FFR-guided Jailed Side Branch Intervention

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FFR-guided Jailed Side Branch Intervention - Pressure wire in Bifurcation lesions - Bon-Kwon Koo, MD, PhD Seoul National University Hospital, Seoul, Korea

Bifurcation Lesions Bifurcation Lesions Still a challenging lesion subset even in the era of DES Complex procedure, Low procedural success, High clinical events Which is the best treatment strategy? - Too many variables: type, vessel diameter, vessel length, angulation, plaque location, main branch lesion, side branch stenosis, lesion length, calcification,,,,

Too many strategies Bifurcation Lesions T-stenting T-stenting Culotte Systemic 2 stenting vs. Provisional side branch intervention in DES era Author Modified T Crush n Stent Skirt 2 stents TLR rate Touching 1 stent Colombo, Circulation 2004 85 Cypher 9.5% 4.5% Ge, AJC 2005 127 Provisional Cypher 8.8% 5.4% Kissing Pen, AHJ 2004 91 Cypher 5% 2%

Provisional SB treatment Provisional side branch intervention Which one needs additional complex intervention? How to assess? How to treat?

Provisional SB treatment To treat? or Not? Reference vessel diameter 2mm? Percent stenosis 75%? Significant myocardial territory?

Provisional SB treatment To treat? or Not? Fractional Flow Reserve (FFR) Lefvre T, AHA 2004 Easily obtained, Stenosis specific, Simple(<0.75 ischemia) ischemia) Reflects both degree of stenosis and myocardial territory

FFR in Jailed Side Branch RADI4 pressure wire: Successful FFR measurement: 94/97 lesions (97%) Initial Post-stent

FFR in Jailed Side Branch Characteristics of lesions (n=94) Bifurcation type (ICPS classification) Type 1 Type 2 Type 3 Type 4 QCA of jailed branches MLD, mm Reference diameter, mm Percent stenosis, % Lesion length, mm 55 (58%) 12 (13%) 17 (18%) 10 (11%) 0.45 ± 0.25 2.2 ± 0.5 79 ± 11 7.0 ± 3.3 Koo BK, et al. JACC 2005

FFR in Jailed Side Branch QCA vs. FFR in Jailed side branch lesions (n=94) 1.0 Fractional Flow Reserve.9.8.7.6 r = - 0.464 p < 0.001 Functionally significant stenosis.5 40 50 60 70 80 90 100 Percent Stenosis (%) Koo BK, et al. JACC 2005

FFR in Jailed Side Branch FFR vs. Percent stenosis by QCA Percent stenosis <75% 75% All lesions (n=94) FFR <0.75 FFR 0.75 Vessel size 2.5mm (n=20) FFR <0.75 FFR 0.75 0 20 0 7 20(27%) 53 8(38%) 13 Koo BK, et al. JACC 2005

FFR in Jailed Side Branch How to Assess? FFR: 0.93 FFR: 0.61 FFR: 0.58 FFR: 0.84

FFR in Jailed Side Branch What if pressure wire is not available?

FFR in Jailed Side Branch Pre-PCI angiographic differences according to post-pci SB FFR FFR<0.75 FFR 0.75 P value Type 1 lesion* 49% 29% < 0.001 Angle < 70 89% 78% NS Plaque location contra-lateral 23% 21% NS SB reference diameter 2.2 ± 0.3 mm 2.3 ± 0.3 mm NS SB percent stenosis 57 ± 18% 46 ± 20% 0.04 * Only angiographic parameter associated with FFR<0.75 after stenting in multivariate analysis Hwang SJ, Koo BK, AHA 2005

FFR in Jailed Side Branch FFR (< 0.75) vs. QCA (% stenosis) - All Lesions (n=94) - 1.00 Sensitivity.75.50 % stenosis 75% Sensitivity 1.0 Specificity 0.39.25 85% 0.8 0.77 0.00 0.00.25.50 1 - specificity.75 1.00 AUC: 0.85 (95% CI: 0.76-0.94)

FFR in Jailed Side Branch Summary In bifurcation lesions with relatively short side branch stenosis. 1. QCA overestimates the functional significance of jailed SB lesions. Most lesions with tight stenosis don t need further intervention.

FFR in Provisional SB intervention How to Treat? FFR: 0.61 FFR: 0.58 Balloon artery ratio? Goal of treatment?

FFR in Provisional SB intervention My Hypothesis The treatment goal of jailed side branch lesion may be to maintain < 75% stenosis. Therefore, balloon inflation with a relatively small size balloon would be enough, if the gain could be maintained.

FFR in Provisional SB intervention : preliminary data Patient selection Inclusion criteria De novo, bifurcation lesion Main branches Successful DES implantation No significant stenosis proximal to the stented segment Jailed side branches Stenosis > 50%, diameter > 2 mm Lesion length < 10 mm Side branch length > 30 mm Exclusion criteria Side branch slow flow after stenting Left main disease, CTO lesions Infarct related artery, thrombus Diffuse or distal lesion at SB RWMA at stented segments Myocardial disease, valvular disease Renal insufficiency

FFR in provisional SB intervention Aims To assess The changes in functional significance of jailed SB after kissing balloon inflation The changes in functional significance of jailed SB during follow-up Clinical outcomes of FFR-guided jailed SB intervention strategy

FFR in provisional SB intervention Procedures Stenting the main branch with DES Measure FFR in jailed SB Side branch intervention, when FFR<0.75 - Kissing balloon technique with a relatively small balloon at side branch FFR: 0.61 FFR: 0.58 - If FFR < 0.75 after kissing balloon, use larger balloon, or stent implantation FFR: 0.80 FFR: 0.80

FFR in provisional SB intervention: preliminary data Jun, 2004 ~ 121 patients, 125 lesions 102 patients, 106 lesions FFR FFR not not measured measured (N=19) (N=19) Slow Slow flow flow : : 8 8 Fail Fail to to GW GW passage passage : : 4 4 Protocol Protocol violation violation : : 6 6 AV AV block block : : 1 1 FFR FFR < 0.75 0.75 :: 30 30 lesions 27 27 lesions: Kissing Bln Bln 3 lesions: No No SB SB PCI PCI FFR FFR 0.75 0.75 :: 76 76 lesions All All lesions: No No SB SB PCI PCI F/U CAG 17/22 eligible patients (77%) F/U FFR : 15/17 (88%) F/U CAG 49/59 eligible patients (84%) F/U FFR : 38/49 (78%)

FFR in provisional SB intervention: preliminary data Baseline characteristics of patients (n=82) Age, yr Male Risk factors Diabetes Mellitus Hypertension Hypercholesterolemia Current smoker Stable angina/unstable angina LVEF, % Multi-vessel disease 62 ± 9 55 (67%) 22 (27%) 46 (56%) 30 (37%) 24 (29%) 36 (43%) / 27 (33%) 60 ± 8 39 (48%)

FFR in provisional SB intervention: preliminary data Baseline characteristics of lesions (n=86) Bifurcation type* Type 1 Type 4 Used stents (n=95) Cypher / TAXUS Diameter, mm Length, mm Lesion Location LAD-Diagonal LCX-OM RCA-PD/PL 33 (38%) 28 (33%) 64 / 31 2.9 ± 0.3 30.1 ± 11.1 64 (74%) 18 (21%) 4 (5%) * ICPS classification

FFR in provisional SB intervention: preliminary data Changes in SB-FFR after Kissing balloon 1 Side branch balloon/artery ratio: 0.84±0.15 0.15 0.86±0.06 SB-FFR 0.8 0.65±0.07 0.6 Post-Stent P<0.001 Post-Kissing Achievement of FFR>0.75: 19/20 lesions (95%)

FFR in provisional SB intervention: preliminary data Changes of FFR during 6M follow-up (53 lesions) Post-PCI 6 Mo Follow-up Main branch 0.96±0.03 0.96±0.04 Jailed SB 0.86±0.05 0.87±0.08 P>0.05 SB-FFRadj* 0.90±0.05 0.91±0.07 *Adjusted side branch FFR; SB-FFRadj = [side branch FFR] / [main branch FFR] Four main branch TVR lesions were excluded.

FFR in provisional SB intervention: preliminary data Changes in SB-FFR after Kissing balloon 1 Side branch balloon/artery ratio: 0.84±0.15 0.15 SB-FFR 0.8 0.65±0.07 0.87±0.04 0.85±0.11 0.6 Post-Stent Post-Kissing Follow-up P<0.001 P=0.57

FFR in provisional SB intervention: preliminary data Changes in Functional Stenosis of Jailed SB Kissing vs. No-Kissing 0.02 P=0.16 ΔSB SB-FFR FFRadj 0 Kissing 0.01±0.04 No-Kissing -0.01±0.10-0.02

FFR in provisional SB intervention: preliminary data Changes in Functional Stenosis of Jailed SB TAXUS vs. Cypher 0.02 P=0.01 0.02±0.04 ΔSB SB-FFR FFRadj 0-0.02 TAXUS Cypher -0.04-0.03±0.09

FFR in provisional SB intervention: preliminary data Summary In bifurcation lesions with relatively short side branch stenosis. 1. Quantitative coronary angiography overestimates the functional significance of jailed side branch lesions. Most lesions with tight stenosis don t need further intervention. 2. Kissing balloon inflation with relatively small size balloon in side branch is effective. 3. Functional significance of jailed side branch lesions do not change significantly during follow-up.

FFR in provisional SB intervention: preliminary data Clinical Outcomes Death: 1 (non-cardiac) Q wave MI: 0, Stent thrombosis: 0 TLR: 4 patients (4.9%) 2 lesions main branch 1 lesion side branch 1 lesion both branches Side branch TLR: 2.3%

FFR in provisional SB intervention: preliminary data Comparison with other strategies Colombo, et al. Ge, et al Ge, et al Koo, et al Strategy 2Stent 1Stent/ PTCA 2Stent 1Stent/ PTCA Crush FFRguided N 65 22 117 57 181 82 SB diameter, mm 2.1 2.1 2.3 2.1 2.42 2.3 SB, %stenosis 57 46 62 54 64 48 SB, lesion length, mm 6.1 5.1 10.2 5.7 10.9 6.7 *MACE, % 14.3 13.6 15.5 10.1 18.2 6.1 *Cardiac death, Q MI, TVR Circulation 2004;109:1244, AJC 2005;95:757, JACC 2005;46:615

FFR in Bifurcation Lesions Summary In bifurcation lesions with relatively short side branch stenosis. 1. QCA overestimates the functional significance of jailed SB lesions. Most lesions with tight stenosis don t need further intervention. 2. Kissing balloon inflation with relatively small size balloon in SB is effective. 3. Functional significance of jailed SB lesions do not change significantly during follow-up. 4. FFR-guided jailed SB intervention strategy seems to be feasible and effective.

CONCLUSION In bifurcation lesions with relatively short side branch lesions. Don t t be too aggressive. If you are in doubt, kissing with a small side branch balloon, or measure the FFR!