Abstracts from the current literature By Rex Pillai, MD; Roger Tomihama, MD; Justin Hernandez, MD This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians.
Drug-eluting resorbable scaffold versus angioplasty for infrapopliteal artery disease
N Engl J Med. 2024 Jan 4;390(1):9–19. doi: 10.1056/NEJMoa2305637. Epub 2023 Oct 25. PMID: 37888915.
Varcoe RL, DeRubertis BG, Kolluri R, Krishnan P, Metzger DC, Bonaca MP, Shishehbor MH, Holden AH, Bajakian DR, Garcia LA, Kum SWC, Rundback J, Armstrong E, Lee J-K, Khatib Y, Weinberg I, Garcia-Garcia HM, Ruster K, Teraphongphom NT, Zheng Y, Wang J, Jones-McMeans JM, Parikh SA, LIFE-BTK Investigators
Background: 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 using drug-eluting resorbable scaffolds on these outcomes remains unknown.
Methods: 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 end point was freedom from the following events at 1 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 end point was freedom from major adverse limb events at 6 months and from perioperative death.
Results: The primary efficacy end point 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% versus 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point 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.
Conclusions: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK
ClinicalTrials.gov number, NCT04227899.).
Single-session ablative transarterial radioembolization for patients with hepatocellular carcinoma to streamline care: An initial experience
Cardiovasc Intervent Radiol. 2024 Jul 8. doi: 10.1007/s00270-024- 03799-6. Online ahead of print. PMID: 38977445.
Berman ZT, Pianka K, Qaseem Y, Redmond J, Minocha J
Purpose: Transarterial radioembolization (TARE) for hepatocellular carcinoma (HCC) is performed after a mapping angiogram involving infusion of radiolabeled macroaggregated albumin to assess for non-target embolization and pulmonary shunting. The purpose of this case series was to evaluate the safety and feasibility of single- session TARE without the initial procedure.
Materials and methods: A single-institution case series of 16 consecutive procedures on 15 patients with 18 tumors who underwent an attempted single-session TARE procedure with glass microspheres are presented. A lung shunt fraction (LSF) of 5% was assumed for planning purposes.
Results: Sixty-seven percent (10 of 15) of patients were male with a median age of 72 years. Median tumor size was 2.5 cm (IQR 2.0–3.2 cm). Sixteen of the 18 targeted tumors were untreated prior to the single-session TARE. Rate of technical success was 88% (14 of 16). Two patients did not ultimately receive a single-session TARE due to intraprocedural findings. The mean administered activity was 2.0 GBq, and the mean MIRD dose was 464 Gy based on pre-treatment anatomic imaging and 800 Gy based on cone-beam CT. There were no cases of radiation pneumonitis. Mean post-procedural calculated lung dose was 4.9 Gy (range 3.1–9.3) based on SPECT.
Conclusions: An initial experience with single-session TARE using Y-90 glass microspheres without pre-procedural mapping angiography and lung shunt estimation demonstrates that it is a feasible and safe treatment option for select patients with small (< 5 cm) HCC.
Level of evidence iv: Level 4 case series.
34 IRQ | FALL 2024
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