Non-LM bifurcation studies of importance in 2011

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1 7th European Bifurcation Club October 2011 LISBON Goran Stankovic MD, PhD Non-LM bifurcation studies of importance in 2011 October 15 th : 08:00 08:10

2 DKCRUSH-II: A Prospective Randomized Trial of Double Kissing Crush vs. Provisional Stenting Technique for Coronary Bifurcation Lesions Shao-Liang Chen, et al. J Am Coll Cardiol 2011;57:

3 DKCRUSH-II: A Prospective Randomized Trial of Double Kissing Crush vs. Provisional Stenting Technique for Coronary Bifurcation Lesions Stenting techniques Double kissing (DK) crush VS. Stepwise Provisional stenting Primary endpoint Composite MACE at 12-month : Cardiac death Myocardial infarction (MI) Target vessel revascularization (TVR)

4 Study flowchart Total population (N=370) Provisional stenting (N=185) DK crush (N=185) Stenting MV only (N=132) Stenting 2-vessel (N=53,28.6%) Stenting 2-vessel (N=185) FKBI(n=92/132) FKBI(n=53) FKBI =185 Clinical F/U: n=132 Angiographic F/ U:n=116 Clinical F/U: n=53 Angiographic F/U:n=53 Clinical F/U: n=185 Angiographic F/ U:n=170 Repeat angiogram at 8-m: 91.6%(339/370)

5 Procedural variables DK (n=185) PS(n=185) p FKBI, n(%) 185(100.0) 147(79.5) <0.001 Angio success-sb, n(%) 185(100.0) 177(95.7) Procedural time(min.) 37.7(20.4) 36.6(30.0) Fluoroscopy time(min.) 23.1(18.1) 22.5( Contrast volume(ml) 148.7(88.2) 137.5(94.9) Side branch closure,n(%) 0 3(1.62) NS

6 DK (n=185) PS(n=185) p Cardiac death,% 2(1.1) 2(1.1) MI,% 6(3.2) 4(2.2) TLR,% 8(4.3) 24(13.0) TVR,% 12(6.5) 27(14.6) MACE,% 19(10.3) 32(17.3) ST(Definite), % 4(2.2) 1(0.5) 0.372

7 In unselected patients with true bifurcation lesions: additional stent for SB was required in 28.6% patients treated by provisional stenting; DK crush stenting was associated with significant reduction of ISR, TLR and TVR; There was no significant difference in MACE between DK crush vs. Provisional stenting.

8 Simple or Complex Stenting for Bifurcation Coronary Lesions: A Patient-Level Pooled Analysis of the Nordic and the BBC Study Behan MW, et al. Circ Cardiovasc Interv 2011;4;57-64

9 Combined Patient-Level Dataset 913 patients 9-month clinical follow up Composite endpoint Target vessel revascularization (TVR) Stent thrombosis (ST) Procedural success All-cause death/mi/tvr at 9 months Repeat attempted revascularization of target vessel ARC definite TIMI 3 flow and <30% stenosis in the main vessel, plus TIMI 3 flow in the side branch.

10 Procedure Characteristics Simple (n=457) Complex (n=456) P value SB stented (%) <0.001 Culotte (%) Crush (%) Other (%) Final kissing balloon (%) <0.001 Procedural success (%) Procedural time (mins) Fluoroscopy time (mins) <0.001 Contrast volume (mls) <0.001 True bifurcation n (%) 316 (69.1%) 341 (74.7%) 0.058

11 Trial Endpoints Composite (death/mi/ TVR) n (%) Simple (n=457) Complex (n=456) P value 46 (10.1) 79 (17.3) All cause death n (%) 5 (1.0) 5 (1.0) 0.99 MI total n (%) 22 (4.8) 56 (12.3) < Periprocedural MI n (%) 16 (3.5) 45 (9.9) < Subsequent MI n (%) 6 (1.3) 11 (2.4) 0.22 TVR total n (%) 26 (5.7) 33 (7.2) TVR PCI n (%) 24 (5.3) 20 (4.4) TVR CABG n (%) 2 (0.4) 13 (2.9) ST n (%) 3 (0.7) 6 (1.3) 0.31

12 Freedom from 1 Endpoint

13 Subgroup Analysis NO ADVANTAGE WITH COMPLEX

14 Conclusions This pooled analysis of the NORDIC I and BBC ONE trials shows that the simple strategy is associated with lower rates of the composite endpoint of death, MI and TVR at 9 months. A simple strategy resulted in lower procedure duration, fluoroscopy times, contrast volume and reduced risk of periprocedural MI. No benefit of complex strategy in true bifurcations, lesions with wide bifurcation angles, those with large SBs, long SB lesions and equivalent sized vessels.

15 Randomized Comparison of Final Kissing Balloon Dilatation vs. no Final Kissing Balloon Dilatation in Patients with Coronary Bifurcation Lesions Treated With Main Vessel stenting Niemelä M, et al. Circulation 2011, 123:79-86.

16 Estimate of eligible patients (n= 2385) Randomized patients (n= 477) No FKBD (n= 239) FKBD (n= 238) 6 month clinical FU (n= 239, 100%) 6 month clinical FU (n= 238, 100%) Stratification at randomization Scheduled angiographic FU after 8 months (n= 189) Scheduled angiographic FU after 8 months (n=185) Angiographic FU available (n= 162, 86%) Angiographic FU available (n=164, 88%)

17 Niemelä M, et al. Circulation 2011, 123:79-86.

18 In-stent restenosis Kiss or Not? The Nordic-Baltic Bifurcation Study III P=0.039 P=1.0 P=1.0 Restenosis was defined as 50% diameter stenosis at the 8-month follow-up. In-stent segments included the stented areas of the MV or the first 5 mm of the SB. Niemelä M et al. Circulation. 2011;123(1):79-86

19 Conclusion In coronary bifurcation lesions MV stenting with and without FKBD was associated with similar 6- month clinical outcome The simple no-fkbd strategy was associated to shorter procedure and fluoroscopy time and reduced use of contrast media FKBD reduced angiographic SB (re)stenosis especially in patients with true bifurcation lesion, which was not, however, translated into the clinical outcome

20 Coronary Bifurcation Lesions Treated With Simple Approach (from the Cordoba & Las Palmas [CORPAL] Kiss Trial) Pan M, et al. Am J Cardiol 2011;107:

21 AIMS Ø To compare the incidence of 1-year clinical events in patients with bifurcation lesions treated with simple approach which were randomized to simultaneous final kissing balloon or isolated SB balloon post-dilation using 2 different stent platforms (Cypher vs. Xience ).

22 CORPAL KISS February/07 - December/08 n= 293 patients 2x2 Randomization after angiography Non included n=22 Cypher n=145 Xience n=148 Non included n=27 Kissing yes n=66 Kissing no n=57 Kissing yes n=58 Kissing no n=63 n=124 n=120 1-year clinical follow-up n=118 n=116

23 IMMEDIATE ANGIOGRAPHIC RESULTS KISSING YES n=118 KISSING NO n=116 p MLD post MV (mm) 2.9± ±0.4 ns % stenosis post MV 7±5 7±5 ns MLD post SB (mm) 2.1± ±0.4 ns % stenosis post SB 13±8 13±10 ns

24 IVUS PARAMETERS LUMEN AREA (mm2) KISSING YES n=76 KISSING NO n=75 p Proximal reference 9.9 ± ± 3.1 ns Proximal border 9.5 ± ± 3.2 ns Proximal stent 9.5 ± ± Under SB 6.1 ± ± Distal stent 6.8 ± ± 1.5 ns Distal border 6.5 ± ± 1.6 ns Distal reference 6.7 ± ± 1.8 ns Presented at ESC 2009

25 MACE KISSING YES n=118 1-month outcome KISSING NO n=116 p - CK post (iu/l) 142 ± ± 124 ns - Non Q AMI 3 (2.5%) 1 (1%) ns - Surgery 0 0 ns - Death 0 2 (2%) ns 1-year outcome - AMI 1 1 ns - Death 3 (2%) 2 (2%) ns - TLR 5 (4%) 2 (2%) ns - Remote intervent 1 (1%) 4 (3%) ns TOTAL MACE 11 (9%) 7 (6%) ns

26 MACE SIROLIMUS n=141 1-month outcome EVEROLIMUS n=141 p - CK post (iu/l) 129 ± ± 160 ns - Non Q AMI 2 (1.4%) 2 (1.4%) ns - Surgery 0 0 ns - Death 1 (0.7%) 1 (0.7%) ns 1-year outcome - AMI 0 0 ns - Death 4 (2.8%) 1 (0.7%) ns - TLR 3 (2.1%) 2 (1.4%) ns - Remote intervent 4 (2.8%) 2 (1.4%) ns TOTAL MACE 9 (7%) 6 (4%) ns

27 CONCLUSIONS No differences in clinical outcome at 1-year follow-up were observed between patients with bifurcation lesions treated with simple approach and simultaneous final kissing balloon or isolated SB balloon post-dilation. No differences in clinical outcome at 1-year follow-up were observed between Cypher or Xience treated patients.

28 Final kissing ballooning and long-term clinical outcomes in coronary bifurcation lesions treated with1- stent technique: results from the COBIS registry Gwon H-C, Hahn J-Y, Koo B-K, et al. Heart (2011).c

29 Clinical outcomes: FKB vs. Non-FKB Gwon H-C, Hahn J-Y, Koo B-K, et al. Heart (2011).c

30 (A) Kaplan Meier curves for major adverse cardiac events (MACE) in the overall population treated by main vessel stenting only (non-final kissing ballooning (FKB) group) versus FKB after main vessel stenting (FKB group). Gwon H et al. Heart doi: /heartjnl

31 Comparison of major adverse cardiac events for subgroups. Gwon H et al. Heart doi: /heartjnl

32 Conclusion FKB in the 1-stent technique increased the long-term risk of MACE, primarily as a result of an increased risk of TLR. However, no significant differences were observed in rates of cardiac death, MI, or stent thrombosis between groups. Gwon H-C, Hahn J-Y, Koo B-K, et al. Heart (2011).c

33 Prospective Randomized Comparison of Sirolimus- or Everolimus-Eluting Stent to Treat Bifurcated Lesions by Provisional Approach: [SEA-SIDE] Burzotta F, et al. J Am Coll Cardiol Intv 2011;4:327 35).

34 STUDY FLOW-CHART 225 CONSECUTIVE UNSELECTED PATIENTS WITH BIFURCATED LESION UNDERGOING DES IMPLANTATION (only exclusion criteria: contraindication to prolonged double antiplatelet therapy, STEMI, TIMI<3) PERIOD 1 (150 PTS) 1:1 RANDOMIZATION TO SES EES PCI with Provisional TAP-stenting strategy PROSPECTIVE EVALUATION OF PROCEDURAL PERFORMANCE OFF-LINE, BLIND, 3DQCA ANALYSIS OF PROCEDURAL RESULTS WITH A BIFURCATION- DEDICATED SOFTWARE PROSPECTIVE EVALUATION OF CLINICAL OUTCOME

35 RESULTS: PROCEDURAL PERFORMANCE STEPS OF PROVISIONAL-TAP MV Stent according to randomization / intention 75 (100%) 75 (100%) ns P SB flow <3 after MV stent SB re-wiring attempted (BMW) Need of guidewires different from BMW for SB re-wiring Failure of SB re-wiring Failure of SB dilation ANY SB TROUBLE (composite of green items) * 7 (9.3%) 8 (10.7%) 52 (69.3%) 55 (73.3%) 6 (8.0%) 3 (4.0%) 2 (2.7%) 3 (4.0%) 1 (1.3%) 1 (1.3%) 12 (16.0%) 8 (10.7%) ns ns ns ns ns 0.34 Kissing inflation performed 50 (66.7%) 51 (68.0%) ns SB stent implantation followed by final kissing (TAP) 6 (8.0%) 6 (8.0%) ns * primary procedural end-point

36 RESULTS: 3DQCA ANGIOGRAPHIC RESULTS P BEFORE PCI MV area stenosis 80.0% 75.8% MV Min. Lum. Area 1.0 mm mm 2 SB area stenosis 50.2% 54.6% SB Min. Lum area 1.7 mm mm 2 Bifurcation angle ns ns ns ns ns MAIN VESSEL POST-PCI MV area stenosis MV Min. Lum area MV MLD prox to bif MV MLD distal to bif 29.3% 30.7% 5.2 mm mm mm 3.1 mm 2.8 mm 3.0 mm ns ns ns ns SIDE BRANCH POST PCI SB area stenosis 43.9% 39.5% 0.07 SB Min. Lum area 2.4 mm mm 2 <0.01 SB MLD at ostium* 1.8 mm 2.7 mm Angle modification ns * Primary angiographic end-point

37 12-month clinical FU rate: 100% RESULTS: 12-MONTH CLINICAL OUTCOME Predefined CLINICAL end-point: TARGET BIFURCATION FAILURE (TBF): MACE or, in the absence of MACE, angiographic FU showing restenosis >50% in the MV or TIMI<3 in the SB 12% 10% 9.3% P= % 8% 6% 5.3% 4% 2.7% 2.7% 4.0% 4.0% 2% 1.3% Cardiac Death MI* *all non-q, half periprocedural TVR TBF

38 CONCLUSIONS In patients with bifurcated lesions treated by provisional stenting technique, EES compared with SES is associated with similar procedural performance and better 3D-QCA result in the SB; Both DES are associated with low rates of major adverse events and angiographic failure.

39 Comparing Two-Stent Strategies for Bifurcation Coronary Lesions: Which Vessel Should be Stented First, the Main Vessel or the Side Branch? Dong-Ho Shin, et al.j Korean Med Sci 2011; 26:

40 Coronary Bifurcation Stent Registry This study compared two-stent strategies for treatment of bifurcation lesions by stenting order, main across side first (A-family) vs. side branch first (S-family) ; Ø The endpoints were cardiac death, myocardial infarction (MI), stent thrombosis (ST), and target lesion revascularization (TLR) during 3 years. Dong-Ho Shin, et al.j Korean Med Sci 2011; 26:

41 COBIS registry and stenting strategies for bifurcation lesions Dong-Ho Shin, et al.j Korean Med Sci 2011; 26:

42 Post-procedural results and clinical outcome at median 20.2 months Dong-Ho Shin, et al.j Korean Med Sci 2011; 26:

43 Clinical outcomes of the A and S family All cases of cardiac death, MI, and ST occurred exclusively in the S family group, despite longer use of anti-platelet agents; No significant difference in TLR between the 2 strategies; Dong-Ho Shin, et al.j Korean Med Sci 2011; 26:

44 Clinical outcomes and FKI FKI was performed in 90.0% in the A family and 67.1% in the S family; The incidence of hard-endpoint of S-family with FKI was comparable to A-family, whereas S-family without FKI showed the poorest prognosis (1.1% vs. 15.9%, P = 0.011). Dong-Ho Shin, et al.j Korean Med Sci 2011; 26:

45 CONCLUSIONS A-family seems preferable to S-family if both approaches are feasible. When two-stent strategy is used, every effort should be made to perform FKI, especially in Sfamily. Dong-Ho Shin, et al.j Korean Med Sci 2011; 26:

46 Thank you!