PCI v. CABG for multivessel disease: Time for a hybrid approach?
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Transcript of PCI v. CABG for multivessel disease: Time for a hybrid approach?
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