Objective Performance Goals Based on a Systematic Review and Meta-Analysis of Clinical Outcomes for Bare-Metal Stents and Percutaneous Transluminal Angioplasty for Hemodialysis-Related Central Venous Obstruction.

Autor:	Razavi MK; St. Joseph Heart and Vascular Center, Orange, California. Electronic address: mrazavi@pacbell.net., Rajan DK; University Medical Imaging Toronto/University of Toronto, Toronto, Ontario, Canada., Nordhausen CT; Merit Medical Systems, Inc., South Jordan, Utah., Bounsanga J; Merit Medical Systems, Inc., South Jordan, Utah., Holden A; Auckland City Hospital, Auckland, New Zealand.
Jazyk:	angličtina
Zdroj:	Journal of vascular and interventional radiology : JVIR [J Vasc Interv Radiol] 2023 Oct; Vol. 34 (10), pp. 1664-1673.e3. Date of Electronic Publication: 2023 Jun 09.
DOI:	10.1016/j.jvir.2023.05.036
Abstrakt:	Purpose: To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs). Methods: A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the upper and lower bounds of the 95% confidence intervals for primary patency and SAE rates. Results: Of 66 articles reviewed, 17 met the inclusion criteria (PTA, n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6- and 12-month primary patency rates for PTA were 50.9% and 36.7%, respectively. Based on these findings, the proposed 6- and 12-month primary patency OPGs identifying superiority against PTA were 66.5% and 52.6%, respectively, and those for noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6- and 12-month primary patency rates were 69.7% and 47.9%, respectively. The proposed 6- and 12-month primary patency OPGs identifying superiority were 82.1% and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, respectively. Proposed safety OPGs for noninferiority versus superiority for PTA and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively. Conclusion: The OPGs derived from real-world studies of PTA and stent placement may serve as a benchmark for future interventions indicated for this patient population. (Copyright © 2023 SIR. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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