Safety of Revascularization Deferral Based on Physiological Significance

Safety of Revascularization Deferral Based on Physiological Significance Javier Escaned MD Ph. D Hospital Clínico San Carlos Universidad Complutense de Madrid / Spain

Speaker's name: Javier Escaned I have the following potential conflicts of interest / relevant financial relationships to report in the field of this presentation: Speaker at educational events and/or consultancies: Abbott, Boston Scientific, Opsens, Philips Healthcare

Physiology-based deferral of coronary revascularisation • Revascularisation deferral is a key aspect of physiology-based PCI. • Avoiding unneded coronary interventions is fundamental in improving outcomes of patients with CAD. • Reassurance of the safety of physiology-based PCI deferral is required for operator adoption. • Evidence is required for both hyperaemic- and non-hyperemic indices.

The DEFER trial (1997 -2001) “Randomized study undertaken in patients referred for PTCA without documented ischemia to investigate whether FFR discriminates patients in whom PTCA is appropriate from those in whom it is not. ” Bech GJ et al Circulation. 2001 Jun 19; 103(24): 2928 -34.

Patient outcomes in the DEFER trial Bech GJ et al Circulation. 2001 Jun 19; 103(24): 2928 -34.

15 -year follow-up of the DEFER trial Myocardial infarction rates occurred more frequently in the Perform and R eference groups than in the Defer group and was linked to the treated vessel. Zimmermann FM et al. Eur Heart J. 2015; 36(45): 3182 -8

Is it safe to defer revascularization using nonhyperemic indices?

IFR-based deferred revascularization in DEFINE FLAIR and i. FR SWEDEHEART studies N=2130 Escaned J et al JACC Cardiovasc Interv. 2018; 11(15): 1437 -1449

Is it safe to defer revascularization based on i. FR/FFR in high-risk stable patient subsets?

Multivessel disease: FAME trial – 1 year Tonino P et al N Engl J Med. 2009 Jan 15; 360(3): 213 -24

Triple vessel disease: SYNTAX II trial Lesion treatment after i. FR/FFR interrogation (n=1177) Lesions treated per patient (n) in SYNTAX II and SYNTAX I P < 0. 001 Cases of three-vessel PCI (%) in SYNTAX II and SYNTAX I P < 0. 001 83. 3% 4. 02 PCI deferred 31% PCI performed 69% 2. 64 37. 2% SYNTAX II Escaned J et al Eur Heart J. 2017 Nov 7; 38(42): 3124 -3134

Triple vessel disease: SYNTAX II trial • 33% of interrogated stenoses were functionally non significant. • At 2 -year follow up revascularisation in deferred lesions was 1% (3/262). • Decision making on revascularisation was based on a non-hyperaemic index (i. FR) in >75% of cases. Escaned J et al Eur Heart J. 2017 Nov 7; 38(42): 3124 -3134

Safety of FFR in deferring left main revascularisation Note: All studies, except Hamilos et al, used a FFR<0. 75 cutoff Cerrato E, Escaned J et al Int J Cardiol 2018

Safety of i. FR in deferring left main revascularisation MACE Warisawa T et al DEFINE-LM study / TCT 2019

Physiology-based revascularisation and diabetes Van Belle E et al. JAMA Cardiol. 2019 doi: 10. 1001

i. FR and FFR to guide revascularisation and diabetes Lee JM et al JAMA Cardiol. 2019. doi: 10. 1001/jamacardio. 2019. 2298

Is it safe to defer revascularization based on i. FR/FFR in patients with acute coronary syndromes?

Does ACS physiology influence FFR measurements? FFR measurements in LAD (non-culprit): During primary PCI: FFR 0. 87 (i. v. ATP infusion 140 mcg/kg/min) Nishina H et al. Coronary Stenosis: Imaging, Structure and Physiology. PCR Books 2015

Does ACS physiology influence FFR measurements? FFR measurements in LAD (non-culprit): During primary PCI: FFR 0. 87 (i. v. ATP infusion 140 mcg/kg/min) One week later: FFR 0. 69 (i. v. ATP infusion 140 mcg/kg/min) Nishina H et al. Coronary Stenosis: Imaging, Structure and Physiology. PCR Books 2015

More false positives with i. FR Acute i. FR in STEMI Follow-up FFR Follow-up i. FR Classification agreement of repeated i. FR/FFR in STEMI Acute FFR in STEMI More false negatives with FFR Van der Hoeven N, Escaned J, van Royen N et al. JAMA Cardiol. 2019 doi: 10. 1001/j 2019. 2138

FFR in ACS and SAP: a study-level analysis Liou KP, West NEJ et al. Open Heart 2019; 6: e 000934.

Patient outcomes of FFR-based PCI in stable and ACS syndromes Patient level analysis of R 3 F, POST-IT, IRIS-FFR, DEFINE FLAIR and i. FR SWEDEHEART studies (n=8579) Treated N=3450 Deferred N=5129 Cerrato E, Davies J, Escaned J et al TCT 2018 / Submitted for publication

FFR-based deferral in ACS and cardiac events FFR i. FR HR 0. 52 (0. 27 -1. 00); p<0. 05 HR 0. 74 (0. 38 -1. 43); p=0. 37 ACS 6. 4% ACS 5. 4% SCD 3. 4% Escaned J et al. JACC Intv. 2018; 11: 1437 -1449 SCD 3. 8%

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