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. 2021 Jul 14;33(6):866–870. doi: 10.1093/icvts/ivab186

Table 1:

Summary of the studies analysed in this BET

Author, date, journal and country Study type (level of evidence) Patients (included/total) Groups (mean age) Questionnaire Name of the trial Primary end point Outcomes Key results Comments

  • Reynolds et al. (2012), J Am Coll Cardiol, USA [2]

  • RCT (level I)

  • 628/699

  • - TF-TAVI cohort 446 [TF 230 (83.8 yo)/sAVR 216 (84.6 yo)]

  • - TA-TAVI cohort 182 [TA 98 (82.6 yo)/sAVR 84 (83.2 yo)]

  • KCCQ

  • EQ-5D

  • SF-12

  • PARTNER 1 trial (high-risk patients)

  • Primary end point: extent of improvement from BS after both

  • TAVR and AVR at different points during the first year of FU

  • Improvement between BS and 6- and 12-month FU

 TF cohort

  • - TAVI: more rapid improvement in the KCCQ than AVR, with a significant benefit at 1 month (mean adjusted difference 5.5, 95% CI 1.2–9.8; P = 0.01) but no significant difference at either 6/12 months

  • - PATNER trial was not blinded

  • - Very early experience with TA

  • - Fewer patients were randomized within the TA-TAVI cohort
1 month KCCQ EQ-5D SF-12
P-value
TAVI 23.7 0.08 5
sAVR 12.1 0.02* 2.6
6 months
TAVI 29.8 0.10 6.7
sAVR 26.9 0.09 7.2
1 year
TAVI 28.7 0.09 6.3
sAVR 26.8 0.08 6.1
TA cohort
1 month KCCQ EQ-5D SF-12
P-value
TAVI 12.5 −0.02* 2.8
sAVR 12.5 0.01* 7
6 months
TAVI 23.8 0.04* 0.5*
sAVR 27.3 0.06 7.0
1 year
TAVI 29.6 0.06 7.1
sAVR 21.6 0.05* 4.5
Results expressed as mean difference versus BS and all yielded statistically significant P-values unless ‘*’ next to the number suggesting a non-significant change

  • Adams et al. (2014), N Engl J Med, USA [3]

  • RCT (level I)

  • 795/871

  • - TAVI 394 (83.2 yo)

  • - sAVR 401 (83.5 yo)

  • KCCQ

  • SF-12

  • COREVALVE trial (high-risk patients)

  • Primary end point: rate of death from any cause at 1 year

  • Changes in functional class and QoL

Change from BS to 1 year:

  • - TAVI: 23.2 ± 25.5

  • - sAVR: 21.88 ± 26.5

QoL was non-inferior with TAVI (P = 0.0063)

  • - More patients declined surgery post-randomization

  • - Rate of death within 30 days (4.5%) was lower than the estimated rate (≥15%), suggesting that the population was lower risk than intended

  • Reardon et al. (2017), N Engl J Med, USA [4]

  • RCT (level I)

  • 1660/1746

  • - TAVI 864 (79.9 yo)

  • - sAVR 796 (79.6 yo)

  • KCCQ

  • SURTAVI trial (intermediate-risk patients)

  • Primary end point: death from any cause or disabling stroke at 24 months

  • Health-related QoL changes from BS

Change from in KCCQ from BS:

1 month

  • - TAVI: 18.4 ± 22.8

  • - sAVR: 5.9 ± 27.0

95% CI for difference in change from BS (10.0–15.1)

6 months

  • - TAVI: 21.8 ± 22.3

  • - sAVR: 21.3 ± 22.3

95% CI for difference in change from BS (−1.9 to 2.8)

1 year

  • - TAVI: 20.9 ± 22.2

  • - sAVR: 20.6 ± 22.2

95% CI for difference in change from BS (−2.2 to 2.9)

  • - Previous CABG 17.2% of the patients in the sAVR group

  • - TAVI 25.9% rate of PPM implantation

  • - TAVI 6% major vascular complication

  • - The next-generation Evolut R bioprosthesis was used in <20% of the patients

  • - Long-term follow-up is needed

  • Baron et al. (2017), JAMA Cardiol, USA [5]

  • RCT (level I)

  • 1833/2032

  • - TAVI 950/1011 (81.5 yo)

  • - sAVR 883/1021 (81.7 yo)

  • KCCQ

  • EQ-5D

  • SF-36

  • PARTNER 2 trial 2-year FU (intermediate-risk patients)

  • Primary end point: health status benefits

  • Early improvement in QoL and at 2 years of follow-up

Rates of substantial improvement (%):

- TF cohort:

1 month     P < 0.01

  • - TAVI: 43.8

  • - sAVR: 26.9

2 year     P = 0.04

  • - TAVI 47.6

  • - sAVR: 46.1

- TA cohort:

1 month     P = 0.32

  • - TAVI: 29.6

  • - sAVR: 27.8

2 year     P = 0.36

  • - TAVI: 44.4

  • - sAVR: 47.4

  • - sAVR patients having more extensive procedures than isolated AVR

  • - sAVR: 9.1% concomitant procedures (aortic endarterectomy, aortic-root enlargement or replacement and mitral valve or tricuspid valve repair or replacement)

  • Once randomized and procedure initiated:

  • - sAVR: 14.5% underwent CABG

  • - TAVI: 3.9% underwent PCI

  • - QoL in the surgical cohort was also assessing complex operations other than isolated sAVR

  • Mack et al. (2019), N Engl J Med, USA [6]

  • RCT (level I)

  • 950/1000

  • - TAVI 496 (73.3 yo)

  • - sAVR 454 (73.6 yo)

  • KCCQ

  • PARTNER 3 trial (low-risk patients)

  • Primary end point: composite of death from any cause, stroke or rehospitalization at 1 year

  • Improvements in QoL at 30 days and at 1 year

Increase in KCCQ from BS (P < 0.001):

1 month

  • - TAVI: 37.8

  • - sAVR: 12.8

1 year

  • - TAVI: 39.7

  • - sAVR: 38.7

  • - More patients in the surgery group than in the TAVI group withdrew from the trial

  • - Missing data from the KCCQ

  • - Does not address the problem of long-term survival or structural valve deterioration

  • Popma et al. (2019), N Engl J Med, USA [7]

  • RCT (level I)

  • 1403/1468

  • - TAVI 725/734 (74 yo)

  • - sAVR 678/734 (74 yo)

  • KCCQ

  • EVOLUT trial (low-risk patients)

  • Primary end point: composite of death from any cause or disabling stroke at 24 months

  • Change of KCCQ score from BS at 30 days, 6 and 12 months

Increase in KCCQ [mean ± SD (n)]

BS

  • - TAVI: 68.7 ± 21.8 (722)

  • - sAVR: 69.3 ± 20.7 (674)

30 days

  • - TAVI: 88.7 ± 14.2 (714)

  • - sAVR: 78.6 ± 18.9 (637)

95% CI for difference in change from BS (8.6–13.2)

6 months

  • - TAVI: 90.3 ± 13.4 (633)

  • - sAVR: 90.2 ± 13.8 (547)

95% CI for difference in change from BS (−1.0 to 3.8)

1 year

  • - TAVI: 90.3 ± 12.7 (429)

  • - sAVR: 90.8 ± 12.4 (349)

95% CI for difference in change from BS (−1.6 to 4.3)

  • - Significant loss of follow-up (40–50%) in just 1 year

  • - Excluded patients with bicuspid aortic valves and candidates for mechanical valves

  • - Different models/generation of valve used in the study

  • Makkar et al. (2020), N Engl J Med, USA [8]

  • RCT (level I)

  • 2032

  • - TAVI 920/1011 (81.5 yo)

  • - sAVR 831/1021 (81.7 yo)

  • (Data available at 5 years)

  • KCCQ

  • PARTNER 2 trial 5-year FU (intermediate-risk patients)

  • Primary end point: death from any cause or disabling stroke

  • Improvements in health status at 5 years

BS

  • - TAVI: 54.2

  • - sAVR: 53.9

1 month

  • - TAVI: 70.2

  • - sAVR: 58.6

1 year

  • - TAVI: 76.3

  • - sAVR: 76.7

5 year

  • - TAVI: 73.8

  • - sAVR: 74.4

*KCCQ score (no P-value reported)

  • - sAVR patients having more extensive procedures than isolated AVR (please see PARTNER 2 comments)

  • - QoL in the surgical cohort was also assessing complex operations, other than just isolated sAVR

  • - More reinterventions, rehospitalizations and at least mild paravalvular leaks in the TAVI cohort at 5 years

AVR: aortic valve replacement; BS: baseline; CI: confidence Interval; EQ-5D: EuroQol 5D; FU: follow-up; KCCQ: Kansas City Cardiomyopathy Questionnaire; QoL: quality of life; RCT: randomized controlled trial; sAVR: surgical aortic valve replacement; SF-12: Short-Form 12 Health Survey Questionnaire; SF-36: Short-Form 36 Health Survey Questionnaire; TA: transapical; TAVI: transcatheter aortic valve implantation; TF: transfemoral.