A major Dutch study, led by Michiel Voskuil from UMC Utrecht, shows that skipping routine percutaneous coronary intervention (PCI) before transcatheter aortic valve implantation (TAVI) is just as safe as performing PCI first. The findings could change how doctors treat older patients with both aortic valve disease and coronary artery disease.
Researchers from 12 hospitals in the Netherlands enrolled 466 patients with significant coronary artery disease who needed a TAVI procedure. Patients were randomly assigned to either undergo PCI before TAVI or to defer PCI unless it was needed later. The main outcome measured was a combination of death, heart attack, stroke, or major bleeding within one year.
The rates of the primary outcome were similar in both groups: 24.1% for patients who did not undergo PCI and 25.8% for those who had PCI first. Importantly, omitting PCI resulted in fewer major bleeding events (6.2% vs. 14.8%). Only about 1 in 10 patients in the no-PCI group required PCI after TAVI, and these procedures were safe. Professor Ronak Delewi (Amsterdam UMC) explains: “By performing PCI, the blood vessel opens up again, but PCI in these patients is burdensome and not without risk. In the PRO-TAVI study, we wanted to know if it is safe to omit the standard PCI before the TAVI procedure. We now see that it is possible: it is less burdensome for the patient and reduces the risk of bleeding.”
Professor Michiel Voskuil, interventional cardiologist at UMC Utrecht and lead of the PRO-TAVI study, emphasizes: “Now that we know the operation is just as safe without PCI, we can save a lot by not performing this procedure. It not only reduces healthcare costs but is also much less burdensome for the patient.” The results suggest that many TAVI patients can safely avoid an additional procedure, reducing bleeding risk and making treatment less intensive. Newer valve designs also make it easier to perform PCI after TAVI if needed.
Earlier studies showed mixed results regarding the benefit of PCI before TAVI. PRO-TAVI adds strong evidence that deferring PCI is safe for most patients, particularly those at higher risk of bleeding. Previous trials (ACTIVATION, NOTION-3) did not show a clear mortality benefit for routine PCI, with NOTION-3 favoring PCI mainly due to reduced myocardial infarction and urgent revascularization.
Current guidelines recommend PCI for severe coronary blockages. These findings suggest a more selective approach, focusing on patients who truly need PCI and avoiding unnecessary procedures. This supports a more conservative, patient-tailored strategy for TAVI candidates with coronary artery disease.
The results of the PRO-TAVI study were presented last Sunday at the ACC.26 Conference in New Orleans and published in The Lancet. The PRO-TAVI trial was funded by ZonMw.
