Final Kissing Ballooning Returns? The analysis of COBIS II registry

Transcription

1 Final Kissing Ballooning Returns? The analysis of COBIS II registry Hyeon- Cheol Gwon Heart Vascular & Stroke Ins?tute, Samsung Medical Center Sungkyunkwan University School of Medicine

2 Final Kissing Ballooning () in 1- Stent Technique Pros Scaffolding of SB osnum (white arrow) Access to SB preserved Correct distal stent sizing OpNmizing proximal stent architecture Cons Complicates procedure SB osnal injury MV stent deformanon (black arrow) Modified from Hildick- Smith D, TCT 2009 Picture from Lefevre T, Heart 2005

3 Stent DeformaNon in BifurcaNon StenNng With Final Kissing Balloon InflaNon Stent deformanon following side- branch angioplasty Stent configuranon following kissing balloon angioplasty Achenbach S, JACC CVI 2015 Image

4 NORDIC III Study vs. no in 1- Stent Technique No Kissing (N=239) Kissing (N=238) P- value Procedure Nme (min) 47±22 61± Fluorosc. Time (min) 11±10 16± Contrast (ml) 200±92 235± mo MACE (%) NS 6- mo Index lesion MI (%) NS 6- mo TLR (%) NS 6- mo Stent thrombosis (%) NS Niemela M, CirculaNon 2011 Short period of follow- up duranon Small sample size for low MACE rate If baseline event rate is 2.9%, you need 3,200 panents to prove 50% of risk reducnon (power 0.8, alpha error 0.05).

5 Final kissing ballooning and long-term clinical outcomes in coronary bifurcation lesions treated with 1-stent technique: results from the COBIS registry Gwon HC, Heart 2012

6 vs. non- Studies Number Design Primary endpoint Outcomes Results Memo Niemela M (NORDIC III) CirculaNon 2011 N=477 RCT 6- mo MACE 2.9%, non- 2.9% P=NS Neutral Gwon HC (COBIS I) Heart 2012 N=1,065 Registry 2- year MACE 9.5%, non- 4.5% p=0.02 Worse Higher MV TLR In group Yamawaki M Circ J 2014 N=253 Registry 3- year MACE 14.6% vs. non- 6.9% p=0.07 Worse Higher MV restenosis in - group Kim TH Int J Cardiol 2014 N=251 Registry 3- year MACE HR=0.40 (95% CI ) p=0.015 Beher ACS panents Biondi- Zoccai G Heart Vessels 2014 N=2,813 Registry 2- year MACE HR=1.01 ( ) p=0.91 Neutral Gao Z Chin Med J 2015 N=790 Registry 4- year MACE non-: 10.0% vs. : 7.8% p=0.33 Neutral Lek main bifurcanon Kim YH (CROSS) JACC CVI 2015 N=306 RCT 1- year MACE Non- 11.6%, 14.0% p=0.57 Worse Higher MV restenosi s in group

7 COBIS II Study Flow COBIS II (N=5,155) COBIS II analysis (N= 2,897) Exclusion populations Side branch < 2.3mm (N=1276) Trifurcation (N=113) RCA-RV (N=44) LAD-Sepal (N=31) Branch bifurcation (N=23) Non-bifurcation lesion (N=255) No crossover stent (N=197) Not available data (N=319) Two stent technique (N=770) One stent technique (N= 2,127) Final analysis for (N= 1,901) Total occlusion in the SB before MV stenting (N = 88) SB intervention for TIMI flow < 3 (N = 134) Dissection in the SB after MV stenting (N = 4) (N=620 ) Non- (N=1,281) Yu CW, JACC CVI 2015

8 COBIS II Study Clinical CharacterisNcs Variables (n=620) Total Population No (n=1281) p value Propensity-Matched Population (n=545) No (n=545) Age, yrs 61.8 ± ± ± ± Sex (male) 438 (70.7) 939 (73.3) (69.5) 384 (70.5) 0.79 Diabetes mellitus 176 (28.4) 390 (30.4) (27.3) 162 (29.7) 0.42 Hypertension 367 (59.2) 739 (57.7) (59.6) 298 (54.7) 0.11 Dyslipidemia 207 (33.4) 381 (29.7) (34.5) 170 (31.2) 0.26 Smoking 153 (24.7) 338 (26.4) (24.0) 140 (25.7) 0.57 Chronic kidney disease 12 (1.9) 42 (3.3) (2.0) 17 (3.1) 0.35 Family history of CAD 21 (3.4) 34 (2.7) (3.3) 14 (2.6) 0.60 Previous history of MI 29 (4.7) 69 (5.4) (4.6) 25 (4.6) 0.99 Previous history of PCI 87 (14.0) 147 (11.5) (13.8) 64 (11.7) 0.34 Previous history of CABG 3 (0.5) 11 (0.9) (0.4) 6 (1.1) 0.29 Previous history of CVA 35 (5.7) 88 (6.9) (6.4) 32 (5.9) 0.80 Peripheral vascular disease 6 (1.0) 16 (1.3) (0.9) 9 (1.7) 0.42 p value LV ejection fraction 60.0 ± ± 9.7 < ± ± Serum creatinine (mg/dl) 1.10 ± ± ± ± Yu CW, JACC CVI

9 COBIS II Study Lesion and Procedural CharacterisNcs Variables (n=620) Total Population No (n=1281) p value Propensity-Matched Population (n=545) No (n=545) Bifurcation location p value Left main bifurcation 184 (29.7) 308 (24.0) 158 (29.0) 140 (25.7) LAD/diagonal 342 (55.2) 704 (55.0) 304 (55.8) 327 (60.0) LCX/OM 64 (10.3) 204 (15.9) 57 (10.5) 51 (9.4) RCA bifurcation 30 (4.8) 65 (5.1) 26 (4.8) 27 (5.0) Calcification, SB 35 (5.7) 61 (4.8) (5.5) 26 (4.8) 0.68 Medina classification < True bifurcation 310 (50.0) 452 (35.3) 260 (47.7) 259 (47.5) (32.7) 260 (20.3) 164 (30.1) 164 (30.1) (7.6) 79 (6.2) 41 (7.5) 38 (7.0) (9.7) 113 (8.8) 55 (10.1) 57 (10.5) Non-true bifurcation 310 (50.0) 829 (64.7) 285 (52.3) 286 (52.5) (9.8) 245 (19.1) 57 (10.5) 65 (11.9) (19.5) 334 (26.1) 116 (21.3) 110 (20.2) (17.6) 231 (18.0) 98 (18.0) 100 (18.4) (3.1) 19 (1.5) 14 (2.6) 11 (2.0) SB predil. before MV stenting 146 (23.6) 190 (14.8) < (21.3) 110 (20.2) 0.71 Use of IVUS 204 (32.9) 453 (35.4) (32.8) 190 (34.9) 0.52 Total stent length (mm) 27.7 ± ± ± ± Maximal stent diameter (mm) 3.24 ± ± 0.42 < ± ± Yu CW, JACC CVI

10 COBIS II Study Major adverse cardiac events (MACE) FU duration: 36 [IQR 25 50] months Total population PS-matched population p=0.05 p=0.02 No. at risk No. at risk No No * MACE = cardiac death, MI, or TLR, PS = propensity score Yu CW, JACC CVI 2015

11 COBIS II Study Clinical Outcomes in PS- Matched PopulaNon (n=620) No (n=1281) Unadjusted HR (95% CI) p value Adjusted HR * (95% CI) p value All-cause death 17 (3.1) 20 (3.7) 0.67 ( ) ( ) 0.39 Cardiac death 3 (0.6) 8 (1.5) 0.43 ( ) ( ) 0.37 MI 4 (0.7) 5 (0.9) 0.50 ( ) ( ) 0.48 Stent thrombosis 3 (0.6) 4 (0.7) 0.72 ( ) ( ) 0.73 Target lesion revascularization 32 (5.9) 43 (7.9) 0.53 ( ) ( ) 0.02 Main vessel 31 (5.7) 40 (7.3) 0.53 ( ) ( ) 0.03 Side branch 12 (2.2) 18 (3.3) 0.57 ( ) ( ) 0.21 Both vessels 23 (4.2) 38 (7.0) 0.47 ( ) ( ) 0.02 MACE 37 (6.8) 53 (9.7) 0.54 ( ) ( ) 0.01 *Adjusted covariates include hypertension, history of coronary artery bypass graft, and distal reference diameter of side branch. Yu CW, JACC CVI

12 COBIS II Study Subgroup analysis in PS- matched populanon Yu CW, JACC CVI

13 Differences between COBIS I and II COBIS I COBIS II PaNent number 1,668 2,897 Enrollment years Jan 2004 Jun 2006 Jan Dec 2009 Second generanon DES 0% 26.0% SB diameter 2.0 mm 2.3 mm (QCA confirmed ) Lek main bifurcanon Excluded Included percentage 30.9% 32.6% Final QCA for MV Similar expansion Larger expansion aker

14 Gwon HC, Heart 2012 COBIS I Study QCA Analysis

15 COBIS II Study QCA Analysis Variables (n=620) Total Population Propensity-Matched Population No (n=1281) p value (n=545) No (n=545) p value Baseline Main vessel Lesion length ± ± ± ± Proximal RD 3.52 ± ± 0.63 < ± ± Distal RD 2.76 ± ± ± ± Proximal MLD 1.75 ± ± ± ± Middle MLD 1.35 ± ± ± ± Distal MLD 1.92 ± ± 0.84 < ± ± Side branch Lesion length 3.71 ± ± ± ± Distal RD 2.60 ± ± ± ± Ostial MLD 1.57 ± ± 0.71 < ± ± Distal MLD 2.05 ± ± ± ± Final Main vessel Proximal MLD 3.29 ± ± 0.57 < ± ± 0.59 <0.001 Middle MLD 2.87 ± ± ± ± Distal MLD 2.84 ± ± ± ± Side branch Ostial MLD 1.84 ± ± 0.73 < ± ± 0.69 <0.001 Distal MLD 2.16 ± ± 0.65 < ± ± Yu CW, JACC CVI 2015

16 Why do we need in the bifurcanon lesion with a large side branch? Distal MV Side branch Proximal MV Proximal MV - Distal MV Small SB Large SB Final result POT The opnmal expansion of MV stent is the most important part of PCI for a bifurcanon lesion

17 COBIS II Study Conclusion In COBIS II registry, we demonstrated that was associated with a favorable long-term clinical outcome when treated with 1-stent technique, mainly driven by the reduction of TLR in the MV as a result of an increase in MV MLD. may be more important in the bifurcation lesion with a large side branch, probably due to proximal optimization effect of kissing ballooning. The positive impact of may be due to the better stent expansion not only in SB, but also in MV, which may be more important for the long-term clinical outcome. Thank you for your attention 17

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19 COBIS II Study Clinical Outcomes in All PopulaNon (n=620) No (n=1281) Unadjusted HR (95% CI) p value Adjusted HR * (95% CI) p value All-cause death 19 (3.1) 42 (3.3) 0.86 ( ) ( ) 0.63 Cardiac death 4 (0.6) 15 (1.2) 0.53 ( ) ( ) 0.35 MI 4 (0.6) 23 (1.8) 0.32 ( ) ( ) 0.19 Stent thrombosis 3 (0.5) 4 (0.3) 1.50 ( ) ( ) 0.72 Target lesion revascularization 36 (5.8) 84 (6.6) 0.78 ( ) ( ) 0.12 Main vessel 35 (5.6) 81 (6.3) 0.79 ( ) ( ) 0.11 Side branch 13 (2.1) 28 (2.2) 0.85 ( ) ( ) 0.28 Both vessels 25 (4.0) 66 (5.2) 0.70 ( ) ( ) 0.10 MACE 42 (6.8) 110 (8.6) 0.70 ( ) ( ) *Adjusted covariates include age, diabetes mellitus, left ventricular ejection fraction, clinical manifestation, bifurcation location, Medina classification, SB predilatation before main vessel stenting, proximal reference diameter of MV, distal minimal luminal diameter of MV, lesion length of SB, distal reference diameter of SB, ostium minimal luminal diameter of SB, middle minimal luminal diameter of MV after MV stenting, and ostium minimal luminal diameter of SB after MV stenting. * Stent thrombosis was defined as definite or probable. * Major adverse cardiac events included cardiac death, recurrent myocardial infarction, and target lesion revascularization. 19

20 COBIS II Study Subgroup analysis in all populanons 20