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Evevident
Original paper
2010NEJMCardiology

PARTNER Cohort B

Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

RCTTAVR for severe aortic stenosis

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Overview

In inoperable severe symptomatic AS, TAVR reduced 1-year mortality versus standard therapy but increased vascular complications and stroke.

Clinical takeaway

PARTNER Cohort B established TAVR as life-prolonging therapy for severe symptomatic aortic stenosis in patients who could not undergo surgical valve replacement.

Key result

All-cause death at 1 year: 30.7% with TAVI vs 50.7% with standard therapy; HR 0.55.

Practice impact

TAVR became standard therapy for inoperable severe symptomatic aortic stenosis and later expanded through subsequent risk-group trials.

Evidence

Study design

Randomized, controlled, multicenter device trial.

Enrollment

358

Follow-up

1 year.

Geography

United States, Canada, Germany

Clinical question

Does TAVR improve survival compared with standard therapy in severe symptomatic aortic stenosis patients who cannot undergo surgery?

Population

  • Patients with severe symptomatic aortic stenosis considered unsuitable candidates for surgical aortic-valve replacement.

Intervention

Transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve.

Comparator

Standard therapy, including balloon aortic valvuloplasty when used.

Primary outcome

Death from any cause at 1 year.

TAVI reduced all-cause mortality at 1 year compared with standard therapy.

Hazard ratio / 0.55 / CI 95% CI 0.40-0.74 / p=<0.001

Key results

  • All-cause death at 1 year: 30.7% with TAVI vs 50.7% with standard therapy; HR 0.55; 95% CI 0.40-0.74; p<0.001.
  • Death or repeat hospitalization: 42.5% with TAVI vs 71.6% with standard therapy; HR 0.46; 95% CI 0.35-0.59; p<0.001.
  • Major stroke at 30 days was higher with TAVI: 5.0% vs 1.1%; p=0.06.
  • Major vascular complications at 30 days were higher with TAVI: 16.2% vs 1.1%; p<0.001.

Harms

  • Major vascular complications were higher with TAVI.
  • Major strokes were numerically higher with TAVI at 30 days.

Clinical Use

When to cite

  • When explaining the original survival evidence for TAVR in inoperable AS.

Practice impact

  • Moved TAVR from procedural innovation to outcomes-based therapy for inoperable severe symptomatic AS.

Applicability

  • Most applicable to severe symptomatic AS patients who are not surgical candidates.

Limitations

  • Used early-generation valve and delivery systems with higher complication rates than contemporary devices.
  • Applies to severe symptomatic AS, not asymptomatic disease.
  • Control standard therapy was variable and could include balloon valvuloplasty.

Common misinterpretations

  • Do not cite Cohort B as a low-risk TAVR trial; it studied inoperable patients.

Citation

Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607. doi:10.1056/NEJMoa1008232

TAVI significantly reduced the rates of death from any cause.