Supporting GPs with Extended Ticagrelor Therapy for Post MI Patients

• Introduction
• Options for clinicians when review is due
• Assessing the risk of bleeding
• The Ticagrelor Virtual Review Service
• FAQs – won’t be applicable when in AL2 guidance format

Introduction

Patients who are taking dual antiplatelet therapy (DAPT) of aspirin and ticagrelor or prasugrel post MI might be suitable for extended ticagrelor therapy if they are at high risk of further atherothrombotic event in line with NICE TA 420.

The NHS Leeds Clinical Commissioning Groups Partnership has commissioned an LTHT consultant cardiology pharmacist to support the review of patients who need extended Ticagrelor therapy post MI. This will be a virtual review by secondary care followed by recommendations and advice. Details of how to access this service are provided below. (The Ticagrelor Virtual Review Service)

Extended Ticagrelor therapy is defined as follows:

• Stopping Ticagrelor 90mg twice daily or Prasugrel 10mg/5mg OD at 12 months.
• Continuing with Aspirin 75mg once daily life long.
• Starting Ticagrelor 60mg twice daily for 3 years post initial 12-month period following MI DAPT course.

Patients at high risk of a further atherothrombotic event include:

Patients who have had a myocardial infarction in the last 1-3 years and at least 50 years of age PLUS at least one of the following additional atherothrombosis risk factors:

• age >=65 years
• diabetes mellitus requiring medication
• a second prior spontaneous myocardial infarction
• multi-vessel coronary artery disease
• Non end stage chronic kidney disease patients (defined as an estimated CrCl < 60 mL/min) who are not active on the renal transplant waiting list

The following patients should be excluded from extended DAPT with Ticagrelor 60mg BD (partially according to PEGASUS[1] study)

• Planned use of P2Y12 antagonist other than ticagrelor or prasugrel e.g., clopidogrel, dipyridamole, cilostazol, or anticoagulation)
• History of gastrointestinal bleed in the past 6 months or bleeding disorder
• Major surgery in the past 30 days
• Central nervous system tumour, intracranial vascular abnormality, prior intracranial haemorrhage.
• Clinically significant bradycardia has occurred during the 12 months while on ticagrelor
• Dialysis or severe liver disease
  • Non end stage chronic kidney disease patients who are active on the kidney transplant waiting list (for potential pre-emptive kidney transplantation)

We would also exclude any patients who were treated with a Coronary artery bypass graft (CABG) for the index event (any patient with a historical CABG can be considered) or who have had a previous ischaemic stroke.

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Options for clinicians when review is due

• Please note continuing a patient on aspirin plus ticagrelor 90mg twice daily or prasugrel 5/10mg OD beyond 12 months is unlicensed and not recommended as this carries a higher bleed risk than the licensed option available.

After 12 months initial DAPT post MI for patients in the at-risk group above, the options for primary care clinicians are:

• If cardiology has already recommended continuing with extended DAPT, then assess risk of bleeding and switch to Ticagrelor 60mg BD if the patient agrees. The GP should record on the repeat prescribing screen the date when the ticagrelor 60mg BD should be reviewed and stopped i.e. 3 years after it was commenced. If you feel a review is needed, then please refer to the Ticagrelor Virtual Review Service. 
• If no recommendation was made and the patient does meet the above high-risk criteria you can either (depending on risk of bleeding and atherothrombosis risk factors[1]):
• with the patient’s agreement, continue the patient on DAPT of aspirin 75mg daily while reducing ticagrelor to 60mg twice daily until review, and refer to Ticagrelor Virtual Review Service.
• Or if you suspect that patient is at high risk of bleeding, stop the second antiplatelet, advise patient to continue a single antiplatelet agent (aspirin), and refer to the Ticagrelor Virtual Review Service.

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Assessing the risk of bleeding

The assessment of the bleeding risks is important at the point of deciding on extended DAPT. NICE TA 420 does not specify how to do this.

GPs should exercise their clinical judgments when assessing the risk of bleeding. However, to support clinicians with this decision, the European Society of Cardiology (ESC) has produced an update on use of DAPT. The ESC 2017 update on use of DAPT asserts that the use of risk stratification scoring tools might prove useful to tailor DAPT duration in order to maximize ischaemic protection and minimize bleeding risks in the individual patient.

The tool recommended is the PRECISE-DAPT scoring tool. This tool was developed to be used at the time of initiation of DAPT but will be adapted in Leeds for use at 12 months by the Ticagrelor Virtual Review Service. As the scoring is dependent on levels of haemoglobin, white cell count and creatinine, it is recommended to have a recent FBC and U&Es especially if the patient is likely to be at high risk of bleeding (e.g., patient with a history of anaemia). Patients with a high risk of bleeding should ideally have recent bloods, no more than 1 month old.

A web-based calculator of the PRECISE-DAPT score can be accessed at:

http://www.precisedaptscore.com/predapt/webcalculator.html

Interpretation of the PRECISE-DAPT score results:

Based on ESC guidance extended DAPT is not recommended in patients with a PRECISE-DAPT score of greater than 25 ²

However, treatment risks and benefits should always be considered in the context of a comprehensive professional clinical assessment, considering all available data and treatment options. Physicians and other healthcare providers should always exercise their own clinical judgment for any given situation.

If unsure, please obtain advice from the Ticagrelor Virtual Review Service.

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The Ticagrelor Virtual Review Service

The assessment of the bleeding risks is important at the point of deciding on extended DAPT. NICE TA 420 does not specify how to do this.

GPs should exercise their clinical judgments when assessing the risk of bleeding. However, to support clinicians with this decision, the European Society of Cardiology (ESC) has produced an update on use of DAPT. The ESC 2017 update on use of DAPT asserts that the use of risk stratification scoring tools might prove useful to tailor DAPT duration in order to maximize ischaemic protection and minimize bleeding risks in the individual patient.

The tool recommended is the PRECISE-DAPT scoring tool. This tool was developed to be used at the time of initiation of DAPT but will be adapted in Leeds for use at 12 months by the Ticagrelor Virtual Review Service. As the scoring is dependent on levels of haemoglobin, white cell count and creatinine, it is recommended to have a recent FBC and U&Es especially if the patient is likely to be at high risk of bleeding (e.g., patient with a history of anaemia). Patients with a high risk of bleeding should ideally have recent bloods, no more than 1 month old.

A web-based calculator of the PRECISE-DAPT score can be accessed at:

http://www.precisedaptscore.com/predapt/webcalculator.html

Interpretation of the PRECISE-DAPT score results:

Based on ESC guidance extended DAPT is not recommended in patients with a PRECISE-DAPT score of greater than 25 ²

However, treatment risks and benefits should always be considered in the context of a comprehensive professional clinical assessment, considering all available data and treatment options. Physicians and other healthcare providers should always exercise their own clinical judgment for any given situation.

If unsure, please obtain advice from the Ticagrelor Virtual Review Service.

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