Abstracts from the current literature By Ripal T. Gandhi, MD, FSIR, and Suvranu Ganguli, MD, FSIR
This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians. If you would like to suggest abstracts you feel should be included, email us at
gandhi@baptisthealth.net or
suvranu.ganguli@
bmc.org.
Since 2013, Dr. Gandhi and Dr. Ganguli have been bringing quarterly updates on recent literature to the IR community. This will be their last issue. IR Quarterly thanks them for the excellence, energy and enthusiasm they have brought to this column for the last 11 years.
Drug-eluting resorbable scaff old versus angioplasty for infrapopliteal artery disease
N Engl J Med. 2023 Oct 25. doi: 10.1056/NEJMoa2305637. Online ahead of print.
Varcoe RL, DeRubertis BG, Kolluri R, Krishnan P, Metzger D, Bonaca MP, Shishehbor MH, Holden AH, Bajakian DR, Garcia LA, Kum SWC, Rundback J, Armstrong E, Lee JK, Khatib Y, Weiberg 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 eff ect of using drug-eluting resorbable scaff olds 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 scaff old or angioplasty. The primary effi cacy 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 effi cacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaff old group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate: 74% versus 44%; absolute diff erence, 30 percentage points; 95% confi dence 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 scaff old group and 90 of 90 patients in the angioplasty group (absolute diff erence, -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 patients in the scaff old 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 scaff old was superior to angioplasty with respect to the primary effi cacy end point. (Funded by Abbott; LIFE-BTK
ClinicalTrials.gov number, NCT04227899.).
Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomized, open-label, multicenter, phase 3 trial
Lancet. 2023 Oct 20. doi: 10.1016/S0140-6736. Online ahead of print.
Qin S, Chen M, Cheng AL, Kaseb AO, Kudi M, Lee HC, Yopp AC, Zhou J, Wang L, Wen X, Heo J, Tak WY, Nakamura S, Numata K, Uguen T, Hsiehchen D, Cha E, Hack SP, Lian Q, Ma N, Spahn JH, Wang Y, Wu C, Chow PKH, IMBrave050 Investigators
Background: No adjuvant treatment has been established for patients who remain at high risk for hepatocellular carcinoma recurrence after curative-intent resection or ablation. We aimed to assess the effi cacy of adjuvant atezolizumab plus bevacizumab versus active surveillance in patients with high- risk hepatocellular carcinoma.
Methods: In the global, open-label, phase 3 IMbrave050 study, adult patients with high-risk surgically resected or ablated hepatocellular carcinoma were recruited from 134 hospitals and medical centers in 26 countries in four WHO regions (European region, region of the Americas, South-East Asia region and Western Pacifi c region). Patients were randomly assigned in a 1:1 ratio via an interactive voice-web response system using permuted blocks, using a block size of 4, to receive intravenous 1200 mg atezolizumab plus 15 mg/kg bevacizumab every 3 weeks for 17 cycles (12 months) or to active surveillance. The primary endpoint was recurrence-free survival by independent review facility assessment in the intention-to-treat population. This trial is registered with
clinicaltrials.gov, NCT04102098.
Findings: The intention-to-treat population included 668 patients randomly assigned between Dec. 31, 2019, and Nov. 25, 2021, to either atezolizumab plus bevacizumab (n=334) or to active surveillance (n=334). At the prespecifi ed interim analysis (Oct. 21, 2022), median duration of follow-up was 17.4 months (IQR 13.9–22.1). Adjuvant atezolizumab plus bevacizumab was associated with signifi cantly improved recurrence-free survival (median, not evaluable [NE]; 95% CI 22.1–NE) compared with active surveillance (median, NE [21.4–NE]; hazard ratio, 0.72 [adjusted 95% CI 0.53–0.98]; p=0·012). Grade 3 or 4 adverse events occurred in 136 (41%) of 332 patients who received atezolizumab plus bevacizumab and 44 (13%) of 330 patients in the active surveillance group. Grade 5 adverse events occurred in six patients (2%, two of which were treatment related) in the atezolizumab plus bevacizumab group, and one patient (<1%) in the active surveillance group. Both atezolizumab and
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