Publications by authors named "Deepak L Bhatt"

1,693 Publications

  • Page 1 of 1

Incidence of Myocardial Infarction Types in Patients Treated With Ticagrelor in the THEMIS Trial.

Circ Cardiovasc Interv 2021 Nov 24:CIRCINTERVENTIONS120011035. Epub 2021 Nov 24.

Université de Paris, Assistance Publique - Hôpitaux de Paris (Hôpital Bichat), FACT (French Alliance for Cardiovascular Trials) and INSERM U-1148, France (J.A., P.G.S.).

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.011035DOI Listing
November 2021

Is the Affordable Care Act Medicaid Expansion Associated with Receipt of Heart Failure Guideline-Directed Medical Therapy By Race and Ethnicity?

Am Heart J 2021 Nov 20. Epub 2021 Nov 20.

Division of Cardiology, University of Colorado, Anschutz Medical Campus, Aurora, CO; Division of Cardiology, Denver Health Medical Center, Denver, CO.

Background: Uninsurance is a known contributor to racial/ethnic health inequities. Insurance is often needed for prescriptions and follow-up appointments. Therefore, we determined whether the Affordable Care Act(ACA) Medicaid Expansion was associated with increased receipt of guideline-directed medical treatment(GDMT) at discharge among patients hospitalized with heart failure(HF) by race/ethnicity.

Methods: Using Get With The Guidelines-HF registry, logistic regression was used to assess odds of receiving GDMT(HF medications; education; follow-up appointment) in early versus non-adopter states before(2012-2013) and after ACA Medicaid Expansion(2014-2019) within each race/ethnicity, accounting for patient-level covariates and within-hospital clustering. We tested for an interaction(p-int) between GDMT and pre/post Medicaid Expansion time periods.

Results: Among 271,606 patients(57.5% early adopter, 42.5% non-adopter), 65.5% were White, 22.8% African American, 8.9% Hispanic, and 2.9% Asian race/ethnicity. Independent of ACA timing, Hispanic patients were more likely to receive all GDMT for residing in early adopter states compared to non-adopter states (p<0.0001). In fully-adjusted analyses, ACA Medicaid Expansion was associated with higher odds of receipt of ACEI/ARB/ARNI in Hispanic patients [before ACA:OR 0.40(95%CI:0.13,1.23); after ACA:OR 2.46(1.10,5.51); p-int=0.0002], but this occurred in the setting of an immediate decline in prescribing patterns, particularly among non-adopter states, followed by an increase that remained lowest in non-adopter states. The ACA was not associated with receipt of GDMT for other racial/ethnic groups.

Conclusions: Among GWTG-HF hospitals, Hispanic patients were more likely to receive all GDMT if they resided in early adopter states rather than non-adopter states, independent of ACA Medicaid Expansion timing. ACA implementation was only associated with higher odds of receipt of ACEI/ARB/ARNI in Hispanic patients. Additional steps are needed for improved GDMT delivery for all.
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http://dx.doi.org/10.1016/j.ahj.2021.11.011DOI Listing
November 2021

Achieving More Rapid Door-to-Needle Times and Improved Outcomes in Acute Ischemic Stroke in a Nationwide Quality Improvement Intervention.

Stroke 2021 Nov 22:STROKEAHA121035853. Epub 2021 Nov 22.

Division of Cardiology, University of California at Los Angeles (G.C.F.).

Background And Purpose: The benefits of tPA (tissue-type plasminogen activator) in acute ischemic stroke are time-dependent. However, delivery of thrombolytic therapy rapidly after hospital arrival was initially occurring infrequently in hospitals in the United States, discrepant with national guidelines.

Methods: We evaluated door-to-needle (DTN) times and clinical outcomes among patients with acute ischemic stroke receiving tPA before and after initiation of 2 successive nationwide quality improvement initiatives: Target: Stroke Phase I (2010-2013) and Target: Stroke Phase II (2014-2018) from 913 Get With The Guidelines-Stroke hospitals in the United States between April 2003 and September 2018.

Results: Among 154 221 patients receiving tPA within 3 hours of stroke symptom onset (median age 72 years, 50.1% female), median DTN times decreased from 78 minutes (interquartile range, 60-98) preintervention, to 66 minutes (51-87) during Phase I, and 50 minutes (37-66) during Phase II (<0.001). Proportions of patients with DTN ≤60 minutes increased from 26.4% to 42.7% to 68.6% (<0.001). Proportions of patients with DTN ≤45 minutes increased from 10.1% to 17.7% to 41.4% (<0.001). By the end of the second intervention, 75.4% and 51.7% patients achieved 60-minute and 45-minute DTN goals. Compared with the preintervention period, hospitals during the second intervention period (2014-2018) achieved higher rates of tPA use (11.7% versus 5.6%; adjusted odds ratio, 2.43 [95% CI, 2.31-2.56]), lower in-hospital mortality (6.0% versus 10.0%; adjusted odds ratio, 0.69 [0.64-0.73]), fewer bleeding complication (3.4% versus 5.5%; adjusted odds ratio, 0.68 [0.62-0.74]), and higher rates of discharge to home (49.6% versus 35.7%; adjusted odds ratio, 1.43 [1.38-1.50]). Similar findings were found in sensitivity analyses of 185 501 patients receiving tPA within 4.5 hours of symptom onset.

Conclusions: A nationwide quality improvement program for acute ischemic stroke was associated with substantial improvement in the timeliness of thrombolytic therapy start, increased thrombolytic treatment, and improved clinical outcomes.
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http://dx.doi.org/10.1161/STROKEAHA.121.035853DOI Listing
November 2021

Assessing reproducibility and utility of clustering of patients with type 2 diabetes and established CV disease (SAVOR -TIMI 53 trial).

PLoS One 2021 19;16(11):e0259372. Epub 2021 Nov 19.

Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Objective: To assess the reproducibility and clinical utility of clustering-based subtyping of patients with type 2 diabetes (T2D) and established cardiovascular (CV) disease.

Methods: The cardiovascular outcome trial SAVOR-TIMI 53 (n = 16,492) was used. Analyses focused on T2D patients with established CV disease. Unsupervised machine learning technique called "k-means clustering" was used to divide patients into subtypes. K-means clustering including HbA1c, age of diagnosis, BMI, HOMA2-IR and HOMA2-B was used to assign clusters to the following diabetes subtypes: severe insulin deficient diabetes (SIDD); severe insulin-resistant diabetes (SIRD); mild obesity-related diabetes (MOD); mild age-related diabetes (MARD). We refer these subtypes as "clustering-based diabetes subtypes". A simulation study using randomly generated data was conducted to understand how correlations between the above variables influence the formation of the cluster-based diabetes subtypes. The predictive utility of clustering-based diabetes subtypes for CV events (3-point MACE), renal function reduction (eGFR decrease >30%) and diabetic disease progression (introduction of additional anti-diabetic medication) were compared with conventional risk scores. Hazard ratios (HR) were estimated by Cox-proportional hazard models.

Results: In the SAVOR-TIMI 53 trial based dataset, the percentage of the clustering-based T2D subtypes were; SIDD (18%), SIRD (17%), MOD (29%), MARD (37%). Using the simulated dataset, the diabetes subtypes could be largely reproduced from a log-normal distribution when including known correlations between variables. The predictive utility of clustering-based diabetic subtypes on CV events, renal function reduction, and diabetic disease progression did not show an advantage compared to conventional risk scores.

Conclusions: The consistent reproduction of four clustering-based T2D subtypes can be explained by the correlations between the variables used for clustering. Subtypes of T2D based on clustering had limited advantage compared to conventional risk scores to predict clinical outcome in patients with T2D and established CV disease.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0259372PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8604302PMC
November 2021

Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI.

J Am Coll Cardiol 2021 Nov;78(21):2060-2072

Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Background: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown.

Objectives: The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation.

Methods: The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI.

Results: A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference -0.2%; 95% CI: -2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference -2.5%; 95% CI: -4.6% to -0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference -1.1%; 95% CI: -2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015).

Conclusions: Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742).
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http://dx.doi.org/10.1016/j.jacc.2021.08.074DOI Listing
November 2021

Recruitment Practices in Multicenter Randomized Clinical Trials: Time for a Relook.

J Am Heart Assoc 2021 Nov 15;10(22):e023673. Epub 2021 Nov 15.

Division of Cardiovascular Medicine Brigham and Women's HospitalHarvard Medical School Boston MA.

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http://dx.doi.org/10.1161/JAHA.121.023673DOI Listing
November 2021

Women and Diabetes: Preventing Heart Disease in a New Era of Therapies.

Eur Cardiol 2021 Feb 21;16:e40. Epub 2021 Oct 21.

Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School Boston, MA, US.

Despite major advances in cardiovascular research over the past decade, women with type 2 diabetes have a high risk of cardiovascular events. Several factors contribute to the poor prognosis for women, including higher levels of frailty and comorbidities, but their cardiovascular risk is underestimated and there is suboptimal implementation and uptitration of new evidence-based therapies, leading to high morbidity and mortality. Recent studies highlight the need for better management of diabetes in women that can be pursued and achieved in light of recent results from randomised controlled trials demonstrating evidence of the benefits of new therapeutic strategies in improving cardiovascular outcomes and quality of life of women covering the entire cardiovascular continuum. This review critically discusses the multiple benefits for women of new pharmacological treatments, such as glucagon-like peptide-1 receptor agonists, sodium-glucose cotransporter type 2 inhibitors (SGLT2i), proprotein convertase subtilisin/kexin type 9 inhibitors, inclisiran, icosapent ethyl and bempedoic acid in preventing cardiovascular events, and treatments, such as angiotensin receptor neprilysin inhibitors, SGLT2i, vericiguat and omecamtiv mecarbil, for preventing heart failure.
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http://dx.doi.org/10.15420/ecr.2021.22DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8576483PMC
February 2021

Impact of sex on outcomes of percutaneous coronary intervention for chronic total occlusion: A meta-analysis.

Catheter Cardiovasc Interv 2021 Nov 12. Epub 2021 Nov 12.

Department of Internal Medicine, Division of Cardiology, University of Nebraska Medical Center, Omaha, Nebraska, USA.

Background: Women are underrepresented in chronic total occlusion (CTO) trials and little is known about sex differences in the outcomes of CTO percutaneous coronary intervention (PCI). This meta-analysis aims to compare the outcomes of CTO PCI in males and females.

Methods: A comprehensive search of PubMed, EMBASE, Cochrane, Web of Science, and Google Scholar was performed for studies comparing outcomes of CTO PCI in females versus males from inception to January 26, 2021. The current statistical analysis was performed using STATA version 15.1 software (Stata Corporation, TX); P < 0.05 indicated statistical significance.

Results: Fourteen observational studies were included in the analysis with 75% males and 25% females. The mean age was 64.47 ± 10.5 years and 68.98 ± 9.5 years for males and females, respectively. The median follow-up duration was 2.4 years. Males had a higher Japanese-CTO (J-CTO) score compared with females (MD = -0.17; 95% CI: -0.25 to -0.10). Females had statistically higher success rates of CTO PCI (RR = 1.03; 95% CI: 1.01 to1.05), required less contrast volume (MD = -18.64: 95% CI: -30.89 to -6.39) and fluoroscopy time (MD = -9.12; 95% CI: -16.90 to -1.34) compared with males. There was no statistical difference in in-hospital (RR = 1.50; 95% CI: 0.73 to 3.09) or longer term (≥6 months) all-cause mortality (RR = 1.10; 95% CI: 0.86 to 1.42) between the two groups.

Conclusions: CTO PCI is feasible and safe in female patients with comparable outcomes in female versus male patients.
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http://dx.doi.org/10.1002/ccd.30017DOI Listing
November 2021

Dual pathway inhibition in atherothrombosis prevention: yes, now we can!

Minerva Cardiol Angiol 2021 Nov 11. Epub 2021 Nov 11.

Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School Boston, MA, USA.

Despite ongoing developments, prevention and treatment of atherothrombotic cardiovascular disease remains a common challenge. Antithrombotic options for cardiocerebrovascular disease prevention involves a choice between dual antiplatelet therapy (DAPT) and dual pathway inhibition (DPI), which includes an antiplatelet agent and a reduced dose anticoagulant agent. In selected patients at high risk of event and low risk of bleeding, especially those undergoing recent and complex coronary revascularization using drug-eluting stents (DES) ("revascularization-driven effect"), DAPT is superior to single antiplatelet therapy with aspirin. DPI involves a wider potential range of treatment and is superior to single antiplatelet therapy with aspirin, particularly in patients with atherothrombotic involvement in different vascular beds both previously revascularized and not ("no revascularization-driven effect"). After nearly thirty years of randomized trials and observational registries, we have sufficient data to customize antithrombotic therapy in patients at high cardiovascular risk. Therefore, "atherothrombosis stakeholders" must identify the right patient for the right therapy to ensure high levels of efficacy and safety with the best of current therapeutic opportunities.
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http://dx.doi.org/10.23736/S2724-5683.21.05867-1DOI Listing
November 2021

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

J Am Coll Cardiol 2021 Nov 28;78(22):e187-e285. Epub 2021 Oct 28.

Aim: This clinical practice guideline for the evaluation and diagnosis of chest pain provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients.

Methods: A comprehensive literature search was conducted from November 11, 2017, to May 1, 2020, encompassing randomized and nonrandomized trials, observational studies, registries, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Additional relevant studies, published through April 2021, were also considered.

Structure: Chest pain is a frequent cause for emergency department visits in the United States. The "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain" provides recommendations based on contemporary evidence on the assessment and evaluation of chest pain. This guideline presents an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain. Cost-value considerations in diagnostic testing have been incorporated, and shared decision-making with patients is recommended.
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http://dx.doi.org/10.1016/j.jacc.2021.07.053DOI Listing
November 2021

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

J Am Coll Cardiol 2021 Nov 28;78(22):2218-2261. Epub 2021 Oct 28.

Aim: This executive summary of the clinical practice guideline for the evaluation and diagnosis of chest pain provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients.

Methods: A comprehensive literature search was conducted from November 11, 2017, to May 1, 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Additional relevant studies, published through April 2021, were also considered.

Structure: Chest pain is a frequent cause for emergency department visits in the United States. The "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain" provides recommendations based on contemporary evidence on the assessment and evaluation of chest pain. These guidelines present an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain. Cost-value considerations in diagnostic testing have been incorporated and shared decision-making with patients is recommended.
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http://dx.doi.org/10.1016/j.jacc.2021.07.052DOI Listing
November 2021

The Role of Combined SGLT1/SGLT2 Inhibition in Reducing the Incidence of Stroke and Myocardial Infarction in Patients with Type 2 Diabetes Mellitus.

Cardiovasc Drugs Ther 2021 Nov 9. Epub 2021 Nov 9.

Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA.

Purpose: In patients with type 2 diabetes mellitus (T2DM), both sodium-glucose cotransporter 2 inhibitors (SGLT2is) and glucagon-like peptide receptor agonists (GLP-1 RAs) have demonstrated significant improvements in cardiovascular and kidney outcomes independent of their glycemic benefits. This paper will briefly compare the effect of SGLT2is and GLP-1 RAs to that of the SGLT1/2 inhibitor sotagliflozin on the incidence of myocardial infarction (MI) and stroke in patients with T2DM and further postulate mechanisms to account for these findings.

Methods And Results: Thus far, the results from SCORED and SOLOIST (trials studying the SGLT1/2 inhibitor sotagliflozin) suggest that an increase in SGLT1 inhibition when added to SGLT2 inhibition may contribute to reductions in MI and stroke in patients with T2DM. This benefit is beyond what SGLT2is alone can accomplish and at least similar to GLP-1 RAs but with the added benefit of a reduction in hospitalizations and urgent visits for HF. Larger and longer studies are required to confirm the effectiveness of SGLT1/SGLT2 inhibition in reducing MI and stroke in patients with T2DM and elucidate the mechanisms associated with this finding.

Conclusions: The role of SGLT1/2 inhibition as an addition to GLP-1 RAs in patients with and without T2DM at increased risk for MI and stroke requires further study. Regardless, the finding that a relative increase in SGLT1/2 inhibition reduces the risk of MI and stroke as well as hospitalizations and urgent visits for heart failure could improve quality of life and reduce the healthcare burden associated with T2DM.
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http://dx.doi.org/10.1007/s10557-021-07291-yDOI Listing
November 2021

Renal Denervation for Hypertension: A Systematic Review and Meta-Analysis of Randomized, Blinded, Placebo-Controlled Trials.

JACC Cardiovasc Interv 2021 Oct 26. Epub 2021 Oct 26.

National Heart and Lung Institute, Imperial College London, London, United Kingdom.

Objectives: The authors performed an updated meta-analysis of randomized placebo-controlled trials of renal denervation and specifically compared the effect of renal denervation in patients taking medications and in those not taking medications.

Background: Renal denervation has now undergone several blinded placebo-controlled trials, covering the spectrum from patients with drug-resistant hypertension to those not yet taking antihypertensive medications.

Methods: All blinded placebo-controlled randomized trials of catheter-based renal sympathetic denervation for hypertension were systematically identified, and a random-effects meta-analysis was performed. The primary efficacy outcome was the change in ambulatory systolic blood pressure beyond the effect of the placebo procedure. Analysis was stratified by whether there was background antihypertensive medication use.

Results: There were 7 eligible trials, totaling 1,368 patients. Denervation significantly reduced ambulatory systolic (mean difference -3.61 mm Hg; 95% confidence interval [CI]: -4.89 to -2.33 mm Hg; P < 0.0001), ambulatory diastolic (-1.85 mm Hg; 95% CI: -2.78 to -0.92 mm Hg; P < 0.0001), office systolic (-5.86 mm Hg; 95% CI: -7.77 to -3.94 mm Hg; P < 0.0001), and office diastolic (-3.63 mm Hg; 95% CI: -4.77 to -2.50; P < 0.0001) blood pressure. There was no evidence that the use of concomitant antihypertensive medication had a significant impact on the effect of denervation on any of these endpoints (P = NS for each comparison).

Conclusions: The randomized placebo-controlled trials show consistently that renal denervation provides significant reduction in ambulatory and office blood pressure. Although the magnitude of benefit, about 4/2 mm Hg, is modest, it is similar between patients on background antihypertensive medications and those who are not. Denervation could therefore be a useful strategy at various points for patients who are not willing to add antihypertensive agents. Whether the effect changes with time is currently unknown.
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http://dx.doi.org/10.1016/j.jcin.2021.09.020DOI Listing
October 2021

In-Stent Restenosis in Saphenous Vein Grafts (from the DIVA Trial).

Am J Cardiol 2021 Nov 1. Epub 2021 Nov 1.

Palo Alto Cooperative Studies Program Coordinating Center, Palo Alto, California.

Saphenous vein grafts (SVGs) have high rates of in-stent restenosis (ISR). We compared the baseline clinical and angiographic characteristics of patients and lesions that did develop ISR with those who did not develop ISR during a median follow-up of 2.7 years in the DIVA study (NCT01121224). We also examined the ISR types using the Mehran classification. ISR developed in 119 out of the 575 DIVA patients (21%), with similar incidence among patients with drug-eluting stents and bare-metal stents (BMS) (21% vs 21%, p = 0.957). Patients in the ISR group were younger (67 ± 7 vs 69 ± 8 years, p = 0.04) and less likely to have heart failure (27% vs 38%, p = 0.03) and SVG lesions with Thrombolysis In Myocardial Infarction 3 flow before the intervention (77% vs 83%, p <0.01), but had a higher number of target SVG lesions (1.33 ± 0.64 vs 1.16 ± 0.42, p <0.01), more stents implanted in the target SVG lesions (1.52 ± 0.80 vs 1.31 ± 0.66, p <0.01), and longer total stent length (31.37 ± 22.11 vs 25.64 ± 17.42 mm, p = 0.01). The incidence of diffuse ISR was similar in patients who received drug-eluting-stents and BMS (57% vs 54%, p = 0.94), but BMS patients were more likely to develop occlusive restenosis (17% vs 33%, p = 0.05).
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http://dx.doi.org/10.1016/j.amjcard.2021.09.024DOI Listing
November 2021

The reduction in cardiovascular risk in REDUCE-IT is due to eicosapentaenoic acid in icosapent ethyl.

Eur Heart J 2021 Nov 3. Epub 2021 Nov 3.

Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.

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http://dx.doi.org/10.1093/eurheartj/ehab760DOI Listing
November 2021

EMPEROR-Preserved: A promise fulfilled.

Cell Metab 2021 Nov;33(11):2099-2103

University of Michigan, Ann Arbor, MI, USA.

Heart failure with preserved ejection fraction (HFpEF) represents one of the greatest unmet needs in medicine. In the EMPEROR-Preserved trial, recently reported in the NEJM, the SGLT2 inhibitor empagliflozin reduced the primary outcome of heart failure hospitalizations and cardiovascular death by 21% in patients with HFpEF. This represents an important breakthrough in the war against heart failure.
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http://dx.doi.org/10.1016/j.cmet.2021.10.011DOI Listing
November 2021

Addressing Imaging Pitfalls to Reduce Cardiovascular Disease Misdiagnosis in Patients With Breast Cancer Following Reconstruction.

JAMA Cardiol 2021 Nov 3. Epub 2021 Nov 3.

Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jamacardio.2021.4564DOI Listing
November 2021

SGLT-2 inhibitors in heart failure: Time for broader eligibility and earlier initiation.

Cleve Clin J Med 2021 Nov 2;88(11):601-606. Epub 2021 Nov 2.

Professor of Medicine, Harvard Medical School, Boston, MA, Executive Director of Interventional Cardiovascular Programs, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA; Chair, SOLOIST and SCORED trials

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http://dx.doi.org/10.3949/ccjm.88a.21045DOI Listing
November 2021

Publisher Correction: Cardiac involvement in the long-term implications of COVID-19.

Nat Rev Cardiol 2021 Nov 1. Epub 2021 Nov 1.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1038/s41569-021-00641-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8559133PMC
November 2021

Innovation in intervention.

Prog Cardiovasc Dis 2021 Oct 27. Epub 2021 Oct 27.

Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States of America. Electronic address:

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http://dx.doi.org/10.1016/j.pcad.2021.10.004DOI Listing
October 2021

Population pharmacokinetic-pharmacodynamic modeling of PB2452, a monoclonal antibody fragment being developed as a ticagrelor reversal agent, in healthy volunteers.

CPT Pharmacometrics Syst Pharmacol 2021 Oct 29. Epub 2021 Oct 29.

PhaseBio Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.

PB2452, a neutralizing monoclonal antibody fragment that binds the antiplatelet drug ticagrelor with high affinity, is being developed as a ticagrelor reversal agent. To identify a clinically useful intravenous (i.v.) reversal regimen, a semimechanistic exposure-response model was developed during the PB2452 first-in-human phase I study. From a randomized, double-blind, placebo-controlled, single-dose trial to evaluate the safety, efficacy, and pharmacokinetics (PKs) of PB2452 in 61 healthy volunteers pretreated with ticagrelor, sequential dose cohort data were used to build and refine an exposure-response model that combined population PK models for ticagrelor (TICA), ticagrelor active metabolite (TAM), and PB2452, and related their binding relationships to the PK of uncomplexed TICA and TAM which is predictive of platelet inhibition. Platelet function was assessed by multiple assays. The model was developed using Bayesian methods in NONMEM. Human PK and pharmacodynamic data from sequential dose cohorts were used to initially define and then refine model parameters. Model simulations indicated that an initial i.v. bolus of PB2452, followed by a high-rate infusion, and then a slower-rate infusion would provide immediate and sustained reversal of the antiplatelet effects of ticagrelor. Based on model predictions, a 6 g i.v. bolus followed by 6 g infused over 4 h and then 6 g over 12 h was identified and tested in study subjects and shown to provide complete reversal within 5 min of infusion onset that was sustained for 20-24 h. The model is predictive of the reversal profile of PB2452 and will inform future trials of PB2452.
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http://dx.doi.org/10.1002/psp4.12734DOI Listing
October 2021

Icosapent Ethyl Reduces Ischemic Events in Patients with a History of Prior Coronary Artery Bypass Grafting: REDUCE-IT CABG.

Circulation 2021 Oct 28. Epub 2021 Oct 28.

Department of Medicine, Baylor College of Medicine; Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX.

Despite advances in surgery and pharmacotherapy, there remains significant residual ischemic risk following coronary artery bypass grafting (CABG) surgery. In the multicenter, placebo-controlled, double-blind trial REDUCE-IT, statin-treated patients with controlled low-density lipoprotein cholesterol (LDL-C) and mild to moderate hypertriglyceridemia were randomized to 4g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy endpoint (cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy endpoint (cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The present analysis reports on the subgroup of patients from the trial with a history of CABG. Of the 8,179 patients randomized in REDUCE-IT, a total of 1,837 (22.5%) had a history of CABG, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary endpoint (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.63-0.92; P=0.004), in the key secondary endpoint (HR, 0.69; 95% CI, 0.56-0.87; P=0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64; 95% CI, 0.50-0.81; P=0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%-10.2%) in first events, with a number needed to treat of 16 (95% CI, 10-44) over a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs. 3.1%; P=0.03) and a non-significant increase in bleeding, occurrences of adverse events were comparable between groups. In REDUCE-IT patients with a history of CABG, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.056290DOI Listing
October 2021

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

Circulation 2021 Nov 28;144(22):e368-e454. Epub 2021 Oct 28.

Aim: This executive summary of the clinical practice guideline for the evaluation and diagnosis of chest pain provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients.

Methods: A comprehensive literature search was conducted from November 11, 2017, to May 1, 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Additional relevant studies, published through April 2021, were also considered. Structure: Chest pain is a frequent cause for emergency department visits in the United States. The "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain" provides recommendations based on contemporary evidence on the assessment and evaluation of chest pain. These guidelines present an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain. Cost-value considerations in diagnostic testing have been incorporated and shared decision-making with patients is recommended.
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http://dx.doi.org/10.1161/CIR.0000000000001030DOI Listing
November 2021

2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

Circulation 2021 Nov 28;144(22):e368-e454. Epub 2021 Oct 28.

Aim: This clinical practice guideline for the evaluation and diagnosis of chest pain provides recommendations and algorithms for clinicians to assess and diagnose chest pain in adult patients.

Methods: A comprehensive literature search was conducted from November 11, 2017, to May 1, 2020, encompassing randomized and nonrandomized trials, observational studies, registries, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, Agency for Healthcare Research and Quality reports, and other relevant databases. Additional relevant studies, published through April 2021, were also considered. Structure: Chest pain is a frequent cause for emergency department visits in the United States. The "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain" provides recommendations based on contemporary evidence on the assessment and evaluation of chest pain. This guideline presents an evidence-based approach to risk stratification and the diagnostic workup for the evaluation of chest pain. Cost-value considerations in diagnostic testing have been incorporated, and shared decision-making with patients is recommended.
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http://dx.doi.org/10.1161/CIR.0000000000001029DOI Listing
November 2021

Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL.

Circulation 2021 Nov 28;144(22):1750-1759. Epub 2021 Oct 28.

Department of Medicine, Baylor College of Medicine, and Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (C.M.B.).

Background: Chronic kidney disease is associated with adverse outcomes among patients with established cardiovascular disease (CVD) or diabetes. Commonly used medications to treat CVD are less effective among patients with reduced kidney function.

Methods: REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) was a multicenter, double-blind, placebo-controlled trial that randomly assigned statin-treated patients with elevated triglycerides (135-499 mg/dL) who had CVD or diabetes and 1 additional risk factor to treatment with icosapent ethyl (4 g daily) or placebo. Patients from REDUCE-IT were categorized by prespecified estimated glomerular filtration rate (eGFR) categories to analyze the effect of icosapent ethyl on the primary end point (composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina) and key secondary end point (a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke).

Results: Among the 8179 REDUCE-IT patients, median baseline eGFR was 75 mL·min·1.73 m (range, 17-123 mL·min·1.73 m). There were no meaningful changes in median eGFR for icosapent ethyl versus placebo across study visits. Treatment with icosapent ethyl led to consistent reduction in both the primary and key secondary composite end points across baseline eGFR categories. Patients with eGFR <60 mL·min·1.73 m treated with icosapent ethyl had the largest absolute and similar relative risk reduction for the primary composite end point (icosapent ethyl versus placebo, 21.8% versus 28.9%; hazard ratio [HR], 0.71 [95% CI, 0.59-0.85]; =0.0002) and key secondary composite end point (16.8% versus 22.5%; HR 0.71 [95% CI, 0.57-0.88]; =0.001). The numeric reduction in cardiovascular death was greatest in the eGFR <60 mL·min·1.73 m group (icosapent ethyl: 7.6%; placebo: 10.6%; HR, 0.70 [95% CI, 0.51-0.95]; =0.02). Although patients with eGFR <60 mL·min·1.73 m treated with icosapent ethyl had the highest numeric rates of atrial fibrillation/flutter (icosapent ethyl: 4.2%; placebo 3.0%; HR 1.42 [95% CI, 0.86-2.32]; =0.17) and serious bleeding (icosapent ethyl: 5.4%; placebo 3.6%; HR, 1.40 [95% CI, 0.90-2.18]; =0.13), HRs for atrial fibrillation/flutter and serious bleeding were similar across eGFR categories (-interaction for atrial fibrillation/flutter=0.92; -interaction for serious bleeding=0.76).

Conclusions: In REDUCE-IT, icosapent ethyl reduced fatal and nonfatal ischemic events across the broad range of baseline eGFR categories. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.121.055560DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8614567PMC
November 2021

Antithrombotic Therapy for Stroke Prevention in Patients With Ischemic Stroke With Aspirin Treatment Failure.

Stroke 2021 Dec 27;52(12):e777-e781. Epub 2021 Oct 27.

Department of Neurology (Y.X.), University of Texas Southwestern Medical Center, Dallas, TX.

Background And Purpose: Many older patients presenting with acute ischemic stroke were already taking aspirin before admission. However, the management strategy for patients with aspirin treatment failure has not been fully established.

Methods: We used data from the American Heart Association Get With The Guidelines Stroke Registry to describe discharge antithrombotic treatment patterns among Medicare beneficiaries with ischemic stroke who were taking aspirin before their stroke and were discharged alive from 1734 hospitals in the United States between October 2012 and December 2017.

Results: Of 261 634 ischemic stroke survivors, 100 016 (38.2%) were taking aspirin monotherapy before stroke. Among them, 44.4% of patients remained on aspirin monotherapy at discharge (20.9% 81 mg, 18.2% 325 mg, 5.3% other or unknown dose). The next most common therapy choice was dual antiplatelet therapy (24.6%), followed by clopidogrel monotherapy (17.8%). The remaining 13.2% of patients were discharged on either aspirin/dipyridamole, warfarin, or nonvitamin K antagonist oral anticoagulants with or without antiplatelet, or no antithrombotic therapy at all.

Conclusions: Nearly half of patients with ischemic stroke while on preventive therapy with aspirin are discharged on aspirin monotherapy without changing antithrombotic class, while the other half are discharged on clopidogrel monotherapy, dual antiplatelet therapy, or other less common agents. These findings emphasize the need for future research to identify best management strategies for this very common and complex clinical scenario.
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http://dx.doi.org/10.1161/STROKEAHA.121.034622DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8608737PMC
December 2021

Same-day discharge after transcatheter mitral valve repair using MitraClip in a tertiary community hospital: a case series.

Eur Heart J Case Rep 2021 Oct 1;5(10):ytab397. Epub 2021 Oct 1.

Department of Cardiology, Sands Constellation Heart Institute, Rochester Regional Health, 1425 Portland Avenue, Rochester, NY 14621, USA.

Background: Due to the current Coronavirus Disease 2019 (COVID-19) pandemic, there is a realization for innovation in procedures and protocols to minimize hospital stay and at the same time ensure continued evidence-based treatment delivered to the patients. We present a same-day discharge protocol for transcatheter mitral valve repair (TMVR) using MitraClip under general anaesthesia in a six-patient case series. This protocol aims to reduce the length of hospital stay, thereby minimizing potential for nosocomial COVID-19 infections and to promote safe discharge with cautious follow-up.

Case Summary: Six patients with severe symptomatic mitral valve (MV) regurgitation underwent successful transfemoral MV repair using standard procedures. Following repair, patients were monitored on telemetry in the recovery area for 3 h, ambulated to assess vascular access stability and underwent post-procedural transthoracic echocardiogram to assess for any pericardial effusion or post-procedural prosthetic mitral stenosis.

Conclusion: Same-day discharge after TMVR is possible when done cautiously with close follow-up, can minimize hospital stay, improve resource utilization, and reduce risk of nosocomial COVID-19 infection.
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http://dx.doi.org/10.1093/ehjcr/ytab397DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8522429PMC
October 2021

Cardiac involvement in the long-term implications of COVID-19.

Nat Rev Cardiol 2021 Oct 22. Epub 2021 Oct 22.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.

Throughout 2021, the medical and scientific communities have focused on managing the acute morbidity and mortality caused by the coronavirus disease 2019 (COVID-19) pandemic. With the approval of multiple vaccines, there is a light at the end of this dark tunnel and an opportunity to focus on the future, including managing the long-term sequelae in patients who have survived acute COVID-19. In this Perspectives article, we highlight what is known about the cardiovascular sequelae in survivors of COVID-19 and discuss important questions that need to be addressed in prospective studies to understand and mitigate these lasting cardiovascular consequences, including in post-acute COVID-19 syndrome. To provide the greatest benefit to these survivors, prospective studies should begin now, with resources made available to monitor and study this population in the coming years.
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http://dx.doi.org/10.1038/s41569-021-00631-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8532434PMC
October 2021

Long-acting antimuscarinic therapy in patients with chronic obstructive pulmonary disease receiving beta-blockers.

Respir Res 2021 Oct 22;22(1):272. Epub 2021 Oct 22.

Formerly of AstraZeneca, Barcelona, Spain.

Background: Beta-blocker therapies for cardiovascular comorbidities are often withheld in patients with chronic obstructive pulmonary disease (COPD) due to potential adverse effects on airway obstruction. We carried out a post hoc analysis to determine the efficacy and safety of aclidinium in patients with moderate-to-very severe COPD and increased cardiovascular risk receiving beta-blockers at baseline versus non-users.

Methods: ASCENT-COPD was a Phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients were randomized 1:1 to aclidinium or placebo twice-daily for up to 3 years. Outcomes included risk of (time to first) major adverse cardiovascular events (MACE), all-cause mortality, and lung function over 3 years, and exacerbations over 1 year.

Results: Of 3589 patients, 1269 (35.4%) used beta-blockers and 2320 (64.6%) were non-users at baseline. Aclidinium did not statistically increase the risk of MACE (beta-blocker user: hazard ratio 1.01 [95% CI 0.62-1.64]; non-user: 0.80 [0.51-1.24]; interaction P = 0.48) or all-cause mortality (beta-blocker user: 1.13 [0.78-1.64]; non-user: 0.89 [0.62-1.26]; interaction P = 0.35), in patients using beta-blockers. Aclidinium reduced annualized rate of moderate-to-severe COPD exacerbation (beta-blocker user: rate ratio 0.75 [95% CI 0.60-0.94, P = 0.013]; non-user: 0.79 [0.67-0.93, P = 0.005]), delayed time to first exacerbation, and improved lung function versus placebo. There was greater trough FEV benefit in beta-blocker users versus non-users (least squares mean difference at 52 weeks: 111 mL [95% CI 74 mL-147 mL] versus 69 mL [42 mL-97 mL]; interaction P = 0.041).

Conclusions: This post hoc analysis supports long-acting anti-muscarinic use with concomitant beta-blockers in patients with moderate-to-very severe COPD and cardiovascular comorbidity.

Trial Registration: ClinicalTrials.gov, NCT01966107, Registered 16 October 2013, https://clinicaltrials.gov/ct2/show/NCT01966107 .
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http://dx.doi.org/10.1186/s12931-021-01861-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8532273PMC
October 2021

Virtual and Augmented Reality in Cardiovascular Care: State-of-the-Art and Future Perspectives.

JACC Cardiovasc Imaging 2021 Oct 7. Epub 2021 Oct 7.

Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine-University, University Hospital Düsseldorf, Düsseldorf, Germany; Cardiovascular Research Institute Duesseldorf, Düsseldorf, Germany.

Applications of virtual reality (VR) and augmented reality (AR) assist both health care providers and patients in cardiovascular education, complementing traditional learning methods. Interventionalists have successfully used VR to plan difficult procedures and AR to facilitate complex interventions. VR/AR has already been used to treat patients, during interventions in rehabilitation programs and in immobilized intensive care patients. There are numerous additional potential applications in the catheterization laboratory. By using AR, interventionalists could combine visual fluoroscopy information projected and registered on the patient body with data derived from preprocedural imaging and live fusion of different imaging modalities such as fluoroscopy with echocardiography. Persistent technical challenges to overcome include the integration of different imaging modalities into VR/AR and the harmonization of data flow and interfaces. Cybersickness might exclude some patients and users from the potential benefits of VR/AR. Critical ethical considerations arise in the application of VR/AR in vulnerable patients. In addition, digital applications must not distract physicians from the patient. It is our duty as physicians to participate in the development of these innovations to ensure a virtual health reality benefit for our patients in a real-world setting. The purpose of this review is to summarize the current and future role of VR and AR in different fields within cardiology, its challenges, and perspectives.
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http://dx.doi.org/10.1016/j.jcmg.2021.08.017DOI Listing
October 2021
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