Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study

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

doi:10.1016/j.jcin.2019.05.054

Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study

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

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

175 Scopus citations

Abstract

Objectives: This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). Background: Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. Methods: DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis. Results: An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. Conclusions: Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI.

Original language	English
Pages (from-to)	1991-2001
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	12
Issue number	20
DOIs	https://doi.org/10.1016/j.jcin.2019.05.054
State	Published - 28 Oct 2019
Externally published	Yes

Keywords

coronary physiology
ischemia
percutaneous coronary intervention

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10.1016/j.jcin.2019.05.054

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Jeremias, A., Davies, J. E., Maehara, A., Matsumura, M., Schneider, J., Tang, K., Talwar, S., Marques, K., Shammas, N. W., Gruberg, L., Seto, A., Samady, H., Sharp, A., Ali, Z. A., Mintz, G., Patel, M., & Stone, G. W. (2019). Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC: Cardiovascular Interventions, 12(20), 1991-2001. https://doi.org/10.1016/j.jcin.2019.05.054

@article{273f8e9eb02c411a8754e0cb2a945442,

title = "Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study",

abstract = "Objectives: This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). Background: Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. Methods: DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis. Results: An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. Conclusions: Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI.",

keywords = "coronary physiology, ischemia, percutaneous coronary intervention",

author = "Allen Jeremias and Davies, {Justin E.} and Akiko Maehara and Mitsuaki Matsumura 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 Andrew Sharp and Ali, {Ziad A.} and Gary Mintz and Manesh Patel and Stone, {Gregg W.}",

note = "Publisher Copyright: {\textcopyright} 2019 American College of Cardiology Foundation",

year = "2019",

month = oct,

day = "28",

doi = "10.1016/j.jcin.2019.05.054",

language = "English",

volume = "12",

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journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

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Jeremias, A, Davies, JE, Maehara, A, Matsumura, M, Schneider, J, Tang, K, Talwar, S, Marques, K, Shammas, NW, Gruberg, L, Seto, A, Samady, H, Sharp, A, Ali, ZA, Mintz, G, Patel, M & Stone, GW 2019, 'Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study', JACC: Cardiovascular Interventions, vol. 12, no. 20, pp. 1991-2001. https://doi.org/10.1016/j.jcin.2019.05.054

TY - JOUR

T1 - Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention

T2 - The DEFINE PCI Study

AU - Jeremias, Allen

AU - Davies, Justin E.

AU - Maehara, Akiko

AU - Matsumura, Mitsuaki

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

AU - Ali, Ziad A.

AU - Mintz, Gary

AU - Patel, Manesh

AU - Stone, Gregg W.

PY - 2019/10/28

Y1 - 2019/10/28

N2 - Objectives: This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). Background: Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. Methods: DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis. Results: An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. Conclusions: Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI.

AB - Objectives: This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). Background: Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. Methods: DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR <0.90. The causes of impaired iFR were categorized as stent related, untreated proximal or distal focal stenosis, or diffuse atherosclerosis. Results: An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. Conclusions: Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI.

KW - coronary physiology

KW - ischemia

KW - percutaneous coronary intervention

UR - http://www.scopus.com/inward/record.url?scp=85073078019&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2019.05.054

DO - 10.1016/j.jcin.2019.05.054

M3 - Article

C2 - 31648761

AN - SCOPUS:85073078019

SN - 1936-8798

VL - 12

SP - 1991

EP - 2001

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 20

ER -

Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study

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Keywords

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