370: Coronary CT Angiography Versus Stress Testing in Predicting Long-Term Adverse Events: Two-Year Follow-up of a Randomized Controlled Trial

AbstractWe report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant. Visits included collection of the following patient-reported outcome measures: nasal obstructive symptom evaluation (NOSE), nasal obstruction visual analog scale (VAS), and the Epworth Sleepiness Scale (ESS). Adverse events were evaluated at each visit. One-hundred-eleven participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates are greater than 80% at all follow-ups through 24 months. Mean reduction from baseline in NOSE scores is ≥30 points and statistically significant (p <0.001) at all time points through 24 months. Mean VAS score reduction is ≥29.7 points and statistically significant (p <0.001) at all time points. The subgroup of participants with baseline ESS values >10 experienced statistically significant (p <0.001) and clinically meaningful reductions at all postimplant periods, suggesting that the reduction in nasal symptoms may reduce daytime sleepiness for patients who have problems with sleep quality. No serious device-/procedure-related adverse events were reported. Implant migration/retrieval rate was 4.5% (10/222) of total implants or 9% of participants (10/111). The implant is safe and effective for dynamic nasal valve collapse in patients with severe/extreme nasal obstruction and provides durable symptom improvement 24 months after placement.

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A Prospective Randomized Controlled Trial to Assess the Diagnostic Performance of Reduced Tube Voltage for Coronary CT Angiography

American Journal of Roentgenology ◽

10.2214/ajr.10.5786 ◽

2011 ◽

Vol 196 (4) ◽

pp. 801-806 ◽

Cited By ~ 23

Author(s):

Jonathon Leipsic ◽

Troy M. LaBounty ◽

G. B. John Mancini ◽

Brett Heilbron ◽

Carolyn Taylor ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Ct Angiography ◽

Diagnostic Performance ◽

Coronary Ct Angiography ◽

Controlled Trial ◽

Tube Voltage ◽

Randomized Controlled ◽

Coronary Ct ◽

Prospective Randomized Controlled Trial

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Ten-Year Follow-Up of Patients Treated with Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection from a Randomized Controlled Trial and Review of the Literature

Microorganisms ◽

10.3390/microorganisms9030548 ◽

2021 ◽

Vol 9 (3) ◽

pp. 548

Author(s):

R. E. Ooijevaar ◽

E. van Nood ◽

A. Goorhuis ◽

E. M. Terveer ◽

J. van Prehn ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Fecal Microbiota Transplantation ◽

Controlled Trial ◽

Fecal Microbiota ◽

Randomized Controlled ◽

Clostridioides Difficile ◽

Clostridioides Difficile Infection

Fecal microbiota transplantation (FMT) has become a well-established treatment for recurrent Clostridioides difficile infection (rCDI). While short-term outcomes and adverse events relating to FMT have been well documented, there still is a paucity of data with regard to long-term safety. In this report, we describe the long-term follow-up of the prospective cohort of the first randomized controlled trial of FMT for rCDI, and review the existing literature. A total of 34 patients were treated with FMT for rCDI. Seven patients were still alive after a follow-up of more than 10 years and three patients were lost to follow-up. None of the 34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up. We did not find any deterioration or amelioration of pre-existing medical conditions. Furthermore, no deaths directly attributable to FMT could be identified. These findings are in accordance with the data in available literature. In conclusion, no long-term adverse events or complications directly attributable to FMT were found in our prospective cohort. Review of the available literature does not point to long-term risks associated with FMT in this elderly population, provided that carefully screened fecal suspensions are being used. No firm conclusion on the long-term safety of FMT in younger patients could be drawn.

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Faculty Opinions recommendation of A 10-year follow-up after transurethral resection of the prostate, contact laser prostatectomy and electrovaporization in men with benign prostatic hyperplasia; long-term results of a randomized controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.3437956.4950054 ◽

2010 ◽

Author(s):

Peter Gilling ◽

Liam Wilson

Keyword(s):

Randomized Controlled Trial ◽

Benign Prostatic Hyperplasia ◽

Transurethral Resection ◽

Controlled Trial ◽

Prostatic Hyperplasia ◽

Long Term Results ◽

Laser Prostatectomy ◽

Randomized Controlled

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Endothelial Dysfunction, Atherosclerosis, and Increase of von Willebrand Factor and Factor VIII: A Randomized Controlled Trial in Swine

Thrombosis and Haemostasis ◽

10.1055/s-0040-1722185 ◽

2021 ◽

Author(s):

Ferdows Atiq ◽

Jens van de Wouw ◽

Oana Sorop ◽

Ilkka Heinonen ◽

Moniek P. M. de Maat ◽

...

Keyword(s):

Cardiovascular Disease ◽

Randomized Controlled Trial ◽

Endothelial Dysfunction ◽

Controlled Trial ◽

Short Term ◽

Randomized Controlled ◽

Von Willebrand ◽

Willebrand Factor

AbstractIt is well known that high von Willebrand factor (VWF) and factor VIII (FVIII) levels are associated with an increased risk of cardiovascular disease. It is still debated whether VWF and FVIII are biomarkers of endothelial dysfunction and atherosclerosis or whether they have a direct causative role. Therefore, we aimed to unravel the pathophysiological pathways of increased VWF and FVIII levels associated with cardiovascular risk factors. First, we performed a randomized controlled trial in 34 Göttingen miniswine. Diabetes mellitus (DM) was induced with streptozotocin and hypercholesterolemia (HC) via a high-fat diet in 18 swine (DM + HC), while 16 healthy swine served as controls. After 5 months of follow-up, FVIII activity (FVIII:C) was significantly higher in DM + HC swine (5.85 IU/mL [5.00–6.81]) compared with controls (4.57 [3.76–5.40], p = 0.010), whereas VWF antigen (VWF:Ag) was similar (respectively 0.34 IU/mL [0.28–0.39] vs. 0.34 [0.31–0.38], p = 0.644). DM + HC swine had no endothelial dysfunction or atherosclerosis during this short-term follow-up. Subsequently, we performed a long-term (15 months) longitudinal cohort study in 10 Landrace–Yorkshire swine, in five of which HC and in five combined DM + HC were induced. VWF:Ag was higher at 15 months compared with 9 months in HC (0.37 [0.32–0.42] vs. 0.27 [0.23–0.40], p = 0.042) and DM + HC (0.33 [0.32–0.37] vs. 0.25 [0.24–0.33], p = 0.042). Both long-term groups had endothelial dysfunction compared with controls and atherosclerosis after 15 months. In conclusion, short-term hyperglycemia and dyslipidemia increase FVIII, independent of VWF. Long-term DM and HC increase VWF via endothelial dysfunction and atherosclerosis. Therefore, VWF seems to be a biomarker for advanced cardiovascular disease.

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