BIFURCATION LESIONS Dr. Tahsin.N Review of Evidence BIFURCATION LESIONS Dr. Tahsin.N 22/6/12

Introduction 22/6/12

Definition of bifurcation lesion(EBC) Coronary artery narrowing occurring adjacent to and /or involving origin of a significant side branch 22/6/12

Bifurcation interventions lower rate of procedural success higher procedural costs longer hospitalization higher clinical and angiographic restenosis. No 2 bifurcations are identical No single strategy to be used on every bifurcation 22/6/12

Medina classification 22/6/12

Provisional side branch stenting Vs Two stent strategy 22/6/12

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Nordic bifurcation study(circulation 2006) 22/6/12

Randomized, multicenter trial Diameter of MV>2.5mm&SB>2.0 mm MV grp Stenting MV Side branch dilatation if TIMI <3 Side branch stenting if TIMI=0 after dilatation MV+SB grp Crush technique in 50%,culotte technique in 21%, other techniques in 29% Final kissing dilatation in 74% 22/6/12

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Procedure related biomarker elevation 18% of MV+SB grp Vs 8% of MV grp,p=0.01 Restenosis rates in MV 4.6% Vs 5.1% in MV &MV+SB groups,P=NS Restenosis rates in SB 19.2% Vs 11.5%,p=NS 22/6/12

Limitations Non blinded Underpowered Conclusions simple stenting strategy procedure is as effective as complex stenting & a/w reduced procedure related biomarker elevation 22/6/12

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9 mth FUP 22/6/12

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2 year outcome 22/6/12

CACTUS study(Circulation 2009) Prospective, randomized, multicenter study Compared elective “crush” stenting & stenting of only main branch with provisional side-branch T-stenting SB T-stenting for Residual stenosis 50% Dissection TIMI ≤ 2 Mandatory final kissing-balloon inflation 22/6/12

provisional stenting,n=173 350 pts elective crush,n=177 provisional stenting,n=173 Provisional group-additional stent on SB 31% Primary clinical end point- MACE at 6 mth crush group-15.8% provisional group-15.0% 22/6/12

Definite ST at 6 mth- 1.7% in crush grp 1.1% in provisional grp Restenosis rate MB 4% vs 8.7% SB 14.6% VS 12.5% 22/6/12

Second stent in the SB needed in 31% Limitations 6 mth FUP Bifurcation lesions with significant stenosis in both branches, a strategy to stent the MB is effective Second stent in the SB needed in 31% Limitations 6 mth FUP No functional assessment 22/6/12

BBC ONE trial(Circulation 2010) 500 pts,9mth clinical and angiographic follow up Simple or complex stenting strategy MV>2.5 mm & SB>2.25 mm Simple strategy(N=250) MV stented F/B optional kissing balloon dilatation/T-stent side branch Stenting TIMI flow <3 90% pinching Threatened side-branch vessel closure dissection Complex strategy(N=250) Culotte or crush technique with mandatory kissing balloon dilatation 22/6/12

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BBC ONE Complex strategy Simple strategy (n = 250) Trial design: Patients with bifurcation lesions were randomized to either a simple stepwise provisional T-stent strategy or a complex strategy involving either crush or culotte techniques. Clinical outcomes were compared at 9 months. Results (p = 0.009) (p > 0.05) MACE (death, MI, or TVF) was more frequent in the complex strategy arm (HR 2.0, 95% CI 1.2-3.5, p = 0.009), as well as MI (p = 0.001) Incidence of mortality, TVF, and stent thrombosis was similar between the two arms (p > 0.05) TIMI major bleeding was higher with the complex strategy (1.2% vs. 0.4%, p > 0.05) 20 20 15.2 15 15 % % 10 10 8.0 Conclusions 5 5 2.0 A simple stepwise T-stent strategy is superior to a more complex strategy involving crush or culotte techniques in patients with bifurcation lesions 0.4 MACE Stent thrombosis Complex strategy (n = 250) Simple strategy Presented by Dr. David J. Hildick-Smith at TCT 2008 22/6/12

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Meta analysis of five RCT 1553 pts 777 treated with simple strategy 776 treated with complex strategy PES in BBC ONE trial,SES in others All pts treated with aspirin and thienopyridines(clopidogrel or ticlopidine) 22/6/12

Endpoints clinical endpoints cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR) and stent thrombosis (ST) binary angiographic restenosis defined as >50% diameter stenosis of treated lesion at FUP of both MV and SB 22/6/12

Results Risk of follow-up MI lower in pts treated with the simple strategy Vs complex approach RR 0.54, 95% CI 0.37 to 0.78, p=0.001 reduced early (in-hospital or 30-day) MI RR 0.52, 95% CI 0.35 to 0.78, p=0.002 risk of non-Q-wave MI lower than that in the complex strategy RR 0.63, 95% CI 0.39 to 0.99, p=0.049 no significant difference in the risk of Q-wave MI RR 0.54, 95% CI 0.15 to 1.95, p=0.35 22/6/12

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No significant difference in risk of cardiac death at follow-up RR 0.68, 95% CI 0.21 to 2.25, p=0.53 No significant difference in TLR at follow-up RR 0.93, 95% CI 0.62 to 1.41,p=0.74 No significant difference in incidence of definite ST(0.6% Vs 1.4% ,RR 0.50, p=0.16) 22/6/12

RR of definite stent thrombosis 22/6/12

Restenosis rates of MV-no significant difference RR 1.15, 95% CI 0.66 to 2.00, p=0.63 Restenosis rates of SB-no significant difference RR 1.12, 95% CI 0.80 to 1.57, p=0.50 22/6/12

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CONCLUSION Simple strategy a/w lower risk of early MI & similar rate of angiographic restenosis at FUP compared to complex strategy for bifurcation lesions Simple strategy comprising MV stenting and provisional stenting for SB can be recommended as a preferred bifurcation stenting technique 22/6/12

Final kissing balloon dilatation 22/6/12

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Acc.to final kissing balloon post-dilation (FKB) FKB group (n=116) 181 pts,Crush technique Acc.to final kissing balloon post-dilation (FKB) FKB group (n=116) Non-FKB(n=65) FUP at 9 mth,angiographic FUP in 80% of pts 22/6/12

Black bars-without FKB 22/6/12

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Nordic III study(circulation 2011) Randomized multicenter trial to compare final kissing balloon dilatation VS no FKBD Vessel size main vessel diameter ≥ 2.50mm side branch diameter ≥ 2.25 mm 22/6/12

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Nordic-Baltic Bifurcation Study III Trial design: Patients with coronary bifurcation lesions treated with a single stent in the main artery were randomized to kissing balloon dilatation post-stenting or conservative management. Patients were followed for a mean of 6 months. Results (p = 1.0) (p > 0.05) MACE at 6 months for kissing balloon vs. no kissing balloon: 2.1% vs. 2.5 (p = 1.0) Stent thrombosis: 0.4% in both, TLR: 1.3% vs. 2.1%, mortality: 1.2% vs. 0% (p > 0.05 for all) Procedure time, fluoroscopic time, and contrast use were higher in kissing balloon arm (p = 0.0001) 10 10 5 5 % % Conclusions 2.5 Strategy of routine side branch kissing balloon dilatation was not associated with better outcomes at 6 months, with an increase in procedure and fluoroscopic times Should be reserved in situations such as plaque shift with clinical changes or poor TIMI flow down side branch 2.1 1.2 MACE at 6 months All-cause mortality Kissing balloon (n = 238) No kissing balloon (n = 239) Niemela M, et al. Circulation 2011;123:79-86

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Restenosis rates MV+SB 11.0% Vs 17.3% ,p=NS MV alone-3.1% VS 2.5%,P=NS 22/6/12

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Conclusion Provisional side branch stenting is the preferred bifurcation stenting strategy Final kissing balloon dilatation is recommended in complex stenting technique,not routine in provisional stenting strategy 22/6/12

FFR in Bifurcation Lesions 22/6/12

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Objectives This study was designed to assess the functional significance of side branches after stent implantation in main vessels using fractional flow reserve (FFR) Methods Between May 2007 and January 2011, 230 side branches in 230 patients after stent implantation in main vessels were assessed by FFR and were consecutively enrolled 22/6/12

Results After stent implantation in main vessels Only 41 (17.8%) side branches had functionally significant stenosis Among 67 side branches with > 50% DS by QCA, 19 (28.4%) had FFR < 0.80 Among 163 side branches with < 50% DS by QCA, 22(13.5%) had FFR < 0.80 22/6/12

Conclusions Most side branch lesions do not have functional significance after stent implantation in the main vessel, and quantitative coronary angiography is unreliable in assessing the functional severity of these lesions 22/6/12

Bifurcation Dedicated Stents 22/6/12

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Nile Pax DES 22/6/12

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Thank You 22/6/12

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