ACCP Cardiology PRN Journal Clubaccpcardsprnjournalclub.pbworks.com/w/file/fetch/138742986/Febru… · ACCP Cardiology PRN Journal Club 2/27/2020 Moderator: Ashley Kasper. Mentor

ACCP Cardiology PRNJournal Club

2/27/2020Moderator: Ashley Kasper

Mentor Biography

• Dr. Libby Orzel is a specialty practice pharmacist and residency program director of the PGY-2 cardiology residency at The Ohio State University Wexner Medical Center. She graduated from St. Louis College of Pharmacy and completed her PGY-1 pharmacy practice residency at Cleveland Clinic and her PGY-2 cardiology residency at The Ohio State University Wexner Medical Center. Currently, Dr. Orzelpractices in the area of cardiothoracic surgery at The Ohio State University Wexner Medical Center and her teaching and research focuses in the area of hemodynamics, mechanical circulatory support, and anticoagulation.

Presenter Biography

• Dr. Justin Joy is a PGY2 Cardiology Pharmacy Resident at Duke University Hospital in Durham, NC. He graduated from University of Georgia College of Pharmacy and completed his PGY1 Pharmacy Residency at Emory University Hospital. His current practice interests include heart failure, acute coronary syndromes, and electrophysiology. After residency, Dr. Joy plans to obtain a clinical position within a cardiology sub-specialty of his interest.

Aspirin Versus Aspirin Plus Clopidogrel Following Transcatheter Aortic Valve

Implantation (ARTE) Trial

Justin Joy, PharmDPGY2 Cardiology Pharmacy Resident

Duke University Hospital, Durham, NC

• Justin Joy and Libby Orzel have no relevant financial relationships to disclose

Disclosures

• Narrowing of the aortic valve opening resulting in obstruction of left ventricular outflow

Background: Aortic Stenosis (AS)

Less Common More Common

Lancet. 2009 Mar 14;373(9667):956-66

• Calcific AS has two distinct phases• Initiation: Endothelial disruption and activation of inflammatory responses

atherosclerosis and calcification• Progression: Decrease in valve area progressively greater intra-ventricular

pressure left ventricular hypertrophy (LVH) fixed cardiac output from insurmountable afterload

Background: Pathophysiology

N Engl J Med. 2002 Feb 28;346(9):677-82.Lancet. 2009 Mar 14;373(9667):956-66

• Myocardial ischemia and angina• Increased LV pressure decreased coronary perfusion pressure and rise LV

wall stress and oxygen demand

• Syncope• Hypotension and compromised cerebral perfusion from fixed output

• Heart Failure/Dyspnea• Increased workload on the heart worsening fatigue and dyspnea

Background: Pathophysiology

N Engl J Med. 2002 Feb 28;346(9):677-82.Lancet. 2009 Mar 14;373(9667):956-66

• Progressive disease • Latent period survival decreases rapidly once symptoms of angina, syncope or heart

failure develop

Background: Aortic Stenosis (AS)

Lancet. 2009 Mar 14;373(9667):956-66

Surgical Aortic Valve Replacement

(SAVR)

Transcatheter Aortic Valve Replacement

(TAVR)

Background: Management

Circulation. 2017 Jun 20;135(25):e1159-e1195

Severe AS Symptomatic

Class I

Class IIa

Low surgical risk Intermediate surgical risk High surgical risk Prohibitive

surgical risk

SAVR SAVR TAVR SAVR or TAVR TAVR

Background: Management


Circ Cardiovasc Interv. 2015 Apr;8(4)J Thorac Dis. 2018 Nov; 10(Suppl 30): S3620–S3628.

Background: TAVR Valves

Evolut R SAPIEN 3

Deployment method Self-expandable Balloon-

expandable

Frame Nitinol Stainless Steel

Leaflet Tissue Porcine Bovine

Repositionability Partial None

Background: TAVR Valves and DAPT

• Rationale for DAPT post TAVR• Assumption that the

thrombogenicity of metal stent struts from a THV is similar to a coronary stent

• Inhibiting platelet-mediated thrombosis on the THV stent frame until endothelializationoccurs

THV = transcatheter heart valveDAPT = Dual Antiplatelet Therapy

Circ Cardiovasc Interv. 2015 Apr;8(4)J Thorac Dis. 2018 Nov; 10(Suppl 30): S3620–S3628.

Evolut R SAPIEN 3

Deployment method Self-expandable Balloon-

expandable

Frame Nitinol Stainless Steel

Leaflet Tissue Porcine Bovine

Repositionability Partial None

Eur Heart J. 2017 Sep 21;38(36):2739-279Can J Cardiol. 2019 Nov;35(11):1437-1448Ann Thorac Surg. 2012 Apr;93(4):1340-95Chest. 2012 Feb;141(2 Suppl):e576S-e600SCirculation. 2017 Jun 20;135(25):e1159-e1195

Guideline Recommendation COR LOE2012 ACCF/AATS/SCAI/STS Expert Consensus Statement Antiplatelet therapy with aspirin and clopidogrel - -

2012 American College of Chest Physicians Aspirin (50-100 mg/d) plus clopidogrel (75 mg/d) forthe first 3 months

IIc -

2017 AHA/ACC Focused Update: Guideline for the Management of Patients with Valvular Heart Disease

Clopidogrel 75 mg daily may be reasonable for the first 6 months after TAVR in addition to life-long aspirin 75 mg to 100 mg daily

IIb C

2017 AHA/ACC Focused Update: Guideline for the Management of Patients with Valvular Heart Disease

Anticoagulation with a VKA to achieve an INR of 2.5 may be reasonable for at least 3 months after TAVR in patients at low risk of bleeding

IIb B-NR

2017 ESC/EACTS –Guidelines on the management of Valvular heart disease

DAPT should be considered for the first 3–6 months after TAVR, followed by lifelong SAPT

IIa C

2019 Canadian Cardiovascular Society Position Statement:TAVR Aspirin monotherapy after TAVR unless there is an indication for dual antiplatelet therapy (ie, recent PCI)

Strong Medium

Background: Guideline Recommendations

VKA = Vitamin K antagonistsSAPT = Single Antiplatelet TherapyPCI = Percutaneous Coronary Intervention

• To compare aspirin plus clopidogrel vs aspirin monotherapy post TAVR for the prevention of ischemic events (MI, stroke or TIA), major or life-threatening bleeding, or death

Objective

• Open-label, prospective, multicenter (Canada, Europe, and South America) randomized studyDesign

ARTE

JACC Cardiovasc Interv. 2017;10(13):1357-1365TIA = Transient Ischemic AttackMI = Myocardial Infarction

Exclusion• Need for chronic anticoagulation

treatment• DES implantation within the year• Major bleeding within the 3 months

prior to the TAVR procedure• Prior intracranial bleeding• Allergy to aspirin and/or clopidogrel

Inclusion• Clinical indication for TAVR with a

balloon-expandable Edwards SAPIEN XT or SAPIEN 3 valve

ARTE: Study Population

JACC Cardiovasc Interv. 2017;10(13):1357-1365

RANDOMIZE

1:1

Day Before Procedure

Aspirin (n=111)ASA 80-100mg ASA 80-100mg/day x at least 6 months

DAPT (n = 111)ASA 80-100mg ASA 80-100mg/day x at least 6 monthsClopidogrel 300mg Clopidogrel 75mg daily x 3 months

Patients were followed either by

clinical visits or phone contact at

1, 3, and 12 month follow-up

ARTE: Trial Design


• Endpoints were defined according to the Valve Academic Research Consortium (VARC)-2 criteria

*protocol amendment from 12-month to 3-month

ARTE: Endpoints

• Incidence of death, MI, ischemic stroke or TIA, or life threatening or major bleeding at 3-month* follow-up

Primary

• Incidence of death, MI, ischemic stroke, and major or life-threatening bleeding at 30 days

Secondary


• The sample size empirically estimated at 300 patients • Categorical variables: Two-sided chi-square or Fisher exact

tests• Continuous variables: 2-sided Student t tests or Mann-Whitney

U tests • Kaplan-Meier-based cumulative incidence rate using the log-

rank test • P value <0.05 indicated statistical significance


ARTE: Statistical Analysis

ARTE: Patient FlowMarch 2012 - February 2017

Randomized 222 patients undergoing TAVR

111 Aspirin group2 clopidogrel was prescribed by physician responsible for patient

111 DAPT group1 clopidogrel never started

3 month follow up0 lost to follow up

3 month follow up0 lost to follow up

N = 111 included in primary analysis N = 111 included in primary analysis


ARTE: Patient Characteristics

CharacteristicDAPT

(n= 111)Aspirin

(n= 111) P ValueAge — yr 79±9 79±9 0.716

Male 63.1% 53.2% 0.174

Current Smoker 2.7% 1.8% 0.504

HTN 77.5% 79.8% 0.743

Diabetes 36.9% 32.7% 0.573

Prior CABG 35.1% 38.5% 0.886

Previous MI 23.4% 18.4% 0.409

Peripheral Vascular Disease 25.2% 20.0% 0.422

Porcelain Aorta 16.2% 10.1% 0.232

eGFR <60 ml/min 63.1% 63.1% -

STS-PROM score 6.2 ±4.4 % 6.2 ±4.6 % 0.769

CharacteristicDAPT

(n= 111)Aspirin

(n= 111) P ValueValve Type

SAPIEN XT 93.7% 90.9% 0.615

SAPIEN 3 6.3% 9.0% -

Approach

Transfemoral 72.1% 65.8% 0.788

Transapical 16.2% 18.0% -

Transaortic 9.0% 12.6% -

Transcarotid 2.7% 3.6% -

New Onset Afib 10.8% 10.8% 0.999

JACC Cardiovasc Interv. 2017;10(13):1357-1365 STS PROM = Society of Thoracic Surgeons Predicted Risk of Mortality

ARTE: Primary Outcome

Endpoint DAPT Aspirin OR (95% CI) P ValueCombined Primary Endpoint at 90 days, n (%) 17 (15.3) 8 (7.2) 2.31 (0.95-5.62) 0.065

Death, n (%) 7 (6.3) 4 (3.6) 1.78 (0.51-6.27) 0.370

Stroke/TIA, n (%) 3 (2.7) 1 (0.9) 3.11 (0.32-30.43) 0.313

Myocardial Infarction, n (%) 4 (3.6) 1 (0.9) 4.13 (0.45-37.60) 0.175

Major Bleeding, n (%) 5 (4.5) 3 (2.7) 1.68 (0.39-7.21) 0.484

Life Threatening Bleeding, n (%) 7 (6.3) 1 (0.9) 7.34 (0.89-60.71) 0.065


ARTE: 30 Day Outcomes

Endpoint DAPT Aspirin OR (95% CI) P ValueCombined Primary Endpoint at 30 days, n (%) 16 (14.4) 7(6.3) 2.48 (0.98-6.31) 0.056

Death, n (%) 6 (5.4) 3 (2.7) 2.04 (0.50-8.37) 0.307

Stroke/TIA, n (%) 3 (2.7) 1 (0.9) 3.11 (0.32-30.43) 0.313

Myocardial Infarction, n (%) 4 (3.6) 1 (0.9) 4.13 (0.45-37.60) 0.175

Major Bleeding, n (%) 5 (4.5) 3 (2.7) 1.68 (0.39-7.21) 0.484

Life Threatening Bleeding, n (%) 7 (6.3) 1 (0.9) 7.34 (0.89-60.71) 0.065


Endpoint DAPT AspirinPrimary Endpoint at 30 days, n (%) 16 (14.4) 7(6.3)

Death, n (%) 6 (5.4) 3 (2.7)

Stroke/TIA, n (%) 3 (2.7) 1 (0.9)

Myocardial Infarction, n (%) 4 (3.6) 1 (0.9)

Major Bleeding, n (%) 5 (4.5) 3(2.7)

Life Threatening Bleeding, n (%) 7(6.3) 1 (0.9)

Endpoint DAPT AspirinPrimary Endpoint at 90 days, n (%) 17 (15.3) 8 (7.2)

Death, n (%) 7 (6.3) 4 (3.6)

Stroke/TIA, n (%) 3(2.7) 1(0.9)

Myocardial Infarction, n (%) 4 (3.6) 1(0.9)

Major Bleeding, n (%) 5 (4.5) 3(2.7)

Life Threatening Bleeding, n (%) 7(6.3) 1(0.9)

ARTE: 30 Day vs 90 Day Outcomes


ARTE: Bleeding Events

Bleeding Events DAPTn=12

Aspirinn=4

Cause of Bleeding

Vascular Complication 7 4

GI Bleeding 5 0

Timing of Bleeding

≤72 hrs 7 4

>72 hrs 5 0

Severity of Bleeding

Life Threatening 7 1

Major 5 3


ARTE: Discontinuation

Reason for Discontinuation DAPTn=21

Aspirinn=1

Bleeding 8 0

New Onset AF (requiring anticoagulation) 11 0

Unknown 1 1

Other 2 0


Authors’ Conclusions

• SAPT (vs. DAPT) was associated with a tendency toward a lower rate of adverse events following TAVR, driven mainly by a lower rate of serious bleeding events while not increasing the risk for MI or stroke


ARTE: Study Critique• Small trial with open label design• Some follow up adjudication done over the phone• Empirically estimated patient population and study was prematurely

terminated

ARTE: Study Critique• Inclusion/Exclusion

• Did not include self-expandable valves (may have helped adequately power the trial)• Excluded ‘DES within a year’ rather than ‘indication for DAPT’• Did not exclude or account for previous stroke/TIA

• Primary outcome as a net clinical benefit/net adverse clinical events• DAPT is expected to improve efficacy at the expense of increased bleeding – skews away from

net clinical benefit • Only 3 month duration of assessment

• Unable to detect long term prevention of significant valve thrombosis and embolization• Patients with complex atherosclerotic disease (i.e history of CABG, prior stroke, and PVD)

increased risk of long term stroke

ARTE: Implications for Practice• Results do not apply to TAVR candidates who present with Afib or

indication for DAPT• ‘Proof of concept‘ for SAPT post TAVR for patients at high risk of bleeding • Institution specific differences

• The 2012 ACCF/AATS/SCAI/STS recommend ACTs >300s vs >250s in PARTNER trial• Early bleeding events after TAVR are associated with procedural/technical factors,

access site, DAPT prior to procedure, valve choice

• Unknown how results will apply to self expandable valves, newer generation valves, and other surgical risk populations

• Differences in biocompatibility and thrombogenicity

Aspirin Versus Aspirin Plus Clopidogrel Following Transcatheter Aortic Valve

Implantation (ARTE) Trial

Justin Joy, PharmDPGY2 Cardiology Pharmacy Resident

Duke University Hospital, Durham, NC

Questions?

Presenter Biography

• Dr. Lindsey Safley graduated from Lipscomb University College of Pharmacy in Nashville, TN. She completed her PGY1 Pharmacy Practice residency at Vanderbilt University Medical Center and continued her residency training there her PGY2 in Cardiology. Her current practice interests include advanced heart failure and heart transplant. After residency, Dr. Safely wishes to pursue an inpatient clinical cardiology position.

A Controlled Trial of Rivaroxabanafter Transcatheter Aortic-Valve

Replacement

GALILEO TRIAL

Lindsey Safley, PharmDPGY2 Cardiology Resident

Vanderbilt University Medical Center

Disclosures

• Lindsey Safley and Libby Orzel have no actual or potential conflict of interest in relation to this program or presentation

Aortic Stenosis• Prevalence: 3.4% of those aged

≥ 75 years have severe aortic stenosis (AS)

• Clinical presentation: angina, dyspnea on exertion, syncope

• Average survival without treatment is only 1 to 3 years after symptom onset

• Aortic valve replacement is the treatment of choice:

• Transcatheter Aortic Valve Replacement (TAVR)

• Surgical Aortic Valve Replacement (SAVR)

Brian R. Lindman . Aortic Valve Disease. Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine.

American Heart Association American College of Cardiology 2017 update Valvular Guidelines• TAVR is recommended for:

• Symptomatic patients with severe AS and a prohibitive risk for surgical aortic valve replacement (AVR) who have a predicted post-TAVR survival greater than 12 months (I-A)

• Symptomatic patients with severe AS (Stage D) and an intermediate surgical risk, depending on patient-specific procedural risks, values, and preferences (II-A)

• SAVR is recommended for:• Symptomatic patients with severe AS (Stage D) and asymptomatic

patients with severe AS (Stage C) who meet an indication for AVR when surgical risk is low or intermediate (I-B)

• TAVR OR SAVR• Surgical AVR or TAVR is recommended for symptomatic patients with

severe AS (Stage D) and high risk for surgical AVR, depending on patient-specific procedural risks, values, and preferences (I-A)


Previous Trials

N Engl J Med 2010; 363:1597-1607

TRIAL PARTNER 1 PARTNER 2 PARTNER 3

Date October 2010 April 2016 May 2019

Population High risk Intermediate risk Low risk

Therapy TAVR vs Standard of Care TAVR vs. SAVR TAVR vs. SAVR

Outcome Death form any cause

30.7% in TAVR vs. 50.7% in Standard of Care

(HR 0.55, 95% CI, 0.40-0.74, p<0.001)

TAVR was superior to Standard of Care

Death from any cause or disabling stroke

19.3% in TAVR vs. 21.1% in SAVR

(HR 0.89,95% CI, 0.73-1.09 p=025)

TAVR was noninferior to SAVR

Death from any cause or disabling stroke or rehospitalization

8.5% in TAVR vs. 15.1% in SAVR

(HR 0.54, 95% CI ,0.37-0.79 p=0.001)

TAVR was superior to SAVR

N Engl J Med 2016; 374:1609-1620N Engl J Med 2019; 380:1695-1705

Antiplatelet Therapy • Goal of antiplatelet post TAVR/SAVR: prevent cerebrovascular complications and

valve thrombosis• Routine use of antiplatelet therapy post-TAVR is endorsed by both American and

European valvular guidelines• Lifelong aspirin and 6 months of clopidogrel (IIB C) (AHA/ACC)• Lifelong aspirin and 3-6 months of clopidogrel (IIA C) (ESC)

• Duration and use of antiplatelet agents is patient and provider specific

Circ Cardiovasc Interv. 2019 Jan;12(1):e007411

PARTNER 1

• DAPT 6 months

PARTNER 2

• DAPT minimum of 1 month

PARTNER 3

• DAPT minimum of 1 month

Eur Heart J. 2017 Sep 21;38(36):2739-2791

*Dual antiplatelet therapy

Subclinical Leaflet Thrombosis

• CT derived hypoattenuating lesions on the aortic valve

• Can have moderate or severe restriction of leaflet motion

• In two large registries, leaflet thrombosis occurred in 4% in patients with anticoagulation vs. 15% in antiplatelet therapy

• Associated with nonprocedural stroke or transient ischemic attack

Lancet. 2017 Jun 17;389(10087):2352-2354.

*Computerized tomography

Purpose

N Engl J Med. 2020 Jan 9;382(2):120-129

Methods

• Men and women 18 years of age or older• Successful TAVR with any approved device for treatment of aortic- valve stenosis• Absence of periprocedural adverse events

Inclusion Criteria:

• Long-term anticoagulation and an absolute indication for dual antiplatelet therapy• Known bleeding • Active infective endocarditis• Use of omeprazole/esomeprazole • Stroke within the last three months• Severe renal (eGFR<30mL/min/1.73 m2) or hepatic impairment (Child-Pugh Class B or C)

Exclusion Criteria:

N Engl J Med. 2020 Jan 9;382(2):120-129

Treatment Groups

If New Atrial Fibrillation Developed

Rivaroxaban 15-20 mg daily Vitamin K antagonists to replace either clopidogrel within 3 months or to replace aspirin thereafter.

After 90 Days

Rivaroxaban monotherapy 10 mg daily Aspirin 75-100mg monotherapy

Randomized 1-7 Days Post TAVR

Rivaroxaban 10 mg daily plus aspirin 75-100mg Aspirin 75-100mg plus clopidogrel 75 mg daily

N Engl J Med. 2020 Jan 9;382(2):120-129

Outcomes

Primary Outcome

• Composite of death from any cause or thromboembolic events

Primary Safety Outcome

• Composite of life-threatening, disabling, or major bleeding according to VARC* criteria

Secondary Outcomes

• Composite of death from cardiovascular causes or thromboembolic events

N Engl J Med. 2020 Jan 9;382(2):120-129

* Valve Academic Research Consortium

Statistical Analysis

• Estimated 440 primary efficacy outcome events would provide the trial with 80% power to detect a 20% lower relative risk in the rivaroxaban group than in the antiplatelet group

• The primary efficacy outcome was to be analyzed for noninferiority with a noninferiority margin for the upper boundary of the hazard ratio of 1.20

• Main analyses utilized the intention-to-treat principle• Kaplan Meier estimates were used to evaluate the timing of events and a Cox

proportional-hazards model was used to generate hazard ratios

*Due to safety concerns immediate termination of the trial was recommended*Only 183 events occurred of the estimated 440

N Engl J Med. 2020 Jan 9;382(2):120-129

Results

• Median trial duration: 17 months• Premature discontinuation:

• 307 patients in rivaroxaban group• 194 patients in control

• Reasons for discontinuation:• Adverse events • Patient withdrawal• Noncompliance with drug regimen

1644 randomized

826 in rivaroxaban

799 completed

818 in DAPT

792 completed

N Engl J Med. 2020 Jan 9;382(2):120-129

Demographics Characteristic Rivaroxaban (n=826) Antiplatelet (n=818)

Age (years) 80 80

Male sex (%) 51.6 49.5

STS risk category: (%)HighIntermediateLow

7.946.445.8

9.047.443.5

Diabetes 28.6 28.7

Hypertension (%) 87.2 85.2

Coronary artery disease (%) 39.3 37.3

Congestive heart failure (%) 47.7 46.5

Valve type: (%)Sapien 3 CoreValve

46.624.9

42.327.5

Body Mass Index (kg/m2) 28.1 28.2

eGFR ml/min/1.73 m2 73.4 73.2

New onset atrial fibrillation(%) 10.4 11.3N Engl J Med. 2020 Jan 9;382(2):120-129

Results

• Primary efficacy outcome: • 12.7% in rivaroxaban group vs. 9.5% in

antiplatelet group• (HR 1.35; 95% CI, 1.01 to 1.81; P = 0.04)

N Engl J Med. 2020 Jan 9;382(2):120-129

Results

• Primary Safety Outcome:• 5.6% in the rivaroxaban group vs. 3.8%

in the antiplatelet group• (HR 1.50; 95% CI, 0.95 to 2.37; P = 0.08)

N Engl J Med. 2020 Jan 9;382(2):120-129

Results

Outcome Rivaroxaban (n=826)

Antiplatelet (n=818)

Hazard Ratio (95% CI)

Death from any cause (%) 7.7 4.6 1.69 (1.13 to 2.53)

Death from CV cause (%) 4.2 3.3 1.30 (0.79 to 2.14)

Symptomatic valve thrombosis (%) 0.4 0.9 0.43 (0.11 to 1.66)

Stroke (%) 3.6 3.1 1.20 (0.71 to 2.05)

TIMI major/minor (%)*Thrombolysis in Myocardial Infarction

5.1 2.9 1.78 (1.08 to 2.94)

ISTH major (%)*International Society on Thrombosis and Hemostasis

0.2 0.1 1.66 (1.05 to 2.62)

BARC type 2,3,5 (%)*Bleeding Academic Research Consortium

3.6 1.8 1.84 (1.41 to 2.41)

N Engl J Med. 2020 Jan 9;382(2):120-129

Authors’ Conclusion

• Those treated with rivaroxaban had higher rates of death or thromboembolic complications as well as higher rates of bleeding complications

• The higher number of deaths in the rivaroxaban group did not appear to be directly attributable to the higher risk of bleeding in the rivaroxaban group

• Event rate in trial was low potentially due to lower risk population

N Engl J Med. 2020 Jan 9;382(2):120-129

Critique

• Strengths• Large randomized trial addressing a needed clinical question• Outcomes were prespecified with the use of standardized definitions• Events were adjudicated by a clinical-events committee • Majority of patients were STS intermediate and low risk

• Weakness• Open label design • Dose of rivaroxaban utilized• Did not reach power secondary to early termination • No consistent assessment of drug compliance• Statistically abandoned original strategy and did not address multiple

comparisons

GALILEO 4-D

• Substudy that was published in NEJM with the goal to evaluate rivaroxaban vs antiplatelet on leaflet thickening and leaflet motion abnormalities post TAVR

• Patients were evaluated 3 months post TAVR by cardiac CT • The primary end point was the percentage of patients with at least

one prosthetic valve leaflet with reduced motion of grade 3 or higher (involving >50% of the leaflet)

• 2.1% in the rivaroxaban group vs. 10.9% in the antiplatelet group (difference, −8.8; 95% CI, −16.5 to −1.9; P = 0.01)

N Engl J Med. 2020 Jan 9;382(2):130-139

Impact on Clinical Practice

• Conflicting results with the GALILEO 4D trial• For now, the risk outweighs the benefit of routine use of

anticoagulation post TAVR to prevent leaflet thrombosis

• More anticoagulation in TAVR trials in the pipeline• ATLANTIS trial: Apixaban (5 mg bid) vs. standard of care• ADAPT-TAVR: Edoxaban (60 mg qd) vs. standard of care

A Controlled Trial of Rivaroxabanafter Transcatheter Aortic-Valve

Replacement (GALILEO TRIAL

Lindsey Safley, PharmDPGY2 Cardiology Resident

Vanderbilt University Medical Center

Questions?

March Journal Club

• Presenters• Dr. Kaitlin Siela• Dr. Rachel Lavalle• Dr. Daniel Galipeau

• Date/Time: TBD

Documents

ACCP Cardiology PRN Journal Clubaccpcardsprnjournalclub.pbworks.com/w/file/fetch/138742986/Febru… · ACCP Cardiology PRN Journal Club 2/27/2020 Moderator: Ashley Kasper. Mentor