Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial

Zimmermann, Frederik M.; Ferrara, Angela; Johnson, Nils P.; Nunen, Lokien X. van; Escaned, Javier; Albertsson, Per; Erbel, Raimund; Legrand, Victor; Gwon, Hyeong Cheol; Remkes, Wouter; Stella, Pieter R.; Schaardenburgh, Pepijn van; Bech, G. Jan Willem; Bruyne, Bernard De; Pijls, Nico H.J.

doi:10.1093/eurheartj/ehv452

Cited by 476 publications

(313 citation statements)

References 25 publications

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“…Although evidence has shown favorable clinical outcomes of deferred lesions with high FFR despite angiographically significant stenosis,17, 18, 28, 29 there remains a paucity of evidence evaluating lesions with low FFR despite angiographically insignificant stenosis. Current guidelines do not recommend FFR measurement in stenosis with %DS <40% to 50% 20, 21.…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of Deferred Lesions With Angiographically Insignificant Stenosis But Low Fractional Flow Reserve

Lee

Koo

Shin

et al. 2017

JAHA

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BackgroundData are limited regarding outcomes of deferred lesions in patients with angiographically insignificant stenosis but low fractional flow reserve (FFR). We investigated the natural history of angiographically insignificant stenosis with low FFR among patients who underwent routine 3‐vessel FFR measurement.Methods and ResultsFrom December 2011 to March 2014, 1136 patients with 3298 vessels underwent routine 3‐vessel FFR measurement (3V FFR‐FRIENDS study, ClinicalTrials.gov identifier NCT01621438), and this study analyzed the 2‐year clinical outcomes of 1024 patients with 2124 lesions with angiographically insignificant stenosis (percentage of diameter stenosis <50%), in which revascularization was deferred. All lesions were classified according to FFR values, using a cutoff of 0.80 (high FFR >0.80 versus low FFR ≤0.80). The primary end point was outcome of major adverse cardiovascular events (a composite of cardiac death, myocardial infarction, and ischemia‐driven revascularization) at 2 years. Mean angiographic percentage of diameter stenosis and FFR of total lesions were 32.5±10.3% and 0.91±0.08%, respectively. Among the total lesions with angiographically insignificant stenosis, 8.7% showed low FFR (185 lesions). The incidence of lesions with low FFR was 2.5%, 3.8%, 9.0%, and 15.1% in categories of percentage of diameter stenosis <20%, 20% to 30%, 30% to 40%, and 40% to 50%, respectively. At 2‐year follow‐up, the low‐FFR group showed a significantly higher risk of major adverse cardiovascular events compared with the high FFR group (3.3% versus 1.2%, hazard ratio: 3.371; 95% CI, 1.346–8.442; P=0.009). In multivariable analysis, low FFR was the most powerful independent predictor of future MACE in deferred lesions with angiographically insignificant stenosis (adjusted hazard ratio: 2.617; 95% CI, 1.026–6.679; P=0.044).ConclusionsIn deferred angiographically insignificant stenosis, lesions with low FFR showed significantly higher event rates than those with high FFR. FFR was an independent predictor of future major adverse cardiovascular events in lesions with angiographically insignificant stenosis.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01621438.

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Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of Deferred Lesions With Angiographically Insignificant Stenosis But Low Fractional Flow Reserve

Lee

Koo

Shin

et al. 2017

JAHA

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“…According to the 15-year outcome data of the DEFER study, which is the first randomised study on FFR, no significant differences existed between stenting and deferred PCI groups with respect to clinical outcomes among patients with stable CAD having non-ischaemic lesions. Furthermore, the deferred PCI group even had a slight advantage regarding the incidence of myocardial infarction over long-term follow-up [20].…”

Section: Discussionmentioning

confidence: 94%

Comparison between fractional flow reserve and visual assessment for moderate coronary artery stenosis

et al. 2017

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A b s t r a c tBackground: Fractional flow reserve (FFR) is an interventional diagnostic method, based on intracoronary pressure measurement, used for the assessment of the severity of coronary artery stenoses. Aim:Our study aimed to compare visual measurements made by multiple observers with FFR measurement in the assessment of angiographically moderate coronary artery stenosis. Methods:The angiographic images of moderate coronary artery lesions of 359 patients enrolled in the study were interpreted independently by three interventional cardiologists assigned as observers (O1, O2, O3). Results:In FFR, 37.9% were haemodynamically significant, while 62.1% were insignificant. 40.3% of the lesions were considered severe by O1, 39.9% by O2, and 44.4% by O3. When we compare the FFR results to the observers' decisions about lesion severity, the serious lesion percentages of all three observers were different both from each other and from the FFR result, at a statistically significant level (respectively, p < 0.001, p < 0.001). The kappa analysis performed to check the agreement between the observers' decisions and FFR revealed significant difference between FFR results and the decisions made by all observers (p < 0.001). The kappa agreement analysis performed by matching observers' decisions in pairs revealed a good agreement between O1 and O2 and a moderate agreement between O2 and O3 as well as O1 and O3, although there was still a significant disagreement between all pairs of observers (p < 0.001). Conclusions:Visual assessment, even when performed by experienced interventional cardiologists, does not yield similar results with FFR procedure in the process of determination of the functional importance of moderately severe coronary artery stenoses.

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“…6,9,10,[12][13][14] In the unlikely event that this role is downgraded, CT-FFR will suffer accordingly. Of note, the clinical use of CT-FFR is not yet guideline recommended.…”

Section: Reliance On Invasive Ffrmentioning

confidence: 99%

“…This cohort has now been followed for 15 years with no significant increase in revascularization rate in the deferral patients and a significantly lower rate of myocardial infarction (2.2 versus 10%, P=0.03). 6 Other observational registries have confirmed the safety of deferring revascularization of coronary disease, which is not significant based on FFR, even if involving the proximal left anterior descending artery 7 or the left main coronary. 8 The Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) trial was a large, multicenter, randomized study that further confirmed the safety of deferring PCI of lesions that are not hemodynamically significant, but more importantly demonstrated the safety, cost-effectiveness, and clinical benefit of routinely measuring FFR in patients with multivessel CAD undergoing PCI.…”

mentioning

confidence: 98%

Fractional Flow Reserve and Coronary Computed Tomographic Angiography

Hecht

Narula

Fearon

2016

Circulation Research

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Obstructive coronary artery disease (CAD) produces symptoms and increases the risk of adverse cardiac outcomes. However, determining whether a particular coronary stenosis is responsible for causing myocardial ischemia can be challenging, even with invasive coronary angiography (ICA). how should high-risk plaque be incorporated into treatment decisions? (7) how will CT-FFR influence other functional imaging test utilization, and what will be the effect on the practice of cardiology? (8) will a workstationbased CT-FFR be mandatory? Rapid progress to date suggests that CTA-based lesion-specific ischemia will be the gatekeeper to the cardiac catheterization laboratory and will transform the world of intervention.

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Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial

Abstract: Deferral of PCI of a functionally non-significant stenosis is associated with a favourable very long-term follow-up without signs of late 'catch-up' phenomenon.

Cited by 476 publications

References 25 publications

Clinical Outcomes of Deferred Lesions With Angiographically Insignificant Stenosis But Low Fractional Flow Reserve

Clinical Outcomes of Deferred Lesions With Angiographically Insignificant Stenosis But Low Fractional Flow Reserve

Comparison between fractional flow reserve and visual assessment for moderate coronary artery stenosis

Fractional Flow Reserve and Coronary Computed Tomographic Angiography

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