. 2021 Oct 12;16:e28. doi: 10.15420/icr.2020.35

Table 1: Summary of the Design and Outcomes of the DIRECT and DIRECTAVI Trials.

Trial	Devices used	Study design and no. of participants	Outcome	Results	Postdilation rate
DIRECT 2019[16]	CoreValve (11.7%) Evolut R (83.6%) Evolut Pro (4.7%)	Study design Multicentre open-label RCT Participants n=171 86 pre-BAV 85 direct TAVR	Primary endpoint Device success defined by VARC-2 criteria Secondary endpoint In-hospital or 30 day Stroke New permanent pacemaker Vascular complications	Primary endpoint Device success Pre-BAV group 76.5% Direct TAVR 74.4% Mean difference 2.1%; 90% CI [−8.9%, 13%] Secondary endpoints Stroke (p=0.32) Pre-BAV group 0% Direct TAVR 0.01% New permanent pacemaker (p=0.54) Pre-BAV group 27.5% Direct TAVR 32.8% Major vascular complications (p=0.49) Pre-BAV group 5.8% Direct TAVR 3.5%	Direct implant 29.4% Pre-BAV 15.1% p=0.03
DIRECTAVI 2020[17]	Edwards Sapien 3 (100%)	Study design Prospective, single-centre, open-labelled RCT Participants n=236 115 pre-BAV 121 direct TAVR	Primary endpoint Device success at 72 h defined by VARC-2 criteria Secondary endpoints Length of procedure Radiation exposure Contrast volume Hospitalisation length All-cause mortality Stroke Major bleeding AKI stage 2–3 Pacemaker implantation	Primary endpoint Device success (p=0.02 for non-inferiority) Pre-BAV group 75.7% Direct TAVR 80.2% Mean difference 4.5%; 95% CI [−4.4%, 13.4%] Secondary endpoints Length of procedure (p=0.31) Pre-BAV group 54.2 ± 18.2 min Direct TAVR 52.0 ± 18.7 min Radiation exposure (p=0.24) Pre-BAV group 3,730 ± 3,487 cGy/cm[2] Direct TAVR 4,073 ± 3,293 cGy/cm[2] Contrast volume (p=0.97) Pre-BAV group 78.2 ± 29.3 ml Direct TAVR 79.7 ± 33.3 ml Hospitalisation length (p=0.90) Pre-BAV group 5.3 ± 23.0 days Direct TAVR 4.9 ± 2.2 days All-cause mortality (p=0.24) Pre-BAV group 0% Direct TAVR 3.2% Stroke (p=0.99) Pre-BAV group 0.9% Direct TAVR 1.7% Major bleeding (p=0.70) Pre-BAV group 2.6% Direct TAVR 4.1% AKI stage 2–3 (p=0.37) Pre-BAV group 0.9% Direct TAVR 3.3% Pacemaker implantation (p=0.72) Pre-BAV group 20.9% Direct TAVR 19.01%	Direct implant 1.7% Pre-BAV 1.7% p=1.00

Trial

Devices used

Study design and no. of participants

Outcome

Results

Postdilation rate

DIRECT 2019[16]

CoreValve (11.7%)
Evolut R (83.6%)
Evolut Pro (4.7%)

Study design
Multicentre open-label RCT
Participants
n=171

86 pre-BAV
85 direct TAVR

Primary endpoint
Device success defined by VARC-2 criteria
Secondary endpoint
In-hospital or 30 day

Stroke
New permanent pacemaker
Vascular complications

Primary endpoint
Device success

Pre-BAV group 76.5%
Direct TAVR 74.4%

Mean difference 2.1%; 90% CI [−8.9%, 13%]
Secondary endpoints
Stroke (p=0.32)

Pre-BAV group 0%
Direct TAVR 0.01%

New permanent pacemaker (p=0.54)

Pre-BAV group 27.5%
Direct TAVR 32.8%

Major vascular complications (p=0.49)

Pre-BAV group 5.8%
Direct TAVR 3.5%

Direct implant 29.4%
Pre-BAV 15.1%

p=0.03

DIRECTAVI 2020[17]

Edwards Sapien 3 (100%)

Study design
Prospective, single-centre, open-labelled RCT
Participants
n=236

115 pre-BAV
121 direct TAVR

Primary endpoint
Device success at 72 h defined by VARC-2 criteria
Secondary endpoints

Length of procedure
Radiation exposure
Contrast volume
Hospitalisation length
All-cause mortality
Stroke
Major bleeding
AKI stage 2–3
Pacemaker implantation

Primary endpoint
Device success (p=0.02 for non-inferiority)

Pre-BAV group 75.7%
Direct TAVR 80.2%

Mean difference 4.5%; 95% CI [−4.4%, 13.4%]
Secondary endpoints
Length of procedure (p=0.31)

Pre-BAV group 54.2 ± 18.2 min
Direct TAVR 52.0 ± 18.7 min

Radiation exposure (p=0.24)

Pre-BAV group 3,730 ± 3,487 cGy/cm[2]
Direct TAVR 4,073 ± 3,293 cGy/cm[2]

Contrast volume (p=0.97)

Pre-BAV group 78.2 ± 29.3 ml
Direct TAVR 79.7 ± 33.3 ml

Hospitalisation length (p=0.90)

Pre-BAV group 5.3 ± 23.0 days
Direct TAVR 4.9 ± 2.2 days

All-cause mortality (p=0.24)

Pre-BAV group 0%
Direct TAVR 3.2%

Stroke (p=0.99)

Pre-BAV group 0.9%
Direct TAVR 1.7%

Major bleeding (p=0.70)

Pre-BAV group 2.6%
Direct TAVR 4.1%

AKI stage 2–3 (p=0.37)

Pre-BAV group 0.9%
Direct TAVR 3.3%

Pacemaker implantation (p=0.72)

Pre-BAV group 20.9%
Direct TAVR 19.01%

Direct implant 1.7%
Pre-BAV 1.7%

p=1.00

AKI = acute kidney injury; BAV = balloon valvuloplasty; RCT, randomised controlled trial; TAVR = transcatheter aortic valve replacement; VARC = Valve Academic Research Consortium.