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Meta-Analysis
. 2022 Jul 25;15(14):1441-1449.
doi: 10.1016/j.jcin.2022.05.023.

Comparative Analysis of Patient Characteristics in Chronic Total Occlusion Revascularization Studies: Trials vs Real-World Registries

Michael Megaly  1 , Kevin Buda  2 , Kambis Mashayekhi  3 , Gerald S Werner  4 , J Aaron Grantham  5 , Stephane Rinfret  6 , Margaret McEntegart  7 , Emmanouil S Brilakis  8 , Khaldoon Alaswad  9
Affiliations
Free article
Meta-Analysis

Comparative Analysis of Patient Characteristics in Chronic Total Occlusion Revascularization Studies: Trials vs Real-World Registries

Michael Megaly et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: The few randomized controlled trials (RCTs) on chronic total occlusion (CTO) percutaneous coronary intervention (PCI) are subject to selection bias.

Objectives: The purpose of this study was to evaluate the differences between real-world CTO patients and those enrolled in RCTs.

Methods: This study performed a meta-analysis of national and dedicated CTO PCI registries and compared patient characteristics and outcomes with those of RCTs that randomized patients to CTO PCI versus medical therapy. Given the large sample size differences between RCTs and registries, the study focused on the absolute numbers and their clinical significance. The study considered a 5% relative difference between groups to be potentially clinically relevant.

Results: From 2012 to 2022, 6 RCTs compared CTO PCI versus medical therapy (n = 1,047) and were compared with 15 registries (5 national and 10 dedicated CTO PCI registries). Compared with registry patients, RCT patients had fewer comorbidities, including diabetes, hypertension, previous myocardial infarction, and prior coronary artery bypass graft surgery. RCT patients had shorter CTO length (29.6 ± 19.7 mm vs 32.6 ± 23.0 mm, a relative difference of 9.2%) and lower Japan-Chronic Total Occlusion Score scores (2.0 ± 1.1 vs 2.3 ± 1.2, a relative difference of 13%) compared with those enrolled in dedicated CTO registries. Procedural success was similar between RCTs (84.5%) and dedicated CTO registries (81.4%) but was lower in national registries (63.9%).

Conclusions: There is a paucity of randomized data on CTO PCI outcomes (6 RCTs, n = 1,047). These patients have lower risk profiles and less complex CTOs than those in real-world registries. Current evidence from RCTs may not be representative of real-world patients and should be interpreted within its limitation.

Keywords: CTO; chronic total occlusion; percutaneous coronary intervention; randomized controlled trials; real-world data.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Mashayekhi has received consulting, speaker, or proctoring honoraria from Abbott Vascular, Abiomed, Ashai Intecc, AstraZeneca, Biotronik, Boston Scientific, Cardinal Health, Daiichi Sankyo, Medtronic, Shockwave Medical, Teleflex, and Terumo. Dr Grantham has received consulting fees and honoraria from Boston Scientific, Asahi Intecc, Medtronic, and Siemens Healthineers; and institutional research grants from Boston Scientific and Asahi Intecc. Dr Rinfret has served as a consultant for Boston Scientific, Abiomed, Abbott Vascular, and Soundbite Medical. Dr McEntegart has received consulting or speaker honoraria from Abbott Vascular, Biosensors, Boston Scientific, Medtronic, Shockwave Medical, and Teleflex. Dr Brilakis has received consulting or speaker honoraria from Abbott Vascular, the American Heart Association (associate editor Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, Cardiovascular Systems Inc, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; has received research support from Regeneron and Siemens; and is a shareholder in MHI Ventures. Dr Alaswad has received consulting or speaker honoraria from Boston Scientific, Cardiovascular Systems, LivaNova, and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

  • The Ultimate Trial of CTO Recanalization.
    Di Mario C, Ciardetti N. Di Mario C, et al. JACC Cardiovasc Interv. 2022 Jul 25;15(14):1450-1452. doi: 10.1016/j.jcin.2022.06.004. JACC Cardiovasc Interv. 2022. PMID: 35863794 No abstract available.

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