Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting email@example.com.
Three studies are summarised in this briefing including a total of 183 lesions in 173 patients who had clinical indication for percutaneous coronary intervention (PCI). These studies have been assessed as most relevant from a wider evidence base.
Table 1 summarises the clinical evidence as well as its strengths and limitations.
The evidence suggests that Optowire may be associated with less pressure drift when measuring fractional flow reserve (FFR). This may mean that FFR is measured more accurately.
The studies in this briefing are non-comparative, single-centre, cohort studies (2 full publications and 1 conference abstract) with a small number of patients. A common feature across these studies was that FFR measurements were used for clinical decision making about whether stenting a stenosis was necessary. Two of the studies showed the feasibility of measuring FFR in a side-branch lesion after main vessel stenting; a procedure which is often difficult to do. No comparison with other guide wires means it is unknown how much reduced drift improves accuracy in FFR measurements. It is also unclear how the studies got the pressure drift threshold and FFR cut‑off points. A variation in FFR cut‑off points is seen across the studies. Results should be interpreted with caution because the impact of this variation is uncertain. Other outcomes assessed include the usability, safety and accuracy of the device.
These studies were not done in the UK and it is likely that clinical practice at the study sites may vary. Therefore the generalisability of the evidence to the NHS may be limited.
There are several published abstracts and conference posters for optical sensor guide wires that were not included in the evidence summary because they give limited additional information.
The drift-reduction for improved FFR using fiberoptic technology (DRIFT) study (OPSENS). ClinicalTrials.gov identifier: NCT03848650. Condition: left anterior descending coronary artery stenosis. Status: recruiting. Estimated completion date: January 2021. Location: US.
Assessing the accuracy of the Optowire Deux in a wire to wire comparison (ACCURACY). ClinicalTrials.gov identifier: NCT01751906. Condition: coronary artery disease. Status: recruiting. Estimated primary completion date: January 2020. Location: Canada.