Impact of Subintimal Plaque Modification on Reattempted Chronic Total Occlusions Percutaneous Coronary Intervention

Effectiveness, safety, and patient reported outcomes of a planned investment procedure in higher‐risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest‐CTO study

“…Multiple dedicated CTO PCI registries have shown a strong association between procedural failure and occlusion complexity, with a success rate of ~75% when the J‐CTO score >2 4,13,14,21,37,49 . Looking retrospectively at registries where an unplanned “CTO modification procedure” was performed in some patients after initial unsuccessful CTO crossing, this was associated with higher procedural success on a subsequent attempt (87%–96% vs. 69–71%) 13,20,27,29,30 …”

“…4,13,14,21,37,49 Looking retrospectively at registries where an unplanned "CTO modification procedure" was performed in some patients after initial unsuccessful CTO crossing, this was associated with higher procedural success on a subsequent attempt (87%-96% vs. 69-71%). 13,20,27,29,30 The sample size calculation for the primary endpoint was based on an expected cumulative procedural success rate of 85% compared to a reference value of 78%. Using a one-sample proportion test with a onesided significance level of 0.05 and power (1-β) of 80%, a total of 190 subjects were required to test the hypothesis that the use of an investment procedure would achieve the performance goal.…”

“…28 Looking retrospectively at registries where an unplanned "CTO modification procedure" was performed, it appears to be safe and associated with higher subsequent procedural success (87%-96% vs. 69%-71%), shorter wire crossing, procedure and fluoroscopy time, and lower radiation and contrast dose during a second procedure. 13,20,27,29,30…”

“…Following unsuccessful CTO crossing, plaque modification of the occlusive segment is sometimes performed, with the intention to improve subsequent procedural success 13,16,19,26,27 . CTO ARC defined a “modification procedure” as modifying the proximal cap and CTO body when complete CTO recanalization could not be achieved at the index procedure, with a scheduled second procedure considered part of the initial therapeutic strategy 28 …”

“…25 Following unsuccessful CTO crossing, plaque modification of the occlusive segment is sometimes performed, with the intention to improve subsequent procedural success. 13,16,19,26,27 CTO ARC defined a "modification procedure" as modifying the proximal cap and CTO body when complete CTO recanalization could not be achieved at the index procedure, with a scheduled second procedure considered part of the initial therapeutic strategy. 28 Looking retrospectively at registries where an unplanned "CTO modification procedure" was performed, it appears to be safe and associated with higher subsequent procedural success (87%-96% vs. 69%-71%), shorter wire crossing, procedure and fluoroscopy time, and lower radiation and contrast dose during a second procedure.…”