A TAVI-first strategy for patients with severe aortic stenosis and concomitant coronary artery disease is noninferior to a PCI-first approach at one year, according to clinical trial results presented at the ESC Congress 2026 and published simultaneously in the New England Journal of Medicine. Researchers evaluated 986 patients across 48 centers to compare the competing treatment strategies.
Evaluating Treatment Strategies for Severe Aortic Stenosis
About half of patients who undergo transcatheter aortic valve implantation (TAVI) also live with coronary artery disease, while roughly 10% to 20% require percutaneous coronary intervention (PCI), according to Professor Barbara Elisabeth Stähli of the University Hospital Zurich in Switzerland. In practice, most patients undergo PCI first and then have TAVI later. However, performing TAVI first can offer clinical advantages, particularly regarding the antiplatelet medications required after PCI.
To test these competing approaches, researchers designed an open-label, randomized, noninferiority trial across 48 centers in Austria, France, Germany, Italy, the Netherlands, and Switzerland. The study included 986 patients with a mean age of 82 years, of whom 34% were women. A multidisciplinary heart team evaluated the participants, ensuring they were eligible for both procedures. Patients were then randomized in a 1:1 ratio to receive either TAVI followed by angiography-guided PCI or angiography-guided PCI followed by TAVI, with both interventions completed within 1 to 45 days of each other.
At the one-year mark, researchers found that the TAVI-first strategy met criteria for noninferiority compared to the PCI-first strategy. According to trial data, the primary composite endpoint—which included all-cause death, nonfatal myocardial infarction, ischaemia-driven revascularisation, valve-, procedure-, or heart failure-related rehospitalisation, or life-threatening, disabling, or major bleeding—occurred in 22.2% of patients in the TAVI-first group and 24.2% in the PCI-first group, yielding a risk difference of −2.0 percentage points.
Individual components of the primary endpoint remained broadly similar across both treatment arms. Subgroup analyses showed no evidence of treatment heterogeneity based on patient age, sex, or the procedural complexity of the PCI.
Safety Profiles and Bleeding Risk Observations
Safety evaluations revealed differences in bleeding complications between the two cohorts. Life-threatening, disabling, or major bleeding occurred in 6.6% of patients assigned to the TAVI-first strategy compared with 9.7% in the PCI-first group. Professor Stähli noted that BARC type 3a bleeding appeared less frequent with the TAVI-first approach, though she emphasized that investigators should interpret this secondary finding cautiously given the variables involved.
“Antiplatelet therapy and the interval between the two procedures may play a role, and these questions need further study,” Professor Stähli stated regarding the observed bleeding differences.
Did You Know? Fewer patients in the TAVI-first group ultimately underwent the planned PCI procedure. Investigators observed that this occurred not because coronary access was impaired after valve replacement, but because clinical assessments regarding the necessity of PCI sometimes shifted once the aortic valve was treated.
Clinical Implications and Personalized Patient Care
The findings provide physicians with validated randomized evidence to tailor treatment sequences based on individual patient profiles. Rather than adhering to a rigid protocol where PCI always precedes valve replacement, clinicians can now weigh coronary disease severity, patient symptoms, anatomical factors, and bleeding risks to decide which procedure should come first.
“The results of the TAVI PCI trial demonstrate that we as clinicians now have a choice,” Professor Stähli concluded, highlighting that symptoms, anatomy, and overall clinical presentation should guide the management strategy.
Frequently Asked Questions
What was the main finding of the TAVI PCI trial?
The trial established that a TAVI-first treatment strategy is noninferior to a PCI-first strategy at one year for patients with severe aortic stenosis and concomitant coronary artery disease.
How many patients participated in the study?
The study population comprised 986 patients with a mean age of 82 years, evaluated across 48 medical centers in six European countries.
Why did some patients in the TAVI-first group skip PCI?
Investigators observed that clinical decisions regarding the necessity of PCI sometimes changed after the aortic valve was successfully treated, rather than coronary access being physically blocked.
Where were the trial results published?
The findings were presented during a Hot Line session at the ESC Congress 2026 and published simultaneously in the New England Journal of Medicine.
Stay Updated on Cardiology Advances
Explore more clinical trial breakdowns and subscribe to our professional newsletter for the latest updates from major medical congresses.
Related reading