Renal denervation for resistant hypertension

Giuseppe Coppolino; Anna Pisano; Laura Rivoli; Davide Bolignano

doi:10.1002/14651858.CD011499.pub2

Почечная денервация при устойчивой гипертензии

Appendices

Appendix 1. Search strategies

Database: Ovid MEDLINE(R) 1946 to Present with Daily Update
Search Date: 15 February 2016
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
1 denervation/ (13728)

2 ((kidney? or renal or transcatheter) adj8 (denervat$ or sympathectom$)).mp. (2344)

3 (RDN or RSDN).tw. (184)

4 or/1‐3 (15195)

5 hypertension/ (206622)

6 hypertens$.tw. (322078)

7 exp blood pressure/ (260289)

8 blood pressure.mp. (366575)

9 or/5‐8 (619538)

10 randomized controlled trial.pt. (406217)

11 controlled clinical trial.pt. (90055)

12 randomized.ab. (303442)

13 placebo.ab. (155007)

14 drug therapy.fs. (1819658)

15 randomly.ab. (214885)

16 trial.ab. (312775)

17 groups.ab. (1360639)

18 or/10‐17 (3449945)

19 animals/ not (humans/ and animals/) (4154861)

20 18 not 19 (2937902)

21 4 and 9 and 20 (275)

22 remove duplicates from 21 (274)

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Database: Cochrane Central Register of Controlled Trials <2016, Issue 2> via Cochrane Register of Studies Online
Search Date: 15 February 2016
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
#1 denerv* 501

#2 sympathectom* 208

#3 #1 OR #2 658

#4 hypertens* 37999

#5 #3 AND #4 176

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Database: Embase <1980 to 2016 February 12>
Search Date: 15 February 2016
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
1 renal denervation/ (2687)

2 ((kidney? or renal or transcatheter) adj8 (denervat$ or sympathectom$)).mp. (4141)

3 or/1‐2 (4141)

4 exp hypertension/ (542358)

5 hypertens$.tw. (473931)

6 exp blood pressure/ (432181)

7 (blood pressure or bloodpressure).mp. (471761)

8 or/4‐7 (1019811)

9 randomized controlled trial/ (392471)

10 controlled clinical trial/ (391924)

11 crossover procedure/ (46039)

12 double‐blind procedure/ (126084)

13 (randomi?ed or randomly).tw. (841320)

14 (crossover$ or cross‐over$).tw. (77898)

15 placebo.ab. (218800)

16 (doubl$ adj blind$).tw. (158837)

17 assign$.ab. (270222)

18 allocat$.ab. (96961)

19 or/9‐18 (1369620)

20 (exp animal/ or animal.hw. or nonhuman/) not (exp human/ or human cell/ or (human or humans).ti.) (5431415)

21 19 not 20 (1206052)

22 3 and 8 and 21 (347)

23 remove duplicates from 22 (331)

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Database: Hypertension Group Specialised Register
Search Date: 16 February 2016
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
#1 denerva*

#2 sympathectom*

#3 #1 OR #2

#4 (CCT OR RCT):DE

#5 (Review OR Meta‐Analysis):MISC2

#6 #4 OR #5

#7 #3 AND #6

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Database: ClinicalTrials.gov
Search Date: 15 February 2016
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Study type: Interventional Studies
Conditions: hypertension
Interventions: denervation
Outcome Measures: blood pressure
First received: From 03/01/2015 to 02/15/2016 (12)

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Database: WHO International Clinical Trials Registry Platform
Search Date: 15 February 2016
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
hypertension AND denervation (139)

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Database: PubMed
Search Date: 16 February 2016
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
((denervation OR sympathectom* OR RDN or RSDN) AND (hypertens* OR high blood pressure) AND ((randomized controlled trial[pt] OR controlled clinical trial[pt] OR randomized[tiab] OR placebo[tiab] OR drug therapy[sh] OR randomly[tiab] OR trial[tiab] OR groups[tiab] NOT (animals [mh] NOT humans [mh]) NOT MEDLINE[sb]) (67)

Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

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

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Analysis 1.1

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 1 Myocardial infarction.

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Analysis 1.2

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 2 ischaemic stroke.

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Analysis 1.3

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 3 unstable angina.

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Analysis 1.4

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 4 systolic 24‐hour ABPM.

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Analysis 1.5

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 5 diastolic 24‐hour ABPM.

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Analysis 1.6

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 6 systolic office BP.

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Analysis 1.7

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 7 diastolic office BP.

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Analysis 1.8

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 8 serum creatinine.

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Analysis 1.9

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 9 eGFR/creatinine clearance.

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Analysis 1.10

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 10 bradycardia.

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Analysis 1.11

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 11 femoral artery pseudoaneurysm.

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Analysis 1.12

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 12 flank pain.

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Analysis 1.13

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 13 hypotensive episodes.

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Analysis 1.14

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 14 hypertensive crisis.

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Analysis 1.15

Comparison 1 Renal denervation vs. sham/standard therapy, Outcome 15 hyperkalemia.

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Renal denervation versus sham denervation or standard treatment
Patient or population: people with resistant hypertension Setting: Outpatient Intervention: renal denervation Comparison: sham denervation or standard treatment
Outcomes	*Illustrative comparative risks (95% CI)**		Effect estimate (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Sham denervation/ Standard treatment	Renal denervation
myocardial infarction	14 per 1000	18 per 1000 (6 to 54)	RR 1.31 (0.45 to 3.84)	742 (4 studies)	⊕⊕⊝⊝ low^1,2
ischaemic stroke	12 per 1000	14 per 1000 (4 to 45)	RR 1.15 (0.36 to 3.72)	823 (4 studies)	⊕⊕⊝⊝ low^1,2
unstable angina	20 per 1000	12 per 1000 (2 to 101)	RR 0.63 (0.08 to 5.06)	201 (2 studies)	⊕⊕⊝⊝ low^1,2
systolic 24‐hour ABPM (mmHg)	‐	‐	MD 0.28 (‐3.74 to 4.29)	797 (5 studies)	⊕⊕⊕⊝ moderate¹
diastolic 24‐hour ABPM (mmHg)	‐	‐	MD 0.93 (‐4.50 to 6.36)	756 (4 studies)	⊕⊕⊕⊝ moderate¹
systolic office BP (mmHg)	‐	‐	MD ‐4.08 (‐15.26 to 7.11)	886 (6 studies)	⊕⊕⊕⊝ moderate¹
diastolic office BP (mmHg)	‐	‐	MD ‐1.30 (‐7.30 to 4.69)	845 (5 studies)	⊕⊕⊕⊝ moderate¹
eGFR or creatinine clearance (mL/min/1.73m²)	‐	‐	MD ‐2.09 (‐8.12 to 3.95)	837 (4 studies)	⊕⊕⊕⊝ moderate¹
The assumed risk* is the observed risk in the reference (control) group. 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). 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. Legend ABPM: ambulatory blood pressure monitoring; BP: blood pressure; CI: Confidence interval; CV: cardiovascular; NA: information not available (data sparse or absent); eGFR: estimated glomerular filtration rate; MD: mean difference; RR: Risk Ratio. 1. Wide confidence intervals. 2. Only reported by less than half of the studies.

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Comparison 1. Renal denervation vs. sham/standard therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Myocardial infarction Show forest plot	4	742	Risk Ratio (M‐H, Random, 95% CI)	1.31 [0.45, 3.84]

2 ischaemic stroke Show forest plot	4	823	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.36, 3.72]

3 unstable angina Show forest plot	2	201	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.08, 5.06]

4 systolic 24‐hour ABPM Show forest plot	5	797	Mean Difference (IV, Random, 95% CI)	0.28 [‐3.74, 4.29]

5 diastolic 24‐hour ABPM Show forest plot	4	756	Mean Difference (IV, Random, 95% CI)	0.93 [‐4.50, 6.36]

6 systolic office BP Show forest plot	6	886	Mean Difference (IV, Random, 95% CI)	‐4.08 [‐15.26, 7.11]

7 diastolic office BP Show forest plot	5	845	Mean Difference (IV, Random, 95% CI)	‐1.30 [‐7.30, 4.69]

8 serum creatinine Show forest plot	3	736	Mean Difference (IV, Random, 95% CI)	0.01 [‐0.12, 0.14]

9 eGFR/creatinine clearance Show forest plot	4	837	Mean Difference (IV, Random, 95% CI)	‐2.09 [‐8.12, 3.95]

10 bradycardia Show forest plot	3	220	Risk Ratio (M‐H, Random, 95% CI)	6.63 [1.19, 36.84]

11 femoral artery pseudoaneurysm Show forest plot	2	201	Risk Ratio (M‐H, Random, 95% CI)	3.96 [0.44, 35.22]

12 flank pain Show forest plot	2	199	Risk Ratio (M‐H, Random, 95% CI)	4.30 [0.48, 38.28]

13 hypotensive episodes Show forest plot	2	119	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.07, 6.64]

14 hypertensive crisis Show forest plot	3	722	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.35, 1.45]

15 hyperkalemia Show forest plot	2	200	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.01, 21.33]

Comparison 1. Renal denervation vs. sham/standard therapy

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Почечная денервация при устойчивой гипертензии

Appendices

Appendix 1. Search strategies

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Appendices

Appendix 1. Search strategies

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