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 oriented 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.
Highlights
When decision has to be made about an eventual addition of a percutaneous coronary intervention (PCI) treatment to the medical treatment, knowledge of the balance between benefit and risk of adverse events is necessary to determine if PCI treatment would be advisable
The initial PCI cannot be held responsible for any subsequent adverse event! The clinical outcome related to the PCI-treatment has to concern the given lesion or vessel and must not involve other vessels or clinical consequences of disease stemming from untreated vessels
It shall again be emphasized, that our measure includes events that are traditionally left out. These two results support that the TOCO rate (TF-123) may serve as a measure that is obviously reflecting the real rate of genuine treatment failure
Summary
When decision has to be made about an eventual addition of a PCI treatment to the medical treatment, knowledge of the balance between benefit and risk of adverse events is necessary to determine if PCI treatment would be advisable. The clinical outcome related to the PCI-treatment has to concern the given lesion or vessel and must not involve other vessels or clinical consequences of disease stemming from untreated vessels. The Academic Research Consortium (ARC [1]) has recommended that the clinical outcome after PCI should be estimated by a patient oriented clinical outcome (POCO) measure consisting of adverse events in a combination of all cause death, any MI or any revascularization. The Major Adverse Cardiac Event (MACE) encompassing cardiac death, Myocardial Infarction (MI) and revascularization of the initially treated vessel (Target Vessel Revascularization, TVR) is not merely a measure of treatment failure but is rather reflecting both the treatment failures as well as further progression of atherosclerotic disease in previously untreated lesions as well as MI caused by occlusions of previously untreated vessels
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