pci vs cabg
TRANSCRIPT
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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