1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial

Manesh R. Patel; Allen Jeremias; Akiko Maehara; Mitsuaki Matsumura; Zixuan Zhang; Joel Schneider; Kare Tang; Suneel Talwar; Koen Marques; Nicolas W. Shammas; Luis Gruberg; Arnold Seto; Habib Samady; Andrew S. P. Sharp; Ziad A. Ali; Gary Mintz; Justin Davies; Gregg W. Stone

doi:https://doi.org/10.1016/j.jcin.2021.09.042

1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial

Manesh R. Patel, Allen Jeremias, Akiko Maehara, Mitsuaki Matsumura, Zixuan Zhang, Joel Schneider, Kare Tang, Suneel Talwar, Koen Marques, Nicolas W. Shammas, Luis Gruberg, Arnold Seto, Habib Samady, Andrew S. P. Sharp, Ziad A. Ali, Gary Mintz, Justin Davies, Gregg W. Stone

Research output: Contribution to journal › Article › Academic › peer-review

41 Citations (Scopus)

Abstract

Objectives: The aim of this study was to identify the post–percutaneous coronary intervention (PCI) target value of instantaneous wave-free ratio (iFR) that would best discriminate clinical events at 1 year in the DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) study. Background: The impact of residual ischemia detected by iFR post-PCI on clinical and symptom-related outcomes is unknown. Methods: Blinded iFR pull back was performed after successful stent implantation in 500 patients. The primary endpoint was the rate of residual ischemia, defined as iFR ≤0.89, after operator-assessed angiographically successful PCI. Secondary endpoints included clinical events at 1 year and change in Seattle Angina Questionnaire angina frequency (SAQ-AF) score during follow-up. Results: As reported, 24.0% of patients had residual ischemia (iFR ≤0.89) after successful PCI, with 81.6% of cases attributable to angiographically inapparent focal lesions. Post-PCI iFR ≥0.95 (present in 182 cases [39%]) was associated with a significant reduction in the composite of cardiac death, spontaneous myocardial infarction, or clinically driven target vessel revascularization compared with post-PCI iFR <0.95 (1.8% vs 5.7%; P = 0.04). Baseline SAQ-AF score was 73.3 ± 22.8. For highly symptomatic patients (baseline SAQ-AF score ≤60), SAQ-AF score increased by ≥10 points more frequently in patients with versus without post-PCI iFR ≥0.95 (100.0% vs 88.5%; P = 0.01). Conclusions: In DEFINE PCI, despite angiographically successful PCI, highly symptomatic patients at baseline without residual ischemia by post-PCI iFR had greater reductions in anginal symptoms at 1 year compared with patients with residual ischemia. Achieving post-PCI iFR ≥0.95 was also associated with improved 1-year event-free survival. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)

Original language	English
Pages (from-to)	52-61
Number of pages	10
Journal	JACC: Cardiovascular Interventions
Volume	15
Issue number	1
DOIs	https://doi.org/10.1016/j.jcin.2021.09.042
Publication status	Published - 10 Jan 2022

Keywords

Seattle Angina Questionnaire Angina Frequency
instantaneous wave-free ratio
percutaneous coronary intervention
physiological measurements
residual ischemia

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https://doi.org/10.1016/j.jcin.2021.09.042

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Patel, M. R., Jeremias, A., Maehara, A., Matsumura, M., Zhang, Z., Schneider, J., Tang, K., Talwar, S., Marques, K., Shammas, N. W., Gruberg, L., Seto, A., Samady, H., Sharp, A. S. P., Ali, Z. A., Mintz, G., Davies, J., & Stone, G. W. (2022). 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial. JACC: Cardiovascular Interventions, 15(1), 52-61. https://doi.org/10.1016/j.jcin.2021.09.042

@article{5c147599c832476d88ac67348fc3fa09,

title = "1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial",

abstract = "Objectives: The aim of this study was to identify the post–percutaneous coronary intervention (PCI) target value of instantaneous wave-free ratio (iFR) that would best discriminate clinical events at 1 year in the DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) study. Background: The impact of residual ischemia detected by iFR post-PCI on clinical and symptom-related outcomes is unknown. Methods: Blinded iFR pull back was performed after successful stent implantation in 500 patients. The primary endpoint was the rate of residual ischemia, defined as iFR ≤0.89, after operator-assessed angiographically successful PCI. Secondary endpoints included clinical events at 1 year and change in Seattle Angina Questionnaire angina frequency (SAQ-AF) score during follow-up. Results: As reported, 24.0% of patients had residual ischemia (iFR ≤0.89) after successful PCI, with 81.6% of cases attributable to angiographically inapparent focal lesions. Post-PCI iFR ≥0.95 (present in 182 cases [39%]) was associated with a significant reduction in the composite of cardiac death, spontaneous myocardial infarction, or clinically driven target vessel revascularization compared with post-PCI iFR <0.95 (1.8% vs 5.7%; P = 0.04). Baseline SAQ-AF score was 73.3 ± 22.8. For highly symptomatic patients (baseline SAQ-AF score ≤60), SAQ-AF score increased by ≥10 points more frequently in patients with versus without post-PCI iFR ≥0.95 (100.0% vs 88.5%; P = 0.01). Conclusions: In DEFINE PCI, despite angiographically successful PCI, highly symptomatic patients at baseline without residual ischemia by post-PCI iFR had greater reductions in anginal symptoms at 1 year compared with patients with residual ischemia. Achieving post-PCI iFR ≥0.95 was also associated with improved 1-year event-free survival. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)",

keywords = "Seattle Angina Questionnaire Angina Frequency, instantaneous wave-free ratio, percutaneous coronary intervention, physiological measurements, residual ischemia",

author = "Patel, {Manesh R.} and Allen Jeremias and Akiko Maehara and Mitsuaki Matsumura and Zixuan Zhang and Joel Schneider and Kare Tang and Suneel Talwar and Koen Marques and Shammas, {Nicolas W.} and Luis Gruberg and Arnold Seto and Habib Samady and Sharp, {Andrew S. P.} and Ali, {Ziad A.} and Gary Mintz and Justin Davies and Stone, {Gregg W.}",

note = "Funding Information: The design and procedures of the DEFINE PCI study have been previously reported ( 8 ). Briefly, DEFINE PCI was a prospective, single-arm, blinded, multicenter study to assess the relationship between distal vessel iFR and iFR pull back and the distribution of physiologically significant coronary stenoses after successful PCI, as assessed by quantitative coronary angiography. DEFINE PCI was conducted at 28 sites in the United States and Europe. Institutional Review Boards or ethics committees at participating sites approved the study protocol, and all participants provided informed consent. The study was sponsored and funded by Philips/Volcano. The Cardiovascular Research Foundation was responsible for clinical event adjudication and core laboratory quantitative coronary angiographic and iFR analyses. An independent steering committee was responsible for the conduct, analysis, and reporting of the primary and 1-year findings of the study. Publisher Copyright: {\textcopyright} 2022",

year = "2022",

month = jan,

day = "10",

doi = "https://doi.org/10.1016/j.jcin.2021.09.042",

language = "English",

volume = "15",

pages = "52--61",

journal = "JACC: Cardiovascular Interventions",

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Patel, MR, Jeremias, A, Maehara, A, Matsumura, M, Zhang, Z, Schneider, J, Tang, K, Talwar, S, Marques, K, Shammas, NW, Gruberg, L, Seto, A, Samady, H, Sharp, ASP, Ali, ZA, Mintz, G, Davies, J & Stone, GW 2022, '1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial', JACC: Cardiovascular Interventions, vol. 15, no. 1, pp. 52-61. https://doi.org/10.1016/j.jcin.2021.09.042

TY - JOUR

T1 - 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI

T2 - DEFINE PCI Trial

AU - Patel, Manesh R.

AU - Jeremias, Allen

AU - Maehara, Akiko

AU - Matsumura, Mitsuaki

AU - Zhang, Zixuan

AU - Schneider, Joel

AU - Tang, Kare

AU - Talwar, Suneel

AU - Marques, Koen

AU - Shammas, Nicolas W.

AU - Gruberg, Luis

AU - Seto, Arnold

AU - Samady, Habib

AU - Sharp, Andrew S. P.

AU - Ali, Ziad A.

AU - Mintz, Gary

AU - Davies, Justin

AU - Stone, Gregg W.

N1 - Funding Information: The design and procedures of the DEFINE PCI study have been previously reported ( 8 ). Briefly, DEFINE PCI was a prospective, single-arm, blinded, multicenter study to assess the relationship between distal vessel iFR and iFR pull back and the distribution of physiologically significant coronary stenoses after successful PCI, as assessed by quantitative coronary angiography. DEFINE PCI was conducted at 28 sites in the United States and Europe. Institutional Review Boards or ethics committees at participating sites approved the study protocol, and all participants provided informed consent. The study was sponsored and funded by Philips/Volcano. The Cardiovascular Research Foundation was responsible for clinical event adjudication and core laboratory quantitative coronary angiographic and iFR analyses. An independent steering committee was responsible for the conduct, analysis, and reporting of the primary and 1-year findings of the study. Publisher Copyright: © 2022

PY - 2022/1/10

Y1 - 2022/1/10

N2 - Objectives: The aim of this study was to identify the post–percutaneous coronary intervention (PCI) target value of instantaneous wave-free ratio (iFR) that would best discriminate clinical events at 1 year in the DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) study. Background: The impact of residual ischemia detected by iFR post-PCI on clinical and symptom-related outcomes is unknown. Methods: Blinded iFR pull back was performed after successful stent implantation in 500 patients. The primary endpoint was the rate of residual ischemia, defined as iFR ≤0.89, after operator-assessed angiographically successful PCI. Secondary endpoints included clinical events at 1 year and change in Seattle Angina Questionnaire angina frequency (SAQ-AF) score during follow-up. Results: As reported, 24.0% of patients had residual ischemia (iFR ≤0.89) after successful PCI, with 81.6% of cases attributable to angiographically inapparent focal lesions. Post-PCI iFR ≥0.95 (present in 182 cases [39%]) was associated with a significant reduction in the composite of cardiac death, spontaneous myocardial infarction, or clinically driven target vessel revascularization compared with post-PCI iFR <0.95 (1.8% vs 5.7%; P = 0.04). Baseline SAQ-AF score was 73.3 ± 22.8. For highly symptomatic patients (baseline SAQ-AF score ≤60), SAQ-AF score increased by ≥10 points more frequently in patients with versus without post-PCI iFR ≥0.95 (100.0% vs 88.5%; P = 0.01). Conclusions: In DEFINE PCI, despite angiographically successful PCI, highly symptomatic patients at baseline without residual ischemia by post-PCI iFR had greater reductions in anginal symptoms at 1 year compared with patients with residual ischemia. Achieving post-PCI iFR ≥0.95 was also associated with improved 1-year event-free survival. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)

AB - Objectives: The aim of this study was to identify the post–percutaneous coronary intervention (PCI) target value of instantaneous wave-free ratio (iFR) that would best discriminate clinical events at 1 year in the DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) study. Background: The impact of residual ischemia detected by iFR post-PCI on clinical and symptom-related outcomes is unknown. Methods: Blinded iFR pull back was performed after successful stent implantation in 500 patients. The primary endpoint was the rate of residual ischemia, defined as iFR ≤0.89, after operator-assessed angiographically successful PCI. Secondary endpoints included clinical events at 1 year and change in Seattle Angina Questionnaire angina frequency (SAQ-AF) score during follow-up. Results: As reported, 24.0% of patients had residual ischemia (iFR ≤0.89) after successful PCI, with 81.6% of cases attributable to angiographically inapparent focal lesions. Post-PCI iFR ≥0.95 (present in 182 cases [39%]) was associated with a significant reduction in the composite of cardiac death, spontaneous myocardial infarction, or clinically driven target vessel revascularization compared with post-PCI iFR <0.95 (1.8% vs 5.7%; P = 0.04). Baseline SAQ-AF score was 73.3 ± 22.8. For highly symptomatic patients (baseline SAQ-AF score ≤60), SAQ-AF score increased by ≥10 points more frequently in patients with versus without post-PCI iFR ≥0.95 (100.0% vs 88.5%; P = 0.01). Conclusions: In DEFINE PCI, despite angiographically successful PCI, highly symptomatic patients at baseline without residual ischemia by post-PCI iFR had greater reductions in anginal symptoms at 1 year compared with patients with residual ischemia. Achieving post-PCI iFR ≥0.95 was also associated with improved 1-year event-free survival. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)

KW - Seattle Angina Questionnaire Angina Frequency

KW - instantaneous wave-free ratio

KW - percutaneous coronary intervention

KW - physiological measurements

KW - residual ischemia

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U2 - https://doi.org/10.1016/j.jcin.2021.09.042

DO - https://doi.org/10.1016/j.jcin.2021.09.042

M3 - Article

C2 - 34991824

SN - 1936-8798

VL - 15

SP - 52

EP - 61

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 1

ER -

1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial

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Keywords

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