A major Dutch study, the PRO-TAVI trial, shows that skipping routine percutaneous coronary intervention (PCI) before transcatheter aortic valve implantation (TAVI) is just as safe as doing PCI first. This finding could change how doctors treat older patients with both aortic valve disease and coronary artery disease.
Study Setup
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 have PCI before TAVI or to skip PCI unless it was needed later. The main outcome measured was a combination of death, heart attack, stroke, or major bleeding within one year.
Main Results
The rates of the main outcome were almost the same in both groups: 24.1% for those who did not have PCI and 25.8% for those who had PCI first. Importantly, not having PCI led to fewer major bleeding events (6.2% vs. 14.8%). Only about 1 in 10 patients who did not have PCI needed it later, and these procedures were safe. Professor and ACS director Ronak Delewi 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.”
Clinical Impact
The results suggest that many TAVI patients can safely avoid an extra procedure, reducing their risk of bleeding and making treatment less stressful. Professor Michiel Voskuil (UMC Utrecht) adds: “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.” Newer valve designs also make it easier to do PCI after TAVI if needed.
Comparison to Other Studies
Earlier studies gave mixed results about the benefits of PCI before TAVI. PRO-TAVI adds strong evidence that skipping PCI is safe for most patients, especially those at higher risk for bleeding. Previous trials (ACTIVATION, NOTION-3) showed no clear mortality benefit for routine PCI, with NOTION-3 favoring PCI mainly due to reduced myocardial infarction and urgent revascularization.
Guideline Implications
Current guidelines recommend PCI for severe blockages. This study suggests doctors can be more selective, focusing on patients who really need PCI and avoiding unnecessary procedures. The findings support a more conservative, patient-tailored approach for TAVI candidates with coronary artery disease.