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Aprotinin and Long Term Mortality

 

 

APPENDIX 1A   |  APPENDIX 1B   |  APPENDIX 2A   |  APPENDIX 2B   |  APPENDIX 3   | 

 APPENDIX 4   |  APPENDIX 5   |  APPENDIX 6   |  APPENDIX 7   |  APPENDIX 8

APPENDIX 5

Findings Using Non-Imputed Data

The following are the principal findings (Cox analyses) using non-imputed data.

Table Appendix 5A.  Cox Proportional Hazards Model for 5-year Mortality among the 4374 Patients by Study Group using Non-Imputed Data *

 

Analysis in Presence
of Covariates without Propensity Adjustment†
Analysis in Presence of
Covariates with Propensity Adjustment‡
Risk Factor
Hazard Ratio (95% CI)
P Value
Hazard Ratio (95% CI)
P Value

Aprotinin vs. control

1.44 (1.15 – 1.81)

.002

1.32 (1.03 – 1.69)

.029

Aminocaproic acid vs. control

1.01 (0.78 – 1.31)

.923

0.89 (0.67 – 1.18)

.428

Tranexamic acid vs. control

1.09 (0.80 – 1.47)

.600

1.04 (0.76 – 1.43)

.794

Propensity score, deciles

           ―

1.06 (1.02 – 1.10)

.003

Complex vs. primary surgery§

1.59 (1.32 – 1.91)

<.001

1.48 (1.21 – 1.81)

<.001

Age per 10 years or part thereof over
    60 years

1.52 (1.37 – 1.70)

<.001

1.49 (1.33 – 1.66)

<.001

History of congestive heart failure with
    hospitalization

1.62 (1.29 – 2.04)

<.001

1.67 (1.31 – 2.12)

<.001

History of valve disease without prior or
    current valve surgery

1.35 (1.04 – 1.77)

.026

1.28 (0.97 – 1.69)

.087

History of diabetes mellitus

1.44 (1.20 – 1.72)

<.001

1.38 (1.14 – 1.68)

.001

History of pulmonary disease

1.26 (1.04 – 1.53)

.017

1.29 (1.05 – 1.58)

.015

History of peripheral vascular disease

1.43 (1.17 – 1.74)

<.001

1.39 (1.13 – 1.71)

.002

Medication of warfarin or coumadin in the
    past week of admission

1.70 (1.31 – 2.21)

<.001

1.57 (1.19 – 2.09)

.002

Creatinine > 1.3 mg/dl on admission║

1.81 (1.48 – 2.20)

<.001

1.83 (1.49 – 2.25)

<.001

Stroke on admission

1.29 (1.08 – 1.54)

.006

1.31 (1.09 – 1.59)

.004

Preoperative congestive heart failure

1.33 (1.10 – 1.61)

.003

1.35 (1.10 – 1.65)

.003

Preoperative myocardial infarction

1.83 (1.17 – 2.84)

.008

1.63 (1.00 – 2.65)

.049

* Cohort includes patients who died in hospital and patients who survived their index hospitalization (N=4374). CI denotes confidence
   interval.
† Excluded were 137 patients with missing values for at least one of the risk factors in the model, including the covariates.
‡ Excluded were 418 patients with missing values for at least one of the risk factors in the model, including the covariates.
§ Complex surgery was defined as surgery under any of the following conditions: a history of coronary-artery bypass grafting, valve surgery,
   noncoronary angioplasty or stenting, or other cardiac or vascular noncardiac surgery, combined current heart surgery, or current surgery
   in emergency status or urgent status with evidence of congestive heart failure preoperatively.
To convert the value for creatinine to micromoles per liter, multiply by 88.4.

Table Appendix 5B.  Cox Proportional Hazards Model for 5-year Mortality among the 4249 Patients Who Survived Index Hospitalization by Study Group using Non-Imputed Data*

 

Analysis in Presence of Covariates without Propensity Adjustment†

Analysis in Presence of Covariates with Propensity Adjustment‡

Risk Factor
Hazard Ratio (95% CI)
P Value
Hazard Ratio (95% CI)
P Value

Aprotinin vs. control

1.46 (1.12 – 1.89)

.005

1.40 (1.05 – 1.87)

.021

Aminocaproic acid vs. control

1.12 (0.84 – 1.50)

.446

1.11 (0.81 – 1.53)

.504

Tranexamic acid vs. control

1.14 (0.80 – 1.62)

.460

1.16 (0.81 – 1.68)

.419

Propensity score, deciles

           ―

1.02 (0.98 – 1.07)

.281

Complex vs. primary surgery§

1.65 (1.34 – 2.02)

<.001

1.60 (1.28 – 2.00)

<.001

Age per 10 years or part thereof over
    60 years

1.58 (1.40 – 1.79)

<.001

1.56 (1.38 – 1.78)

<.001

History of smoking

1.37 (1.08 – 1.73)

.009

1.38 (1.07 – 1.78)

.013

History of congestive heart failure with
    hospitalization

1.58 (1.22 – 2.06)

<.001

1.52 (1.14 – 2.03)

.004

History of no angina║

1.49 (1.13 – 1.96)

.005

1.47 (1.09 – 1.99)

.012

History of valve disease without prior or
    current valve surgery

1.42 (1.05 – 1.92)

.024

1.39 (1.00 – 1.92)

.049

History of diabetes mellitus

1.46 (1.18 – 1.80)

<.001

1.45 (1.16 – 1.81)

.001

History of pulmonary disease

1.34 (1.08 – 1.66)

.008

1.45 (1.15 – 1.82)

.002

History of peripheral vascular disease

1.49 (1.20 – 1.86)

<.001

1.41 (1.11 – 1.79)

.005

Creatinine > 1.3 mg/dl on admission¶

1.55 (1.24 – 1.95)

<.001

1.55 (1.22 – 1.98)

<.001

Stroke on admission

1.44 (1.18 – 1.76)

<.001

1.46 (1.18 – 1.80)

<.001

Preoperative myocardial infarction

2.30 (1.41 – 3.73)

<.001

2.01 (1.18 – 3.41)

.010

In-hospital composite outcome events**

1.47 (1.19 – 1.83)

<.001

1.55 (1.23 – 1.95)

<.001

* Cohort includes patients who survived their index hospitalization (N=4249). CI denotes confidence interval.
† Excluded were 67 patients with missing values for at least one of the risk factors in the model, including the covariates.
‡ Excluded were 403 patients with missing values for at least one of the risk factors in the model, including the covariates.
§ Complex surgery was defined as surgery under any of the following conditions: a history of coronary-artery bypass grafting, valve surgery,
   noncoronary angioplasty or stenting, or other cardiac or vascular noncardiac surgery, combined current heart surgery, or current surgery
   in emergency status or urgent status with evidence of congestive heart failure preoperatively.
No angina indicates admission to cardiac surgery without angina, and generally for other reasons, such as: heart failure, myocardial
    infarction, sudden death, or failed percutaneous intervention.
¶ To convert the value for creatinine to micromoles per liter, multiply by 88.4.
** In-hospital outcome events included: cardiovascular events (myocardial infarction, congestive heart failure), cerebrovascular events
   (stroke, encephalopathy), and renal events (renal dysfunction, renal failure).