Advice

Summary

Summary

Effectiveness

  • Evidence comes from 3 large multicentre randomised controlled trials, 1 single centre randomised controlled trial and 1 large register.

  • Three systematic reviews, 4 randomised controlled trials and 1 large cohort study indicate that the PressureWire devices can be effective as adjuncts to coronary angiography to identify functionally significant stenosis.

  • In patients with stable coronary artery disease and fractional flow reserve (FFR) of less than 0.8, outcomes were better for FFR-guided percutaneous coronary intervention (PCI) than for medical treatment alone.

Adverse events and safety

  • An FFR-guided strategy, compared with an angiography-guided approach, resulted in no statistically significant difference in relative risk reduction for major adverse cardiac event outcomes.

  • In 1 randomised controlled trial, major adverse cardiac events were significantly improved by FFR-guided PCI at 1 year, but the difference was not significant at 2 years. There were significantly fewer myocardial infarction events in the FFR-guided PCI group at 2 years than in the angiography group.

Costs and resource use

  • The PressureWire Aeris costs £598.80 and PressureWire Certus (with Agile tip) costs £499. Each PressureWire FFR device is single use.

  • Four economic analyses evaluated FFR guided-strategies using the PressureWire FFR devices, but no published economic analyses based in the UK were identified.

Technical factors

  • PressureWire FFR devices are used by interventional cardiologists in a cardiac catheterisation laboratory setting.

  • The PressureWire Certus device is used with the Quantien proprietary monitor unit (St Jude Medical), purchased separately; the PressureWire Aeris device uses wireless transmission to a receiver unit connected to monitoring platforms with FFR capability.