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Administration périopératoire d'Inhibiteurs de l'enzyme de conversion de l'angiotensine ou d'antagonistes des récepteurs de type 1 de l'angiotensine II pour prévenir la mortalité et la morbidité chez les adultes

Appendices

Appendix 1. Search strategies

MEDLINE (Ovid SP)

1. exp angiotensin‐converting‐enzyme‐inhibitors/ or (alacepril or benazepril* or captopril or ceranapril or cilazapril*or delapril or enalapril* or fosinopril* or imidapril or libenzapril or quinaprilat or ramipril* or rentiapril or saralasin or spirapril or temocapril hydrochloride or teprotide or trandolapril or zofenopril or cozaar or valsartan or diovan or telmisartan or micardis or candesartan or tasosartan or verdia or eprosartan or irbesartan).mp. or exp ramipril/ or exp receptors, angiotensin/ or exp losartan/
2. (surg* or perioperative or preoperative or intraoperative or postoperative).mp.
3. ((randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or clinical trials as topic.sh. or randomly.ab. or trial.ti.) not (animals not (humans and animals)).sh.
4. 1 and 2 and 3

EMBASE (Ovid SP)

1. angiotensin‐converting‐enzyme‐inhibitors/ or alacepril/ or alacepril.mp. or benazepril/ or benazepril*.mp. or captopril/ or captopril.mp. or ceranapril/ or ceranapril*.mp. or cilazapril/ or cilazapril*.mp. or cilazaprilat/ or delapril/ or delapril.mp. or enalapril/ or enalapril*.mp. or enalaprilat/ or fosinopril/ or fosinopril*.mp. or fosinoprilic acid/ or fosinoprilic acid.mp. or imidapril/ or imidapril.mp. or libenzapril/ or libenzapril.mp. or quinaprilat/ or quinaprilat.mp. or ramipril/ or ramipril*.mp. or ramiprilat/ or rentiapril/ or rentiapril*.mp. or saralasin/ or saralasin.mp. or spirapril/ or spirapril.mp. or temocapril hydrochloride/ or temocapril hydrochloride.mp. or teprotide/ or teprotide.mp. or trandolapril/ or trandolapril.mp. or zofenopril/ or zofenopril.mp. or angiotensin II receptor blocker/ or losartan/ or losartan.mp. or cozaar/ or cozaar.mp. or valsartan/ or valsartan.mp. or diovan/ or diovan.mp. or telmisartan/ or telmisartan.mp. or micardis/ or micardis.mp. or candesartan/ or candesartan.mp. or tasosartan/ or tasosartan.mp. or verdia/ or verdia.mp. or eprosartan/ or eprosartan.mp. or irbesartan/ or irbesartan.mp.
2. (surg* or perioperative or preoperative or intraoperative or postoperative).ti,ab.
3. (placebo.sh. or controlled study.ab. or random*.ti,ab. or trial*.ti,ab. or ((singl* or doubl* or trebl* or tripl*) adj3 (blind* or mask*)).ti,ab.) not (animals not (humans and animals)).sh.
4. 1 and 2 and 3

The Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library)

#1 MeSH descriptor: [Angiotensin‐Converting Enzyme Inhibitors] explode all trees
#2 alacepril or benazepril* or captopril or ceranapril or cilazapril*or delapril or enalapril* or fosinopril* or imidapril or libenzapril or quinaprilat or ramipril* or rentiapril or saralasin or spirapril or temocapril hydrochloride or teprotide or trandolapril or zofenopril or cozaar or valsartan or diovan or telmisartan or micardis or candesartan or tasosartan or verdia or eprosartan or irbesartan
#3 MeSH descriptor: [Ramipril] explode all trees
#4 MeSH descriptor: [Receptors, Angiotensin] explode all trees
#5 MeSH descriptor: [Losartan] explode all trees
#6 #1 or #2 or #3 or #4
#7 surg* or perioperative or preoperative or intraoperative or postoperative
#8 #6 and #7

Appendix 2. Data extraction form

Study Selection, Quality Assessment & Data Extraction Form

 

First author

Journal/Conference Proceedings etc

Year

 

 

 

 

 Study eligibility

 

RCT/Quasi/CCT  (delete as appropriate)

Relevant participants

Relevant interventions

Relevant outcomes

 

Yes / No / Unclear

 

Yes / No / Unclear

 

Yes / No / Unclear

 

Yes / No* / Unclear

 

* Issue relates to selective reporting, when authors may have taken measurements for particular outcomes, but not reported these within the paper(s). Reviewers should contact trialists for information on possible non‐reported outcomes & reasons for exclusion from publication. Study should be listed in Studies awaiting assessment until clarified. If no clarification is received after three attempts, study should then be excluded.

Do not proceed if any of the above answers are 'No'. If study to be included in 'Excluded studies' section of the review, record below the information to be inserted into 'Table of excluded studies'

 

Freehand space for comments on study design and treatment:

References to trial 

Check other references identified in searches. If there are further references to this trial link the papers now & list below. All references to a trial should be linked under one Study ID in RevMan.

 

Code each paper

Author(s)

Journal/Conference Proceedings etc

Year

Participants and trial characteristics

 

Participant characteristics

 

Further details

Age (mean, median, range, etc)

 

Sex of participants (numbers / %, etc)

 

Disease status / type, etc 02(if applicable)

 

Comorbidities (diabetes, hypertension, etc)

 

Prior drug therapy (beta‐blockers, statins, ACEIs/ ARBs and other antihypertensive drugs)

 

Other

 

Trial characteristics

seeAppendix 1, usually just completed by one reviewer

Methodological quality

 

State here method used to generate allocation and reasons for grading

Grade (circle)

 

 

 

Low risk of bias

 

 

High risk of bias

 

 

Unclear

 

 

Blinding

 

 

Person responsible for participants care

Low/high/unclear

 

Participant

Low/high/unclear

 

Outcome assessor

Low/high/unclear

 

Other (please specify)

Low/high/unclear

 

Intention‐to‐treat

An intention‐to‐treat analysis is one in which all the participants in a trial are analysed according to the intervention to which they were allocated, whether they received it or not.

 

 

All participants entering trial

 

 

15% or fewer excluded

 

 

More than 15% excluded

 

 

Not analysed as 'intention‐to‐treat'

 

 

Unclear

 

Were withdrawals described?    Yes  ?   No ?   not clear  ?  

Discuss if appropriate

Data extraction

 

Outcomes relevant to your review

Copy and paste from ‘Types of outcome measures’

 

Reported in paper (circle)

All cause mortality (up to 30 days postoperatively)

Yes / No

Long term all cause mortality

Yes / No

Rate of acute myocardial infarction (AMI)

Yes / No

Myocardial ischaemia

Yes / No

Cerebrovascular complications

Yes / No

Congestive heart failure

Yes / No

Length of hospital stay

Yes / No

For Continuous data

Code of paper

 

Outcomes (rename)

Unit of measurement

Intervention group

Control group

Details if outcome only described in text

 

 

 

n

Mean (SD)

n

Mean (SD)

 

A etc

Length of hospital stay

 

 

 

 

 

 

For Dichotomous data

Code of paper

Outcomes (rename)

Intervention group (n)

n = number of participants, not number of events

Control group (n)

n = number of  participants, not number of events

A

All cause mortality (up to 30 days postoperatively)

 

 

 

Long term all cause mortality

 

 

 

Rate of acute myocardial infarction (AMI)

 

 

 

Myocardial ischaemia

 

 

 

Cerebrovascular complications

 

 

 

Congestive heart failure

 

 

Other information which you feel is relevant to the results

Indicate if: any data were obtained from the primary author; if results were estimated from graphs etc; or calculated by you using a formula (this should be stated and the formula given). In general if results not reported in paper(s) are obtained this should be made clear here to be cited in review.

Freehand space for writing actions such as contact with study authors and changes

References to other trials

 

Did this report include any references to published reports of potentially eligible trials not already identified for this review?

First author

Journal / Conference

Year of publication

 

 

 

Did this report include any references to unpublished data from potentially eligible trials not already identified for this review? If yes, give list contact name and details

  

Appendix 1

 

Trial characteristics

 

Further details

Single centre / multicentre

 

Country / Countries

 

How was participant eligibility defined?

 

 

How many people were randomized?

 

Number of participants in each intervention group

 

Number of participants who received intended treatment

 

Number of participants who were analysed

 

Drug treatment(s) used

 

Dose / frequency of administration

 

Duration of treatment (State weeks / months, etc, if cross‐over trial give length of time in each arm)

 

Median (range) length of follow‐up reported in this paper (state weeks, months or years or if not stated)

 

Time‐points when measurements were taken during the study

 

Time‐points reported in the study

 

Time‐points you are using in RevMan

 

Trial design (e.g. parallel / cross‐over*)

 

Other

 

* If cross‐over design, please refer to the Cochrane Editorial Office for further advice on how to analyse these data

Flow diagram of study selection process.
Figuras y tablas -
Figure 1

Flow diagram of study selection process.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Forest plot of comparison: 1 All‐cause mortality, outcome: 1.1 All‐cause mortality.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 All‐cause mortality, outcome: 1.1 All‐cause mortality.

Forest plot of comparison: 1 ACEIs or ARBs versus placebo, outcome: 1.2 ST‐elevation or new Q wave in ECG test.
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 ACEIs or ARBs versus placebo, outcome: 1.2 ST‐elevation or new Q wave in ECG test.

Forest plot of comparison: 1 ACEIs or ARBs versus placebo, outcome: 1.3 Cardiac index.
Figuras y tablas -
Figure 6

Forest plot of comparison: 1 ACEIs or ARBs versus placebo, outcome: 1.3 Cardiac index.

Forest plot of comparison: 1 ACEIs or ARBs versus placebo, outcome: 1.4 Rate of perioperative cerebrovascular complications.
Figuras y tablas -
Figure 7

Forest plot of comparison: 1 ACEIs or ARBs versus placebo, outcome: 1.4 Rate of perioperative cerebrovascular complications.

Forest plot of comparison: 1 ACEIs or ARBs versus placebo, outcome: 1.5 Length of hospital stay.
Figuras y tablas -
Figure 8

Forest plot of comparison: 1 ACEIs or ARBs versus placebo, outcome: 1.5 Length of hospital stay.

Comparison 1 ACEIs or ARBs versus placebo, Outcome 1 All cause mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 ACEIs or ARBs versus placebo, Outcome 1 All cause mortality.

Comparison 1 ACEIs or ARBs versus placebo, Outcome 2 ST‐elevation or new Q wave in ECG test.
Figuras y tablas -
Analysis 1.2

Comparison 1 ACEIs or ARBs versus placebo, Outcome 2 ST‐elevation or new Q wave in ECG test.

Comparison 1 ACEIs or ARBs versus placebo, Outcome 3 Cardiac index.
Figuras y tablas -
Analysis 1.3

Comparison 1 ACEIs or ARBs versus placebo, Outcome 3 Cardiac index.

Comparison 1 ACEIs or ARBs versus placebo, Outcome 4 Rate of perioperative cerebrovascular complications.
Figuras y tablas -
Analysis 1.4

Comparison 1 ACEIs or ARBs versus placebo, Outcome 4 Rate of perioperative cerebrovascular complications.

Comparison 1 ACEIs or ARBs versus placebo, Outcome 5 Length of hospital stay.
Figuras y tablas -
Analysis 1.5

Comparison 1 ACEIs or ARBs versus placebo, Outcome 5 Length of hospital stay.

Summary of findings for the main comparison. ACEIs or ARBs compared to placebo for preventing surgery‐related mortality and morbidity in adults

ACEIs or ARBs compared to placebo for preventing surgery‐related mortality and morbidity in adults

Patient or population: Patients undergoing any type of surgery under general anaesthesia receiving ACEIs or ARBs perioperatively
Settings: All settings
Intervention: ACEIs or ARBs
Comparison: Placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

ACEIs or ARBs

All‐cause mortality

Study population

RR 1.61
(0.44 to 5.85)

419
(3 studies)

⊕⊝⊝⊝
very low1

All the included trials were at high risk of bias.

Total sample size is lower than the calculated.

Duration of follow‐up: until discharge from hospital

16 per 1000

25 per 1000
(7 to 90)

Moderate

7 per 1000

11 per 1000
(3 to 41)

Risk of acute myocardial ischaemia

Study population

RR 0.55
(0.14 to 2.26)

345
(2 studies)

⊕⊝⊝⊝
very low1

All the included trials were at high risk of bias.

Total sample size is lower than the calculated.

Duration of follow‐up: until discharge from hospital

30 per 1000

16 per 1000
(4 to 67)

Moderate

56 per 1000

31 per 1000
(8 to 127)

Congestive heart failure

The mean cardiac index in the intervention groups was
0.6 higher
(0.7 to 0.5 higher)

34
(2 studies)

⊕⊝⊝⊝
very low1

All the included trials were at high risk of bias.

Total population size is less than 400.

Duration of follow‐up: not specified

Hypotension

RR 1.95 (0.86 to 4.41)

298 (1 study)

⊕⊝⊝⊝
very low1

All the included trials were at high risk of bias.

Total population size is less than 400.

Duration of follow‐up: not specified

Rate of perioperative cerebrovascular complications

Study population

RR 0.48
(0.18 to 1.28)

459
(3 studies)

⊕⊝⊝⊝
very low1

All the included trials were at high risk of bias.

Duration of follow‐up: until discharge from hospital (Billings 2012; Pretorius 2012); 90 days after surgery (Flesch 2009)

50 per 1000

24 per 1000
(9 to 65)

Moderate

71 per 1000

34 per 1000
(13 to 92)

Length of hospital stay

The mean length of hospital stay in the intervention groups was
0.54 lower
(0.93 lower to 0.16 lower)

372
(2 studies)

⊕⊝⊝⊝
very low1

All the included trials were at high risk of bias.

Total population size is less than 400.

Duration of follow‐up: until discharge from hospital

Treatment related adverse events

385 (2 studies)

⊕⊝⊝⊝
very low1

All the included trials were at high risk of bias.

Total population size is less than 400.

Authors did not provided detailed information on adverse events, which made the synthesis of the results less clinically relevant.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
ACEIs: angiotensin‐converting enzyme inhibitors; ARBs: angiotensin II type 1 receptor blockers; CI: confidence interval; ECG: electrocardiograph; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded by three levels due to very serious study limitations (all the trials included were at high risk of bias) and serious imprecision (total population size is less than 400).

Figuras y tablas -
Summary of findings for the main comparison. ACEIs or ARBs compared to placebo for preventing surgery‐related mortality and morbidity in adults
Table 1. Rate of hypotension

Outcome or subgroup

Studies

Participants

Statistical method

Effect estimate

Rate of hypotension

1

298

Risk Ratio (M‐H, Fixed, 95% CI)

1.95 [0.86, 4.41]

Risk ratio < 1 favours angiotensin‐converting enzyme inhibitors and angiotensin II type 1 receptor blockers group. Risk ratio > 1 favours control group.

Figuras y tablas -
Table 1. Rate of hypotension
Table 2. Glomerular filtration rate

Outcome or subgroup

Studies

Participants

Statistical method

Effect estimate

Glomerular filtration rate

1

16

Mean Difference (IV, Random, 95% CI)

‐1.40 [‐10.30, 7.50]

IV ‐ inverse variance

IV: intravenous

Figuras y tablas -
Table 2. Glomerular filtration rate
Comparison 1. ACEIs or ARBs versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All cause mortality Show forest plot

3

419

Risk Ratio (M‐H, Fixed, 95% CI)

1.61 [0.44, 5.85]

2 ST‐elevation or new Q wave in ECG test Show forest plot

2

345

Risk Ratio (M‐H, Fixed, 95% CI)

0.55 [0.14, 2.26]

3 Cardiac index Show forest plot

2

34

Mean Difference (IV, Random, 95% CI)

‐0.60 [‐0.70, ‐0.50]

4 Rate of perioperative cerebrovascular complications Show forest plot

3

459

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.18, 1.28]

5 Length of hospital stay Show forest plot

2

372

Mean Difference (IV, Fixed, 95% CI)

‐0.54 [‐0.93, ‐0.16]

Figuras y tablas -
Comparison 1. ACEIs or ARBs versus placebo