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Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data.

ABSTRACT:

Aims

To assess the effect of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with contemporary drug-eluting stents on the composite of cardiac death or myocardial infarction (MI) vs. medical therapy in patients with stable coronary lesions.

Methods and results

We performed a systematic review and meta-analysis of individual patient data (IPD) of the three available randomized trials of contemporary FFR-guided PCI vs. medical therapy for patients with stable coronary lesions: FAME 2 (NCT01132495), DANAMI-3-PRIMULTI (NCT01960933), and Compare-Acute (NCT01399736). FAME 2 enrolled patients with stable coronary artery disease (CAD), while the other two focused on non-culprit lesions in stabilized patients after acute coronary syndrome. A total of 2400 subjects were recruited from 54 sites world-wide with 1056 randomly assigned to FFR-guided PCI and 1344 to medical therapy. The pre-specified primary outcome was a composite of cardiac death or MI. We included data from extended follow-ups for FAME 2 (up to 5.5 years follow-up) and DANAMI-3-PRIMULTI (up to 4.7 years follow-up). After a median follow-up of 35 months (interquartile range 12-60 months), a reduction in the composite of cardiac death or MI was observed with FFR-guided PCI as compared with medical therapy (hazard ratio 0.72, 95% confidence interval 0.54-0.96; P = 0.02). The difference between groups was driven by MI.

Conclusion

In this IPD meta-analysis of the three available randomized controlled trials to date, FFR-guided PCI resulted in a reduction of the composite of cardiac death or MI compared with medical therapy, which was driven by a decreased risk of MI.

SUBMITTER: Zimmermann FM

PROVIDER: S-EPMC6321954 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Backgroundintravascular ultrasound (IVUS) and fractional flow reserve (FFR) have both been shown to be superior to angiography in optimizing percutaneous coronary intervention (PCI). However, there is still a lack of comparative studies between PCI optimization using physiology and intravascular imaging head-to-head. The aim of this study was to compare the effectiveness of FFR and IVUS PCI optimization strategies on the functional PCI result (assessed with FFR) immediately post-PCI and at 9-12 months after the treatment of long coronary lesions.MethodsThis was a single-center study comparing post-PCI FFR between two different PCI optimization strategies (FFR and IVUS). The study included 154 patients who had hemodynamically significant long lesions, necessitating a stent length of 30 mm or more. The procedural outcomes were functional PCI result immediately post-PCI and at 9-12 months after treatment. Clinical outcomes included target vessel failure (TVF) and functional target vessel restenosis rate during follow-up.ResultsBaseline clinical characteristics and FFR (0.65 [0.55-0.71]) did not differ significantly between the two groups and the left anterior descending artery was treated in 82% of cases. The FFR optimization strategy resulted in a significantly shorter stented segment (49 mm vs. 63 mm, p = 0.001) compared to the IVUS optimization strategy. Although the rates of optimal functional PCI result (FFR > 0.9) did not significantly differ between the FFR and IVUS optimization strategies, a proportion of patients in the FFR group (12%) experienced poor post-PCI functional outcome with FFR values ≤ 0.8, which was not observed in the IVUS group. At the 9-12 month follow-up, 20% of patients in the FFR group had target-vessel-related myocardial ischemia, compared to 6% in the IVUS group. The rates of TVF and functional target vessel restenosis during follow-up were also numerically higher in the FFR optimization group.ConclusionsThe use of FFR PCI optimization strategy in the treatment of long coronary artery lesions is associated with a higher incidence of poor functional PCI result and larger myocardial ischemia burden at follow-up compared to the IVUS optimization strategy. However, this discrepancy did not translate into a statistically significant difference in clinical outcomes. This study highlights the importance of using IVUS to optimize long lesions functional PCI outcomes.