Trial Outcomes & Findings for Physiologic Assessment of Coronary Stenosis Following PCI (NCT NCT03084367)

NCT ID: NCT03084367

Last Updated: 2022-05-10

Results Overview

Residual ischemia is defined as iFR measurement \<0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis \<50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR\<0.90) after a PCI that appeared to be successful based on angiography.

• Recruitment status: COMPLETED
• Target enrollment: 500 participants
• Primary outcome timeframe: end of procedure/intervention
• Results posted on: 2022-05-10

Participant Flow

Participant milestones

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.
Overall Study STARTED	500
Overall Study Analyzable iFR Pullback Assessment Post Angiographically Successful PCI	467
Overall Study COMPLETED	463
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.
Overall Study Lost to Follow-up	32
Overall Study Withdrawal by Subject	4
Overall Study Other	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Diagnostic Test: iFR Pullback n=500 Participants iFR (instantaneous wave free ratio) pullback assessment post angiographically successful PCI
Age, Continuous	66.4 years STANDARD_DEVIATION 9.9 • n=500 Participants
Sex: Female, Male Female	121 Participants n=500 Participants
Sex: Female, Male Male	379 Participants n=500 Participants
BMI (Body Mass Index)	30.8 kg/m^2 STANDARD_DEVIATION 8.8 • n=500 Participants
Smoker	83 Participants n=500 Participants
Diabetes Mellitus	169 Participants n=500 Participants
Insulin treated diabetes	48 Participants n=500 Participants
Hyperlipidemia	351 Participants n=500 Participants
Hypertension	383 Participants n=500 Participants
Renal disease	39 Participants n=500 Participants
Prior Percutaneous Coronary Intervention (PCI)	227 Participants n=500 Participants
Prior Myocardial Infarction	134 Participants n=500 Participants
Left ventricular ejection fraction (%)	56.3 % of blood ejected with each contraction STANDARD_DEVIATION 9 • n=500 Participants
Stable angina	212 Participants n=500 Participants
Unstable Angina	155 Participants n=500 Participants
NSTEMI (Non-ST Elevated Myocardial Infarction)	85 Participants n=500 Participants
Silent Ischemia	27 Participants n=500 Participants
Recent STEMI (ST Elevated MI) (>7days)	21 Participants n=500 Participants

PRIMARY outcome

Timeframe: end of procedure/intervention

Population: Total vessels/units (535) in participant population (467)

Residual ischemia is defined as iFR measurement <0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis <50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR<0.90) after a PCI that appeared to be successful based on angiography.

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=535 Number of vessels in 467 participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 Participants with iFR \< 0.90 post-procedure
Number of Participants With Residual Ischemia (iFR <0.90)	112 participants	—

SECONDARY outcome

Timeframe: 12 months

Population: The total number of participants was divided in two groups based on their post-PCI iFR result. (see primary endpoint) The total number of participants still in study at one year is 467.

Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=355 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 n=112 Participants Participants with iFR \< 0.90 post-procedure
Cardiac Events	9 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 months

Population: The total number of participants was divided in two groups based on their post-PCI iFR result. (see primary endpoint) The total number of participants still in study at one year is 467.

Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=355 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 n=112 Participants Participants with iFR \< 0.90 post-procedure
Target Vessel Failure	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 months

Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months).

Minimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score.

Outcome is the change in score from baseline to 12 months follow-up.

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=246 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 n=150 Participants Participants with iFR \< 0.90 post-procedure
Quality of Life Change From Baseline to 12 Months Follow-up	21.42 units on a scale Standard Deviation 24.99	20.73 units on a scale Standard Deviation 21.83

SECONDARY outcome

Timeframe: 12 months

All-cause and cardiac mortality at one year

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=355 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 n=112 Participants Participants with iFR \< 0.90 post-procedure
Cardiac Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 month

Target vessel Myocardial infarction at one year

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=355 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 n=112 Participants Participants with iFR \< 0.90 post-procedure
Target Vessel MI	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 month

Ischemia-driven target vessel revascularization at one year

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=355 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 n=112 Participants Participants with iFR \< 0.90 post-procedure
Target Vessel Revascularization	10 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 month

Recurrent ischemia at one-year

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=355 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 n=112 Participants Participants with iFR \< 0.90 post-procedure
Recurrent Ischemia	6 Participants	1 Participants

SECONDARY outcome

Timeframe: at the end of the procedure/intervention

Population: The correlation calculation was performed on the total number of analyzable participants with a post-PCI iFR pullback assessment.

Correlation between iFR <0.90 and coronary stenosis >50% assessed by visual interpretation.

This was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject.

An absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography.

Outcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR <0.90 and coronary stenosis >50% assessed by visual interpretation the correlation is 1).

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=467 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 Participants with iFR \< 0.90 post-procedure
Correlation Between iFR and Angiographic Visual Interpretation	0.03 coefficient of determination (R2)	—

SECONDARY outcome

Timeframe: Procedural

Population: This analysis assumes that all focal lesions with post-PCI iFR \<0.90 were successfully treated with additional PCI. Using the cutoff of iFR \<0.90, the outcome is the number of participants that would remain, or not have been treated, because the iFR measurements are under 0.90.

Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=467 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 Participants with iFR \< 0.90 post-procedure
Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI	23 Participants	—

SECONDARY outcome

Timeframe: End of procedure /intervention

Population: Number of vessels in which residual ischemia (post-PCI iFR \<0.90) after angiographically successful PCI

Differentiation of the cause for impaired iFR

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=114 vessels all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 Participants with iFR \< 0.90 post-procedure
Differentiation single or multiple residual focal lesions	93 vessels	—
Differentiation diffuse disease	21 vessels	—

SECONDARY outcome

Timeframe: at the end of the procedure/intervention

Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be <0.90. An OR > 1 means greater odds that the post-PCI iFR is <0.90, OR = 1 means there is no association, and OR < 1 means there is a lower odds that the post-PCI iFR is <0.90.

Outcome measures

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=467 Participants all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.	iFR < 0.90 Participants with iFR \< 0.90 post-procedure
Delta iFR pre-PCI reference vessel diameter	0.32 Odds ratio	—
Delta iFR lesion location in left anterior descending coronary artery	5.65 Odds ratio	—

Adverse Events

All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI n=467 participants at risk all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.
Cardiac disorders Target Vessel Myocardial Infarction	1.3% 6/467 • Number of events 6 • Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects were collected and if any occurred, they would likely occur during the procedure when the device is being used. Subjects were followed for 12 months and all complaints promptly reported. As noted above, the only reportable events were Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects. Subjects were followed for 12 months, with follow-up visits at 1, 6, and 12 months.
Cardiac disorders Ischemia-driven Target Vessel Revascularization	0.00% 0/467 • Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects were collected and if any occurred, they would likely occur during the procedure when the device is being used. Subjects were followed for 12 months and all complaints promptly reported. As noted above, the only reportable events were Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects. Subjects were followed for 12 months, with follow-up visits at 1, 6, and 12 months.
Cardiac disorders Recurrent Ischemia	1.5% 7/467 • Number of events 7 • Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects were collected and if any occurred, they would likely occur during the procedure when the device is being used. Subjects were followed for 12 months and all complaints promptly reported. As noted above, the only reportable events were Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects. Subjects were followed for 12 months, with follow-up visits at 1, 6, and 12 months.
Cardiac disorders Cardiac Death	0.00% 0/467 • Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects were collected and if any occurred, they would likely occur during the procedure when the device is being used. Subjects were followed for 12 months and all complaints promptly reported. As noted above, the only reportable events were Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects. Subjects were followed for 12 months, with follow-up visits at 1, 6, and 12 months.

Other adverse events

Adverse event data not reported

Additional Information

Becky Inderbitzen, Global Director, Clinical Development

Philips (Volcano)

Phone: +1.858.764.1336

Email: becky.inderbitzen@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place