Document Type

Conference Proceeding

Publication Date


Publication Title

J Am Coll Cardiol


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

Methods: We 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 vs medical therapy. Given the large sample size differences between RCTs and registries, we focused on the absolute numbers and their clinical significance. We considered a 5% relative difference between groups to be potentially clinically relevant.

Results: From 2012 to 2022, 6 RCTs compared CTO PCI vs 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 vs 32.6 ± 23.0 mm, a relative difference of 9.2%) and lower J-CTO 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%).

Conclusion: There is a paucity of randomized data on CTO PCI outcomes (6 RCTs, 1,047 patients). 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.

Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP)





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