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Disclosures Updates in Interventional Cardiology and Guidelines No - - PowerPoint PPT Presentation

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6/18/2018 Disclosures Updates in Interventional Cardiology and Guidelines No Conflicts of Interest Krishan Soni, MD, MBA, FACC Assistant Professor of Medicine Division of Cardiology Krishan.soni@ucsf.edu Advances in Internal Medicine 2018

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6/18/2018 1

Updates in Interventional Cardiology and Guidelines

Krishan Soni, MD, MBA, FACC

Assistant Professor of Medicine Division of Cardiology

Advances in Internal Medicine 2018

Disclosures

No Conflicts of Interest

Krishan.soni@ucsf.edu

฀ Major Society Guideline

Updates 2016-2017

฀ Clinical Trials Published

2016-2017

Updates in Interventional Cardiology and Guidelines

TOPICS

฀ Dual Antiplatelet Therapy (DAPT)

฀ Choice and Dosing ฀ Duration ฀ Interruption for Surgery

฀ Triple Therapy (Anticoagulation+DAPT) ฀ Quality Care after Myocardial Infarction

Updates in Interventional Cardiology and Guidelines

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6/18/2018 2

฀

Recognize important differences between oral P2Y12 inhibitors

฀

Understand differences in DAPT duration after PCI

฀ based on use of bare metal / drug eluting stent ฀ based on stable or acute presentation

฀

Be aware of factors influencing risk and benefit on deciding duration of antiplatelet therapy

฀

Understand timing of non-cardiac surgery after coronary stent placement

฀

Know options for managing triple therapy

฀

Be aware of new quality metrics when caring for patients after myocardial infarction

Objectives Strength of Guideline Recommendations

฀ ACS: Acute Coronary Syndrome ฀ BMS: Bare Metal Stent ฀ CAD: Coronary Artery Disease ฀ CABG: Coronary Artery Bypass Graft Surgery ฀ DAPT: Dual Antiplatelet Therapy ฀ DES: Drug Eluting Stent ฀ PCI: Percutaneous Coronary Intervention ฀ PPI: Proton Pump Inhibitor ฀ SIHD: Stable Ischemic Heart Disease ฀ VKA: Vitamin K Antagonist

Acronyms

TOPICS

฀ Dual Antiplatelet Therapy (DAPT)

฀ Choice and Dosing ฀ Duration ฀ Interruption for Surgery

฀ Triple Therapy ฀ Quality Care after Myocardial Infarction

Updates in Interventional Cardiology and Guidelines

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6/18/2018 3

Oral Antiplatelet Agents

Aspirin Clopidogrel Prasugrel Ticagrelor Indication ACS Post PCI Stroke PVD ACS Post PCI Stroke PVD Post PCI ACS Post PCI Dose Load Maintenance 325 mg 81 mg DAILY 300-600 mg 75 mg DAILY 60 mg 10 mg DAILY 180 mg 90 mg BID Class NSAID 2nd gen thienopyridine (PRODRUG) 2nd gen thienopyridine (PRODRUG) CTPT Mechanism IRREVERSIBLE COX 1 IRREVERSIBLE P2Y12 IRREVERSIBLE P2Y12 REVERSIBLE P2Y12 Peak Effect 1-3 hours 6 hours 4 hours 2 hours CYP Metabolism NA 2C19 3A4 3A4/5

P2Y12 Inhibitors: Mechanism of Action

Schomig A; N Eng J Med 2009

Aspirin dosing in patients with CAD

฀ Higher doses of aspirin are associated with

bleeding and no increased anti-ischemic benefit

฀ When used with ticagrelor, aspirin doses of >100

mg are contraindicated.

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According to US Guidelines, how long should patients be on Dual Antiplatelet Therapy (DAPT) after percutaneous coronary intervention (PCI) with a Drug Eluting Stent?

  • A. 3 months
  • B. 6 months
  • C. 12 months
  • D. It depends on the

indication for PCI

  • E. Call a cardiology

consult

3 m

  • n

t h s 6 m

  • n

t h s 1 2 m

  • n

t h s I t d e p e n d s

  • n

t h e i n d i c a t . . . C a l l a c a r d i

  • l
  • g

y c

  • n

s u l t

14% 10% 0% 17% 59%

Duration of dual antiplatelet therapy (DAPT)

฀

Duration of DAPT depends on:

฀ Underlying condition ฀ Treatment provided

Stable Ischemic Heart Disease (SIHD) Acute Coronary Syndromes (ACS)

Duration of dual antiplatelet therapy (DAPT) in patients with ACS

ACS = 1 year

Stopping early at 6 months Acute Coronary Syndromes (ACS)

Duration of dual antiplatelet therapy (DAPT) in patients with SIHD

PCI with Bare Metal Stent (BMS) 1 MONTH PCI with Drug Eluting Stent (DES) 6 MONTHS Stable Ischemic Heart Disease (SIHD) Stopping early at 3 months

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When should DAPT therapy be continued for LONGER duration?

Risk of Ischemia Risk of Bleeding

The DAPT score can guide risk / benefit

  • f longer therapy

Score ≥ 2 Favorable benefit/risk For prolonged DAPT Score <2 NOT Favorable benefit/risk For prolonged DAPT

Which P2Y12 agent should I recommend?

For Medically Managed ACS Reasonable to choose Ticagrelor over Clopidogrel For ACS with PCI Reasonable to choose Ticagrelor

  • r Prasugrel over Clopidogrel

Other pearls regarding P2Y12 inhibitors

฀ Ticagrelor

฀ can cause dyspnea (14%) and

bradycardia (6%)

฀ Prasugrel

฀ may be less effective in patients < 60 kg

and > 75 years of age

฀ should not be given until after invasive

angiography (Class III)

฀ do not give to patients with a history of

TIA or stroke (Class III)

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6/18/2018 6

You receive a message from the patient’s pharmacy

“Ticagrelor is not covered by this patient’s insurance and he wont be able to receive the medication at home unless he pays out

  • f pocket”

What do you do? Your patient was admitted with an NSTEMI. Your friendly interventional cardiologist placed a drug eluting stent. The patient was started on ticagrelor 90 mg PO BID.

Ticagrelor is not covered by the patient’s

  • insurance. What do you do?
  • A. Switch to clopidogrel 75

mg daily

  • B. Switch to clopidogrel,

load with 600 mg, then 75 mg daily

  • C. Make a plea to the

insurance company

  • D. Tell your patient “It’s

worth paying for”

S w i t c h t

  • c

l

  • p

i d

  • g

r e l 7 5 . . . S w i t c h t

  • c

l

  • p

i d

  • g

r e l , l . . . M a k e a p l e a t

  • t

h e i n s u r . . . T e l l y

  • u

r p a t i e n t “ I t ’ s w

  • r

. .

44% 3% 9% 44%

Switching between oral P2Y12 inhibitors acute settings (ACS, recent PCI)

Always reload in the acute setting (ESC IIb recommendation)

Switching between oral P2Y12 inhibitors chronic settings

Reload only if switching from ticagrelor to another agent

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6/18/2018 7

TOPICS

฀ Dual Antiplatelet Therapy (DAPT)

฀ Choice and Dosing ฀ Duration ฀ Interruption for Surgery

฀ Triple Therapy ฀ Quality Care after Myocardial Infarction

Updates in Interventional Cardiology and Guidelines

65 yo man underwent PCI with a drug eluting stent to the Left Anterior Descending artery 2 months ago for stable angina. He now has severe knee

  • steoarthritis and is asking you when he can have
  • surgery. How long after his stent should he wait?
  • A. 1 month
  • B. 3 months
  • C. 6 months
  • D. 12 months
  • E. He should be managed

medically indefinitely

1 month 3 months 6 months 12 months He should be managed m...

3% 21% 0% 17% 59%

Perioperative management and timing of non cardiac surgery

Wait 30 days after PCI with BMS Wait at least 3 months and preferably 6 months after PCI with DES

Perioperative management and timing of non cardiac surgery

฀ During perioperative period: ฀ Continue aspirin if possible ฀ Restart P2Y12 as soon as possible

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6/18/2018 8

Perioperative management and timing of non cardiac surgery

฀ How long before surgery should DAPT be stopped?

฀

CONTINUE ASPIRIN if possible! Ticagrelor 3 days prior to surgery Clopidogrel 5 days prior to surgery Prasugrel 7 days prior to surgery

Key points regarding DAPT (2/2)

฀

Dose of Aspirin for all patients is 81 mg daily

฀

Duration of DAPT:

฀ ACS Patients: 1 YEAR for ALL (with/without stent) ฀ SIHD (Stable Ischemic Heart Disease) Patients:

฀ Drug Eluting Stent (DES): 6 MONTHS ฀ Bare Metal Stent (BMS): 1 MONTH ฀

Stopping Early:

฀ DAPT could be stopped 3 months after DES (drug

eluting stent) for high bleeding risk patients

฀

Longer Therapy:

฀ Risk benefit between bleeding and ischemia ฀ DAPT score can be helpful

Key points regarding DAPT (2/2)

฀

Choice of Agents:

฀ Ticagrelor reasonable over Clopidogrel for ACS ฀ Ticagrelor or Prasugrel are reasonable over

Clopidogrel after PCI for ACS

฀ Do NOT USE Prasugrel if history of stroke or TIA ฀ When switching agents, reload if ACS or switching

from Ticagrelor

฀

Timing of Non-Cardiac Surgery:

฀ Ideally > 1 month after BMS, 6 months after DES ฀ Continue Aspirin if possible ฀ Hold:

฀ Ticagrelor 3 days prior to surgery ฀ Clopidogrel 5 days prior to surgery ฀ Prasugrel 7 days prior to surgery

TOPICS

฀ Dual Antiplatelet Therapy (DAPT)

฀ Choice and Dosing ฀ Duration ฀ Interruption for Surgery

฀ Triple Therapy ฀ Quality Care after Myocardial Infarction

Updates in Interventional Cardiology and Guidelines

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6/18/2018 9

฀

Long-term treatment with oral anticoagulants is necessary in patients with:

฀ Mechanical heart valves ฀ Many with atrial fibrillation

฀

20–30% of these patients have concomitant ischemic heart disease that requires (PCI) with stenting and subsequent antiplatelet therapy.

฀

The combination of oral anticoagulants and antiplatelets is associated with a high annual risk (4–16%) of fatal and non-fatal bleeding episodes.

Triple Therapy: The conundrum

Dewilde, Lancet 2013

A 65 yo M presents to the clinic. He had a myocardial infarction 10 days ago, and was treated with PCI, aspirin and clopidogrel. An EKG reveals that he is now in atrial fibrillation. CHADS2Vasc score is 3. What regimen do you recommend?

  • A. Aspirin + Clopidogrel

(No change)

  • B. Aspirin + Clopidogrel +

Coumadin

  • C. Aspirin + Ticagrelor +

Coumadin

  • D. Clopidogrel + Coumadin

E. Clopidogrel + Rivaroxaban F. That’s a hard choice!

Aspirin + Clopidogrel (N... Aspirin + Clopidogrel + ... Aspirin + Ticagrelor + C... Clopidogrel + Coumadin Clopidogrel + Rivaroxaban That’s a hard choice!

3% 35% 16% 13% 3% 29%

What is the indication for triple therapy?

  • Recent ACS (<1 year)
  • Recent PCI (< 6 months)
  • Chronic Ischemic heart

disease

  • Stroke
  • Peripheral vascular disease

Dual Antiplatelet (DAPT) Anticoagulation

  • Atrial fibrillation
  • Mechanical heart valves
  • Deep venous thrombosis
  • Pulmonary embolism
  • Other indications
  • Need to balance risk of thrombotic / ischemic events with

bleeding

  • Use risk scores to help assess:
  • CHADS2VASC for stroke risk in AF
  • HAS-BLED for bleeding risk

Multiple medical options for therapy

  • Aspirin
  • P2Y12 Inhibitors
  • Clopidogrel
  • Ticagrelor
  • Prasugrel

Dual Antiplatelet (DAPT) Oral Anticoagulation

  • Coumadin
  • Dabigatran
  • Rivaroxaban
  • Apixaban
  • Edoxaban
  • What is the safety and efficacy of each

medication?

  • What combinations offer the greatest

reduction in ischemic / thrombotic events?

  • Which combinations have the lowest

bleeding risk? Three recent trials:

฀ WOEST (2013) ฀ PIONEER AF (2016) ฀ RE DUAL PCI (2017) ฀ RE-ALIGN (2013)

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What’s the update on triple therapy? Recent studies

WOEST Trial (Lancet 2013)

  • RCT, Europe, 2008-2011
  • 573 patients on anticoagulation undergoing PCI
  • Randomized to:
  • Double Therapy: Clopidogrel + Coumadin
  • Triple Therapy: Clopidogrel + Aspirin + Coumadin

Any bleeding at 1 year Incidence of death, MI, stroke, stent thrombosis, revascularization

Dewilde, Lancet 2013

44.4% 19.4% 17.6% 11.1%

What’s the update on triple therapy? Recent studies

PIONEER AF PCI (NEJM 2016)

  • RCT
  • 2124 patients with nonvalvular AF undergoing PCI
  • Randomized to:
  • (1) Rivaroxaban 15 mg Daily + P2Y12
  • (2) Rivaroxaban 2.5 mg BID + Aspirin + P2Y12
  • (3) Coumadin + Aspirin + P2Y12

Any bleeding at 1 year Incidence of death, MI, stroke, stent thrombosis 26.7% 16.8% ~6%

GIbson, NEJM 2016

What’s the update on triple therapy? Recent studies

REDUAL PCI (NEJM 2017)

  • RCT
  • 2725 patients with AF undergoing PCI
  • Randomized to:
  • (1) Coumadin + P2Y12 + aspirin
  • (2) Dabigatran 110 mg BID + P2Y12
  • (3) Dabigatran 150 mg BID + P2Y12

Major or clinically relevant bleeding at 2 years Incidence of death, MI, stroke, systemic embolism, unplanned revascularization 25.7% 20.2% 13.7% 13.4%

Cannon, NEJM 2017

What’s the update on triple therapy? Summary of recent studies

WOEST

Coumadin + Clopidogrel 19% 11% Coumadin + Clopidogrel + Aspirin 44% 18%

PIONEER AF PCI

Rivaroxaban 15 mg Daily + P2Y12 17% 6.5% Rivaroxaban 2.5 mg BID + P2Y12 + Aspirin 18% 5.6% Coumadin + P2Y12 + Aspirin 27% 6.0%

RE DUAL PCI

Dabigatran 110 mg BID + P2Y12 15% 13% Dabigatran 150 mg BID + P2Y12 20% 13% Coumadin + P2Y12 + Aspirin 26% 14%

Preferred options in United States

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6/18/2018 11

What’s the update on triple therapy? Summary of recent studies

WOEST Trial: Clopidogrel + Coumadin = Significant reduction in bleeding with no increase in thrombosis. PIONEER AF Trial:

  • Rivaroxaban 15 mg daily plus a P2Y12 inhibitor

OR

  • Rivaroxaban 2.5 mg BID plus DAPT

Associated with a lower rate of clinically significant bleeding than standard therapy with a VKA plus DAPT. The three groups had similar efficacy rates. RE DUAL PCI:

  • Bleeding lower among patients on dual therapy with

dabigatran and a P2Y12 inhibitor than triple therapy.

  • Dual therapy was non inferior to triple therapy with

respect to the risk of thromboembolic events.

How about mechanical heart valves?

RE-ALIGN (NEJM 2013)

  • Phase -2 Dose Validation
  • 252 patients undergoing mechanical aortic or mitral valve

replacement

  • (1) Dabigatran (dose to plasma trough level)
  • (2) Coumadin (INR 2-3 or 2.5-3.5)

Eikelboom, NEJM 2013

Terminated early due to excess events in Dabigatran group

What’s the update on triple therapy? American Guidelines (2016)

฀ For patients who require triple therapy:

Use Coumadin (keep INR at low end of range) Use Clopidogrel (NOT Prasugrel/Ticagrelor) Use low dose aspirin Consider PPI Minimize duration of therapy

What’s the update on triple therapy? European Guidelines (2017)

฀ Major differences

NOACs can be used (IIa indication) Consider lower dose rivaroxaban (15 mg daily)

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Key points regarding triple therapy

฀

US Guidelines (2016) recommend:

฀ Low dose aspirin (81 mg) ฀ Clopidogrel (not ticagrelor or prasugrel) ฀ Coumadin with goal INR 2-2.5 ฀ Minimize duration of therapy ฀ Consider PPI

฀

Recent studies have shown safety and efficacy of:

฀ Coumadin + Clopidogrel 75 mg daily ฀ Rivaroxaban 15 mg daily + P2Y12 ฀ Dabigatran 150 mg BID + P2Y12

฀

European Guidelines (2017) allow for:

฀ Use of a NOAC ฀ Rivaroxaban 15 mg daily recommended

฀

Use Coumadin for mechanical heart valves!

TOPICS

฀ Dual Antiplatelet Therapy (DAPT)

฀ Choice and Dosing ฀ Duration ฀ Interruption for Surgery

฀ Triple Therapy ฀ Quality Care after Myocardial Infarction

Updates in Interventional Cardiology and Guidelines 2017 ACS Performance Measures (TOP 10)

Arrival

฀ Aspirin ฀ Troponin

within 6 hours

Hospitalization

฀ Evaluation of LVEF ฀ ACEi or ARB (if low EF) ฀ Non invasive stress test

(if no cath)

Discharge

฀ Aspirin ฀ P2Y12 Inhibitor ฀ Beta Blocker ฀ Statin (High intensity) ฀ Cardiac Rehab

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2017 ACS Quality Measures

฀

Avoid Using NSAIDS for pain control!

฀

Don’t prescribe prasugrel for patients with a history of Stroke/TIA

฀

Use Aspirin 81 mg daily with Ticagrelor

฀

Metrics may be useful for local quality improvement but are not yet appropriate for public reporting or pay for performance programs.

฀

New measures are initially evaluated for potential inclusion as performance measures.

What have we learned?

Dual Antiplatelet Therapy

฀

Choice of Antiplatelet Agents

฀

Duration of DAPT after ACS and PCI

฀

Timing of Non Cardiac Surgery after PCI

Triple Therapy

฀

An Approach to Anticoagulation and DAPT

฀

Recent data suggesting safety and efficacy of drug combinations

฀

US vs European guidelines

Performance Measures for ACS in 2017

฀

Medications on discharge (Aspirin, P2Y12, Beta Blocker, ACEi)

฀

Assessment of LV function

฀

Referral to Cardiac Rehab

Thank You!

Questions: Email Krishan Soni @ Krishan.soni@ucsf.edu 415-476-6541

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References

Guidelines

฀

LevineGN, Bates ER, Bittl JA, BrindisRG, Fihn SD, Fleisher LA, Granger CB, Lange RA,MackMJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O’Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines:. J Am Coll Cardiol 2016;68:1082–115; http://dx.doi.org/10.1016/j.jacc.2016.03.513.

฀

Marco Valgimigli* (Chairperson) (Switzerland), He´ctor Bueno (Spain), Robert A. Byrne (Germany), Jean-Philippe Collet (France), Francesco Costa (Italy), Anders Jeppsson1 (Sweden), Peter Ju¨ni (Canada), Adnan Kastrati (Germany), Philippe Kolh (Belgium), Laura Mauri (USA), Gilles Montalescot (France), Franz-Josef Neumann (Germany), ate Petricevic1 (Croatia), Marco Roffi (Switzerland), Philippe Gabriel Steg (France), Stephan Windecker (Switzerland), and Jose Luis Zamorano (Spain). 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. European Heart Journal (2017) 0, 1–48. doi:10.1093/eurheartj/ehx419.

฀

Jneid H, Addison D, Bhatt DL, Fonarow GC, Gokak S, Grady KL, Green LA, Heidenreich PA, Ho PM, Jurgens CY, King ML, Kumbhani DJ, Pancholy S. 2017 AHA/ACC clinical performance and quality measures for adults with ST-elevation and non–ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2017.

References

Trials

฀

Cannon CP et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med 2017;377:1513-24. DOI: 10.1056/NEJMoa1708454.

฀

Gibson CM et al. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med 2016;375:2423-34. DOI: 10.1056/NEJMoa1611594.

฀

Dewilde WJM et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled

  • trial. Lancet 2013; 381: 1107–15. http://dx.doi.org/10.1016/.