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 journalArticleAcademicpeer-review

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 languageEnglish
Pages (from-to)52-61
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume15
Issue number1
DOIs
Publication statusPublished - 10 Jan 2022

Keywords

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

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