Author + information
- Received April 8, 2019
- Revision received May 28, 2019
- Accepted May 31, 2019
- Published online October 21, 2019.
- Allen Jeremias, MD, MSca,b,∗ (, )
- Justin E. Davies, MBBS, PhDc,
- Akiko Maehara, MDb,d,
- Mitsuaki Matsumura, BSb,
- Joel Schneider, MDe,
- Kare Tang, MBBAf,
- Suneel Talwar, MBBAg,
- Koen Marques, MDh,
- Nicolas W. Shammas, MD, MSi,
- Luis Gruberg, MDj,
- Arnold Seto, MDk,
- Habib Samady, MDl,
- Andrew Sharp, MDm,
- Ziad A. Ali, MD, DPhilb,d,
- Gary Mintz, MDb,
- Manesh Patel, MDn and
- Gregg W. Stone, MDb,d
- aSt. Francis Hospital, Roslyn, New York
- bCardiovascular Research Foundation, New York, New York
- cHammersmith Hospital, Imperial College NHS Trust, London, United Kingdom
- dColumbia University Medical Center, New York, New York
- eNorth Carolina Heart and Vascular, Raleigh, North Carolina
- fEssex Cardiothoracic Centre, Basildon, United Kingdom
- gRoyal Bournemouth Hospital, Bournemouth, United Kingdom
- hVU University Medical Center, Amsterdam, the Netherlands
- iMidwest Cardiovascular Research Foundation, Davenport, Iowa
- jNorthwell Health, New York, New York
- kVAMC Long Beach, Long Beach, California
- lEmory University Hospital, Atlanta, Georgia
- mRoyal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom
- nDuke University Hospital, Durham, North Carolina
- ↵∗Address for correspondence:
Dr. Allen Jeremias, St. Francis Hospital, The Heart Center, Department of Cardiology, 100 Port Washington Boulevard, #105, Roslyn, New York 11576.
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. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)
This study was supported by funding from Philips/Volcano Corporation. The funding source was uninvolved with the design of the protocol and the analysis and interpretation of the study results. Dr. Jeremias has received institutional funding (unrestricted education grant) from and serves as a consultant for Philips/Volcano, Abbott Vascular, Opsens Medical, and Boston Scientific. Dr. Davies has patents pertaining to the instantaneous wave-free ratio technology; and has received research funding from and is a consultant for Philips/Volcano. Dr. Shammas has received research and educational grants from Boston Scientific, Phillips, Intact Vascular, VentureMed Group, and Bard; and is a member of the Speakers Bureaus of Janssen, Boehringer Ingelheim, Novartis, and Zoll Medical. Dr. Sharp is a consultant for Philips Volcano. Dr. Ali has received grant support from Abbott Vascular; is a consultant for Abbott Vascular, Boston Scientific, Opsens Medical, Cardinal Health, and Cardiovascular Systems; and holds equity in Shockwave Medical. Dr. Patel has received research grants from Philips/Volcano, Bayer, Janssen, and the National Heart, Lung, and Blood Institute; and is an advisory board member for Bayer and Janssen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 8, 2019.
- Revision received May 28, 2019.
- Accepted May 31, 2019.
- 2019 American College of Cardiology Foundation
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