A Modified Treatment Failure Classification System with Complete and Exhaustive Accounting of Any Adverse Events Related to the Previous Percutaneous Coronary Intervention

Abstract

Objectives: To determine the clinical outcome related to treatment failure of the percutaneous coronary intervention (PCI) itself. Background: When considering the addition of PCI to the medical treatment of angina, it is necessary to know the balance between the benefit and the risk of the PCI itself, but the latter remains unknown. The usual outcome measures are imprecise because they contain events unrelated to the previous PCI and because some events clearly caused by PCI treatment failures are omitted. Methods: In total, 2098 unselected patients were randomized to receive either sirolimus-(n = 1065) or paclitaxel-(n = 1033) eluting coronary stents and followed for five years in the SORT OUT II. Any death, cardiac death, myocardial infarction (MI), stent thrombosis and documented stenosis was classified and combined to a "patient oriented clinical outcome" (POCO), the classical "major adverse cardiac events" (MACE) and the new "PCI-treatment * Corresponding author. A. M. Galløe et al. 406oriented clinical outcome" (TOCO). Results: POCO occurred in 746 patients (35.6%), MACE in 467 patients (22.3%) and TOCO in 293 patients (14.0%), thus TOCO amounted to 39% of the POCO and to 63% of the MACE. Conclusion: By introduction of the present PCI treatment failure classification system, the clinical outcome of PCI-treatment itself may be credulously estimated by the rate of TOCO and eventually PCI is substantially better than what might be perceived from the classically used POCO and MACE rates.