International Post PCI FFR Registry
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Observational [Patient Registry]

Summary: 
      The prognostic factors after a percutaneous coronary intervention (PCI) have not been
      comprehensively investigated. The investigators sought to develop a risk model to predict
      future clinical events after PCI using contemporary coronary stents.
    

Detailed description: 
      Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery
      disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death,
      myocardial infarction (MI) and revascularization compared to medical therapy. However, the
      risk of future clinical events still remain high and about 10% of patients experienced
      further cardiovascular events after PCI. There are several factors that are associated with
      these poor outcomes. Known patient-related risk factors are diabetes mellitus, chronic kidney
      disease, left ventricular dysfunction, previous MI and presentation with the acute coronary
      syndrome. Procedure-related factors, such as stent underexpension, malapposition, edge
      dissection, the number of the used stent and total stent length, are also related to poor
      prognosis after PCI. Recent studies reported that fractional flow reserve (FFR) after
      coronary stenting, or post PCI FFR, was associated with future clinical outcomes after PCI
      and low post PCI FFR value was associated with procedural factors. However, all of these risk
      factors were identified in individual studies there have been no studies that comprehensively
      evaluated these risk factors. Therefore, the investigators sought to investigate the risk
      predictors of future clinical events in patients after PCI and develop a risk model,
      incorporating clinical, angiographic, and physiologic factors, to predict the clinical events
      after PCI using contemporary coronary stents.

      The study population of this study is from the International Post PCI FFR Registry, which
      included 4 different registries from Korea, China, and Japan. All patients in this registry
      are available with clinical, angiographic and physiologic data and used 2nd generation
      drug-eluting stent (DES) for PCI. The COE-PERSPECTIVE registry (NCT01873560) was designed to
      evaluate the clinical relevance of post PCI FFR from 9 hospitals in Korea and Japan and
      enrolled a total of 835 patients available post PCI FFR value after angiographically
      successful PCI between May 2013 and December 2016. The 3V-FFR-FRIENDS registry (NCT01621438)
      enrolled a total of 1,136 patients (3,298 vessels) who underwent 3-vessel FFR measurements
      from 12 centers in Korea, Japan, and China between November 2011 and March 2014. Among them,
      266 patients with 337 vessels who measure post PCI FFR values were included in this
      international registry. The DKCRUSH VII registry (ChiCTR-PRCH-12001976) enrolled a total of
      1,476 patients from 9 hospitals (5 hospitals in China, 2 hospitals in the United States, 1
      hospital in Asia and 1 hospital in European country) between May 2012 and September 2013 to
      evaluate the prognostic value of post PCI FFR on patients' future outcome. For this
      international registry, 780 patients with 794 vessels from Nanjing First Hospital in China,
      who were available with whole clinical, angiographic and physiologic data, were included in
      this registry. Last, the Institutional registry of Tsuchiura Kyodo General Hospital, Ibaraki,
      Japan included 347 patients (357 vessels) who underwent PCI and final post-PCI FFR
      measurement.
    

Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Device
Intervention description(s): PCI was performed using 2nd generation DES
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were diagnosed as obstructive coronary artery disease and treated by 2nd
        generation DES and measured post PCI FFR after PCI.
      
Keywords: drug eluting stent; coronary atherosclerosis