Atrial fibrillation medical therapy in patients presenting with ACS and/or PCI or valve intervention

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]

Overview

Oral anticoagulation therapy with either vitamin K antagonist (VKA) or non-oral anticoagulants (NOAC)s is the mainstay of the stroke prevention therapy among patients with atrial fibrillation (AF). Antithrombotic therapy consisting of dual antiplatelet drugs is administered among patients with acute coronary syndrome (ACS) with or without percutaneous coronary intervention (PCI) or those undergoing valvular intervention. A challenge in the treatment decision exists among AF patients who present with ACS with or without PCI or those those require valvular interventions. In this category of patients, the treatment regimen should be chosen carefully in order to achieve a balance between ensuring prevention of stroke and ischemic events and not increasing the risk of bleeding. In order to choose a treatment regimen for AF patients who present with ACS with or without PCI or those those require valvular interventions, the risk of stroke and the risk of bleeding must be assessed using CHA2DS2-VASc score and HAS-BLED score, respectively.

Medical Therapy

Shown below are algorithms depicting the recommended treatment regimens and duration according to the 2014 joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Triple therapy consisting of oral anticoagulant and dual antiplatelet therapy is considered among selected patients. Recent findings from the WOEST trial has contributed to challenge triple therapy by omitting aspirin without increasing ischemic events. Large scale randomized clinical trials are needed to accurately determine the best regimen that ensures protection against thromboembolic and ischemic events without increasing the bleeding risk.

Low or Moderate Risk of Stroke

Low or moderate risk of stroke (CHA2DS2-VASC = 1)

Determine the risk of bleeding

Low or moderate bleeding risk (HAS-BLED 0–2)

High bleeding risk (HAS-BLED ≥3)

Determine the clinical setting

Determine the clinical setting

PCI performed for stable CAD

ACS

PCI performed for stable CAD

ACS

At least 4 weeks (no longer than 6 months) Triple therapy: OAC + aspirin 75–100 mg/day + clopidogrel 75 mg/day Up to 12th month OAC and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) Lifelong OAC

4 weeks Triple therapy: OAC + aspirin 75–100 mg/day + clopidogrel 75 mg/day Up to 12th month OAC and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) Lifelong OAC

At least 4 weeks (no longer than 6 months) Triple therapy of OAC + aspirin 75–100 mg/day + clopidogrel 75 mg/day Up to 12th month OAC and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) Lifelong OAC

4 weeks Triple therapy: OAC + aspirin 75–100 mg/day + clopidogrel 75 mg/dayd Up to 12th month OAC and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) Lifelong OAC

High Risk of Stroke

High risk of stroke (CHA2DS2-VASC ≥2)

Determine the risk of bleeding

Low or moderate bleeding risk (HAS-BLED 0–2)

High bleeding risk (HAS-BLED ≥3)

Determine the clinical setting

Determine the clinical setting

PCI performed for stable CAD

ACS

PCI performed for stable CAD

ACS

12 months OAC and clopidogrel 75 mg/day Lifelong OACc

6 months Triple therapy: OAC + aspirin 75–100 mg/day + clopidogrel 75 mg/day Up to 12th month OAC and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) Lifelong OAC

4 weeks Triple therapy: OAC + aspirin 75–100 mg/day + clopidogrel 75 mg/daya Up to 12th month OAC and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) Lifelong AC

6 months Triple therapy of OAC + aspirin 75–100 mg/day + clopidogrel 75 mg/day Up to 12th month OAC and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) Lifelong OAC

2014 Management of Antithrombotic Therapy in AF Patients Presenting with ACS and/or Undergoing PCI or Valve Interventions: A Joint Consensus Document (DO NOT EDIT)

General

Class I

"1. In AF patients, stroke risk must be assessed using the CHA2-DS2-VASc score, and bleeding risk assessed using the HAS-BLED score. Risk stratification is a dynamic process, and must be performed at regular intervals (i.e. on a yearly basis). (Level of Evidence: C)"

"2. Where adjusted dose VKA is used, good quality anticoagulation control is recommended, with a TTR >70%. (Level of Evidence: A)"

Class III

"1. Novel P2Y12 receptor inhibitors (prasugrel and ticagrelor) should not be part of a triple therapy regimen in patients with AF. (Level of Evidence: C)"

Class IIa

"1. When VKA is given in combination with clopidogrel and/or low-dose aspirin, the dose intensity of VKA should be carefully regulated, with a target INR range of 2.0–2.5. (Level of Evidence: Grade C)"

"2. In a patient with AF and stable vascular disease (arbitrarily defined as being free from any acute ischemic event or repeat revascularization for >1 year) the patient should be managed with OAC alone (i.e. whether NOAC or a VKA). (Level of Evidence: Grade B)"

"3. Radial access should be considered as the default for coronary angiography/intervention to minimize the risk of access related bleeding depending on operator expertise and preference. (Level of Evidence: Grade C)"

Class IIb

"1. Where a NOAC is used in combination with clopidogrel and/or low-dose aspirin, the lower tested dose for stroke prevention in AF (that is, dabigatran 110 mg b.i.d., rivaroxaban 15 mg o.d. or apixaban 2.5 mg b.i.d.) may be considered (Prescribing information for edoxaban awaited.). (Level of Evidence: Grade C)"

"2. New generation DES may be preferred over BMS in patients at low risk of bleeding (i.e. HAS-BLED 0–2). (Level of Evidence: Grade C)"

Stable CAD

Class I

"1. Long-term antithrombotic therapy with OAC (i.e. whether NOAC or a VKA) (beyond 12 months) is recommended in all patients. (Level of Evidence: B)"

Class IIa

"1. In patients with stable CAD and AF undergoing PCI at low bleeding risk (HAS-BLED 0–2), triple therapy (OAC, aspirin 75–100 mg daily, clopidogrel 75 mg daily) should be given for a minimum of 4 weeks (and no longer than 6 months) after PCI following which dual therapy with OAC (i.e. whether NOAC or a VKA) and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) should be continued for up to 12 months. (Level of Evidence: Grade C)"

"2. In selected patients with a CHA2DS2-VASc score= 1 (by virtue of their vascular disease only) at low-bleeding risk (HAS-BLED 0–2), dual antiplatelet therapy consisting of aspirin 75–100 mg and clopidogrel 75 mg/day; or dual therapy consisting of OAC (i.e. whether NOAC or a VKA) and clopidogrel 75 mg/day should be considered. (Level of Evidence: Grade C)"

"3. In patients with stable CAD and AF undergoing PCI at high bleeding risk (HAS-BLED .3), triple therapy (OAC, aspirin 75–100 mg daily, clopidogrel 75 mg daily) or dual therapy consisting of OAC (i.e. whether NOAC or a VKA) and clopidogrel 75 mg/day should be given for 4 weeks after PCI following which dual therapy with OAC and clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day) should be continued for up to 12 months. (Level of Evidence: Grade C)"

"4. Gastric protection with PPIs should be considered in patients with OAC plus antiplatelet therapy. (Level of Evidence: Grade C)"

"5. Where OAC patients are at moderate-to-high risk of thromboembolism (i.e. CHA2DS2-VASc ≥2), an uninterrupted anticoagulation strategy with no additional heparin boluses during PCI is the preferred strategy and radial access used as the first choice during therapeutic anticoagulation with a VKA ([[INR] 2–3). This strategy might reduce periprocedural bleeding and thromboembolic events. (Level of Evidence: Grade C)"

Class IIb

"1. Dual therapy of OAC (i.e. whether NOAC or a VKA) and clopidogrel 75 mg/day may be considered as an alternative to initial triple therapy in selected patients with CHA2DS2-VASc score ≥2. (Level of Evidence: Grade C)"

"2. In selected patients with a CHA2DS2-VASc score= 1 at high-bleeding risk (HAS-BLED >3), dual antiplatelet therapy consisting of aspirin 75–100 mg and clopidogrel 75 mg/day; or dual therapy consisting of OAC (i.e. whether NOAC or aVKA) and clopidogrel 75 mg/day may be considered for 12 months. (Level of Evidence: Grade C)"

"3. Combination OAC plus single antiplatelet therapy [preferably clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day)] may be considered in only very selected cases, e.g. stenting of the left main, proximal left anterior descending, proximal bifurcation, recurrent MIs, etc.. (Level of Evidence: Grade C)"

"4. Where NOAC patients are at moderate-to-high risk of thromboembolism (i.e. CHA2DS2-VASc ≥2), cessation of the drug for 48 h and parenteral anticoagulation as per standard practice during PCI may be prudent in a non-emergency situation. (Level of Evidence: Grade C)"

"5. When the procedures require interruption of OAC for longer than 48 h in high-risk patients (i.e. TAVI or other non-PCI procedures at high-bleeding risk), enoxaparin may be administered subcutaneously, although the efficacy of this strategy is uncertain. Pharmacodynamic data suggest that enoxaparin might be a better option than UFH, because of the more predictable and stable level of anticoagulation. Such ‘bridging’ therapies may actually be associated with an excess bleeding risk, possibly due to dual modes of anticoagulation in the overlap periods. When NOACs are used, timing of any bridging therapy should be tailored on the basis of renal function and the pharmacokinetics of the specific NOAC. (Level of Evidence: Grade C)"

NSTE-ACS Including Unstable Angina and NSTEMI

Class I

"1. Long-term antithrombotic therapy (beyond 12 months) is recommended with OAC whether with VKA or a NOAC in all patients. (Level of Evidence: B)"

Class IIa

"1. Patients with moderate-to-high-risk NSTE-ACS and AF at low risk of bleeding (HAS-BLED 0–2) should receive dual antiplatelet therapy with aspirin plus clopidogrel andOAC (i.e. whether NOAC or a VKA) should also be given/continued. ([EHS ESC guidelines classification scheme#Level of Evidence|Level of Evidence: Grade C]])"

"2. An early invasive strategy (within 24 h) should be preferred among patients with moderate-to-high-risk NSTE-ACS in order to expedite treatment allocation (medical vs. PCI vs. CABG) and to determine the optimal antithrombotic regimen. (a) Pre-treatment with glycoprotein (GP) IIb/IIIa inhibitors should be avoided in such patients. (b) Pre-treatment with P2Y12 receptor antagonists may be withheld until the time of coronary angiography in case of an early invasive strategy within 24 h. (Level of Evidence: Grade C)"

"3. When a parenteral anticoagulant is needed to support PCI in a patient at high risk of bleeding, bivalirudin should be considered as an alternative to unfractionated heparin. (Level of Evidence: Grade A)"

"4. When a parenteral anticoagulant is needed to support PCI in a patient at lowrisk of bleeding, bivalirudin should be considered as alternative to unfractionated heparin. ([EHS ESC guidelines classification scheme#Level of Evidence|Level of Evidence: Grade B]])"

"5. In patients with ACS and AF at lowrisk of bleeding (HAS-BLED 0–2), the initial use of triple therapy (OAC, aspirin, and clopidogrel) should be considered for 6 months following PCI irrespective of stent type; this should be followed by long-term therapy (up to 12 months) with OAC and clopidogrel 75 mg/ day (or alternatively, aspirin 75–100 mg/day). (Level of Evidence: Grade C)"

"6. In patients with ACS and AF at high risk of bleeding (HAS-BLED ≥3), the initial use of triple therapy (OAC, aspirin, and clopidogrel) should be considered for 4 weeks following PCI irrespective of stent type; this should be followed by long-term therapy (up to 12 months) with OAC and a single antiplatelet drug (preferably clopidogrel 75 mg/day, or as an alternative, aspirin 75–100 mg/day). (Level of Evidence: Grade C)"

Class IIb

"1. In the ACS setting, patients are often given aspirin, clopidogrel, heparin (whether UFH or enoxaparin) or bivalirudin and/or a GP IIb/IIIa inhibitors. Given the risk of ischaemia and bleeding it may be prudent to stop OAC (i.e. whether NOAC or a VKA) therapy, and where a VKA or NOAC is used, administer UFH or bivalirudin only as bailout (but avoiding GP IIb/IIa inhibitors) or if INR ≤2 in a patient on VKA, balancing the acute need for additional antithrombotic therapy with the excess bleeding risk and the ‘thrombus burden’. (Level of Evidence: Grade C)"

"2. In low-risk ACS patients with delayed transfer for an invasive strategy at .24 h of admission, it may be prudent to stop OAC therapy and bridge the patient with unfractionated heparin or enoxaparin. (Level of Evidence: Grade C)"

"3. For a NOAC, cessation of the drug for 36–48 h (based on the biological half-life of the respective agents and the actual kidney function) may be prudent. (Level of Evidence: Grade B)"

"4. In selected patients with aCHA2DS2-VASc score ≥2 at low risk of bleeding (HAS-BLED 0–2), continuation of triple therapy or dual antiplatelet therapy consisting of OAC (i.e. whether NOAC or a VKA) and clopidogrel 75 mg/day may be considered between 6 and 12 months. (Level of Evidence: Grade C)"

"5. As an alternative to initial triple therapy in selected patients at high risk of bleeding (e.g. HAS-BLED ≥3) and low risk of stent thrombosis/recurrent ischaemic events, dual therapy consisting of OAC and clopidogrel 75 mg/day may be considered. (Level of Evidence: Grade C)"

"6. Combination OAC plus single antiplatelet therapy (preferably clopidogrel 75 mg/day, or as an alternative, aspirin 75–100 mg/day) may be considered in very selected cases, e.g. stenting of the left main, proximal left anterior descending, proximal bifurcation, recurrent MIs, etc. (Level of Evidence: Grade B)"

"7. The use of ticagrelor or prasugrel in combination with OAC may only be considered under certain circumstances (e.g. definite stent thrombosis while on clopidogrel, aspirin, and OAC). (Level of Evidence: Grade C)"

Primary PCI

Class I

"1. In the setting of STEMI, radial access for primary PCI is the best option to avoid procedural bleeding depending on operator expertise and preference. (Level of Evidence: A)"

"2. Long-term antithrombotic therapy (beyond 12 months) is recommended with OAC in all patients. (Level of Evidence: B)"

Class III

"1. The routine use of ticagrelor or prasugrel in combination with OAC is not recommended. (Level of Evidence: B)"

Class IIa

"1. In patients with STEMI and AF at low risk of bleeding (HAS-BLED 0–2), the initial use of triple therapy (OAC, aspirin, and clopidogrel) should be considered for 6 months following PCI irrespective of stent type; this should be followed by long-term therapy (up to 12 months) withOACand clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day). (Level of Evidence: Grade C)"

"2. In patients with STEMI and AF at high risk of bleeding (HAS-BLED ≥3), the initial use of triple therapy (OAC, aspirin, and clopidogrel) should be considered for 4 weeks following PCI irrespective of stent type; this should be followed by long-term therapy (up to 12 months) withOACand clopidogrel 75 mg/day (or alternatively, aspirin 75–100 mg/day). (Level of Evidence: Grade C)"

Class IIb

"1. In the acute setting, a patient with AF and STEMI may be treated with primary PCI, aspirin, clopidogrel, and heparin (UFH) or bivalirudin, while GP IIb/IIIa inhibitors in bailout situations might be useful in some cases. Given the risk of bleeding with such combination antithrombotic therapies, it may sometimes be prudent to temporarily stop OAC therapy. Regular or even ‘routine’ use of GP IIb/IIIa inhibitors is discouraged, as are the novel P2Y12 inhibitors. (Level of Evidence: Grade B)"

"2. In selected patients with STEMI and a CHA2DS2-VASc score ≥2 at low risk of bleeding (HAS-BLED 0–2), continuation of triple therapy or dual antiplatelet therapy consisting of OAC (i.e. whether NOAC or a VKA) and clopidogrel 75 mg/day may be considered between 6 and 12 months. (Level of Evidence: Grade C)"

"3. As an alternative to the initial triple therapy in selected patients at high risk of bleeding (e.g. HAS-BLED ≥3) and low risk of stent thrombosis/recurrent ischaemic events, dual therapy consisting of OAC and clopidogrel 75 mg/ day may be considered. (Level of Evidence: Grade B)"

"4. Combination OAC plus single antiplatelet therapy (preferably clopidogrel 75 mg/day, or as an alternative, aspirin 75– 100 mg/day) may sometimes be continued in very selected cases, e.g. stenting of the left main, proximal bifurcation, recurrent MIs, etc. (Level of Evidence: Grade B)"

"5. The use of ticagrelor or prasugrel in combination withOAC may only be considered under very circumstances (e.g. definite stent thrombosis while on clopidogrel, aspirin, and OAC). (Level of Evidence: Grade C)"

Application to General Anticoagulated Patients Who May or May Not Have AF

Class III

"1. NOACs must not be used in patients with mechanical heart valves or valvular atrial fibrillation. (Level of Evidence: B)"

Class IIa

"1. Where patients have AF and a prosthetic mechanical heart valve, such patients would be at substantial risk of thromboembolism and/or prosthetic valve thrombosis during interruption of anticoagulation using a VKA. These patients should undergo percutaneous procedures during anticoagulation with VKA with the lowest possible median INR within the therapeutic range based on risk factors and prosthesis thrombogenicity. (Level of Evidence: Grade B)"

"2. Patients with recent (3–6 months) or recurrent venous thromboembolism are at risk of recurrent events if anticoagulation is interrupted. Arterial access via the radial route should be preferred in such patients, especially during therapeutic anticoagulation (VKA, with INR 2–3; or NOACs) depending on operator expertise. (Level of Evidence: Grade C)"

"3. In patients with stable vascular disease (e.g. with no acute ischaemic events or PCI/stent procedure in the preceding 1 year),OAC monotherapy (well-controlledVKAor aNOAC) should be used, and concomitant antiplatelet therapy should not be prescribed on a routine basis. (Level of Evidence: Grade B)"

Class IIb

"1. Combination of OAC plus single antiplatelet therapy (preferably clopidogrel 75 mg/day, or as an alternative, aspirin 75–100 mg/day) may be sometimes continued in very selected cases, e.g. stenting of the left main, proximal left anterior descending, proximal bifurcation, recurrent MIs, etc. (Level of Evidence: Grade B)"

References

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