Clinical outcomes of deferred revascularisation using fractional flow reserve in patients with and without diabetes mellitus

Abstract

ObjectiveDeferred revascularisation based upon fractional flow reserve (FFR >0.80) is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown.MethodsAll DM patients and the next consecutive Non-DM patients who underwent a FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/07/2015. Patients with lesions FFR >0.80 were analysed according to the presence vs. absence of DM, while patients who underwent index revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI).ResultsA total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR >0.80) were compared. At a mean follow up of 39.8 ± 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1 vs 7.5 %, logrank p ≤ 0.01, Cox regression-adjusted HR 3.65 (95 % CI 1.40–9.53, p < 0.01), which was largely driven by a higher incidence of TLR (17.2 vs. 7.5 %, HR 3.52, 95 % CI 1.34–9.30, p = 0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1 vs. 2.0 %, HR 3.34, 95 % CI 0.64–17.30, p = 0.15) was observed.ConclusionsThis study, the largest to directly compare the clinical outcomes of FFR-guided deferred revascularisation in patients with and without DM, shows that DM patients are associated with a significantly higher TLF rate. Whether intravascular imaging, additional invasive haemodynamics or stringent risk factor modification may impact on this higher TLF rate remains unknown.

Factors associated with deferred lesion failure following fractional flow reserve assessment in patients with diabetes mellitus

“…Furthermore, within this group, DM was identified as an independent predictor of poor outcomes. These findings are in keeping with those previously mentioned studies showing that deferred revascularization based upon FFR is not as safe in DM patients as compared with non‐DM patients . In this study, based upon the ROC curve analysis, we show that further efforts to define an alternative cut‐off value to improve outcomes with a FFR guided‐revascularization strategy in DM patients appears to be of little value.…”

“…Based upon the results of landmark trials, deferred revascularization in those lesions with a FFR >0.80 is associated with a low risk of future adverse cardiac outcomes . However, more recently, several studies have shown that deferred revascularization based on FFR assessment of intermediate lesions in high risk patients and specifically in DM patients may not be as safe and is associated with worse outcomes than in non‐DM patients .…”

“…Whilst fractional flow reserve (FFR) has an extensive evidence base, a low proportion of patients with DM were included in the landmark studies . Recent evidence has suggested that deferred revascularization based upon FFR in DM patients may not be associated with a similar low risk of MI or target lesion revascularization as seen in non‐DM patients . Whilst risk prediction models have been developed to better predict the risk of FFR‐guided deferred lesion failure (DLF), such models may not be as applicable in DM patients, given the significantly different nature of atherosclerosis seen in this condition .…”

Diabetes does not impact the diagnostic performance of contrast-based fractional flow reserve: insights from the CONTRAST study

“…Indeed, a recent study has showed that in patients with diabetes, particularly those with previous MI, FFR-based deferred revascularization was associated with poor medium-term outcomes suggesting that the combining of FFR with imaging techniques may be useful to guide our treatment strategy in these patients with high-risk, fast-progressing disease [28]. Comparing FFR-guided deferred revascularization in patients with and without diabetes, Kennedy et al also showed that those with diabetes were associated with a significantly higher rate of target lesion failure [29]. Accordingly, a recent study by Liu et al showed that a higher FFR was associated with lower rates of death, myocardial infarction and revascularization among non-diabetic patients with deferred PCI, but in diabetic patients with deferred revascularization, FFR was not able to differentiate the risk of cardiovascular events [30].…”

Deferred lesion failure in diabetes: A truly bad actor

“…The 15‐year follow‐up of the DEFER trial has shown that patients with FFR > 0.75 who had their lesions deferred had a lower rate of myocardial infarction than similar patients who had their lesions revascularized (2.2% vs. 10%, P = 0.03) . Johnson et al showed in a meta‐analysis of patient‐ and study‐level data from 9,173 patients that FFR has a continuous and independent relationship with patient outcomes, such that patients with lower FFRs had larger clinical benefits from revascularization . Most recently, two‐year data from the medical treatment arm of the FAME2 trial showed that in patients with stable coronary disease, major adverse cardiac events decreased with each increasing quartile of FFR.…”