ABSTRACT
STUDY OBJECTIVE: To evaluate the diagnostic performance of chest ultralow-dose computed tomography (CT) compared with chest radiograph for minor blunt thoracic trauma. METHODS: One hundred sixty patients with minor blunt thoracic trauma were evaluated first by chest radiograph and subsequently with a double-acquisition nonenhanced chest CT protocol: reference CT and ultralow-dose CT with iterative reconstruction. Two study radiologists independently assessed injuries with a structured report and subjective image quality and calculated certainty of diagnostic confidence level. RESULTS: Ultralow-dose CT had a sensitivity and specificity of 100% compared with reference CT in the detection of injuries (187 lesions) in 104 patients. Chest radiograph detected abnormalities in 82 patients (79% of the population), with lower sensitivity and specificity compared with ultralow-dose CT (P<.05). Despite an only fair interobserver agreement for ultralow-dose CT image quality (κ=0.26), the diagnostic confidence level was certain for 95.6% of patients (chest radiograph=79.3%). Ultralow-dose CT effective dose (0.203 mSv [SD 0.029 mSv]) was similar (P=.14) to that of chest radiograph (0.175 mSv [SD 0.155 mSv]) and significantly less (P<.001) than that of reference CT (1.193 mSv [SD 0.459 mSv]). CONCLUSION: Ultralow-dose CT with iterative reconstruction conveyed a radiation dose similar to that of chest radiograph and was more reliable than a radiographic study for minor blunt thoracic trauma assessment. Radiologists, regardless of experience with ultralow-dose CT, were more confident with chest ultralow-dose CT than chest radiograph.
Subject(s)
Emergency Service, Hospital , Radiography, Thoracic , Thoracic Injuries/diagnostic imaging , Tomography, X-Ray Computed , Wounds, Nonpenetrating/diagnostic imaging , Humans , Radiation Dosage , Sensitivity and SpecificityABSTRACT
BACKGROUND: Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery obstructions. METHODS AND RESULTS: Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85+/-57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P=0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P=0.047). No serious adverse events (death or prolonged hospitalization) were reported. CONCLUSIONS: The use of sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.
Subject(s)
Arterial Occlusive Diseases/drug therapy , Femoral Artery/drug effects , Immunosuppressive Agents/therapeutic use , Sirolimus/therapeutic use , Stents , Aged , Alloys/chemistry , Arterial Occlusive Diseases/diagnostic imaging , Arterial Occlusive Diseases/metabolism , Double-Blind Method , Female , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/prevention & control , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/pharmacokinetics , Male , Radiography , Sirolimus/adverse effects , Sirolimus/pharmacokinetics , Stents/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART Stents in superficial femoral artery obstructions. METHODS AND RESULTS: Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85 +/- 57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART Stents and 18 patients received uncoated SMART Stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The instent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P = 0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P = 0.047). No serious adverse events (death or prolonged hospitalization) were reported. CONCLUSIONS: The use of sirolimus-eluting SMART Stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.
Subject(s)
Arterial Occlusive Diseases/therapy , Drug-Eluting Stents , Femoral Artery , Stents , Aged , Arterial Occlusive Diseases/diagnostic imaging , Constriction, Pathologic , Female , Femoral Artery/diagnostic imaging , Femoral Artery/pathology , Humans , Immunosuppressive Agents/administration & dosage , Intermittent Claudication/therapy , Male , Radiography , Recurrence , Sirolimus/administration & dosage , Treatment OutcomeABSTRACT
PURPOSE: To investigate further the safety and efficacy of the sirolimus-eluting S. M.A.R.T. Nitinol Self-expanding Stent by comparison with a bare stent in superficial femoral artery (SFA) obstructions. MATERIALS AND METHODS: This randomized, double-blind study involved 57 patients (29 in the sirolimus-eluting stent group and 28 in the bare stent group) with chronic limb ischemia and SFA occlusions (66.7%) or stenoses (average lesion length, 81.5 mm +/- 41.2). Stent implantation followed standard interventional techniques and a maximum of two stents could be implanted. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography. RESULTS: Both stent types were effective in revascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 mm +/- 0.69 and 4.76 mm +/- 0.54 mm for sirolimus-eluting and bare stent groups, respectively; P = .31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the sirolimus-eluting stent, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 mm +/- 0.64 and 0.68 mm +/- 0.97 for the sirolimus-eluting stent group and the bare stent group, respectively (P = .20). The binary restenosis rates, with a cutoff of 50% at 6 months, were zero in the sirolimus-eluting stent group and 7.7% in the bare stent group (P = .49). Clinical outcomes matched angiographic outcomes with improvements in ankle-brachial index and symptoms of claudication. There was no significant difference between treatments in terms of adverse events. CONCLUSION: Although there is a trend for greater efficacy in the sirolimus-eluting stent group, there were no statistically significant differences in any of the variables.