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Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.
No full textThis Summary of Research summarises results from the BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) studies and their open-label extension, BE VITAL (NCT04009499). These phase 3 studies looked at how well bimekizumab treatment worked in patients with psoriatic arthritis, and the safety of bimekizumab treatment, over the long term. Two patient groups were included in these studies: patients who had not previously been treated with biologic disease-modifying antirheumatic drugs (bDMARD-naïve; BE OPTIMAL) and patients who had a poor response or were intolerant to tumour necrosis factor (TNF) inhibitors (BE COMPLETE). These studies showed that the beneficial effects of bimekizumab treatment on patients\u27 symptoms reported at year 1 of treatment were sustained up to 2 years, regardless of whether patients were bDMARD-naïve or had previously had a poor response or intolerance to TNF inhibitors. Bimekizumab was well tolerated up to 2 years. The data from this study may help clinicians and patients when they are making shared decisions on treatment options for psoriatic arthritis
Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy.
No full textBACKGROUND: A novel optical coherence tomography (OCT)-based physiology assessment technique, virtual flow reserve (VFR), has been demonstrated to perform as a reliable surrogate for invasive physiology.
OBJECTIVES: The authors sought to examine the performance of post-percutaneous coronary intervention (PCI) VFR as a predictor of 2-year clinical outcomes independent from the OCT-based minimal stent area (MSA).
METHODS: The ILUMIEN IV (Optical Coherence Tomography [OCT] Guided Coronary Stent Implantation Compared With Angiography: A Multicenter Randomized Trial in PCI) trial prospectively recruited 2,487 patients with diabetes or high-risk coronary lesions randomizing to OCT- vs angiography-guided drug-eluting stent implantation. All patients with single-lesion treatment who had a final OCT imaging available underwent retrospective post-PCI VFR analysis offline. Of 2,128 eligible patients, VFR analysis was successfully performed in 2,057 (96.6%). Independent OCT predictors for the primary endpoint of 2-year target vessel failure (TVF), a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target vessel revascularization, were evaluated by multivariable analysis.
RESULTS: The median post-PCI VFR was 0.90 (Q1-Q3: 0.86-0.92), with a significant difference in VFR observed between the angiography- and OCT-guided groups (0.89 [Q1-Q3: 0.86-0.92] vs 0.90 [Q1-Q3: 0.87-0.92]; P \u3c 0.001). By multivariable analysis, both MSA (per 1 mm
CONCLUSIONS: Post-PCI OCT-based VFR assessment is predictive of 2-year clinical outcomes independent of MSA. Online VFR analysis can provide operators with an immediate assessment of post-PCI physiology in addition to OCT anatomy, providing incremental value in assessing procedural success and informing on clinical prognosis (ILUMIEN IV [Optical Coherence Tomography (OCT) Guided Coronary Stent Implantation Compared With Angiography: A Multicenter Randomized Trial in PCI]; NCT03507777)
When Disaster Strikes: A Nurse initiated Quality Improvement Project to Elevate Disaster Preparedness in the Emergency Department
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Clinical and Electrophysiological Characteristics of Inducible Polymorphic Ventricular Tachycardia in Repaired Tetralogy of Fallot.
No full textBackground: Although sustained monomorphic ventricular tachycardia (MVT) in repaired tetralogy of Fallot (TOF) is linked to abnormally conducting anatomical isthmuses, the clinical importance of inducible polymorphic ventricular tachycardia (PVT) is unclear.
Objectives: The aim of this study was to determine the clinical and electrophysiological characteristics of inducible PVT in TOF.
Methods: Patients from the ongoing CATAPULT-TOF (Catheter Ablation of Ventricular Tachycardia Before Transcatheter Pulmonary Valve Replacement in Repaired Tetralogy of Fallot) registry with inducible sustained PVT at index electrophysiology study were included. Abnormal anatomical isthmus was defined as conduction velocity \u3c 0.5 m/s. Centrally adjudicated episodes with ≥3 consecutive beats of similar morphology (10 of 12 leads) were labeled transiently organized PVT (TO-PVT). TO-PVT was analyzed in relation to three-dimensional substrate characteristics and postablation inducibility.
Results: Of 186 patients (mean age 40 years; 55% male), sustained PVT was induced at 27 procedures (15%). Patients with PVT vs MVT were more likely to undergo operation in the current era (P = 0.008), not require palliative shunt (P = 0.01), exhibit a lower right ventricular end-diastolic volume/left ventricular end-diastolic volume ratio (P = 0.02), and harbor faster anatomical isthmus conduction velocity (P = 0.03). Of those with available electrocardiography data, greater number of TO beats was associated with ≥1 anatomical isthmus (median 3 vs 0 beats; P = 0.001). The proportion with TO-PVT decreased with catheter ablation, with 14 of 24 identified at baseline (58%; median 3.5 beats; cycle length 181 milliseconds), 3 (23%) of 13 postablation, and 1 (8%) of 13 at follow-up electrophysiology study (Ptrend = 0.001).
Conclusions: Patients with inducible PVT display a lower clinical risk profile and healthier myocardial substrate than those with MVT. Organized beats at episode onset appear to be associated with anatomical isthmuses that can be targeted by catheter ablation
Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization.
No full textThe efficacy and safety of acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, was evaluated in 2 phase 2 studies in hospitalized patients with coronavirus disease 2019 (COVID-19) who received acalabrutinib + best supportive care (BSC) versus BSC alone (Clinicaltrials.gov: NCT04380688 and NCT04346199). The primary endpoint was the percentage of patients alive and free of respiratory failure on day 14 (rest of the world [RoW] study) and day 28 (US study). In the RoW study, 177 patients were randomized (acalabrutinib + BSC: n = 89; BSC: n = 88); in the US study, 62 patients were randomized (acalabrutinib + BSC: n = 31; BSC: n = 31). The percentage of patients who met the primary endpoint was similar in both studies (RoW study: acalabrutinib + BSC: 83.1%, BSC: 90.9%; US study: acalabrutinib + BSC: 80.6%, BSC: 83.9%). No new safety concerns were reported. Overall, no significant clinical benefit of adding acalabrutinib to BSC in patients hospitalized with COVID-19 was observed
Examining the effect of a Whole Health Primary Care Pain Education and Opioid Monitoring Program (PC-POP) at preventing opioid-induced constipation.
No full textOBJECTIVE: The prevention of opioid-induced constipation (OIC) in patients treated for chronic pain is important for an improved quality of life and prevention of complications. This study aims to determine whether the implementation of the Primary Care Pain Education and Opioid Monitoring Program (PC-POP) improved the management of OIC in patients receiving opioids for chronic noncancer pain. Design/measure: Pharmacy records regarding the presence of an appropriate laxative prescription, prescription fills, and laxative types were obtained. The primary outcome was the proportion of patients with an appropriate laxative prescription on file for the management of OIC.
SETTING: This study was conducted in the Salt Lake City Veterans Affairs (VA) Medical Center\u27s primary care setting.
SUBJECTS: Patients aged 18 and older being treated with opioids for chronic noncancer pain \u3e3 months who were enrolled in PC-POP and had attended at least two classes were compared to patients receiving standard primary care at a VA Medical Center.
RESULTS: Of the 698 patients included, 39.2 percent of patients enrolled in PC-POP had a laxative prescription on file compared to 20.9 percent for patients receiving standard primary care from a VA provider. Presence of appropriate laxative prescription was significantly higher for the PC-POP group (p = \u3c 0.001).
CONCLUSION: PC-POP enrollment was associated with a significantly higher number of appropriate laxative prescription for the management of OIC. This study indicates that there is potential for improvement in prescribing practices to ensure patients receive appropriate laxatives to mitigate the impact of OIC. It also indicates that implementation of a similar program at other VA Medical Centers could improve OIC management in veterans receiving opioids for chronic noncancer pain
An Increasing Role for Cytoreductive Surgery in Metastatic Colorectal Cancer-National Trends in the Era of More Effective Systemic Therapy.
No full textBACKGROUND AND OBJECTIVES: Treatment guidelines on cytoreductive surgery (CRS) for metastatic colorectal cancer (mCRC) continue to have variability. This study investigated survival outcomes and utilization trends of CRS on mCRC.
METHODS: Patients from the National Cancer Database with mCRC who received systemic chemotherapy 2004-2015 were categorized by colectomy, colectomy and metastasectomy (CRS), and no surgery (NS). Kaplan-Meier analyses with inverse probability of treatment weighting (IPTW) were performed.
RESULTS: Of 88 593 patients in the study cohort, 39 028 had a colectomy, 21 462 CRS, and 28 103 NS. CRS utilization increased from 33.1% (2004) to 38.3% (2015). CRS (aHR = 0.36) and colectomy (aHR = 0.47) were associated with significantly improved OS compared to NS. Median OS with IPTW remained longer in CRS versus colectomy versus NS (34.4 months vs. 26.7 vs. 13.2) (p \u3c 0.001). Patients who received hyperthermic intraperitoneal chemotherapy (HIPEC) had improved OS compared to non-HIPEC patients (aHR = 0.55, p \u3c 0.001).
CONCLUSIONS: National utilization of CRS for mCRC is steadily increasing and associated with improved OS, supporting the use of more aggressive surgical approaches in select patients
