Trial Outcomes & Findings for The Oxford Optimisation of PCI Study (OXOPT-PCI Study) (NCT NCT03111940)
NCT ID: NCT03111940
Last Updated: 2021-04-08
Results Overview
After administration of intracoronary nitrates, FFR was measured under maximal hyperaemia, using intravenous adenosine (140 mg kg-1 min-1) as the ratio between distal coronary pressure (Pd) and aortic pressure (Pa)
COMPLETED
NA
35 participants
Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A
2021-04-08
Participant Flow
Eligible subjects were referred for elective or urgent complex PCI between September 2016 and July 2017 at the John Radcliffe Hospital, Oxford Heart Centre, United Kingdom. All patients underwent conventional angiography-guided stent deployment, until an acceptable angiographic result was achieved. Following completion of conventional PCI, FFR was measured, and intracoronary OCT imaging was performed. The study population was then divided into two groups based on the observed FFR value.
35 pts recruited
Participant milestones
| Measure |
Group 1 Patients With a Suboptimal Functional Result (FFR <0.90) After Conventional PCI
OCT was performed per protocol after achievement of satisfactory angiographic results. OCT was analysed according to the presence of one or more of the following according to CLI-OPCI study criteria: stent underexpansion and/or incomplete lesion coverage and/or stent malapposition and/or stent-edge dissection and/or intra-stent plaque/thrombus protrusion. Operators were mandated to perform PCI optimisation according to the respective OCT finding.
|
Group 2 Patients With a Satisfactory Functional Result (FFR ≥0.90) After Conventional PCI
No further PCI optimisation was performed and OCT acquisition was performed only as a safety measure, to assess the frequency of relevant vessel-related complications
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
14
|
|
Overall Study
COMPLETED
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Oxford Optimisation of PCI Study (OXOPT-PCI Study)
Baseline characteristics by cohort
| Measure |
Group 1 Patients With a Suboptimal Functional Result (FFR <0.90) After Conventional PCI
n=21 Participants
In patients in Group 1, OCT was performed per protocol after achievement of satisfactory angiographic results. OCT was analysed according to the CLI-OPCI study defining a suboptimal stent result according to specific criteria. For patients that fulfilled OCT criteria for optimisation (Group 1A), operators were mandated to perform PCI optimisation according to the respective OCT finding. For patients in Group 1 who did not fulfil the OCT criteria (Group 1B), further PCI optimisation was not performed.
|
Group 2 Patients With a Satisfactory Functional Result (FFR ≥0.90) After Conventional PCI
n=14 Participants
For patients in Group 2, no further PCI optimisation was performed and OCT acquisition was performed only as a safety measure, to assess the frequency of relevant vessel-related complications.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=5 Participants
|
14 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1APopulation: OCT-guided PCI optimisation was only performed in Group 1A
After administration of intracoronary nitrates, FFR was measured under maximal hyperaemia, using intravenous adenosine (140 mg kg-1 min-1) as the ratio between distal coronary pressure (Pd) and aortic pressure (Pa)
Outcome measures
| Measure |
Group 1A: OCT-guided PCI Optimisation
n=13 Participants
Patients from Group 1 who fulfilled the OCT criteria and further PCI optimisation was performed
|
Group 1B: No PCI Optimisation Performed
n=8 Participants
Patients from Group 1 who did not fulfil the OCT criteria, and thus, further PCI optimisation was not performed
|
|---|---|---|
|
Final Fractional Flow Reserve (FFR) After Intracoronary Stenting
Immediately post-stenting
|
0.80 Ratio
Standard Deviation 0.02
|
0.84 Ratio
Standard Deviation 0.03
|
|
Final Fractional Flow Reserve (FFR) After Intracoronary Stenting
Post OCT-guided optimisation
|
0.88 Ratio
Standard Deviation 0.01
|
—
|
SECONDARY outcome
Timeframe: During PCI procedure, OCT typically adds 5 minutes to the procedureDefined as presence of a linear rim of tissue ≥200 μm in width and with clear separation from the vessel wall, or underlying plaque \<5 mm from stent edges
Outcome measures
| Measure |
Group 1A: OCT-guided PCI Optimisation
n=13 Participants
Patients from Group 1 who fulfilled the OCT criteria and further PCI optimisation was performed
|
Group 1B: No PCI Optimisation Performed
n=14 Participants
Patients from Group 1 who did not fulfil the OCT criteria, and thus, further PCI optimisation was not performed
|
|---|---|---|
|
Number of Participants With Stent-edge Dissection Assessed by OCT
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During PCI procedure, OCT typically adds 5 minutes to the procedureDefined as reference lumen area \<4.5 mm2, with significant residual plaque within 10 mm of stent edges
Outcome measures
| Measure |
Group 1A: OCT-guided PCI Optimisation
n=13 Participants
Patients from Group 1 who fulfilled the OCT criteria and further PCI optimisation was performed
|
Group 1B: No PCI Optimisation Performed
n=14 Participants
Patients from Group 1 who did not fulfil the OCT criteria, and thus, further PCI optimisation was not performed
|
|---|---|---|
|
Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During PCI procedure, OCT typically adds 5 minutes to the procedureDefined as stent-adjacent vessel lumen distance \> 200 μm
Outcome measures
| Measure |
Group 1A: OCT-guided PCI Optimisation
n=13 Participants
Patients from Group 1 who fulfilled the OCT criteria and further PCI optimisation was performed
|
Group 1B: No PCI Optimisation Performed
n=14 Participants
Patients from Group 1 who did not fulfil the OCT criteria, and thus, further PCI optimisation was not performed
|
|---|---|---|
|
Number of Participants With Stent Malapposition Assessed by OCT
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During PCI procedure, OCT typically adds 5 minutes to the procedureDefined as tissue prolapsing between stent struts extending inside a circular arc connecting adjacent struts or intraluminal mass ≥500 μm thick with no direct connection to the vessel wall, or highly backscattered luminal protrusion in continuity with the vessel wall, resulting in signal-free shadowing
Outcome measures
| Measure |
Group 1A: OCT-guided PCI Optimisation
n=13 Participants
Patients from Group 1 who fulfilled the OCT criteria and further PCI optimisation was performed
|
Group 1B: No PCI Optimisation Performed
n=14 Participants
Patients from Group 1 who did not fulfil the OCT criteria, and thus, further PCI optimisation was not performed
|
|---|---|---|
|
Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During PCI procedure, OCT typically adds 5 minutes to the procedureDefined as minimal stent area (MSA) \< 70% of average reference lumen area and/or MSA \< 4.5 mm2
Outcome measures
| Measure |
Group 1A: OCT-guided PCI Optimisation
n=13 Participants
Patients from Group 1 who fulfilled the OCT criteria and further PCI optimisation was performed
|
Group 1B: No PCI Optimisation Performed
n=14 Participants
Patients from Group 1 who did not fulfil the OCT criteria, and thus, further PCI optimisation was not performed
|
|---|---|---|
|
Number of Participants With Stent Under-expansion Assessed by OCT
|
6 Participants
|
0 Participants
|
Adverse Events
PCI Optimisation
No PCI Optimisation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof Adrian Banning
Oxford Heart Centre, John Radcliffe Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place