Feature | Fast Takes From TCT 2023
Here's a lightening round of takeaways from a few coronary and structural trials presented during TCT 2023 that bring us new insights to consider for refining clinical practice.
AGENT IDE, the first trial in the U.S. to evaluate a drug-coated balloon (DCB) in the setting of coronary in-stent restenosis (ISR), showed the paclitaxel-coated balloon was superior to conventional balloon angioplasty for the primary endpoint of target lesion failure at one year (17.9% vs. 28.7%; p=0.006), driven by approximately 50% reductions in rates of target lesion revascularization and target vessel myocardial infarction (MI) in the AGENT DCB arm.
These results may expand options for patients with ISR, where the use of DCB for coronary intervention is not currently approved. Indeed, in presenting the findings, Robert W. Yeh, MD, MSc, MBA, FACC, noted that AGENT DCB is an U.S. Food and Drug (FDA)-designated breakthrough device and these trial findings will be the primary evidence used to support FDA approval. "Given the marked superiority over conventional balloon angioplasty at reducing recurrent events, the AGENT DCB is likely to become an important new treatment option for patients with coronary restenosis in the U.S.," he said.
While comparing DCB to angioplasty alone was a major limitation of AGENT IDE, this was addressed by the DCB-ACS trial, which explored DCBs as a potential strategy for treating patients with acute coronary syndrome (ACS) without a previous coronary intervention. The study revealed that DCBs were noninferior to drug-eluting stents (DES) in terms of the functional condition of the target lesion at nine months. However, the DCB group had a slightly higher in-segment diameter stenosis compared with the DES group with no difference in late lumen loss between the two groups with similar risk profiles for target lesion outcomes and patient-oriented composite endpoints at 12 months. The value of DCBs in ACS, in my view, resides in cases when shorter dual antiplatelet therapy (DAPT) is needed, patients at high bleeding risk and those with small luminal disease.
The five-year results from the PARTNER 3 Low-Risk follow-up study presented at TCT 2023 were consistent with the previously reported outcomes. In low-risk patients with severe, symptomatic aortic stenosis (AS), there was no difference with TAVR or surgical aortic valve replacement (SAVR) for the combined composite outcome of death, stroke or rehospitalization. Similarly, the four-year findings from the EVOLUT Low Risk trial showed the same favorable outcome of TAVR with self-expanding valves in low-risk populations compared with SAVR. These results continue to support the current guidelines. Two concerns persist – the durability of the valves and re-access to coronaries for future interventions – and no answers came from these new results. In the near future, I hope to see more results that speak to these concerns.
New to the space of aortic valve regurgitation is the ALIGN-AR trial which examined patients with severe aortic regurgitation (AR) and high surgical risk. The JenaValve Trilogy valve successfully met its 30-day safety goals and one-year efficacy goals for all-cause mortality. The hemodynamics of the valve and the rate of paravalvular leak was low in these patients. Furthermore, although the rate of new pacemaker implantation was close to 24% at the beginning of the trial, this rate decreased to 14% in the latter portion of enrolled patients.
Staying in the structural space, another study of interest is the VIVA trial which aimed to determine the optimal treatment for patients with severe AS with a small aortic annulus. At 30 days, there was no difference between the TAVR and SAVR groups for mortality and stroke rates, and at 60 days, no significant difference in terms of severe prosthesis-patient mismatch or moderate to severe AR. At two years, no significant between-group differences were seen for mortality, stroke or cardiac hospitalization. Based on these findings, the TAVR procedure may be making its way toward a new indication for patients with severe AS and a small annulus with no difference in hemodynamics and clinical events compared with SAVR. Root enlargement was done in less than 30% of patients in the SAVR group.
Visit ACC.org/TCT2023 for ACC's complete coverage including trial summaries, news stories, visual abstracts, videos and more.
To combine procedures, the WATCH-TAVR trial studied the safety and efficacy of concurrent TAVR and left atrial appendage occlusion (LAAO) using the WATCHMAN device in patients with atrial fibrillation (AFib). WATCHMAN LAAO plus TAVR was noninferior to TAVR with medical treatment in patients with severe AS and AFib. While a combined procedure may be more convenient than two separate procedures for patients, experts cautioned when presenting the results that the combined procedure should be performed at high-volume centers given the difference in the procedure's technique and setup across different centers.
A prespecified analysis from the TRILUMINATE Pivotal trial looked at the health status of patients with severe tricuspid regurgitation (TR) randomized to tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip system or medical therapy alone. Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess health status at baseline and at one, six and twelve months revealed that T-TEER was superior to medical therapy alone for the hierarchical composite endpoint of all-cause death or tricuspid-valve surgery, heart failure (HF) hospitalization and increase of ≥15 points on the KCCQ overall summary score, with a win-ratio of 1.48. Researchers noted this result was driven primarily by the health status results, with no meaningful between-group differences in mortality or HF hospitalization. These findings suggest that patients with lower baseline functional capacity with severe TR could be ideal candidates for T-TEER.
Staying in the tricuspid valve space, findings from the TRISCEND II trial suggest that transcatheter tricuspid valve replacement (TTVR) using the EVOQUE system effectively eliminated TR in most patients, including severe TR or torrential TR. TTVR led to significant improvements in functional status and symptoms at the six-month mark, consistent with the TRILUMINATE Pivotal trial. Other major clinical outcomes such as mortality and HF hospitalization rates will be studied once recruitment for the trial is complete which is aiming for 400 total patients.
Finally, one study worth mentioning related to the duration of antiplatelet therapy is T-PASS. This study investigated early discontinuation of aspirin after one month of DAPT (ticagrelor plus aspirin) after PCI with drug-eluting stenting and found it was noninferior to a standard 12-month regimen of DAPT for patients with ACS. At the one-year follow-up, discontinuing aspirin within one month and continuing with ticagrelor monotherapy was associated with lower rates of death, MI, stent thrombosis, stroke and major bleeding. The benefit of early discontinuation of aspirin was primarily due to a significant reduction in major bleeding events. While this may move us one step closer to earlier monotherapy after coronary intervention, it must be noted that the patients enrolled in T-PASS had lower risk profiles, which could limit this strategy to the patients at high thrombotic risk.
This article was authored by M. Chadi Alraies, MD, FACC, medical director of the cardiac catheterization laboratory, cardiac rehabilitation, and interventional cardiology research at Detroit Medical Center, Harper University Hospital, in Michigan.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Prevention
Keywords: ACC Publications, Cardiology Magazine, Drug-Eluting Stents, Secondary Prevention, Percutaneous Coronary Intervention, Myocardial Infarction, TCT23
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