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Brophy et al. [ 44 ], in an analysis of 29 trials involving 9918 patients, reported no difference between bare metal stent (BMS) and balloon angioplasty in terms of death, MI, or the need for CABG, but an ∼5% absolute reduction in restenosis with stenting. Subsequent meta-analyses [ 45 ] of RCTs comparing DES with BMS reported similar rates of death, cardiac death, and non-fatal MI, but a significant reduction in the need for subsequent or repeat target vessel revascularization (TVR) with DES. In contrast, Kirtane et al. [ 46 ], in an unadjusted analysis of 182 901 patients in 34 observational studies of BMS and DES, reported a significant reduction in mortality (HR 0.78, 95%CI 0.71–0.86) and MI (HR 0.87, 95%CI 0.78–0.97) with DES. After multivariable adjustment, the benefits of DES were significantly attenuated and the possibility that at least some of the clinical benefit of DES might be due to concomitant dual antiplatelet therapy (DAPT) could not be excluded. In a network meta-analysis restricted to patients with non-acute CAD, sequential advances in PCI techniques were not associated with incremental mortality benefit in comparison with OMT [ 42 ].

The superiority of CABG to medical therapy in the management of specific subsets of CAD was firmly established in a meta-analysis of seven RCTs [ 31 ], which is still the major foundation for contemporary CABG. It demonstrated a survival benefit of CABG in patients with LM or three-vessel CAD, particularly when the proximal LAD coronary artery was involved. Benefits were greater in those with severe symptoms, early positive exercise tests, and impaired LV function. The relevance of these findings to current practice is increasingly challenged as medical therapy used in the trials was substantially inferior to current OMT. However, a recent meta-analysis reported a reduction in the HR for death with CABG vs. OMT (HR 0.62, 95%CI 0.50–0.77) [ 30 ]. In addition, the benefits of CABG might actually be underestimated because:

most patients in the trials had a relatively low severity of CAD;

analysis was conducted on an intention-to-treat basis (even though 40% of the medical group crossed over to CABG);

only 10% of CABG patients received an internal thoracic artery (ITA); however the most important prognostic component of CABG is the use of one [ 47 , 48 ] or preferably two [ 49 ] ITAs.

There are two meta-analyses of > 1900 [ 50 ] and > 1200 [ 51 ] patients, both of which reported no significant difference in mortality, MI, or cerebrovascular accident (CVA), but a threefold increase in recurrent angina and a five-fold increase in repeat TVR with PCI at up to 5 years of follow-up.

There have been > 15 RCTs of PCI vs. CABG in MVD [ 52 ] but only one of OMT vs. PCI vs. CABG (MASS II) [ 53 ]. Most patients in these RCTs actually had normal LV function with single or double vessel CAD and without proximal LAD disease. Meta-analyses of these RCTs reported that CABG resulted in up to a five-fold reduction in the need for reintervention, with either no or a modest survival benefit or a survival benefit only in patients > 65 years old (HR 0.82) and those with diabetes (HR 0.7) [ 29 ]. The 5-year follow-up of the MASS II [ 53 ] study of 611 patients (underpowered) reported that the composite primary endpoint (total mortality, Q-wave MI, or refractory angina requiring revascularization) occurred in 36% of OMT, 33% of PCI and 21% of CABG patients ( P = 0.003), with respective subsequent revascularization rates of 9%, 11% and 4% ( P =0.02).

Table 3.

Summary of Available Tests for Infection, in Decreasing Order of Sensitivity

Must be combined with a toxin test.

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Table 3.

Summary of Available Tests for Infection, in Decreasing Order of Sensitivity

Must be combined with a toxin test.

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The other reference method is the cell cytotoxicity neutralization assay (CCNA), which detects toxin directly in stool. This assay begins with preparation of a stool filtrate, which is applied to a monolayer of an appropriate cell line, such as Vero cells, or human fibroblasts, among others. Following incubation, the cells are observed for cytopathic effect (CPE); duplicate testing is usually carried out simultaneously with neutralizing antibodies to Clostridium sordellii or C. difficile toxin, to ensure that the observed CPE is truly caused by C. difficile toxins and not by other substances in the stool. Incubation continues for up to 48 hours, but the majority of positives are detected after overnight incubation. This method is cumbersome, time-consuming, and lacks standardization, although if optimized, it is one of the most sensitive and specific methods available for C. difficile toxin detection. As laboratories abandoned their viral cell culture facilities in favor of antigen and molecular tests, CCNA became less popular. Enzyme immunoassays, initially for toxin A detection alone, and later both toxins, became available and replaced the above reference methods for routine clinical testing in the late 1980s and early 1990s. EIAs use monoclonal or polyclonal antibodies to detect C. difficile toxins and there are numerous commercial assays available. Performance is variable and their overall poor performance sparked development of other methods such as GDH immunoassays and molecular tests for toxin gene detection [ 174 , 176 , 177 ]. While toxin EIAs remain insensitive in the detection of toxigenic C. difficile when compared with these successive technologies, sensitivities vary among available toxin EIA tests. Results across both sponsored and nonsponsored studies should be considered to select a relatively more sensitive EIA for general use [ 174 ]. Also, there is some evidence that newer EIAs have improved sensitivity compared with those examined in older studies [ 178 ].

Glutamate dehydrogenase immunoassays detect the highly conserved metabolic enzyme (common antigen) present in high levels in all isolates of C. difficile . Since this antigen is present in both toxigenic and nontoxigenic strains, GDH immunoassays lack specificity and must be combined with another (usually toxin) test. GDH testing is the initial screening step in 2- and 3-step algorithms that combine it with a toxin test and/or a molecular test for toxin gene detection. The combination has allowed for rapid results and improved sensitivity compared with toxin EIA testing alone, and can be economical [ 174 , 176 , 177 ].

The target of revascularization therapy is myocardial ischaemia, not the epicardial coronary disease itself. Revascularization procedures performed in patients with documented ischaemia reduce total mortality [ 13 ] through reduction of ischaemic burden [ 14 ]. Discrepancies between the apparent anatomical severity of a lesion and its functional effects on myocardial blood supply are common, especially in stable CAD. Thus, functional assessment, non-invasive or invasive, is essential for intermediate stenoses. Revascularization of lesions without functional significance can be deferred [ 15 ].

Another indication for non-invasive imaging before revascularization is the detection of myocardial viability in patients with poor left ventricle (LV) function. Patients who have viable but dysfunctional myocardium are at higher risk if not revascularized, while the prognosis of patients without viable myocardium is not improved by revascularization [ 16 , 17 ].

The current evidence supporting the use of various tests for the detection of CAD is based on meta-analyses and multicentre studies ( Table 7 ). Few RCTs have assessed health outcomes for diagnostic testing and the available evidence has been derived largely from non-randomized studies. On many occasions the choice of the test is based on local expertise and availability of the test. Although several tests can be used, it is important to avoid unnecessary diagnostic steps.

Table 7
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Indications of different imaging tests for the diagnosis of obstructive coronary artery disease and for the assessment of prognosis in subjects without known coronary artery disease

Table 7
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Indications of different imaging tests for the diagnosis of obstructive coronary artery disease and for the assessment of prognosis in subjects without known coronary artery disease

When considering any test to detect CAD one must also take into account the risks associated with the test itself. The risks of exercise, pharmacological stressors, contrast agents, invasive procedures, and cumulative ionizing radiation must be weighed against the risk of disease or delayed diagnosis.

In summary, documentation of ischaemia using functional testing is strongly recommended before elective invasive procedures, preferably using non-invasive testing before invasive angiography.

There are two non-invasive angiographic techniques that can directly image coronary arteries: multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI).

The studies and meta-analyses of MDCT to detect CAD have generally shown high negative predictive values (NPVs), suggesting that MDCT is excellent in excluding significant CAD [ 18 , 19 ], while positive predictive values (PPVs) were only moderate. In the two multicentre trials published, one was consistent with the results of prior meta-analyses [ 20 ] but the other showed only moderate NPV (83–89%) [ 21 ]. Only about half of the stenoses classified as significant by MDCT are associated with ischaemia [ 22 ] indicating that MDCT angiography cannot accurately predict the haemodynamic significance of coronary stenosis.

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