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Valvular & structural heart diseaseRandomised controlled trial

TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial

LancetPublished

  • Randomised controlled trial
  • international
  • multicentre
  • prospective
  • open-label
  • non-inferiority
  • 18 tertiary centres in Europe
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Authors' conclusion

The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment.

Study context

Population
Patients aged ≥70 years with severe AS and complex CAD, feasible for percutaneous or surgical treatment per Heart Team
Participants
172 patients
Comparison
Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) plus transcatheter aortic valve implantation (TAVI) vs surgical aortic valve replacement (SAVR) plus coronary artery bypass grafting (CABG)
  • FFR-guided PCI plus TAVIn = 91
  • SAVR plus CABGn = 81reference
Primary endpoint
Composite of:
  • All-cause mortality
  • MI
  • Disabling stroke
  • Clinically driven target-vessel revascularisation
  • Valve reintervention
  • Life-threatening or disabling bleeding
Follow-up
1 year post-treatment

Primary result

As reported in the abstract

1 year
FFR-guided PCI plus TAVI vs SAVR plus CABGRisk difference (90% CI)P value
below 15% non-inferiority margin
−18.5(−27.8 to −9.7)
P < 0.001for non-inferiority
FFR-guided PCI plus TAVI vs SAVR plus CABGHazard ratio (95% CI)P value
superiority
0.17(0.06–0.51)
P < 0.001for superiority

Non-inferiority margin 15 as printed, not drawn

Further findings

All-cause mortality (primary endpoint component)

P = 0.0025

Safety

Life-threatening bleeding

P = 0.010

Original publication

TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial. Lancet. Published 4 December 2024. doi:10.1016/s0140-6736(24)02100-7
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Summarised from the published abstract; every number is checked against it