Fractional Flow Reserve or Intravascular Ultrasonography to Guide PCI


Abstract

Background

In patients with coronary artery disease who are being evaluated for percutaneous coronary intervention (PCI), procedures can be guided by fractional flow reserve (FFR) or intravascular ultrasonography (IVUS) for decision making regarding revascularization and stent implantation. However, the differences in clinical outcomes when only one method is used for both purposes are unclear.

Methods

We randomly assigned 1682 patients who were being evaluated for PCI for the treatment of intermediate stenosis (40 to 70% occlusion by visual estimation on coronary angiography) in a 1:1 ratio to undergo either an FFR-guided or IVUS-guided procedure. FFR or IVUS was to be used to determine whether to perform PCI and to assess PCI success. In the FFR group, PCI was to be performed if the FFR was 0.80 or less. In the IVUS group, the criteria for PCI were a minimal lumen area measuring either 3 mm2 or less or measuring 3 to 4 mm2 with a plaque burden of more than 70%. The primary outcome was a composite of death, myocardial infarction, or revascularization at 24 months after randomization. We tested the noninferiority of the FFR group as compared with the IVUS group (noninferiority margin, 2.5 percentage points).

Results

The frequency of PCI was 44.4% among patients in the FFR group and 65.3% among those in the IVUS group. At 24 months, a primary-outcome event had occurred in 8.1% of the patients in the FFR group and in 8.5% of those in the IVUS group (absolute difference, −0.4 percentage points; upper boundary of the one-sided 97.5% confidence interval, 2.2 percentage points; P=0.01 for noninferiority). Patient-reported outcomes as reported on the Seattle Angina Questionnaire were similar in the two groups.

Conclusions

In patients with intermediate stenosis who were being evaluated for PCI, FFR guidance was noninferior to IVUS guidance with respect to the composite primary outcome of death, myocardial infarction, or revascularization at 24 months.

Source: NEJM

FFRCT on par with invasive coronary angiography


 Coronary computed tomographic angiography (CTA) with fractional flow reserve (FFRCT) analysis might be a better alternative to invasive coronary angiography for patients with suspected coronary artery disease, a study suggests.

Care guided by CTA and selective FFRCT was associated with equivalent clinical outcomes and quality of life (QOL), and lower costs, compared with usual care over 1-year follow-up, according to investigators.

To determine the 1-year clinical, economic, and QOL outcomes of FFRCT use instead of usual care, researchers managed consecutive patients (mean age 61 years; mean pretest probability of coronary artery disease 49 percent) with stable, new onset chest pain by either usual testing (n=287) or CTA (n=297) with selective FFRCT (submitted in 201, analysed in 177). Of the patients, 581 (99.5 percent) completed 1-year follow-up.

The primary endpoints were adjudicated major adverse cardiac events (MACE; death, myocardial infarction, unplanned revascularisation), total medical costs, and QOL.

After follow-up, MACE events were infrequent, with 2 in each arm of the planned invasive group and 1 in the planned noninvasive cohort (usual care strategy).

In the planned invasive group, mean costs were 33 percent lower with CTA and selective FFRCT ($8,127 vs $12,145 usual case; p<0.0001). In the planned noninvasive cohort, mean costs did not differ when using an FFRCT cost weight of zero ($3,049 FFRCT vs $2,579; p=0.82), but were higher when using an FFRCT cost weight equal to CTA.

At 1 year, QOL scores improved, with similar improvements in both groups, apart from the 5-item EuroQOL scale scores in the noninvasive stratum (mean change of 0.12 for FFRCT vs 0.07 for usual care; p=0.02).

Researchers suggest further randomized trials to compare the clinical utility of FFRCT with invasive strategies for evaluation of patients with suspected coronary disease.