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March 20th 2012 Case #19: FE, 61 yrs F Presentation: Patient with prior DES PCIs of LAD and RCA in 2010, presented on 3/2/2012 with cresendo angina CCS class III. No Stress done and pt underwent cath revealing distal LM bifurcation with Medina 1,1,1 along with 90% lesion in small size LPL and LVEF 60%. Syntax Score 23. Pt was taken of the table for Heart Team discussion & enrollment in EXCEL trial. Prior History: Hyperlipidemia, Hypertension, IDDM, Asthma, Hepatitis C and mild cirrhosis with esophageal variceal bleed in remote past Medications: All once daily dosage ASA 81mg, Clopidogrel 75mg, Bisoprolol 5mg, Rosuvastatin 20mg, Insulin, Case# 19: cont Cardiac Cath 03/02/2012: Syntax score 23 2 Vessel +LM CAD with LVEF 60% Left Main: 60% distal LM bifurcation LAD: 70% ostial LAD with other DES patent in LAD LCx: 80% ostial LCx with 90% lesion in small LPL1 RCA: 30% lesion in mid with patent DES sites Subsequent Course: - Pt underwent evaluation by Heart Team and declined for CABG due to Cirrhosis Child class A and hence no EXCEL trial also Plan Today: - PCI of IVUS guided distal LM bifurcation Appropriateness Criteria for Coronary Revascularization
Appropriateness Use Criteria for PCI AUC Criteria from ACC-NCDR Results (n=500,00) 98.6 100 90 % 84.6 80 ALL 70 ACS PCI (71%) 60 Elective PCI (29%) 50 50.4 38.0 40 30 20
11.2 10 0 11.6 0.3 Appropriate Uncertain 4.1 1.1 Inappropriate Paul Chan. ACC i2 Summit 2011 Appropriateness of Revascularization by PCI for Stable CAD: NY State vs. MSH: 2010 70 60 51.8 48.2 50 %
N Stable CAD % Not Rated % NYS 14743 37.4 27.5 MSH 2575 62.3 13.7 NYS-DOH Report of PCI 2007-9 Data on Top 10 Volume Centers in NY State 30-Day RAMR PCI Statistics for 2007-9 # cases All cases Non-Emergency
cases 1. Mount Sinai Hospital 13993 0.67** 0.45** 2.21 2. Columbia Presbyterians H 8741 0.96 0.66 2.79 3. Lenox Hill Hospital 8704 0.86 0.50 3.88
4. Saint Francis Hospital 8703 0.67** 0.37** 3.19 5. North Shore Hospital 6779 0.76 0.63 1.72** 6. Saint Josephs Hospital 6064 0.93 0.62 3.09 7. Rochester General Hospital
6056 1.21 0.71 4.43 8. LIJ Medical Center 5642 0.62** 0.39 2.31 9. Stony Brook Hospital 5233 0.98 0.65 3.32 10. Beth Israel Medical Ctr 4861
0.65 0.36 3.20 160576 0.94 0.59 3.27 NYS Total Emergency cases **RAMR significantly lower than statewide rate NYS-DOH Report of PCI 2009 Data on Top 10 Volume Centers in NY State # cases Risk-adjusted 30-day Mortality All cases Risk-adjusted Mortality Rates Non-emergency cases
1. Mount Sinai Hospital 5060 0.81 0.45 2. Saint Francis Hospital 3105 0.53 0.21 3. Lenox Hill Hospital 2940 0.38 0.24 4. Columbia Presbyterians H 2881 1.09 0.71
5. Saint Josephs Hospital 2144 1.03 0.71 6. North Shore Hospital 1991 0.66 0.61 7. LIJ Medical Center 1963 0.67 0.28 8. Stony Brook Hospital 1829 0.88 0.41
9. Rochester General Hospital 1813 1.17 0.59 10. Beth Israel Medical Ctr NYS Total 1637 53893 0.61 0.91 0.21 0.53 PCI Statistics for 2009 Technical Pearls and Issues With the Case by Dr Kini Guide catheter selection Role of plaque modification
Role of imaging to optimize results; IVUS, OCT Issues Involving The Case Comparison of Newer DES; Xience vs. Resolute Left Main Bifurcation Intervention Techniques Issues Involving The Case Comparison of Newer DES; Xience vs. Resolute Left Main Bifurcation Intervention Techniques Resolute Integrity DES System Components Established Components Integrity cobalt alloy stent Unique Polymer Technology BioLinx polymer is a unique blend of three polymers to control drug release, support biocompatibility and enhance elution rate MicroTrac delivery system Zotarolimus antiproliferative drug
Zotarolimus Release (%) Drug-release kinetics: complete elution by 180 days 100 80 60 % eluted 40 20 0 0 50 100 150 200 Days Udipi K, et al. EuroIntervention. 2007; 3:137-9 Meredith IT, et al. J Am Coll Cardiol Intv. 2009; 2:977-85 Resolute Integrity Platform Sinusoidal Design Allows for Continuous Flexibility
Flex f Stif Stiff Separate stiff segments connected by flexible connectors limit range of motion Flex iff St Stif f Promus Element Platform Flex if f St Stif f Flex Fle Continuous sinusoid technology
will flex continually Xience Prime Multi-link Platform x 115 Bend Resolute Integrity Platform Continuous sinusoid technology allows for continuous flex, which is not possible with laser-cut stents Stent Conformability and Stent Strut Apposition Stent strut apposition is an important factor for a stent to resist post-dilatation or other secondary devices from catching on the stent. Element Platform Multi-link 8 Platform Promus Element DES 0.05 Xience Prime DES Strut to Artery Distance (mm) Nominal pressure deployment
Integrity Platform Resolute Integrity DES Resolute Integrity DES has better strut apposition as compared to Xience Prime DES and Promus Element DES 0.00 RESOLUTE US All Patients Safety and Efficacy Outcomes at 12 Months Resolute ZES (n=1376/1402) Events % Target lesion failure (TLF): cardiac death, target vessel MI and TLR; Historical 6.5% 5.5 4.7 2.8 1.4 0.7 TLF MACE TLR Cardiac Death 0.1 MI
ST (ARC Def/Prob) Yeung AC, et al. J Am Coll Cardiol. 2011;57:1778. Resolute All Comers Trial Clinical Outcomes at 12 Months Zotarolimus-Eluting Stent (n=1119) Resolute DES Everolimus-Eluting Stent (n=1126) XienceV DES 15 p=0.42 12 9.7 p=0.92 9 % 6 3 0 8.7 p=0.92 p=0.08
4.2 4.1 2.8 4.9 4.8 p=0.01 1.6 Death 1.2 MI TVR MACE 0.3 Stent Thrombosis Definite/probable Serruys et al. N Engl J Med 2010;363:136. RESOLUTE All Comers Trial: Cumulative Incidence
of Definite or Probable Stent Thrombosis Serruys et al., N Engl J 2010;363:136 Resolute All Comers Trial Clinical Outcomes at 24 Months Zotarolimus-Eluting Stent (n=1119) Resolute DES Everolimus-Eluting Stent (n=1126) XienceV DES p=0.75 15 p=0.52 12 10.0 9 % 6 3 0 12.5 12.9 9.1 p=0.57 p=0.36
3.2 4.0 5.5 5.0 p=0.07 1.9 Death MI TVR MACE 1.0 Stent Thrombosis Definite/Probable Silber et al., thelancet. 2011;377:1241 TWENTE Trial: 1-Year Clinical Outcomes in the Intention to Treat Study Population ZES Resolute (n= 695) EES Xience V (n= 692) P= 0.48 P=0.94
% P=0.86 P=0.99 P=0.54 P=0.59 Death MI TVR TVF MACE Definite or Probable ST Von Birgelen et al, JACC 2012;59:000 The TWENTE Trial: Cumulative Incidence of Definite or Probable Stent Thrombosis Von Birgelen et al, JACC 2012;59:000 The TWENTE Trial: Subgroup Analysis for TVF @ 1Year
Von Birgelen et al, JACC 2012;59:000 Platinum Chromium (PtCr) Stent Material Radial Strength Biocompatibility 0.30 Bench Test Data 0.26 0.24 0.25 0.17 0.20 Newtons/mm 0.15 0.11 0.15 0.10 0.05 0.00 CoCr
P=0.97 4.9 5.0 P=0.83 4 2 P=0.85 1.2 1.3 P=0.25 1.8 1.1 All Death MI 2.9 2.7 P=0.72 3.2 3.5 P=1.00 0.4 0.4 0 Death/MI/TVR TVR
Target lesion Stent failure thrombosis Stone et al., JACC 2011;57:1700 Issues Involving The Case Comparison of Newer DES; Xience vs. Resolute Left Main Bifurcation Intervention Techniques EXCEL Trial (Evaluation of Xience Prime vs. CABG for Examination of LM Disease) LM disease (1, 2 or 3 vessel disease) and a SYNTAX score of 32 @ 165 International sites Randomize 2600 pts XIENCE Prime Everolimus Eluting Stent Universal Registry N=1000 Subset of pts with Intermediate lesions (n=100) CABG The primary endpoint is the composite incidence of death, large MI or stroke at a median FU duration of 3 years, with minimum FU of 2 yrs in all pts.
The major secondary endpoint is the composite incidence of death, large MI or stroke at 30-days, stroke at 30-days, unplanned revascularization at 3yrs and MACCE at 3yrs. Coronary Artery Bifurcation Lesion Interventional Techniques Interventional Bifurcation Techniques One Stent Technique (OST) OST with SBR Dilatation (SBT) Kissing Stent Technique (SKS) T Stent Technique (TST) Crush Stent Technique (CrST) Culotte Stent Technique (CUT) LM Bifurcation Lesion: Two Stent Approach An approach for bifurcation lesions when using 2 stents as intention to treat Bifurcation lesion with no disease proximal to the bifurcation or very short
proximal lesion SKS/VSTENT Bifurcation lesion with main branch disease extending proximal to the bifurcation and side branch which has origin with about 900 angle T- STENT Culotte Bifurcation lesion with main branch disease extending proximal to the bifurcation and side branch which has origin with about 600 angle SHORTMINI Crush Proposed Approach to LM PCI Sign LCX Crush or T stenting Kissing (Culotte) stents Single across
LCX Single across LCX 50% Insign or small LCX Small LM 4 mm Large LM When PTCA or Stent Through MB: Absolutely End with a Kiss Provisional T-Stent Nordic-Baltic Bifurcation Study III Estimate of eligible patients (n=2385) Randomized patients (n=477) FKBD* (n=477) *Final kissing balloon dilatation No FKBD*
(n=238) 6 months clinical F/U (n=239,100%) 6 months clinical F/U (n=238,100%) Scheduled Angiographing F/U After 8 months (n=189) Scheduled Angiographing F/U After 8 months (n=185) Angiographic F/U available (n=162, 86%) Angiographic F/U available (n=164, 88%) Niemela M et al. Circulation 2011:123:79 Nordic Bifurcation Study III- Final Kiss or No Kiss MACE and Clinical Outcomes at 6 Months 4 3
No FKBD (n=239) FKBD (n=238) No FKBD 0.4 ST p=1.00 CCS >2 Angina 12.0 FKBD 0.4 11.7 2.5 % 2 p=1.00 2.1 p=0.62 p=0.24 1 1.7
1.3 1.3 0.8 0.4 0 0 MACE Death MI TLR Niemela M et al. Circulation 2011:123:79 Take Home Message: Newer DES and LM PCI Both newer DES (Xience V/prime and Resolute Integrity) seems to provide comparable long-term MACE with lower ST in favor of Xience V in RAC trial (while NS in TWENTE Trial) Unprotected LM lesions with Syntax score <33 seems to have excellent long-term outcome after properly done PCI; EXCEL Trial will be the final answer
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