The study, conducted across 34 participating sites spanning Italy, Spain, and Poland, was unveiled during the ESC Congress 2023, marking a significant step for Supraflex Cruz in the interventional cardiology space
SMT (Sahajanand Medical Technologies), medical device company in India has announced late-breaking data of its stent Supraflex Cruz at the ESC Congress 2023.
The study, conducted across 34 participating sites spanning Italy, Spain, and Poland, was unveiled during the ESC Congress 2023, marking a significant step for Supraflex Cruz in the interventional cardiology space.
Principal Investigator Dr Simone Biscaglia from University Hospital of Ferrara, Italy presented primary endpoint data at one year from this study at the ESC Congress 2023. A total of 1445 older (at least 75 years of age) patients with MI (with or without ST-segment elevation) and multivessel disease were enrolled in this study from July 18, 2019, to October 25, 2021.
The study was an investigator-initiated, multicenter, prospective randomised (1:1) trial, to compare a strategy of physiology-guided complete myocardial revascularisation versus a culprit-only strategy.
Speaking more on the trial, Dr Biscaglia said, “Our landmark study published in the prestigious New England Journal of Medicine is an important step forward in interventional cardiology. We were extremely pleased to demonstrate that physiology-guided complete revascularisation with implantation of Supraflex Cruz stents led to a highly significant 27 per cent reduction in cardiovascular events.”
The primary end point was the patient-oriented composite end point (POCE) of all-cause death, any MI, any stroke, and any revascularisation at 1 year. Commenting more on the trial results, Study Chair Dr Gianluca Campo from the University Hospital of Ferrara, Italy said, “The FIRE trial addressed the lack of evidence for a revascularization strategy beyond culprit lesion treatment in older patients with a mean age of 81 years, with MI and multivessel disease. We proved our hypothesis that complete revascularization with Supraflex Cruz, guided by coronary physiology, yielded superior results to a culprit lesion only strategy in these patients.”
Chief Medical Officer at SMT, Dr Krishna Sudhir commented, “This trial is a game changer for the treatment of elderly patients with MI. At SMT we are delighted that Supraflex Cruz was chosen as the stent in the study and showed excellent results with low event rates in an extremely high risk group of patients, optimally treated with physiology-guided complete revascularisation.”
While complete revascularisation is well documented in younger MI patients, its applicability and advantages in older patients with MI who are prone to having a higher risk of complications has been uncertain until this trial. The findings will influence the interventional treatment of elderly patients with MI, driving physicians to optimally treat with complete revascularisation guided by physiology.