FFR vs. icecg in Coronary Bifurcations (FIESTA) - preliminary results. Dobrin Vassilev MD, PhD National Heart Hospital Sofia, Bulgaria

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1 FFR vs. icecg in Coronary Bifurcations (FIESTA) - preliminary results Dobrin Vassilev MD, PhD National Heart Hospital Sofia, Bulgaria

2 I would like to express my personal gratitude to Dr. BK Koo for opening my eyes about potential of icecg On behalf of all FIESTA and COSIBRIA & Co investigators: the teams of National Heart Hospital, Sofia, MedicaCore Heart Hospital, Russe, Bulgaria, CSK MSWiA Warsaw, Poland ClinicalTrials.gov Identifiers: NCT & NCT Nothing to disclose regarding this presentation

3 Our target is ischemia! Hachamovitch et al. Circulation. 2003;107:

4 What we don t know during bifurcation PCI? If patient is asymptomatic and ECG is normal is there ischemia in treated region? Does SB compromise cause ischemia? During the procedure? After the procedure? What is importance of end-procedural ischemia?

5 FFR is the invasive standard for ischemia detection! Park & Koo Journal of Geriatric Cardiology (2012) 9:

6 SB%DS after stenting does not correlate with ischemia! Koo et al. European Heart Journal (2008) 29,

7 The results based on FFR in bifurcations are sustained at one year Koo et al. European Heart Journal (2008) 29,

8 The alternative - ic ECG mapping Vassilev et al. J. Am. Coll. Cardiol., 2011; 58: B81.

9 COronary SIde Branch Residual IschemiA and COllateralization Assessment Study (COSIBRIA & Co Study) Study aims To compare occurrence of ischemia in MB and SB during the procedure To establish sensitivity of a method for detection of significant SB region ischemia after stenting To assess sensitivity and specificity of a method to predict periprocedural myonecrosis and to localize the area/s with residual ischemia To assess possible long-term influence of periprocedural ischemia

10 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.

11 Exclusion criteria Subjects with significant ST-T change ( 1mm). Non-cardiac co-morbid conditions are present with 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.

12 Demographics Age, years 68±8 Sex, males 69% CCS class 3 (including UA) 51% NYHA class 3 19% Hypertension 97% Family history for CAD 12% Dyslipidemia 90% Smoking 34% Diabetes 34% Cancer 5% PAD 9% CVD 11% Renal failure 9% COPD 14% Previous MI 38% Previous CABG 2% Previous PCI 52%

13 COSIBRIA results SB%DS is not associated with icecg STE

14 COSIBRIA results P=.037 P=.031 P<.001

15 COSIBRIA results MACE Angina or new onset CHF 31,9 30,6 p = p = Tn (+) Tn (-)

16 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

17 FIESTA Started in December pts screened with FFR at the beginning of PCI 15 pts enrolled, the rest ns FFR Anticipated number of pts to be enrolled 40

18 TYPICAL EXCLUSION CASE FFR 0.91 FFR 0.79

19 icecg (+), FFR (-) STE = 4.7 MM FFR = 0.88

20 icecg (+), FFR (-) Final result after POBA SB (2.0/8mm/14atm) next day Tn 0.1 (before PCI 0.01) icecg STE 2.0 mm FFR = 0.91

21 icecg (-), FFR (++) FFR = 0.58 icecg <0.5 mm

22 icecg (-), FFR (++) Final result after POBA SB 1.5/15mm/15 atm next day Tn 0.01 icecg <0.5 mm FFR = 0.75

23 icecg (+), FFR (+) icecg STE 7 mm FFR = 0.45

24 icecg (+), FFR (+) Final result after KBI icecg STE <0.5 mm next day Tn 0.01 FFR = 0.83

25 Can FFR detect periprocedural ischemia or just potential postprocedural ischemia? Final icecg STE 4 mm in MB at stent region FFR normal range LAD 0.87; D2 0.83

26 After stenting FFR <.80 FFR >.80 IcECG (+) 2 2 IcECG (-) 2 9 FFR.76 &.58 Final FFR <.80 FFR >.80 IcECG (+) 1 2 IcECG (-) 1 11 FFR.75 Possible distal embolism, microcirculatory spasm

27 Conclusions: Periprocedural ischemia is associated with long term outcomes TLR, MI, New onset angina/chf We still did not observed case with FFR<.75 and no ischemia on final ic ECG Ic ECG reveals other mechanisms for ischemia occurrence than significant ostial stenosis at SB ostium

28 THANK YOU FOR YOUR ATTENTION!