Supraflex Cruz Stent Non-Inferior to Synergy at 1 Year in Multivessel TALENT Trial: TCT 2025
This news was covered by the Medical Dialogues Bureau, which was present at the TCT Conference 2025 held in San Francisco, USA.
The Supraflex Cruz sirolimus-eluting stent was found to be non-inferior to the everolimus-eluting Synergy stent for the 12-month patient-oriented composite endpoint (POCE) in patients with three-vessel coronary artery disease, according to results from the Multivessel TALENT trial presented by Patrick W. Serruys at TCT 2025.
Conducted across 54 sites, the Multivessel TALENT trial was a prospective, randomized, multicenter study enrolling 1,548 patients with de novo three-vessel disease without left-main involvement. Patients were randomized 1:1 to Supraflex Cruz (n=774) or Synergy (n=774). Eligibility was based on ≥50% angiographic stenosis and Heart Team approval. Quantitative flow ratio (QFR) and intravascular imaging were used for procedural guidance and optimization. The study was powered for non-inferiority of POCE at 12 months, with a non-inferiority margin of 4.28% and one-sided alpha of 5%.
Baseline demographics and comorbidities were similar between groups: mean age 68.2 vs 67.9 years, 74.9% vs 77.5% men, and diabetes in 36.0% vs 35.1% of patients. Median anatomical SYNTAX score was 20.0 in both arms. On average, 3.8 and 3.7 stents per patient were implanted, with total stent lengths of approximately 96 mm and 95 mm in the Supraflex and Synergy arms, respectively. Post-PCI intravascular imaging was performed in more than 93% of patients in both groups, and device success exceeded 97%. Median vessel QFR increased from 0.66–0.67 pre-PCI to 0.95 post-PCI in both arms. A total of 9,961 lesions were analyzed in the core lab review.
At one year, the primary endpoint (POCE: all-cause death, any myocardial infarction, any stroke, or any revascularization) occurred in 15.3% of Supraflex Cruz patients and 14.6% of Synergy patients. The absolute risk difference was 0.73%, meeting the prespecified criteria for non-inferiority. Using the assumed event rate (10.7%), the one-sided p-value for non-inferiority was 0.026; using the observed event rate (14.6%), the one-sided p-value was <0.001.
POCE excluding periprocedural MI (“NOBLE approach”) was 9.7% vs 9.2%. Individual clinical components were:
• All-cause death: 3.2% vs 2.9%
• Any MI: 10.1% vs 8.2%
• Any revascularization: 6.5% vs 6.9%
Device-oriented composite endpoint (DOCE) was 4.5% vs 4.1%. Bleeding occurred in 6.5% of patients in both groups. Subgroup analysis by anatomical SYNTAX score did not show treatment interaction. QFR-based core-lab assessment reclassified several visually diagnosed three-vessel cases into fewer-vessel disease categories.
Taken together, the 12-month findings support the clinical non-inferiority of Supraflex Cruz compared with Synergy in contemporary multivessel PCI, with low event rates and consistent outcomes across secondary endpoints.
Reference: Dr. Alexandre Abizaid, Best PCI practice in Three Vessel Disease Combining SYNTAX Score, CTO expertise, Angiography derived Physiology, Post PCI Intravascular Imaging and One Month DAPT: The Multivessel TALENT Randomized Trial comparing Supraflex Cruz stent and SYNERGY stent Best PCI practice in Three Vessel Disease, TCT Conference 2025, San Francisco.
https://www.tctconference.com/
About the Study Presenter: Professor Patrick Serruys is a world-renowned expert in interventional cardiology and imaging with more than four decades of experience in clinical trials and innovation in medicine. He has pioneered several interventional procedures and devices such as BMS, DES, BRS and TAVI as well as imaging techniques including quantitative coronary angiography, quantitative IVUS, OCT, near spectroscopy combined with IVUS.
Professor Serruys has conducted over 90 trials including over 191,000 patients including many interventional trials to assess the clinical benefit of coronary procedures.
In parallel he has developed interest for non-invasive imaging of coronary artery disease combining anatomy and functional assessments of CTA. For twenty years he was the chief of department of interventional cardiology at the Thoraxcenter Rotterdam. He has been awarded several gold medals including the ESC and ACC career achievements awards. He is the author and co-author of more than 4000 peer-reviewed publications and is the author, co-author and editor of more than 42 books including the textbook of the European Society of Cardiology.
