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Complex Coronary Cases Supported by: Abbott Vascular Boston Scientific Corporation Medtronic, Inc. AstraZeneca St Jude’s Medical Abiomed Vascular solution.

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Presentation on theme: "Complex Coronary Cases Supported by: Abbott Vascular Boston Scientific Corporation Medtronic, Inc. AstraZeneca St Jude’s Medical Abiomed Vascular solution."— Presentation transcript:

1 Complex Coronary Cases Supported by: Abbott Vascular Boston Scientific Corporation Medtronic, Inc. AstraZeneca St Jude’s Medical Abiomed Vascular solution Bracco Diagnostic

2 Disclosures Samin K. Sharma, MBBS, FACC Speaker’s Bureau – Boston Scientific Corporation, Abbott Vascular Inc, AngioScore, The Medicines Company, Daiichi Sankyo, Inc. and Lilly USA, LLC Annapoorna S. Kini, MBBS, FACC Nothing to disclose Sameer Mehta, MBBS, FACC Consulting Fees – The Medicines Company American College of Cardiology Foundation staff involved with this case have nothing to disclose

3 Presentation: Patient presented with new onset exertional angina class II and positive high risk MPI for large infero-lateral and inferior ischemia. Cardiac cath on 10/21/13 revealed 3 V CAD (90% D1, 100% moderate size OM1 and 100% prox RCA with extensive collaterals from LAD/LCx) and LVEF 60%. Syntax score 21. Patient underwent EES DES x2 to D1. Pt still continued exertional angina despite MMT Prior History: Hypertension, Hyperlipidemia, +F/H Medications: All once daily dosage Metoprolol XL 50mg, ISMN 30mg, Losartan/HCTZ 50/25mg, ASA 81mg, Clopidogrel 75mg, Simvastatin 80mg Nov 19th 2013 Case #17: WR, 73 yr M

4 Cardiac Cath 10/21/2013: Right Dominance 3 V CAD with LVEF 60% Left Main: No obstruction LAD: 30% pLAD and 90% calcific D1 LCx: 100% OM1 moderate size RCA: 100% pRCA, distal vessel large and fills via LAD/LCx collaterals Pt underwent PCI using 2 EES DES (2.5/23 and 2.5/12mm) of D1 with excellent results. Pt was discharged same day. Pt continued to have exertional angina despite MMT Plan Today: - PCI of CTO RCA using antegrade or retrograde approach Case# 17: cont…

5 Appropriateness Criteria for Coronary Revascularization

6 Issues Involving The Case Recent Trials of Coronary Bifurcation Lesion PCI Update in Duration & DAPT Interruption post- DES

7 Issues Involving The Case Recent Trials of Coronary Bifurcation Lesion PCI Update in Duration & DAPT Interruption post- DES

8 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) Culotte Stent Technique (CUT) Crush Stent Technique (CrST)

9 One stent (ok & simple but may have difficulty in rewiring or inserting second stent as bailout) or 2 stents (guaranteed coverage of both lesions but higher MACE, TVR or ST in many studies) If 2 stents; ?technique Bifurcation Lesion Intervention: 1 vs. 2 Stents Technical Issues

10 Conventional (n= 185) DK Crush (n=185) 9.7 Angiographic Restenosis % A Randomized Clinical Study Comparing Double Kissing Crush With Provisional Stenting for Treatment of Coronary Bifurcation Lesions: DK Crush II Study Main Vessel TVR p= p< p= MACE ST p= p= Chen S et al, JACC 2011;57:914 Side Vessel

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12 Nordic-Baltic Bifurcation Study IV: Patient Flow Chart Kumsars et al., TCT 2013 Nordic Baltic Bifurcation study IV n=450 Provisional SB stening n=221* Two stent n=229* 1 lost to FU 1 excluded due to protocol violation Provisional Completed 6M FU n=220 Two stent Completed 6M FU n=227 1 withdrawal

13 Nordic-Baltic Bifurcation Study IV: Procedural Data Kumsars et al., TCT 2013 Provisional (n=221) Two-stent (n=229)p SB dilatation (%) SB dilation or final kissing (%) Final kissing balloon dilatation (%) SB stented (%) Culotte T-stent-7.0- Other Tx succesful* (%) ns *Residual stenosis <30% of MV + TIMI flow III in SB

14 Nordic-Baltic Bifurcation Study IV: Procedural Data Kumsars et al., TCT 2013 *Residual stenosis <30% of MV + TIMI flow III in SB **Assessment possible in 327 patients Provisional (n=221)Two-stent (n=229)p Procedure time (min) < Contrast volume (mL)187238< Flouroscopy time (min) < Tx succesful* (%) ns Procedural CK-MB>5x UPL** (%)3.03.1ns Procedural CK-MB>3x UPL** (%) ns

15 Nordic-Baltic Bifurcation Study IV: Event Free Survival Curve at 6 Months Kumsars et al., TCT % 1.8% p=0.09

16 Nordic-Baltic Bifurcation Study IV: Individual Endpoints at 6 Months Kumsars et al., TCT 2013 p=0.32 p=0.50 p=0.54 p=0.11 p=0.39 Provisional (n=220) Two-stent (n=227) %

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18 TRYTON Bifurcation Trial: Study Design Leon et al., TCT 2013 % DS side branch (N=374) Secondary Endpoint TVF Primary Endpoint N = 704 IVUS Cohort n~96

19 TRYTON Bifurcation Trial: Patient Flow Leon et al., TCT 2013 TRYTON 4= Lost to F/U 2= Patient withdrawal 4= Death Provisional 6= Lost to F/U 5= Patient withdrawal 4= Death

20 TRYTON Bifurcation Trial: TVF at 9 Months Leon et al., TCT 2013 Primary Endpoint TRYTON (N=355) 17.4% Provisional (N=349) 12.8% Non- inferiority p value = Difference 4.6% Upper 1- Sided 95% CI 10.3% Zone of non-inferiority pre-specified margin = 5.5% % Non-inferior Primary Non-Inferiority Endpoint Not Met

21 TRYTON Bifurcation Trial: TVF Leon et al., TCT 2013 Primary Endpoint Non-Hierarchical % Provisional S (N=349) TRYTON S (N=355 p =0.108 p =0.109 p =0.564 ST 0.3% 0.6%

22 TRYTON Bifurcation Trial: Leon et al., TCT 2013 Additional Side Branch Stents Indications Provisional TRYTON %

23 TRYTON Bifurcation Study: SB %DS (In-segment) Leon et al., TCT 2013 Secondary Endpoint Secondary Superiority Endpoint Met p=0.002 %

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25 COBIS II Registry: Independent Predictors of Side Branch Occlusion (Occurs in 8.4% cases) Hahn et al., JACC 2013;62:1654 VariableOdds Ratio (95% CI)p Pre-procedural %DS of the SB ≥50% 2.34 ( )<0.001 Pre-procedural %DS of the proximal MV ≥50% 2.34 (1/ )0.03 SB lesion length1.03 ( )<0.001 Acute coronary syndrome1.53 ( )0.02 Left main lesions (vs. non-left main lesions) 0.34 ( )0.005

26 COBIS II Registry: Clinical Outcomes at 1-Yr F/U Hahn et al., JACC 2013;62:1654 SB Occlusion (n=187) No SB Occlusion (n=2040) p=0.002 p=0.46 p=0.002 p=0.36 p=0.03 % Of the 187 SBr occlusion 31% of SBr occlusion remained post PCI

27 Issues Involving The Case Recent Trials of Coronary Bifurcation Lesion PCI Update in Duration & DAPT Interruption post- DES

28 Optimal Duration of ADP Receptor Blockers Post DES Still Remain Unclear (Aspirin mg daily for life) Cypher Stent Launch 5/2003 AHA/ACC PCI Guidelines 2001 (TAXUS stent 6 months post PCI) (Cypher stent 3 months post PCI) AHA/ACC/SCAI Updated Guidelines 2005 ESC 2005/ACC 2006 PCI Updated Guidelines (12 months post PCI) CURE, PCI-CURE – 2001 CREDO – 2002 TAXUS Stent Launch 3/2004 (1-12 months post BMS) 9-12 months BMS Era DES Era (FDA recommendations) Clopido/Prasugrel/Ticag should be continued for 1 yr or even longer if no contraindications If not sure about DAPT compliance or has to be interrupted in 12M then BMS (Basket late) is safer & should be preferred AHA/ACC Updated Guidelines 2006

29 Randomized Trials of DAPT Duration % MACE Bleeding REAL-LATE PRODIGY RESET

30 OPTIMIZE Trial: Study Design Feres et al., Am Heart J 2012;164:810 N = 3120 patients 1:1 Randomization 33 Sites in Brazil Broad patient population undergoing PCI with Endeavor ZES RVD 2.5 mm – 4.0 mm Broad patient population undergoing PCI with Endeavor ZES RVD 2.5 mm – 4.0 mm Primary Endpoint : NACCE (Death / MI / Stroke / Major Bleeding) at 12 months Secondary Endpoints: ARC defined ST, TVR, TLR, MACE, DAPT compliance, and major bleeding (REPLACE-2 & GUSTO definitions) Primary Endpoint : NACCE (Death / MI / Stroke / Major Bleeding) at 12 months Secondary Endpoints: ARC defined ST, TVR, TLR, MACE, DAPT compliance, and major bleeding (REPLACE-2 & GUSTO definitions) 6-mo.18-mo.12-mo. Clinical endpoints 30-d.36-mo.3-mo. 3 Months DAPT N = Months DAPT N = Months DAPT N = Months DAPT N = 1560 NACCE = Net Adverse Clinical and Cerebral Events MACE is composed of Death, MI, Emergent CABG, TLR 24-mo.

31 OPTIMIZE Trial: DAPT Usage Feres et al., TCT Months DAPT (N=1563)12 Months DAPT (N=1556) Time After Initial Procedure Patients on DAPT (%)

32 Cumulative Incidence of NACCE (%) Time After Initial Procedure (Months) M DAPT 3M DAPT OPTIMIZE Trial: NACCE at 1 Year (All-Cause Death, MI, Stroke, Major Bleeding) Feres et al., TCT 2013 Log-Rank P = 0.84 HR 1.03 (0.77 – 1.38) Non-inferiority P-value = 0.002

33 Feres et al., TCT 2013 OPTIMIZE Trial: Other Clinical Events at 1 Year Events (%) p=0.36 p=0.82 p=0.47 p=0.49 p=0.99 p=0.41 p= Months DAPT (N=1563) 12 Months DAPT (N=1556)

34 ARCTIC-Interruption Study: Flow Chart Montalescot, TCT 2013 Rd#1: 2440 patients in ARCTIC Rd#2: 1259 randomized by IVRS one year after stenting 635 DAPT FOR ITT ANALYSIS624 SAPT FOR ITT ANALYSIS 6-18 months of Follow-up death, MI, stroke, stent thrombosis, or urgent revascularization 1181 were excluded

35 ARCTIC-Interruption Study: All Ischemic Endpoints Montalescot, TCT 2013 % Primary ST or urg. Death Any death MI ST Stroke Urgent Endpoint* revasc or MI or TIA revasc DAPT (N= 635) SAPT (N= 624) p =0.57 p =0.58 p =0.52 p =0.58 p =0.94 p =0.56 p =0.74 *Any death, MI, ST, Stroke or TIA, Urgent revasc

36 ARCTIC-Interruption Study: Key Safety Outcome Montalescot, TCT 2013 p=0.07 p=0.29 p=0.03 p=0.07 DAPT (N= 635) SAPT (N= 624) %

37 DAPT DURATION POST DES Therefore DAPT duration of 6M (?3M) is now becoming the new 12M with newer generation DES What about DAPT discontinuation POST DES?

38 Xience V USA Registry: Late ST Rates (30 D – 1 Year) After DAPT Interruption Subsequent Late ST (ARC Def/Prob) (%) No InterruptionInterruption After 30 Days 13/3500 2/12720/292 0/120 Interruption After 180 Days 2/435 0/157 Interruption After 90 Days 1/378 0/147 Overall Standard (Low) Risk Krucoff, Hermiller, Sharma et al. JACC Intervent 2011;4:1298.

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41 Modes of DAPT Cessation Discontinuation –patients had discontinued DAPT as per recommendation of their physician who felt the patient no longer needed therapy Interruption –patients had interrupted DAPT use on a voluntary basis and as guided by a physician due to (e.g. surgery) –DAPT was then reinstituted within 14 days DisruptionDisruption –patients had disrupted DAPT use due to bleeding or non-compliance.

42 PARIS Study: 2-Year K-M Plot of Any DAPT Cessation Time since PCI, Months 50 Cumulative Incidence, % Days (2.9%) One Year (23.3%) Two Years (57.3%)

43 PARIS Study: 2-Year Kaplan-Meier Plots of Any Discontinuation, Interruption and Disruption Time since PCI, Months 50 Cumulative Incidence, % Discontinuation Disruption Interruption 40.8% 14.4% 10.5%

44 1.00 (Ref) 0.63 (0.46, 0.86) 1.41 (0.94, 2.12) 1.50 (1.14, 1.97) On-DAPT Discontinuation Interruption Disruption (3.31, 14.95) 2.17 (0.97, 4.88) 1.30 (0.97, 1.76) 0-7 Days 8-30 days 31+ days < HR (95% CI) PEvents (n) PARIS Study: DAPT Cessation and MACE Hazard Ratio Mehran et al., TCT 2013

45 On-DAPT Discontinuation Interruption Disruption 0-7 Days 8-30 days 31+ days (5.57, 45.58) 2.68 (0.36, 19.68) 1.35 (0.50, 3.64) < Hazard Ratio HR (95% CI)P PARIS Study: DAPT Cessation and Def/Prob Stent Thrombosis 1.00 (Ref) 0.39 (0.11, 1.35) 0.64 (0.09, 4.82) 2.58 (1.22, 5.46)

46 50% of patients receive aspirin + placebo Dual Antiplatelet Therapy (DAPT) Study Mehran et al., TCT months18 months DES n= BMS n= % of patients continue o dual antiplatelet therapy (clopidogre or prasugrel) All patients on aspirin + open-label thienopyridine therapy for 12 months 1:1 Randomization at 12 months Total 33-month patient evaluation including additional 3-month follow-up

47 Take Home Message Trials of Bifurcation Lesions and DAPT duration/Interruption Trials of large bifurcation lesion interventions have suggested favorable outcomes with 2S vs. 1S strategy without higher ST. Dedicated TRYTON bifurcation (BMS) stent was not superior to provisional stent approach Trials of DAPT duration post DES support a shorter (3-6M) vs. 1+ year with lower bleeding and similar MACE. Hence 6M (?3M) DAPT duration should be routine post DES. Also physician directed DAPT interruption post DES is not associated with adverse outcomes

48 Which of the following trial compared 6M vs. 24M of DAPT duration: A. PARIS Study B. PRODIGY Trial C. REAL LATE Trial D. OPTIMIZE Trial E. RESET Trial Question # 1

49 TRYTON bifurcation trial showed the following superior results over provisional stent strategy : A. Lower TVR B. Lower MI C. Lower SBr %DS D. Lower stent thrombosis E. Higher CVA Question # 2

50 Sidebranch occlusion post PCI is associated with the following except : A. Higher mortality B. Higher MI C. Higher Stent thrombosis D. Lower TVR E. Higher MACE Question # 3

51 Which of the following trial compared 6M vs. 24M of DAPT duration: A. PARIS Study B. PRODIGY Trial C. REAL LATE Trial D. OPTIMIZE Trial E. RESET Trial Question # 1 The correct answer is B as other trials have either 3M or 1Y DAPT duration

52 TRYTON bifurcation trial showed the following superior results over provisional stent strategy : A. Lower TVR B. Lower MI C. Lower SBr %DS D. Lower stent thrombosis E. Higher CVA Question # 2 The correct answer is C as there was lower SBr % DS in the TRYTON stent arm vs. provisional stent arm Leon M, TCT 2013

53 Sidebranch occlusion post PCI is associated with the following except : A. Higher mortality B. Higher MI C. Higher Stent thrombosis D. Lower TVR E. Higher MACE Question # 3 The correct answer is D as SBr occlusion is associated with higher TVR along with higher MACE and its other components Hahn et al., JACC 2013;62:1654


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