Creighton W. Don, MD, PhDAssociate Director, Interventional Cardiology FellowshipAssistant Professor of MedicineUniversity of Washington

PCI V. CABG FOR MULTIVESSEL DISEASE:

TIME FOR A HYBRID APPROACH?

2001 2002 2003 2004*

2005 2006 2007 2008 20090.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

40.0

45.0

50.0 Invasive Cardiac Procedures in Medicare

Stent (92980)

Balloon (only) (92982)

Diagnostic Cath (93508 - 93529)

CABGs (33510 - 36)pe

r 1,0

00 M

edic

are

Bene

ficia

ries

TRENDS IN REVASCULARIZATION

Riley RF, Don CW, Dean LS. Circulation Cardiovasc Qual Outcomes. 2011

MULTIVESSEL INTERVENTIONS

2001 2002 2003 2004* 2005 2006 2007 2008 20090%

5%

10%

15%

20%

25%

30%

35%

Multivessel PCI

Multiple Vessel Stenting

Multiple Vessel Bal-looning

Riley RF, Don CW, Dean LS. Circulation Cardiovasc Qual Outcomes. 2011

PCI OR CABG FOR MULTIVESSEL DISEASE

PCI CABG

Procedural Less invasive •Higher procedural complications•Complete revascularization

Hospital Earlier recovery

Lower initial costs

Initial revascularization

Excellent Excellent

Later outcomes •10-20% restenosis (BMS)•2.5-10% restenosis (DES)

•Excellent…for LIMA, DM•SVG closure 40%+ at 10y

Other complications Repeat procedures •Neurologic abnormalities•Adhesions/scarring

CABG V. PCI

Clinical trialsVein grafts versus stentsGuidelinesHybrid Approaches

CABG V. PCI

PTCA BARI (1996) ERACI (1996) CABRI (2001)

BMS ARTS (2005) ERACI II (2005) MASS II (2005) SOS (2008)

DES SYNTAX (2009) CARDIa (2010) Freedom (2012)

Non-randomized-DES ARTS II (2006) ERACI III (2010)

NCDR 2004-2008

Weintraub W. NEJM. 2012.

TECHNOLOGY – DATA GAP

What does an interventional cardiologist say when shown data that doesn’t favor PCI?

You weren’t using the right: <choose any answer from below> Patients Stents Anticoagulants Antiplatelet agents New technology not invented yet

Hostile chestPoor rehabilitation potential

Wheelchair bound Walker dependent

Peripheral vascular diseaseSevere lung diseaseLeft ventricular dysfunctionRenal failureObesity

THE SURGICAL TURN DOWN

PCI VS. CABG IN MULTIVESSEL CAD(REVASCULARIZATION)

3.3

33.7

Metanalysis (Pocok)0

10

20

30

40

(%)

CABG

POBA

3.5 4.8 4

16.8 16.8 17

ARTS (1 y) ERACI II (18m) SOS (1 y)0

10

20

30

40

(%)

CABG STENT

STENT EraSTENT EraPOBA EraPOBA Era

ARTSARTS

Cardialysis/Cordis ESC 1999

CABRI: 1994, ARTS: 1999

3.5 4.8 4

16.8 16.8 17

ARTS ERACI II SOS0

10

20

30

40

(%)

CABG STENT

Bare Metal STENT EraBare Metal STENT Era

3.5 4.88.5

8.8

ARTS II ERACI III0

10

20

30

40

(%)

CABG STENT

DES EraDES Era

PCI VS. CABG IN MULTIVESSEL CAD(REVASCULARIZATION)

INCREASED REVASCULARIZATION

Mercado N et al. J Thoracic and Cardiov Surgery. 2005Mercado N et al. J Thoracic and Cardiov Surgery. 2005

PCI

CABG

Meta-analysis of ARTS, SOS, ARTS2

1800 patients 3 vessel disease or left main diseaseRandomization to PCI versus surgery

SYNTAX STUDY 1-YEAR OUTCOMES

N Engl J Med 2009; 360:961-972.

SYNTAX 5-YEAR OUTCOMES

SYNTAX 5-YEAR MACE OUTCOMES

Mohr. Lancet. 2013

Syntax 0-22

Syntax 23-32

Syntax ≥ 33

Left main 3V Disease

Instent thrombosis/restenosis

LEFT MAIN INTERVENTIONS

Seung KB. NEJM. 2009.Park SJ. Circ: Cardiov Interv. 2009.

CA

BG

v.

PC

IIV

US v

. A

ngio

guid

ed P

CI

Death Death, MI, CVA TVR

From AM et al. Eurointervention. June 2010.

DM AND CABG—MORTALITY

Levine, G. N. et al. J Am Coll Cardiol 2011

FREEDOM1900 pts with DM2+ vesselsCABG v. PCI

REVASCULARIZATION AND DM

Farkouh ME et al. N Engl J Med 2012;367:2375-2384.

CABG V. PCI

Clinical trialsVein grafts versus stentsGuidelinesHybrid Approaches

Retrospective review of coronary angiograms 1996-2001

Selection bias

LIMA V. SAPHENOUS VEIN GRAFTS

Khot,UN et al. Circulation 2004;109:2086-2091

PROPER COMPARISON? SVG GRAFT FAILURE

Harskamp. Annals of Surgery. 2013.

SYNTAX: STENT V. GRAFT OCCLUSION

Farooq. JACC. 2013.

5 year f/u 1676 pts

Stent thrombosis 109 total 48 definite

Graft occlusion 84 total 32 definite

CABG graft occlusion 42% in the RCA

PCI stent thrombosis 19% Left main 31% Prox LAD

Unknown… Clinically silent ST/GO

LOCATION OF ST/GRAFT OCCLUSION

Farooq. JACC. 2013.

VA Cooperative Studies Trial (July 1983 to September 1988)

1254 men undergoing CABGRoutine angiography 3, 5 10 years

ARTERIAL V. VEIN GRAFTS

Goldman S. JACC. 2004.

From time of surgery If graft was open 1 week post surgery

*P < 0.001

IMA: 85% patency 10 ySVG: 60% patency 10 y

SAPHENOUS VEIN GRAFT FAILURE

Goldman S. JACC. 2004.

VA Cooperative Studies Trial Platinum TrialIschemia driven TLR

Meredith IT. AJC. 2013.

SAPHENOUS VEIN TARGET VESSEL

Goldman S. JACC. 2004.

Variation by target vessel Variation by target size

*P < 0.001

VA Cooperative Studies Trial

Retrospective study of patients with CABG undergoing coronary angiography for symptoms

2127 conduits evaluated 0 to 15 years post-op

ARTERIAL GRAFT PATENCY BY TARGET

LAD CxOMRCA/PDA p Value

LIMA 97.1% 91.7% - 0.012

RIMA 94.9% 90.1% 83.1% 0.008

Radial 87.1% 91.6% 88.2% 0.392

SVG 60.2% 61.2% 61.6% 0.688

Tatoulis J. Annals of Thoracic Surg. 2004.

FUNCTIONAL SYNTAX SCORE

497 patients enrolled in the FAME study

Nam CW, J Am Coll Cardiol. 2011;58:1211-1218

ISCHEMIC BURDEN

Hachamovitch R et al. Circulation 2003;107:2900-2907

56%

41% 42%

MAE OUTCOMES BASED ON THE EXTENT OF REVASCULARIZATION

p=0.03

(0-2) (3-5) (6-11)

90 day MAE

Extent of Revascularization(change in ischemic zones)

1st Tercile 2nd Tercile 3rd Tercile

Limited Revasc. Extensive Revasc.

COURAGE: ISCHEMIA AND OUTCOMES

All patients Patients with mod-sev ischemia

Shaw L J et al. Circulation 2008;117:1283-1291

CABG V. PCI

Clinical trialsVein grafts versus stentsGuidelinesHybrid Approaches

AHA/ACC GUIDELINES 2013

Clinical setting Recommendation ClassUnprotected Left Main Stenosis ≥ 50%    No surgical contraindication CABG 1High risk surgical patients (STS ≥ 5%), with ostial or trunk lesion, and SYNTAX score ≤ 22

PCI 2A

Unstable angina/NSTEMI in non-surgical candidates where left main is the culprit lesion

PCI 2A

ST-elevation MI where left main is the culprit lesion PCI 2AHigh risk surgical patients (STS > 2%) and SYNTAX score < 33 PCI 2B     Multivessel Disease (≥ 70% stenosis in ≥ 2 major coronary arteries)

   

Symptomatic 2 vessel disease despite medical therapy (not involving proximal LAD)

CABG or PCI 1A

3 vessel disease or proximal LAD plus 1 other major artery CABG 1B2-3 vessel or proximal LAD disease and LV dysfunction (EF 35-50%) or > 20% perfusion defect

CABG 2A

Diabetics with multivessel coronary artery disease especially if a left internal mammary graft will be anastomosed to the LAD

CABG 2A

2-3 vessel disease and prior CABG PCI 2AHybrid coronary revascularization (LIMA to LAD, and PCI of non-LAD vessels) if 1 of the following apply:1. Surgical limitations2. Lack of graft conduits3. LAD unfavorable for PCI

CABG + PCI 2A

APPROPRIATE MIS-USE CRITERIA

Patel, et al. JACC 2012; 59:

CABG V. PCI

Clinical trialsVein grafts versus stentsGuidelinesHybrid Approaches

HYBRID REVASCULARIZATION

Harskamp RE. Ann Thorac Surg. 2013.

One stage: Simultaneous

Two stage PCI followed by CABG (LIMA-LAD) CABG (LIMA-LAD) followed by PCI

Surgical techniques Sternotomy MID-CAB Endoscopic/Robotic On/Off-pump

HYBRID REVASCULARIZATION

STS Database (July 2011 to March 2013)CABG procedures 198,622 Conventional CABG 197,672Staged Hybrid-CABG 809Concurrent Hybrid-CABG 141Similar baseline characteristicsTrend toward reduced strokes

Hybrid-CABGIMA usedCoronary stent placed

US PRACTICE PATTERNS

Harskamp RE. Circulation. 2014.

HYBRID V. CABG COHORTS

Harskamp RE. Ann Thorac Surg. 2013.

Improved quality of life (SF-12)More pain (MID-CAB), but faster recovery

COSTS AND QUALITY OF LIFE

Harskamp RE. Ann Thorac Surg. 2013.Bachnisky WB. J Interv Cardiol. 2012.

6 studies—single center registries 1,190 patients (366 Hybrid, 824 CABG)

LAD/LM + other lesionsLess transfusion, shorter LOS

META-ANALYSIS HYBRID V. CABG

Harskamp RE. Am Heart J. 2014.

Hybrid Revascularization Outcomes Study (observ cohort) 298 patients LAD + other vessels Excluded LM disease, CTOs in LAD or >2 vessels, EF < 30% 12 month f/u (death, stroke, MI, revasc)

POL-MIDES (RCT hybrid revasc v. CABG) 200 patients randomized to CABG v. hybrid LAD+ other vessel Excluded LM, CTOs PCI success rate 93.9%, with 6.1 % conversion to CABG MACE free 1-yr

CABG 92.2% (2.9% mortality) Hybrid 89.9% (2.0% mortality)

ONGOING STUDIES

CABG Diffuse disease Lower surgical risk

PCI Focal disease (SYNTAX <23) Higher surgical risk, limited conduit Small targets (<2 mm) Non-LAD disease

Hybrid LAD/LM + other disease Higher surgical risk Small targets Off pump/minimal invasive benefits? Concomitant, sequential?

CURRENT STRATEGY