Time-Dependent Associations Between Actionable Bleeding, Coronary Thrombotic Events, and Mortality Following Percutaneous Coronary Intervention: Results From the PARIS Registry.

Baber, Usman; Dangas, George; Chandrasekhar, Jaya; Sartori, Samantha; Steg, Philippe Gabriel; Cohen, David J; Giustino, Gennaro; Ariti, Cono; Witzenbichler, Bernhard; Henry, Timothy D; Kini, Annapoorna S; Krucoff, Mitchell W; Gibson, C Michael; Chieffo, Alaide; Moliterno, David J; Weisz, Giora; Colombo, Antonio; Pocock, Stuart; Mehran, Roxana

OBJECTIVES The aim of this study was to examine the independent associations between actionable bleeding (AB) and coronary thrombotic events (CTE) on mortality risk after percutaneous coronary intervention (PCI). BACKGROUND The independent impact of AB and CTE on mortality risk after PCI remains poorly characterized. METHODS A post hoc analysis was conducted of the PARIS (Patterns of Non-Adherence to Dual Antiplatelet Therapy in Stented Patients) registry, a real-world cohort of 5,018 patients undergoing PCI with stent implantation. CTE included definite or probable stent thrombosis or myocardial infarction. AB was defined as Bleeding Academic Research Consortium type 2 or 3. Associations between CTE and AB, both of which were modeled as time-dependent covariates, and 2-year mortality risk were examined using extended Cox regression. RESULTS Over 2 years, the cumulative incidence of CTE, AB, and all-cause mortality was 5.9% (n = 289), 8.1% (n = 391), and 4.7% (n = 227), respectively. Adjusted hazard ratios for mortality associated with CTE and AB were 3.3 (95% confidence interval: 2.2 to 4.9) and 3.5 (95% confidence interval: 2.3 to 5.4), respectively. Temporal gradients in risk after either event were highest in the first 30 days and declined rapidly thereafter. Thrombotic events occurring while patients were on versus off dual-antiplatelet therapy were associated with a higher mortality risk, whereas risk related to AB was not influenced by dual-antiplatelet therapy status at the time of bleeding. CONCLUSIONS Intracoronary thrombosis and AB are associated with mortality risks of comparable magnitude over a 2-year period after PCI, findings that might inform risk/benefit calculations for extension versus discontinuation of dual-antiplatelet therapy.