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 sganguli@mgh.harvard.edu.


Circulation. 2020 Jun 9;141(23):1859-1869. doi: 10.1161/ CIRCULATIONAHA.119.044697. Epub 2020 May 6.


Mortality and paclitaxel-coated devices: An individual patient data meta-analysis.


Krishna J Rocha-Singh, Sue Duval, Michael R Jaff, Peter A Schneider, Gary M Ansel, Sean P Lyden, Christopher M Mullin, John P A Ioannidis, Sanjay Misra, Abraham R Tzafriri, Elazer R Edelman, Juan F Granada, Christopher J White, Joshua A Beckman, VIVA Physicians, Inc.


Background: Paclitaxel-containing devices (PTXDs) significantly reduce reintervention in patients with symptomatic femoropopliteal peripheral artery disease. A recent aggregate-data meta-analysis reported increased late mortality in patients with peripheral artery disease treated with PTXDs. We performed an individual patient data meta-analysis to evaluate mortality.


Methods: Manufacturers of U.S. Food and Drug Administration- approved and commercially available devices in the United States provided deidentified individual patient data for independent analysis. Cox proportional hazards 1-stage meta- analysis models using intention-to-treat methods were used for the primary analysis. A secondary analysis of recovered missing vital status data was performed. The impact of control crossover to PTXDs, cause-specific mortality and drug dose mortality were assessed.


Results: A total of 2,185 subjects and 386 deaths from eight PTXD trials with 4-year median follow-up were identified. The primary analysis indicated a 38% (95% CI, 6%–80%) increased relative mortality risk, corresponding to 4.6% absolute increase, at 5 years associated with PTXD use. Control and treatment arm loss to follow-up and withdrawal were 24% and 23%, respectively. With inclusion of recovered vital status data, the excess relative mortality risk was 27% (95% CI, 3%–58%). This observation was consistent across various scenarios, including as-treated analyses, with no evidence of increased risk over time with PTXDs. Mortality risk tended to be increased for all major causes of death. There were no subgroup differences. No drug dose–mortality association was identified.


Conclusions: This individual patient data meta-analysis, based on the most complete available data set of mortality events from PTXD randomized controlled trials, identified an absolute 4.6% increased mortality risk associated with PTXD use.


N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/ NEJMoa1915745.


Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma.


Richard S Finn, Shukui Qin, Masafumi Ikeda, Peter R Galle, Michel Ducreux, Tae-You Kim, Masatoshi Kudo, Valeriy Breder, Philippe Merle, Ahmed O Kaseb, Daneng Li, Wendy Verret, Derek-Zhen Xu, Sairy Hernandez, Juan Liu, Chen Huang, Sohail Mulla, Yulei Wang, Ho Yeong Lim, Andrew X Zhu, Ann-Lii Cheng, IMbrave150 Investigators


Background: The combination of atezolizumab and bevacizumab showed encouraging antitumor activity and safety in a phase 1b trial involving patients with unresectable hepatocellular carcinoma.


Methods: In a global, open-label, phase 3 trial, patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment were randomly assigned in a 2:1 ratio to receive either atezolizumab plus bevacizumab or sorafenib until unacceptable toxic effects occurred or there was a loss of clinical benefit. The co-primary end points were overall survival and progression-free survival in the intention-to-treat population, as assessed at an independent review facility according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).


Results: The intention-to-treat population included 336 patients in the atezolizumab-bevacizumab group and 165 patients in the sorafenib group. At the time of the primary analysis (Aug. 29, 2019), the hazard ratio for death with atezolizumab-bevacizumab as compared with sorafenib was 0.58 (95% confidence interval [CI], 0.42–0.79; P<0.001). Overall survival at 12 months was 67.2% (95% CI, 61.3–73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2–64.0) with sorafenib. Median progression-free survival was 6.8 months (95% CI, 5.7–8.3) and 4.3 months (95% CI, 4.0–5.6) in the respective groups (hazard ratio for disease progression or death, 0.59; 95% CI, 0.47–0.76; P<0.001). Grade 3 or 4 adverse events occurred in 56.5% of 329 patients who received at least one dose of atezolizumab-bevacizumab and in 55.1% of 156 patients who received at least one dose of sorafenib. Grade 3 or 4 hypertension occurred in 15.2% of patients in the atezolizumab-bevacizumab group; however, other high-grade toxic effects were infrequent.


Conclusions: In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival outcomes than sorafenib. (Funded by F. Hoffmann-La Roche/Genentech; ClinicalTrials.gov number, NCT03434379.)


36 IRQ | FALL 2020


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