Coronary bypass studies

Question 1

ROOBY trial

Answer 1

Randomized On/Off BYpass Study
Prospective randomized of 2203 pts undergoing urgent or elective CABG
GRoup 1 (n= 1104) Off pump
Group 2 ( n = 1099) On pump
Demonstrated that 12.4% of patients in the off pump required conversion.
No difference in short term (30 day) outcomes including death, reoperation, stroke, renal failure
Lower graft patency at 1 year in the off pump 82.6% vs 87.8 in the on pump
Higher composite outcome of death, MI, and repeat revascularization at 1 year in the off pump group (9.9% vs on pump 7.4%).
Off pump resulted in lower FitzGibbon A for arterial 85.5% vs 91.4%
Off pump vein was 72% vs 80.4% for veins at 2 years (FitzGibbon A)

Question 2

Combined Carotid endarterectomy/coronary artery bypass graft and the effect of patient risk
J Vasc Surg 2012;56:668-76

Answer 2

The goal of this study was to compare the outcomes of combined CEA and CABG in a New England Group from 2003 to 2009.

This large study showed that the risk of complications (stroke, and death) were significantly higher in a combined group when compared to isolated CEA.

Most suggest ideal patient for combined approach is symptomatic carotid artery stenosis and an indication for CABG (unstable angina or left main) and most agree this is an ok treatment.

Question 3

Predictive Risk Factors for Patients with Cirrhosis Undergoing Heart Surgery

Raqa Arif: Heidelberg Germany: Annals of thoracic surgery Dec 2012: 94:6: 1952-1953

Answer 3

This study invested the predictive factors and long-term mortality of patients with cirrhosis undergoing open heart surgery with extra coporeal circulation

CHILD A 70% alive 1 year, 26% at 5 year; CHILD B 33% and %5 , and CHILD C 33% and 0%
The preoperative MELD (9.5 appears a good cut-off) and total protein are useful to predict 30 day mortality.

Patients categories as CHILD B have a significantly higher risk of dying then those with CHILD A

Question 4

FREEDOM study–Future Revascularization Evaluation in patients with Diabetes mellitus: Optimal management of multivessel disease

NEJM 2012 Dec 20: 367 (25) 2375-84

Answer 4

Randomized trial of assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG

Followed for 2 years (median among survivors 3.8 years).

from 2005 to 2010–enrolled 1900 patients at 140 international centers.

Primary outcome of death, myocardial infarction and stroke was 26.6% in PCI in 18.7% in CABG. (5 year outcome)

Stroke was more frequent in CABG and benefit of CABG was driven by improved rates of

Question 5

CORONARY study: Off-pump or on-pump coronary artery bypass grafting at 30 days

NEJM 2012 April 19

Answer 5

70 centers in 10 countries
4752 patients in whom CABG was planned to undergo the procedure off-pump or on pump.

Primary outcome was composite of Death, Nonfatal stroke, nonfatal MY, or new renal failure requiring dialysis at 30 days.

There was no significant difference in rate of primary outcome between off and on-pump 9.8% vs 10.3%).

Off pump was associated with significantly reduced rates of blood-product transfusion (50.7% vs 63%), acute kidney injue 28 vs 32%) and respiratory complication (5.9% vs 7.5%) but increased rate of revasculaizations 0.7% vs 0.2%.

Question 6

SHOCK trial

JAMA 2001

Answer 6

Reports from 30 day and 1 year outcomes

All cause mortality @ 1 year between initial medical therapy vs mandated revasculaization (within 6 hours) showed outcomes that were beneficial for revascularization 46% vs 33.% for IMT.

IMT could have used an IABP.

This was especially the case in patients < 75 years of age (greatest benefit).

AHA does recommend early revascularization therapy in patients with CS within 36 hours of AMI.

Question 7

Syntax 5 year results

Answer 7

62 EU site and 23 USA sites ; TAXUS stent

CABG 805 pts and PCI had 871 (in the randomized arms) There is a registry arm as well.

63% were complete revascularization

At 1 year: DEATH/CVA/MI rates were similar between CABG and PCO
Stroke was increased in CABG vs PIC
Repeat revasculaization and MACE were increasaed in PCI vs CABG

Question 8

Syntax 5 year

Answer 8

All cause mortality was 13.9% for PCI and 11.4% for CABG
Cardiac Death was 9.0% vs 5.3% for PCI and CABG
Myocardial Infarction was 9.7% vs 3.8 % for PCI and CABG
CVA was 2.4% vs 3.7 % for PCI and CABG
All-Cause Death CVA/MI/ to 5 years 20.8% for PCI and 16.7% for CABG
Repeat revascularixation 25.9% and 13.7% for PCI and CABG
MACE 37.3% and 26.9% for PCI and CABG

Question 9

Syntax 5 years

Answer 9

Low scores (0-22) [about 300 patients in each arm)
Death 10.1% CABG and 8.9% PCO
overall no different in PCI and CABG

Question 10

Syntax score

Answer 10

Intermediate (23-32)
Death 12.7% vs 13.8% for CABG and PCI
Repeat revascularization 12.7 vs 24.1% CABG and PCI
MI 3.6% vs 11.2% CABG and PCI
statistically significant overall improvement

High Scores (> 33)
Death 11.4% vs 19.2% CABG and PCI
MI 3.9% vs 10.1 CABG and PCI
Overall 44.0% vs 26.8 % for PCI and CABG

Question 11

Syntax 5 years

Answer 11

5 year results suggest that 71% of all patients are still best treated with CABG, however, for the remaining patients PCI is an alternative to surgery

Question 12

Syntax 5 year registry

Answer 12

644 in CABG and 192 in PCI
MACE in CABG was 23.2 and PCI 49.2
Cardiac death 3.6 in CABG and 9.8 in PCI

Question 13

Freedom study

Answer 13

Comes from Mount Sinai
1900 pts from 2005 to 2010

Type 1 and type 2 DM (3VD)
Median follow up was 3.8 years

MI was 10.4 % vs 5.1% for PCI and CABG
Cardiovascular events 21.5% vs 15.5% for PCI and CABG
Death from any cause 12.4% and 9.1% for PCI and CABG
stroke 2.3% for PCI and 3.9% for CABG

Question 14

Coronary Trial at 30 days

Answer 14

Dr. Andre Lamy

MI 6.7 % and 7.2% Off and ON
Stroke 1.0 % and 1.1 %

Question 15

SHOCK II-IABP

Answer 15

Randomized 600 patients AMI with cardiogenic Shock to IABP or no IABP; all were scheduled for early PCI and optimal medical therapy

30 days 39.7% of the IABP and 41.3% of controls had died (p= 0.69)

No significant significant difference in length of stay, duration of catecholamines, renal function.

No safety differences were seen in bleeding, peripheral ischemic complications, sepsis, or stroke.

ESC 2012 meeting—IABP in STEMI was downgraded from 1 c to 2B

Question 16

IABP-SHOCK trial

Answer 16

limitation was that 86.6% of IABP were placed post procedure and this may have had a bearing on negative results.

10% of control patients crossed over to IABP treatment, which may have a minor impact.

600 pts enrolled in 37 centers in Germany

No reduction in 30-day mortality

Question 17

Best Bypass Surgery trial (BBS)
From Denmark

Circulation 2010; Feb 2; 121

Moller and group

Answer 17

Purpose to determine the positive and negative effects of CABG with and without the use of CPB.

EF had to be > 30% and EuroScore > 4 but < 17

No significant difference in composite endpoint of all-cause mortality, Acute MI, cardiac arrest, LCOA, and coronary intervention) 15% vs 17% at 30 days.

Question 18

What are 3 year outcomes of Best Bypass surgery trial

Answer 18

341 patients in study.

MACE in 40% in the offpump vs 33% in the on pump.
Mean year follow up 3.7.

all-cause mortality was 24% in off vs 15% in on. No difference in cardiac related death.

Trend towards reduction in MI with off-pump 7% vs 14%

Question 19

An analysis of progression of native vessel disease–Should all moderate coronary lesions be grafted during primary coronary bypass surgery
JTCS; 145:140-9
Philip A hayward, Brian Bixton

Answer 19

620 pt who underwent on-pump CABG–405 with follow-up angiogram
3816 total vessels of which 1242 are bypass grafts.
386 moderate lesions were identified of which 323 were grafted
moderate lesions where more likely than severe to remain unchanged (52.5% vs 31.1%)
Arterial and vein graft patenency to left lesions had good patencey (83% and 77% at 8 years)
Placement of a graft for a moderate lesion was associated with greater incidence of disease progression, most marked in the right coronary territory

Question 20

Treatment of complex coronary artery disease in patients with Diabetes: 5 year results comparing outcome of bypass surgery and PCI in the syntax trial

Answer 20

1800 pts of which 452 had dabetes
No difference in the composite outcome of all-cause mortality/stroke/MI (PCI 23.9% and CABG 19.1%)
Individual mortality (19.5% PCI and 12% CABG)
Rate of MI was 9.0% PCI and 5.4% for CABG

Overall PCI results in higher of MACCE and repeat revascularization at 5 years. CABG should be the revascularization option of choice for pts with more-complex anatomic disease,

Question 21

Randomized trial to compare bilateral vs single internal mammary coronary artery grafting: 1 year results of the Arterial revascularisation trial (ART)
Dr. Taggart
Eur Heart J.2 2010

Answer 21

3102 pts enrolled in 28 hospital in severe countries
Mean number of grafts is 3
42% of BIMA were performed off pump
Mortality at 30 days was 1.2% for each group. rates of stroke, MI, and repeat revascularization were all the same for each group.

So overall no difference between the two groups at 1 year. The 10 year results will confirm BIMA grafting resulting in lower mortality and the need for repeat intervention

Question 22

What were the results of 5 year Syntax for DM

Answer 22

25% of patients in syntax were DM

MACCE was higher in PCI 46.5% vs CABG 29.0%

Question 23

What were some high lights from Freedom study

Answer 23

5 year primary endpoint was 18.7% in CABG and 26.6% in PCI
Death 10.9% in CABG and 16.3% in PCI
MI 6% in CABG and 13% in PCI
stroke 5.2% in CABG and 2.4% in PCI

Question 24

What is the BIMA study from Cleveland Clinic

Answer 24

Non emergent-primary isolated CABG from 1971
2001 BITA and 8123 SITA
Mean follow up 16.2 years

Survival for BITA at 7, 10, 15 and 20 years was 89%, 81%, 67% and 50%
Survival for SITA at 7, 10, 15 and 20 years was 87%, 78%, 58%, and 37%

Question 25

What study resulted in ASA showing survival benefit for revascularization

Answer 25

ASA within 48 hours of revascularization resulting in mortality decrease from 4% in control to 1.3%
Combined non fatal ischemic complication in the heart brain, kidney, GI tract in the ASA group was 60^ of that in the control group

Question 26

What did RAPS say about patency of radial grafts when comparing degree of lesion

Answer 26

The combined string and occlusion sign

When RA target > 90% the rate was 9.6%
When RA taget was 70 to 89% the rate was 24.2%

Question 27

What are details of RAPS

Answer 27

Initially 500+ pts but only 234 for 7.7 year follow-up
Overall rates of complete occlusion 18% for SVG and 9% for radial artery
Functional graft occlusion 12. 3% for radial and 19.9% for SVG

This was performed in 9 centers, 3VD, had to have high grade stenosis in left circumflex and right.

Question 28

ARTS- I NEJM 2001

Answer 28

CABG vs BMS
Similar survival and freedom from MI and stroke at 1 year follow-up
Reintervention free survival at one year 88% CAB and 74% stenting

Question 29

SOS Lance 202

Answer 29

CABG vs BMS 
3 year follow-up 
Similar combined risk of death and MI 
Lower rate of death with CABG 
Higher rate of reintervention with stents (21% vs 6%) in CABG over 3 year

Question 30

ECSS NEJM 1988

Answer 30

Surgery was superior to medical therapy in the following subgroups

1. LM
2. Peripheral vascular disease
3. Proximal LAD

• all had normal LV

Question 31

BARI NEJM 1996

Answer 31

Compared CABG with PTCA non medical therapy
Comparison of subgroups of diabetic pts
7 and 10 year follow up
In diabetics better survival in CABG
Survival in other population the same with rate of reintervention in the PCI of 77% and 20% at 10 years
*LITA to LAD only 80%,

Question 32

Coronary at 1 year

Answer 32

4,752 coronary artery disease enrollees of the CORONARY trial, who were recruited from 79 centers in 19 countries, who were scheduled to undergo CABG.

The resulting findings showed similarities in the rate of the primary composite outcome between off-pump and on-pump CABG (12.1% vs.13.2%;

Moreover, the occurrence of coronary revascularization (CABG/PCI) was reported in 1.4% of the patients in the off-pump group and 0.8% of the patients in the on-pump

Question 33

What are limitations of studies examine cabg and pci

Answer 33

Most trials did not report outcomes on subset such as race/renal/obesity/PAD
Most enrolled pt were male, 1-3 vessel disease, and normal LV function–which would make them unlikely to benefit from CABG
The enrolled pts were only a small fraction of screened pts (5-10%), making the generalizability of the results poor

Question 34

Syntax trial

Answer 34

Synergy between PCI with TAXUS and and cardiac surgery
Prospective, randomised controlled trial between 2005 to 2007
1800 patients with 3 vessel coronary disease or left main disease randomised to
1) Group 1 (n = 897) PCI and Group 2 ( n = 903)
At 1 year f/u CABG had decreased MACE CABG 12.4% vs PCI 17.8%; decreased repeat revascularization CABG 6% and PCI 13%–No difference in death or MI
At 3 years MI rate was 3.6% vs PCI 7.1%;
At 5 years
*Important to do syntax score 0 -21; 22-32; > 32