Table 1.
Study and patient characteristics at baseline
| Study (all RCTs) | Region | BP assessment | Intervention description (catheter) | Control | Maximum length of follow-up (months) | Number of participants (R/C) | Mean age (years) (R/C) | Race | Coronary heart disease (%) (R/C) | Type 2 diabetes mellitus (%) (R/C) | eGFR (ml·min−1·1.73 m−2) (R/C) | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| White (%) (R/C) | Black (%) (R/C) | Asian (%) (R/C) | |||||||||||
| DENERHTN 2015[8] (NCT01570777) | French | O and A | Adjusted drugs and Simplicity RDN System (Medtronic, Mountain View, CA, USA) | A standardized stepped-care antihypertensive treatment | 6 | 101 (48/53) | 55.2/55.2 | 79/77 | -/- | -/- | 30.2/20.8 | 12/26 | 88/90 |
| DENERVHTA 2016[4] (NCT02039492) | Spain | O and A | Simplicity RDN System (Medtronic, Galway, Ireland) | Spironolactone as add-on therapy | 6 | 24 (11/13) | 61.9/64.9 | 100/85 | -/- | -/- | 18/23 | 36/62 | 74.6/85 |
| OSLO 2014[10] (NCT01673516) | Norway | O and A | Simplicity RDN System (Ardian, Mountain View, CA, USA) | Adjusted drug treatment | 6 | 19 (9/10) | 57/62.5 | 100/100 | 0/0 | 0/0 | 11/60 | 22/30 | 78/77 |
| Prague-15 2015,[7] 2016,[16] 2017[20] (NCT01560312) | Czech republic | O and A | Simplicity RDN System (Medtronic Inc., Mountain View, CA, USA) | Spironolactone as add-on therapy | 24 | 106 (52/54) | 56/59 | 100/100 | 0/0 | 0/0 | 6/7 | 22/17 | 84/80 |
| ReSET 2016[5] (NCT01762488) | Denmark | A | Simplicity RDN system (Medtronic) | An invasive sham procedure, and NDC | 6 | 69 (36/33) | 54.3/57.1 | 97/97 | -/- | -/- | 6/15 | 63/33 | -/- |
| SYMPLICITY-FLEX 2015[6] (NCT01656096) | Germany | A | Symplicity Flex RDN System (Medtronic) | An invasive sham procedure, and NDC | 6 | 67 (32/35) | 64.5/57.4 | 100/100 | 0/0 | 0/0 | 60/47 | 54/36 | 79/84 |
| SYMPLICITY HTN-Japan 2015[9] (NCT01644604) | Japan | O and A | Symplicity™ RDN system (Medtronic, Santa Rosa, CA, USA) | NDC | 6 | 41 (22/19) | 59.5/56 | 0/0 | 0/0 | 100/100 | -/- | 36.4/63.2 | 70/70 |
| SYMPLICITY HTN-2 2010,[2] 2012,[17] 2014,[18] (NCT00888433) | Europe, Australia and New Zealand | O and A | Symplicity RDN system (Ardian, Mountain View, CA, USA) | NDC | 36 | 106 (52/54) | 58/58 | 98/96 | -/- | -/- | 19/7 | 40/28 | 77/86 |
| SYMPLICITY HTN-3 2014,[3] 2015,[19] (NCT01418261) | United States | O and A | Symplicity RDN system (Medtronic) | An invasive sham procedure, and NDC | 12 | 535 (364/171) | 57.9/56.2 | 24.8/29.2 | 73/69.6 | 0.6/0 | 36.5/31.5 | 47/20.9 | 73/74 |
A: Ambulatory blood pressure measurement; C: Control group; eGFR: Estimated glomerular filtration rate; HR: Heart rate; O: Office blood pressure measurement; R: Catheter-based renal denervation group; RCTs: Randomized controlled trials; NDC: No antihypertensive drugs change; BP: Blood pressure; RDN: Renal denervation; -: Not applicable.