PCI and TAVI Safe, Even When Done at the Same Time: TVT Registry

LONG BEACH, CA—Operators can be assured that it’s possible to safely perform PCI before, during, or after a TAVI procedure, according to new data from the TVT Registry

In the analysis of nearly 50,000 patients with stable CAD, the composite rate of all-cause mortality and stroke was similar at 3 years regardless of when PCI was performed in relation to TAVI.

“This is a very, sensitive and tricky topic that comes up very often in treating these valvular heart disease patients,” said Abhijeet Dhoble, MD, MPH (University of Texas Health Science Center at Houston, TX), during his presentation here in a featured clinical research session at SCAI 2024.

Nonetheless, the findings are reassuring on the background of limited evidence to guide physicians on management in this patient population, which can account for up to 75% of patients requiring TAVI, Dhoble told TCTMD.

“The takeaway from this study is number one, that concomitant PCI along with TAVR has higher procedural complication rates and higher short-term—up to 1 year—mortality rates. However, if you look at the mid-term outcomes over 3 years, they are the same,” he said.

Despite the reassurance, panelist Ethan C. Korngold, MD (Providence St. Vincent Medical Center, Portland, OR), said even when hybrid rooms are available, separating the procedures should be done whenever possible.

“The meticulousness of coronary PCI is just not the same mindset as putting in a TAVR,” he noted.

Korngold said their thinking on how to best manage these patients has evolved over time, adding that it’s not uncommon to deal with these cases “every week, multiple times a week.” Since patients with both CAD and TAVI can have very complicated presentations, he advised that a concomitant procedure is best avoided, if possible.

Propensity Matching With TVT Data

The procedures included in the analysis were performed between June 2015 and September 2023 in patients with stable CAD who received a balloon-expandable Sapien 3, Sapien 3 Ultra, or Sapien 3 Ultra Resilia (Edwards Lifesciences) valve concomitantly (n = 7,152) or within 90 days prior to (43,610) or after TAVI (n = 718). The mean age was 79 years, and the majority of patients were male, with diabetes in more than 40%, atrial fibrillation in more than 30%, PAD in approximately 25%, and chronic lung disease in about 30%.

At 3 years, mortality in the unmatched cohort was 32.8% in those who underwent PCI before TAVI, 39.4% in those who underwent concomitant PCI and TAVI, and 34.2% in those who had PCI after TAVI. Rates of stroke were 10.3%, 11.0%, and 9.3%, respectively.

For the combined endpoint of death/stroke at 3 years, the risk was highest in the concomitant PCI and TAVR group at 43.9% (P < 0.0001), followed by PCI after TAVR at 37.6% (P = 0.005) and PCI before TAVR at 37.6% (P = 0.3).

If you feel like the patient cannot make frequent visits to the hospital for a different procedure . . . it's okay to go ahead and do the concomitant PCI and TAVR. Abhijeet Dhoble

Procedural complication rates in a propensity-matched analysis were similar across all three groups (n = 717 patients in each). However, the median length of stay was longer and the rate of discharge to home was lower in the concomitant group compared with the other two.

All-cause mortality at 30 days and 1 year also was higher in the concomitant group, and rates of stroke were 4% with concomitant procedures versus 2.3% and 2.9%, respectively, for those having PCI before or after TAVI.

The composite of death and stroke was 6.4% at 30 days in the concomitant group compared with 2.6% and 2.1%, respectively in the pre- and post-TAVI groups (P < 0.001), while at 1 year, rates were 17.9%, 14.5%, and 13.6%, respectively (P = 0.03).

By 3 years, however, there were no differences in the rate of death or stroke in the matched cohort across the three arms. Similarly, death/stroke at 3 years was 37.7% in the PCI after TAVI arm, 37.4% in the concomitant arm, and 36.3% in the PCI before TAVI arm (P = 0.28).

An additional propensity-matched analysis of the PCI before TAVI compared with the other groups combined showed a slightly higher mortality rate at 3 years for the latter (38.8% vs 38.1%; P = 0.01), as well as a slightly higher risk of the composite of death or stroke (43.2% vs 42.8%; P = 0.01).

The meticulousness of coronary PCI is just not the same mindset as putting in a TAVR. Ethan C. Korngold

Dhoble said future studies should compare the long-term outcomes of the timing of PCI intervention and TAVI in a randomized setting. One such ongoing trial is COMPLETE TAVR, which plans to randomize 4,000 patients with a median follow-up out to 3.5 years.

For now, Dhoble said the TVT Registry findings reassure physicians that a patient-centered approach to this situation is clinically acceptable.

“I think at least this trial tells us that you don't have to think beyond your clinical judgment,” he told TCTMD. “We get referrals from patients who live 2 or 3 hours away from our medical center. So, sometimes, you also have to think about how far the patient is coming, for example. If you feel like the patient cannot make frequent visits to the hospital for a different procedure . . . it's okay to go ahead and do the concomitant PCI and TAVR, keeping in mind that the complication rate may be slightly higher. So, with the use of judicious anticoagulation and other things, I think you can manage this patient as safely as if you would have PCI before or after the TAVR.”