Table 1. The summary for TAVR trials.
Company | TAVR valve | Study | Surgical risk | Number of patients assigned to TAVR | Follow-up duration | Mortality (%) | Cardiovascular events (%) | Major vascular complications (%) | Incidence of new pacemaker (%) | Moderate/Severe PVR (%) |
---|---|---|---|---|---|---|---|---|---|---|
Edwards | SAPIEN THV | PARTNER Cohort B49) | Inoperable | 179 | 1 year | 30.7 | 10.6 | 22.3 | 4.5 | 10.5 |
SAPIEN THV | PARTNER Cohort A59) | High-risk | 348 | 2 years | 35.0 | 11.2 | 11.6 | 7.2 | 6.9 | |
SAPIEN XT | PARTNER 252) | Intermediate-risk | 1,011 | 2 years | 16.7 | 12.7 | 8.6 | 11.8 | 3.7* | |
SAPIEN 3 | PARTNER 354) | Low-risk | 496 | 1 year | 1.0 | 1.2 | 2.8 | 7.3 | 0.6* | |
Medtronic | Core Valve | Core Valve Extreme Risk Pivotal60) | Inoperable | 489 | 1 year | 24.3 | 7.0 | 8.4 | 26.2 | 4.3 |
Core Valve | Core Valve High Risk50) | High-risk | 394 | 1 year | 14.2 | 8.8 | 6.2 | 22.3 | 6.1 | |
Core Valve | NOTION61) | >70 years | 145 | 1 year | 4.9 | 5.0 | 5.6* | 38.0 | 15.7 | |
Core Valve | SURTAVI62) | Intermediate-risk | 864 | 2 years | 11.4 | 10.0 | 6.0* | 25.9* | 5.3 | |
Core Valve Evolut R | ||||||||||
Core Valve Evolut PRO | FORWARD63) | High-risk | 1,038 | 30 days | 1.9 | 2.8 | 6.5 | 19.7 | 2.0† | |
Core Valve Evolut PRO | Medtronic Evolut PRO US Clinical study53) | Extreme or high-risk | 60 | 30 days | 1.7 | 1.7 | 10.0 | 11.8 | 0* | |
Core Valve Evolut PRO | The International FORWARD PRO study64) | High or greater risk | 629 | 30 days | 4.8 | 3.8 | 3.0 | 20.7 | 1.8 | |
Core Valve | Evolut R Low Risk55) | Low-risk | 734 | 2 years | 5.3 | 4.1‡ | 3.8‡ | 19.4‡ | 3.5* | |
Core Valve Evolut R | ||||||||||
Core valve Evolut PRO |
TAVR = transcatheter aortic valve replacement.
The incidence is reported based on the follow-up duration of each study, but the following are the exceptions; *Results at 30 days; †Results at discharge; ‡Results at one year.
With permission from Bourantas CV, Modolo R, Baumbach A, et al. The evolution of device technology in transcatheter aortic valve implantation. EuroIntervention 2019;14:e1826-33.65)