Drug Eluting Stents: Bifurcation and Left Main Approach

Transcription

1 TCT Asia 2006 Drug Eluting Stents: Bifurcation and Left Main Approach Eberhard Grube MD FACC, FSCAI Heart Center,, Germany Stanford University, School of Medicine, CA, USA

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3 DES in High Risk Lesions TAXUS VI Control TAXUS MR Binary restenosis in-stent (%) P< P< P= % 86 % 80 % /57 4/55 17/34 3/43 17/42 3/37 P< % /55 3/62 Small vessels <2.5mm Long lesions 26mm Diabetics Overlapping stents

4 Bifurcation Lesions One term Many variations type 1 type 2 type 3 type 4 type 4b type 4a Y shape T shape >70

5 Bifurcation Lesions Restenosis Rates BMS 100 (%) 100 (%) Global 62% 48% Main Branch 100 (%) 38% 33% Side Branch 51% 33% Stent/Stent Stent/PTCA Yamashita et al. JACC 2000; 35:

6 Bifurcation Lesions Specific Techniques T, V Provisional T Coulotte Kissing Crush Reverse/Inverse Crush Mini-Crush etc.

7 Dedicated Bifurcation Bare Metal Stents AST petal Guidant frontier YMed sidekick Devax true bifurcation designs sidebranch designs

8 SIRIUS Bifurcation Study In-lesion Restenosis (treatment received); 78% FU Total Restenosis (MV and/or SB) 25.7% (17/66) Total MV 6.1% (4/66) (17%) (13%) (29%) (32%) 0 3/50 1/16 12/50 3/16 Main Vessel Total SB 22.7% (15/66) 24.0 P = Side Branch Mean DS% in parentheses

9 SIRIUS Bifurcation Study Restenosis Site (17 cases) Stent + Stent Stent + PTCA *2 11 *1 3 1! 1

10 Results with Crush stenting according to performance of final kiss (n=148) Restenosis Rate (%) Late Lumen Loss (mm) No final Kissing Yes final Kissing No final Kissing Yes final Kissing % (22/58) % (9/58) 8.9% (8/90) 11.1% (10/90) P=0.33 Main Branch P<0.001 Side Branch 0 P=0.10 Main Branch P<0.05 Side Branch

11 Bifurcation Lesions Drug Eluting Stents Colombo A et al. Circulation ;109(10): Binary Restenosis at 6 MFU T-stenting 55 (94.8%) Y Stenting 2 (3.4%) V Stenting 1 (1.7%) 22,0% 18,7% ,1% 0 Main Branch St/St St/PTCA Side Branch

12 LM PCI: No one likes surgery

13 LMCA Stenting in S. Korea Matched Comparison with BMS BMS group SES group 121 patients 102 patients March arch March arch March arch Park SJ et al, JACC 2005;45:351

14 LM-Stenting Techniques Diameter stenosis of LCX (%) Small LM LCX disease + Big LM LCX disease + 40 Across LCX Crush or T 20 Kissing Small LM Big LM 0LCX disease - LCX disease Reference diameter of LMCA (mm) SJ Park et al 2005

15 LM-Stenting Restenosis Rates % 30 Overall P= ,7 11,6 10 5,8 0 SJ Park et al /86 3/52 3/18 4/16 Total Across LCX Kissing Crush

16 LM-Stenting Restenosis Rates % Main Vessel P= ,1 5 0 SJ Park et al ,3 0 2/86 0/52 2/18 0/16 Overall Across LCX Kissing 0 Crush

17 LM-Stenting Restenosis Rates % 30 Circumflex Ostium P= ,3 5,8 5,6 0 SJ Park et al /86 3/52 1/18 4/16 Total Across LCX Kissing Crush

18 LMCA Stenting in S. Korea MACE free survival (%) MACE-free Survival at 1 year 100 SES group P<0.001 BMS group 96.2 ± 1.4% 81.4 ± 3.7% Months Park SJ et al, JACC 2005;45:351

19 Sirolimus-Eluting Stents for Unprotected Left Main The Scripps Clinic Experience (n = 50) n = 47 (94%) distal LMN involving bifurcation LAD Left main ostial or mid LMN n = 3 (6%) LCX

20 LM DES at SCRIPPS: Angiographic Restenosis at 9 Mos QCA performed on 48/50 patients (96%) Left Main Late-loss (mm) Left Main Restenosis 8.3% In-lesion Late Loss (mm) LMN - LAD 0.44 ± 0.68 Circumflex 0.66 ± 0.77 In-stent Late-Loss (mm) 0.48 ± ± 0.89 In-lesion Restenosis 23% 35%

21 LM DES at SCRIPPS Distribution of angiographic in-stent restenosis Overall, restenosis occurred in 21 patients (44%) Only 4 pts (8%) had restenosis within the LMCA itself Restenosis was focal (Mehran class I) in 85% Site LMCA (N, %) LAD ostium only LCX ostium only Both LAD, LCX ostia N = 21 4 (19%) 2 (9.5%) 10 (48%) 5 (24%)

22 LM DES at SCRIPPS In-hospital Outcomes Death MI Acute thrombosis TLR Non-Q-Wave Q-Wave (N=50) Death, any MI, TLR, or thrombosis 0 4 (8%) 3 (6%) 1 (2%) 2 (4%) 3 (6%) 5 (10%)

23 LM DES at SCRIPPS: Clinical Outcomes at 9 mos Events (n=50) Death 5 (10%) Cardiac death 1 (2%) Non-cardiac death 4 (8%) Sub-acute Thrombosis 0 MI 1 (2%) TLR 19 (38%) TLR ischemia driven 7 (14%) Death, any MI, any TLR 22 (44%) 12/19 pts with TLR (63%) were asymptomatic

24 Unprotected Left Main Milan DES Experience at 1 Year (n=107) Distal bifurcation 73%; 51% Cypher, 48% TAXUS; 39% crush, 19% V stent; 73% sidebranch Rx; 70% final kiss 12 month outcomes 30% 25% 20% 15% 10% 5% 0% 29.9% Late loss = 0.58 mm 19.6% 17.9% 15.8% 2.8% Death TLR TVR MACE Restenosis

25 Lesion Specific DES Concept

26 Axxess Bifurcation Stent System Stent: Self expanding nickeltitanium (Nitinol) alloy Axxess Biolimus Eluting Stent Drug: Biolimus A9 Dose: 22 ug/mm sent length Drug carrier: Bioabsorbable PLA polymer Rapid Exchange Delivery System Delivery: covered sheath RX delivery catheter

27 Complete Ostial Coverage Stent flares to cover ostia of Both branching vessels Carina area is covered By stent struts

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30 AXXESS PLUS Results Angiographic Follow Up Binary Restenosis - Axxess Plus only - All stents (Axxess + distal DES) - In segment 124/136 (91.2%) 4.0% 5.6% 10.5% Axxess Plus Control p Angiographic Late Loss 0.11 ± 0.62 mm 0.46 ± 0.51 mm 0.002

31 SYNTAX TAXUS vs. CABG bei LM-Stenosen / Mehrgefäß-Erkrankung All patients with 3VD/LM Heart Team (surgeon & interventionalist) 2 treatment options 1 treatment option only Randomized Arm Two Registry Arms TAXUS PCI vs CABG PCI CABG

32 SYNTAX Study Current Status 500 enrollment status Left main enrollment exceeds expectations Patients Randomized Registry % of Randomized LM: 37% Protocol amended to allow up to 710 pts 100 3VD: 63% 0 Mar-05 Apr-05 May-05 Jun-05 Jul-05 Aug-05 Sep-05 Oct-05 Actual

33 FREEDOM Trial Multivessel Sirolimus Stenting vs. CABG in Diabetics Eligibility: DM patients with MV-CAD eligible for stent or surgery Exclude: Patients with acute MI and/or cardiogenic shock 2300 pts Randomized 1:1 MV-sirolimus stenting With abciximab CABG With or without CPB All concomitant Meds shown to be beneficial are encouraged, including: Plavix, ACE inhibitors, b-blockers, statins, etc. 1 o Endpoint: 5-year mortality 5-year MACE 2 o Endpoint : MACE/stroke at 12 months