A new analysis has found that performing percutaneous coronary intervention (PCI) alongside transcatheter aortic valve replacement (TAVR) may not benefit frail patients, despite clear advantages in those who are nonfrail.
Frailty is increasingly recognised as a critical factor influencing outcomes in cardiovascular disease, particularly among patients undergoing complex procedures such as TAVR. While previous findings from the NOTION-3 trial suggested that PCI could reduce major adverse cardiac events (MACE), uncertainty remained over whether this approach was appropriate for more vulnerable patient groups.
PCI in TAVR Patients: Diverging Outcomes by Frailty
In this substudy of the NOTION-3 trial, researchers evaluated 407 patients with coronary artery disease and severe aortic stenosis undergoing TAVR. 130 patients (32%) were classified as frail using a composite score based on baseline function and quality of life. Patients were randomised to receive PCI or conservative management and followed for a median of 2 years.
The results revealed a clear divergence. Among nonfrail patients, PCI significantly reduced the risk of MACE (15% versus 33%; hazard ratio: 0.42; 95% confidence interval: 0.25–0.69; p<0.001). Reductions were also observed in all-cause mortality, myocardial infarction, and urgent revascularisation.
However, in frail patients, PCI offered no such benefit. Rates of major outcomes were similar between treatment groups, suggesting that the invasive strategy did not translate into improved clinical outcomes in this subgroup.
Increased Bleeding Risk Raises Concerns
Importantly, PCI in TAVR patients who were frail was associated with a significantly higher risk of bleeding complications (hazard ratio: 2.51; 95% confidence interval: 1.23–5.11; p=0.011). This raises concerns about the safety of routine PCI in this population, where physiological reserve is already limited.
No meaningful differences were reported in other safety endpoints, such as acute kidney injury, but the increased bleeding risk alone may influence clinical decision-making.
Implications for PCI in TAVR Patients
These findings highlight the need for a more individualised approach to PCI in TAVR patients, particularly when frailty is present. While nonfrail patients appeared to benefit from revascularisation, frail patients experienced harm without clear clinical gain.
The study also underscored the importance of incorporating frailty assessment into routine pre-procedural evaluation. As TAVR use expands, identifying those most likely to benefit from additional interventions such as PCI will be essential.
The authors noted that frailty was assessed post hoc and that larger prospective studies are needed to confirm these findings. Until then, clinicians may need to exercise caution when considering PCI in frail patients undergoing TAVR.
Reference
Joshi SS et al. Myocardial fibroblast activation in ischemic and nonischemic cardiomyopathy. JAMA Cardiol. 2026;DOI:10.1001/jamacardio.2026.0661.
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