Provisional strategy is the gold standard for bifurcation stenting: Often but not always!

Transcription

1 Provisional strategy is the gold standard for bifurcation stenting: Often but not always! Ramesh Daggubati, MD FACC FSCAI Clinical Professor of Medicine Director of Interventional Cardiology Clinical Associate Professor Brody School of Medicine Greenville, NC, USA

2 Disclosures Speaker s Bureau: Abbott, Abiomed, Astra Zeneca, Gilead, Janssen, Medtronic, Volcano

3 David thinks he crushed the 2-stent strategy with one sling shot

4 What all David said is true, but In BBC one and Nordic one, side branch intervention is required in 28% of patients. BBC one showed peri-procedural MI is greater(13 patients) in complex stent strategy. David said that the significance of these MI is debatable. Circulation. 2010; 121: JACC: Cardiovascular Interventions, Volume 6, Issue 2, 2013,

5 Limitations of BBC One Clinical trial without angiographic f/u. Study not restricted to true bifurcations. Additional lesions were treated in 16% of simple vs 20% of complex groups. Local PI bias Allowed only Culotte and Crush for the 2 stent strategy. Circulation. 2010; 121:

6 Why does David do PCI? Regardless of technique used, bifurcation PCI improved functional status and QOL. JACC: Cardiovascular Interventions, Volume 6, Issue 2, 2013,

7 Figure 4 Direction of Change in Individual Patients Scores on SAQ Patients' scores at baseline (pre-pci) and at 9 month follow-up were compared. The graphs indicate the proportions of patients who improved, deteriorated, and remained unchanged over this... Alex Sirker, Manav Sohal, Keith Oldroyd, Nick Curzen, Rod Stables, Adam de Belder, David Hildick-Smith The Impact of Coronary Bifurcation Stenting Strategy on Health-Related Functional Status : A Quality-of-Life Analysis From the BBC One (British Bifurcation Coronary; Old, New, and Evolving Strategies) Study JACC: Cardiovascular Interventions, Volume 6, Issue 2, 2013,

8 He does have an open mind

9 Applying the data (and conventions) of bifurcation PCI to UPLM CAD. Issues to consider: Single vs. Double? Does the Data Support a Preferred Technique? DES vs BMS? 79 year old male. Recent diagnosis of pancreatic cancer. Seen pre-op in the setting of ACS. To undergo a Whipple procedure.

10 Current standards The main vessel stent should be sized according to the distal diameter Proximal Optimization Technique Kissing NC balloon inflations Wire the SB via the distal stent strut Provisional T stent is the standard Culotte is better than crush

11 BBC ONE NORDIC metaanalysis True bifurcations (657) Angle>60-70 (217) SB diameter 2.75mm (281) SB lesion>5mm (464) SB diameter 2.75mm/lesion>5mm (137) Equivalence (111) Total (913) Odds ratio and 95% CI 1.91 ( ) 1.69 ( ) 2.34 ( ) 1.66 ( ) 2.55 ( ) 1.62 ( ) 1.84 ( ) Favours Simple Favours Complex Behan et al Circ Card Intvn 2012

12 5 Year Follow-Up Nordic Bifurcation Study Simple vs Complex Stenting Strategy in Non-LM PCI MACE event were low and did not differ significantly in patients treated with a simple versus a complex bifurcation stenting technique. Stent thrombosis rate was not increased in patients treated with 2-stents.

13 Meta-Analysis: NORDIC I & BBC I (Non LM Bifurcations) Probability of MACE (Death/MI/TVR) In the Nordic-BBC meta analysis the average SB stenosis was 59% and 65% for the simple & complex strategy respectively. Difference in MACE favoring a simple strategy In many of these trials, up to 25% of patients have no SB disease.

14 BBK I study - Clinical outcome 5 year post PCI Provisional Systematic T-Stenting T-Stenting n=101 n=101 p Death (%) Death and/or MI (%) Stent thrombosis def./probable (%) TLR (%) MACE (%)

15 Influence of FKB from CACTUS Widely Perceived to Be Applicable to Left Main and Non-LM Disease Myocardial infarction YES Final Kissing 163 pts. NO Final Kissing 14 pts. 7.5% 29% TLR 6.3% 12.9% 0.25 P MB restenosis SB restenosis Stent thrombosis 4.7% 16% % 36% % 6.5% 0.06

16 DK Crush Technique Double Kiss and Crush

17 1 Year Outcomes DK Crush Versus Provisional Stenting TLR and TVR favoring DK Crush in MB and SB angiographic restenosis favoring DK Crush Trend toward reduced MACE Table 1. One- Year Outcomes TLR and TVR Angiographic restenosis (MB & SB) Trend toward a DK Crush in non-lm Bifurcation in MACE Double Kissing Crush Provisional Stenting P Value MACE 10.3% 17.3% Cardiac Death 1.1% 1.1% MI 3.2% 2.2% TVR 6.5% 14.6% TLR 4.3% 13.0% Definite Stent Thrombosis 2.2% 0.5% 0.372

18 DK CRUSH vs Cuolotte in UPLM DK Crush in UPLM PCI ACC 2013

19 A Randomized Pilot Trial for Treatment of Large Bifurcation Lesions with Simultaneous Kissing Stents: PRECISE-SKS Trial Optimal stenting strategy for coronary bifurcation lesions continues to evolve with most of the earlier studies favoring stenting the main vessel (MV) over stenting both MV and the side-branch (SB). Simultaneous kissing stents (SKS) techniques involves deploying two stents simultaneously in both branches with guaranteed coverage of SB ostium, no stent deformation and excellent long-term results. Present SKS- Precise study is a randomized trial comparing SKS technique vs conventional stent strategy (CSS) of deploying stent in MV and provisional stent of the SB for the treatment of large bifurcation lesions (Duke type D). The primary endpoints were angiographic restenosis (>50% diameter stenosis of the target lesion) at 8-month and a major adverse cardiac events (MACE: TLR, stent thrombosis, MI or death) at 1-yr. A total of 100 pts were randomized (51 in SKS group and 49 in CSS group), with 1-yr clinical follow-up available in all pts and angiographic follow-up in 83 cases. The SB stenting in CSS group was needed in 28%. All pts received sirolimus-eluting stents (SES). Baseline clinical and angiographic variables were comparable, with lower angiographic success of SB in CSS. The SKS technique for large bifurcation lesions resulted in a trend towards better acute success and long-term patency, especially in the SB, compared to conventional stent technique. Therefore, SKS technique can be safely recommended in the treatment of the true large coronary bifurcations. Numbers in these studies are generally small

20 DK Crush Showing excellent results for systematic two-stent technique

21 NORDIC IV What did I learn as it flashed by?

22 NORDIC IV 1.3% vs 4.6% in favour of the two-stent approach Huge difference! (p=0.09)

23 NORDIC IV Difference largely driven by reintervention large side branches cause angina! We have found our group at last

24 Nordic-Baltic Bifurcation Study IV Methods Inclusion criteria Age 18 Stable Angina, UAP, NSTEMI MV 3.0mm SB 2.75mm Bifurcation stenosis involving both MV and SB ( 50%DS by eyeballing) Exclusion criteria STEMI Cardiogenic shock Other critical illness Relevant allergies Cr 200 µmol/l SB lesion length >15mm

25 The Nordic-Baltic PCI Study Group Nordic-Baltic Bifurcation Study IV Lesion characteristics Provisional (n=221) Two-stent (n=229) p LAD/diagonal (%) ns CX/obtuse marginal (%) ns RCA PDA/PLA (%) ns LM/LAD/CX (%) ns Ref. diameter main vessel (mm)* Ref. diameter side branch (mm)* ns Lesion length SB (mm)* < Angulation > (%)* ns *visual estimation

26 PCI in Coronary Bifurcation Lesions The Evidence-Base SB Stenosis Severity SB Lesion Length (mm) SB Lesion Severity (%) No Data NORDIC BBK CACTUS BBC- ONE CHEN et al 20 0 NORDIC BBK CACTUS BBC-ONE CHEN et al No QCA

27 RCTs of Provisional vs. Elective Stenting Higher-Risk Bifurcations Chen SL, et al. J Am Coll Cardiol 2011;57:

28 Recent Metaanalysis by Gao EuroIntervention Sep 22;10(5): doi: /EIJY14M06_06

29 Double vessel stenting is safe EuroIntervention Sep 22;10(5): doi: /EIJY14M06_06

30 Why Does PCI of Coronary Bifurcations Remain a Challenge? Bifurcation Type Technique X X Provisional Stenting Provisional Stenting Medina1,1,1 1,1,1 Medina Elective Double Stenting

31 Fallacies in Zimarino s study Several non-randomized registries and not true bifurcation studies. Selection bias. Increased TLR, TVR could be due to first generation stents and patient factors. JACC: Cardiovascular Interventions, Volume 6, Issue 7, July 2013, Pages

32 David now is against strong data Simple vs Complex DK Crush Nordic IV David

33 Conclusions Bifurcation stenting is Class II b. Differentiate Simple vs Complex bifurcation SB > 2.5 mm, >10 mm long, >75% is complex, eccentric plaque and DM are complex features and need 2 stent strategy.