Does a sirolimus-eluting iron scaffold cause more late lumen loss than everolimus stents for myocardial ischemia?
Late lumen loss (LLL) is a measure of how much the inside of a treated artery narrows over time after a stent is placed. More LLL can mean a higher chance of needing another procedure. The IRONMAN-II trial directly compared a new sirolimus-eluting iron bioresorbable scaffold (IBS) with a standard everolimus-eluting cobalt-chromium stent (CoCr-EES) in patients with myocardial ischemia. The trial found that the IBS had higher LLL at 2 years, meaning it did not keep the artery as open as the everolimus stent.
What the research says
The IRONMAN-II trial was a prospective, multicenter, single-blinded, noninferiority randomized trial across 36 centers in China. It included patients with myocardial ischemia and 1 or 2 de novo target lesions. Patients were randomly assigned to receive either the sirolimus-eluting iron bioresorbable scaffold (IBS) or the everolimus-eluting cobalt-chromium stent (CoCr-EES). The primary endpoint was 2-year angiographic in-segment late lumen loss (LLL). The results showed that the IBS had higher LLL compared to the CoCr-EES, meaning the IBS was associated with more narrowing of the artery over time 4. This finding is important because higher LLL can lead to a greater need for repeat procedures. The study also included optical coherence tomography (OCT) in a subset of patients and clinical follow-up for up to 5 years 4. Other sources in this set do not directly address this comparison. For example, one meta-analysis compared drug-coated balloons to drug-eluting stents, but not these specific devices 1. Another study focused on paclitaxel-coated balloons versus sirolimus-eluting stents in bifurcation lesions 3. The remaining sources cover unrelated topics such as skin cancer in transplant recipients 2, heart-brain interactions 5, eye disease 6, and leukemia treatment 78. Therefore, the best evidence for this question comes directly from the IRONMAN-II trial 4.
What to ask your doctor
- What are the differences in late lumen loss between bioresorbable scaffolds and standard drug-eluting stents?
- Based on the IRONMAN-II trial, how does the sirolimus-eluting iron scaffold compare to everolimus stents for my condition?
- What are the potential advantages and disadvantages of choosing a bioresorbable scaffold over a permanent stent?
- How does late lumen loss affect my long-term outlook and the need for future procedures?
- Are there any ongoing studies or newer devices that might offer better outcomes for myocardial ischemia?
This question is drawn from common patient questions about Cardiology and answered using cited medical research. We do not provide individualized advice.