Trial Outcomes & Findings for Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain? (NCT NCT01070771)

Last Updated: 2019-05-22

Results Overview

This outcome measure was assessing agreement in the management plan (MP) derived from angiographic assessment alone compared to a MP derived from angiographic assessment plus the use of FFR data acquired at the time of angiography. The study assessed the proportion of cases in which the angiogram directed MP changed after FFR data were disclosed.

Recruitment status

COMPLETED

Study phase

Target enrollment

203 participants

Primary outcome timeframe

Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.

Results posted on

2019-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Radi Pressure Wire Assessment of physiological significance of coronary artery narrowings by measurement of blood flow limitation across lesion.
Overall Study STARTED	203
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Radi Pressure Wire Assessment of physiological significance of coronary artery narrowings by measurement of blood flow limitation across lesion.
Overall Study Adverse Event	2
Overall Study Protocol Violation	1

Baseline Characteristics

Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radi Pressure Wire n=200 Participants
Age, Continuous	64 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants
Region of Enrollment United Kingdom	200 participants n=5 Participants

PRIMARY outcome

Timeframe: Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.

Outcome measures

Outcome measures
Measure	Radi Pressure Wire n=200 Participants
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) Agreement with management plan	147 participants
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) Change in management plan after FFR	53 participants
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) Recommended medical treatment alone	72 participants
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) Revascularisation was advised after FFR	9 participants
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) Optimal medical therapy recommended after FFR	89 participants
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) Recommended revascularisation after angiogram	25 participants
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) Recommendation of PCI after angio assessment	90 participants
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) Of the 90 FFR detected no significant stenosis	24 participants

SECONDARY outcome

Timeframe: Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected.

This compared the number of vessels in which there was a discrepant result in relation to angiographically and FFR defined significance. Angiographic significance was visually assessed by operators whereas the pressure wire provided objective data as to a narrowing's significance: an FFR reading of \<0.8 indicated a significant restriction in blood flow with a recommendation for revascularisation. The difference in indication for revascularisation of each major coronary artery was also judged according to angiogram alone compared with angiogram plus FFR dtaa.

Outcome measures

Outcome measures
Measure	Radi Pressure Wire n=200 Participants
To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. significant 3 vessel disease at angio:negative FFR	1 participants
To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. Number of vessels significantly changed after FFR	64 participants
To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. No significant CAD after angiography alone	81 participants
To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. Of the 81, significant FFR (<0.8)	18 participants
To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. No haemodynamically signifiacnt CAD after FFR	89 participants
To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. Of the 89, angio labelled as single vessel disease	24 participants
To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. of the 89, angio labelled as 2 vessel disease	1 participants
To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. of the 89, angio labelled as 3 vessel disease	1 participants

Adverse Events

RADI Pressure Wire

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RADI Pressure Wire n=200 participants at risk
Cardiac disorders Vessel occlusion	0.50% 1/200 • Number of events 1 Only serious adverse events were collected
Cardiac disorders Coronary artery dissection	0.50% 1/200 • Number of events 1 Only serious adverse events were collected
Cardiac disorders Ventricular fibrillation	0.50% 1/200 • Number of events 1 Only serious adverse events were collected
Vascular disorders Deep vein thrombosis	0.50% 1/200 • Number of events 1 Only serious adverse events were collected

Other adverse events

Adverse event data not reported

Additional Information

Professor Nick Curzen

University Hospital Southampton NHS Foundation Trust

Phone: +44 023 80777222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60