Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, NEJMoa2305637. https://doi.org/10.1056/NEJMoa2305637 Dr. Ramon L. Varcoe et al.
Points
- A randomized controlled trial compared everolimus-eluting resorbable scaffolds to angioplasty in patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease.
- The study found that using everolimus-eluting resorbable scaffolds was superior to angioplasty in achieving the primary efficacy endpoint, which included freedom from amputation, occlusion, revascularization, and restenosis.
- Among patients in the scaffold group, 74% achieved freedom from events compared to 44% in the angioplasty group.
- The primary safety endpoint, freedom from major adverse limb events, was similar between the two groups.
- Serious adverse events related to the index procedure were rare in both the scaffold and angioplasty groups.
Summary
Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of drug-eluting resorbable scaffolds on these outcomes remains unknown.
In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy endpoint was freedom from the following events at one year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety endpoint was freedom from major adverse limb events at six months and perioperative death.
The primary efficacy endpoint was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety endpoint was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group.
Among patients with CLTI due to infrapopliteal artery disease, using an everolimus-eluting resorbable scaffold was superior to angioplasty concerning the primary efficacy endpoint. Freedom from amputation, occlusion, revascularization, and restenosis was significantly higher in the scaffold group compared to the angioplasty group (74% vs. 44%). The scaffold group also demonstrated a lower rate of major adverse limb events (165 out of 170 patients) than the angioplasty group (90 out of 90 patients). Serious adverse events related to the index procedure were rare in both groups, occurring in 2% of the patients in the scaffold group and 3% in the angioplasty group. These findings suggest that using everolimus-eluting resorbable scaffolds may improve outcomes for patients with CLTI and infrapopliteal artery disease.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2305637
References Varcoe, R. L., DeRubertis, B. G., Kolluri, R., Krishnan, P., Metzger, D. C., Bonaca, M. P., Shishehbor, M. H., Holden, A. H., Bajakian, D. R., Garcia, L. A., Kum, S. W. C., Rundback, J., Armstrong, E., Lee, J.-K., Khatib, Y., Weinberg, I., Garcia-Garcia, H. M., Ruster, K., Teraphongphom, N. T., … Parikh, S. A. (2023). Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. New England Journal of Medicine, NEJMoa2305637. https://doi.org/10.1056/NEJMoa2305637
