TAVI and Complex/High-Risk PCI Safer if Staged, Registry Confirms

Patients who undergo both TAVI and complex/high-risk PCI see fewer adverse events and less procedural risk if their procedures are done using a staged rather than concomitant strategy, data from the Aortic Stenosis with COmplex PCI (ASCoP) international registry confirm.

Coexisting severe aortic stenosis (AS) and cardiovascular disease with challenging features, such as left main and multivessel involvement, bifurcation lesions, long lesions, LVEF ≤ 30%, need for mechanical circulatory support, among others, was rare—2.83% of all TAVI patients—but on the rise during the decade-long study, hitting nearly 4% by 2023.

Researchers reported the findings in a paper published recently online in EuroIntervention.

Speaking with TCTMD, lead author Claudio Montalto, MD (Niguarda Hospital, Milan, Italy), pointed out that cases once considered untreatable are becoming more routine.

“Every day we are treating patients that we wouldn’t [have been] treating just a few years ago,” he said. The question of how best to stagger TAVI and complex/high-risk PCI is “clearly something that will come up even more frequently as time goes by.”

Their results, said Montalto, “favor a more PCI-focused strategy” where the cardiovascular disease is addressed prior to the valvular disease. “Even though we perceive aortic stenosis as the main [problem] in these patients, really when the patients have such heavy coronary artery disease, it’s likely that [the latter] might contribute much more to the overall clinical picture and probably is also more complex to treat,” he explained.

There’s also the option of doing a staged procedure that prioritizes TAVI ahead of PCI. Although still in the minority, this approach is gaining traction, said Montalto.

Toby Rogers, MD, PhD (MedStar Heart & Vascular Institute, Washington, DC), commenting for TCTMD, said that the ASCoP paper “ really just validates our clinical practice,” in which staged procedures are preferred over concomitant.

Although “it’s hard to come up with a blanket strategy” in these complex scenarios, “what this basically shows is there doesn’t seem to be any mortality advantage to either strategy, but there’s clearly a trade-off with more bleeding and more vascular complications [with combined procedures],” he said.

For Rogers, a more interesting question isn’t combined versus staged but rather whether TAVI or PCI should take precedence.

Difference Occurs Early

The ASCoP investigators analyzed data on 519 patients with a clinical indication for both TAVI and complex or high-risk PCI who were treated between January 2013 and May 2023 across 14 centers in Europe and the US. Among these patients, 363 (69.9%) had staged procedures and 156 (30.1%) had concomitant TAVI and PCI using a broad mix of bioprosthetic valve types.

For both groups, PCI was most often done before TAVI: 86.7% of concomitant procedures and 91.7% of staged procedures. With the staged strategy, the median time between PCI and TAVI was 10.5 days and 41.3% had both done during the same hospital stay.

Major vascular complications (4.5% vs 1.9%) and major bleeding (10.9% vs 3.9%) were both more common in the concomitant group than in the staged group.

Nearly all patients (98.8%) were discharged alive from the hospital. After a median follow-up of 441 days, the primary endpoint of all-cause death and unplanned rehospitalization for cardiovascular causes occurred in 36.1% of concomitant cases and 36.7% of staged cases (log-rank P = 0.980).

The study’s secondary endpoint—all-cause death, stroke, acute myocardial infarction, major bleeding, major vascular complications, and unplanned revascularization—occurred more often with combined PCI/TAVI than with a staged strategy, however (25.8% vs 17.4%; log-rank P = 0.014).

Landmark analysis showed no difference in the primary endpoint between groups for events occurring before versus after 30 days. For the secondary endpoint, the gap between concomitant and staged strategies was restricted to the first 30 days (15.8% vs 6.3%; log-rank P < 0.001) and mainly due to major vascular complications and bleeding.

Independent predictors of the primary endpoint included platelet count and LVEF but not procedural timing. With the secondary endpoint, predictors included concomitant PCI/TAVI (HR 1.85; 95% CI 1.09-3.14) as well as creatinine level and platelet count.

When managing patients with CVD and AS, “planning is crucial,” said Montalto, who advised these cases should be handled at high-volume centers. “We shouldn’t rush into either complex PCI or TAVI, even if the TAVI looks easier than expected.” Their results also are a reminder, he added, to be mindful about complications when doing combined PCI/TAVI, “ always with a focus on trying to minimize the invasiveness.”

TAVI First?

In clinical practice, the discussion has moved beyond the timing of PCI and TAVI.

“ I think the bigger debate right now is whether you should do the coronaries at all,” Rogers said. The pivotal TAVI trials, by design, mandated addressing patients’ CVD before they could enroll, he explained. “In the early days of TAVR, we all got into this mindset of ‘You have to fix all the coronaries before,’ and then over the years I think we’ve all sort of backed off from doing that, because the truth is it’s very rare that TAVR patients come back after TAVR and say, I’ve got angina.”

For many patients with both aortic stenosis and cardiovascular disease, “AS is the predominant problem that’s causing their shortness of breath and their dizziness and their blackouts and [other] symptoms,” said Rogers.

It’s hard to come up with a blanket strategy. Toby Rogers

Montalto and colleagues put forth a rationale for taking a TAVI-first perspective, to be followed by PCI in a staged fashion. This is because “performing PCI in the setting of ongoing, severe AS can augment procedural risk,” especially in higher-risk cases, they say.

“It should further be noted that the widespread adoption of the commissural alignment technique during valve implantation and the availability of newer-generation valve models that allow easier coronary cannulation after TAVI have increased the feasibility of PCI post-TAVI over the years, along with the overall rate of cannulation post-TAVI,” they specify.

RCTs and Guidelines

Tiffany Patterson, MBBS, PhD, and Benedict McDonaugh, MSc (both from Guy’s and St Thomas’ NHS Foundation Trust, London, England), in an editorial, say that despite its limitations as a retrospective analysis, the registry provides “invaluable data” regarding the higher risk of complications with concomitant versus staged PCI/TAVI.

Dual management of severe AS and CAD is “one of the most challenging questions posed to the heart team,” they write. “Once the decision for aortic valve intervention is made, which patients should undergo revascularization and when this should be performed remain open to debate.”

This is especially true for the high-risk population studied in ASCoP, Patterson and McDonaugh note, given that the ACTIVATION and NOTION-3 trials showed conflicting results and involved lower-risk cases.

International guidelines, too, are vague on the issue of timing.

The European Society of Cardiology/European Association for Cardio-Thoracic Surgery, gave a class IIa, level of evidence C recommendation for PCI only in cases of severe AS (> 70%) affecting the proximal coronary vessel. That same year, the American College of Cardiology/American Heart Association gave a class 2a, level of evidence C recommendation for PCI of the left main or proximal segment before TAVI. Only the US document mentions optimal timing, advising PCI should be performed before TAVI as a way to reduce procedural complexity and complications.