Highlights
- FFR-guided PCI plus TAVI was non-inferior and statistically superior to SAVR plus CABG for the composite endpoint at 1 year in elderly patients with severe aortic stenosis and complex coronary artery disease.
- Percutaneous treatment achieved lower all-cause mortality (0% vs 10%) and reduced life-threatening bleeding compared to surgical treatment.
- The TCW trial is the first head-to-head randomized trial comparing these two strategies in this high-risk population.
Clinical Background and Disease Burden
Severe aortic stenosis (AS) frequently coexists with obstructive coronary artery disease (CAD), affecting nearly half of elderly patients with AS. These patients often present with complex or multivessel CAD, further compounding their cardiovascular risk and complicating management. Historically, the standard of care has been surgical aortic valve replacement (SAVR) combined with coronary artery bypass grafting (CABG), a strategy supported by major cardiology guidelines for patients with severe AS and significant CAD. However, surgical intervention carries substantial morbidity and mortality, especially in older adults or those with frailty and comorbidities. As transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) have evolved, these less invasive techniques—especially when guided by fractional flow reserve (FFR) to identify functionally significant lesions—offer potential alternatives to surgery, aiming to reduce perioperative risk without compromising efficacy.
Research Methodology
The Transcatheter versus Conventional surgery in aortic stenosis with complex or multivessel coronary disease (TCW) trial was an international, multicentre, prospective, open-label, non-inferiority, randomized controlled trial. It enrolled 172 patients aged 70 years or older with severe aortic stenosis and complex coronary artery disease across 18 European tertiary centers from 2018 to 2023. Eligible patients were considered suitable for either percutaneous or surgical revascularization by a multidisciplinary Heart Team. Participants were randomized 1:1 to receive either FFR-guided PCI followed by TAVI or SAVR plus CABG. Randomization was stratified by site with permuted blocks. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularization, valve reintervention, and life-threatening or disabling bleeding at 1 year post-procedure. The trial was powered for non-inferiority (margin 15%) and, if met, for superiority. Analyses were performed on an intention-to-treat basis.
Key Findings
Between May 31, 2018, and June 30, 2023, 172 patients were randomized: 91 to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age was 76.5 years, with 69% male participants. The key findings include:
- The primary composite endpoint occurred in 4% of the FFR-guided PCI plus TAVI group compared to 23% of the SAVR plus CABG group (risk difference: -18.5%, 90% CI -27.8 to -9.7; p for non-inferiority <0.001).
- FFR-guided PCI plus TAVI was statistically superior to SAVR plus CABG (hazard ratio 0.17, 95% CI 0.06–0.51; p for superiority <0.001).
- This benefit was driven primarily by differences in all-cause mortality (0% in PCI+TAVI vs 10% in SAVR+CABG; p=0.0025) and life-threatening bleeding (2% vs 12%; p=0.010).
The results suggest that percutaneous, FFR-guided revascularization with TAVI not only meets non-inferiority criteria but achieves superior outcomes in terms of the composite endpoint and key safety measures in this older, high-risk population.
Mechanistic Insights and Biological Plausibility
The superior outcomes with the percutaneous strategy likely reflect reduced surgical trauma, lower risk of perioperative bleeding, and avoidance of cardiopulmonary bypass, which can be particularly hazardous in elderly patients. FFR-guided PCI allows for targeted treatment of hemodynamically significant lesions, potentially minimizing unnecessary interventions and associated risks. TAVI has also become established as a safe and effective alternative to SAVR in elderly or high-risk patients with severe AS, supported by numerous randomized trials.
Expert Commentary
Current European and American guidelines recommend SAVR plus CABG for suitable patients with AS and significant CAD, but acknowledge that TAVI and PCI may be considered in high-risk or inoperable patients. The TCW trial provides the first randomized evidence suggesting that a fully percutaneous, FFR-guided approach can yield clinical outcomes at least as good as, if not better than, conventional surgery in selected elderly patients. This may prompt future revision of guidelines, particularly for patients with high surgical risk or frailty.
Controversies and Limitations
The TCW trial had a relatively small sample size (n=172), which may limit the generalizability of its findings. The trial was conducted exclusively in European tertiary centers with experienced Heart Teams, potentially limiting applicability to lower-volume or less specialized centers. The open-label design could introduce bias, though objective endpoints like mortality are less susceptible. The follow-up duration was limited to one year; longer-term valve durability, reintervention rates, and late adverse events remain to be determined. Additionally, the study population was elderly (mean age 76.5 years) and may not represent younger or lower-risk patients.
Conclusion
The TCW trial is a landmark study providing robust evidence that FFR-guided PCI plus TAVI is not only non-inferior but clinically superior to SAVR plus CABG in elderly patients with severe aortic stenosis and complex coronary artery disease. These findings support consideration of a percutaneous, FFR-guided approach as a valid first-line option for selected patients, particularly those at increased surgical risk or with preferences for less invasive therapy. Further research is warranted to assess long-term outcomes, cost-effectiveness, and applicability to broader patient populations.
References
Kedhi E, Hermanides RS, Dambrink JE, Singh SK, Ten Berg JM, van Ginkel D, Hudec M, Amoroso G, Amat-Santos IJ, Andreas M, Campante Teles R, Bonnet G, Van Belle E, Conradi L, van Garsse L, Wojakowski W, Voudris V, Sacha J, Cervinka P, Lipsic E, Somi S, Nombela-Franco L, Postma S, Piayda K, De Luca G, Kolkman E, Malinowski KP, Modine T; TCW study group. 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. 2025 Dec 21;404(10471):2593-2602. doi: 10.1016/S0140-6736(24)02100-7. Epub 2024 Dec 4. PMID: 39644913.
