Key Points
- In patients with significant coronary artery disease undergoing TAVI, deferral of PCI was noninferior to routine PCI before TAVI for the composite of death, myocardial infarction, stroke, or major bleeding at 1 year (24% vs. 26%; HR 0.89; 95% CI, 0.62–1.28; p=0.0008 for noninferiority; p=0.68 for superiority).
- Deferral of PCI was associated with a substantially lower risk of major bleeding compared with routine PCI (6% vs. 15%; HR 0.39; 95% CI, 0.21–0.73), highlighting a key tradeoff between bleeding and ischemic risk.
- A selective, deferred revascularization strategy was feasible, with only 11% of patients requiring PCI during follow-up and no major periprocedural complications observed.
Coronary artery disease (CAD) is present in approximately half of patients undergoing transcatheter aortic valve implantation (TAVI), yet the optimal timing and necessity of percutaneous coronary intervention (PCI) in this population remain uncertain. While guidelines recommend PCI in selected patients, routine revascularization before TAVI has not consistently demonstrated clinical benefit and may increase bleeding risk. The PRO-TAVI trial (NCT05078619), simultaneously published in The Lancet, was designed to evaluate whether deferral of PCI is noninferior to routine PCI prior to TAVI in patients with significant CAD.
PRO-TAVI was an investigator-initiated, multicenter, open-label randomized controlled trial conducted across 12 centers in the Netherlands, enrolling 466 patients with severe aortic stenosis and significant CAD. Patients were randomized 1:1 to a strategy of PCI before TAVI (n=233) or deferral of PCI with revascularization only if clinically indicated after TAVI (n=233). The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding at 1 year.
Median age was 81 years (IQR 78–84), and 166 (36%) of 466 patients were female. At 1 year, the primary composite endpoint occurred in 56 patients (24%) in the PCI deferral group and 60 patients (26%) in the routine PCI group, corresponding to a rate difference of −1.7% (95% CI, −9.5 to 6.2) and a hazard ratio of 0.89 (95% CI, 0.62–1.28), meeting criteria for noninferiority (p=0.0008) but not superiority (p=0.68) . Individual components of the composite endpoint were similar between groups, including all-cause mortality (12% vs. 11%; HR 1.12; 95% CI, 0.66–1.93), myocardial infarction (6% vs. 5%; HR 1.08; 95% CI, 0.49–2.36), and stroke (6% vs. 4%; HR 1.43; 95% CI, 0.63–3.21).
A key differentiator between strategies was bleeding risk. Major bleeding events (VARC-3 types II–IV) occurred in 6% of patients in the deferral group compared with 15% in the PCI group (HR 0.39; 95% CI, 0.21–0.73), with access-site bleeding notably higher among patients undergoing PCI prior to TAVI. Any bleeding (VARC-3 types I–IV) was also significantly lower with deferral (18% vs. 43%; HR 0.34; 95% CI, 0.24–0.50). Conversely, there was a numerically higher rate of ischemic composite events (death, MI, or stroke) in the deferral group (21% vs. 16%; HR 1.28; 95% CI, 0.84–1.96), though this did not reach statistical significance.
During follow-up, 24 patients (11%) in the deferral group ultimately underwent PCI, including 13 (6%) requiring urgent revascularization and 11 (5%) undergoing elective procedures. Importantly, all delayed PCI procedures were performed without major periprocedural complications, supporting the feasibility of a staged or selective approach. These findings suggest that routine PCI prior to TAVI may not be necessary in many patients with stable CAD and that a conservative strategy of deferral can reduce bleeding risk without compromising overall clinical outcomes. The results support a more individualized, heart team–based approach that balances ischemic and bleeding risks while considering patient comorbidities and procedural complexity.
Dr. Michiel Voskuil, the study’s lead investigator, emphasized that “this study is about intermediate- and high-risk patients only,” noting that “for low-risk TAVI patients… this question remains open,” highlighting the need for further data in younger, lower-risk populations.