«Αγγειοπλαστική ή CABG. Ποιεςείναι οι εναπομένουσες γκρίζες

ζώνες?»

ΠΕΤΡΟΣ ΔΑΡΔΑΣ, MD, FESCΚλινική ‘Αγιος Λουκάς

36ο ΚΑΡΔΙΟΛΟΓΙΚΟ ΣΥΝΕΔΡΙΟ – ΕΚΕ 2015

NO CONFLICT OF INTEREST

www.escardio.org/guidelinesEuropean Heart Journal

doi:10.1093/eurheartj/ehu278

Recomendations Regarding CABG vs. PCI asType of Revascularization in SCAD

Recommendations for left mainand 3 VD were mainly based on5-year data from the SYNTAX trial

SYNTAX Score II Variables

ANATOMICALSYNTAX SCORE

AGE

Gender

LVEF

COPD

Cr Clearance

PVD

LM/3VD

1. Farooq V et al. Lancet 2013; 381: 639–50

Abbott Confidential. For Internal Use Only. Not to be reproduced,excerpted or distributed. ©2013 Abbott Laboratories.

• 56, male• No previous symptoms• Acute inferior MI during exercise• Smoker, no other risk factors• Admitted for primary PCI

Case 1-History

BLOCKED LADSEVERE CALCIFIED MULTIPLE CX DISEASE

TOTALLY OCCLUDED RCA WITH HEAVYTHROMBUS BURDEN

• Cardiogenic shock

• SYNTAX SCORE = 37.5

GREY AREASPCI vs CABG

LEFT MAIN DISEASE

Meta Analysis of Existing Trials Comparing PCIto CABG (n=1611)

PCI CABG p value1 year MACCEDeathMICVATVR

14.5%3.0%2.8%0.1%11.4%

11.8%4.1%2.9%1.7%5.4%

0.110.290.950.013<0.001

No difference in death or MILess stroke with PCILess repeat revascularization with CABG

Capodanno et al J Am Coll Cardiol 2011;58:1426-32

Low Scores (0-22) Intermediate Scores (23-32) High Score 33

MACCE to 5 Years by SYNTAX ScoreTercile in Patients With Left Main CAD

Cumulative Event Rate (%)

Death

CVA

CABG PCI

15.1% 7.9%

3.9% 1.4%

Pvalue

0.02

0.11

MI 3.8% 6.1% 0.33

Death,CVA or 19.8% 14.8% 0.16

MI

Revasc 18.6% 22.6% 0.36

32.1%31.3%

0

50

0

25

12 24 36 48Months Since Allocation

60

CABG (N=196)TAXUS (N=221)

LM DiseaseP=0.74

Serruys PW et al. Lancet 2013;381:629–38

MACCE to 5 Years by SYNTAX Score TercileLM Subset Low to Intermediate Scores (0-32)

Randomized Trial of Stents versus Bypass Surgeryfor Left Main Coronary Artery Disease

Five-Year Outcomes ofPRECOMBAT Study

Ahn JM, Park SJ, et al. JACC 2015;65(20):2198-206

5 Year Kaplan-Meier Event Rate, % 5 Year Kaplan-Meier Event Rate, %

SYNTAX ScorePCICABG

Death, MI, or Stroke

P for Interaction = 0.30

iTVR

P for Interaction = 0.37P=0.98 P=0.38 P=0.20 P=0.73 P=0.061 P=0.024

Number 129/104 102/97 58/68 129/104 102/97 58/68Number

ESC Guidelines 2014Elective PCI for LM Stenosis

CABG PCI

Recommendationaccording to extent of CAD

LM disease a SYNTAX score < 22

LM disease a SYNTAX score 23 -32

LM disease a SYNTAX score > 32

Class

I

I

I

Level

B

B

B

Class

I

IIa

III

Level

B

B

B

Reference; SYNTAX Study, PRECOMBAT study, MAINCOMPARE registry study and Meta-Analysis. Patrick, SW et al, NEJM. 2009 March 5;360(10), Park SJ et al, NEJM. 2011 May5;364(18):1718-27, Levin GN et al. ACC/AHA guidelines. JACC 2011;58:44-122,Capodanno et al, JACC 2011;58:1426-32

2014 ACC/AHA SIHD Guidelines:UPLM Revascularization for Survival

Class Of Recommendation LOE

CABG

PCI

IIIaFor SIHD when low risk of PCI complications and high likelihoodof good long-term outcome (e.g., SYNTAX score of ≤22, ostial ortrunk left main CAD), and a signficantly increased CABG risk (e.g.,STS-predicted risk of operative mortality ≥5%)

IIbFor SIHD when low to intermediate risk of PCI complications andintermediate to high likelihood of good long-term outcome (e.g.,SYNTAX score of <33, bifurcation left main CAD) and increasedCABG risk (e.g., moderate-severe COPD, disability from prior stroke,prior cardiac surgery, STS-predicted operative mortality >2%)

III: HarmFor SIHD in patients (versus performing CABG) withunfavorable anatomy for PCI and who are good candidates for CABG

B

B

B

B

Case 2

• 82 male• Increasing angina• Severe mid-shaft unprotected LMS• Syntax score =12

Pre

Post

MULTIVESSEL DISEASE

MACCE to 5 Years by SYNTAX ScoreMohr FW et al. Lancet 2013; 381:629-38

Low Scores (0-22) Intermediate Scores (23-32) High Score 33

PCICABG

Death MI Death MI Death MI8.9

10.1P=0.64

7.84.2P=0.11

13.812.7P=0.68

11.23.6P=0.0009

19.211.4P=0.005

10.13.9P=0.004

Importance of Complete RevascularizationA meta analysis of 89,883 pts in RCT or observational studies

Incomplete revascularization is more commonwith PCI than with CABG (56% vs 25%)Less events with complete revascularization(CR) regardless of revascularization modality

Relative risk reduction with CR

•

•

•

Survival:

Myocardial Infarction:

Repeat revascularization:

0.71

0.78

0.74

Garcia S et al JACC 2013;62:1421-31

www.escardio.org/guidelinesEuropean Heart Journal

doi:10.1093/eurheartj/ehu278

Recomendations Regarding CABG vs. PCI asType of Revascularization in SCAD

‒ 3-VD ‒

DIABETES

11.9%

Strategies for Multivessel Revascularizationin Patients with Diabetes – the FREEDOM Trial

Farkouh ME et al. N Engl J Med 2012; 367:2375-84

Death, MI, or Stroke Through 5 Years

Median SYNTAX-Score = 26

26.6%

13.0%

18.7%

In patients with DM and MV CAD, CABG was superior to PCI by reducingrates of death and myocardial infarction with a higher rate of stroke

Primary Outcome: Death, Stroke, MI

3VD + DM

The Trial was Heavily Criticized…because not all 3VDs are similar…

3VD + DM

3VD + DM

Myocardial Infarction, %

Years post-randomization0 1 2 3 4 5

10

0

30

MYOCARDIAL INFARCTION

PCI/DESCABG

CABG

853 798 636 422 220PCI/DES N 953947 824 772 629 432 229CABG N

Logrank P<0.000120

13.9 %

PCI/DES6.0%

Stroke, %

Years post-randomization0 1 2 3 4 5

0

20

30

PCI/DES

CABG

PCI/DES 2.4%

CABG

953

947

891

844

833

791

673

640

460

439

241

230

PCI/DES N

CABG N

Logrank P=0.03410

5.2%

STROKESeverely Disabling

Scale CABG PCI/DES

NIH > 4 55% 27%Rankin >1 70% 60%

MACCE

Revaculariztion

Death/MI/CVA

SYNTAX: Diabetic Subgroup Analysis

DM No DM

Similar results tomain study• CABG improvedoutcomes whenSYNTAX > 33

Limitations••Small n (= 499)PES

Meta-analysis: DES vs CABG in Diabetic PatientsHakeem A et al. J Am Heart Assoc 2013

1°EP MACE: Death, MI, or Stroke @ 4 Years

Sensitivity Analysis According to SYNTAX score

• Mortality rates favored the EES group at 30 days (0.57% vs 1.11%;P = .04), though long-term data showed similar mortality betweenthe EES and CABG arms (10.50% vs 10.23%; P = .16)

• MI risk was higher with EES vs CABG, but not in the subset ofpatients who had complete revascularization (P = .30)

• EES were linked with less stroke but more revascularization

Analysis of 8,096 propensity-matched patients from New York Stateregistries, 2008-2011

Bangalore S, et al. Circ Cardiovasc Interv.2015;Epub ahead of print.

EES vs CABG for PatientsWith Diabetes and Multivessel Disease

Conclusion: With similar long-term survival, second-generation DES andCABG may be reasonable options for diabetics with multivessel disease.

Specific Recommendations For Revascularization inPatients With Diabetes

.

Windecker S et al. –Eur Heart J2014;35:2541-2619

ACUTE CORONARYSYNDROMES

Recommendations for invasive coronary angiography andrevascularization in NSTE-ACS (continued)

17

www.escardio.org/guidelines Roffi M et al. Eur Heart J 2015;doi:10.1093/eurheartj/ehv320

Acute HF with NSTE-ACSecho, angio, revasc, heart team

NEW

Steg et al. 2012ESC STEMI GL

Hochman et al. NEJM1999;341:625-34.SHOCK. 302 LV failurecomplicating AMIPCI or CABG vs MEDimproved 6 mo survival

CHRONIC KIDNEY DISEASE

Specific recommendations for patients with mild to moderate chronic kidney disease.

The Task Force on Myocardial Revascularization of theEuropean Society of Cardiology (ESC) and the EuropeanAssociation for Cardio-Thoracic Surgery (EACTS) Eur JCardiothorac Surg 2010;38:S1-S52© 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights

reserved.

SBP : 70mmHgIABC was inserted

Guide Wire PT2

Large thrombus burdenMechanical aspiration with Angiojet

Post Angiojet

4.0 X 30 mm BMS Final Result

3 days laterSyntax Score = 27.5

PCI to Cx

Guide wire BMW, NC balloon,undilatable lesion

Exchange with Rotawire 1,5 burr

Final result

Follow up

• Asymptomatic for the next 6 months• Underwent Thallium scan• Extensive anterior ischemia• “Attempt to open” LAD

Fielder and Confianza Pro

NC balloon, undilatable

Short cutting Balloon – undilatable lesion

Intermediate result

10 days later

1.5 burr

Final result

Follow up

• 5 years• Completely asymptomatic• Continued daily training• Echo: EF=45%, apical hypokinesia

Follow up 6 years…

• Symptoms of chest discomfort and fatique• Echo: LV slight deterioration• Thallium scan: extensive ischemia of the

inferior and apical segments

Patent LAD - Cx

Tight proximal RCA

Unable to advance balloon, use of Guideliner

Balloon anchoring-guideleneradvancement

Stent delivery

Final result

• Pt asymptomatic 2 years later

What has changed?

•FFR guided therapy•New stents

FAME Study: Two Year Outcomes

Death/MI was significantly reduced from 12.9% to 8.4% (p=0.02)

Pijls, et al. J Am Coll Cardiol 2010;56:177-184

FAME 3 Study Flow

NCT02100722 Non-inferior Design

2nd Generation DES

Sripal Bangalore et al. BMJ 2012;345:bmj.e5170

Meta-analysis: EES reduced MI, TVR vs SES, PES

BEST Study: EES vs. CABG4654 patients were screened

1725 patients were eligible

880 patients consented and enrolledBetween July 2008 and September 2013

438 patients assigned to PCITreated CABG: 19Treated PCI: 413Treated medically: 6

1 Year FU (N=438)

3 Year FU (N=369)

5 Year FU (N=172)

442 patients assigned to CABGTreated CABG: 382Treated PCI: 51Treated medically: 9

1 Year FU (N=438)

3 Year FU (N=369)

5 Year FU (N=172)

Park SJ et al. N Engl J Med. 2015;372:1204

Cumulative Incidence, %

Primary End Point of MACEDeath, MI, Repeat revascularization

0 1 2 3 4 5

30

25

20

15

10

5

0

No. at RiskPCICABG

402415

362377

305326

438442

242262

126145

PCICABG

17.0%

11.7%

Log-rank P=0.043

Years Since Randomization

Crude Incidence, % Crude Incidence, %

Crude Incidence, % Crude Incidence, %

Death, MI, Stroke, or Repeat Revascularization

Pinteraction=0.053

Death from any cause

Pinteraction=0.77

Repeat Revascularization

Pinteraction=0.041

Death, MI, or Stroke

Pinteraction=0.54

HR (95%CI)1.46 (0.78-2.74)

HR (95%CI)2.29 (1.35-3.87)

HR (95%CI)1.13 (0.66-1.93)

HR (95%CI)4.31 (1.76-10.6)

HR (95%CI)1.38 (0.75-2.53)

HR (95%CI)1.25 (0.58-2.70)

HR (95%CI)1.47 (0.66-3.28)

HR (95%CI)1.16 (0.78-1.79)

Diabetic Subgroup in BEST TrialPCICABG

Percentages are crude rates throughout the available follow-up period

Kaul U, Bangalore et al. N Engl J Med. 2015

1-Year Follow-up(N=1783; 97.4%)

TAXUS(N=914)

Withdrawal = 12Lost to f/u = 10

Investigator decision = 5

XIENCE(N=916)

9 = Withdrawal9 = Lost to f/u2 = Investigator decision

Tuxedo India Patient FlowEnrolled(N=1851)

21 = Screen Failed

Randomized(N=1830)

XIENCE(N=896)

TAXUS(N=887)

Tuxedo India

Kaul U, Bangalore et al. N Engl J Med. 2015

SUMMARY: PCI vs CABG in Left Main or MVD

YES: Call a surgeon. Use the HEART TEAM approach!!

Determine clinical risk (STS calculator)

Determine SYNTAX score. High SYNTAX does betterwith CABG

Best outcomes with complete revascularizationregardless of strategy

Diabetic subset does better LONG TERM with CABG

Await results from EXCEL for left main subset.

The best decisions are made with a team approach.

Why Not PCI?

• Inability to take DAPT• Diffuse disease and/or unprotectable

major branches••••

Absent accessInability to completely revascularizePatient preferenceCKD (?)

Two Very Different Procedures…

CABG vs. PCIWith 2 very different local skin results

«Αγγειοπλαστική ή CABG. Ποιεςείναι οι εναπομένουσες γκρίζες

ζώνες?»

ΠΕΤΡΟΣ ΔΑΡΔΑΣ, MD, FESCΚλινική ‘Αγιος Λουκάς

36ο ΚΑΡΔΙΟΛΟΓΙΚΟ ΣΥΝΕΔΡΙΟ – ΕΚΕ 2015

• 82 male– severe LMS and proximal LAD stenosis– blocked Cx and RCA– severe Aortic stenosis (max gradient 80mmHg)

• Admitted with severe LV failure andcardiogenic shock

Severe Ostial distal LMS –proximal LAD – blocked Cx Blocked RCA

Severe AS – max gradient80mmHg

Severe MR – LVF cardiogenicshock

PCI LMS LAD

Pre Post

TAVI – EVOLUT R

PRE ANGIO SEVERE AS TAVI PRE DEPLOYMENT

TAVI – EVOLUT R - FINAL

Post TAVI 2D Post TAVI 3D

• PROCEDURE DURATION: 95 mins• HOSPITALIZATION: 4 days

1 month: pt asymptomatic-NYHA I

LV – MR improved

«Αγγειοπλαστική ή CABG.Υπάρχουν πλέον εναπομένουσες

γκρίζες ζώνες?»

ΠΕΤΡΟΣ ΔΑΡΔΑΣ, MD, FESCΚλινική ‘Αγιος Λουκάς

36ο ΚΑΡΔΙΟΛΟΓΙΚΟ ΣΥΝΕΔΡΙΟ – ΕΚΕ 2015