1. General Overview and Highlights of the
North American Consensus Document on Anticoagulation in the Atrial Fibrillation Patients with ACS or PCI
Dominick J. Angiolillo, MD, PhD
Professor of Medicine
Medical Director - Cardiovascular Research
Program Director – Interventional Cardiology Fellowship
University of Florida College of Medicine - Jacksonville

2. Presenter Disclosure Information
Name: Dominick J Angiolillo
Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below.
Received payment as an individual for:
a) Consulting fee or honorarium from Amgen, Bayer, Chiesi, Sanofi, Eli Lilly, Daiichi-Sankyo, The Medicines Company, AstraZeneca, Merck, Abbott Vascular, Pfizer, and PLx Pharma;
b) Honorarium for participation in review activities (DSMB member) from CeloNova, Johnson & Johnson, St. Jude, and Sunovion.
c) Honorarium from the American Board of Internal Medicine (Interventional Cardiology Subspecialty Exam Writing Committee Member)
Institutional payments for:
a) Grant support industry: from Amgen, Glaxo-Smith-Kline, Eli Lilly, Daiichi-Sankyo, The Medicines Company, AstraZeneca, Janssen Pharmaceuticals, Inc., Osprey Medical, Inc., Novartis, CSL Behring, and Gilead.
b) Grant in gift: Spartan; Scott R. MacKenzie Foundation
c) Federal agency: NIH

3. AF + PCI: Dimension of the Problem
AF is the most common cardiac arrhythmia occurring in 1- 2% of the general population, with a prevalence that increases with age. Among AF patients at moderate-to-high risk for cardioembolic events, the use of chronic OAC is the mainstay of stroke prevention.
The prevalence of CAD also increases with age and coexists in % of AF patients; ~ 5–7% of PCI patients, who are routinely treated with DAPT, also have AF or other indications for OAC.
These estimates are expected to increase as the global burden of AF increases, driven in large part to the aging population.
These observations raise an important clinical problem regarding the optimal antithrombotic management of patients undergoing PCI who also have AF.
Currently, there are limited evidenced-based data on the optimal antithrombotic treatment regimen of PCI patients who also require OAC due to AF, and Guidelines provide limited insights on the management of these high-risk patients.

4. The 2011 North American Perspective
Faxon DP et al. Circ Cardiovasc Interv. 2011;4:

5. AF + PCI: A North American Perspective – 2016 Update
Dominick J. Angiolillo, MD, PhD; Shaun G. Goodman, MD; Deepak L. Bhatt, MD, MPH;
John W. Eikelboom, MD; Matthew J. Price, MD; David J. Moliterno, MD;
Christopher P. Cannon, MD; Jean-Francois Tanguay, MD; Christopher B. Granger, MD;
Laura Mauri, MD; David R. Holmes, MD; C. Michael Gibson, MD; David P. Faxon, MD

6. AF + PCI: A North American Perspective – 2016 Update
The Challenge: Discerning the choice of antithrombotic therapy
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

7. AF + PCI: A North American Perspective – 2016 Update
Consensus Document Objectives
Provide current views on:
embolic/stroke risk
ischemic/thrombotic cardiac risk
bleeding risk
Describe the recent advances in antithrombotic (antiplatelets and anticoagulants) pharmacology, stent designs, and clinical trials relevant to the field.
Provide expert consensus derived recommendations, using a pragmatic approach, on the management of patients with AF undergoing PCI.
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

8. AF + PCI: A North American Perspective – 2016 Update
Defining the need for chronic OAC
CHA2DS2-VASc Score
CHF/LV dysfunction (LVEF ≤40%) 1
Stroke/TIA/TE 2
Hypertension 1
Vascular disease (prior
MI, PAD, or aortic) 1
Age ≥75 years 2
Age 65–74 years 1
Diabetes mellitus 1
Sex category (ie,
female sex) 1
Low risk (no antithrombotic therapy) defined as
CHA2DS2-VASc of 0 in males (“age <65 and lone AF”)
CHA2DS2-VASc of 1 in females (“age <65 and lone AF”)
Lip GY, et al. Chest. 2010;137:263–272

9. The North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

10. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI

11. AF + PCI: A North American Perspective – 2016 Update
Pre-procedural Considerations
1. Define “Appropriateness” for PCI.
- Consider Appropriateness Criteria for PCI
- Nothing wrong with trying medical therapy first
- Once stent is implanted: point of no return! A U I
Patel M et al JACC 2009

12. AF + PCI: A North American Perspective – 2016 Update
Pre-procedural Considerations
2. Ischemic/thrombotic & bleeding risk stratification
Levine G et al. Circulation 2016

13. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI

14. The North American Perspective – 2016 Update
Procedural Considerations
1. Vascular Access: Radial
Consistently shown to be associated with less bleeding
Mortality benefit
2. Stent choice: New generation DES
- New generation DES: better safety even compared with BMS; typically AF patients also have more complex CAD
- BMS: if considered, should only be for simple lesions (short length/ large diameter)
- BVS: high early ST rates which increase with lesion complexity (some advocate more potent antithrombotic therapy)
- Other new stent platforms (e.g., DCS): not available in the US

15. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI
Whenever possible (i.e., elective / non-emergent procedures), a brief period of wash- out from the anticoagulant effect of OAC is preferable.
For patients on a VKA: INR to be preferably ≤2.0 when using a radial approach (recommended) and ≤ 1.5 if femoral approach is used.
Patients on a NOAC: withhold therapy for 24 hours (or 48 hours for patients with impaired renal function with dabigatran) irrespective of vascular access site.
Although patients with stable CAD can forgo bridging with parenteral anticoagulation, this should be considered for patients presenting with an ACS.

16. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI
Given the current controversies over the net benefits of bivalirudin over other antithrombotic treatment regimens as well as differences in practice patterns among interventionalists, this expert consensus does not recommend a specific parenteral antithrombin agent over another.
However, bivalirudin appears to be a reasonable treatment option in patients at higher risk of bleeding, particularly in those presenting with ACS and if a femoral approach is being used.

17. AF + PCI: A North American Perspective – 2016 Update
The choice of OAC (VKA or NOAC) is at the discretion of the treating physician, with patients informed on the risk-benefit profiles of each agent based on available data.
Continuing with the same OAC after PCI may be reasonable, particularly if the patient has been compliant and has not experienced complications.
If a VKA is chosen, maintain an INR in the range (ideally between 2.0–2.5).
A NOAC at lowest therapeutic dose effective for stroke prevention should be preferred over a VKA in patients unable to have their INR routinely monitored or are unable to maintain INR in the therapeutic range. A recommendation on use of doses lower than the full anticoagulant dose of a specific NOAC cannot be provided until further data become available.

18. The North American Perspective – 2016 Update
This expert consensus recommends that the duration of DAPT in AF patients treated with stents also on OAC should not extend to a full 12 months and to consider SAPT starting within the first 6-months (0 to 6 months post-stenting depending on the ischemic/thrombotic and bleeding risk profile) for up to 12 months.
This group consensus recommends that dropping aspirin rather than a P2Y12 receptor inhibitor should be considered (favoring the use of clopidogrel and avoiding prasugrel or ticagrelor).

19. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI
Discontinuation of one antiplatelet agent should be considered 1-3 months after PCI, this may occur sooner (including immediately after PCI) or later (but not beyond 6 months) according to the ischemic/thrombotic and bleeding risk profiles of the patient.
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

20. AF + PCI: A North American Perspective – 2016 Update
Aspirin might be no longer needed after 12 months in AF patients with stable CAD on VKA
Age ad gender adj. HR (95% CI)
No difference
In CV death/MI/CVA in
patients treated with VKA + APT versus patients treated with VKA alone
adj. HR: 1.15
95% CI p=0.697
SAT
Reference
DAPT
1.58 [ ]
VKA+SAT
7.30 [ ]
VKA alone
1.69 [ ]
0.1 1
100
CORONOR – 4,184 patients on oral anticoagulation with stable (>12 mo) CAD
Hamon M, et al. J Am Coll Cardiol 2014;64:1430–6

21. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI
Balanced thrombotic / bleeding risk
Shorter (e.g., 1 month) and longer (e.g., 3 months) DAPT duration
should be considered in patients treated with BMS and DES, respectively.
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

22. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI
High bleeding / low thrombotic risk
Discontinuation of one antiplatelet agent may be considered
immediately after PCI if patients at very-high bleeding risk
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

23. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI
High thrombotic / low bleeding risk
Shorter (e.g., 3 month) and longer (e.g., 6 months) DAPT duration
should be considered in patients treated with BMS and DES, respectively.
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

24. AF + PCI: A North American Perspective – 2016 Update
Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI
More frequent follow-up visits.
Don’t leave in the exclusive care of PCP.
Choice/duration of antithrombotic therapy may change over time depending on clinical evolution.
At 1-year post-PCI need to evaluate need to continue with any antiplatelet agent based on bleeding/thrombotic risk.

25. AF + PCI: A North American Perspective – 2016 Update
Peri- and post-procedural Considerations
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

26. AF + PCI: A North American Perspective – 2016 Update
Ongoing trials of NOACs in AF patients undergoing PCI
AHA 2016
NOAC wins
ESC 2017 ?
Angiolillo DJ et al. Circ Cardiovasc Interv. 2016

27. AF + PCI: A North American Perspective – 2016 Update
Stay tuned for 2017 Update
Dominick J. Angiolillo, MD, PhD; Shaun G. Goodman, MD; Deepak L. Bhatt, MD, MPH;
John W. Eikelboom, MD; Matthew J. Price, MD; David J. Moliterno, MD;
Christopher P. Cannon, MD; Jean-Francois Tanguay, MD; Christopher B. Granger, MD;
Laura Mauri, MD; David R. Holmes, MD; C. Michael Gibson, MD; David P. Faxon, MD