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Data Supplement 24. Management of Hyperlipidemia

Study Name

Aim of

Study

Study

Patient Population/Inclusion &

Endpoints

Statistical

P-Values &

OR / HR /

Study Summary

Study

 

Other

 

Study

Type

Size

Exclusion Criteria

 

 

 

Analysis

95% CI

RR

 

Limitations

 

Informa

 

 

 

 

 

 

 

 

 

Reported

 

 

 

 

 

tion

 

 

 

 

Inclusion

Exclusion Criteria

Primary Endpoint

 

Secondary

 

 

 

 

 

 

 

 

 

 

 

Criteria

 

 

 

Endpoint OR/HR:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(95% CI)

 

 

 

 

 

 

 

The Post

To compare

RCT

1,192

1) Patients 1 to

1) Likelihood of

Percent of grafts

 

Lipid lowering:

Intention-

p<0.001

N/A

Reduced rate of

Not powered to

 

Mean

Coronary

2 strategies

 

 

11 y post-

revascularization/deat

with angiographic

 

mean 93 to 97

to-treat

 

 

SVG

detect

 

follow-

Artery

of lipid-

 

 

CABG;

h within 5 y; 2)

evidence of

 

mg/dL (intensive)

 

 

 

atherosclerotic

difference in

 

up 4.3 y

Bypass Graft

lowering

 

 

2) Baseline

UA/MI within 6 mo;

atherosclerotic

 

vs. 132 to 136

 

 

 

progression with

clinical events

 

 

Trial

and their

 

 

LDL 130 to 175

3) Severe angina; 4)

progression: 27%

 

mg/dL

 

 

 

intensive lipid-

 

 

 

Investigators.

effect on

 

 

mg/dL 3) ≤1

HF; 5)

(intensive) vs. 39%

 

(moderate)

 

 

 

lowering (statin)

 

 

 

1997 (170)

bypass graft

 

 

patent vein

Contraindication to

(moderate)

 

 

 

 

 

therapy

 

 

 

 

disease

 

 

graft on

prescription with

 

 

 

 

 

 

 

 

 

 

 

 

 

 

baseline

medication

 

 

 

 

 

 

 

 

 

 

 

 

 

 

angiogram

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rate of repeat

 

p=0.03

 

 

 

 

 

 

 

 

 

 

 

 

 

revascularization:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6.5% (intensive)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

vs. 9.2%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(moderate)

 

 

 

 

 

 

 

Dotani 2000

To examine

Retrosp

323

Consecutive

None

60 d

 

None

N/A

p<0.001

OR: 0.28

N/A

N/A

 

N/A

(171)

effect of

ective

 

patients

 

death/MI/recurrent

 

 

 

 

 

 

 

 

 

 

preoperativ

case-

 

admitted for

 

angina: 9%

 

 

 

 

 

 

 

 

 

 

e statins on

control

 

CABG over 10

 

(nonstatin) vs. 1%

 

 

 

 

 

 

 

 

 

 

60 d and 1 y

 

 

mo period in

 

(statin)

 

 

 

 

 

 

 

 

 

 

post-CABG

 

 

1997

 

 

 

 

 

 

 

 

 

 

 

 

outcomes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

60 d any adverse

 

 

 

p<0.0001

OR: 0.31

 

 

 

 

 

 

 

 

 

 

outcome (death,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MI, UA, CHF,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

arrhythmia, CVA):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

37% (nonstatin) vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15% (statin use)

 

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

 

 

1 y any adverse

 

 

p<0.001

OR: 0.26

Preoperative statin

Nonrandomized

 

 

 

 

 

 

 

outcome: 45%

 

 

 

 

therapy associated

, retrospective

 

 

 

 

 

 

 

(nonstatin) vs. 18%

 

 

 

 

with reduced CV

(may be

 

 

 

 

 

 

 

(statin)

 

 

 

 

events at 60 d and

unmeasured

 

 

 

 

 

 

 

 

 

 

 

 

1 y

factors that

 

 

 

 

 

 

 

 

 

 

 

 

 

account for

 

 

 

 

 

 

 

 

 

 

 

 

 

difference

 

 

 

 

 

 

 

 

 

 

 

 

 

between statin

 

 

 

 

 

 

 

 

 

 

 

 

 

and nonstatin

 

 

 

 

 

 

 

 

 

 

 

 

 

outcomes)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pan 2004 (172)

To examine

Retrosp

1,663

Consecutive

N/A

N/A

N/A

30 d all

p<0.05; 95%

OR: 0.53

Preoperative statin

Nonrandomized

Confirm

 

effect of

ective

 

patients

 

 

 

cause

CI: 0.28 to

 

therapy may

, retrospective

ed in a

 

statin

case-

 

undergoing

 

 

 

mortality:

0.99

 

reduce early

(may be

propensit

 

therapy on

control

 

CABG at single

 

 

 

3.75%

 

 

mortality of

unmeasured

y-

 

perioperativ

 

 

institution from

 

 

 

(nonstatin)

 

 

CABG

factors that

matched

 

e CABG

 

 

2000 to 2001

 

 

 

vs. 1.8%

 

 

 

account for

cohort of

 

mortality

 

 

 

 

 

 

(preoperati

 

 

 

difference

1,362

 

 

 

 

 

 

 

 

ve statin)

 

 

 

between statin

patients

 

 

 

 

 

 

 

 

 

 

 

 

and nonstatin

 

 

 

 

 

 

 

 

 

 

 

 

 

outcomes)

 

Collard 2006

To assess

Retrosp

2,663

Patients

N/A

Risk of early

No difference in

N/A

p<0.03;

OR: 0.25;

Preoperative statin

Retrospective,

Postoper

(173)

preoperativ

ective

 

undergoing

 

cardiac death post-

postoperative

 

95% CI: 0.07

for early

use is associated

nonrandomized

ative

 

e statin

case-

 

CABG in 70

 

CABG: 0.3%

nonfatal, in-

 

to 0.87

cardiac

with reduced

 

statin

 

therapy on

control

 

centers/17

 

(statin-treated) vs.

hospital MI

 

 

death

cardiac mortality

 

discontin

 

postoperativ

 

 

countries from

 

1.4% (not-statin

 

 

 

 

after CABG

 

uation

 

e

 

 

1996 to 2000

 

treated)

 

 

 

 

 

 

associate

 

mortality/M

 

 

 

 

 

 

 

 

 

 

 

d with

 

I

 

 

 

 

 

 

 

 

 

 

 

increased

 

 

 

 

 

 

 

 

 

 

 

 

 

in-

 

 

 

 

 

 

 

 

 

 

 

 

 

hospital

 

 

 

 

 

 

 

 

 

 

 

 

 

mortality

 

 

 

 

 

 

 

 

 

 

 

 

 

: 1.9%

 

 

 

 

 

 

 

 

 

 

 

 

 

(disconti

 

 

 

 

 

 

 

 

 

 

 

 

 

nued) vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

0.5%

 

 

 

 

 

 

 

 

 

 

 

 

 

(continue

 

 

 

 

 

 

 

 

 

 

 

 

 

d) (OR:

 

 

 

 

 

 

 

 

 

 

 

 

 

2.95 for

 

 

 

 

 

 

 

 

 

 

 

 

 

death;

 

 

 

 

 

 

 

 

 

 

 

 

 

95% CI:

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.31 to

 

 

 

 

 

 

 

 

 

 

 

 

 

6.66;

 

 

 

 

 

 

 

 

 

 

 

 

 

p<0.01)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clark 2006 (174)

To assess

Retrosp

3,113

Consecutive

N/A

30 d

N/A

N/A

p<0.05

N/A

Preoperative statin

Nonrandomized

N/A

 

statin

ective

with

cardiac surgery

 

mortality/morbidit

 

 

 

 

use confers a

, retrospective

 

 

therapy on

case-

CABG

patients over 8

 

y (risk-adjusted):

 

 

 

 

"protective effect"

 

 

 

postoperativ

control

± valve

y period

 

mortality OR:

 

 

 

 

with regard to

 

 

 

e surgical

 

 

 

 

0.55; (95% CI:

 

 

 

 

postoperative

 

 

 

outcomes

 

 

 

 

0.32 to 0.93);

 

 

 

 

outcomes

 

 

 

(included

 

 

 

 

morbidity OR:

 

 

 

 

 

 

 

 

CABG

 

 

 

 

0.76 (95% CI: 0.62

 

 

 

 

 

 

 

 

alone, valve

 

 

 

 

to 0.94) favoring

 

 

 

 

 

 

 

 

alone or

 

 

 

 

statin users

 

 

 

 

 

 

 

 

combined)

 

 

 

 

 

 

 

 

 

 

 

 

Kulik 2008 (175)

To assess

Retrosp

7,503

Medicare

N/A

All cause mortality

MACE HR: 0.89;

Intention-

N/A

N/A

Postoperative

Nonrandomized

N/A

 

early

ective

 

patients

 

(median follow-up

(95% CI: 0.81 to

to-treat

 

 

statin use within 1

, retrospective

 

 

postoperativ

case-

 

undergoing

 

4 y) HR: 0.82

0.98); p=0.02

 

 

 

mo of discharge

 

 

 

e statin use

control

 

CABG from

 

favoring statin

 

 

 

 

reduces all-cause

 

 

 

vs. no early

 

 

1995 to 2003

 

users within 1 m

 

 

 

 

mortality and

 

 

 

postoperativ

 

 

 

 

(95% CI: 0.72 to

 

 

 

 

MACE following

 

 

 

e statin use

 

 

 

 

0.94); p=0.004

 

 

 

 

CABG

 

 

 

and post-

 

 

 

 

 

 

 

 

 

 

 

 

 

CABG

 

 

 

 

 

 

 

 

 

 

 

 

 

outcome

 

 

 

 

 

 

 

 

 

 

 

 

CABG indicates coronary artery bypass graft; CHF, congestive heart failure; CI, confidence interval; CVA, cerebral vascular accident; CV, cardiovascular; d, day; HF, heart failure; HR, hazard ratio; LDL, low-density lipoprotein; m, month; MACE, major adverse cardiac events; MI, myocardial infarction; N/A, not applicable; OR, odds ratio; RR, relative risk; SVG, saphenous vein graft; UA, unstable angina; and y, year.

Data Supplement 25. Beta Blockers

Author (Trial)

Drug

Number of

AF Episode

RR (95%

ARR (95% CI)

P-Value

Comments

 

 

Patients

(Percent)

CI)

 

 

 

 

 

 

 

 

 

 

 

Halonen et al.2006 (176)

IV metoprolol administration (1

119

20 (17%)

0.4 (0 .02

0.11 (0.01 to 0.22)

p=0.04

Dosing started on the first postoperative morning;

 

to 3 mg/h)

 

 

to 0.63)

 

 

Continued for 48 h; No difference in onset of AF

 

 

 

 

 

 

 

in h after surgery (26.5 h IV vs. 30.1 h oral); IV

 

 

 

 

 

 

 

metoprolol temporarily discontinued for ≥1 h due

 

 

 

 

 

 

 

to hypotension or bradycardia in 15.1%

 

 

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

Halonen et al. 2006 (176)

Oral metoprolol administration

121

34 (28%)

 

 

 

 

 

(25 mg bid up to 50 mg bid

 

 

 

 

 

 

 

titrated to heart rate)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AF indicates atrial fibrillation; ARR, absolute risk reduction; bid, twice daily; IV, intravenous; mg, milligram; and RR, relative risk.

Data Supplement 26. ACE Inhibitors: Table 1

Author

 

 

Definition

 

 

Inclusion

 

 

Exclusion

 

 

Statistical

 

 

Primary Outcome

 

 

Secondary Outcomes

 

 

 

Primary Results OR (95%

 

 

 

Secondary Results

 

 

 

 

 

 

 

 

 

 

 

 

 

Methods

 

 

 

 

 

 

 

 

 

CI); P-Value

 

 

 

[OR (95% CI); P-Value]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Miceli et al.

 

 

Use of ACE

 

 

10,023 isolated

 

 

Unknown ACE

 

 

Propensity

 

 

30 d mortality, overall

 

 

Renal dysfunction, AF, MI,

 

 

 

OR: 2.0 (1.2 to 3.4); p=0.01,

 

 

 

Renal dysfunction OR 1.4; (1.1

 

2009 (177)

 

 

inhibitors within

 

 

CABG, single

 

 

inhibitor status,

 

 

matching 3,052

 

 

rate 1%

 

 

stroke, inotrope use

 

 

 

ACE inhibitor vs. Non-ACE

 

 

 

to 1.7); p=0.006

 

 

 

 

24 h of surgery

 

 

site, 1996 to

 

 

preoperative shock

 

 

patients per group,

 

 

 

 

 

 

 

 

 

inhibitor

 

 

 

AF: OR: 1.3; 1.2 to 1.5;

 

 

 

 

 

 

2008

 

 

 

 

 

OPCAB 49%

 

 

 

 

 

 

 

 

 

 

 

 

 

p<0.0001

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Inotrope: OR: 1.2 (1.1 to 1.4);

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

p<0.0001

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

No difference in MI or stroke

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rader et al.

 

 

Use of ACE or

 

 

10,552 CABG ±

 

 

Preoperative AF or

 

 

Propensity

 

 

Postoperative AF

 

 

VT, VF, cardiac arrest,

 

 

 

Unadjusted OR: 1.13 (1. 05 to

 

 

 

Trend towards longer LOS

 

2010 (178)

 

 

ARB (ABDT)

 

 

valve, single

 

 

paced rhythm (prior

 

 

matching (6,744

 

 

 

 

 

inotrope use, stroke, in

 

 

 

1.25); p<0.01

 

 

 

(p=0.07), however no evidence

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

prescription

 

 

site, 1997 to

 

 

history of AF

 

 

patients, 70%

 

 

 

 

 

hospital death, renal

 

 

 

 

 

 

 

found an association between

 

 

 

 

within 30 d and

 

2003

 

 

allowed)

 

 

cohort)

 

 

 

 

 

failure, pulmonary

 

 

 

 

 

 

 

preoperative angiotension

 

 

 

 

last dose within

 

 

 

 

 

 

 

 

 

 

 

 

 

 

embolism, LOS

 

 

 

 

 

 

 

blockade and occurrence of

 

 

 

 

24 h of surgery

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

POAF.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OR: 1.05 (0.95 to 1.16);

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

p=0.38

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ABDT, indicates angiotensin-blocking drug therapy ACEI, angiotensin converting enzyme inhibitor; AF, atrial fibrillation; ARB, angiotensin II receptor blockers; CABG, coronary artery bypass graft; CI, confidence interval; h, hour; LOS, length of stay; MI, myocardial infarction; OPCAB, off-pump coronary artery bypass; OR, odds ratio; POAF, postoperative atrial fibrillation, VF, ventricular fibrillation; and VT, ventricular tachycardia.

© American College of Cardiology Foundation and American Heart Association, Inc.

Data Supplement 27. ACE Inhibitors: Table 2

Author (Trial)

Intervention

Number

Inclusion/Exclusion

Dates

Outcome

Results; HR (95% CI)

Kjoller-Hansen et. al. 2000

Ramipril 5 to 10 mg, 5 to 7

80

Key inclusion: preoperative LVEF

1994 to 1996, single

Triple (cardiac death, MI, CHF)

Reduction in triple composite only

(APRES) (179)

d post uncomplicated

 

0.3 to 0.5 and uncomplicated

Danish site, terminated

or quadruple composite

(58% risk reduction), (7% to 80%).

 

CABG, median follow-up

 

postoperative course.

early (lack of enrollment)

outcome (recurrent angina)

Trend to higher incidence recurrent

 

33 mo, 82% post-CABG

 

Exclusion: hx recent MI, clinical

 

 

angina first 6 mo. No interaction with

 

(vs. PCI)

 

heart failure, or valve disease.

 

 

EF.

 

 

 

 

 

 

 

 

Placebo

79

 

 

 

 

 

 

 

 

 

 

 

Oosterga et. al. 2001 (Quo

Quinapril (40 mg), 4

75

Key inclusion: exercise induced

1994 to 1997; 2 sites,

Clinical ischemic events,

Reduction of clinical ischemic events

Vadis) (180)

wkspreoperative,

 

ischemia. Key exclusions: clinical

Dutch

Ischemia on ETT, Holter

only

 

prescription 1 y

 

heart failure, severe renal disease,

 

 

HR: 0.2; (95% CI: 0.06 to 0.87)

 

postoperative

 

severe hypertension, AF, diuretic

 

 

 

 

 

 

prescription

 

 

 

 

 

 

 

 

 

 

 

Placebo

73

 

 

 

 

 

 

 

 

 

 

 

Rouleau et al. 2008

Quinapril (titrate up to 40

1,280

Key exclusion: insulin-dependent

1999 to 2004; 57 sites, 4

Composite MACE, CVA; drug

Primary outcome NS (HR: 1.15; 95%

(IMAGINE) (181)

mg), 7 to 10 d

 

diabetes mellitus, or type 2 diabetes

countries

AEs

CI: 0.92 to 1.42; p=0.212); first 3 mo

 

postoperative, Prescription

 

with microalbuminuria, significant

 

 

postoperative worse outcome treated

 

6 to 43 mo

 

renal disease, microalbuminuria,

 

 

group (HR: 1.60; 95% CI: 0.73 to

 

 

 

preoperative LVEF <40%,

 

 

3.52; p=0.240), more AE's

 

 

 

perioperative MI.

 

 

 

 

 

 

 

 

 

 

 

Placebo

1,273

 

 

 

 

 

 

 

 

 

 

 

Fox et al. 2007

Perindopril 8 mg after 4 wk

3,340

Key inclusion: CAD without heart

1997 to 2000, multicenter

Primary (cardiovascular death,

CABG only in 3,136 patients, CABG

(182)

run in period. Prescription

 

failure. Key Exclusions: renal

European 24 countries

nonfatal MI or cardiac arrest) at

and PCI in 451, PCI only in 3122 pts.

 

for at least 3 wk.

 

insufficiency; revascularization

 

4.2 y of follow-up

RRR 17.3% (95% CI: 1.3 to 30.8;

 

 

 

within 6 mo of enrollment

 

 

p=0.035) (vs. 20% in entire EUROPA

 

 

 

 

 

 

trial); RRR in pts without prior MI

 

 

 

 

 

 

23% (95% CI: 2.7 to 42.2, p=0.074);

 

 

 

 

 

 

RRR for fatal or nonfatal outcome

 

 

 

 

 

 

alone 23% (95% CI: 4.9 to 37.6%;

 

 

 

 

 

 

p=0.015).

 

Placebo

3,369

 

 

 

 

 

 

 

 

 

 

 

AE indicates adverse event; AF, atrial fibrillation; APRES, Angiotension-converting Enzyme Inhibition Post Revascularization Study; CABG, coronary artery bypass graft; CAD, coronary artery disease; CI, confidence interval; CVA, cerebral vascular accident; d, day; EF, ejection fraction; ETT, exercise tolerance test; HTN, hypertension; HR, hazard ratio; hx, history; IMAGINE, Ischemia Management with Accupril post-bypass Graft via Inhibition of the converting Enzyme; LV, left ventricular; LVEF, left ventricular ejection fraction; m, month; MACE, major adverse cardiac events; MI, myocardial infarction; NS, non significant; PCI, percutaneous coronary infection; Quo Vadis, QUinapril on Vascular Ace and Determinants of Ischemia; RRR, relative risk reduction; w, week, and y, year.

© American College of Cardiology Foundation and American Heart Association, Inc.

Data Supplement 28. Smoking Cessation

Study Name

Study Type

Patient Population

Findings

Statistical Significance

 

 

Sample Size

 

 

Cavender et al. 1992 (183)

Randomized

780

Increased survival in nonsmokers vs. smokers (82% and

p=0.025

 

Study

 

77%, respectively)

 

 

 

 

 

 

Vlietstra et al. 1986 (184)

Observational Study

4,165

Lower mortality in quitters vs. those who continued to

N/A

 

 

 

smoke (15% vs. 22% respectively)

 

 

 

 

RR: 1.55; 95% CI: 1.29 to 1.85

 

 

 

 

 

 

Voors et al. 1996 (185)

Observational Study

415

No difference in survival; compared to nonsmokers,

N/A

 

 

 

smokers were at increased risk for MI, repeat CABG and

 

 

 

 

recurrent angina

 

 

 

 

 

 

van Domburg et al. 2000 (186)

Observational Study

985

Nonsmokers were less likely to undergo repeat CABG or

N/A

 

 

 

PCI

 

 

 

 

RR: 1.41; 95% CI: 1.02 to 1.94

 

 

 

 

 

 

van Domburg et al. 2008 (187)

Observational Study

1,041

Smoking cessation was an independent predictor of lower

N/A

 

 

 

mortality

 

 

 

 

HR: 0.60; 95% CI: 0.48 to 0.72

 

 

 

 

 

 

CABG indicates coronary artery bypass graft; CI, confidence interval; HR, hazard ratio; MI, myocardial infarction; N/A, not applicable; OR, odds ratio; PCI, percutaneous coronary intervention; and RR, relative risk.

Data Supplement 29. Cardiac Rehabilitation

Study Name

Study Type

Patient Population

Findings

Statistical Significance

 

 

Sample Size

 

 

Engbloom et al. 1997 (188)

Randomized Trial

Post-CABG n=119 randomized to rehabilitation vs.

5 y rates of physical mobility, health status

p=0.002

 

 

n=109 usual hospital treatment

improved

 

Millani et al. 1998 (189)

Observational Study

500 consecutive patients entering rehabilitation following

Decrease body fat 5% from 26.2±8.0 to 24.8±7.5

p<0.0001

 

 

cardiac event (MI, PCI, CABG)

 

 

Hansen et al. 2009 (190)

Observational Study

PCI n=194 and CABG n=149 undergoing rehabilitation

CABG and PCI patients getting rehabilitation had

p<0.005

 

 

compared to controls

lower 2 y mortality compared to controls

 

Moholdt et al. 2009 (191)

Randomized Trial

59 CABG randomized to AIT vs. MCT

4 wk and 6 mo follow-up with improved VO max

p<0.001

 

 

 

in AIT group

 

 

 

 

 

 

AIT indicates aerobic interval training; CABG, coronary artery bypass graft; MCT, moderate continuous training; MI, myocardial infarction; mo, month; PCI, percutaneous coronary intervention; VO max, oxygen uptake maximum; wk, week; and y, year.

© American College of Cardiology Foundation and American Heart Association, Inc.

Data Supplement 30. Central Nervous System Monitoring

Author

Aim of Study

N of

Patients

Relative RR;

Absolute RR;

P-Value

Number of

RR; (95%

Absolute RR

P-

Comments

 

 

Patients

With ≥1

(95% CI)

(95% CI)

 

Patients With

CI)

(95% CI)

Value

 

 

 

 

MOMM

 

 

 

≥1 any STS

 

(%)

 

 

 

 

 

Outcome

 

 

 

30-d Outcomes

 

 

 

 

 

 

 

N (%)

 

 

 

N (%)

 

 

 

 

Murkin et al.

Active

100

3 (3%)

0.73; (95% CI:

0.08; (95%

0.048

23 (23%)

0.25 (95% CI:

0.10; (95% CI:

NS

MOMM variables: death,

2007(192)

intraoperative

 

 

0.05 to 0.92)

CI: 0.01 to

 

 

-0.10 to 0.49)

-0.03 to 0.23)

 

ventilation >48 h, stroke, MI,

 

rSO cerebral

 

 

 

0.15)

 

 

 

 

 

return for reexploration; alarm

 

oximetry

 

 

 

 

 

 

 

 

 

threshold of 75% of resting rSO

 

monitoring with

 

 

 

 

 

 

 

 

 

used for intervention;

 

treatment

 

 

 

 

 

 

 

 

 

concomitant procedure or

 

 

 

 

 

 

 

 

 

 

 

OPCAB in 12 control vs. 7

 

 

 

 

 

 

 

 

 

 

 

intervention patients

 

Active

100

11 (11%)

 

 

 

30 (30%)

 

 

 

 

 

intraoperative

 

 

 

 

 

 

 

 

 

 

 

rSO cerebral

 

 

 

 

 

 

 

 

 

 

 

oximetry

 

 

 

 

 

 

 

 

 

 

 

monitoring with

 

 

 

 

 

 

 

 

 

 

 

treatment

 

 

 

 

 

 

 

 

 

 

 

 

 

Postoperativ

 

 

 

Other major

 

 

 

 

 

 

 

e Cognitive

 

 

 

postoperative

 

 

 

 

 

 

 

Decline

 

 

 

complications

 

 

 

 

Slater et al. 2009

Active

125

73 (58%)

0.05 (95% CI:

0.03 (95% CI:

NS

6 (5%)

0 (95% CI:

0 (95% CI: -

NS

Other complications=CVA, MI,

(193)

intraoperative

 

 

0.17 to 0.23)

-0.09 to 0.15)

 

 

-202 to 67)

0.06 to 0.06)

 

renal insufficiency, reoperation;

 

rSO cerebral

 

 

 

 

 

 

 

 

 

prolonged rSO was higher in

 

oximetry

 

 

 

 

 

 

 

 

 

pooled cognitive decline patients

 

monitoring with

 

 

 

 

 

 

 

 

 

(33% vs. 20%; p=0.02) and was

 

treatment

 

 

 

 

 

 

 

 

 

associated with hospital stay >6

 

 

 

 

 

 

 

 

 

 

 

d (25%) OR: 2.71 (95% CI 1.3

 

 

 

 

 

 

 

 

 

 

 

to 5.6); p=0.007

 

Active

115

70 (61%)

 

 

 

6 (5%)

 

 

 

 

 

intraoperative

 

 

 

 

 

 

 

 

 

 

 

rSO cerebral

 

 

 

 

 

 

 

 

 

 

 

oximetry

 

 

 

 

 

 

 

 

 

 

 

monitoring with

 

 

 

 

 

 

 

 

 

 

 

treatment

 

 

 

 

 

 

 

 

 

 

CI indicates confidence interval; CVA, cerebral vascular accident, MI, myocardial infarction; MOMM, major organ morbidity and mortality; N, number; NS, non-significant; OPCAB, off-pump coronary artery bypass; RR, relative risk; rSO , regional oxygen saturation; and STS, Society of Thoracic Surgeons.

© American College of Cardiology Foundation and American Heart Association, Inc.

Data Supplement 31. Performance

Article Name

Aim of Study

Study Design

Study Size

Patient Population

Endpoints

Results

 

 

 

 

 

 

 

Comparing hospitals

To determine if hospital

Observational

2,867 CABG patients

10 WI hospitals, April 1990

Risk-adjusted mortality and

Low correlations between adjusted hospital

that perform CABG: the

quality comparisons

 

 

to June 1991

morbidity

rankings derived from the clinical and

effect of outcome

impacted by use of

 

 

 

 

administrative databases were 0.48 for

measures and data

administrative vs. clinical

 

 

 

 

mortality, 0.21 for major complications, and -

sources. 1994 (194)

data

 

 

 

 

0.14 for any complication.

 

 

 

 

 

 

Assessing provider quality using administrative

 

 

 

 

 

 

data may not be adequate.

Using Medicare claims

Determine adequacy of

Observational,

13,577 CABG patients

Isolated CABG patients, NY

Model performance, outcomes,

Performance of administrative models

data to assess provider

administrative claims data

comparing risk

 

state, 1991 to 1992

outlier determination.

diminished substantially when complications

quality for CABG: does

for profiling.

models and provider

 

 

 

separated from co-morbidities (from c-

it work well enough?

 

performance based

 

 

 

index=0.78 to c-index=0.71 and c-index=0.73).

1997 (195)

 

on Medicare vs. NY

 

 

 

 

 

 

clinical data registry.

 

 

 

NY clinical registry-based model based on all

 

 

 

 

 

 

patients had best performance (c-

 

 

 

 

 

 

statistic=0.813).

 

 

 

 

 

 

Different risk-adjusted mortality rates and

 

 

 

 

 

 

outliers using administrative vs. clinical data.

 

 

 

 

 

 

Clinical database better for profiling

 

 

 

 

 

 

Performance of administrative models improved

 

 

 

 

 

 

by adding a few clinical variables

Clinical versus

To compare the ability of

Observational,

22, 827 CABG

NY CABG patients, 1989 to

Risk factor coding, observed and

Substantial differences between databases in

administrative data

clinical and administrative

comparing NY

patients

1990

risk-adjusted mortality, outlier

risk factor coding.

bases for CABG. Does

databases to predict CABG

clinical and

 

 

determination.

 

it matter? 1992 (196)

mortality and assess provider

administrative

 

 

 

For some hospitals, substantial differences

 

performance.

databases.

 

 

 

between risk-adjusted mortality rates and

 

 

 

 

 

 

ranking determined by administrative model and

 

 

 

 

 

 

clinical model (the gold standard).

 

 

 

 

 

 

Clinical data much better at predicting mortality

 

 

 

 

 

 

and for use in profiling.

 

 

 

 

 

 

Administrative model can be improved with the

 

 

 

 

 

 

addition of some clinical variables.

Does reporting of

To assess accuracy of CABG

Observational,

1,121 confirmed

Single hospital isolated

Case volumes and mortality rates

Case volumes over-reported as much as 21% in

© American College of Cardiology Foundation and American Heart Association, Inc.

coronary artery bypass

outcomes from

comparing STS

CABG patients

CABG 1999 to 2001

 

all patients, underreported up to 16% or more in

grafting from

administrative databases

database results with

 

 

 

Medicare patients

administrative

 

those from 4

 

 

 

 

databases accurately

 

administrative data

 

 

 

Mortality in administrative data exceeded that in

reflect actual clinical

 

sources and risk

 

 

 

clinical data by 21%.

outcomes? 2005 (197)

 

models.

 

 

 

 

 

 

 

 

 

 

Different administrative data-derived risk

 

 

 

 

 

 

models had risk-adjusted mortality rates that

 

 

 

 

 

 

exceeded STS rates by as much as 61%

Comparison of clinical

To compare the accuracy of

Observational,

4,440 isolated CABG

MA CABG patients, FY

Observed and risk-adjusted

27% higher number of patients (5,657 vs. 4,440

and administrative data

administrative and clinical

comparing audited,

in audited clinical

2003

mortality, outliers.

actual) in administrative data due to

sources for hospital

data sources for public report

clinical registry and

registry, 5,657

 

 

inappropriate inclusion of nonisolated CABG

coronary artery bypass

cards.

state administrative

“CABG” in state

 

 

cases.

graft report cards. 2007

 

data.

administrative data.

 

 

 

(198)

 

 

 

 

 

Administrative data in-hospital mortality 2.88%

 

 

 

 

 

 

vs. 2.05% in audited clinical registry.

 

 

 

 

 

 

Differences in risk-adjusted mortality rates and

 

 

 

 

 

 

outliers between administrative and clinical data

 

 

 

 

 

 

based-models.

 

 

 

 

 

 

Recommend clinical data for profiling.

Mortality after cardiac

To compare mortality

Observational

15,288 CABG patients

43 VA hospitals, October 1,

Model performance, risk-adjusted

Administrative model c-index=0.698, clinical

bypass surgery:

prediction and outlier

 

 

1993, to March 30, 1996

mortality rates, outliers.

model c-index=0.761.

prediction from

determination from

 

 

 

 

 

administrative versus

administrative vs. clinical

 

 

 

 

6 hospitals (14%) changed more than 2 deciles

clinical data. 2005

data.

 

 

 

 

in rank when using administrative vs. clinical

(199)

 

 

 

 

 

data.

 

 

 

 

 

 

Administrative models identified only 2 of 6

 

 

 

 

 

 

high and 1 of 4 low outlier hospitals determined

 

 

 

 

 

 

by the clinical model.

 

 

 

 

 

 

Clinical models have better performance, but

 

 

 

 

 

 

administrative models can be improved by

 

 

 

 

 

 

adding clinical variables

Assessing the outcomes

To determine the impact of

Observational,

5,517 isolated CABG

Ontario, FY 1993, 9

Model performance, risk adjusted

Model performance stable after the inclusion of

of coronary artery

number of risk factors on the

comparing the

patients.

hospitals.

mortality rates, and rankings.

6 core clinical variables (c-index=0.77).

bypass graft: how many

accuracy of risk-adjusted

results of models

 

 

 

 

risk factors are enough?

mortality rates.

using an increasing

 

 

 

In comparison with unadjusted results, 6-

1997 (200)

 

number of risk

 

 

 

variable clinical model resulted in a change in

 

 

factors.

 

 

 

risk-adjusted mortality rates and rankings for

© American College of Cardiology Foundation and American Heart Association, Inc.

most hospitals.

CABG, coronary artery bypass graft; FY; fiscal year; MA, Massachusetts; NY, New York; STS, Society of Thoracic Surgeons; VA, Veterans Administration; and WI, Wisconsin.

Data Supplement 32. Outcomes or Volume as CABG Quality Measures

 

Article Name

 

 

Aim of Study

 

 

Study Design

 

 

Study Size

 

 

Patient

 

 

Endpoints

 

 

Results

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

population/Year/Hospital

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Should operations be

 

 

To determine the impact

 

 

Observational

 

 

34,505 CABG patients

 

 

CABG patients/1974 to

 

 

Adjusted mortality

 

 

Mortality 5.7% for ≤200 CABG; 3.4% for >200

 

 

regionalized? The empirical

 

 

of volume on mortality.

 

 

 

 

 

 

 

 

1975/The Professional

 

 

 

 

 

CABG.

 

 

relation between surgical

 

 

 

 

 

 

 

 

 

 

 

Activity Study Database.

 

 

 

 

 

 

 

 

volume and mortality. 1979

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(201)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hospital volume and

 

 

To determine the

 

 

Observational

 

 

901,667 CABG patients

 

 

Medicare CABG patients/

 

 

Adjusted mortality

 

 

Continuous inverse association between volume and

 

 

surgical mortality in the

 

 

association between

 

 

 

 

 

 

 

 

1994 to 1999/1,068 hospitals.

 

 

 

 

 

outcome.

 

 

United States. 2002 (202)

 

 

procedural volume and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

mortality.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted mortality 5.6% for <230 procedures vs. 4.5%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

for >849 procedures.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Relatively weak association compared to other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

procedures.

 

 

Association of volume with

 

 

To determine volume-

 

 

Observational

 

 

18,986 CABG patients

 

 

CA CABG patients/1983/ 77

 

 

Adjusted mortality

 

 

Patients undergoing CABG in hospitals with volume

 

 

outcome of CABG.

 

 

outcome association for

 

 

 

 

 

 

 

 

hospitals

 

 

 

 

 

>350 cases had lowest mortality, and this effect was

 

 

Scheduled vs. nonscheduled

 

 

scheduled vs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

most pronounced in nonscheduled cases.

 

 

operations. 1987 (203)

 

 

nonscheduled

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

operations.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Regionalization of cardiac

 

 

To determine the impact

 

 

Observational

 

 

116,593 CABG patients

 

 

CABG patients in NY,

 

 

Adjusted mortality

 

 

Highest adjusted mortality rate (4.7%) in CA CABG

 

 

surgery in the United States

 

 

of CABG

 

 

 

 

 

 

 

 

Canada, and CA/1987 to 1989.

 

 

 

 

 

patients having surgery at hospitals with annual volume

 

 

and Canada. Geographic

 

 

regionalization.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

<100 CABG.

 

 

access, choice, and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

outcomes. 1995 (204)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CABG: the relationship

 

 

To determine association

 

 

Observational

 

 

12,448 CABG patients

 

 

NY isolated CABG

 

 

Risk-adjusted mortality

 

 

Overall crude mortality rate 3.68%.

 

 

between in-hospital

 

 

of hospital and surgeon

 

 

 

 

 

 

 

 

patients/1989/126 surgeons, 30

 

 

 

 

 

 

 

 

mortality rate and surgical

 

 

volume with CABG

 

 

 

 

 

 

 

 

hospitals

 

 

 

 

 

Crude mortality rates decrease monotonically from

 

 

volume after controlling for

 

 

outcome.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5.38% for hospital volumes 1 to 199 to 3.08% for

 

 

clinical risk factors. 1991

 

 

 

 

 

 

 

 

 

 

 

Cardiac Surgery Reporting

 

 

 

 

 

hospital volumes ≥890.

 

(205)

 

 

 

 

 

 

 

 

 

 

 

System.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hospital risk-adjusted mortality rates decrease

 

© American College of Cardiology Foundation and American Heart Association, Inc.