SCAI 2009 Fellows Course Mirage Hotel Las Vegas, NV Dec 8 th , 2009 State of the Art: Bifurcation Treatment Strategies James B. Hermiller, MD The Care Group, LLC The Heart Center of Indiana St. Vincent Hospital Indianapolis, IN
– Abbott, BSC and St Jude Disclosures • Consultant:
Bifurcations: Dangerous – High Stakes
Wrong Tool for the Job
It can get you killed. Ingenuity
Outline • Introduction • DES vs BMS • One vs. Two Stents • Two Stent Techniques • If Two Stents, which Technique Best? • Conclusions
Classification Schemes Parent Prebranch Vessel Only French/Lefevre Duke Postbranch Prebranch Ostial Bifurcation and Branch Safien Chen-Gao Movahed Sanborn
Coronary Bifurcation Lesions Medina Classification Medina A, Rev Esp Cardiol.2006 Feb;59(2):183
The Key: The Branch
Main Consideration: The Branch • Will the side branch close? – Plaque at ostium and angulation ( Aliabadi: Am J Cardiol,1997;80:994-997) • Is the side branch large enough to Stent? (>2.5 mm) Dauerman HL, et al. JACC.1998;32:1845-52 ) • Is the side branch plaque lengthy (not focal)? • What’s the sidebranch angle? (<70 o or > 70 o ) • Can you rewire after main branch stent?
Oculostenotic Reflex Eyeball – effect of angiography
Bifurcations IVUS CSA : 3.4 mm 2 Result after Kissing FFR : 0.80
Oculostenosis and Branch Lesions • 97 consecutive branch ostial lesions • 2mm side branch with > 50% angiographic stenosis • FFR measured in 94 of the vessels • No lesion less than 75% stenosis had abnormal FFR < 0.75 • Of the 73 with >75% stenosis, only 20 had were functionally significant. In those > 2.5 mm in diameter only 38% had abnormal FFR Koo BK. JACC. 2005;46:633-637
Outline • Introduction • DES vs BMS • One vs. Two Stents • Two Stent Techniques • If Two Stents, which Technique Best? • Conclusions
DES vs. BMS 126 with bifurcation lesions SES vs. BMS from overall SCANDSTENT trial Sirolimus Eluting stent N=68 Bare Metal StentBare N=58 Theusen L, et. Al. Am Heart J. 2006;152:1140-5.
DES vs. BMS: Bifurcations 55 DES - Ge et al. AJC 2005 51 BMS - Yamashita JACC 2000 45 38 38 36 35 % 25 13.3 15 8.9 5.4 5.4 5 -5 TLR MACE TLR MACE One Stent Two Stent
Outline • Introduction • DES vs BMS • One vs. Two Stents • Two Stent Techniques • If Two Stents, which Technique Best? • Conclusions
NORDIC TRIAL Circulation 2006;114:1955-1961 BBK ( Bifurcations Bad Krozingen) Eur Heart J. 2008; 29(23): 2859–2867. CACTUS Circulation 2009;119:71-78. BBC ONE TCT 2008
One stent vs. Two: TLR 10.9 12 One Stent Two-Stent 8.9 10 8 5.6 5.8 %TLR 4.3% 6 4.8 Crossover; 3.8 TIMI 0 post 18.8% 31% SB PTCA 4 Crossover; Crossover; 3% 1.9 >60% and/ >50% and/ Crossover; 1 or flow-limiting or flow-limiting >70% and/ 2 dissection dissection or < TIMI 3 0 Nordic I BBK CACTUS BBC One N= 413 202 350 500
Nordic I End points after 36 months MV MV+SB P-value (n=201) (n=196) Total death (%) 2.9 5.8 0.15 Cardiac death (%) 1.4 1.5 1.00 Myocardial infarction (%)3.0 3.6 0.78 TLR (%) 8.0 9.7 0.60 TVR (%) 9.5 11.7 0.52 Def. stent thromb. (%) 2.5 1.0 0.45 Sjögren EuroPCR 2009
CKmb Down Side of Two Stents
Consensus: 1 Stent Preferred Over 2
What Patients in These Trials: Short Lesion in SB with Moderate Stenosis TULIPE 2 Bestent 1 Sirolimus 3 Sirolimus 4 85 47 Patients (n) 105 187 2.1 ± 0.3 2.1 ± 0.5 2.3 ± 0.5 2.7 ± 0.4 Reference (mm) 5.3 ± 4.2 4.5 ± 3.0 5.6 ± 4.2 3.7 ± 3.3 Lesion length (mm) 52 ± 19 42 ± 23 49 ± 37 52 ± 17 Stenosis SB (%) 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: 1244-9, 4 Sengotuvel et al, JACC 2004 (abst.supp.)
When PTCA or Stent Through MB: Absolutely End with a Kiss Provisional T-stent
Stent Strategy Provisional Single Stent Approaches Keep It KIO
Trapping the Wire TULIPE study (N=186): • Failure to use a “jailed wire in the SB was an independent predictor of reintervention at 7 months (OR 4.26; 95% CU 1.27 –14.2) • Favorably modifies angulation • Maintains patency of SB • Identifies ostium when rewiring • Non-hydrophilic/no-shaping ribbon • Don’t trap large amount of wire • If trouble removing – balloon backup Brunel et al CCI 2006;68:67-73
Keep It Open (KIO) When the SB has ostial or diffuse disease AND when the SB is not suitable (too small) for stenting or clinically not relevant 6 Fr guiding catheter 1. Wire both branches 2. Dilate MB if needed 3. Stent MB and leave wire in the SB 4. Perform post-dilatation of the MB with jailed wire in the SB Do not re-wire SB or postdilate or predilate SB
NORDIC 3: KISS vs No KISS • In a randomized clinical trial, to compare outcome of two side-branch strategies in coronary bifurcation lesions treated with main vessel stenting using sirolimus eluting stents Kissing balloon No kissing balloon dilatation dilatation
Randomization Bifurcation patients with successful MV stenting n: 477 No Kissing balloon Kissing balloon n: 238 n: 239 Clinical follow ‐ up after 1 and 6 months n: 477 (100%)
Primary Endpoint A 6-month composite end point of: – Cardiac death – Index lesion myocardial infarction* – Target lesion revascularisation (TLR) – Stent thrombosis • angiographic confirmation • cardiac death * Non-procedure related
Procedure data I P value Culotte No kissing Kissing p-value Crush Culotte P-value n=210 n=210 n=239 n=238 (n=210)(n=215) Aspirin Tx (%) 99.6 100.0 ns Clopidogrel Tx (%) 98.7 99.2 ns GPIIb/IIIa Tx (%) 28.9 29.1 ns Bivalirudin Tx (%) 20.9 26.2 ns Procedure time (min) 47 + 22 61 + 28 0.0001 Fluorosc. time (min) 11 + 10 16 + 12 0.0001 Contrast (ml) 200 + 92 235 + 97 0.0001
Primary end point MACE (cardiac death, index lesion MI, TLR, stent thrombosis) after 6 months 6 5 4 2.9 2.9 % 3 2 ns 1 0 KISSING NO KISSING
Conclusion • In coronary bifurcation lesions, a strategy of routine kissing balloon dilatation of side branch through the MV stent did not improve the 6-month clinical outcome as compared to a strategy of no kissing balloon dilatation • In the kissing balloon dilatation group, the procedure and fluoroscopy time and the use of contrast were significantly increased
Outline • Introduction • DES vs BMS • One vs. Two Stents • Two Stent Techniques • If Two Stents, which Technique Best? • Conclusions
Culotte Two Stent Appoaches Crush Kiss (SKS) T
Various Techniques for Stenting Bifurcation Lesions Stent+stent Bifurcation Lesion Stent+PTCA (“T stenting”) Side- branch Main vessel
Blocking Balloon Technique: Schwartz L, et al J Invasive Cardiol.2002;14:66-71 Dardas PS, et al, J Invasive Cardiol.2003;15:180-183
Ballon-Alignment Technique
Various Techniques for Stenting Bifurcation Lesions Stent+stent Stent+stent Bifurcation Lesion Stent+PTCA (“reverse-T”) (“T stenting”) TAP Side- branch Main vessel
TAP: T-stenting and small protrusion Reverse T Stenting • Stent main branch trapping wire • Rewire sidebranch • Dilate through struts of MB stent • Deliver SB stent (proximal end of SB stent 1 mm into MB) • Deploy SB stent (balloon in MB) • Pull back SB deployment balloon slightly and kiss • Exchange for non-compliant SB balloon – 2 step SB dilatation (high pressure in SB then Kiss)
TAP Results 10 N=207 Provisional TAP Technique 58% 8 Remainder 1 MB Stent 1 Stent TAP 6 % 4 2 0 Death TLR TVR ST* Gwon et al. ACC 2008
T Stent Summary • Indications – Bifurcation lesions with an angle between MB and SB of ~ 90 degrees. – TAP default strategy when single stent strategy fails • Advantages – The technique is easy, fast and not technically demanding. • Drawbacks – When trying to position the SB stent exactly at the ostium without minimal protrusion into the MB the stent often misses the ostium (gap) – particularly true as the side branch angle becomes less acute
Various Techniques for Stenting Bifurcation Lesions Stent+stent Stent+stent Bifurcation Lesion Stent+PTCA (“reverse-T”) (“T stenting”) Side- branch Main vessel Stent+stent Stent+stent (“Kissing” “SKS”) (“V” - < 5mm) “V” 1 1
Coronary Bifurcation Lesions THERAPEUTIC APPROACH: 5 types V or Double D or SKS • Simultaneous placement of 2 stents at each ostium of the bifurcation; if more than 5 mm proximal overlap this is called a SKS (simultaneous kissing stent technique) • Used in type 4 lesion (looks like aorto-iliac stenosis)
Iakovou et al. JACC 2005:46:1446-55.
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