ONE YEAR OUTCOME AFTER MEDICAL THERAPY, PERCUTANEOUS CORONARY

INTERVENTION (PCI), AND CORONARY ARTERY BYPASS GRAFT (CABG) IN PATIENTS WITH 3-

VESSEL AND/OR LEFT MAIN CORONARY ARTERY DISEASE

Gerard Ryan T. Mercadal, MDTHE MEDICAL CITY

PHILIPPINE HEART ASSOCIATIONMay 24, 2012

OBJECTIVES

PRIMARY OBJECTIVES

• Investigate the one-year clinical outcomes of patients with three-vessel and/or left main coronary artery disease who underwent medical therapy, percutaneous coronary intervention and coronary artery bypass graft, admitted at The Medical City from January to December 2010.

SPECIFIC OBJECTIVES• To identify patients with three-vessel

and/or left main coronary artery disease (CAD) on coronary angiography performed at the Cardiac Catheterization Laboratory of The Medical City from January to December 2010.

• To categorize these patients into those who had medical therapy (MT), percutaneous coronary intervention (PCI) and coronary bypass graft (CABG).

SPECIFIC OBJECTIVES

•To determine and compare the baseline characteristics of patients in the three treatment group including risk factors and indication for coronary angiography.•To identify and assess the angiographic characteristics of the three treatment groups consisting of SYNTAX score, vessels and number of lesions involved and presence of total occlusion.

SPECIFIC OBJECTIVES

•To determine and assess the maintenance medications given to patients in each group.•To identify and compare the clinical events and outcomes of these CAD patients in hospital, 30 days, 6 months and 12 months after, according to treatment groups and SYNTAX category.

METHODOLOGY

CORONARY ANGIOGRAPHY FROM JAN-DEC 2010

3-VESSEL AND/OR LEFT MAIN INVOLVEMENT

MEDICAL CABG

MEDICAL AND CATHETERIZATION

RECORDS

BASELINE CHARACTERISTICS

•gender•age•body mass index (kg/m2)•risk factors•creatinine clearance (mg/dl)•ejection fraction (%)•indication for coronary angiography

ANGIOGRAPHIC CHARACTERISTICS

•SYNTAX SCORE•Vessels and number of lesions involved•Presence of total vessel occlusion

SYNTAX SCORE

•algorithm available on the SYNTAX score website (www.syntaxscore.com)•each coronary lesion producing > 50% luminal obstruction, in vessels > 1.5 mm, was separately scored and added to provide the overall SYNTAX score.

EXCLUSION CRITERIA

• Previous percutaneous coronary intervention (PCI)

• Severe hepatic or renal disease• Neutropenia or thrombocytopenia• Intolerance or contraindication to

acetylsalicylic acid or thienopyridines• Need for concomitant major surgery• Life-limiting major concomitant non-

cardiac diseases

CLINICAL ENDPOINTS

MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS (MACCE)

In-hospi

tal30

days6

months

12 mont

hsDEATH FROM ANY CAUSE (CARDIAC, CARDIOVASCULAR AND NON-CARDIOVASCULAR)

STROKE

MYOCARDIAL INFARCTION

REPEAT REVASCULARIZATION

SECONDARY ENDPOINTS

In-hospi

tal30

days6

months

12 mont

hsOther cardiac and non-cardiac events

Incidence of angina and heart failure symptoms

STATISTICAL ANALYSIS

STATISTICAL ANALYSIS

• Microsoft Office and SPSS v16• Categorical data: frequencies and

percentages ( Chi-square test)• Numerical data: mean ± standard

deviation (SD) (One Way Anova).   • 12-month rates of MACCE according to

the treatment group and SYNTAX score classification: Chi-square test

• Cumulative survival function and event rates: Kaplan–Meier method

RESULTS

CORONARY ANGIOGRAPHY FROM JAN-DEC 2010 (N= 616 PATIENTS)

3-VESSEL AND/OR LEFT MAIN INVOLVEMENT (N= 75)

MEDICAL(N=17 )

CABG (N=33)

PCI (N=17)

NO DEFINITE MANAGEMENT/

LOST TO FOLLOW-

UP (N=8)

  MEDICAL (N=17)

CABG (N=33)

PCI (N=17)

P-VALUE(< 0.05)

Male 12 (70.6%) 28 (84.8%) 11 (64.7%) 0.236Age 62.9 ± 7.9 56 ± 7.8 60.2 ± 11.9 0.035Body mass index 25.3 ± 4.2 27.2 ± 3.9 24.5 ± 3.9 0.081

RISK FACTORS        Hypertension 15 (88.2%) 28 (84.8%) 13 (76.5%) 0.627Diabetes 10 (58.8%) 23 (69.7%) 9 (52.9%) 0.474Previous myocardial infarction

5 (29.4%) 5 (15.2%) 1 (5.9%) 0.173

Dyslipidemia 6 (35.3%) 12 (36.4%) 4 (23.5%) 0.637Family history of

coronary artery disease

3 (17.6%) 13 (39.4%) 5 (29.4%) 0.286

Smoker 6 (35.3%) 18 (54.5%) 8 (47.1%) 0.434Peripheral artery

disease0 (0%) 2 (6.1%) 3 (17.6%) 0.134

Chronic obstructive pulmonary disease

0 (0%) 2 (6.1%) 2 (11.8%) 0.351

Previous cerebrovascular

accident

2 (11.8%) 4 (12.1%) 0 (0%) 0.326

Creatinine clearance, (mg/dl)

57.4 ± 20 64.1 ± 22.3 70.7 ± 36.3 0.345

Ejection fraction (%) 61.9 ± 20.4 59.5 ± 19.8 65.3 ± 14.7 0.607

TABLE I. Baseline characteristics of patients with 3-vessel arterial disease and/or left main involvement on coronary angiography performed at the Cardiac Catheterization Laboratory of the Cardiovascular Center of The Medical City from January to December 2010.

  MEDICAL (N=17)

CABG (N=33)

PCI (N=17)

P-VALUE(< 0.05)

INDICATION FOR CORONARY ANGIOGRAPHY

      0.951

NSTEMI 4 (23.5%)

9 (27.3%) 3 (17.6%)  

STEMI 3 (17.6%)

4 (12.1%) 5 (29.4%)  

Cardiogenic Shock 0 (0%) 1 (3%) 1 (5.9%)  Stable angina 4

(23.5%)5 (15.2%) 2 (11.8%)  

Unstable angina 1 (5.9%) 5 (15.2%) 2 (11.8%)  Congestive heart Failure

1 (5.9%) 1 (3%) 1 (5.9%)  

Positive treadmill test 2 (11.8%)

1 (3%) 1 (5.9%)  

Segmental wall motion abnormality on 2d echo

1 (5.9%) 2 (6.1%) 2 (11.8%)  

Positive CT- Angiography

0 (0%) 1 (3%) 0 (0%)  

Positive stress echo 1 (5.9%) 3 (9.1%) 0 (0%)  Positive nuclear viability study

0 (0%) 1 (3%) 0 (0%)  

  MEDICAL(N=17)

CABG(N=33)

PCI(N=17)

TOTAL(N=67)

P-VALUE(<0.05)

SYNTAX score 33.6 ± 17 40.1 ± 11.9

34.4 ± 13.6

37 ± 13.9

0.197

No. of lesions          

-3 vessel 13 (76.5%)

25 (75.8%)

14 (82.4%)

52 (77.6%)

0.671

-1 vessel with left main

1 (5.9%)

1 (3%)

0 (0%)

2 (3%)

 

-2 vessel with left main

0 (0%)

2 (6.1%)

2 (11.8%)

4 (6%)

 

-3 vessel with left main

3 (17.6%)

5 (15.2%)

1 (5.9%)

9 (13.4%)

 

Total occlusion

10 (58.8%)

24 (72.7%)

6 (37.5%)

40 (60.6%)

0.060

  MEDICAL (N=17)

CABG (N=33)

PCI (N=17)

P-VALUE(< 0.05)

MEDICATIONS        

Aspirin 14 (82.4%)

21 (67.7%)

16 (100%) 0.032

Clopidogrel 16 (94.1%)

15 (46.9%)

15 (93.8%) 0.000

Statin 17 (100%) 29 (90.6%) 16 (100%) 0.198

Angiotensin receptor blocker

9 (52.9%) 23 (71.9%) 8 (50%) 0.237

B-blockers 12 (70.6%)

23 (71.9%) 11 (68.8%) 0.975

Nitrates 11 (64.7%)

20 (62.5%) 11 (68.8%) 0.913

CLINICAL OUTCOMES

 MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS (MACCE) ACCORDING TO TREATMENT GROUP IN HOSPITAL, 30 DAYS, 6 AND 12 MONTHS AFTER TREATMENT/PROCEDURE

Medical(n=17)

CABG(n=33)

PCI(n=17)

Total (n=67)

p-value(<

0.05)MACE IN HOSPITAL 0 (0%) 3 (9.1%) 1 (5.9%) 4 (6%) 0.437Death 0 2 1 3 From cardiac causes 0 2 0 2 From cardiovascular Causes

0 0 0 0

From non- cardiovascular causes

0 0 1 1

Stroke 0 1 0 0MI 0 0 0 2Repeat CABG 0 0 0 0Repeat PCI 0 0 0 0

  Medical(n=17)

CABG(n=31)

PCI(n=16)

Total (n=64)

P- Value

MACE 30 DAYS AFTER TREATMENT/PROCEDURE

0 (0%) 0 (0%) 0 (0%) 0 (0%)

Lost to follow-up 0 (0%) 6 (19.4%)

0 (0%) 6 (9.4%)

 Medical(n=17)

CABG(n=25)

PCI(n=16)

Total (n=58)

P- Value

MACE 6 MONTHS AFTER TREATMENT/PROCEDURE

1 (5.9%) 1 (4%) 0 (0%) 2 (3.4%) 0.639

Death 1 0 0 1From cardiac causes 1 0 0 1From cardiovascular Causes

0 0 0 0

From non- cardiovascular causes

0 0 0 0

Stroke 0 0 0 0MI 1 1 0 2Repeat CABG 0 0 0 0Repeat PCI 0 0 0 0

  Medical(n=16)

CABG(n=25

)

PCI(n=16)

Total (n=57

)

P- Value(<0.05)

MACE 12 MONTHS AFTER TREATMENT/PROCEDURE

1 (6.3%) 0(0%)

1 (6.3%)

2 (3.5%)

0.445

Death 1 0 0 1 From cardiac causes 1 0 0 1 From cardiovascular Causes

0 0 0 0

From non-cardiovascular causes

0 0 0 0

Stroke 0 0 0 0MI 1 0 1 2Repeat CABG 0 0 0 0Repeat PCI 0 0 1 1

OTHER CARDIAC AND NON-CARDIAC EVENTS (MULTIPLE)

Medical (n=17)

CABG (n=33)

PCI (n=17)

Total (n=67)

P value < 0.05

arrhythmia 1 (6.3%)

5 (15.2%)

3 (17.6%)

8 (12.1%)

0.247

pneumonia 0 (0%) 3 (9.1%) 3 (17.6%)

4 (6.1%) 0.10

sepsis 0 (0%) 0 (0%) 2 (11.8%)

1 (1.5%)

urinary tract infection

0 (0%) 0 (0%) 1 (5.9%) 0 (0%) 0.225

CARDIAC SYMPTOMS

         

Angina 5 (29.4%)

3 (9.1%)

1 (5.9%)

9 (13.4%)

0.123

Failure symptoms

3 (17.6%)

0 (0%) 1 (5.9%) 4 (5.9%) 0.095

 MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS (MACCE) ACCORDING TO SYNTAX CATEGORY IN HOSPITAL, 30 DAYS, 6 AND 12 MONTHS AFTER TREATMENT/PROCEDURE

 

  LOW(n=12)

INTERMEDIATE (n=15)

HIGH(n=40)

Total (n=67)

p-value(< 0.05)

MACCE IN HOSPITAL 0 (0%) 1 (6.7%) 3 (7.5%) 4 (6%) 0.624

Death 0 1 2 3 From cardiac causes 0 0 2 2 From cardiovascular Causes

0 0 0 0

From non- cardiovascular causes

0 1 0 1

Stroke 0 0 1 0MI 0 0 0 0Repeat CABG 0 0 0 0Repeat PCI 0 0 0 0

  LOW(n=12

)

INTERMEDIATE (n=14)

HIGHn=38)

Total(n=64

)

P-Value(<0.05)

MACCE 30 DAYS AFTER TREATMENT/PROCEDURE

0 (0%) 0 (0%) 0 (0%) 0 (0%)

Lost to follow-up 0 (0%) 2 (14.3%) 4 (10.5%) 6 (9.4%)

  LOW(n=12

)

INTERMEDIATE (n=12)

HIGH(n=34)

Total(n=58)

MACCE 6 MONTHS AFTER TREATMENT/PROCEDURE

1 (8.3%)

0 (0%) 1 (2.9%) 2 (3.4%)

0.518

Death 1 0 0 1From cardiac causes 1 0 0 1From cardiovascular causes

0 0 0 0

From non- cardiovascular causes

0 0 0 0

Stroke 0 0 0 0MI 1 0 1 2Repeat CABG 0 0 0 0Repeat PCI 0 0 0 0

  LOW(n=11

)

INTERMEDIATE (n=12)

HIGH(n=34)

Total(n=57

)

P-value(<0.05)

MACCE 12 MONTHS AFTER TREATMENT/ PROCEDURE

0 (0%) 0 (0%) 2 (5.9%)

2 (3.5%)

0.496

Death 0 0 1 1 From cardiac causes

0 0 1 1

From cardiovascular causes

0 0 0 0

From non- cardiovascular causes

0 0 0 0

Stroke 0 0 0 0MI 0 0 2 2Repeat CABG 0 0 0 0Repeat PCI 0 0 1 1

KAPLAN-MEIER CURVES

A. MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS (MACCE)

Survival Functions

time (in months)

14121086420-2

Cum

Sur

viva

l

1.02

1.00

.98

.96

.94

.92

.90

procedure

PCI

PCI-censored

CABG

CABG-censored

Medical

Medical-censored

LOG p-value =.9809

B. DEATH FROM ANY CAUSE

Survival Functions

time (in months)

14121086420-2

Cum

Sur

viva

l

1.2

1.0

.8

.6

.4

.2

0.0

-.2

procedure

PCI

PCI-censored

CABG

CABG-censored

Medical

Medical-censored

LOG p-value =.6516

C. MYOCARDIAL INFARCTION

Survival Functions

time (in months)

14121086420-2

Cum

Sur

viva

l

1.2

1.0

.8

.6

.4

.2

0.0

-.2

procedure

PCI

PCI-censored

CABG

CABG-censored

Medical

Medical-censored

LOG p-value =.6015

A. MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS (MACCE)

LOG p-value =.6625

Survival Functions

time (in months)

14121086420-2

Cum

Sur

viva

l

1.02

1.00

.98

.96

.94

.92

.90

Syntax Score

High

High-censored

Intermediate

Intermediate

-censored

Low

Low-censored

B. DEATH FROM ANY CAUSE

LOG p-value =.3356

Survival Functions

time (in months)

14121086420-2

Cum

Sur

viva

l

1.2

1.0

.8

.6

.4

.2

0.0

-.2

Syntax Score

High

High-censored

Intermediate

Intermediate

-censored

Low

Low-censored

C.MYOCARDIAL INFARCTION

LOG p-value =cannot be computed

Survival Functions

time (in months)

14121086420-2

Cum

Sur

viva

l1.2

1.0

.8

.6

.4

.2

0.0

-.2

Syntax Score

High

High-censored

Intermediate

Intermediate

-censored

Low

Low-censored

DISCUSSION

PRIMARY GOALS OF REVASCULARIZATION FOR

PATIENTS WITH CAD

•to improve survival•relieve symptoms

4. Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/ AHA Guideline for coronary artery bypass graft surgery: Executive summary: A report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists and Society of Thoracic Surgeons. Journal of the American College of Cardiology 2011; 58 (24):2584-2614

CABG is a class I indication to improve survival in patients

with significant left main and/or 3 vessel coronary

artery stenosis.•Percutaneous coronary intervention is another alternative to CABG (Class IIa)… to improve survival in selected patients:• with significant unprotected left main CAD, with unstable angina or

non-ST elevation myocardial infarction who are not eligible for CABG, and in acute ST-elevation myocardial infarction(4).

4. Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/ AHA Guideline for coronary artery bypass graft surgery: Executive summary: A report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists and Society of Thoracic Surgeons. Journal of the American College of Cardiology 2011; 58 (24):2584-2614

THE MEDICAL CITY 2010

• 25.37% of 67 patients: PCI•49.25% : CABG•25.37% : Medical therapy

2368 patients with diabetes and multi-

vessel CAD with stable symptoms

•angiographic features associated with extent, location, and nature of CAD had the greatest influence in the decision to select CABG over PCI. •introduction of the first generation drug eluting stents (DES) decreased the likelihood of the selection of CABG in these patients.

6. Kim LJ, King III SB, Kent K, et al. Factors Related to the Selection of Surgical Versus Percutaneous Revascularization in Diabetic Patients With Multivessel Coronary Artery Disease in the BARI 2D (Bypass Angioplasty RevascularizationInvestigation in Type 2 Diabetes) Trial. JACC: Cardiovascular Interventions 2009; 2(5): 384-392

A meta-analysis of 13 randomized trials on 7964 patients comparing PCI with CABG showed a lower risk of death at five-years (risk difference (RD) 2.3%, CI 0.29% to 4.3%, p= 0.025) and eight-years (risk difference (RD) 3.4%, CI 0.32% to 6.4%, p= 0.03) for patients with multi-vessel disease who underwent bypass surgery (7).

7. Hoffman SN, TenBrook Jr JA, Wolf MP, et al. A meta-analysis of randomized controlled trials comparing coronary artery bypass graft with percutaneous transluminal coronary angioplasty: One- to eight-year outcomes. Journal of the American College of Cardiology 2003; 41(8):1293-1304

A meta-analysis of 4 randomized trials in 3051 patients with

multi-vessel disease• No difference was noted in the cumulative incidence of

death, stroke and myocardial infarction between patients who were randomized to CABG versus PCI with stenting.

• MACCE was higher in the PCI group as demonstrated by a significantly higher rate of revascularization (28.9 versus 7.8%, p <0.001) (8).

8. Daemen J, Boersma E, Flather M, et al. Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: A meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS Trials. Circulation 2008; 118: 1146-54

9. Boeden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary artery disease. N Engl J Med 2007; 356: 1503-151610. Pell JP, Walsh D, Norrie J, et al. Outcomes following coronary artery bypass grafting and percutaneous transluminal coronary angioplasty in the stent era: a prospective study of all 9890 consecutive patients operated on in Scotland over a two year period. Heart 2001; 85: 662-666 11. Park DW, Yun SC, Lee SW, et al. Long term mortality after percutaneous coronary intervention with drug-eluting stent implantation versus coronary artery bypass surgery for the treatment of multivessel coronary artery disease. Circulation 2008; 117: 2079-208612. Rodriguez AE, Maree AO, Mieres J, et al. Late loss of early benefit from drug-eluting stents when compared with bare-metal stents and coronary artery bypass surgery: 3 years follow-up of the ERACI III registry. European Heart Journal 2007; 28: 2118-2125

At 13 years follow-up, both CABG and PCI showed comparable long-term survival, degree of angina, functional capacity and use of anti-anginal medication (

1

3

).

9. Boeden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary artery disease. N Engl J Med 2007; 356: 1503-1516

14. Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N ENGL J MED 2009; 360: 961-72

SYNTAX score

•developed to predict outcomes in patients with three vessel and/or left main disease who undergo either CABG or PCI. •SYNTAX trial: in patients who underwent PCI, the rate of major adverse cardiac or cerebrovascular events was significantly increased among patients with high SYNTAX scores(14). 14. Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-

artery bypass grafting for severe coronary artery disease. N ENGL J MED 2009; 360: 961-72

ARTS II trial showed that patients with multi-vessel disease with low SYNTAX score may be adequately treated with PCI while CABG may be more beneficial for those patients with high SYNTAX scores(

1

5

).

In a randomized study of 1800 patients, rates of MACCE was similar among patients with low and intermediate scores in the CABG and PCI groups while in the patients with high score, the adverse event rate was significantly increased in the PCI group (

1

6

).

15. Serruys PW, Ong ATL, van Herwerden LA, et al. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: The final analysis of the Arterial Revascularization Therapies Study (ARTS) Randomized Trial. Journal of the American College of Cardiology 2005; 46:575-58116. Serruys PW, Onuma Y, Garg S, et al. Five-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. Journal of the American College of Cardiology 2010; 55(11):1093-1101

In this study, no significant difference in the rates of MACCE among patients with low, intermediate and high scores in the medical, CABG and PCI groups.

10 out of the 17 patients in the PCI group had high SYNTAX scores.

The most common reason for choice of treatment was the preference of the patient and relatives even after explaining the benefits, disadvantages and risks of CABG and PCI.

Two patients at high risk for surgery underwent PCI while another three patients had emergency PCI of the culprit vessel for ST elevation myocardial infarction.

LIMITATIONS OF THE STUDY

•Limited by the availability of the pertinent data or values in the hospital records. •Data from this study was dependent on the record keeping and monitoring of the hospital, and were presumed correct and accurate. •Availability of records on follow-up and by the short follow-up interval.

RECOMMENDATIONS

•Prospective study•Include and follow-up all patients undergoing coronary angiography at the Cardiac Catheterization Laboratory of The Medical City and their clinical outcome after definitive treatment for a longer period of time (5 years or more).

CONCLUSION

•Patients who underwent CABG were significantly younger compared to those who opt medical treatment and PCI. •Clinical events and outcomes of patients with three-vessel and/or left main involvement shown were similar in the medical therapy, PCI and CABG group. •MACCE in hospital and on 12 months follow-up showed no statistically significant difference.

CONCLUSION

•Clinical events and outcomes according to SYNTAX category likewise showed no statistical significant difference in the occurrence of major cardiac and cerebrovascular events (MACCE) in hospital and at 30 days, 6 and 12 months after discharge.

THANK YOU!