Personalized or Standard Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: The PARTHENOPE Randomized Trial.
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Piccolo Raffaele, Calabrò Paolo, Carrara Greta, Simonetti Fiorenzo, Varricchio Attilio, Attisano Tiziana, Napolitano Giovanni, De Simone Ciro, Carpinella Gerardo, Stabile Eugenio, Cirillo Plinio, Di Serafino Luigi, Caiazzo Gianluca, Tesorio Tullio, Boccalatte Marco, Tuccillo Bernardino, Avvedimento Marisa, Leone Attilio, Galasso Gennaro, Cesaro Arturo, Perrotta Rocco, Niglio Tullio, Castiello Domenico Simone, Immobile Molaro Maddalena, Bardi Luca, Spinelli Alessandra, Cristiano Stefano, Bellino Michele, Leonardi Sergio, Biscaglia Simone, Costa Francesco, Cassese Salvatore, McFadden Eugene, Heg Dik, Stefanini Giulio G, Franzone Anna, Capodanno Davide, Esposito Giovanni, PARTHENOPE Study Group
Аннотация
OBJECTIVES: The authors performed a randomized trial comparing a personalized duration of DAPT, based on a risk score, for 3, 6, or 24 months with a standard duration of DAPT for 12 months after PCI.
METHODS: We randomly assigned 2,107 patients undergoing PCI to receive either a personalized or a standard DAPT. The primary endpoint was a net adverse clinical event (NACE) at 24 months, defined as the composite of all-cause death, myocardial infarction, stroke, urgent target vessel revascularization, or type 2, 3, or 5 bleeding according to the Bleeding Academic Research Consortium criteria.
RESULTS: At 24 months, NACE occurred in 196 of 1,055 patients (18.6%) in the personalized DAPT group and in 232 of 1,052 patients (22.2%) in the standard DAPT group (difference, 3.54 percentage points; 95% CI: -6.99 to -0.99; P = 0.040). This difference was mainly related to decreased rates of myocardial infarction (difference, -2.29 percentage points; 95% CI: -4.43 to -0.14) and urgent target vessel revascularization (difference, -1.30 percentage points; 95% CI: -2.55 to -0.05). Bleeding occurred at similar rates between the 2 groups (difference, -0.41 percentage points; 95% CI: -2.92 to 2.10).
CONCLUSIONS: In patients undergoing PCI, a personalized DAPT duration from 3 to 24 months based on a clinical risk score led to a lowered risk of NACE than standard care consisting of 12 months of DAPT. (Personalized Vs. Standard Duration of Dual Antiplatelet Therapy and New-generation Polymer-Free vs- Biodegradable-Polymer DES [PARTHENOPE]; NCT04135989).