FFR vs icecg in Coronary Bifurcations FIESTA ClinicalTrials.gov Identifier: NCT

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1 FFR vs icecg in Coronary Bifurcations FIESTA ClinicalTrials.gov Identifier: NCT Dobrin Vassilev MD, PhD Assoc. Prof. in Cardiology Head Cardiology Clinic, Alexandrovska University Hospital Medical University, Sofia, Bulgaria

2 I have nothing to disclose about this presentation

3 What FFR actually tell us: Ability of given coronary lesion to limit coronary blood flow at maximal hyperemia with maximal flow through this lesion. However, it tells nothing about the maximum amount of blood that can pass through this lesion. This amount of blood is responsible for ischemia appearance, because of supply-demand imbalance. i.c. ECG demonstrates the actual myocardial ischemia

4 40% of FFR positive pts have N CFR! ~26% ~26% 40% of FFR negative pts have pathologic CFR! ~32% ~17% Johnson et al. J Am Coll Cardiol Img 2012;5:

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6 DK CRUSH VI Spontaneous MI 2/160, 1.3% (angio) vs. 0 (FFRG) JACC : CARDIOVASCULAR INTERVENTIONS VOL. 8, NO. 4, 2015 FFR- vs. Angiography-Guided Provisional Stenting APRIL20,2015:536 46

7 Fractional Flow Reserve Versus Intracoronary ECG for Detection of Post Stenting Ischemia in Side Branch Territory in coronary Bifurcation Lesions (FIESTA) Study aims to verify in head-to-head comparison ability to detect periprocedural ischemia of FFR vs. icecg to verify ability of icecg to identify ischemia generating (hemodynamically significant?) SB stenosis at the ostium of side branches

8 Inclusion criteria Subject at least 18 years of age. Stabile or unstable angina; Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Target vessel with last lesion remaining for treatment; Main branch lesion(s) located in a native coronary artery with diameter of 2.5 mm and 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of 2.0 mm. Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.

9 Exclusion criteria Subjects with significant ST-T change ( 1mm). Non-cardiac co-morbid conditions are presentwith life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment). Subjects with the following angiographic characteristics: left main coronary artery stenosis, total occlusion before occurrence of SB, lesion of interest located at infarct-related artery. Subjects with LVEF < 30%. Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy. LBBB, RBBB, atrial fibrillation/flutter with no identifiable isoelectric line.

10 icecg guided strategy for side branch treatment after stenting main vessel Stenting main vessel SB icecg + SB FFR SB icecg without ST-elevation (STE) (no matter how large is ostial SB%DS) SB icecg with ST-elevation (STE) SB%DS <50% SB%DS >50% End procedure Possible IIB/IIIA Vasodilators SB balloon dilatation; +/- kissing balloon infation

11 73 patients screened 36 patients rejected: - Incomplete dataset 6 pts; - Non-significant FFR in main vessel 30 pts!!! 37 patients included

12 Results: Age 65±11 Males 76% (n=28/37) Smokers 76% HTN 100% Previous MI 38% (n=14/37) DM 43% (n=16/37) GFR 84±38 TnT pre-pci.01±.004; post-pci.11±.26

13 Results: SYNTAX score 13±4 MVD 63% MB: SB: MB RVD 3.50±.25mm SB RVD 2.5±.31 mm %DS prepci 67%±9% %DS prepci 53%±15% %DS post-pci 0%±1% %DS after stenting MV 70%±21% %DS post-pci 41% ± 31%

14 Results: Number of stents/bifurcation 1.9 Stent length 40±17mm Stent pressure 13±2 mmhg Proximal stent diameter 3.20±.32mm Distal stent diameter 2.95±.33mm KBI or SBB+POT n=31/37 (84%)

15 1 0,9 0,8 0,7 Mean FFR changes during procedure , , , , , ,6 0,5 0,4 0,3 MB before SB before SB after stenting SB final MB final 0,2 0,1 0

16 Case 1 (FFR+; icecg+) Male 69 years old Unstable angina Arterial Hypertension Dyslipidemia Echo normal EF, no valvular lesions, anteroseptal hypokinesis

17 Diagnostic Pictures Diagonal 0,86 LAD 0,75

18 After stent Picture Diagonal 0,60

19 Kissing dilation result Diagonal 0,96

20 Case 2 (FFR -; icecg -) Male 62 years old Unstable angina Arterial hypertension Dyslipidemia Echo normal EF, normokinetic LV

21 Diagnostic angio pictures LAD 0,65 Diagonal 0,93

22 After stent in LAD final result pictures Diagonal 0,89 No ST elevation

23 Case 3 FFR+; icecg- Female 68 years old Unstable angina Arterial Hypertension Dyslipidemia Echo normal EF, normokinetic LV Only one single case

24 Diagnostic angio pictures Diagonal 0,91 LAD 0,73

25 Predilation in LAD and SB

26 Final result SB dissection LAD Diagonal Diagonal 0,78

27 Case 4; FFR-; icecg+ Male 76 years old Unstable Angina Previous PCI, stent in RCA Arterial Hypertension Dyslipidemia Echo normal EF, normokinesis

28 Diagnostic angio picture Diagonal LAD

29 Result after stent in LAD Diagonal LAD

30 SB ostium postdilation

31 Final result picture Diagonal

32 Correlation between side branch icecg STS sustained elevation and FFR SB FFR 0.80 Sensitivity = 85% Specificity = 73% PPV = 79% NPV = 80% Accuracy = 79% SB FFR 0.75 Sensitivity = 100% Specificity = 67% PPV = 64% NPV = 100% Accuracy = 79% SB FFR 0.77 Sensitivity = 100% Specificity = 77% PPV = 79% NPV = 100% Accuracy = 88% There is NO CASE with icecg SB sustained STE and FFR 0.77!

33 i.c. ECG accuracy to predict positive FFR for SB jailing According to ROC analysis (AUC.921, p=.001) a FFR.77 best predicted icecg SB sustained elevation after main vessel stenting

34 SB FFR 0.77 has best correlation with sustained icecg STE (Spearman r=-.721, p<.001) SB FFR > 0.77 SB FFR 0.77 SB sustained icecg STS elevation after MB stenting SB without icecg STE elevation after MB stenting

35 p<.001

36 There is a significant p<.001 difference regarding SB FFR in SB icecg groups with and without STS elevation.

37 Conclusions: Intracoronary ECG (based on ST-segment elevation) could predict a significant FFR in SB region after main vessel stenting with high overall accuracy of 88%; In case of negative icecg signs of ischemia (no STS elevation, no change in QRS amplitude (R>S) and width (QRS>110ms)) FFR is not necessary, no matter how large is SB and how severe the ostial stenosis in SB looks like; A COSIBRIA II randomized study is planned to assess in long-term effect of SB pharmaco-mechanical intervention on patient oriented events in icecg ischemic SBs

38 Thank you for your attention!