5 takeaways from late-breaking studies at EuroPCR
The Society for Cardiovascular Angiography and Interventions (SCAI) offered its top five key takeaways from the late-breaking studies presented at the EuroPCR 2024 meeting May 14-17 in Paris.
The four-day interventional cardiology conference featured 12,100 participants, more than 550 educational sessions and 12 live cases.
Early Outcomes of a Randomized Non-Inferiority Trial Comparing TAVI Devices: The LANDMARK Trial
The developing world has an epidemic of heart disease, and alternative options may help with delivery of care and cost. The LANDMARK trial looks at the latest balloon expandable platform, Myval, which was developed in India as an alternative transcatheter aortic valve replacement (TAVR) valve. The study, which was done as a non-inferiority trial, compared Myval to the Edwards and Medtronic TAVR systems. The study included 384 patients that were randomized to contemporary treatment with Medtronic or Edwards, or Myval.
Despite good performing and well researched TAVR systems made by western nations already being available on the market, there is a need for alternative options that can offer delivery of care at a lower cost. The Myval is unique in that it offers more device sizing increments of 1.5 mm than the Edwards or Medtronic devices. This allows TAVR devices to be better tailored to patients’ anatomy.
"Non-inferiority was reached in all of the primary endpoints. Of interest, there were much fewer post-dilations done with the Myval system in 38 patients compared to 80 patients in the Edwards and Medtronic arms. It is hypothesized that the better available size options were the reason behind this finding," explained Brian C. Kolski, MD, director of the Orange County Heart Institute noninvasive vascular lab, who reviewed the study for SCAI.
First TAVI vs. SAVR Randomized Trial in Younger Low-Risk Patients With Severe Tricuspid or Bicuspid Aortic Valve Stenosis: Results From NOTION-2
This study at EuroPCR explored the clinical outcomes in low-risk and young (75 years or younger) aortic stenosis (AS) patients treated with TAVR and surgical aortic valve replacement (SAVR), including those with both tricuspid and bicuspid AS.
Prior studies comparing low-risk patients such as PARTNER 3, Evolut Low-risk, and NOTION trials demonstrated similar or lower mortality and stroke with TAVR when compared to SAVR. However, a significant portion of the patients in the trial were older than 75, and bicuspid AS patients were excluded. This study included 370 bicuspid patients randomized to TAVR (n=187) and SAVR (n=183),
"There is clinical equipoise for TAVR Vs. SAVR in the overall study cohort of low-risk, young patients (≤75yrs old) concerning death, stroke, or rehospitalization at one year. TAVR was associated with higher non-disabling stroke and moderate or greater paravalvular regurgitation. However, the difference was contributed by the higher rate of events in bicuspid TAVR cohort," explained Ajoe John Kattoor, MBBS, FSCAI, a member of the SCAI Communications Committee who looked at the study.
Long-Term Outcomes of Transcatheter Aortic Valve vs. Surgical Aortic Valve Replacement
A new study published in JSCAI and presented at EuroPCR demonstrates the long-term safety and efficacy of TAVR compared to SAVR. This meta-analysis included 7 trials with 7,785 patients.
"There was no significant difference in death or disabling stroke in TAVR patients as compared to SAVR patients, and there were no significant differences in mortality between the TAVR patients and SAVR patients," explained Sanjeev Nair, MD, FSCAI, interventional cardiologist and a study reviewer for SCAI.
The study found TAVR did result in higher pacemaker rates, and that self-expandable valves had a significantly higher rate than balloon-expandable valves. There were also more moderate-to-severe paravalvular leaks compared to SAVR.
OCT vs. Angiography for Guidance of Calcified Lesions PCI: The CALIPSO Trial
The use of optical coherence tomography (OCT) for plaque characterization and preparation guidance has been advocated for versus conventional methods to improve calcified lesions percutaneous coronary intervention (PCI) outcomes. The CALIPSO trial aimed to assess the technical outcome superiority of OCT over angiography alone for calcified lesions PCI guidance.
The CALIPSO trial shows that OCT guidance resulted in better stent implantation than angiographic guidance alone, without any safety concerns. However, whether this technical superiority in terms of imaging endpoints will translate into clinical benefit should be assessed in future studies.
One-Month DAPT Followed by 5-Month Ticagrelor Monotherapy in Acute Coronary Syndromes With DCB
Patients treated with drug-coated balloons (DCB) theoretically require less intense antiplatelet therapy. However, to date, there are no randomized data exploring the tailored antiplatelet strategies or clinical guideline recommendations for these patients. The study presented at EuroPCR was an open-label, investigator-initiated, noninferiority trial at 41 sites in China.
The REC-CAGEFREE II study is the first randomized controlled trial investigating a tailored antiplatelet strategy for DCB-treated patients. At 12-month follow-up among 1,948 patients who were treated exclusively by paclitaxel-coated balloon angioplasty, the stepwise DAPT de-escalation therapy using one-month DAPT with aspirin and ticagrelor followed by five months of ticagrelor monotherapy and then aspirin was noninferior to standard ticagrelor-based DAPT for 12 months in terms of a composite endpoint of all-cause death, myocardial infarction, stroke, revascularization and BARC type 3 or 5 bleeding.
"When considering all clinically relevant ischemic or bleeding events, stepwise DAPT de-escalation tended to exhibit greater overall benefit than standard 12-month DAPT, explained Emad Abdel Hay, MD, FSCAI, Mahalla Cardiac Center in Egypt, who reviewed the study for SCAI.
Watch an overview of coronary interventions highlights at EuroPCR 2024
Watch a video overview of interventions for valvular disease at EuroPCR 2024
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com