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. 2020 Apr 17;9(8):e015921. doi: 10.1161/JAHA.120.015921

Table 1.

Summary of Major TAVR Clinical Trials

Trial Year Patient Population n % Male Mean Age (y) Follow‐up (y) Short‐Term Outcomes Long‐Term Outcomes
PARTNER 19 2010 Inoperable patients

n=358

179 TAVR

179 standard therapy

 46% 83 1.6 At 30 d, TAVR vs standard of care:

  • All‐cause death (5% vs 2.8%, nss)

  • Repeat hospitalization (5.6% vs 10.1%, nss)

  • Major strokes (5.0% vs 1.1%, nss)

  • Major vascular complications (16.2% vs 1.1%, ss)

  • Major bleeding (16.8% vs 3.9%, ss)

 At 1 y, TAVR vs standard of care:

  • All‐cause death (30.7% vs 49.7%, ss)

  • Repeat hospitalization (22.3% vs 44.1%, ss)

  • Major stroke (7.8% vs 3.9%, nss)

  • Major vascular complications (16.8% vs 2.2%, ss)

  • Major bleeding (22.3% vs 11.2%, ss)
PARTNER 110 2011 High surgical risk patients (STS ≥10%)

n=699

348 TAVR

351 SAVR

 58% 84 1.4 At 30 d, TAVR vs SAVR:

  • All‐cause death (3.4% vs 6.5%, nss)

  • Major stroke (3.8% vs 2.1%, nss)

  • Major vascular complications (11.0% vs 3.2%, ss)

  • Major bleeding (9.3% vs 19.5%, ss)

  • New‐onset atrial fibrillation (8.6% vs 16.0%, ss)

 At 1 y, TAVR vs SAVR:

  • All‐cause death (24.2 vs 26.8%, nss)

  • Major stroke (5.1% vs 2.4%, nss)

  • Major vascular complications (11.3% vs 3.5%, ss)

  • Major bleeding (14.7% vs 25.7%, ss)

  • New‐onset atrial fibrillation (12.1% vs 17.1%, nss)
CoreValve13 2014 Inoperable (≥50% 30‐d risk of mortality or irreversible morbidity)

N=489

489 TAVR

compared with meta‐analysis data

 48% 83 1 At 30 d, TAVR

  • All‐cause death or major stroke (9.8%)

  • Major stroke (2.3%)

  • Major vascular complications (8.2%)

  • Major/life‐threatening bleeding (36.7%)

 At 1 y, TAVR

  • All‐cause death or major stroke (26.0%)

  • Major stroke (4.3%)

  • Major vascular complications (8.4%)

  • Major/life‐threatening bleeding (42.8%)
CoreValve14 2014 High surgical risk patients (STS ≥15%)

n=747

390 TAVR

357 SAVR

 53% 83 1 At 30 d, TAVR vs SAVR:

  • All‐cause death (3.3% vs 4.5%, nss)

  • Major stroke (3.9% vs 3.1%, nss)

  • Major vascular complications (5.9% vs 1.7%, ss)

  • Major/life‐threatening bleeding (41.7% vs 69.5%, ss)

  • New‐onset atrial fibrillation (11.7% vs 30.5%, ss)

  • Permanent pacemaker (19.8% vs 7.1%, ss)

 At 1 y, TAVR vs SAVR:

  • All‐cause death (14.2% vs 19.1%, ss)

  • Major stroke (5.8% vs 7.0%, nss)

  • Major vascular complications (6.2% vs 2.0%, ss)

  • Major/life‐threatening bleeding (46.1% vs 75.1%, ss)

  • New‐onset atrial fibrillation (15.9% vs 32.7%, ss)

  • Permanent pacemaker (22.3% vs 11.3%, ss)
PARTNER 215 2016

Intermediate surgical risk patients

(STS 4–8%)

n=2032

1011 TAVR

1021 SAVR

 55% 82 2 At 30 d, TAVR vs SAVR:

  • All‐cause death or disabling stroke (6.1% vs 8.0%, nss)

  • Major vascular complications (7.9% vs 5.0%, ss)

  • Major bleeding (10.4% vs 43.4%, ss)

  • Acute kidney injury (1.3% vs 3.1%, ss)

  • New atrial fibrillation (9.1% vs 26.4%, ss)

 At 2 y, TAVR vs SAVR:

  • All‐cause death or disabling stroke (19.3% vs 21.1%, nss)

  • Major vascular complications (8.6% vs 5.5%, ss)

  • Major bleeding (17.3% vs 47%, ss)
SURTAVI16 2017

Intermediate surgical risk patients

(STS 3–15%)

n=1660

864 TAVR

796 SAVR

 56% 80 2 At 30 d, TAVR vs SAVR:

  • All‐cause death or disabling stroke (2.8% vs 3.9%, nss)

  • Rehospitalization (AVR‐related disease) (2.9% vs 4.2%, nss)

  • Major bleeding (12.2% vs 9.3%, nss)

  • Acute kidney injury (1.7% vs 4.4%, ss)

  • Major vascular complication (6% vs 1.1%, ss)

  • Permanent pacemaker implantation (25.9% vs 6.6%, ss)

  • Atrial fibrillation (12.9% vs 43.4%, ss)

 At 2 y, TAVR vs SAVR:

  • All‐cause death or disabling stroke (12.6% vs 14%, nss)

  • Rehospitalization (13.2% vs 9.7%, ss)

  • Aortic valve reintervention (2.8% vs 0.7%, ss)
PARTNER 317 2019 Low surgical risk patients (STS <4%)

n=950

496 TAVR

454 SAVR

 69% 73 1 At 30 d, TAVR vs SAVR:

  • All‐cause death, stroke, or rehospitalization (4.2% vs 9.3%, ss)

  • All‐cause death (0.4% vs 1.1%, nss)

  • All strokes (driven primarily by nondisabling stroke) (0.6% vs 2.4%, ss)

  • Rehospitalization (for AVR‐related disease) (3.4% vs 6.5%, ss)

  • Major bleed (3.6% vs 24.5%, ss)

  • Major vascular complications (2.2% vs 1.5%, nss)

  • New permanent pacemaker (6.5% vs 4%, nss)

  • New‐onset atrial fibrillation (5% vs 39.5%, ss)

 At 1 y, TAVR vs SAVR:

  • All‐cause death, stroke, or rehospitalization (8.5% vs 15.1%, ss)

  • All‐cause death (1.0% vs 2.5%, nss)

  • All strokes (1.2% vs 3.1%, nss)

  • Rehospitalization (7.3% vs 11%, nss)

  • Major bleed (7.7% vs 25.9%, ss)
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients18 2019 Low surgical risk patients (STS <3%)

n=1403

725 TAVR

678 SAVR

 65% 74 1.1 At 30 d, TAVR vs SAVR:

  • All‐cause death or disabling stroke (0.8% vs 2.6%, ss)

  • All‐cause death (0.5% vs 1.3%, nss)

  • Disabling stroke (0.5% vs 1.7%, ss)

  • Major bleed (2.4% vs 7.5%, ss)

  • New permanent pacemaker (17.4% vs 6.1%, ss)

  • New‐onset atrial fibrillation (7.7% vs 35.4%, ss)

  • Major vascular complications (3.8% vs 3.2%, nss)

 At 1 y, TAVR vs SAVR:

  • All‐cause death or disabling stroke (2.9% vs 4.6%, nss)

  • All‐cause death (2.4% vs 3%, nss)

  • Disabling stroke (0.8% vs 2.4%, ss)

  • Major bleed (3.2% vs 8.9%, ss)

  • New permanent pacemaker (19.4% vs 6.7%, ss)

  • New‐onset atrial fibrillation (9.8% vs 38.3%, ss)

nss indicates not statistically significant; PARTNER, Placement of Aortic Transcatheter Valve Trial; SAVR, surgical aortic valve replacement; ss, statistically significant; STS, Society of Thoracic Surgeons; SURTAVI, Surgical Replacement and Transcatheter Aortic Valve Implantation; and TAVR, transcatheter aortic valve replacement.