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First Meeting of the (EBC) European Bifurcation Club Thursday 15 – Friday 16 September 2005

First Meeting of the (EBC) European Bifurcation Club Thursday 15 – Friday 16 September 2005. Hotel Mercure Cité Mondiale, 20 Parvis des Chartrons -33080 Bordeaux, France. Which approach for LM stenting with DES? Insights from the Thoraxcenter DES Registries. Angela Hoye Marco Valgimigli

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First Meeting of the (EBC) European Bifurcation Club Thursday 15 – Friday 16 September 2005

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  1. First Meeting of the (EBC) European Bifurcation ClubThursday 15 – Friday 16 September 2005 Hotel Mercure Cité Mondiale, 20 Parvis des Chartrons -33080 Bordeaux, France

  2. Which approach for LM stenting with DES?Insights from the Thoraxcenter DES Registries Angela Hoye Marco Valgimigli Patrick W Serruys

  3. Dec 2003 May 2003 Apr 2002 Mar 2003 BMS 86 LMS stenting SES 52 LMS stenting PES 43 LMS stenting Since April 2002, we have used DES (either sirolimus or paclitaxel) as a default strategy

  4. Methodology • As a policy, all elective patients presenting with significant (>50% by visual estimation) LM disease are evaluated by both interventional cardiologists and cardiac surgeons and the decision to opt for PCI or surgery is reached by consensus • The interventional strategy was left to the operator’s discretion • All patients were maintained on lifelong aspirin, with clopidogrel for 1 month in those treated with BMS, and 6 months for those treated with DES • MACE: death AMI (≥2x ULN CK levels) TVR (in-stent or within 5mm including the ostium of the LAD / LCx

  5. HR 0.52 [95% CI: 0.31-0.88]; p=0.01 50 Pre-DES: 45% 40 30 DES: 24% 20 10 0 0 3 6 9 12 Time (months) Patients at risk (n) Pre-DES 86 67 53 47 44 DES 95 81 81 76 69 Valgimigli et al Circulation 2005: 111 Probability of adverse events for patients treated with DES versus those treated in the pre-DES era for LM disease Probability of MACE (%)

  6. Multivariable predictors of MACE Valgimigli et al Circulation 2005: 111

  7. Patients with DES therapy who had TVR Valgimigli et al Circulation 2005: 111

  8. Technique of bifurcation stenting of the distal LMS with DES n=94 60 % 50 40 30 20 10 0 Single stent Culotte T-stenting Crush Kissing

  9. Median follow-up 587 days (range 328-1179)

  10. 50 HR 1.03 [95% CI: 0.3-3.2]; p=0.38 40 Probability of TVR (%) 30 Bifurcation Stenting: 15% 20 Single Stenting: 11% 10 0 0 200 400 600 Days Patients at risk (n) Single stent group 48 41 31 18 Bifurcation group 46 35 25 14 Probability of TVR

  11. HR 0.96 [95% CI: 0.46-1.99]; p=0.92 50 40 Bifurcation Stenting: 31% Probabiity of MACE (%) 30 Single Stenting: 28% 20 10 0 0 200 400 600 Days Patients at risk (n) Single stent group 48 39 29 18 Bifurcation group 46 34 24 13 Probability of MACE

  12. p=0.8 p=0.9 p=0.4 p=0.6 p=0.3 p=1.0 • Late loss: Bifurcation stent: 0.25 ± 0.50mm p=1.0 Single stent: 0.26 ± 0.72mm • Binary restenosis: Bifurcation stent: 11% p=1.0 Single stent: 11% In-lesion QCA of the main branch MLD (mm) DS (%) 3.0 70 60 2.5 50 2.0 40 1.5 30 1.0 20 0.5 10 0 0 Pre Post Follow-up Pre Post Follow-up Bifurcation stent (n=36) Single stent (n=35)

  13. p=0.5 p=0.1 p=0.4 In-lesion QCA of side branch MLD (mm) DS (%) p<0.01 p<0.001 p=0.07 2.2 60 2.0 50 1.8 1.6 40 1.4 1.2 30 1.0 0.8 20 0.6 0.4 10 0.2 0 0 Pre Post Follow-up Pre Post Follow-up Bifurcation stent (n=36) Single stent (n=35) • Acute luminal gain: Bifurcation stent: 0.8 ± 0.6mm p<0.0001 Single stent: 0.09 ± 0.7mm • Late loss: Bifurcation stent: 0.32 ± 0.55mm p=0.02 Single stent: 0.04 ± 0.42mm • Binary stenosis: Bifurcation stent: 14% p=0.8 Single stent: 20%

  14. FU FU FU FU Pre Pre Pre Pre Post Post Post Post Side branch MLD (mm) Stented Not Stented Untreated Balloon Overall N=36 N=35 N=11 N=24 3.5 ALG: acute luminal gain LL: late loss NLG: net luminal gain 3.0 2.5 2.0 1.5 ALG 1.0 NLG NLG ALG LL NLG 0.5 ALG NLG LL ALG LL LL 0.0 -0.5

  15. CONCLUSIONS • Compared with historical data of bare metal stents, the adverse event rate is lower following DES implantation for LMS disease • The majority of adverse events occur within 1 year • The long-term angiographic outcome of the main vessel was not significantly affected whether or not the side branch was stented • The long-term angiographic outcome of non-stented side branches was similar to that of stented side branches

  16. CONCLUSIONS • Both single stent and 2-stent strategies appear to be reasonable options for the therapy of distal LMS disease • There is unlikely to be a single strategy that is broadly applicable to all anatomies and lesion subtypes. Further research with randomised studies is needed to evaluate outcomes with respect to the strategy used for differing bifurcation lesions

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