Coronary Artery Disease
Conditions
Brief summary
The OxOPT-PCI study addresses patients with coronary artery disease who are referred to the John Radcliffe Hospital because of the need for treatment with an intra-coronary stent (metal scaffold) for clinical reasons. Although, this has become a highly standardised procedure it is still challenging for the clinician to assess the final success of this procedure at the end of intervention with conventional methods. This shortcoming can potentially translate into a worse clinical outcome for approximately 10 percent of all patients treated with an intra-coronary stent for this type of disease. This study (OxOPT-PCI) investigates if the use of blood flow measurements (namely measurement of fractional flow reserve (FFR)) and intravascular imaging (namely optical coherence tomography (OCT)) after the implantation of a stent can improve the treatment result for these patients. Both, FFR and OCT are being used already in daily clinical routing but their usefulness especially in combination is not clear. In order to standardise the optimisation procedure we developed a specific algorithm to make sure that all patients receive the same optimisation measures based on the assessment of FFR and OCT. The benefit of this specific optimisation algorithm will be assessed by measuring 1) indices of coronary blood flow, 2) intravascular imaging at the end of the procedure, and 3) by contacting the patients 12 months after stenting to verify the clinical mid-term success.
Interventions
PROCEDUREOptimisation of the result of intracoronary stenting according to specific algorithm
Sponsors
Oxford University Hospitals NHS Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* participant is willing and able to give informed consent for participation in the study * angiogram shows haemodynamically relevant lesion suitable for PCI and suitable for the use of intravascular imaging (OCT)
Exclusion criteria
* patients in whom safety or clinical concerns preclude participation * ST-segment elevation myocardial infarction * presentation with cardiogenic shock * revascularization by mean of balloon angioplasty without stenting * contraindications to adenosine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Fractional Flow Reserve (FFR) After Intracoronary Stenting | Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stent-edge Dissection Assessed by OCT | During PCI procedure, OCT typically adds 5 minutes to the procedure | Defined 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 |
| Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT | During PCI procedure, OCT typically adds 5 minutes to the procedure | Defined as reference lumen area \<4.5 mm2, with significant residual plaque within 10 mm of stent edges |
| Number of Participants With Stent Malapposition Assessed by OCT | During PCI procedure, OCT typically adds 5 minutes to the procedure | Defined as stent-adjacent vessel lumen distance \> 200 μm |
| Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT | During PCI procedure, OCT typically adds 5 minutes to the procedure | Defined 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 |
| Number of Participants With Stent Under-expansion Assessed by OCT | During PCI procedure, OCT typically adds 5 minutes to the procedure | Defined as minimal stent area (MSA) \< 70% of average reference lumen area and/or MSA \< 4.5 mm2 |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
35 pts recruited
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Patients With a Suboptimal Functional Result (FFR <0.90) After Conventional PCI 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. | 21 |
| Group 2 Patients With a Satisfactory Functional Result (FFR ≥0.90) After Conventional PCI 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. | 14 |
| Total | 35 |
Baseline characteristics
| Characteristic | Group 1 Patients With a Suboptimal Functional Result (FFR <0.90) After Conventional PCI | Total | Group 2 Patients With a Satisfactory Functional Result (FFR ≥0.90) After Conventional PCI |
|---|---|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 8.4 | 64.4 years STANDARD_DEVIATION 8.4 | 64.8 years STANDARD_DEVIATION 8.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 35 Participants | 14 Participants |
| Region of Enrollment United Kingdom | 21 participants | 35 participants | 14 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 18 Participants | 29 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 14 |
| other Total, other adverse events | 0 / 21 | 0 / 14 |
| serious Total, serious adverse events | 0 / 21 | 0 / 14 |
Outcome results
Primary
Final Fractional Flow Reserve (FFR) After Intracoronary Stenting
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)
Time frame: Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A
Population: OCT-guided PCI optimisation was only performed in Group 1A
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1A: OCT-guided PCI Optimisation | Final Fractional Flow Reserve (FFR) After Intracoronary Stenting | Immediately post-stenting | 0.80 Ratio | Standard Deviation 0.02 |
| Group 1A: OCT-guided PCI Optimisation | Final Fractional Flow Reserve (FFR) After Intracoronary Stenting | Post OCT-guided optimisation | 0.88 Ratio | Standard Deviation 0.01 |
| Group 1B: No PCI Optimisation Performed | Final Fractional Flow Reserve (FFR) After Intracoronary Stenting | Immediately post-stenting | 0.84 Ratio | Standard Deviation 0.03 |
Secondary
Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT
Defined 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
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1A: OCT-guided PCI Optimisation | Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT | 1 Participants |
| Group 1B: No PCI Optimisation Performed | Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT | 1 Participants |
Secondary
Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT
Defined as reference lumen area \<4.5 mm2, with significant residual plaque within 10 mm of stent edges
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1A: OCT-guided PCI Optimisation | Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT | 5 Participants |
| Group 1B: No PCI Optimisation Performed | Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT | 0 Participants |
Secondary
Number of Participants With Stent-edge Dissection Assessed by OCT
Defined 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
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1A: OCT-guided PCI Optimisation | Number of Participants With Stent-edge Dissection Assessed by OCT | 2 Participants |
| Group 1B: No PCI Optimisation Performed | Number of Participants With Stent-edge Dissection Assessed by OCT | 1 Participants |
Secondary
Number of Participants With Stent Malapposition Assessed by OCT
Defined as stent-adjacent vessel lumen distance \> 200 μm
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1A: OCT-guided PCI Optimisation | Number of Participants With Stent Malapposition Assessed by OCT | 7 Participants |
| Group 1B: No PCI Optimisation Performed | Number of Participants With Stent Malapposition Assessed by OCT | 3 Participants |
Secondary
Number of Participants With Stent Under-expansion Assessed by OCT
Defined as minimal stent area (MSA) \< 70% of average reference lumen area and/or MSA \< 4.5 mm2
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1A: OCT-guided PCI Optimisation | Number of Participants With Stent Under-expansion Assessed by OCT | 6 Participants |
| Group 1B: No PCI Optimisation Performed | Number of Participants With Stent Under-expansion Assessed by OCT | 0 Participants |