PCI vs CABG IN CSAPCI vs CABG IN CSA

DR VINIT KUMAR

CSACSAStable coronary artery disease is generally Stable coronary artery disease is generally

characterized by episodes of reversible characterized by episodes of reversible myocardial demand/supply mismatch, myocardial demand/supply mismatch, related to ischaemia or hypoxia, which are related to ischaemia or hypoxia, which are usually inducible by exercise, emotion or usually inducible by exercise, emotion or other stress and reproducible—but, which other stress and reproducible—but, which may also be occurring spontaneously.may also be occurring spontaneously.

Treatment optionTreatment optionGDMTGDMTRevascularisationRevascularisation PCIPCI CABGCABG

Evolution of CABG

1818Heberden coins the term “angina pectoris”

1950Vineburg reroutes IMA into heart muscle

1953Gibbon performs 1st successful open heart surgery using a cardio-pulmonary bypass machine

1957/8Bailey/Longmire report successful coronary revascularization on a beating heart

1962Sabiston attempts to suture an SVG into coronary circulation

1968Favaloro 1st surgeon to perform bypass surgery (SVG)

1999Diegler et al publish OPCAB technique

1958Sones discovers the diagnostic coronary angiogram

1996Greenspun et aland Benetti et al publish MIDCAB technique

2000Falk et al publish TECAB technique

2003Shrivastava et al publish ThoraCAB technique

1876Hammer diagnoses the first cardiac infarct in a living human

1910Carrell presents a paper describing coronary artery bypass

2005Updated ACC/AHA/SCAI guidelines: CABG remains the standard of care for 3VD/LM disease

Evolution of PCI

1844Bernard coins the term “cardiac catheterization”

1929Forssmann peforms the 1st human cardiac catheterization

1958Sones discovers the diagnostic coronary angiogram

1962Ricketts and Abrams use the percutaneous approach in coronary arteries

1964Dotter introduces transluminal angioplasty

1977Gruentzig peforms the 1st PTCA

1967Judkins perfects the transfemoral approach

1986Sigwart and Puel implant the 1st coronary stent

19941st coronary stent approved by the FDA 2003

FDA approval of 1st DES

2006FDA panel on the safety of DES

TodayIncreasing real-world use of PCI in LM and 3VD

2002CE Mark on 1st DES

CABGCABG PCIPCI

+ Angina reliefAngina relief+ Reduced reinterventionReduced reintervention+ Complex anatomyComplex anatomy+ CompleteComplete

revascularizationrevascularization+ Mortality benefit in selected Mortality benefit in selected

patient groupspatient groups Potential high costsPotential high costs InvasiveInvasive

+ Initially cost effective Initially cost effective + Fast recoveryFast recovery+ Reduced acute Reduced acute

complicationscomplications+ Least invasiveLeast invasive- Increased restenosisIncreased restenosis- Repeat revascularizationRepeat revascularization

CABG is standard of care in patients with left main & multivessel disease

Historical Pros & Cons

Why is CABG better than PCI?Why is CABG better than PCI?

PCI treats an isolated PCI treats an isolated lesion in the proximal lesion in the proximal vessel.vessel.

CABG bypasses the CABG bypasses the proximal 2/3 of the proximal 2/3 of the vessel, where the vessel, where the current lesion current lesion and and future threatening future threatening lesions lesions occuroccur..

This advantage of This advantage of CABG will persist, CABG will persist, even if Stent even if Stent restenosis is ZERO.restenosis is ZERO.

Gersh and Frye NEJM , May 2005

CABGCABG

PCIPCI

Evolution of Revascularization

+ Improved Improved techniquetechnique

+ Improved stent Improved stent designdesign

+ DESDES+ Improved Improved

guidewiresguidewires

+ Off pump techniqueOff pump technique+ Less invasive Less invasive

approachapproach+ Increased arterialIncreased arterial

revascularizationrevascularization+ Optimal perioperative Optimal perioperative

carecare

?How does modern CABG compare to

PCI in high-risk patients eligible for both techniques ?

Randomized Trial

Comparison of Revascularization Comparison of Revascularization Strategies in Multivessel DiseaseStrategies in Multivessel Disease

Eras of Comparative CABG Trials

Drug Eluting StentsDES vs CABG (randomized)

Plain Balloon Angioplasty POBA vs CABG

Bare Metal StentsBMS vs CABG

Drug Eluting StentsDES vs CABG

CABG

PCI

Diffuse MVD

SVD

ComplexMVD

LMS

MVD + Complex

LMS + MVD

CTO

CABG

PCI

Diffuse MVD

SVD

ComplexMVD

LMS

MVD + Complex

LMS + MVD

CTO

PCI Vs CABG in MVD - POBA eraPCI Vs CABG in MVD - POBA era

Observational studiesObservational studies Randomised controlled trialsRandomised controlled trials

OBSERVATIONAL STUDIES.OBSERVATIONAL STUDIES.

CABG ass. with less mortality in long runCABG ass. with less mortality in long run recurrent events, including angina pectoris and the need recurrent events, including angina pectoris and the need

for repeat revascularization procedures, were more for repeat revascularization procedures, were more frequent in the PTCA than the CABG group, frequent in the PTCA than the CABG group,

largely as a consequence of incomplete largely as a consequence of incomplete revascularization and restenosis.revascularization and restenosis.

Impact of Coronary Bypass Impact of Coronary Bypass Surgery on SurvivalSurgery on Survival

Coronary Artery Surgery Study (CASS)

PCI vs CABG Trial Results PCI vs CABG Trial Results SummarySummary

Significant decrease of

revascularization expected with

DES

BARIBARI

1829 pts. of multivessel CAD1829 pts. of multivessel CAD Primary endpoint was all-cause mortality at 5-yrs Primary endpoint was all-cause mortality at 5-yrs Separate analysis of diabetic pts.Separate analysis of diabetic pts. RESULT- RESULT- No significant differences overall No significant differences overall the composite end point of cardiac mortality or MIthe composite end point of cardiac mortality or MI cardiac mortality in nondiabetic patients regardless ofcardiac mortality in nondiabetic patients regardless of symptoms, symptoms, LV function, LV function, number of diseased vessels, or number of diseased vessels, or stenotic p-LAD artery.stenotic p-LAD artery.

The 5-year cardiac mortality rate for the total population of 1829 patients was 4.9% for CABG vs 8% for PTCA (RR=1.55; P=.022).

Copyright © American Heart Association, Inc. All rights reserved.

In the 1476 nondiabetic patients, the 5-year cardiac mortality rate was 4.2% for CABG vs 4.6% for PTCA (P=NS).

Copyright © American Heart Association, Inc. All rights reserved.

Treatment comparison of 5-year cardiac mortality rates for all patients (left) and for patients without diabetes drug therapy at baseline (right) stratified by subgroup.

Copyright © American Heart Association, Inc. All rights reserved.

CAD & DM- BARICAD & DM- BARI

BMS Vs CABGBMS Vs CABG

BMS Vs CABG IN SVD (p-LAD)BMS Vs CABG IN SVD (p-LAD)

MASSMASS (Medicine, Angioplasty or Surgery Study, 1995) & (Medicine, Angioplasty or Surgery Study, 1995) & Lausanne TrialLausanne Trial, 1994 (LIMA to LAD), 1994 (LIMA to LAD)

– – No difference in overall survival in both studiesNo difference in overall survival in both studies – – In Lausanne Trial, more CABG pts were free from late In Lausanne Trial, more CABG pts were free from late

events such as angina at 2.5 yearsevents such as angina at 2.5 years The RITA, subset of 45% had SVD. The RITA, subset of 45% had SVD. Over 2 to 3 years, the rates of mortality, MI and Over 2 to 3 years, the rates of mortality, MI and

improvement in symptoms were similarimprovement in symptoms were similar Frequent reintervention in patients treated with PTCA.Frequent reintervention in patients treated with PTCA.

Comparison of BMS With MinimallyComparison of BMS With MinimallyInvasive Bypass Surgery for LADInvasive Bypass Surgery for LAD

PCI Vs CABG in MVD - BMS eraPCI Vs CABG in MVD - BMS era

Observational studiesObservational studies Randomised controlled trialsRandomised controlled trials

Northern New England DatabaseNorthern New England Database1994-2001 N=14,4931994-2001 N=14,493

Circulation 2005;112[suppl I]:I-371-I-376.

New York State 1997-2000New York State 1997-20003-Vessel Disease N=23,022 3-Vessel Disease N=23,022

Adjusted Survival

N Engl J Med 2005;352:2174-83.

Stenting vs Surgery for MVD Patients: Stenting vs Surgery for MVD Patients: New York State Registry (3-yr survival %) New York State Registry (3-yr survival %)

Stent CABGStent CABG2V No LAD 91.4 93.52V No LAD 91.4 93.52V non prox LAD 90.9 93.02V non prox LAD 90.9 93.03V non prox LAD 84.6 89.33V non prox LAD 84.6 89.33V prox LAD 84.5 89.33V prox LAD 84.5 89.3 ( HR for 3V CABG 0.64 )( HR for 3V CABG 0.64 )

Hannan EL, NEJM, 2005

Absolute Survival AdvantageCABG vs BMS

• A significant survival advantage for CABG has been demonstrated, and appears to increase with longer F.U.

Patients Source 1 year 3 years 5 Years 7 years14,493 NNE 1.7% 3.1% 4.6% 6.3%23,022 NY State 2.8% 4.9%1,722 Duke 1.6% 6.8% 9.4% 6.6%

39,237 Overall 2.3% 4.3% 5.1% 6.3%

Survival Advantage of CABG vs BMS for 3 Vessel Disease

Peter K. Smith, MD Duke University

Death , MI , CVA and one – year mortality were similar . Death , MI , CVA and one – year mortality were similar . In PCI group DM was the main factor for poor out come In PCI group DM was the main factor for poor out come PCI was associated with a greater need for Repeat PCI was associated with a greater need for Repeat

Revascularization .Revascularization .

N Engl J Med 344:1117, 2001N Engl J Med 344:1117, 2001

Arterial Revascularization Arterial Revascularization Therapies Study (ARTS) 1205 ptsTherapies Study (ARTS) 1205 pts

ARTS trial

The ‘Stent or Surgery’ TrialThe ‘Stent or Surgery’ TrialLonger Term Follow UpLonger Term Follow Up

Well matched between randomised groupsWell matched between randomised groups488- PCI, 500- CABG.488- PCI, 500- CABG.• • Mean age - 61 years Males - 79%Mean age - 61 years Males - 79%• • LV EF (by 2D echo) - 57%LV EF (by 2D echo) - 57%• • Diabetes - Insulin Tx 3%, Other Tx 12%Diabetes - Insulin Tx 3%, Other Tx 12%• • 2 vessel disease - 57% 3VD - 42%2 vessel disease - 57% 3VD - 42%

At a median follow-up of 6 years, a continuing survival advantage At a median follow-up of 6 years, a continuing survival advantage was observed for patients managed withwas observed for patients managed with

CABG, which is not consistent with results from other stent-versus-CABG, which is not consistent with results from other stent-versus-CABG studies.CABG studies.

Mortality by subgroups at a Mortality by subgroups at a median follow-up of 6 yearsmedian follow-up of 6 years

A meta-analysis of 10 RCT comparing A meta-analysis of 10 RCT comparing CABG and PTCA: 1 to 8 yr outcomesCABG and PTCA: 1 to 8 yr outcomes The early studies (patient entry fromThe early studies (patient entry from 1987 to 1993) used balloon angioplasty as the PCI 1987 to 1993) used balloon angioplasty as the PCI

technique, and the later studies (patient entry from 1994 technique, and the later studies (patient entry from 1994 to 2002) used stents (BMS) as the PCI techniqueto 2002) used stents (BMS) as the PCI technique

Most RCTs comparing CABG and PCI have been Most RCTs comparing CABG and PCI have been conducted in populations with double-vessel disease, conducted in populations with double-vessel disease, good LV function.good LV function.

Copyright ©2003 American College of Cardiology Foundation. Restrictions may apply.

Hoffman, S. N. et al. J Am Coll Cardiol 2003;41:1293-1304

Risk difference for all-cause mortality for years 1, 3, 5, and 8 post-initial revascularization

Copyright ©2003 American College of Cardiology Foundation. Restrictions may apply.

Hoffman, S. N. et al. J Am Coll Cardiol 2003;41:1293-1304

Risk difference for subsequent revascularization comparing coronary artery bypass graft surgery (CABG) to

percutaneous transluminal coronary angioplasty (PTCA) ({+/-} stents) for years 1 and 3

CABG vs. PCI Multivessel DiseaseCABG vs. PCI Multivessel Disease

Restenosis and the need for repeat revascularization Restenosis and the need for repeat revascularization has been the main difference between PCI and CABG in has been the main difference between PCI and CABG in the majority of patients undergoing revascularization for the majority of patients undergoing revascularization for chronic multivessel CAD.chronic multivessel CAD.

Some predicted that DES would eliminate the sole Some predicted that DES would eliminate the sole remaining gap between PCI and CABG. remaining gap between PCI and CABG.

This prediction may have overstated and oversimplified This prediction may have overstated and oversimplified reality.reality.

DES Vs CABGDES Vs CABG

DES Vs CABGDES Vs CABG

ARTS-II TrialARTS-II Trial FREEDOMFREEDOM• • SYNTAXSYNTAX• • CARDia (UK & Ireland)CARDia (UK & Ireland)

ARTS-II TrialARTS-II Trial

Arterial Revascularization Therapies Part II: a non-Arterial Revascularization Therapies Part II: a non-randomized comparison of contemporary PCI and randomized comparison of contemporary PCI and coronary artery bypass grafting (CABG) in patients with coronary artery bypass grafting (CABG) in patients with multi-vessel coronary artery lesionsmulti-vessel coronary artery lesions

Registry n = 607 MV revasc by DESRegistry n = 607 MV revasc by DES

More diabetes than ARTS 1 (26% v 18%)More diabetes than ARTS 1 (26% v 18%)

More 3 VD (54% v 28%)More 3 VD (54% v 28%)

More stents (3.7 [73mm] v 2.8 [48mm])More stents (3.7 [73mm] v 2.8 [48mm]) 6 month freedom from MACCE 6 month freedom from MACCE

ARTS 2 - 93.6 %ARTS 2 - 93.6 %

ARTS 1: PCI - 84.7% CABG - 94.5%ARTS 1: PCI - 84.7% CABG - 94.5%

ARTS 2ARTS 2

Differences between ARTS I andDifferences between ARTS I and ARTS II ARTS II

Drug eluting stentsDrug eluting stents ClopidogrelClopidogrel IIb/IIIaIIb/IIIa More aggressive lipid lowering, ?BP control andMore aggressive lipid lowering, ?BP control and diabetes managementdiabetes management Improved techniqueImproved technique

All could contribute to improved outcomesAll could contribute to improved outcomes

ARTS II – Study designARTS II – Study design

Primary endpoint: effectiveness of coronary stent implantation using the CYPHER® Sirolimus-eluting stent with that of surgery as observed in ARTS I measured as MACCE free survival at 1 year.

FREEDOM TRIALFREEDOM TRIAL

FREEDOM DesignFREEDOM Design

To evaluate whether PCI with drug eluting stenting is more or To evaluate whether PCI with drug eluting stenting is more or less effective than CABG in diabetic patients with multivessel less effective than CABG in diabetic patients with multivessel disease.disease.

Treated Diabetes Mellitus Treated Diabetes Mellitus Angiographically confirmed multivessel CAD and Angiographically confirmed multivessel CAD and

amenable to either PCI or CABGamenable to either PCI or CABG Indication for revascularizationIndication for revascularization

Primary End-point-Primary End-point- MI, stroke, death.MI, stroke, death.

SYNTAXSYNTAX

SYNTAX Trial (SYNergy between PCI SYNTAX Trial (SYNergy between PCI with TAXUS and Cardiac Surgery)with TAXUS and Cardiac Surgery)

DES vs CABG in patients with 3 vessel or left main DES vs CABG in patients with 3 vessel or left main diseasedisease

• • 104 sites over 3 months 104 sites over 3 months • • Primary outcome- 12mo MACCEPrimary outcome- 12mo MACCE• • Exclusions- prior CABG or PCI, AMI at presentation, valve Exclusions- prior CABG or PCI, AMI at presentation, valve

disease requiring Surgerydisease requiring Surgery 74% treated with CABG74% treated with CABG

71% enrolled (N=3,075)

All Pts with de novo 3VD and/or LM disease (N=4,337)

Treatment preference (9.4%) Referring MD or pts. refused

informed consent (7.0%) Inclusion/exclusion (4.7%) Withdrew before consent (4.3%) Other (1.8%) Medical treatment (1.2%)

23 US Sites62 EU Sites +

SYNTAX Trial Design

*TAXUSTM Express2TM Stent System

SYNTAX Primary EndpointRandomized TrialRandomized TrialThe Primary Clinical Endpoint is the 12 Month Major

Cardiovascular or Cerebrovascular Event Rate (MACCE *)

MACCE is defined as:• All cause Death• Cerebrovascular Event (Stroke)• Documented Myocardial Infarction• Any Repeat Revascularization (PCI and/or CABG)

Patients were treated with the intention of achieving complete revascularization of all vessels at least 1.5 mm in diameter with stenosis of 50% or more.

Patient Characteristics (RCT)Patient Characteristics (RCT)

SYNTAX, Serruys P, et al. ESC 2008.

Cerebrovascular Events to 12 Months

0.6%2.2%

0 6 12

10

20

0Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

) P=0.003¥

Event Rate ± 1.5 SEITT population¥Fisher Exact Test

TAXUS* (N=903)CABG (N=897)

* TAXUS® Express® Stent System

MACCE events in SYNTAX Score MACCE events in SYNTAX Score CategoryCategory

low SYNTAX scores (0 to 22)

intermediate SYNTAX scores (23 to 32)

SYNTAX scores Low- 0 to 22 Intermediate- 23 to 32 High ≥33

Medically Treated Diabetes and Non-DiabeticAll-Cause Death/CVA/MI and MACCE at 12 MonthsAll-Cause Death/CVA/MI and MACCE at 12 Months

ITT population

Diabetes (Medical Treatment)N=452

Non-DiabeticN=1348

TAXUS*CABG

Death/CVA/MI MACCE Death/CVA/MI MACCE

P=0.96 P=0.0025 P=0.08P=0.97

* TAXUS® Express® Stent System

SYNTAX ConclusionsSYNTAX Conclusions The primary endpoint (12-months MACCE) in The primary endpoint (12-months MACCE) in

this noninferiority trial for PCI was not met.this noninferiority trial for PCI was not met. Overall MACCE higher in the PCI group (17.8% Overall MACCE higher in the PCI group (17.8%

vs 12.1%) due to an excess of redo vs 12.1%) due to an excess of redo revascularization in the PCI vs CABG (13.7% vs revascularization in the PCI vs CABG (13.7% vs 5.9%), 5.9%),

Comparable safety outcomes (death, CVA, MI,) Comparable safety outcomes (death, CVA, MI,) in CABG and PCI patients at 12 months.in CABG and PCI patients at 12 months.

Rates of symptomatic graft occlusion and stent Rates of symptomatic graft occlusion and stent thrombosis were similar.thrombosis were similar.

Significantly higher rate of CVA in the CABG Significantly higher rate of CVA in the CABG groupgroup

The SYNTAX score will help stratify patients for The SYNTAX score will help stratify patients for the appropriate revascularization optionthe appropriate revascularization option

• The The largest benefit from CABG seems to be largest benefit from CABG seems to be in patients with diabetes mellitus. in patients with diabetes mellitus.

• The results of this trial also suggest that The results of this trial also suggest that patients with LM only, LM + 1-VD, and patients with LM only, LM + 1-VD, and nondiabetics may do as well with both nondiabetics may do as well with both CABG and PCICABG and PCI, although the trial was not , although the trial was not powered to study these differences individually.powered to study these differences individually.

PCI vs CABG: Gap NarrowingPCI vs CABG: Gap Narrowing

BARI/CABRI: Difference between PCI andBARI/CABRI: Difference between PCI and CABG ~ 34%CABG ~ 34% ARTS: Reduced to ~ 14%ARTS: Reduced to ~ 14% SYNTAX: More complex patients ~ 5.5%SYNTAX: More complex patients ~ 5.5% differencedifference SYNTAX score:SYNTAX score: Score < 22, no difference PCI vs CABGScore < 22, no difference PCI vs CABG Score 22 - 33, slight advantage for CABGScore 22 - 33, slight advantage for CABG Score > 33, surgical candidateScore > 33, surgical candidate

SYNTAX, Serruys P, et al. ESC 2008.

Limitations of SYNTAXLimitations of SYNTAX

Follow-up period was only 12 months; Follow-up period was only 12 months; Most of the patients (> 78%) were men, Most of the patients (> 78%) were men, Patients who underwent CABG were less likely Patients who underwent CABG were less likely

to receive optimal medical therapy(DAPT), which to receive optimal medical therapy(DAPT), which may have contributed to their increased risk for may have contributed to their increased risk for stroke.stroke.

Time to procedure longer for CABGTime to procedure longer for CABG

SYNTAX: LM, 5yrs follow upSYNTAX: LM, 5yrs follow up

SYNTAX: 3VD 5yrs follow upSYNTAX: 3VD 5yrs follow up

CARDiaCARDia

BEST TrialBEST Trial

18 years of age or older,18 years of age or older, angiographically confirmed multivessel CAD angiographically confirmed multivessel CAD

with stenosis of more than 70% of the vessel with stenosis of more than 70% of the vessel diameter in major epicardial vessels in the diameter in major epicardial vessels in the territories of at least two coronary arteries, territories of at least two coronary arteries, and wereand were

considered by the physicians and surgeons, considered by the physicians and surgeons, a suitable candidates for either PCI or a suitable candidates for either PCI or CABGCABG

CONCLUSIONS CABG does not hold any advantage over CABG does not hold any advantage over

multivessel PCI in preventing death or MImultivessel PCI in preventing death or MINo advantage of CABG except for the No advantage of CABG except for the

decrease in repeat revascularisation decrease in repeat revascularisation procedures procedures

PCI comparable to CABG even in PCI comparable to CABG even in diabetics in terms of death ,MI, and strokediabetics in terms of death ,MI, and stroke

PCI or CABG which strategy ? SVD : PCI

2VD

Multivessel disease : PCI as initial strategy especially in patients with good LV function , suitable anatomy and patient preference .

CABG : Severe LAD proximal lesion , DM LV dysfunction , LM lesion , Diffuse disease .

Advanced age and comorbidity : PCI is better

Younger patient < 50 y : PCI is initial strategy

Factors in patient selection

1. The need for mechanical revascularization as opposed to medical treatment & risk factor modification .

2. The likelihood of success ( vessel size , calcification , tortuosity , side branches )

3. The risk and potential consequences of acute failure of PCI ( Coronary anatomy % viable myocardium , LV function .

4.The likelihood of restenosis ( diabetes , prior restenosis , small vessel , long lesion , Total occlusion , SVG disease) .

5. The need for complete revascularization based on the extent of CAD , severity of ischemia ,

LV function .

6. The presence of comorbid conditions

7. Patient preference

2013 ESC guidelines on the management of 2013 ESC guidelines on the management of stable coronary artery diseasestable coronary artery disease

CABG VS PCI

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