Rivaroxaban for PAD or CAD: Review in Primary Care (Guidelines)

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Rivaroxaban is an oral anticoagulant licensed for prevention of atherothrombotic event in patients with peripheral arterial disease (PAD)  or coronary artery disease (CAD) at high risk of these events. 

It is licensed at a dose of 2.5mg twice daily in combination with aspirin 75mg daily.  Initiation will be on the advice of a Consultant Vascular Surgeon or Consultant Cardiologist only, but prescribing and review will take place in primary care.

Patients should be reviewed in line with this guideline at initiation of therapy (as the secondary care physician recommending initiation of therapy may not have access to other medicines taken, for example) and thereafter annually, or if the patient presents with any signs or symptoms of an adverse drug reaction.

Management

Patients should be reviewed and the following contra-indications, cautions, drug interactions and counselling points should be checked at initiation of therapy and annually thereafter.

There is no formal tool to assess bleeding risk with rivaroxaban 2.5mg for this indication. Therefore risks and benefits of treatment should be reviewed and referral to secondary care considered if any concerns around continuing therapy (see below).

Review should include FBC to check Hb and haematocrit to detect any occult bleeding. The patient should be asked about any signs of bleeding including epistaxis, gingival, gastro-intestinal and genito-urinary.

Contra-indications (do NOT prescribe rivaroxaban):
  • Clinically significant active bleeding (resulting in Hb drop)
  • Current or recent GI ulcers
  • Malignant neoplasms at high risk of bleeding
  • Recent brain or spinal injury or surgery
  • Recent ophthalmic surgery
  • Recent intracranial haemorrhage
  • Known or suspected oesophageal varices
  • Arteriovenous malformations
  • Vascular aneurysms
  • Cirrhotic patients with a Childs-Pugh score of B or C
  • Pregnancy and breast feeding
  • Previous stroke or TIA
  • Creatinine clearance less than 15mL/min
Cautions (review risks and benefits of initiating or continuing therapy, consider referral back to secondary care)
  • Congenital or acquired bleeding disorders
  • Inflammatory bowel disease; oesophagitis; gastritis; GORD; previous gastroduodenal ulcer or GI bleed
  • On concomitant medicines increasing risk of GI bleed (see below and BNF)
  • Old age/frailty with multiple co-morbidities: consider GI protection in these patients.
  • Bronchiectasis or history of pulmonary bleeding
  • Uncontrolled hypertension with systolic BP greater than 160mmHg
  • Previous major bleed
  • Renal disease with Creatinine less than 200 micromol/L

See gastro-protection guidance for patients on dual anti-platelet therapy, which could also be extrapolated for this treatment combination. 

Drug interactions

Assess individually; consider whether interacting medicine can be reviewed, refer back to secondary care if already on dual antiplateley therapy (DAPT) or anticoagulation to confirm that combination should be continued.
Note this list is not comprehensive, also refer to BNF or Stockley’s Drug Interactions (www.medicinescomplete.com – no login required on NHS computers)

  • Other anticoagulant therapy
  • Patients already receiving DAPT
  • Patients taking azole antifungals (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) – these can increase the concentration of rivaroxaban and increase risk of bleeding
  • NSAIDs
  • SSRIs and SNRIs (inhibitor platelet aggregation)
Counselling
  • Ensure taken with food 
  • Review and optimise other secondary preventative measures for PAD/CAD including smoking cessation, diet, use of lipid lowering agents and blood pressure control.

Referral

If any contra-indications present at initial prescribing or subsequent reviews: do not prescribe, or stop therapy. Refer back to Consultant Vascular Surgeon or Consultant Cardiologist initiating therapy.

Any concerns that risk of bleeding may exceed benefits of therapy: discuss with Consultant Vascular Surgeon or Consultant Cardiologist initiating therapy.

Patient already prescribed DAPT or anticoagulation: discuss with Consultant Vascular Surgeon or Consultant Cardiologist to confirm duration of therapy (e.g. DAPT likely to be short-term only) and plans for long-term treatment.

Further information for Healthcare Professionals

Summary of Product Characteristics, rivaroxaban 2.5mg (Bayer Plc Ltd): https://www.medicines.org.uk/emc/product/3410/smpc#gref

SMC Advice, rivaroxaban 2.5mg film coated tablets: https://www.scottishmedicines.org.uk/media/4130/rivaroxaban-xarelto-final-jan-2019-for-website.pdf

Patient information

Refer to patient information leaflet provided with medication.

Xarelto PIL: https://www.medicines.org.uk/emc/product/3410/pil

Glossary

  • BNF: British National Formulary
  • BP: blood pressure
  • CAD: coronary artery disease
  • DAPT: Dual antiplatelet therapy
  • GI: gastrointestinal
  • GORD: gastro-oesophageal reflux disease
  • Hb: haemoglobin
  • IBD: inflammatory bowel disease
  • NSAIDs: non-steroidal anti-inflammatory drugs
  • PAD: peripheral arterial disease
  • SNRIs: selective noradrenalin reuptake inhibitors
  • SSRIs: selective serotonin reuptake inhibitors

Editorial Information

Last reviewed: 29/10/2020

Next review date: 29/10/2023

Author(s): Formulary .

Version: 1

Approved By: TAM subgroup of ADTC

Reviewer name(s): Jane Wylie, Lead Pharmacist .

Document Id: TAM464