were those with 50% luminal diameter narrowing of an epicardial coronary artery.
Management decision
The choice of management, i.e. revascularization by surgery (CABG) or angioplasty (PCI), or medicine/no treatment, was based exclusively on history, physical, and angiographic findings as the MPS results were not communicated.
Statistical analyses
Descriptive statistics were generated using percentages for discrete variables and mean values and standard deviations for continuous variables. Significant differences between males and females were tested for using the unpaired Student's t-test or Fisher's exact test. P-values less than 0.05 (two-sided) were considered significant.
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Results |
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Two-fifths of the study population were women who differed from men only by having had fewer previous infarctions and revascularizations (Table 1). Out of 507 included patients, 258 (51%) had normal perfusion, 201 (40%) had reversible defects, and 48 (9%) had fixed defects. In comparison, 252 (53%) out of 476 catheterized patients had insignificant coronary disease, whereas 79 (17%) had one-vessel, 67 (14%) two-vessel, and 78 (16%) three-vessel disease (Table 2). From Figure 1, it is seen that
40% of patients with typical angina and nearly 60% of patients with atypical angina had normal perfusion, whereas more than one-fourth of patients with non-cardiac or no chest pain had abnormal perfusion in the shape of primarily reversible defects. Similarly, one-fourth of patients with CCS grade 3 pain and 40% of those with grade 2 pain had normal perfusion, whereas one-third of patients with no chest pain within the last fortnight or CCS grade 1 chest pain had abnormal perfusion, mainly reversible defects (Figure 2). From Table 2, it appears that revascularization was carried out in 168 patients (PCI/CABG 81/87) and that 27 (16%) of these procedures were undertaken in 258 patients with normal perfusion and 13 (8%) in 48 patients with fixed defects. Thus, 13 out of 48 (27%) patients with fixed defects and 27 of 258 (10%) patients with normal perfusion underwent revascularization (Figure 3).
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In Table 3, we have computed the percentage of avoidable catheterizations and revascularizations, assuming that 20% of patients with fixed perfusion defects had viable tissue and that this proportion was also valid in the revascularized patients. As we observed in 883 catheterized patients among the 972 consecutive patients a rate of 40.9% of patients with insignificant angiographic disease compared with a rate of 52.9% in 476 catheterized patients in our study group, we added a second computation assuming that the rate of normal perfusion in the entire series was actually lower by the factor of 0.77
40.9%/52.9%, but that the ratio between reversible and fixed perfusion patterns remained constant.
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Discussion |
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Principal findings
Half of our patients had normal and the other half had abnormal myocardial perfusion with a 4:1 ratio between reversible and fixed abnormalities (Table 2). This share of patients with a normal scan appeared high considering that a Danish registry recently reported insignificant coronary artery disease in one-third of 2885 catheterized patients with stable ischaemic heart disease.14 Such a high fraction might perhaps be anticipated in the USA with its higher catheterization activity when compared with most European countries. Thus, Shaw et al.2 reported in their economic multi-centre study that 43% in a group of 5423 stable angina patients referred directly to catheterization without preceding MPS. This rate is identical to the rate of insignificant angiographic disease in our entire series of consecutive patients, suggesting that the rate of normal perfusion in this category of patients is, in fact, quite high in Denmark.
As many as 42% of patients with typical angina, 41% of patients with CCS grade 2 pain, and 24% of patients with CCS grade 3 (no patient had CCS grade 4) had normal MPS (Figures 1 and 2), suggesting that clinical evaluation of these patients is unreliable for prediction of perfusion status. This might explain why 10% of our patients with normal perfusion and 27% of patients with fixed defects underwent coronary revascularization, whereas 36% of patients with reversible defects did not (Table 2; Figure 3).
Strengths and weaknesses
In contrast to previous studies, we could avoid post-test referral bias, i.e. the phenomenon that knowledge of the test result strains out many patients with normal findings,2,15,16 leaving a highly selected material for catheterization. However, we could not exclude that other testing, primarily exercise electrocardiography, may have caused some non-MPS-related post-test referral bias in our study. But as exercise electrocardiography is not a routine procedure in Denmark in this category of patients, we considered such ‘parallel’ post-test referral bias less important and, in any case, operational in previous studies, too.
It is a limitation that not all patients in our consecutive series underwent MPS. Owing to a limited examination capacity, many patients with known coronary or ischaemic heart disease were excluded in order to get closer to a diagnostic population, but in doing this, we were not consequent by allowing patients with previous infarction and revascularization to remain in order to reach a reasonably high number of study patients, e.g. patients >75 years and diabetic patients. Several excluded subgroups were clearly higher-than-average-risk, e.g. patients >75 years and diabetic patients. They were excluded because we feared they would become too small for separate analysis. Afterwards, we regard this as an unfortunate choice because an increasing proportion of these patients is now being considered for perfusion imaging. However, by relating the rate of normal MPS to the rate of insignificant angiographic disease in those 91% of eligible patients who underwent catheterization, we were able to make a correction for this.
Most randomized studies of this category of patients included not all, but a fraction of, eligible patients, various physicians determined the type of chest discomfort according to principles seldom stated, and important clinical details were often not mentioned or commented upon. In our material, patients with ‘no complaints of angina’ were excluded, whereas patients with ‘no chest pain’ were not. This apparent contradiction stems from the fact that the former category was strained of by reviewing the referrals, whereas the latter comprised patients who had been referred because of chest pain but whose symptoms had not been present within the last fortnight before interrogation and MPS. We could account for every single patient, and using a generally accepted classification,8 all our study patients were evaluated by a single physician (H.W.C.), whose skills were found similar to those of a professor in cardiology (T.H.).17
Potential impact of MPS as gatekeeper
What would be the consequences of accepting MPS as guidance and to offer catheterization and revascularization exclusively to patients with reversible defects or fixed defects with sufficient viability? In our study cohort, we would have spared 57% of catheterizations and 22% of revascularizations. Even if we assumed that the rate of normal perfusion in the whole population was lower by a factor of 0.77, we could still spare 48% of catheterizations and 19% of revascularizations (Table 3). In addition, with primary MPS, a larger proportion than the present two-thirds of patients with reversible defects might be offered revascularization (Figure 3).
American and European studies demonstrate that patients with normal perfusion appear to have a better prognosis without invasive procedures than with it.1–4,15 A normal MPS implies a risk of future cardiac events of <1% per year, in certain groups as low as 0.5% per year.4,6 In comparison, the risk of death or serious complications (myocardial infarction, stroke, renal failure, etc.) range in stable angina pectoris patients from 0.2 to >1% with angiography18 and from 3 to >10% with CABG and PCI, depending on lesion type, patient age, ventricular function, co-morbidity, and the number of repeat interventions.19–21 This speaks in favour of a ‘no revascularization policy’ in patients with normal perfusion. In the case of fixed defects, one cannot expect improvement, except in those 10–20% who have sufficient viability.4,5 In fact, in a recent study originating from the same material, we have shown that revascularization does not improve anginal symptoms in the group of patients with fixed perfusion defects.22
What speaks against such a new strategy? First, MPS may appear normal in patients with angiographic three-vessel disease because of globally reduced perfusion. In this way, MPS may potentially ‘overlook’ severe ischaemia, including sometimes patients with a left main or a left main equivalent lesion, which according to most guidelines should be treated invasively regardless of the result of MPS. In our material, only five (1.1%) of our 476 patients who underwent angiography had severe untreated coronary artery disease (i.e. three-vessel and/or left main) and a normal MPS and hence they were at risk of being ‘overlooked’.
Secondly, angina pectoris, and not hypoperfusion, is the advocated major indication of coronary angiography.15 Most reviews and recent guidelines recommend that patients with typical chest pain and patients who suffer from refractory severe chest pain should be referred directly for catheterization and subsequent revascularization.4,6,15 However, among our 290 patients with typical angina, 42% had normal perfusion and, thus, no indication for angiography and revascularization (Figure 1). In our 38 patients (7% of 507) with severe pain (CCS grade >2), nine (24%) had normal myocardial perfusion and two (5%) had fixed defects (Table 2). Thus, this subgroup also comprised a substantial fraction with no indication for revascularization. Moreover, with <10% of our patients having severe chest discomfort, insisting on referring these patients directly to catheterization would have little impact on the consequences of using MPS as gatekeeper. In addition, one should keep in mind that fear of ‘cardiac pain’ is predominant in these patients,23 and that this may lead to invasive management, despite a generally low degree of pain (Table 2) and the fact that the 5-year mortality of this category of patients has decreased from 25 to 5–8% during the last 30 years with little advantage of invasive over medical treatment.15,24,25
Implications
The use of MPS as gatekeeper results in a more goal-directed and resource-optimized patient course avoiding that a substantial number of patients undergo unnecessary invasive procedures, whereas more patients with reversible ischaemia are considered for revascularization.
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Conclusion |
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In patients with known or suspected stable angina pectoris, primary MPS as gatekeeper for invasive procedures may change management decisions considerably and spare a substantial number of catheterizations and revascularizations for patients who are more in need of these procedures. Randomized studies elucidating these issues are recommended.
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Acknowledgements |
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We are indebted to secretaries Anne-Marie Møller and Bente Wichmann and consultant Hans Mickley of the Department of Cardiology for valuable help. We are also grateful to the personnel of the Department of Nuclear Medicine, especially secretary Anette Albæk, laboratory technicians Karina Madsen and Tina Godskesen. We thank the colleagues in the MILES study group for their cooperation in data collection and management. The MILES study was supported by grants from the Danish Heart Foundation; Novo Nordisk Foundation; Faculty of Health of the University of Southern Denmark; and NORDUnet Scandinavia.
Conflict of interest: none declared.
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