Early vs Late Staged PCI After Subintimal Tracking and Re-Entry for Chronic Total Occlusions

BACKGROUND Subintimal tracking and re-entry (STAR) with staged stenting may increase the success and safety of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) when used as a bailout strategy. The optimal timing for staged stenting is unknown. OBJECTIVES In this study, the authors sought to evaluate the timing of staged PCI after STAR by randomizing to an earlier (5-7 weeks) or later (12-14 weeks) timeframe. METHODS Patients undergoing CTO PCI with the use of STAR (n = 150) were randomized at 6 centers to early or late staged PCI. The primary endpoint was partial technical success of the staged procedure, defined as TIMI flow grade 2-3 with <30% residual stenosis into at least 1 ≥2.5 mm distal branch. Study outcomes were compared between groups with the use of chi-square and Fisher exact tests. RESULTS Seventy-three patients were randomized to the early group and 77 to the late group. The mean Japanese-CTO score was 2.9 ± 1.1. Differences in the primary endpoint between the early group and the late group did not reach statistical significance (83.6% vs 71.4%; P = 0.08). TIMI flow grade 2-3 in the target vessel at the start of staged procedure was higher in the early group (64.4% vs 44.2%; P = 0.012; P = 0.048 after adjustment). CONCLUSIONS Among patients undergoing STAR with deferred stenting after an unsuccessful index CTO PCI attempt, the partial technical success rate of staged procedures was high. Although vessel patency was higher at the start of early staged procedures, there were no statistically significant differences for partial technical success of the staged procedure with early or late treatment. (STAR and Deferred Stenting Study [STAR]; NCT05089864).