PRO-TAVI
Deferral of Routine PCI in Patients Undergoing Transcatheter Aortic Valve Implantation
Published in Lancet
Key Result
Deferring PCI until after TAVI was noninferior to PCI-first (24% vs 26% composite endpoint, HR 0.89) with significantly less major bleeding (6% vs 15%). Only 11% of deferred patients needed subsequent PCI.
What did this trial find?
The PRO-TAVI trial randomized 466 elderly patients with concomitant CAD and aortic stenosis across 12 Dutch centers to PCI before TAVI or deferral of PCI until after TAVI. Deferring PCI was noninferior (24% vs 26% composite endpoint; HR 0.89; noninferiority p=0.0008) and led to significantly less major bleeding (6% vs 15%), with only 11% of deferred patients needing subsequent PCI. Coverage includes supportive commentary from the lead author, a cautionary Lancet editorial, and an enthusiastic ACC discussant, with debate centered on whether findings apply to younger, lower-risk populations.
Why does this trial matter?
Moderate controversy. The core noninferiority finding is straightforward, but there is meaningful debate about generalizability to younger/lower-risk populations and whether the results should discourage PCI entirely. The editorial explicitly cautions against overinterpretation, and the lead author acknowledges the gap for low-risk patients. The ACC discussant was supportive but framed it as a deferral-strategy paradigm question. Coverage is limited to ACC presentation reports and the Lancet editorial — no strongly dissenting voices yet.
Study Design
Randomized, controlled, noninferiority trial across 12 sites in the Netherlands (N=466)
Clinical Implications
For elderly high-risk TAVI patients with concomitant CAD, deferring PCI reduces bleeding risk without compromising outcomes. Supports a TAVI-first approach with PCI reserved for persistent symptoms.
Abstract
The PRO-TAVI trial randomized 466 high-risk, older patients (median age 81, 36% female) with concomitant coronary artery disease across 12 Netherlands sites to either PCI before TAVI or TAVI first with deferred PCI if necessary. The primary composite (death, MI, stroke, or moderate-to-severe bleeding at 12 months) occurred in 24% of the deferral group vs 26% of the PCI-first group (HR 0.89, 95% CI 0.62-1.28, noninferiority p=0.0008). The deferral strategy led to significantly reduced major bleeding: 6% vs 15%. Only 11% of deferred PCI patients eventually required the procedure within one year.