Complex coronary cases
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Complex Coronary Cases. Supported by: Abbott Vascular Boston Scientific Corporation Medtronic, Inc. AstraZeneca St Jude’s Medical Abiomed Vascular solution Bracco Diagnostic. Disclosures. Samin K. Sharma, MBBS, FACC

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Complex coronary cases

Complex Coronary Cases

Supported by:

Abbott Vascular

Boston Scientific Corporation

Medtronic, Inc.

AstraZeneca

St Jude’s Medical

Abiomed

Vascular solution

Bracco Diagnostic


Disclosures

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


Complex coronary cases

Nov 19th 2013 Case #17: WR, 73 yr M

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


Complex coronary cases

Case# 17: cont…

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


Complex coronary cases

Appropriateness Criteria for Coronary Revascularization


Issues involving the case

Issues Involving The Case

  • Recent Trials of Coronary Bifurcation

  • Lesion PCI

  • Update in Duration & DAPT Interruption

  • post- DES


Issues involving the case1

Issues Involving The Case

  • Recent Trials of Coronary Bifurcation

  • Lesion PCI

  • Update in Duration & DAPT Interruption

  • post- DES


Coronary artery bifurcation lesion interventional techniques

Coronary Artery Bifurcation Lesion Interventional Techniques

Interventional Bifurcation Techniques

One Stent

Technique (OST)

Crush Stent

Technique (CrST)

Kissing Stent

Technique (SKS)

‘T’ Stent

Technique (TST)

OST with SBR

Dilatation (SBT)

Culotte Stent

Technique (CUT)


Bifurcation lesion intervention 1 vs 2 stents

Bifurcation Lesion Intervention: 1 vs. 2 Stents

Technical Issues

  • 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


Complex coronary cases

A Randomized Clinical Study Comparing Double Kissing

Crush With Provisional Stenting for Treatment of Coronary Bifurcation Lesions: DK Crush II Study

Conventional (n= 185)

p<0.001

%

DK Crush (n=185)

22.2

p=0.017

p=0.07

17.3

14.6

p=0.036

10.3

9.7

p=0.37

6.5

4.9

3.8

2.2

0.5

ST

Main Vessel

Side Vessel

MACE

TVR

Angiographic Restenosis

Chen S et al, JACC 2011;57:914


Complex coronary cases

Nordic-Baltic Bifurcation Study IV:

Patient Flow Chart

Nordic Baltic Bifurcation study IV

n=450

Provisional SB stening

n=221*

Two stent

n=229*

1 lost to FU

1 excluded due to protocolviolation

1 withdrawal

Provisional

Completed 6M FU

n=220

Two stent

Completed 6M FU

n=227

Kumsars et al., TCT 2013


Complex coronary cases

Nordic-Baltic Bifurcation Study IV:

Procedural Data

*Residual stenosis <30% of MV + TIMI flow III in SB

Kumsars et al., TCT 2013


Complex coronary cases

Nordic-Baltic Bifurcation Study IV:

Procedural Data

*Residual stenosis <30% of MV + TIMI flow III in SB

**Assessment possible in 327 patients

Kumsars et al., TCT 2013


Complex coronary cases

Nordic-Baltic Bifurcation Study IV:

Event Free Survival Curve at 6 Months

1.8%

4.6%

p=0.09

Kumsars et al., TCT 2013


Complex coronary cases

Nordic-Baltic Bifurcation Study IV:

Individual Endpoints at 6 Months

Provisional (n=220)

p=0.11

Two-stent (n=227)

p=0.39

%

p=0.50

p=0.54

p=0.32

Kumsars et al., TCT 2013


Complex coronary cases

TRYTON Bifurcation Trial: Study Design

Baseline Angiography – Eligible for Randomization

TRYTON side branch + DES (main vessel)

DES (main vessel) + Provisional side branch

N = 704

TVF

PrimaryEndpoint

Clinical F/U

at 9 months

Clinical F/U

at 9 months

%DS side branch

(N=374)

Secondary Endpoint

Angiographic F/U

at 9 months

Angiographic F/U

at 9 months

IVUS Cohort n~96

IVUS F/U

at 9 months

IVUS F/U

at 9 months

Leon et al., TCT 2013


Complex coronary cases

TRYTON Bifurcation Trial: Patient Flow

Randomized

N=704

TRYTON + DES

N=355

Provisional + DES

N=349

9 Month Follow-up

N=681

TRYTON = 345

Provisional = 336

Provisional

6=LosttoF/U

5=Patientwithdrawal

4= Death

TRYTON

4=LosttoF/U

2=Patientwithdrawal

4= Death

Angiographic

N=326

TRYTON = 158

Provisional = 168

IVUS

N=94

TRYTON = 59

Provisional = 35

  • Clinical FU at 9 months = 97%

  • Angiographic FU at 9 months = 87%

Leon et al., TCT 2013


Complex coronary cases

TRYTON Bifurcation Trial: TVF at 9 Months

Primary Endpoint

TRYTON

(N=355)

17.4%

Difference 4.6%

Upper 1-

Sided 95% CI 10.3%

Non-inferiority

p value

= 0.4167

Provisional

(N=349)

12.8%

Zone of non-inferiority pre-specified

margin = 5.5%

Non-inferior

0

1.0

2.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0%

11.0

3.0

Primary Non-Inferiority Endpoint Not Met

Leon et al., TCT 2013


Complex coronary cases

TRYTON Bifurcation Trial: TVF

Primary Endpoint

ST

0.3%

0.6%

Provisional S (N=349)

TRYTON S (N=355

p =0.108

p =0.109

%

p =0.564

Non-Hierarchical

Leon et al., TCT 2013


Complex coronary cases

TRYTON Bifurcation Trial:

Additional Side Branch Stents Indications

Provisional

TRYTON

%

Leon et al., TCT 2013


Complex coronary cases

TRYTON Bifurcation Study: SB %DS (In-segment)

Secondary Endpoint

p=0.002

%

Secondary Superiority Endpoint Met

Leon et al., TCT 2013


Complex coronary cases

COBIS II Registry: Independent Predictors of Side Branch Occlusion (Occurs in 8.4% cases)

Hahn et al., JACC 2013;62:1654


Complex coronary cases

COBIS II Registry: Clinical Outcomes at 1-Yr F/U

Of the 187 SBr occlusion 31% of SBr occlusion remained post PCI

p=0.03

SB Occlusion (n=187)

No SB Occlusion (n=2040)

p=0.36

%

p=0.002

p=0.002

p=0.46

Hahn et al., JACC 2013;62:1654


Issues involving the case2

Issues Involving The Case

  • Recent Trials of Coronary Bifurcation

  • Lesion PCI

  • Update in Duration & DAPT Interruption

  • post- DES


Complex coronary cases

Optimal Duration of ADP Receptor Blockers Post DES Still Remain Unclear (Aspirin 81-325 mg daily for life)

AHA/ACC

Updated Guidelines 2006

Cypher Stent

Launch

5/2003

AHA/ACC/SCAI

Updated Guidelines 2005

CURE, PCI-CURE – 2001

CREDO – 2002

(TAXUS stent 6 months post PCI)

(Cypher stent 3 months post PCI)

9-12 months

(FDA recommendations)

Clopido/Prasugrel/Ticag

should be

continued for 1 yr

or even longer if no

contraindications

DES Era

BMS Era

AHA/ACC PCI

Guidelines 2001

TAXUSStent

Launch

3/2004

ESC 2005/ACC 2006

PCI Updated Guidelines

(12 months post PCI)

(1-12 months post BMS)

If not sure about DAPT compliance or has to be interrupted in

12M then BMS (Basket late) is safer & should be preferred


Complex coronary cases

Randomized Trials of DAPT Duration

MACE

Bleeding

%

REAL-LATE

RESET

PRODIGY


Complex coronary cases

OPTIMIZE Trial: Study Design

Broad patient population

undergoing PCI with Endeavor ZES

RVD 2.5 mm – 4.0 mm

12 Months DAPT

N = 1560

3 Months DAPT

N = 1560

N = 3120 patients

1:1 Randomization

33 Sites in Brazil

Clinical endpoints

30-d.

3-mo.

6-mo.

12-mo.

18-mo.

24-mo.

36-mo.

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)

NACCE = Net Adverse Clinical and Cerebral Events

MACE is composed of Death, MI, Emergent CABG, TLR

Feres et al., Am Heart J 2012;164:810


Complex coronary cases

OPTIMIZE Trial: DAPT Usage

3 Months DAPT (N=1563)

12 Months DAPT (N=1556)

Patients on DAPT (%)

Time After Initial Procedure

Feres et al., TCT 2013


Complex coronary cases

OPTIMIZE Trial: NACCE at 1 Year

(All-Cause Death, MI, Stroke, Major Bleeding)

15

3MDAPT

12M DAPT

10

Non-inferiority

P-value = 0.002

Cumulative Incidence

of NACCE (%)

6.0

Log-Rank P = 0.84

HR 1.03 (0.77 – 1.38)

5.8

5

0

0

3

6

9

12

Time After Initial Procedure (Months)

Feres et al., TCT 2013


Complex coronary cases

OPTIMIZE Trial: Other Clinical Events

at 1 Year

3 Months DAPT (N=1563)

12 Months DAPT (N=1556)

p=0.36

Events (%)

p=0.49

p=0.70

p=0.47

p=0.82

p=0.41

p=0.99

Feres et al., TCT 2013


Complex coronary cases

ARCTIC-Interruption Study: Flow Chart

Rd#1: 2440 patients in ARCTIC

1181 were excluded

Rd#2: 1259 randomized by IVRS one year after stenting

635 DAPT FOR ITT ANALYSIS

624 SAPT FOR ITT ANALYSIS

6-18 months of Follow-up

death, MI, stroke, stent thrombosis, or urgent revascularization

Montalescot, TCT 2013


Complex coronary cases

ARCTIC-Interruption Study: All Ischemic Endpoints

DAPT (N= 635)

p=0.57

SAPT (N= 624)

p=0.52

%

p=0.58

p=0.58

p=0.74

p=0.94

p=0.56

Primary ST or urg. Death Any death MI ST Stroke Urgent

Endpoint* revasc or MI or TIA revasc

*Any death, MI, ST, Stroke or TIA, Urgent revasc

Montalescot, TCT 2013


Complex coronary cases

ARCTIC-Interruption Study: Key Safety Outcome

DAPT (N= 635)

p=0.03

SAPT (N= 624)

p=0.07

%

p=0.07

p=0.29

Montalescot, TCT 2013


Dapt duration post des

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?


Complex coronary cases

Xience V USA Registry: Late ST Rates (30 D – 1 Year)

After DAPT Interruption

Overall

Standard (Low) Risk

Subsequent Late ST (ARC Def/Prob) (%)

0.49

0.37

0.26

0.16

0

0

0

0

13/3500 2/1272

2/435 0/157

1/378 0/147

0/292 0/120

No Interruption

Interruption

After 30 Days

Interruption

After 180 Days

Interruption

After 90 Days

Krucoff, Hermiller, Sharma et al. JACC Intervent 2011;4:1298.


Complex coronary cases

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

  • Disruption

    • patients had disrupted DAPT use due to bleeding or non-compliance.


Complex coronary cases

PARIS Study: 2-Year K-M Plot of Any DAPT Cessation

60

Two Years

(57.3%)

50

40

Cumulative Incidence, %

30

One Year

(23.3%)

20

10

30 Days

(2.9%)

0

6

12

18

24

Time since PCI, Months


Complex coronary cases

PARIS Study: 2-Year Kaplan-Meier Plots of

Any Discontinuation, Interruption and Disruption

60

Discontinuation

Disruption

Interruption

50

40.8%

40

Cumulative Incidence, %

30

14.4%

20

10.5%

10

0

6

12

18

24

Time since PCI, Months


Complex coronary cases

PARIS Study: DAPT Cessation and MACE

P

Events (n)

HR (95% CI)

On-DAPT

1.00 (Ref)

413

Discontinuation

0.63 (0.46, 0.86)

0.004

52

Interruption

1.41 (0.94, 2.12)

0.101

26

Disruption

1.50 (1.14, 1.97)

0.004

67

7.04 (3.31, 14.95)

<0.001

7

0-7 Days

8-30 days

2.17 (0.97, 4.88)

0.06

6

31+ days

1.30 (0.97, 1.76)

0.083

54

0.25

0.5

1

2

4

8

16

Hazard Ratio

Mehran et al., TCT 2013


Complex coronary cases

PARIS Study: DAPT Cessation and Def/Prob

Stent Thrombosis

HR (95% CI)

P

1.00 (Ref)

On-DAPT

0.39 (0.11, 1.35)

Discontinuation

0.64 (0.09, 4.82)

Interruption

2.58 (1.22, 5.46)

Disruption

15.94 (5.57, 45.58)

<0.001

0-7 Days

2.68 (0.36, 19.68)

0.334

8-30 days

1.35 (0.50, 3.64)

0.551

31+ days

0.25

0.5

1

2

4

8

16

32

64

Hazard Ratio

Mehran et al., TCT 2013


Complex coronary cases

Dual Antiplatelet Therapy (DAPT) Study

12 months

18 months

DES

n= 15245

BMS

n=5400

All patients on

aspirin + open-label

thienopyridine

therapy for

12 months

1:1 Randomization

at 12 months

50% of patients continue o dual antiplatelet therapy

(clopidogre or prasugrel)

50% of patients receive

aspirin + placebo

Total 33-month patient evaluation including additional 3-month follow-up

Mehran et al., TCT 2013


Take home message trials of bifurcation lesions and dapt duration interruption

Take Home MessageTrials 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


Question 1

Question # 1

  • Which of the following trial compared 6M vs. 24M of DAPT duration:

    • PARIS Study

    • PRODIGY Trial

    • REAL LATE Trial

    • OPTIMIZE Trial

    • RESET Trial


Question 2

Question # 2

  • TRYTON bifurcation trial showed the following superior results

  • over provisional stent strategy :

    • Lower TVR

    • Lower MI

    • Lower SBr %DS

    • Lower stent thrombosis

    • Higher CVA


Question 3

Question # 3

  • 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 11

Question # 1

  • Which of the following trial compared 6M vs. 24M of DAPT duration:

    • PARIS Study

    • PRODIGY Trial

    • REAL LATE Trial

    • OPTIMIZE Trial

    • RESET Trial

The correct answer is B as other trials have either 3M or 1Y DAPT duration


Question 21

Question # 2

  • TRYTON bifurcation trial showed the following superior results

  • over provisional stent strategy :

    • Lower TVR

    • Lower MI

    • Lower SBr %DS

    • Lower stent thrombosis

    • Higher CVA

The correct answer is C as there was lower SBr % DS in the TRYTON stent arm vs. provisional stent arm

Leon M, TCT 2013


Question 31

Question # 3

  • 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

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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