![]() 10 The semi-quantitative analysis was performed using the normal databases that the software package implements for each acquisition system (General Electric, Philips, Siemens, DPSECT). The SPECT images were reconstructed using an Iterative Reconstruction Algorithm, and the INVIA Corridor 4DM v2017 software was adopted for semi-quantitative analysis, providing perfusion defect scores (SSS, SRS, SDS), and perfusion defects extent globally and for specific vascular territories using a 17-segment model. The core lab processed the DICOM data in a standard format for qualitative analysis. Collected counts, presence of artefacts, patient motion, presence of interfering visceral activity, its intensity and distance from myocardial wall, detectable attenuation artifacts were all taken into consideration in determining ischemic burden. Quality control of the raw data was performed for all studies. Data submitted to the core lab were de-identified, and the core lab readers were unaware of treatment allocation. If the participating centers adopted resolution recovery acquisition protocols (GE Evolution for Cardiac, Philips Astonish, Siemens IQ SPECT or D-SPECT), they uploaded both raw data (for quality control) and reconstructed data for processing. Image processing and analysis at the core lab Investigators at the Indian Institute of Public Health, Delhi, India devised the randomisation scheme, developed the electronic case record forms, managed the data, and performed the statistical analysis. The Nuclear Medicine division at the University of Brescia, Italy was the central core lab for the trial. Patients were recruited from clinical centres in nine countries: Brazil, Cuba, India, Mexico, Pakistan, Serbia, Singapore, Spain, and Turkey. 7 The trial is registered in the Clinical Trials Registry, India (CTRI/2084) which is a primary register of the International Clinical Trials Registry Platform (ICTRP) ( ). The study rationale and design have been outlined previously. The study was initiated and funded by the International Atomic Energy Agency. The Value of Gated-SPECT MPI for Ischemia-Guided PCI of non-culprit vessels in STEMI Patients with Multi vessel Disease after primary PCI (IAEA SPECT STEMI) trial was an international, randomised, non-inferiority trial, comparing a strategy of ischemia guided non-culprit vessel PCI to a strategy of routine non-culprit vessel PCI, among patients with STEMI and multi-vessel disease. We hypothesized that a strategy of systematic non-invasive assessment of inducible ischemia to guide decisions regarding non-culprit PCI, will be non-inferior to routine non-culprit PCI, in reducing ischemia burden. 6 Therefore, a strategy to identify physiologically significant lesions in non-culprit vessels which might benefit from revascularization, may be more efficient than routine PCI of all anatomically significant non-culprit lesions. Likewise, in the FLOWER-MI trial, 44% of angiographically significant lesions had an FFR > 0.80. Nearly half the patients in the Compare Acute trial, 4 and 31% in the DANAMI-3-PRIMULTI trial, 5 had an FFR > 0.80, and did not undergo non-culprit PCI. This is supported by findings from previous trials using FFR to guide revascularization of non-culprit coronary lesions. On the other hand, angiographically significant lesions in non-culprit vessels, may not be functionally significant, and consequently, many PCI procedures performed without assessment of ischemia may be unnecessary. 3 Such an approach may deny many patients timely, appropriate revascularization, and may increase the risk of ischemic events. On the contrary, in some studies, the thresholds for revascularization were kept high, despite the presence of objective evidence of ischemia. It is unclear from the published reports if patients in the culprit-only PCI arms of these trials underwent routine evaluation for inducible ischemia following primary PCI. 2 Though these data are compelling, one important limitation of the existing data has not been widely acknowledged. There was a reduction in cardiovascular mortality, but there was no significant effect on all-cause mortality. ![]() 2 The principal benefits of routine non-culprit PCI in meta-analyses of these trials were a reduction in the risk of re-infarction and repeat revascularization. These recommendations are based on evidence from about 7000 patients enrolled in randomized trials comparing routine non-culprit PCI to guideline directed medical therapy. 1 Non-culprit PCI may be performed either at the time of primary PCI for STEMI, or up to 45 days after the procedure, without the need for documentation of ischemia. Current guidelines recommend the routine performance of percutaneous coronary angioplasty (PCI) of significantly stenosed non-culprit vessels, in patients with STEMI and multi-vessel disease. ![]()
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