Table 1.
Study characteristics
| Study ID*, linked publications | Recruit-ment dates | Total sample size | Disease | Patient age (years)† | Level of surgical risk‡ | TAVI route | Valve type(s) | Valve name | Funding source |
| High risk | |||||||||
| PARTNER 1A26 35 59–67 | May 2007 to Aug 2009 | 699 | SAS and cardiac symptoms | Not prespecified TAVI: 83.6 (6.8) SAVR: 84.5 (6.4) |
TAVI: 11.8 (3.3); SAVR: 11.7 (3.5) | TF-first; TA if vascular access was limited | Balloon-expandable | Edwards Sapien | Pharma (EW) |
| US CoreValve68–81,23 | Feb 2011 to Sep 2012 | 797 | SAS and heart failure symptoms | No limits TAVI: 83.1 (7.1) SAVR: 83.2 (6.4) |
TAVI: 7.3 (3.0); SAVR: 7.5 (3.4) | TF or non-TF (SC or direct aortic) | Self-expanding | MDT CoreValve | Pharma (MDT) |
| High-intermediate risk | |||||||||
| UK TAVI11¶ | Apr 2014 to Apr 2018 | 913 | Symptomatic SAS | ≥80 or ≥70† TAVI: 81.1 (4.4) SAVR: 81.0 (4.5) |
TAVI: 2.6 (2.0 to 3.5)§; SAVR: 2.7 (2.0 to 3.4)§ | TF, TA, SC, direct aortic | Any CE-marked valve | SAPIEN, SAPIEN XT; SAPIEN 3 (all EW); CoreValve, Evolut/ Evolut R, Evolut Pro (all MDT); Lotus, Symetis Acurate/Neo (all BSX); Other (Portico, Direct Flow Medical) | Public/government (NIHR) |
| Intermediate risk | |||||||||
| PARTNER 2 A213421 34 82 83 | Dec 2011 to Nov 2013 | 2032 | SAS | No limits TAVI: 81.5 (6.7) SAVR: 81.7 (6.7) |
TAVI: 5.8 (2.1); SAVR: 5.8 (1.9) | TF or transthoracic (TA or TAO) | Balloon-expandable | SAPIEN XT (EW) | Pharma (EW) |
| SURTAVI28 84–92 | Jun 2012 to Jun 2016 | 1660 | Symptomatic SAS | No limits TAVI: 79.9 (6.2) SAVR: 79.7 (6.1) |
TAVI: 4.4 (1.5); SAVR: 4.5 (1.6) | TF-first; SC or TAO in the case of unsuitable iliofemoral anatomy | Self-expanding | CoreValve, Evolut R (all MDT) | Pharma (MDT) |
| Low risk | |||||||||
| EVOLUT24 93 | Mar 2016 to Nov 2018 | 1468 | SAS | No limits TAVI: 74.0 (5.9) SAVR: 73.8 (6.0) |
TAVI: 1.9 (0.7); SAVR: 1.9 (0.7) | TF, subclavian or TAO | Self-expanding | CoreValve, Evolut R, Evolut PRO (all MDT) | Pharma (MDT) |
| PARTNER 322 94–97 | Mar 2016 to Oct 2017 | 950 | SAS | No limits TAVI: 73.3 (5.8) SAVR: 73.6 (6.1) |
TAVI: 1.9 (0.7); SAVR: 1.9 (0.6) | TF | Balloon-expandable | SAPIEN 3 (EW) | Pharma (EW) |
| All risk | |||||||||
| NOTION25 98–105 | Dec 2009 to Apr 2014 | 280 | Degenerative SAS | ≥70 TAVI: 79.2 (4.9) SAVR: 79.0 (4.7) |
TAVI: 2.9 (1.6); SAVR: 3.1 (1.7) | TF-first; left SC access considered when the TF route not accessible | Self-expanding | CoreValve (MDT) | Charity (The Danish Heart Foundation) |
| STACCATO27 106 107 | Nov 2008 to May 2011 | 70 | SAS | Initially ≥70; later modified to ≥75 TAVI: 80 (3.6) SAVR: 82 (4.4) |
‘Operable’ TAVI: 3.1 (1.5); SAVR: 3.4 (1.2) |
TA | Balloon-expandable | Edwards Sapien | Public/ government (University, DHF) |
All studies are randomised controlled trials, as per our inclusion criteria.
*Main publication provided.
†Mean (SD) are provided.
‡STS-PROM scores are provided (mean (SD)).
§Median and IQR.
¶If patients are considered at intermediate or high operative risk from conventional AVR by a multidisciplinary heart team.
AVR, aortic valve replacement; BSX, Boston Scientific; CE, Conformité européenne; DHF, Danish Heart Foundation; EW, Edward Lifesciences; MDT, Medtronic; NA, not applicable; NIHR, National Institute for Health Research; NYHA, New York Heart Association; SAS, severe aortic stenosis; SAVR, surgical aortic valve replacement; SC, subclavian; STS, society for thoracic surgeons; STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality; TA, transapical; TAO, transaortic; TAVI, transcatheter aortic valve implantation; TF, transfemoral.