Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone. (Funded by an Uppsala institutional Avtal om Läkarutbildning och Forskning [Agreement concerning Cooperation on Medical Education and Research] and others; Swedish Spinal Stenosis Study ClinicalTrials.gov number, NCT01994512.).
BACKGROUNDThe instantaneous wave-free ratio (iFR) is an index used to assess the severity of coronary-artery stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. We aimed to evaluate whether iFR is noninferior to FFR with respect to the rate of subsequent major adverse cardiac events.
METHODSWe conducted a multicenter, randomized, controlled, open-label clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2037 participants with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary-artery stenosis were randomly assigned to undergo revascularization guided by either iFR or FFR. The primary end point was the rate of a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization within 12 months after the procedure.
RESULTSA primary end-point event occurred in 68 of 1012 patients (6.7%) in the iFR group and in 61 of 1007 (6.1%) in the FFR group (difference in event rates, 0.7 percentage points; 95% confidence interval [CI], −1.5 to 2.8; P = 0.007 for noninferiority; hazard ratio, 1.12; 95% CI, 0.79 to 1.58; P = 0.53); the upper limit of the 95% confidence interval for the difference in event rates fell within the prespecified noninferiority margin of 3.2 percentage points. The results were similar among major subgroups. The rates of myocardial infarction, target-lesion revascularization, restenosis, and stent thrombosis did not differ significantly between the two groups. A significantly higher proportion of patients in the FFR group than in the iFR group reported chest discomfort during the procedure.
CONCLUSIONSAmong patients with stable angina or an acute coronary syndrome, an iFR-guided revascularization strategy was noninferior to an FFR-guided revascularization strategy with respect to the rate of major adverse cardiac events at 12 months. (Funded by Philips Volcano; iFR SWEDEHEART ClinicalTrials.gov number, NCT02166736.) a bs tr ac t
The sources of variability in variability of scintigraphic measurements of glomerular filtration rate (GFR) have not been determined. The day to day variability of GFR was studied in 18 healthy beagle dogs. The renal uptake of 99mTc-diethylenetriaminepentaacetic acid (DTPA) of each dog was measured using a scintigraphic technique three times at intervals of 5-26 days. GFR was calculated from a regression equation relating uptake to plasma clearance, derived in our laboratory. The mean GFR was 3.97 +/- 0.72 (SD) ml/min/kg with values from 2.66 to 5.67 ml/min/kg. Analysis of variance (ANOVA) using a linear mixed model showed that most variability is a result of the dogs, less because of day to day variability and very little to the measurement variability. The repeatability coefficients for the day to day variability and measurement variability were 1.06 and 0.21 ml/min/kg respectively. The day to day variability can be caused by physiological homeostatic adjustments by the kidneys needed because of fluctuations in food and fluid intake, each dog's individual capacity to adjust, and to intrinsic errors in the measurement method. These results should be considered when using the scintigraphic method for clinical evaluation and research.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.