FIRE Trial Shows Supraflex Cruz Stent Reduces Cardiovascular Events in Elderly Heart Attack Patients
核心洞察
The FIRE Trial demonstrated that physiology-guided complete revascularization using Supraflex Cruz (搜索) drug-eluting stents significantly reduced cardiovascular events compared to culprit-only treatment in elderly myocardial infarction (搜索) patients.
The 3-year follow-up data from 1,445 patients aged 75 and older showed consistently low stent thrombosis (搜索) rates of 1.03% at 1 year and 1.17% at 3 years.
Results presented at ESC 2025 confirmed sustained benefits over three years, with reduced risk of death, MI, stroke (搜索), and revascularization in high-risk elderly patients with multivessel disease (搜索).
Sahajanand Medical Technologies (搜索) (SMT (搜索)) announced positive 3-year results from the FIRE Trial at ESC 2025, demonstrating the safety and efficacy of its Supraflex Cruz (搜索) drug-eluting stent in patients aged 75 years and older with myocardial infarction (搜索) and multivessel disease (搜索). The study provides compelling evidence for physiology-guided complete revascularization strategies in elderly high-risk patients.
Trial Design and Patient Population
The FIRE Trial evaluated revascularization strategies in elderly MI patients with multivessel disease (搜索) across 1,445 patients at 34 centers in Italy, Spain, and Poland. Patients were randomized to receive either functionally guided complete revascularization or culprit-only treatment, with Supraflex Cruz (搜索) as the designated stent. The primary endpoint was a patient-oriented composite of all-cause death, MI, stroke (搜索), and revascularization, assessed over three years.
Key Clinical Outcomes
At 3-year follow-up, physiology-guided complete revascularization demonstrated superior outcomes compared to culprit-only revascularization strategy, with reduced risk of both primary and key secondary endpoints. The trial showed consistently low stent thrombosis (搜索) rates of 1.03% at 1 year and 1.17% at 3 years, along with a lowered risk of adverse cardiovascular events.
"The FIRE trial demonstrates that physiology-guided complete revascularization using Supraflex Cruz (搜索) lowered the risk of a composite endpoint of death, MI, stroke (搜索), or ischemia-driven revascularization compared to a culprit-only approach," stated Prof. Gianluca Campo, Study Chair. "Importantly, these benefits were sustained over 3 years, with a very low rate of stent thrombosis (搜索) at both 1 and 3 years, highlighting the safety and reliability of Supraflex Cruz in elderly patients with multivessel disease (搜索)."
Clinical Significance for Elderly Patients
Dr. Simone Biscaglia, Principal Investigator, emphasized the importance of these findings for elderly patients: "The FIRE trial shows that physiology-guided complete revascularization with Supraflex Cruz (搜索) offers benefits in elderly MI patients with multivessel disease (搜索). It reduced primary endpoints versus a culprit-only approach, with sustained benefits over three years and very low stent thrombosis (搜索) rates, confirming the safety and efficacy of Supraflex Cruz."
Broader Clinical Evidence
Dr. Krishna Sudhir, Chief Medical Officer at SMT (搜索), noted that these results reinforce existing evidence: "The FIRE Trial reinforces evidence from TALENT, COMPARE 60/80, and other studies showing Supraflex Cruz (搜索) consistently delivers positive outcomes in high-risk patients. With safety and enhanced deliverability, Supraflex Cruz continues to set benchmarks in coronary care globally."
Device Technology
Supraflex Cruz (搜索) belongs to the Supraflex family of drug-eluting stents, which have been proven clinically safe and effective through multiple clinical trials including the TALENT trial. SMT (搜索) was the first company worldwide to receive CE certification for a drug-eluting stent with a biodegradable polymer, and maintains a global presence in more than 75 countries.