Validation of the Ayurvedic construct, Rasadhatudushti, in adults at risk of cardiovascular diseases - A mixed-method study.

BACKGROUND: Rasadhatudushti (RD), the deranged state of Rasadhatu, is a construct in Ayurveda mentioned as the cause of diseases affecting the circulatory channels and the heart, collectively called cardiovascular diseases (CVD). It is a morbid condition generic to some other disorders, hence is non-specific to CVD. It was observed that RD was present in majority of acute coronary artery disease in a cross-sectional, descriptive study in 250 patients stabilized after an acute episode. OBJECTIVES: To validate the available scale for assessing RD in the context of CVD risk. To study the prevalence of RD in participants at risk of cardiovascular diseases. METHOD: In the first part, validation of the scale for assessing RD, as mentioned in the texts, was done through standard steps for scale validation in the context of CVD risk. Psychometric analysis was done after administering the draft scale of 39 items in 218 participants above the age of 40 years who were not yet diagnosed with overt CVD conditions. Construct validation was done by comparing mean score of Framingham global risk score in high and low RD scores and comparing the reduction in CVD risk score assessed by Qrisk®2-2017 by life style modification and a conventional RD correction as add on. Second part was a cross sectional survey study to estimate the prevalence of RD in a specific population vulnerable to CVD. This was done in a sample of 160 sedentary government employees of Thiruvananthapuram District, Kerala, aged above 40, using the validated RD assessment scale. RESULT: -The final scale to assess RD, 'RAS-RCVD', with 25 symptoms was found to have concurrent validity using WHO/ISH risk prediction as the reference standard. Framingham global risk score also showed significant but low positive correlation with eight as the cut off for RD score. The reduction in mean (SD) Qrisk score was 2.53 (3.22) in the trial group receiving RD correction drug and 0.30 (3.43) in the control with statistical significance (p < 0.05). The prevalence of RD as assessed by RD score above the cut off in the second part of the study was 49.4%. The prevalence of RD was significantly high in participants with moderate to high risk for CVD (61.3%). CONCLUSION: - The construct RD was observed to be valid in pre-clinical states of CVD. There was a high prevalence of this morbid construct in moderate to high-risk individuals. Ayurvedic CVD prevention strategies need to target on correction of RD along with individual risk factor management.

Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment.

BACKGROUND: The risk of serious infectious events (SIEs) is increased in patients with rheumatoid arthritis (RA). The aim of this study was to develop an age-adjusted comorbidity index (AACI) to predict, using baseline characteristics, the SIE risk in patients with RA treated with certolizumab pegol (CZP). METHODS: Data of CZP-treated patients with RA were pooled from the RAPID1/RAPID2 randomized controlled trials (RCT CZP) and their open-label extensions (All CZP). Predictors of the first SIE were examined using multivariate Cox models. The AACI was developed by assigning specific weights to patient age and comorbidities on the basis of relative SIE risk. SIE rates were predicted using AACI score and baseline glucocorticoid use, and they were compared with observed rates. The percentage of patients in each SIE risk group achieving low disease activity (LDA)/remission was examined at 1 year of treatment. RESULTS: Among 1224 RCT CZP patients, 40 reported ≥ 1 SIE (incidence rate [IR] 5.09/100 patient-years [PY]), and 201 of 1506 All CZP patients reported ≥ 1 SIE (IR 3.66/100 PY). Age ≥ 70 years, diabetes mellitus, and chronic obstructive pulmonary disease/asthma made the greatest contributions to AACI score. SIE rates predicted using AACI and glucocorticoid use at baseline showed good agreement with observed SIE rates across low-risk and high-risk groups. At 1 year, more high-risk All CZP patients than low-risk All CZP patients reported SIEs (IR 8.4/100 PY vs. IR 3.4/100 PY). Rates of LDA/remission were similar between groups. CONCLUSIONS: AACI and glucocorticoid use were strong baseline predictors of SIE risk in CZP-treated patients with RA. Predicted SIE risk was not associated with patients' likelihood of clinical response. This SIE risk score may provide a valuable tool for clinicians when considering the risk of infection in individual patients with RA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00152386 (registered 7 September 2005); NCT00160602 (registered 8 September 2005); NCT00175877 (registered 9 September 2005); and NCT00160641 (registered 8 September 2005).

Global Risk Score and Clinical SYNTAX Score as Predictors of Clinical Outcomes of Patients Undergoing Unprotected Left Main Percutaneous Catheter Intervention.

BACKGROUND: Risk stratification is an important component of left main percutaneous catheter intervention (PCI) which has emerged as a feasible alternative to cardiac surgery. We sought to compare the clinical SYNTAX score and the global risk score in predicting outcomes of patients undergoing unprotected left main PCI in our institution. METHODS: Clinical, angiographic and procedural characteristics of 92 patients who underwent unprotected left main PCI (mean age 62 ± 12.1 years) were analyzed. Patients were risk stratified into tertiles of high, intermediate and low risk using the global risk score (GRS) and the clinical SYNTAX score (CSS) and were prospectively followed up at 1 year for the occurrence of major adverse cardiovascular events (MACEs), defined as a composite of all cause mortality, cardiac mortality, non-fatal myocardial infarction, stroke, coronary artery bypass, and target vessel revascularization. RESULTS: There were 26 (28.2%) who experienced MACEs, of which 10 (10.8%) patients died. Multivariable hazards analysis showed that the GRS (hazard ratio (HR) = 5.5, P = 0.001) and CSS (HR = 4.3, P = 0.001) were both independent predictors of MACEs. Kaplan-Meier analysis showed higher incidence of MACEs with the intermediate and higher risk categories compared to those classified as low risk. Receiver-operator characteristic analysis showed that the GRS has better discriminatory ability than the CSS in the prediction of 1 year MACEs (0.891 vs. 0.743, P = 0.007). CONCLUSION: The GRS and CSS are predictive of outcomes after left main PCI. The GRS appears to have superior predictive and prognostic utility compared to the CSS. This study emphasizes the importance of combining both anatomic and clinical variables for optimum prognostication and management decisions in left main PCI.

Assessment of the new appropriate use criteria for diagnostic catheterization in the detection of coronary artery disease following noninvasive stress testing.

BACKGROUND: Appropriate use criteria (AUC) for diagnostic catheterization (DC) developed by the American College of Cardiology Foundation (ACCF) and other professional societies were recently published. These criteria have yet to be examined thoroughly using existing DC databases. METHODS AND RESULTS: New York State's Cardiac Diagnostic Catheterization Database was used to identify patients undergoing DC "for suspected coronary artery disease (CAD)" in 01/2010-06/2011 who underwent noninvasive stress testing. Patients rated for appropriateness using symptoms and stress test results were examined to determine the percentage with obstructive CAD and to explore the benefit of adding Global Risk Score (GRS) to the AUC. Of the 4432 patients who could be rated, 1530 (34.5%) had obstructive CAD, which varied from 22% for patients rated inappropriate to 47% for patients rated appropriate. Of all patients with low risk stress test results/no symptoms, all of whom were rated "inappropriate" for DC, only 8% of those patients with low GRS had obstructive CAD, whereas 44% of the patients with high GRS had obstructive CAD. CONCLUSIONS: Global Risk Score improved the ability of symptoms and stress test results to identify obstructive CAD in patients with "suspected CAD" with prior stress tests, and it might be helpful to add GRS to the DC AUC for those patients. These findings should be regarded as hypothesis generating unless/until they can be confirmed by other data bases.