Publications by authors named "Sonia S Anand"

257 Publications

Reduction in Acute Limb Ischemia with Rivaroxaban versus Placebo in Peripheral Artery Disease after Lower Extremity Revascularization: Insights from VOYAGER PAD.

Circulation 2021 Oct 12. Epub 2021 Oct 12.

Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO; CPC Clinical Research, Aurora, CO.

Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. VOYAGER PAD (NCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan Meier estimates, and Cox proportional-hazards models were used to generate hazard ratios and associated confidence intervals. Analyses were performed as intention-to-treat. Among 6,564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, prior LER, baseline ABI <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (HR 2.59, 95% CI 1.98-3.39) and major amputation (HR 24.87, 95% CI 18.68-33.12). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction 2.6% at 3 years, HR 0.67, 95% CI 0.55-0.82, P=0.0001), with benefit starting early (HR 0.45, 95% CI 0.24-0.85, P=0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and ICU stay, HR 0.58, 95% CI 0.40-0.83, P=0.003) and regardless of LER type (surgical vs endovascular revascularization, p-interaction=0.42) or clopidogrel use (p-interaction=0.59). After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.055146DOI Listing
October 2021

Studies to Improve Perinatal Health through Diet and Lifestyle among South Asian Women Living in Canada: A Brief History and Future Research Directions.

Nutrients 2021 Aug 24;13(9). Epub 2021 Aug 24.

Population Health Research Institute, Hamilton Health Sciences Corporation, Hamilton, ON L8L 2X2, Canada.

South Asians (i.e., people who originate from India, Pakistan, Sri Lanka, Nepal, and Bangladesh) have higher cardiovascular disease rates than other populations, and these differences persist in their offspring. Nutrition is a critical lifestyle-related factor that influences fetal development, and infant and child health in early life. In high-income countries such as Canada, nutrition-related health risks arise primarily from overnutrition, most strikingly for obesity and associated non-communicable diseases. Evidence for developmental programming during fetal life underscores the critical influence of maternal diet on fetal growth and development, backed by several birth cohort studies including the Pune Maternal Nutrition Study, the South Asian Birth Cohort Study, and the Born in Bradford Study. Gestational diabetes mellitus is a strong risk factor for type 2 diabetes, future atherosclerosis and cardiovascular disease in the mother and increases the risk of type 2 diabetes in her offspring. Non-pharmacological trials to prevent gestational diabetes are few, often not randomized, and are heterogeneous with respect to design, and outcomes have not converged upon a single optimal prevention strategy. The aim of this review is to provide an understanding of the current knowledge around perinatal nutrition and gestational diabetes among the high-risk South Asian population as well as summarize our research activities investigating the role of culturally-tailored nutrition advice to South Asian women living in high-income settings such as Canada. In this paper, we describe these qualitative and quantitative studies, both completed and underway. We conclude with a description of the design of a randomized trial of a culturally tailored personalized nutrition intervention to reduce gestational glycaemia in South Asian women living in Canada and its implications.
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http://dx.doi.org/10.3390/nu13092932DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8465246PMC
August 2021

Effect of Cognitive Reserve on the Association of Vascular Brain Injury With Cognition: Analysis of the PURE and CAHHM Studies.

Neurology 2021 Sep 9. Epub 2021 Sep 9.

Department of Social Medicine, Wroclaw Medical University.

Objective: To determine whether cognitive reserve attenuates the association of vascular brain injury with cognition.

Methods: Cross-sectional data were analyzed from two harmonized studies: the Canadian Alliance for Healthy Hearts and Healthy Minds (CAHHM) and the Prospective Urban and Rural Epidemiology (PURE) study. Markers of cognitive reserve were education, involvement in social activities, marital status, height, and leisure physical activity, which were combined into a composite score. Vascular brain injury was defined asnon-lacunar brain infarcts or high white matter hyperintensity (WMH) burden on MRI. Cognition was assessed using the Montreal Cognitive Assessment Tool (MoCA) and the Digit Symbol Substitution Test (DSST).

Results: There were 10,450 participants age 35-81. Mean age was 58.8 years (range 35 to 81) and 55.8% were female. Education, moderate leisure physical activity, being in a marital partnership, being taller, and participating in social groups were each independently associated with higher cognition, as was the composite cognitive reserve score. Vascular brain injury was associated with lower cognition (beta-0.35 [95% CI -0.53 to -0.17] for MoCA and beta -2.19 [95% CI-3.22 to -1.15] for DSST)-but the association was not modified by the composite cognitive reserve variable (interaction p=0.59 for MoCA and p=0.72 for DSST).

Conclusions: Both vascular brain injury and markers of cognitive reserve are associated with cognition. However, the effects were independent such that the adverse effects of covert vascular brain injury were not attenuated by higher cognitive reserve. To improve cognitive brain health, interventions to both prevent cerebrovascular disease and promote positive lifestyles are needed.
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http://dx.doi.org/10.1212/WNL.0000000000012765DOI Listing
September 2021

Low-dose rivaroxaban and aspirin among patients with peripheral artery disease: a meta-analysis of the COMPASS and VOYAGER trials.

Eur J Prev Cardiol 2021 Aug 31. Epub 2021 Aug 31.

Department of Cardiology, University of Colorado School of Medicine, 13001 E 17th Pl, Boulder, Colorado 80045, USA.

Aims: Peripheral artery disease (PAD) patients suffer a high risk of major cardiovascular (CV) events, with athero-thrombo-embolism as the underlying pathophysiologic mechanism. Recently, two large randomized clinical trials evaluated the efficacy and safety of low-dose rivaroxaban twice daily plus aspirin in stable PAD outpatients and those immediately after peripheral revascularization. We sought to determine if the effects of low-dose rivaroxaban and aspirin compared to aspirin alone are consistent across this broad spectrum of PAD patients.

Methods And Results: We conducted a random-effects meta-analysis of the COMPASS and VOYAGER randomized trials among 11 560 PAD patients (4996 from COMPASS and 6564 from VOYAGER) in the primary analysis and 9332 (2768 from COMPASS and 6564 from VOYAGER) with lower extremity (LE)-PAD in the secondary analysis. The hazard ratio (HR) for the composite of CV death, myocardial infarction, ischaemic stroke, acute limb ischaemia, or major vascular amputation was 0.79 (95% confidence interval, CI: 0.65-0.95) comparing low-dose rivaroxaban plus aspirin to aspirin alone. While the risk of major bleeding was increased with low-dose rivaroxaban plus aspirin compared to aspirin alone [HR: 1.51 (95% CI: 1.22-1.87)], there was no significant increase in severe bleeding [HR: 1.18 (95% CI: 0.79-1.76)]. Similar effects were observed in the subset with symptomatic LE-PAD.

Conclusions: Among PAD patients, low-dose rivaroxaban plus aspirin is superior to aspirin alone in reducing CV and limb outcomes including acute limb ischaemia and major vascular amputation. This reduction is offset by a relative increase in major bleeding, but not by an excess of fatal or critical organ bleeding. The consistency of findings of these trials supports the use of combination low-dose rivaroxaban plus aspirin in PAD patients across a broad spectrum of disease.
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http://dx.doi.org/10.1093/eurjpc/zwab128DOI Listing
August 2021

Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER PAD trial.

Eur Heart J 2021 Oct;42(39):4040-4048

CPC Clinical Research, 2115 N Scranton Street, Suite 2040, Aurora, CO, USA.

Aims: In this secondary analysis of the VOYAGER trial, rivaroxaban 2.5 mg twice/day plus aspirin 100 mg/day was assessed in older adults. Advanced age is associated with elevated bleeding risk and unfavourable net benefit for dual antiplatelet therapy in chronic coronary artery disease. The risk-benefit of low-dose rivaroxaban in patients ≥75 years with peripheral artery disease (PAD) after lower extremity revascularization (LER) has not been described.

Methods And Results: The primary endpoint was a composite of acute limb ischaemia, major amputation, myocardial infarction, ischaemic stroke, or cardiovascular death. The principal safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding analysed by the pre-specified age cut-off of 75 years. Of 6564 patients randomized, 1330 (20%) were >75 years. Absolute 3-year Kaplan-Meier cumulative incidence rates for primary efficacy (23.4% vs. 19.0%) and safety (3.5% vs. 1.5%) endpoints were higher in elderly vs. non-elderly patients. Efficacy of rivaroxaban (P-interaction 0.83) and safety (P-interaction 0.38) was consistent irrespective of age. The combination of intracranial and fatal bleeding was not increased in patients >75 years (2 rivaroxaban vs. 8 placebo). Overall, benefits (absolute risk reduction 3.8%, number needed to treat 26 for the primary endpoint) exceeded risks (absolute risk increase 0.81%, number needed to harm 123 for TIMI major bleeding).

Conclusion: Patients ≥75 years with PAD are at both heightened ischaemic and bleeding risk after LER. No excess harm with respect to major, intracranial or fatal bleeding was seen in older patients yet numerically greater absolute benefits were observed. This suggests that low-dose rivaroxaban combined with aspirin should be considered in PAD after LER regardless of age.
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http://dx.doi.org/10.1093/eurheartj/ehab408DOI Listing
October 2021

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

Circulation 2021 Oct 12;144(14):1104-1116. Epub 2021 Aug 12.

CPC Clinical Research, Aurora, CO (M.R.N., N.G., W.H.C., T.B., N.J., C.N.H., W.R.H., M.P.B.).

Background: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER.

Methods: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee.

Results: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; =0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; =0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (=0.95) and postprocedural bleeding requiring intervention (=0.93) was not significantly increased.

Conclusions: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.054835DOI Listing
October 2021

Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease.

J Am Coll Cardiol 2021 07;78(1):14-23

Population Health Research Institute, Hamilton Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Background: The combination of 2.5 mg rivaroxaban twice daily and 100 mg aspirin once daily compared with 100 mg aspirin once daily reduces major adverse cardiovascular (CV) events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

Objectives: The aim of this work was to report the effects of the combination on overall and cause-specific mortality.

Methods: The COMPASS trial enrolled 27,395 patients of whom 18,278 were randomized to the combination (n = 9,152) or aspirin alone (n = 9,126). Deaths were adjudicated by a committee blinded to treatment allocation. Previously identified high-risk baseline features were polyvascular disease, chronic kidney disease, mild or moderate heart failure, and diabetes.

Results: During a median of 23 months of follow-up (maximum 47 months), 313 patients (3.4%) allocated to the combination and 378 patients (4.1%) allocated to aspirin alone died (hazard ratio [HR]: 0.82; 95% confidence interval [CI]: 0.71-0.96; P = 0.01). Compared with aspirin, the combination reduced CV death (160 [1.7%] vs 203 [2.2%]; HR: 0.78; 95% CI: 0.64-0.96; P = 0.02) but not non-CV death. There were fewer deaths following MI, stroke, and CV procedures, as well as fewer sudden cardiac, other, and unknown causes of CV deaths and coronary heart disease deaths. Patients with 0, 1, 2, and 3 or 4 high-risk features at baseline had 4.2, 4.8, 25.0, and 53.9 fewer deaths, respectively, per 1000 patients treated for 30 months.

Conclusions: The combination of rivaroxaban and aspirin compared with aspirin reduced overall and CV mortality with consistent reductions in cause specific CV mortality in patients with chronic CAD or PAD. The absolute mortality benefits are greater with increasing baseline risk. (Cardiovascular Outcomes for People Using Anticoagulant Strategies [COMPASS]; NCT01776424).
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http://dx.doi.org/10.1016/j.jacc.2021.04.083DOI Listing
July 2021

Low-dose rivaroxaban plus aspirin in patients with polypharmacy and multimorbidity: an analysis from the COMPASS trial.

Eur Heart J Cardiovasc Pharmacother 2021 Jun 30. Epub 2021 Jun 30.

Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.

Background: In patients with coronary or peripheral arterial disease, adding low dose rivaroxaban to aspirin reduces cardiovascular events and mortality. Polypharmacy and multimorbidity are frequent in such patients.

Aims: To analyze whether the benefits and risks of rivaroxaban plus aspirin varies in patients with comorbidities and receiving multiple drugs.

Methods And Results: We describe ischemic events (cardiovascular death, stroke, or myocardial infarction) and major bleeding in participants from the randomised, double-blind COMPASS study by number of cardiovascular medications and concomitant medical conditions. We compared event rates and hazard ratios (HR) for rivaroxaban plus aspirin versus aspirin alone by the number of medications and concomitant conditions, and tested for interaction between polypharmacy or multimorbidity and the antithrombotic regimen.The risk of ischemic events was higher in patients with more concomitant drugs (HR 1.7, 95%CI 1.5-2.1 for >4 vs 0-2) and with more comorbidities (HR 2.3, 1.8-2.1 for >3 vs 0-1). Multimorbidity, but not polypharmacy, was associated with a higher risk of major bleeding. The relative efficacy, safety, and net clinical benefit of rivaroxaban were not affected by the number of drugs or comorbidities. Patients taking more concomitant medications derived the largest absolute reduction in the net clinical outcome with added rivaroxaban (1.1% vs 0.4% reduction with >4 vs 0-2 cardiovascular drugs, NNT 91 vs 250).

Conclusion: Adding low-dose rivaroxaban to aspirin resulted in benefits irrespective of the number of concomitant drugs or comorbidities. Multiple comorbidities and/or polypharmacy should not dissuade the addition of rivaroxaban to aspirin in otherwise eligible patients.
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http://dx.doi.org/10.1093/ehjcvp/pvab050DOI Listing
June 2021

The Rise in Cardiovascular Risk Factors and Chronic Diseases in Guyana: A Narrative Review.

Ann Glob Health 2021 05 31;87(1):46. Epub 2021 May 31.

Population Health Research Institute, Hamilton, ON, Canada.

Background: Guyana experiences health challenges related to both communicable and non-communicable diseases. Cardiovascular disease (CVD) is the most common non-communicable disease in Guyana. The main causes of the increased prevalence of non-communicable diseases are modifiable risk factors (e.g. obesity, hypertension, elevated cholesterol, unhealthy dietary patterns) and non-modifiable risk factors (e.g. age and genetics).

Objective: The aim of this review is to understand CVD and risk factor data, in the context of ethnicity in Guyana.

Methods: A review of the published literature as well as government and international health agency reports was conducted. All publications from 2002-2018 describing CVD and related risk factors in Guyana were screened and extracted.

Findings: The population of Guyana is comprised of six ethnic groups, of which East Indian (39.8%) and African (29.3%) are the majority. CVD accounts for 526 deaths per 100,000 individuals per year. Among Indo-Guyanese and Afro-Guyanese, CVD is the primary cause of death affecting 32.6% and 22.7% of the populations, respectively. Within the Indo-Guyanese and Afro-Guyanese communities there is a high prevalence of hypertension and diabetes among individuals over the age of 50. There is a lack of available data describing ethnic disparities in CVD and related risk factors such as obesity, smoking, alcohol, physical activity and diet in Guyana.

Conclusions: Important knowledge gaps remain in understanding the ethnic disparities of CVD and related risk factors in Guyana. Future research should focus on high risk populations and implement widespread screening and treatment strategies of common risk factors such as hypertension, diabetes, and elevated cholesterol to curb the epidemic of CVD in Guyana.
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http://dx.doi.org/10.5334/aogh.3060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176929PMC
May 2021

Considerations for use of direct oral anticoagulants in arterial disease.

Res Pract Thromb Haemost 2021 May 28;5(4). Epub 2021 May 28.

Department of Medicine McMaster University Hamilton ON Canada.

Cardiovascular diseases including coronary heart disease, stroke, and peripheral arterial disease were responsible for an estimated 18 million deaths in 2017. Despite advances in management over the past several decades, these patients continue to have substantial risk of subsequent cardiovascular events. We provide a narrative review of randomized clinical trials evaluating direct oral anticoagulants (DOACs) for the treatment of acute coronary syndromes, noncardioembolic ischemic stroke, embolic stroke of undetermined source, and peripheral arterial disease. In these conditions, considerations for use of single antiplatelet therapy, dual antiplatelet therapy, or low-dose DOACs used together with antiplatelet therapy are presented.
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http://dx.doi.org/10.1002/rth2.12502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162231PMC
May 2021

Nutritional Metabolomics and the Classification of Dietary Biomarker Candidates: A Critical Review.

Adv Nutr 2021 May 20. Epub 2021 May 20.

Department of Chemistry and Chemical Biology, McMaster University, Hamilton, Canada.

Recent advances in metabolomics allow for more objective assessment of contemporary food exposures, which have been proposed as an alternative or complement to self-reporting of food intake. However, the quality of evidence supporting the utility of dietary biomarkers as valid measures of habitual intake of foods or complex dietary patterns in diverse populations has not been systematically evaluated. We reviewed nutritional metabolomics studies reporting metabolites associated with specific foods or food groups; evaluated the interstudy repeatability of dietary biomarker candidates; and reported study design, metabolomic approach, analytical technique(s), and type of biofluid analyzed. A comprehensive literature search of 5 databases (PubMed, EMBASE, Web of Science, BIOSIS, and CINAHL) was conducted from inception through December 2020. This review included 244 studies, 169 (69%) of which were interventional studies (9 of these were replicated in free-living participants) and 151 (62%) of which measured the metabolomic profile of serum and/or plasma. Food-based metabolites identified in ≥1 study and/or biofluid were associated with 11 food-specific categories or dietary patterns: 1) fruits; 2) vegetables; 3) high-fiber foods (grain-rich); 4) meats; 5) seafood; 6) pulses, legumes, and nuts; 7) alcohol; 8) caffeinated beverages, teas, and cocoas; 9) dairy and soya; 10) sweet and sugary foods; and 11) complex dietary patterns and other foods. We conclude that 69 metabolites represent good candidate biomarkers of food intake. Quantitative measurement of these metabolites will advance our understanding of the relation between diet and chronic disease risk and support evidence-based dietary guidelines for global health.
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http://dx.doi.org/10.1093/advances/nmab054DOI Listing
May 2021

Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial.

J Am Coll Cardiol 2021 Jul 16;78(4):317-326. Epub 2021 May 16.

CPC Clinical Research, Aurora, Colorado, USA; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA. Electronic address:

Background: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. The VOYAGER PAD (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities) trial demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%. The benefit of rivaroxaban on total (first and subsequent) events in this population is unknown.

Objectives: This study sought to evaluate the total burden of vascular events in patients with PAD after LER and the efficacy of low-dose rivaroxaban on total events.

Methods: VOYAGER PAD randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to first event of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The current analysis considered all events (first and subsequent) for components of the primary endpoint as well as additional vascular events including peripheral revascularizations and venous thromboembolism. HRs were estimated by marginal proportional hazards models.

Results: Among 6,564 randomized events, there were 4,714 total first and subsequent vascular events including 1,614 primary endpoint events and 3,100 other vascular events. Rivaroxaban reduced total primary endpoint events (HR: 0.86; 95% CI: 0.75-0.98; P = 0.02) and total vascular events (HR: 0.86; 95% CI: 0.79-0.95; P = 0.003). An estimated 4.4 primary and 12.5 vascular events per 100 participants were avoided with rivaroxaban over 3 years.

Conclusions: Patients with symptomatic PAD who are undergoing LER have a high total event burden that is significantly reduced with rivaroxaban. Total event reduction may be a useful metric to quantify the efficacy of rivaroxaban in this setting. (Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities [VOYAGER PAD]; NCT02504216).
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http://dx.doi.org/10.1016/j.jacc.2021.05.003DOI Listing
July 2021

Risk stratification of cardiovascular complications using CHADS-VASc and CHADS scores in chronic atherosclerotic cardiovascular disease.

Int J Cardiol 2021 Aug 3;337:9-15. Epub 2021 May 3.

Cardiology Research Unit, University Hospital Geelong, Barwon Health, Geelong, Australia.

Background The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial showed that rivaroxaban plus aspirin reduced major adverse cardiovascular events (MACE) in patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD). We explored whether CHADS-VASc or CHADS scores, well-validated tools for assessing risk of thromboembolic events in atrial fibrillation, can identify vascular patients at highest risk of recurrent events who may derive greatest benefits of treatment. Methods Predictive accuracies of the CHADS-VASc and CHADS scores for MACE, were assessed in this analysis of the COMPASS trial. Kaplan-Meier estimates of cumulative risk were used to compare the effects of rivaroxaban plus aspirin (n = 9152) with aspirin alone (n = 9126) according to risk scores. Results High CHADS-VASc (6-9) or CHADS (3-6) scores were associated with over three times greater absolute risk of MACE compared with CHADS-VASc score of 1-2 or CHADS score of 0. The effects of rivaroxaban plus aspirin compared with aspirin alone were consistent across CHADS-VASc and CHADS score categories for MACE, bleeding and net clinical benefit, with greatest reduction in MACE observed in patients treated for 30 months with highest CHADS score (3-6) (hazard ratio = 0.67, 95% CI: 0.53-0.86, p = 0.0012, 25 events per 1000 patients prevented). Conclusion The CHADS-VASc and CHADS scores can be used in patients with chronic CAD and/or PAD to identify patients who are at highest risk of MACE. Those identified at highest risk by CHADS scores had greatest benefit from dual pathway inhibition with rivaroxaban plus aspirin. Clinical Trial Registration: NCT01776424.
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http://dx.doi.org/10.1016/j.ijcard.2021.04.067DOI Listing
August 2021

Effectiveness of programs aimed at obesity prevention among Indigenous children: A systematic review.

Prev Med Rep 2021 Jun 9;22:101347. Epub 2021 Mar 9.

Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University, Canada.

Given the significant health burden of childhood obesity, it is imperative that effective programs be better understood. When evaluating obesity prevention efforts, one must recognize the contextual factors which drive the disproportionate risk of obesity between populations. This systematic review sought to understand if programs aimed at obesity prevention and/or the promotion of healthy lifestyle behaviours for Indigenous children are effective. We conducted a search using Medline, EMBASE, PsychINFO, ERIC, CINAHL and iPORTAL databases from inception to August 13, 2019. We included experimental and quasi-experimental studies. The main outcomes of interest were change in anthropometrics, nutrition or physical activity. Our narrative synthesis included an assessment of study quality using the Effective Public Health Practice Project Quality assessment tool. A total of 34 studies met selection criteria. Most studies used a quasi-experimental design (n = 25) and were assessed as low to moderate quality (n = 32). Three studies showed a significant change in anthropometric measures, 14 studies demonstrated at least one significant nutrition-related behaviour or dietary-pattern change, and six studies demonstrated a significant impact on physical activity. This systematic review of programs to prevent obesity among Indigenous children finds a limited impact on anthropometric measurements. Future studies must prioritize Indigenous knowledge and ways of knowing to lead all phases of development, implementation, and evaluation of programs.
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http://dx.doi.org/10.1016/j.pmedr.2021.101347DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8050026PMC
June 2021

Reply to "The VOYAGER PAD Trial in Surgical Perspective: A Debate".

Eur J Vasc Endovasc Surg 2021 05 1;61(5):723-724. Epub 2021 Apr 1.

Department of Surgery, Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, CO, USA.

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http://dx.doi.org/10.1016/j.ejvs.2021.02.051DOI Listing
May 2021

Prevention and Management of Urgent/Emergent Limb Ischemia.

Curr Cardiol Rep 2021 03 11;23(5):41. Epub 2021 Mar 11.

Population Health Research Institute, 20 Copeland Ave, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada.

Purpose Of Review: Patients who require urgent or emergent peripheral revascularization represent one of the highest risk subgroups of PAD patients. They suffer unacceptably high complication rates including recurrent ALI, vascular amputation, and death. In this article, we examine (1) the burden of cardiovascular complications according to PAD severity, (2) discuss medical optimization to improve vascular outcomes in symptomatic LE-PAD patients, and (3) review the evidence for management of patients following urgent/emergent limb ischemia.

Recent Findings: The VOYAGER trial recently demonstrated that rivaroxaban 2.5 mg BID + ASA daily significantly reduces major adverse cardiac and limb events in patients following lower extremity revascularization. A recent Canadian survey also demonstrated that significant heterogeneity exists in antithrombotic prescribing practices following urgent/emergent revascularization. COMPASS and VOYAGER have demonstrated the efficacy of aspirin 81 mg daily and rivaroxaban 2.5 mg twice daily at reducing MACE and MALE events in stable PAD patients and those undergoing elective revascularization. Patients who require urgent or emergent peripheral revascularization remain the highest thrombotic risk subgroup of PAD patients, in whom there is insufficient evidence to guide antithrombotic therapy. Despite clear evidence that multi-modal medical therapy (including statins, antihypertensive agents and smoking cessation) benefits patients with atherosclerosis, their use remains unacceptably low in PAD, and greater efforts are needed to understand and address patient, health provider, and system issues that prevent their optimal implementation in practice.
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http://dx.doi.org/10.1007/s11886-021-01472-9DOI Listing
March 2021

The maternal serum metabolome by multisegment injection-capillary electrophoresis-mass spectrometry: a high-throughput platform and standardized data workflow for large-scale epidemiological studies.

Nat Protoc 2021 04 5;16(4):1966-1994. Epub 2021 Mar 5.

Department of Chemistry and Chemical Biology, McMaster University, Hamilton, Ontario, Canada.

A standardized data workflow is described for large-scale serum metabolomic studies using multisegment injection-capillary electrophoresis-mass spectrometry. Multiplexed separations increase throughput (<4 min/sample) for quantitative determination of 66 polar/ionic metabolites in serum filtrates consistently detected (coefficient of variance (CV) <30%) with high frequency (>75%) from a multi-ethnic cohort of pregnant women (n = 1,004). We outline a validated protocol implemented in four batches over a 7-month period that includes details on preventive maintenance, sample workup, data preprocessing and metabolite authentication. We achieve stringent quality control (QC) and robust batch correction of long-term signal drift with good mutual agreement for a wide range of metabolites, including serum glucose as compared to a clinical chemistry analyzer (mean bias = 11%, n = 668). Control charts for a recovery standard (mean CV = 12%, n = 2,412) and serum metabolites in QC samples (median CV = 13%, n = 202) demonstrate acceptable intermediate precision with a median intraclass coefficient of 0.87. We also report reference intervals for 53 serum metabolites from a diverse population of women in their second trimester of pregnancy.
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http://dx.doi.org/10.1038/s41596-020-00475-0DOI Listing
April 2021

The Time Has Come for Vascular Medicine in Canada.

Can J Cardiol 2021 Jan 19. Epub 2021 Jan 19.

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http://dx.doi.org/10.1016/j.cjca.2021.01.011DOI Listing
January 2021

The Canadian Alliance for Healthy Hearts and Minds: How Well Does It Reflect the Canadian Population?

CJC Open 2020 Nov 22;2(6):599-609. Epub 2020 Jul 22.

ICES, Toronto, Ontario, Canada.

Background: The intent of the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort is to understand the early determinants of subclinical cardiac and vascular disease and progression in adults selected from existing cohorts-the Canadian Partnership for Tomorrow's Health, the Prospective Urban and Rural Evaluation (PURE) cohort, and the Montreal Heart Institute Biobank. We evaluated how well the CAHHM-Health Services Research (CAHHM-HSR) subcohort reflects the Canadian population.

Methods: A cross-sectional design was used among a prospective cohort of community-dwelling adults aged 35-69 years who met the CAHHM inclusion criteria, and a cohort of adults aged 35-69 years who responded to the 2015 Canadian Community Health Survey-Rapid Response module. The INTERHEART risk score was calculated at the individual level with means and proportions reported at the overall and provincial level.

Results: There are modest differences between CAHHM-HSR study participants and the 2015 Canadian Community Health Survey-Rapid Response respondents in age (56.3 vs 51.7 mean years), proportion of men (44.9% vs 49.3%), and mean INTERHEART risk score (9.7 vs 10.1). Larger differences were observed in postsecondary education (86.8% vs 70.2%), Chinese ethnicity (11.0% vs 3.3%), obesity (23.2% vs 29.3%), current smoker status (6.1% vs 18.4%), and having no cardiac testing (30.4% vs 55.9%).

Conclusions: CAHHM-HSR participants are older, of higher socioeconomic status, and have a similar mean INTERHEART risk score, compared with participants in the Canadian Community Health Survey. Differing sampling strategies and missing data may explain some differences between the CAHHM-HSR cohort and Canadian community-dwelling adults and should be considered when using the CAHHM-HSR for scientific research.
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http://dx.doi.org/10.1016/j.cjco.2020.07.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711015PMC
November 2020

Sex, Gender, and Equity in Cardiovascular Medicine, Surgery, and Science in Canada Challenges, Successes, and Opportunities for Change.

CJC Open 2020 Nov 2;2(6):522-529. Epub 2020 Jul 2.

Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.

Background: A previous review of sex, gender, and equity within cardiovascular (CV) medicine, surgery, and science in Canada has revealed parity during medical and graduate school training. The purpose of this study was to explore sex and gendered experiences within the Canadian CV landscape, and their impact on career training and progression.

Methods: An environmental scan was conducted of the Canadian CV landscape, which included an equity survey using Qualtrics software.

Results: The environmental scan revealed that women remain underrepresented within CV training programs as trainees (12%-30%), program directors (33%), in leadership roles at the divisional level (21%), and in other professional or career-related activities (< 30%). Our analysis also showed improvements of career engagement at these levels of women at over time. The thematic analysis of the equity survey responses (n = 71 respondents; 83% female; 9.7% response rate among female Canadian Cardiovascular Society members) identified the following themes reported within the socio-ecological framework: desire to report inequities vs staying the course (individual level); desire for social support and mentorship and challenges of dual responsibilities (interpersonal level); concerns over exclusionary cliques and desire for respect and opportunity (organizational level); and increasing awareness and actions to overcome institutional barriers and accountability (societal level).

Conclusions: Although women face challenges and remain underrepresented in CV medicine, surgery, and science, this study highlights potential opportunities for improving access of female medical, surgical, and research trainees and professionals to specialized cardiovascular training, career advancement, leadership, and research.
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http://dx.doi.org/10.1016/j.cjco.2020.06.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711008PMC
November 2020

Diabetes, Brain Infarcts, Cognition, and Small Vessels in the Canadian Alliance for Healthy Hearts and Minds Study.

J Clin Endocrinol Metab 2021 01;106(2):e891-e898

Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.

Background: Diabetes is a risk factor for cerebrovascular disease and cognitive impairment. The anatomical basis for this is uncertain.

Methods: The Canadian Alliance for Healthy Hearts and Minds collected brain and carotid magnetic resonance imaging (MRI) and 2 cognitive tests (the Digit Symbol Substitution Test and the Montreal Cognitive Assessment test) in a cross-sectional sample of men and women. Brain MRIs identified brain infarcts (BI), lacunar BI, high white matter hyperintensity (WMH), vascular brain injury (VBI; BI or high WMH), and small vessel VBI (lacunar BI or high WMH). Carotid MRIs estimated carotid wall volume, a measure of subclinical atherosclerosis. Cognitive scores were standardized to each site's mean score, and cognitive impairment was identified by 1 or both test scores ≤1 standard deviation below the site's mean score on that test.

Results: The 7733 participants included 495 participants (6.4%) with diabetes, of whom 388 were taking diabetes drugs. After age and sex adjustment, diabetes was independently associated with BI (odds ratio [OR] 1.53, 95% confidence interval [CI] 1.05, 2.24), VBI (OR 1.64, 95% CI 1.26, 2.13), small vessel VBI (OR 1.67, 95% CI 1.28, 2.19), and cognitive impairment (OR 1.47, 95% CI 1.20, 1.80). The association between diabetes and small vessel VBI persisted after adjustment for cerebrovascular disease risk factors and nonlacunar infarcts (OR 1.52, 95% CI 1.15, 2.01), and the association with cognitive impairment persisted after adjustment for small vessel VBI (OR 1.27, 95% CI 1.03, 1.56).

Conclusion: Small vessel disease characterizes much of the relationship between diabetes and VBI. However, additional factors are required to disentangle the relationship between diabetes and cognitive impairment.
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http://dx.doi.org/10.1210/clinem/dgaa815DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7823245PMC
January 2021

Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety.

Circulation 2020 12 3;142(23):2219-2230. Epub 2020 Nov 3.

Department of Vascular Medicine, Klinikum Darmstadt GmbH, Germany (R.B.).

Background: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization. Whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described.

Methods: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in patients with symptomatic PAD undergoing lower extremity revascularization randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety end point was TIMI (Thrombolysis in Myocardial Infarction) major bleeding, with International Society on Thrombosis and Haemostasis major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to 6 months after the qualifying revascularization.

Results: Of the randomized patients, 3313 (50.6%) received clopidogrel for a median duration of 29.0 days. Over 3 years, the hazard ratio for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI, 0.71-1.01) with clopidogrel and 0.86 (95% CI, 0.73-1.01) without clopidogrel without statistical heterogeneity ( for interaction=0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia within 30 days (hazard ratio, 0.45 [95% CI, 0.14-1.46] with clopidogrel; hazard ratio, 0.48 [95% CI, 0.22-1.01] without clopidogrel; for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use ( for interaction=0.71). With clopidogrel use >30 days, rivaroxaban was associated with more International Society on Thrombosis and Haemostasis major bleeding within 365 days (hazard ratio, 3.20 [95% CI, 1.44-7.13]) compared with shorter durations of clopidogrel ( for trend=0.06).

Conclusions: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use but with a trend for more International Society on Thrombosis and Haemostasis major bleeding with clopidogrel use >30 days than with a shorter duration. These data support the addition of rivaroxaban to aspirin after lower extremity revascularization regardless of concomitant clopidogrel, with a short course (≤30 days) associated with less bleeding. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02504216.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050465DOI Listing
December 2020

Ethnoracial variations in venous thrombosis: Implications for management, and a call to action.

J Thromb Haemost 2021 01 20;19(1):30-40. Epub 2020 Nov 20.

Hamilton Health Sciences, Population Health Research Institute, McMaster University, Hamilton, ON, Canada.

Despite decades of improvement in its diagnosis and management, venous thromboembolism (VTE) remains a significant cause of cardiovascular morbidity and mortality. Clinically relevant differences exist in the risk of symptomatic VTE among ethnoracial groups. Underlying these differences in rates of VTE are patterns of known genetic thrombophilias, which may also influence the risks of major bleeding related to vitamin K antagonists or direct oral anticoagulants. In addition, social factors, differential access to care, and disease awareness differ between ethnoracial groups, which contributes to disparities in VTE outcomes that include higher fatal events. The vast majority of participants included in clinical trials for the prevention and treatment of VTE have been White Caucasian, which limits our understanding of the differential impact of these agents in non-White ethnoracial groups. Increasing the participation in clinical trials of diverse ethnoracial groups should be a priority, especially those groups who are disproportionately affected by the burden of VTE, or possible bleeding complications when exposed to anticoagulants. Advocacy by patients, researchers, and regulatory bodies is crucial to ensure adequate enrolment of diverse ethnoracial groups in order to best inform clinical decisions to optimize VTE prevention and treatment for non-White populations.
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http://dx.doi.org/10.1111/jth.15140DOI Listing
January 2021

Maternal Diet and the Serum Metabolome in Pregnancy: Robust Dietary Biomarkers Generalizable to a Multiethnic Birth Cohort.

Curr Dev Nutr 2020 Oct 2;4(10):nzaa144. Epub 2020 Sep 2.

Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.

Background: Advances in metabolomics are anticipated to decipher associations between dietary exposures and health. Replication biomarker studies in different populations are critical to demonstrate generalizability.

Objectives: To identify and validate robust serum metabolites associated with diet quality and specific foods in a multiethnic cohort of pregnant women.

Design: In this cross-sectional analysis of 3 multiethnic Canadian birth cohorts, we collected semiquantitative FFQ and serum data from 900 women at the second trimester of pregnancy. We calculated a diet quality score (DQS), defined as daily servings of "healthy" minus "unhealthy" foods. Serum metabolomics was performed by multisegment injection-capillary electrophoresis-mass spectrometry, and specific serum metabolites associated with maternal DQSs were identified. We combined the results across all 3 cohorts using meta-analysis to classify robust dietary biomarkers ( > ± 0.1; < 0.05).

Results: Diet quality was higher in the South Asian birth cohort (mean DQS = 7.1) than the 2 white Caucasian birth cohorts (mean DQS <3.2). Sixty-six metabolites were detected with high frequency (>75%) and adequate precision (CV <30%), and 47 were common to all cohorts. Hippuric acid was positively associated with healthy diet score in all cohorts, and with the overall DQS only in the primarily white Caucasian cohorts. We observed robust correlations between: ) proline betaine-citrus foods; ) 3-methylhistidine-red meat, chicken, and eggs; ) hippuric acid-fruits and vegetables; ) trimethylamine -oxide (TMAO)-seafood, meat, and eggs; and ) tryptophan betaine-nuts/legumes.

Conclusions: Specific serum metabolites reflect intake of citrus fruit/juice, vegetables, animal foods, and nuts/legumes in pregnant women independent of ethnicity, fasting status, and delays to storage across multiple collection centers. Robust biomarkers of overall diet quality varied by cohort. Proline betaine, 3-methylhistidine, hippuric acid, TMAO, and tryptophan betaine were robust dietary biomarkers for investigations of maternal nutrition in diverse populations.
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http://dx.doi.org/10.1093/cdn/nzaa144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7547851PMC
October 2020

Barriers to, and Facilitators of, Lifestyle Changes to Prevent Gestational Diabetes: An Interpretive Description of South Asian Women and Health-Care Providers Living and Working in Southern Ontario, Canada.

Can J Diabetes 2021 Mar 11;45(2):144-154. Epub 2020 Jul 11.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Chanchlani Research Centre, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada. Electronic address:

Objectives: People of South Asian ancestry are the fastest growing non-Caucasian ethnic group in Canada and are at high risk for developing type 2 diabetes and coronary heart disease. Pregnant South Asian women have a 2-fold increased risk of developing gestational diabetes, which increases their risk of type 2 diabetes and coronary heart disease. The specific objectives of this study were to explore the perceptions of health behaviours (diet and physical activity) during pregnancy in the South Asian community.

Methods: We used interpretive description to further understand the cultural and contextual factors that influence the knowledge, attitudes and practices of diet and physical activity of South Asian women of childbearing age and those who provide health care to this group.

Results: Two major themes that emerged from the perspectives of 10 South Asian pregnant women included: (1) importance of considering an individual's locus of control; and (2) support (emotional and information exchange) from family, friends and health-care providers. Two major themes identified by the 11 health-care providers were: (1) cultural awareness in caring for South Asian women during pregnancy; and (2) clinic management, logistics and resources. A common theme for both South Asian pregnant women and health-care providers was the importance of considering the cultural landscape in relation to how knowledge is obtained, shared and valued.

Conclusion: A better understanding of these cultural underpinnings may support the development of interventions tailored for pregnant South Asian women and their health-care providers.
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http://dx.doi.org/10.1016/j.jcjd.2020.07.001DOI Listing
March 2021

Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial.

JAMA Cardiol 2021 Jan;6(1):21-29

Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.

Importance: Patients with symptomatic lower extremity peripheral artery disease (LE-PAD) experience an increased risk of major vascular events. There is limited information on what clinical features of symptomatic LE-PAD prognosticate major vascular events and whether patients at high risk have a greater absolute benefit from low-dose rivaroxaban and aspirin.

Objective: To quantify the risk of major vascular events and investigate the response to treatment with low-dose rivaroxaban and aspirin among patients with symptomatic LE-PAD based on clinical presentation and comorbidities.

Design, Setting, And Participants: This is a subanalysis of a previously reported subgroup of patients with symptomatic LE-PAD who were enrolled in a large, double-blind, placebo-controlled randomized clinical trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies [COMPASS]) in 602 centers in 33 countries from March 2013 to January 2020. Data analysis was completed from May 2016 to June 2020.

Interventions: A combination of low-dose rivaroxaban and aspirin compared with aspirin alone.

Main Outcomes And Measures: Thirty-month incidence risk of myocardial infarction, stroke and cardiovascular death (MACE), major adverse limb events (MALE) including major vascular amputation, and bleeding.

Results: The COMPASS trial enrolled 4129 patients with symptomatic LE-PAD (mean [SD] age, 66.8 [8.8] years; 2932 men [71.0%]). The 30-month Kaplan-Meier incidence risk of MACE or MALE, including major amputation, was 22.6% in those with prior amputation (this outcome was observed in 54 patients), 17.6% (n = 15) in those with Fontaine III or IV symptoms, and 11.8% (n = 142) in those with previous peripheral artery revascularization, classifying these features as high-risk limb presentations. The 30-month incidence risk of MACE or MALE, including major amputation, was 14.1% (n = 118) in those with kidney dysfunction, 13.5% (n = 67) in those with heart failure, 13.4% (n = 199) in those with diabetes, and 12.8% (n = 222) in those with polyvascular disease, classifying these features as high-risk comorbidities. Among patients with either high-risk limb presentations or high-risk comorbidities, treatment with rivaroxaban and aspirin compared with aspirin alone was associated with an estimated 4.2% (95% CI, 1.9%-6.2%) absolute risk reduction for MACE or MALE, including major amputation, at 30 months. Although the estimated absolute risk increase of major bleeding was higher with rivaroxaban and aspirin in combination than aspirin alone (2.0% [95% CI, 0.5%-3.9%]) for patients with either high-risk limb presentation or high-risk comorbidity, the estimated absolute risk increase of fatal or critical organ bleeding was low in this high-risk group (0.4% [95% CI, 0.2%-1.8%]), such that the net clinical benefit was estimated to be 3.2% (95% CI, 0.6%-5.3%).

Conclusions And Relevance: Patients with LE-PAD with high-risk limb presentations or high-risk comorbidities had a high incidence of major vascular events. For these patients, treatment with rivaroxaban and aspirin in combination compared with aspirin alone led to a large absolute reduction in vascular risk.
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http://dx.doi.org/10.1001/jamacardio.2020.4390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7527938PMC
January 2021

Global evidence of gender inequity in academic health research: a living scoping review protocol.

JBI Evid Synth 2020 10;18(10):2181-2193

Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa.

Objective: The objective of this review is to describe the global evidence of gender inequity among individuals with appointments at academic institutions that conduct health research, and examine how gender intersects with other social identities to influence outcomes.

Introduction: The gender demographics of universities have shifted, yet the characteristics of those who lead academic health research institutions have not reflected this change. Synthesized evidence will guide decision-making and policy development to support the progress of gender and other under-represented social identities in academia.

Inclusion Criteria: This review will consider any quantitative, qualitative, or mixed methods primary research that reports outcome data related to gender equity and other social identities among individuals affiliated with academic or research institutions that conduct health research, originating from any country.

Methods: The JBI Manual for Evidence Synthesis and the Cochrane Collaboration's guidance on living reviews will inform the review methods. Information sources will include electronic databases, unpublished literature sources, reference scanning of relevant systematic reviews, and sources provided by experts on the research team. Searches will be run regularly to monitor the development of new literature and determine when the review will be updated. Study selection and data extraction will be conducted by two reviewers working independently, and all discrepancies will be resolved by discussion or a third reviewer. Data synthesis will summarize information using descriptive frequencies and simple thematic analysis. Results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension to scoping reviews.

Registration: Open Science Framework: https://osf.io/8wk7e/.
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http://dx.doi.org/10.11124/JBIES-20-00078DOI Listing
October 2020

A National Canadian Survey of Antithrombotic Therapy After Urgent and Emergent Limb Revascularization.

Can J Cardiol 2021 03 22;37(3):504-507. Epub 2020 Jun 22.

Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada. Electronic address:

Patients with peripheral artery disease who undergo urgent or emergent lower extremity revascularization have the highest risk of major adverse cardiac and limb events. Although available evidence suggests that antithrombotic therapy reduces this risk, optimal antithrombotic therapy is unclear. In this report, we aim to describe current practice patterns for use of antithrombotic therapies after urgent/emergent peripheral artery revascularization. A self-administered online survey was distributed to all active vascular surgeons registered through the Canadian Society of Vascular Surgery (n = 149) between March 19 and April 29, 2019. The overall response rate was 53% (79/149). More than half of the respondents use a medical specialist service in aiding decision-making (52% (95% confidence interval [CI], 40.9%-63.0%). When concerned for high rethrombosis risk, respondents most commonly favoured initiation of either aspirin plus full dose anticoagulation (60% [95% CI, 49.2%-70.8%]) or dual antiplatelet therapy (58% (95% CI, 47.1%-68.9%]). Intraoperative findings and patient characteristics prompting concern for high rethrombosis risk include residual proximal/distal occlusive disease (75% [95% CI, 65.5%-84.5%]), poor-quality venous conduit (76% [95% CI, 66.6%-85.4%]), distal/infrapopliteal synthetic conduit (77% [95% CI, 67.7%-86.3%]), and history of multiple previous failed vascular interventions (98% [95% CI, 94.9%-100%]). More than 90% of respondents believe significant uncertainty exists in antithrombotic decision-making after urgent/emergent peripheral revascularization. Substantial uncertainty exists regarding antithrombotic therapy after urgent/emergent revascularization. In patients at high perceived rethrombosis risk, vascular surgeons preferentially choose aspirin with full-dose anticoagulation or dual antiplatelet therapy. Because of the clinical uncertainty in this domain, trials to determine optimal antithrombotic therapy in this high-risk population are required.
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http://dx.doi.org/10.1016/j.cjca.2020.06.008DOI Listing
March 2021

Validity and Reproducibility of a Semi-Quantitative Food-Frequency Questionnaire Designed to Measure the Nutrient Intakes of Canadian South Asian Infants at 12 Months of Age.

Can J Diet Pract Res 2020 12 4;81(4):170-178. Epub 2020 Jun 4.

Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON.

Validated methods to assess diet of non-European infants are sparse. We assessed the validity and reliability of a semi-quantitative food-frequency questionnaire (FFQ) for South Asian infants in Canada. We developed an 80-item FFQ to assess infant nutrient intake in the South Asian Birth Cohort study (START). Caregivers completed the FFQ twice along with two 24-hour diet recalls. We measured infant plasma ferritin to cross-validate reported iron intake. We evaluated validity using Spearman's rho (), and reliability using the intraclass correlation coefficient. Seventy-six caregivers provided 2 FFQs and 2 24-hour diet recalls. Energy-adjusted, de-attenuated correlations between the FFQs and 24-hour diet recalls ranged from -0.29 (monounsaturated fat) through 1.00 (cholesterol). The FFQ overestimated energy intake by 128%. Iron intake by 24-hour diet recalls correlated with plasma ferritin ( = 0.41;  = 0.01; n = 37), but iron intake by FFQ did not. The average reproducibility coefficient of the FFQ ranged from 0.24 (macronutrients) to 0.65 (minerals). Among South Asian infants living in Canada, at least 2 days of diet recall completed with the primary caregiver yields more valid and reproducible estimates of nutrient intakes than a semi-quantitative FFQ, and it highlights that careful selection of FFQ portion sizes is important for assessing dietary intake with an FFQ.
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http://dx.doi.org/10.3148/cjdpr-2020-011DOI Listing
December 2020
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