Bifurcation Stenting. European Bifurcation Club update. Ioannis Iakovou, MD Onassis Cardiac Surgery Center Athens, Greece

Transcription

1 Bifurcation Stenting. European Bifurcation Club update. Ioannis Iakovou, MD Onassis Cardiac Surgery Center Athens, Greece

2 The not so new development One vs. two stents General consensus In most bifurcational lesions one stent is the treatment of choice!!!

3 Why 1 Stent probably is sufficient? SB Lesions are Usually Short!!! Bestent 1 TULIPE 2 Sirolimus 3 Sirolimus 4 Patients (n) Reference (mm) 2.7± ± ± ±0.5 Lesion length (mm) 5.6± ± ± ±3.0 Stenosis SB (%) 49±37 52±17 52±19 42±23 Significant SB LL>3mm 10-24% 1 Gobeil et al, Am J Cardiol 2001, 2 Brunel et al Cathet Cardiovasc Intervent 68:67 73 (2006) 3 Colombo et al, Circulation 2004; 109: , 4 Sengotuvel et al, JACC 2004 (abst.supp.)

4 RADI pressure wire: Successful FFR measurement: 94/97 lesions (97%) Initial Post-stent

5 FFR-guided Jailed SB Intervention Conclusions Stenting the main branch with DES Side branch intervention, when DS>75% or FFR< Kissing balloon technique with a relatively small balloon at side branch - If Stenosis > 75% or FFR < 0.75 after kissing balloon, use larger balloon, or stent FFR: 0.61 FFR: 0.80 FFR: 0.58 FFR: 0.80

6 1 vs.2 stent Metanalysis 845 Potentially relevant (>100 pts, follow-up 6 mo) citations identified ( ) 30 potentially relevant articles retrieved (comparing DDS vs SDS) 815 articles discarded after abstract evaluation: Non relevant Comparison of different 2 stent techniques Dedicated bifurcation devices Reviews Editorials/expert opinions 7 meta-analyses 12 studies finally included: 5 Randomized Controlled Trials 7 non-randomized Observational Studies 6 studies with BMS use 3 studies with sample size < 100 pts 1 non-english language manuscript 1 study excluded for incomplete data (only %) Zimarino M et al, JACC Intv 2013; 6:

7 Nordic BBK CACTUS BBC-ONE DK-CRUSH- II Ge et al. Di Mario et al. ARTS-II COBIS Registry J CYPHER Registry J-PMS Registry Study RCT RCT RCT RCT RCT nros nros nros nros nros nros nros Year Patients Assali et al. SDS/DDS 199/ / / / / /57 38/ / / / /37 260/141 Follow-up 14 mo 9 mo 6 mo 6 mo 12 mo 9 mo 12 mo 12 months 22 mo 36 mo 36 mo 24 mo DES Sirolimus Sirolimus Sirolimus Palclitaxel Sirolimus Sirolimus Palclitaxel Sirolimus operator's discretion Sirolimus Crush Crush operator's Sirolimus discretion Crush Crush Crush Crush Crush Crush mini-crush DDS technique Coulotte Coulotte V-stent T-stent V-stent V-stent T-stent T-stent T-stent T- stent Crush Crush Other T-stent T-stent Coulotte T-stent T-stent Coulotte Coulotte V- stent Other Coulotte Kiss stents Coulotte Coulotte Kiss stents Kiss stents Coulotte True Bif NA 68% 94% 83% 100% NA NA 62 % 69% 56% NA NA GP IIb/IIIa 51% 0 20% 36% 3% 47% 23% 37% NA NA NA 58% FKB 52% 100% 91% 52% 85% 59% 75% 12 % 41% 59% 30% 79% DAPT 14 mo 6 mo 6 mo > 9 mo > 12 mo > 3 mo > 3 mo 2 mo 3-6 mo (recomd) 3 mo (recomd) 3 mo (recomd) Crossover 4,30% 19% 31% mo (recomd)

8 Overall Mortality Zimarino M et al, JACC Intv 2013; 6:

9 Myocardial Infarction Zimarino M et al, JACC Intv 2013; 6:

10 DES Thrombosis Zimarino M et al, JACC Intv 2013; 6:

11 Predictors of stent thrombosis Prior Brachytherapy Renal Failure Unprotected Left Main 2 stents per bifurcation Stents per lesion Bifurcation Diabetes Ejection Fraction OR=4.18; 95%CI, , p=0.1 OR=11.48;95%CI, , p< OR=2.96; 95%CI, , p=0.1 OR=1.23; 95%CI, , p=0.7 OR=1.49; 95%CI, , p=0.2 OR=7.19; 95%CI, , p< OR=3.36; 95%CI, , p=0.02 OR=1.09; 95%CI, , p< Iakovou et al JAMA 2005, EBC

12 Bifurcation Stent Techniques More Complex Technique Crush Culotte Kissing Less Ostial Coverage Most Ostial Coverage T-Stent Provisional Less Complex Technique

13 Bifurcation Techniques Crossover simple straightforward cheaper Suboptimal result in the side branch Kissing stent simple and quick only large vessel with narrow angulation metallic new carena more difficult future access Crush excellent lesion coverage increased metal difficulty in recrossing struts Culotte excllent lesion coverage increased metal rewiring may be problematic T stent less deformity of stents potential geographic miss Iakovou, Colombo JACC 2006

14 Why do we need a treatment classification? Maerten I van Valckenborch 1595

15 M Main prox. first A Main Accross side first D Distal first S Side branch first 1 Stent PM stenting MB stenting accross SB DM stenting SB ostial stenting After balloon Skirt MB stenting + SB balloon MB stenting + kissing ½ V ½ SKS SB minicrush SB crush 2 Stents Elective T stenting Internal crush Culotte Exagerated Y V stenting SKS Syst. T Stenting Minicrush Crush 3 Stents Extended V Trouser legs Louvard et al CCI 2008

16 Provisional stenting Wire both vessels. Stent main vessel. Probably rewire sidebranch and kiss. Only treat flow in the sidebranch. If 2 nd stent needed

17

18 The case of true bifurcation (1,1,1) We should avoid Side Branch pre-dilation and take advantage of the carina shift the guidewire (GW) will cross the stent strut exactly at the carina No Pre-dilatation Carena shift Courtesy G.Stankovic Post MB stenting

19 Assessment of side branch predilatation prior to a provisional T stent strategy Footer Text 10/7/

20 Treatment of Coronary Bifurcations When is a 2 stent strategy advisable? Problematic the treatment of true bifurcations (both branches have a stenosis) with 1 stent The advantage of 2 vs. 1 stent depends on: - size and distribution of the SB - extent of the disease into the SB

21 Treatment of Coronary Bifurcations In true bifurcations, with SB suitable for stenting and significantly diseased, the strategy of elective implantation of 2 stents may have the following advantages: Lower risk of SB closure during MB stent implantation. Less difficulties in recrossing through stent struts with the second stent. Full lesion coverage (crush, culotte, V-stent, )

22 NORDIC II Nordic Stent Technique Study (NORDIC II): the first randomized clinical and angiographic comparison of the crush and the culotte bifurcation stent techniques True bifurcations: 73.3% Crush vs. 82.3% Culotte, p=0.03 (Medina classification 1,1,1-1,0,1-0,1,1) Erglis et al, Circ Cardiovasc Interv. 2009;2:27-34

23 Low MACE Rates also at 14 Months with Both Crush and Culotte (Nordic II) Primary Endpoint Cardiac death, MI, TVR and stent thrombosis 25 P=NS 20 % ,7 P=NS 6,4 6 months 14 months 5 4,3 3,7 0 Crush Culotte Erglis et al, Circ Cardiovasc Interv. 2009;2:27-34

24 Culotte Compared to Crush has a Trend Towards Less Restenosis There is a trend towards less restenosis of the entire bifurcation lesion because of significantly reduced SB in-stent restenosis in patients treated with the CULOTTE technique (Nordic II) In-segment In-stent Erglis et al, Circ Cardiovasc Interv. 2009;2:27-34

25 TLR/TVR-freeSurvival 863 pts (18 centers of 4 countries) with ULMCA dist-bifurcation lesions

26 MACE-free Survival Rate at 12-months

27 Ormiston JA. Euro PCR 2010

28 Ormiston JA. Euro PCR 2010

29 Optimal FKB in The Bench Minimal overlaping Long overlaping Murasato et al. PCR 2010

30 Assymetric expansion induced by KBT

31 Procedure related complications Murasato EBC 2013 Footer Text

32 9mos

33 Optimal FKB in The Bench 12 atm* 5sec 12 atm* 60sec Hikichi et al. EBC 2009

34 IVUS Main vessel stent Optimal FKB in The Bench Simultaneous MV balloon First SB balloon First CSA (mm 2 ) 10 Prox. Carina Dist. Prox. Carina Dist. Prox. Carina Dist * p<0.05 vs. Simultaneous, p<0.02 vs. Simultaneous Sung-Jin Oh et al. PCR 2010

35 Kissing Balloon Technique Study Results Inflation of side branch 1 st results in less malapposed metal in the side branch PROMUS/Xience V Liberte PREMIER Main Artery Inflation Started 1 st with Kissing Balloons Direct Kissing Balloons Side Branch Inflation 1 st then Direct Kissing Balloons Update Pic Darremont Athens, October et al. 3 rd EBC,

36 Optimal FKB in The Bench Kissing With Non Compliant Balloons Kinoshita et al. EBC 2009

37 POT technique 40

38 POT 41

39 How to perform optimal Final Kissing? Balloon size according to distal reference; Short balloons & non-compliant balloons; Side branch first, then simultaneous; At least seconds; Final single-balloon proximal inflation (2 nd POT). issing balloon inflation to correct distortion but the procedure could be further optimized: - ovalisation of the proximal main branch Balloon LAD 90º 3.0 LCx Balloon LM

40 MACE-free survival Influence of Bifurcation Angle on Outcome of Crush Technique T-shape Y-shape Bifurcation Bifurcation T-stenting Crush Kaplan-Meier plot comparing MACE-free Survival up to 648 days between the low-angle group (BA<50 o and high-angle group BA>50 o Culotte Dzavik et al AHJ 2006;152:762-9

41 restenosis rate (%) DES in Bifurcation Lesions Milan Experience One stent only 155 pts Stents on both branches 119pts P=0.03 P= % 28% % 15 11% % 4.0% 4.6% % Main branch Side branch Main branch Side branch = final kissing = No kissing

42 NORDIC III Nordic-Baltic Bifurcation Study III: A prospective randomized trial of side branch dilatation strategies in patients with coronary bifurcation lesions undergoing treatment with a single stent True bifurcations: 51.8% Kissing vs. 54.6% No kissing, p=ns Medina classification 1,1,1-1,0,1-0,1,1 Matti Niemela TCT 2009

43 Value of kissing inflations in simple stenting? NORDIC III Primary end point MACE (cardiac death, index lesion MI, TLR, stent thrombosis) after 6 months Conclusion: Routine use of Final Kissing Balloon (FKB) did not improve clinical outcome, but there was not a penalty for undertaking FKB Niemela, M.et al. Circulation 2011; 123(1):

44 NORDIC III Secondary end point Side Branch (SB) Binary (Re)stenosis after 8 months In-stent restenosis 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

45 CORPAL KISS MACE KISSING YES n=118 KISSING NO n=116 p 1-month outcome - 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 0 0 ns - Death 3 (2.5%) 2 (2%) ns - TLR 3 (2.5%) 1 (1%) ns - Remote intervention 1 (1%) 4 (3%) ns TOTAL MACE 9 (8%) 6 (5%) ns Pan, M.et al. Am J Cardiol 2011; 15;107(10):1460-5

46 FKB in the 1-stent technique - the COBIS registry 16 Korean centres, 736 pts. in non-fkb group, 329 in FKB group. Propensity score-matching analysis performed in 222 patient pairs. FU 22 mo. Gwon H-C et al. Heart 2012; 98:

47 FKB in the 1-stent technique - the COBIS registry 16 Korean centres, 736 pts. in non-fkb group, 329 in FKB group. Propensity score-matching analysis performed in 222 patient pairs. FU 22 mo. Stent thrombosis rate: 0.5% in the non-fkb group vs. 0.6% in the FKB group, NS Gwon H-C et al. Heart 2012; 98:

48 Why kissing after simple strategy? To correct a poor result in SB (but QCA / FFR discrepancy): - TIMI flow < 3, EKG, Pain - carina / plaque shift - previous stenosis - to prepare a SB stenting When SB angiographic result / flow are good?: to remove the jail strut (possible SB stenting: > 2 mm)

49 Case presentation IVUS interrogation Boston Opticross 5Fr LAD ost 3.32mm 2 LM mid 3.22mm 2 Bifurcation Workshop, OCSC, Sep24th 2015

50 Case presentation Plan provisional stenting with FKBI and POT Predilatation Sprinter 2.5 x 12 Resolute Int 3.5 x 22 (16) Bifurcation Workshop, OCSC, Sep24th 2015

51 Case presentation No POT, Rewiring of the LCX with Pilot 50 SB NC Sprinter 2.5 x 12 (18) Bifurcation Workshop, OCSC, Sep24th 2015

52 Case presentation FKBI (NC Sprinter 2.5 x12 NC 3.5 x12) Post FKBI Bifurcation Workshop, OCSC, Sep24th 2015

53 Case presentation Post FKBI IVUS LAD & LCX pullbacks LM:8.98mm 2 LAD: 10.4mm 2 LCX: 9.2mm 2 IVUS Ring-down artifact Bifurcation Workshop, OCSC, Sep24th 2015

54 Case presentation POT (NC sprinter 4.0 x 6) post POT IVUS Bifurcation Workshop, OCSC, Sep24th 2015

55 Case presentation post POT IVUS 10.9mm mm 2 Bifurcation Workshop, OCSC, Sep24th 2015

56 Case presentation final result Bifurcation Workshop, OCSC, Sep24th 2015

57 IVUS usage in coronary bifurcations IVUS is useful in coronary bifurcation (both LM & non-lm) stenting Vessel size information Stent selection SB ostium evaluation Stent strategy Stent expansion and apposition Reduce complications

58 ADAPT DES Relationship between IVUS Use and Definite or Probable ST within 1 Year Circulation 2014

59 Long-Term Events after IVUS v Angio Guided DES Stenting 758 Consecutive Bifurcation Pts/7731Pts treated 420 DES (82% Cypher) v 338 BMS 473 IVUS Guided v 284 Angio Guided 82% v 92% 1 Stent Technique All- Cause Mortality Stent Thrombosis SH Kim et al, CCI 2009

60 IVUS Guidance May Improve Safety in Bifurcation Stenting COBIS registry: N=1688, med FU=22 mos Kim JS, Am Heart J 2011

61 Conclusions Provisional T stenting remains the gold standard technique for most bifurcations. Large side branches with ostial disease extending >5mm from the carina are likely to require a two-stent strategy. Side branches whose access is particularly challenging should be secured by stenting once accessed.

62 Conclusions (2) Value of kissing inflations in simple stenting no advantage / no harm. Kissing balloon inflations, or pressure wire interrogation, should be used when an angiographically significant (>75%) side branch lesion remains after main vessel stenting. Final kissing balloon inflation is mandatory in two-stent techniques.

63 Conclusions (3) When using a single stent technique, in the absence of kissing balloon inflations, the proximal main vessel stent should be postdilated to an appropriate diameter. POT is an important step in bifurcation stenting. IVUS usage provides important information in LM PCI especially regarding the correct sizing of devices and in identifying complications. 74

64 Thank you!

65 Conclusions Provisional SB stenting strategy is the gold standard: POT No advantage, no harm of systematic final KB: result, SB size, FFR non compliant balloons? When using 2 stents? With a mandatory kissing - long SB lesions (> 3 mm, > 5 mm?) - but why not provisional strategy? - very difficult SB access: SB first? When not to using SB stent first?: Wide B angle Dedicated stents: randomized studies / biodegradable stents!