Publications by authors named "Mark J Eisenberg"

231 Publications

Cardiovascular Pathophysiology, Epidemiology, and Treatment Considerations of Coronavirus Disease 2019 (COVID-19): A Review.

CJC Open 2021 Jan 5;3(1):28-40. Epub 2020 Sep 5.

Center of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital/McGill University, Montreal, Quebec, Canada.

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is rapidly evolving, with important cardiovascular considerations. The presence of underlying cardiovascular risk factors and established cardiovascular disease (CVD) may affect the severity and clinical management of patients with COVID-19. We conducted a review of the literature to summarize the cardiovascular pathophysiology, risk factors, clinical presentations, and treatment considerations of COVID-19 patients with underlying CVD. Angiotensin-converting enzyme 2 (ACE2) has been identified as a functional receptor for the SARS-CoV-2 virus, and it is associated with the cardiovascular system. Hypertension, diabetes, and CVD are the most common comorbidities in COVID-19 patients, and these factors have been associated with the progression and severity of COVID-19. However, elderly populations, who develop more-severe COVID-19 complications, are naturally exposed to these comorbidities, underscoring the possible confounding of age. Observational data support international cardiovascular societies' recommendations to not discontinue ACE inhibitor/angiotensin-receptor blocker therapy in patients with guideline indications for fear of the increased risk of SARS-CoV-2 infection, severe disease, or death. In addition to the cardiotoxicity of experimental antivirals and potential interactions of experimental therapies with cardiovascular drugs, several strategies for cardiovascular protection have been recommended in COVID-19 patients with underlying CVD. Troponin elevation is associated with increased risk of in-hospital mortality and adverse outcomes in patients with COVID-19. Cardiovascular care teams should have a high index of suspicion for fulminant myocarditis-like presentations being SARS-CoV-2 positive, and remain vigilant for cardiovascular complications in COVID-19 patients.
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http://dx.doi.org/10.1016/j.cjco.2020.09.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801216PMC
January 2021

Non-medical cannabis use among Indigenous Canadians: A systematic review of prevalence and associated factors.

Int J Drug Policy 2020 Dec 23;90:103081. Epub 2020 Dec 23.

Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital/McGill University, Montreal, QC, Canada; Departments of Medicine and Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada; Division of Cardiology, Jewish General Hospital/McGill University, Montreal, QC, Canada. Electronic address:

Background: Indigenous Canadians may be at an increased risk of non-medical cannabis use. The aim of this review was to synthesize the prevalence of non-medical cannabis use and its associated factors among Indigenous Canadians.

Methods: We systematically searched MEDLINE, EMBASE, Web of Science, and Scopus from inception to January 29th, 2020 for publications reporting the prevalence of non-medical cannabis use among Indigenous Canadians. We included studies published in English after January 1st, 2000. Included publications were hand-searched for potentially relevant peer-reviewed and gray literature publications. Results were synthesized descriptively.

Results: We identified 16 peer-reviewed and 7 gray literature publications which met our inclusion criteria. All data were collected prior to cannabis legalization in Canada (October 17th, 2018). The most recent estimates of prevalence of use in the past year were 27% among on-reserve First Nations adults, 50% among off-reserve First Nations adults, and 60% among Nunavik Inuit. In youth, they were 45% among all Indigenous youth grades 9-12, 27% among on-reserve First Nations youth aged 12-17, and 69% in Nunavik Inuit aged 16-22. Direct comparisons indicated a 1.2-15 times higher prevalence of use in Indigenous compared to non-Indigenous youth. Factors associated with cannabis use in adults included younger age and male sex. In youth, factors included older age, poorer mental and physical health, and a poorer relationship with school.

Conclusion: Results suggest that Indigenous Canadians are at a higher risk for non-medical cannabis use than the general Canadian population. Further research is warranted to inform the development of targeted interventions.
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http://dx.doi.org/10.1016/j.drugpo.2020.103081DOI Listing
December 2020

Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial.

JAMA 2020 11;324(18):1844-1854

Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.

Importance: Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial.

Objective: To evaluate e-cigarettes with individual counseling for smoking cessation.

Design, Setting, And Participants: A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported.

Interventions: Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling.

Main Outcomes And Measures: The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence.

Results: Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, -1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).

Conclusions And Relevance: Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.

Trial Registration: ClinicalTrials.gov Identifier: NCT02417467.
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http://dx.doi.org/10.1001/jama.2020.18889DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656286PMC
November 2020

Meta-Analysis of Complete versus Culprit-Only Revascularization in Patients with ST-Segment Elevation Myocardial Infarction and Multivessel Coronary Disease.

Am J Cardiol 2020 11 29;135:40-49. Epub 2020 Aug 29.

Center of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital/McGill University, Montreal, Quebec, Canada; Faculty of Medicine, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Division of Cardiology, Jewish General Hospital/McGill University, Montreal, Quebec, Canada. Electronic address:

Approximately half of patients with ST-segment elevation myocardial infarction (STEMI) present with noninfarct related multivessel coronary artery disease (CAD) during primary percutaneous coronary intervention (PCI). However, questions remain concerning whether patients with STEMI and multivessel CAD should routinely undergo complete revascularization. Our objective was to compare the risks of major cardiovascular outcomes and procedural complications in patients with STEMI and multivessel CAD randomized to complete revascularization versus culprit-only PCI. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing complete revascularization to culprit-only PCI. RCTs were identified via a systematic search of MEDLINE, Embase, and Cochrane CENTRAL. Count data were pooled using DerSimonian and Laird random-effects models with inverse variance weighting to obtain relative risks (RRs) and 95% confidence intervals (CIs). A total of 9 RCTs (n = 6,751) were included, with mean/median follow-up times ranging from 6 to 36 months. Compared with culprit-only PCI, complete revascularization was associated with a substantial reduction in major adverse cardiovascular events (13.1% vs 22.1%; RR: 0.54; 95%CI: 0.43 to 0.66), repeat myocardial infarction (4.9% vs 6.8%; RR: 0.64; 95%CI: 0.48 to 0.84), and repeat revascularization (3.7% vs 12.3%; RR: 0.33; 95%CI: 0.25 to 0.44). Complete revascularization may have beneficial effects on all-cause and cardiovascular mortality, but 95%CIs were wide. Findings for stroke, major bleeding, and contrast-induced acute kidney injury were inconclusive. In conclusion, complete coronary artery revascularization appears to confer benefit over culprit-only PCI in patients with STEMI and multivessel CAD, and should be considered a first-line strategy in these patients.
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http://dx.doi.org/10.1016/j.amjcard.2020.08.030DOI Listing
November 2020

A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design.

CJC Open 2020 May 19;2(3):168-175. Epub 2020 Mar 19.

Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.

Background: Smoking cessation improves morbidity and mortality among smokers who achieve long-term abstinence. Many smokers are using electronic cigarettes (e-cigarettes) to attempt to quit, despite a lack of data concerning their efficacy and safety for smoking cessation.

Methods: The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) trial is a multicentre randomized controlled trial (NCT02417467) with a treatment period of 12 weeks and follow-up of 52 weeks. A total of 376 participants motivated to quit smoking were enrolled at 17 Canadian centres (November 2016 to September 2019). Participants were randomized (1:1:1) to 1 of 3 treatment arms: nicotine e-cigarettes, non-nicotine e-cigarettes, or no e-cigarettes. All groups received individual counselling. Treatment allocation was double-blind for the e-cigarette groups. The trial includes follow-ups by telephone at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52. The primary endpoint is to compare nicotine e-cigarettes to counselling alone in terms of biochemically validated point-prevalence smoking abstinence at 12 weeks; the primary endpoint was changed from 52 weeks after early termination (77% of targeted enrollment) due to a prolonged delay in e-cigarette manufacturing. The secondary objectives are to examine the efficacy of nicotine and non-nicotine e-cigarettes in terms of point-prevalence and continuous smoking abstinence, and reduction in daily cigarette consumption at all follow-ups through week 52, and to describe the occurrence of adverse events.

Conclusion: The E3 trial will provide regulators, health care professionals, and smokers with important information about the efficacy and safety of e-cigarettes for smoking cessation.
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http://dx.doi.org/10.1016/j.cjco.2020.03.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242503PMC
May 2020

Smoking Cessation During the COVID-19 Epidemic.

Nicotine Tob Res 2020 08;22(9):1664-1665

Division of Clinical Epidemiology, Center of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital/McGill University, Montreal, QC, Canada.

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http://dx.doi.org/10.1093/ntr/ntaa075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239173PMC
August 2020

An exercise in scientific writing for physicians in training.

Clin Invest Med 2020 Apr 5;43(1):E35-E38. Epub 2020 Apr 5.

Division of Cardiology, Jewish General Hospital, McGill University, Montréal, QC.

It is important to strengthen critical thinking and scientific writing abilities during medical training to support trainees in their research endeavors and prepare students for careers in academic medicine. This commentary describes an interactive workshop to encourage student engagement with scientific literature and contribution to scholarly discourse by writing letters to the editor (LTEs). Students in the MD-PhD program at McGill University were asked to identify an article from a high-impact journal and think about ways in which they could address its scientific content. Students completed this preparation on their own time and then attended a 90-minute workshop where their LTEs were finalized and submitted. The LTE workshops were conducted in 2017 and 2019, and student participation and informal feedback indicated that perceptions of the workshops were positive. The workshops provided students an opportunity to strengthen their critical appraisal and academic communication skills while also contributing to the scientific literature. Letters written by aspiring and practicing physicians add valuable clinical insight to the literature and promote physician engagement with research. Strategies to support the adoption of LTE workshops include incorporating them into longitudinal curricula in medical school and integrating them into journal clubs during residency or fellowship.
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http://dx.doi.org/10.25011/cim.v43i1.33647DOI Listing
April 2020

Bright light therapy for depressive symptoms in hospitalized cardiac patients: A randomized controlled pilot trial.

PLoS One 2020 30;15(3):e0230839. Epub 2020 Mar 30.

Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.

Depression is common among cardiac patients and associated with adverse cardiovascular outcomes. Bright light therapy has emerged as a promising treatment for depressive symptoms, however it has not yet been investigated in this population. We conducted a double-blind, randomized, placebo-controlled pilot trial to assess the feasibility of a larger-scale trial testing bright light therapy for depressive symptoms in cardiac patients. Patients hospitalized for an acute coronary syndrome or undergoing cardiac surgery were randomized to either bright light (10,000 lux) or dim light placebo (500 lux) lamps for 30 minutes each day over 4 weeks, beginning in-hospital. Depression was quantified using the Patient Health Questionnaire 9 (PHQ-9) and Depression Anxiety and Stress Scales (DASS-21). The Short-Form Health Survey 36 (SF-36) was used to measure quality of life. A total of 175 patients were screened and 15 were randomized (8 treatment, 7 placebo) (8.6%) over 10 months. Despite protocol amendments which broadened the inclusion criteria, the trial was terminated early for infeasibility based on the rate of enrollment (1-2 participants/month), with 39.5% of the target sample (38 participants) enrolled. Future trials should take into account the timing of the onset of depressive symptoms in these patients, and consider a less conservative approach to eligibility as well as ways to increase the acceptability of bright light therapy in hospitalized cardiac patients. Once enrolled, our findings suggest that most participants will adhere to the assigned treatment and complete follow-up.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0230839PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105123PMC
June 2020

Cholesteryl Ester Transfer Protein Inhibitors and Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Cardiology 2020 13;145(4):236-250. Epub 2020 Mar 13.

Center for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital/McGill University, Montreal, Québec, Canada,

Background: Cholesteryl ester transfer protein (CETP) inhibitors increase serum high-density lipoprotein cholesterol (HDL-c) concentration; however, their impact on cardiovascular outcomes is not clear. This systematic review examines the effect of CETP inhibitors on serum lipid profiles, cardiovascular events, and all-cause mortality.

Methods: We searched MEDLINE, Embase, and the Cochrane Library of Clinical Trials for placebo-controlled randomized controlled trials (RCTs) that examined the effect of a CETP inhibitor (dalcetrapib, anacetrapib, evacetrapib, or TA-8995) on all-cause mortality, major adverse cardiovascular events (MACE), or the components of MACE at ≥6 months. Data were pooled using random-effects models.

Results: A total of 11 RCTs (n = 62,431) were included in our systematic review; 4 examined dalcetrapib (n = 16,612), 6 anacetrapib (n = 33,682), and 1 evacetrapib (n = 12,092). Compared to dalcetrapib, ana-cetrapib and evacetrapib were more efficacious at raising HDL-c levels (∼100-130 vs. ∼30%). Anacetrapib and evacetrapib also decreased low-density lipoprotein cholesterol (LDL-c) by approximately 30% while dalcetrapib did not affect the LDL-c level. Overall, CETP inhibitors were not associated with the incidence of MACE (pooled relative risk [RR]: 0.97; 95% confidence interval [CI]: 0.91-1.04). CETP inhibitors may decrease the risks of nonfatal myocardial infarction (MI) (RR: 0.93; 95% CI: 0.87-1.00) and cardiovascular death (RR: 0.92; 95% CI: 0.83-1.01), though these trends did not reach statistical significance.

Conclusions: CETP inhibitors are not associated with an increased risk of MACE or all-cause mortality. There is a trend towards small reductions in nonfatal MI and cardiovascular death, though the clinical im-portance of such reductions is likely modest.
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http://dx.doi.org/10.1159/000505365DOI Listing
March 2020

Meta-Analysis of Transcatheter Versus Surgical Aortic Valve Replacement in Low Surgical Risk Patients.

Am J Cardiol 2020 04 28;125(8):1230-1238. Epub 2020 Jan 28.

Division of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital/McGill University, Montreal, Quebec; Department of Medicine, McGill University, Montreal, Quebec; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec; Division of Cardiology, Jewish General Hospital/McGill University, Montreal, Quebec. Electronic address:

Current guidelines recommend transcatheter aortic valve implantation (TAVI) for patients with severe aortic stenosis at elevated surgical risk, but not for patients at low surgical risk. Our objective is to compare major clinical outcomes and procedural complications with TAVI versus surgical aortic valve replacement in patients with severe aortic stenosis at low surgical risk. We conducted a systematic review and meta-analysis of randomized controlled trials, identified through a systematic search of the MEDLINE, Embase, and Cochrane databases. Count data were pooled across trials using random-effects models with inverse variance weighting to obtain relative risks (RRs) and corresponding 95% confidence intervals (CIs). Three randomized controlled trials (n = 2,629) were included. At 30 days, TAVI was associated with a substantial reduction in all-cause mortality (RR: 0.45, 95%CI: 0.20 to 0.99), atrial fibrillation (RR: 0.27, 95%CI: 0.17 to 0.41), life threatening/disabling bleeding (RR: 0.29, 95%CI: 0.12 to 0.69), and acute kidney injury (RR: 0.28, 95%CI: 0.14 to 0.57). The reduction in atrial fibrillation persisted at 12 months (RR: 0.32, 95%CI: 0.21 to 0.49). However, TAVI patients had an increased risk of permanent pacemaker implantation at both 30 days (RR: 3.13, 95%CI: 1.36 to 7.21) and 12 months (RR: 2.99, 95%CI: 1.19 to 7.51). Due to the low absolute numbers of events, results were inconclusive at 30 days and 12 months for cardiovascular mortality, stroke, transient ischemic attack, and myocardial infarction. In conclusion, while some outcomes remained inconclusive, these data suggest that TAVI should be considered as a first-line therapy for the treatment of severe aortic stenosis in low surgical risk patients.
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http://dx.doi.org/10.1016/j.amjcard.2020.01.017DOI Listing
April 2020

E-cigarettes and youth: Patterns of use, potential harms, and recommendations.

Prev Med 2020 Feb 3;133:106009. Epub 2020 Feb 3.

Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada. Electronic address:

Electronic cigarette (e-cigarette) use has risen to unprecedented levels among youth in the United States. In this review, we discuss the patterns of use underlying the current youth vaping epidemic, potential harms from e-cigarette use, and the regulatory, public health, and clinical responses to e-cigarette use among youth. Between 2017 and 2018, past 30-day use of nicotine e-cigarettes among high school seniors nearly doubled, from 11% to 21%, representing the largest recorded increase for any adolescent substance use in over four decades. There are concerns that e-cigarette use could renormalize smoking behaviors, lead to the uptake of conventional cigarette use by youth, and have adverse effects in the developing brain and lungs of adolescents. Prevention and harm reduction efforts thus far have focused on policies to prevent youth access to vaping products and on public health strategies to expose the risks of youth vaping. However, it remains unclear if ongoing initiatives are sufficient to curb e-cigarette use by youth. Most health professionals agree that youth exposure to e-cigarettes needs to be addressed but feel uninformed, rely on unconventional information sources such as the media and their patients, and report that routine screening procedures concerning e-cigarettes are lacking. A coordinated effort from policy makers, public health agencies, parents, educators, health practitioners, and researchers is essential to mitigate harms from e-cigarette use in this vulnerable population.
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http://dx.doi.org/10.1016/j.ypmed.2020.106009DOI Listing
February 2020

Ionizing Radiation in Interventional Cardiology and Electrophysiology.

Can J Cardiol 2019 04 25;35(4):535-538. Epub 2019 Jan 25.

McGill University Health Center, Division of Cardiology, Montréal, Québec, Canada; Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada; Division of Cardiology, Jewish General Hospital/McGill University, Montréal, Québec, Canada.

Fluoroscopy-guided procedures constitute a major part in the practice of cardiology. These procedures are also a source of human-made ionizing radiation. Although the benefits of performing the procedure surpass the radiogenic risks in most cases, the risks are not negligible. Exposure to ionizing radiation may lead to tissue injuries and potential increase in risk of cancer. Both patients and operating physicians are exposed to these risks in variable degrees. The institution of radiation safety practices alone significantly reduces radiation exposure. Beyond the interventional laboratory, increasing physicians' awareness to health-related risks of ionizing radiation is crucial in reducing unnecessary testing and increases receptiveness to patient risks. Incorporating the radiogenic risks of a future procedure in patient-informed consent also increases patients' awareness to potential consequences. Innovation in imaging technology resulted in a plethora of alternate modalities. Electroanatomical mapping, magnetic navigation systems, robotic and magnetic resonance imaging (MRI)-assisted techniques are examples of clinically used modalities that limit the exposure of patients and operating physicians to radiation. Documentation of patients' exposure in their medical records is essential. Tracking of patients' cumulative exposure can be implemented at an institutional level. Identifying patients with the highest exposure would help shed light on a blind spot in our current practice, as the implications are unclear.
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http://dx.doi.org/10.1016/j.cjca.2019.01.006DOI Listing
April 2019

Potential harms from legalization of recreational cannabis use in Canada.

Can J Public Health 2019 04 13;110(2):222-226. Epub 2019 Feb 13.

Lady Davis Institute, Jewish General Hospital, Montreal, QC, Canada.

With the recent legalization of recreational cannabis use in Canada, questions remain concerning optimal regulation to minimize harms and ensure public health and safety. Patterns of use are subject to change following legalization, and it is important to consider the potential adverse effects that this may have on public health. Important areas of consideration are methods of consumption (e.g., vaping, edibles) and product proliferation; acute and long-term health and behavioural effects (including impaired driving); and use in vulnerable groups, such as children and youth, pregnant women, individuals with mental illness, individuals with low socio-economic status, and Indigenous populations. To support harm reduction measures and evidence-based policy, there is a need to anticipate the potential ramifications that legalization of recreational cannabis use may have on public health in Canada.
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http://dx.doi.org/10.17269/s41997-018-00173-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6964625PMC
April 2019

Hybrid Coronary Revascularization vs Complete Coronary Artery Bypass Grafting for Multivessel Coronary Artery Disease: A Systematic Review and Meta-Analysis.

J Invasive Cardiol 2018 12;30(12):E131-E149

Professor of Medicine, Jewish General Hospital/McGill University, 3755 Côte Ste-Catherine Road, Suite H-421.1, Montreal, Quebec, Canada H3T 1E2.

Background: Hybrid coronary revascularization (HCR) has emerged as a potential alternative to complete coronary artery bypass graft (CABG) surgery. However, the efficacy and safety of HCR vs CABG remain unclear. We therefore conducted a systematic review and meta-analysis to compare these interventions.

Methods: We systematically searched PubMed, MEDLINE (via Ovid), EMBASE (via Ovid), Cochrane Library of Clinical Trials, and the Web of Science for studies comparing HCR to CABG in patients with multivessel coronary artery disease. The primary outcome was major adverse cardiovascular and cerebrovascular events (MACCE) and its components (myocardial infarction, stroke, mortality, and target-vessel revascularization [TVR]) at ≥1 year. Secondary outcomes included MACCE at ≤30 days, its components, and postoperative safety outcomes (renal failure, blood transfusion, new-onset atrial fibrillation, and infection).

Results: One randomized controlled trial and 9 cohort studies were included in our systematic review. Pooled results indicate that HCR is associated with a lower risk for postoperative blood transfusion (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.27-0.68) and infection (OR, 0.19; 95% CI, 0.04-0.98), and a shorter hospital stay (6.0 days for HCR vs 7.8 days for CABG) and intensive care unit (ICU) stay (25.4 hours for HCR vs 45.7 hours for CABG). Long-term outcome data showed an association between HCR and long-term TVR (OR, 3.10; 95% CI, 1.39-6.90).

Conclusions: Our results suggest that compared to CABG, HCR is associated with a lower risk of postoperative blood transfusion and infection, as well as a shorter ICU stay and hospital stay. HCR was also associated with a higher risk of long-term TVR.
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December 2018

2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 1: Radiation Physics and Radiation Biology: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways Developed in Collaboration With Mended Hearts.

Catheter Cardiovasc Interv 2018 08 29;92(2):203-221. Epub 2018 Aug 29.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure for clinical personnel. Although the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. The American College of Cardiology leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. Optimal Use of Ionizing Radiation in Cardiovascular Imaging: Best Practices for Safety and Effectiveness is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. Part I: Radiation Physics and Radiation Biology addresses the issue of medical radiation exposure, the basics of radiation physics and dosimetry, and the basics of radiation biology and radiation-induced adverse effects. Part II: Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy) and will be published in the next issue of the Journal.
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http://dx.doi.org/10.1002/ccd.27660DOI Listing
August 2018

2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging-Best Practices for Safety and Effectiveness, Part 2: Radiological Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection.

Catheter Cardiovasc Interv 2018 08 29;92(2):222-246. Epub 2018 Aug 29.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure to clinical personnel. While the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. ACC leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. "Optimal Use of Ionizing Radiation in Cardiovascular Imaging - Best Practices for Safety and Effectiveness" is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. "Part I: Radiation Physics and Radiation Biology" addresses radiation physics, dosimetry and detrimental biologic effects. "Part II: Radiologic Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection" covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy). For each modality, it includes the determinants of radiation exposure and techniques to minimize exposure to both patients and to medical personnel.
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http://dx.doi.org/10.1002/ccd.27661DOI Listing
August 2018

Reply to Madias-The Case of Takotsubo and Myocardial Infarction Without Obstructive Coronary Disease.

Can J Cardiol 2018 08 25;34(8):1089.e15. Epub 2018 Apr 25.

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http://dx.doi.org/10.1016/j.cjca.2018.04.017DOI Listing
August 2018

Smoking abstinence 1 year after acute coronary syndrome: follow-up from a randomized controlled trial of varenicline in patients admitted to hospital.

CMAJ 2018 03;190(12):E347-E354

Jewish General Hospital, McGill University (Windle, Eisenberg), Montréal, Que.; Prairie Vascular Research Network (Dehghani), University of Saskatchewan, Regina, Sask.; Centre de santé et de services sociaux de Chicoutimi (Roy), Chicoutimi, Que.; Sentara Cardiovascular Research Institute (Old), Norfolk, Va.; Centre intégré de santé et de services sociaux Chaudière-Appalaches (Grondin), Hôtel-Dieu de Lévis site, Lévis, Que.; Queen Elizabeth II Health Sciences Centre (Bata), Halifax, NS; SJH Cardiology Associates and St. Joseph's Hospital Health Centre (Iskander), Liverpool, NY; Centre intégré de santé et de services sociaux Chaudière-Appalaches (Lauzon), Hôpital de Saint-Georges site, Thetford Mines, Que.; Spartanburg Regional Medical Center (Srivastava), Spartanburg, SC; Valley Regional Hospital (Clarke), Kentville, NS; Toledo Hospital (Cassavar), Toledo, Ohio; Centre de santé et de services sociaux de Beauce (Dion), Beauce, Que.; Heart Center Research (Haught), Huntsville, Ala.; McMaster University and Hamilton Health Sciences (Mehta), Hamilton, Ont.; Dr. Georges-L.-Dumont University Hospital Centre (Baril), Moncton, NB; Florida Hospital Pepin Heart Institute (Lambert), Tampa, Fla.; Sunnybrook Health Sciences Centre (Madan), University of Toronto, Toronto, Ont.; St. Michael's Hospital (Abramson), Toronto, Ont.

Background: Patients who continue to smoke after acute coronary syndrome are at increased risk of reinfarction and death. We previously found use of varenicline to increase abstinence 24 weeks after acute coronary syndrome; here we report results through 52 weeks.

Methods: The EVITA trial was a multicentre, double-blind, randomized, placebo-controlled trial of varenicline for smoking cessation in patients admitted to hospital with acute coronary syndrome. Participants were randomly assigned (1:1) to receive varenicline or placebo for 12 weeks, in conjunction with low-intensity counselling. Smoking abstinence was assessed via 7-day recall, with biochemical validation using exhaled carbon monoxide. Participants lost to follow-up or withdrawn were assumed to have returned to smoking.

Results: Among the 302 participants, abstinence declined over the course of the trial, with 34.4% abstinent 52 weeks after acute coronary syndrome. Compared with placebo, point estimates suggest use of varenicline increased point-prevalence abstinence (39.9% v. 29.1%, difference 10.7%, 95% confidence interval [CI] 0.01% to 21.44%; number needed to treat 10), continuous abstinence (31.1% v. 21.2%, difference 9.9%, 95% CI -0.01% to 19.8%) and reduction in daily cigarette smoking by 50% or greater (57.8% v. 49.7%, difference 8.1%, 95% CI -3.1% to 19.4%). Varenicline and placebo groups had similar occurrence of serious adverse events (24.5% v. 21.9%, risk difference 2.7%, 95% CI -7.3% to 12.6%) and major adverse cardiovascular events (8.6% v. 9.3%, risk difference -0.7%, 95% CI -7.8% to 6.5%).

Interpretation: Varenicline was efficacious for smoking cessation in this high-risk patient population. However, 60% of patients who received treatment with varenicline still returned to smoking. ClinicalTrials.gov, no. NCT00794573.
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http://dx.doi.org/10.1503/cmaj.170377DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5871438PMC
March 2018

Myocardial Infarction With No Obstructive Coronary Artery Disease: Angiographic and Clinical Insights in Patients With Premature Presentation.

Can J Cardiol 2018 04 17;34(4):468-476. Epub 2018 Jan 17.

Center for Outcomes Research and Evaluation, Research Institute, McGill University Health Centre, Montreal, Quebec, Canada; Department of Experimental Medicine, McGill University, Montreal, Quebec, Canada; Divisions of General Internal Medicine and Clinical Epidemiology, McGill University Health Centre, Montreal, Quebec, Canada. Electronic address:

Background: Premature myocardial infarction (MI) is an increasingly prevalent cause of morbidity and mortality worldwide. A subset of patients, predominantly young women, present with MI with no obstructive coronary artery disease (MINOCA), a nomenclature gaining recognition. However, few data exist on presentation and prognosis according to the severity of coronary artery disease (CAD).

Methods: We studied patients with premature (younger than 55 years of age) acute MI enrolled in a large cohort in 24 centres across Canada. Baseline clinical, psychosocial, and coronary anatomy characteristics as well as 12-month outcomes were compared between patients with MINOCA (< 50% stenosis) and patients with MI with obstructive CAD (≥ 50% stenosis; MICAD).

Results: From a cohort of 1210 patients with acute coronary syndrome, we examined 998 MI patients with available angiography core lab readings: 82 (8.2%) had a MINOCA and 916 (91.8%) had a MICAD. Forty percent of patients with MINOCA were women compared with one-third with MICAD. The prevalence of traditional risk factors and chest pain at presentation was lower in MINOCA patients, yet 37% had a ST-elevation MI and 10% presented with a cardiac arrest. No evident etiology was detected in > 70% of MINOCA, but 10% presented with either spontaneous coronary dissection or Takotsubo cardiomyopathy. Although combined major adverse cardiovascular events and all-cause readmission rate was lower in the MINOCA group (14% vs 25%; adjusted hazard ratio, 0.51; 95% confidence interval, 0.28-0.93), it was not negligible.

Conclusions: Patients with MINOCA present with high-risk features despite the absence of obstructive CAD. A search for etiology and eventual treatment provides a rich avenue for improving prognosis in young women with premature MI.
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http://dx.doi.org/10.1016/j.cjca.2018.01.004DOI Listing
April 2018

Smoking Cessation in Patients With Acute Coronary Syndrome.

Am J Cardiol 2018 05 6;121(9):1105-1111. Epub 2018 Feb 6.

Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Québec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, Canada; Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Québec, Canada. Electronic address:

Over 30% of the nearly 1 million North Americans hospitalized annually with an acute coronary syndrome (ACS) are smokers. Despite a substantially increased risk of morbidity and mortality, 2/3 of patients who quit smoking after ACS return to smoking within 1 year. To summarize the evidence of smoking cessation in patients hospitalized after ACS, we systematically reviewed all randomized controlled trials of pharmacologic and behavioral smoking cessation therapies in patients with ACS. In addition, we reviewed the clinical considerations surrounding the use of smoking cessation therapies, including their broad mechanisms of action and possible alternative treatments, including cardiac rehabilitation programs and electronic cigarettes. A total of 7 randomized controlled trials met our inclusion criteria (4 pharmacotherapies and 3 behavioral therapies). In pharmacologic trials, only varenicline increased point prevalence abstinence at 12 months. Behavioral interventions produced significantly improved abstinence rates at 6 and 12 months. However, these studies had substantial limitations affecting their generalizability. Overall, currently available smoking cessation therapies are limited in their efficacy in patients hospitalized after ACS. Because of the relative scarcity of data and the urgency of establishing clinical guidelines, there is a critical need to continue examining the efficacy and safety of smoking cessation interventions in patients hospitalized after ACS.
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http://dx.doi.org/10.1016/j.amjcard.2018.01.017DOI Listing
May 2018

The effectiveness and safety of the Impella ventricular assist device for high-risk percutaneous coronary interventions: A systematic review.

Catheter Cardiovasc Interv 2018 06 20;91(7):1250-1260. Epub 2017 Sep 20.

Faculty of Medicine, McGill University, Montreal, Quebec, Canada.

Background: Small randomized controlled trials (RCTs) and observational studies have examined the effectiveness and safety of the Impella device, a percutaneous left ventricular assist device, in the setting of high-risk percutaneous coronary intervention (PCI). However, data are sparse and results are conflicting. Our objective was to evaluate the effectiveness and safety of the Impella device in high-risk patients undergoing PCI via a systematic review of the literature.

Methods: We searched Medline, EMBASE, and the Cochrane Library for RCTs and observational studies that evaluated the Impella device in high-risk patients undergoing PCI. Inclusion was restricted to studies in which ≥10 patients received the Impella device; both uncontrolled and controlled (versus intra-aortic-balloon pump [IABP]) studies were included.

Results: A total of 20 studies (4 RCTs, 2 controlled observational studies, and 14 uncontrolled observational studies; 1,287 patients) were included, with follow-up ranging from 1 to 42 months. The use of Impella resulted in improved procedural and hemodynamic characteristics in controlled and uncontrolled studies. In controlled studies, the 30-day rates of all-cause mortality and MACE were similar across groups. In most uncontrolled studies, the 30-day rates of all-cause mortality were generally low (range: 3.7%-10%), though rates of MACE were slightly higher (range: 5%-20%).

Conclusion: The Impella device was found to improve procedural and hemodynamic parameters, but only limited randomized data are available regarding clinical outcomes associated with its use. Large, multicenter RCTs are needed to definitively establish the effectiveness of the Impella device among high-risk PCI patients.
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http://dx.doi.org/10.1002/ccd.27316DOI Listing
June 2018

Carotid Stenting Versus Endarterectomy for Asymptomatic Carotid Artery Stenosis: A Systematic Review and Meta-Analysis.

Stroke 2017 08 5;48(8):2150-2157. Epub 2017 Jul 5.

From the Center for Clinical Epidemiology, Lady Davis Institute (P.M., B.H., P.R., M.H.S., M.J.E., K.B.F.) and Division of Cardiology (M.J.E.), Jewish General Hospital, Montreal, Quebec, Canada; and Departments of Epidemiology, Biostatistics, and Occupational Health (M.J.E., K.B.F.) and Department of Medicine (K.B.F.), McGill University, Montreal, Quebec, Canada.

Background And Purpose: There is no consensus on the comparative efficacy and safety of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in patients with asymptomatic carotid artery stenosis. To evaluate CAS versus CEA in asymptomatic patients, we conducted a systematic review and meta-analysis of randomized controlled trials.

Methods: We systematically searched EMBASE, PubMed, MEDLINE, and the Cochrane Library for randomized controlled trials comparing CAS to CEA in asymptomatic patients using a pre-specified protocol. Two independent reviewers identified randomized controlled trials meeting our inclusion/exclusion criteria, extracted relevant data, and assessed quality using the Cochrane risk of bias tool. Random effects models with inverse-variance weighting were used to estimate pooled risk ratios (RRs) comparing the incidences of periprocedural and long-term outcomes between CAS and CEA.

Results: We identified 11 reports of 5 randomized controlled trials for inclusion (n=3019) asymptomatic patients. The pooled incidences of any periprocedural stroke (RR, 1.84; 95% confidence interval [CI], 0.99-3.40), periprocedural nondisabling stroke (RR, 1.95; 95% CI, 0.98-3.89), and any periprocedural stroke or death (RR, 1.72; 95% CI, 0.95-3.11) trended toward an increased risk after CAS. We could not rule out clinically significant differences between treatments for long-term stroke (RR, 1.24; 95% CI, 0.76-2.03) and the composite outcome of periprocedural stroke, death or myocardial infarction, or long-term ipsilateral stroke (RR, 0.92; 95% CI, 0.70-1.21).

Conclusions: Although uncertainty surrounds the long-term outcomes of CAS versus CEA, the potential for increased risks of periprocedural stroke and periprocedural stroke or death with CAS suggests that CEA is the preferred option for the management of asymptomatic carotid stenosis.
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http://dx.doi.org/10.1161/STROKEAHA.117.016824DOI Listing
August 2017

Characteristics and outcomes of Canadian MD/PhD program graduates: a cross-sectional survey.

CMAJ Open 2017 Apr;5(2):E308-E314

Affiliations: Faculty of Medicine (Skinnider, Squair, Twa, Ji, Raymond), University of British Columbia, Vancouver, BC; Clinician-Investigator Training Association of Canada(Kuzyk, Wang, Steadman, Zaslavsky, Dey); Faculty of Health Sciences (Kuzyk, HayGlass), University of Manitoba, Winnipeg, Man.; Faculty of Medicine (Wang, Steadman, Zaslavsky, Dey, Rosenblum), University of Toronto, Toronto, Ont.; Faculty of Medicine (Eisenberg), McGill University, Montréal, Que.; Faculty of Medicine (Gagné), Université de Sherbrooke, Sherbrooke, Que.; Faculty of Medicine (Lewis), Western University, London, Ont.; Faculty of Medicine (Margetts), McMaster University, Hamilton, Ont.; Faculty of Medicine (Underhill), University of Alberta, Edmonton, Alta.; Canadian Society for Clinical Investigation (Underhill), Ottawa, Ont.

Background: Combined MD/PhD programs provide a structured path for physician-scientist training, but assessment of their success within Canada is limited by a lack of quantitative data. We collected outcomes data for graduates of Canadian MD/PhD programs.

Methods: We developed and implemented a Web-based survey consisting of 41 questions designed to collect outcomes data for Canadian MD/PhD program alumni from 8 Canadian universities who had graduated before September 2015. Respondents were categorized into 2 groups according to whether they had or had not completed all training.

Results: Of the 186 eligible alumni of MD/PhD programs, 139 (74.7%) completed the survey. A total of 136/138 respondents (98.6%) had completed or were currently completing residency training, and 66/80 (82%) had completed at least 1 postgraduate fellowship. Most (58 [83%]) of the 70 respondents who had completed all training were appointed as faculty at academic institutions, and 37 (53%) had been principal investigators on at least 1 recent funded project. Among the 58 respondents appointed at academic institutions, 44/57 (77%) dedicated at least 20% of their time to research, and 25/57 (44%) dedicated at least 50% to research. During their combined degree, 102/136 respondents (75.0%) published 3 or more first-author papers, and 133/136 (97.8%) matched with their first choice of specialty. The median length of physician-scientist training was 13.5 years. Most respondents graduated with debt despite having been supported by Canadian Institutes of Health Research MD/PhD studentships.

Interpretation: Most Canadian MD/PhD program alumni pursued careers consistent with their physician-scientist training, which indicates that these programs are meeting their primary objective. Nevertheless, our findings highlight that a minority of these positions are research intensive; this finding warrants further study. Our data provide a baseline for future monitoring of the output of Canadian MD/PhD programs.
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http://dx.doi.org/10.9778/cmajo.20160152DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5498176PMC
April 2017

Smokers and Postcessation Weight Gain After Acute Coronary Syndrome.

J Am Heart Assoc 2017 Apr 18;6(4). Epub 2017 Apr 18.

Division of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital/McGill University, Montréal, Quebec, Canada

Background: Smoking cessation and weight management are recommended after acute coronary syndrome (ACS); however, little is known about the effects of smoking cessation on weight change after ACS. We aimed to assess the effect of smoking cessation after ACS on weight over a 12-month follow-up period.

Methods And Results: Data were prospectively collected from the EVITA (Evaluation of Varenicline in Smoking Cessation for Patients Post-Acute Coronary Syndrome) trial. Weight change was compared among 3 groups of patients: those who were completely abstinent (n=70), those who smoked intermittently (n=68), and those who smoked persistently (n=34). Patients' mean baseline weight was 83.9 kg (SD 17.7) with a mean body mass index of 28.5 (SD 5.4). Patients smoked a mean of 37.7 years (SD 17.7) and a mean of 21.0 cigarettes (SD 9.0) per day prior to their ACS. Weight change varied across groups, with abstainers gaining a mean of 4.8 kg (SD 8.6), intermittent smokers gaining a mean of 2.0 kg (SD 8.9) and persistent smokers losing a mean of 0.7 kg (SD 7.4). At 52 weeks, abstainers were more likely to gain weight than persistent smokers (difference in means 5.5 kg; 95% CI 2.3-8.8). This weight gain was not associated with an increase in the use of antihypertensive or antidiabetic medications.

Conclusions: Following an ACS, significant weight is gained by patients who quit smoking. Weight-management interventions among smokers who quit after ACS should be a focus of investigation in future research so that the cardiovascular benefits achieved by smoking cessation are not offset by weight gain in this high-risk population.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00794573.
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http://dx.doi.org/10.1161/JAHA.116.004785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532997PMC
April 2017

Optimal Timing of Complete Revascularization in Acute Coronary Syndrome: A Systematic Review and Meta-Analysis.

J Am Heart Assoc 2017 Apr 10;6(4). Epub 2017 Apr 10.

Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada

Background: Studies have suggested that complete revascularization is superior to culprit-only revascularization for the treatment of enzyme-positive acute coronary syndrome. However, the optimal timing of complete revascularization remains unclear. We conducted a systematic review and meta-analysis of randomized controlled trials comparing single-stage complete revascularization with multistage percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction with multivessel disease.

Methods And Results: We systematically searched the Cochrane Central Register of Controlled Trials, Embase, PubMed, and MEDLINE for randomized controlled trials comparing single-stage complete revascularization with multistage revascularization in patients with enzyme-positive acute coronary syndrome. The primary outcome was the incidence of major adverse cardiovascular events at longest follow-up. Data were pooled using DerSimonian and Laird random-effects models. Four randomized controlled trials (n=838) were included in our meta-analysis. The risk of unplanned repeat revascularization at longest follow-up was significantly lower in patients randomized to single-stage complete revascularization (risk ratio, 0.68; 95% CI, 0.47-0.99). Results also suggest a trend towards lower risks of major adverse cardiovascular events for patients randomized to single-stage revascularization at 6 months (risk ratio, 0.67; 95% CI, 0.40-1.11) and at longest follow-up (risk ratio, 0.79; 95% CI, 0.52-1.20). Risks of mortality and recurrent myocardial infarction at longest follow-up were also lower with single-stage revascularization, but 95% CIs were wide and included unity.

Conclusions: Our results suggest that single-stage complete revascularization is safe. There also appears to be a trend towards lower long-term risks of mortality and major adverse cardiovascular events; however, additional randomized controlled trials are required to confirm the potential benefits of single-stage multivessel percutaneous coronary intervention.
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http://dx.doi.org/10.1161/JAHA.116.005381DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5533029PMC
April 2017

Early non-persistence with dabigatran and rivaroxaban in patients with atrial fibrillation.

Heart 2017 09 12;103(17):1331-1338. Epub 2017 Mar 12.

Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canda.

Objective: Dabigatran and rivaroxaban are novel oral anticoagulants (NOACs) approved for stroke prevention in atrial fibrillation (AF). Although NOACs are more convenient than warfarin, their lack of monitoring may predispose patients to non-persistence. Limited information is available on NOAC non-persistence rates and related clinical outcomes in clinical practice.

Methods: We conducted a retrospective cohort study using administrative data from Ontario, Canada, from January 1998 to March 2014 of patients with AF who were dispensed dabigatran or rivaroxaban. Non-persistence was defined as a gap in dabigatran or rivaroxaban prescriptions ≥14 days. A multivariable Cox proportional hazards model was used to estimate the primary composite outcome of stroke, transient ischaemic attack (TIA) and mortality associated with non-persistence.

Results: The cohort consisted of 15 857 dabigatran (age 80.7±6.7 year) and 10 119 rivaroxaban users (age 77.0±7.1 year) with women comprising 52% of each medication group. At 6 months, 36.4% of patients were non-persistent to dabigatran, while 31.9% of patients were non-persistent to rivaroxaban. Stroke/TIA/death was significantly higher for those non-persistent to dabigatran (HR 1.76 (95% CI 1.60 to 1.94); p<0.0001) or rivaroxaban (HR 1.89 (95% CI 1.64 to 2.19); p<0.0001) compared with those who were persistent. Risk of stroke/TIA was markedly higher in non-persistent patients to dabigatran (HR 3.75 (95% CI 2.59 to 5.43); p<0.0001) and rivaroxaban (HR 6.25 (95% CI 3.37 to 11.58); p<0.0001) than those persistent.

Conclusions: NOAC non-persistence rates are high in clinical practice, with approximately one in three patients becoming non-persistent to dabigatran or rivaroxaban within 6 months after drug initiation. Non-persistence with either dabigatran or rivaroxaban is significantly associated with worse clinical outcomes of stroke/TIA/death.
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http://dx.doi.org/10.1136/heartjnl-2016-310672DOI Listing
September 2017