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.


Lancet. 2021 Jul 31;398(10298):403-415. doi: 10.1016/ S0140-6736(21)00766-2.


Central venous access devices for the delivery of systemic anticancer therapy (CAVA): A randomized controlled trial


Jonathan G. Moss, Olivia Wu, Andrew R. Bodenham, Roshan Agarwal, Tobias F. Menne, Brian L. Jones, Robert Heggie, Steve Hill, Judith Dixon-Hughes, Eileen Soulis, Evi Germeni, Susan Dillon, Elaine McCartney, CAVA trial group


Background: Hickman-type tunneled catheters (Hickman), peripherally inserted central catheters (PICCs) and totally implanted ports (PORTs) are used to deliver systemic anticancer treatment (SACT) via a central vein. We aimed to compare complication rates and costs of the three devices to establish acceptability, clinical effectiveness and cost- effectiveness of the devices for patients receiving SACT.


Methods: We did an open-label, multicenter, randomized controlled trial (Cancer and Venous Access [CAVA]) of three central venous access devices: PICCs vs. Hickman (noninferiority; 10% margin); PORTs vs. Hickman (superiority; 15% margin); and PORTs vs. PICCs (superiority; 15% margin). Adults (aged 18 years) receiving SACT (12 weeks) for solid or hematological malignancy from 18 oncology units in the United Kingdom were included. Four randomization options were available: Hickman vs. PICCs vs. PORTs (2:2:1), PICCs vs. Hickman (1:1), PORTs vs. Hickman (1:1) and PORTs vs. PICCs (1:1). Randomization was done using a minimization algorithm stratifying by center, body-mass index, type of cancer, device history and treatment mode. The primary outcome was complication rate (composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure and other) assessed until device removal, withdrawal from study or 1-year follow-up. This study is registered with ISRCTN, ISRCTN44504648.


Findings: Between Nov. 8, 2013, and Feb. 28, 2018, of 2,714 individuals screened for eligibility, 1,061 were enrolled and randomly assigned, contributing to the relevant comparison or comparisons (PICC vs. Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs. Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs. PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC). Similar complication rates were observed for PICCs (110 [52%] of 212) and Hickman (103 [49%] of 212). Although the observed difference was less than 10%, noninferiority of PICCs was not confirmed (odds ratio [OR] 1.15 [95% CI 0.78–1.71]) potentially


34 IRQ | FALL 2021


due to inadequate power. PORTs were superior to Hickman with a complication rate of 29% (73 of 253) vs. 43% (131 of 303; OR 0.54 [95% CI 0.37–0.77]). PORTs were superior to PICCs with a complication rate of 32% (47 of 147) vs. 47% (93 of 199; OR 0.52 [0.33–0.83]).


Interpretation: For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for solid tumors should receive a PORT within the U.K. National Health Service.


J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j. jacc.2021.05.003.


Total ischemic event reduction with rivaroxaban after peripheral arterial revascularization in the VOYAGER PAD trial


Rupert M. Bauersachs, Michael Szarek, Marianne Brodmann, Ivan Gudz , Eike Sebastian Debus, Mark R. Nehler, Sonia S. Anand, Manesh R. Patel, Connie N. Hess, Warren H. Capell, Kevin Rogers, Eva Muehlhofer, Lloyd P. Haskell, Scott D. Berkowitz, William R. Hiatt, Marc P. Bonaca, VOYAGER PAD Committees and Investigators


Background: Patients with peripheral artery disease (PAD) undergoing lower extremity revascularization (LER) are at high risk of major adverse limb and cardiovascular events. The VOYAGER PAD (efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with symptomatic peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities) trial demonstrated that rivaroxaban 2.5 mg twice daily reduced first events by 15%. The benefit of rivaroxaban on total (first and subsequent) events in this population is unknown.


Objectives: This study sought to evaluate the total burden of vascular events in patients with PAD after LER and the efficacy of low-dose rivaroxaban on total events.


Methods: VOYAGER PAD randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily plus aspirin or aspirin alone. The primary endpoint was time to first event of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke or cardiovascular death. The current analysis considered all events (first and subsequent) for components of the primary endpoint as well as additional vascular events including peripheral revascularizations and venous thromboembolism. HRs were estimated by marginal proportional hazards models.


Results: Among 6,564 randomized events, there were 4,714 total first and subsequent vascular events including 1,614 primary endpoint events and 3,100 other vascular events.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40