Gianluca Campo1, Matteo Tebaldi2, Pascal Vranckx3, Simone Biscaglia2, Carlo Tumscitz2, Roberto Ferrari4, Marco Valgimigli2. 1. Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy; Laboratorio per le Tecnologie delle Terapie Avanzate Center, Ferrara, Italy. Electronic address: cmpglc@unife.it. 2. Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy. 3. Virga Jesse Ziekenhuis, Hasselt, Belgium. 4. Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy; Cardiovascular Research Centre, Salvatore Maugeri Foundation, IRCCS, Lumezzane, Italy.
Abstract
OBJECTIVES: This study sought to investigate the clinical outcome of patients treated withpercutaneous coronary intervention (PCI) for in-stent restenosis (ISR) randomized to short (6 months) versus long (24 months) dual antiplatelet therapy (DAPT) regimen. BACKGROUND: It is still unclear if patients treated for ISR may benefit from a long DAPT regimen. METHODS: For the present purpose, we selected 224 patients undergoing the PCI procedure for ISR enrolled in the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial and randomized to short (6 months) versus long (24 months) DAPT regimen. The primary objective was the cumulative incidence of death, nonfatal myocardial infarction (MI), or cerebrovascular accident at 24 months. Safety endpoints were moderate and major bleeding complications. RESULTS: Overall, 114 patients were allocated to short DAPT regimen, whereas 110 patients were allocated to long DAPT regimen. Twenty-seven patients reached the primary endpoint (19 in short DAPT regimen vs. 8 in long DAPT regimen; p = 0.02). The cumulative incidence of the primary endpoint at 24 months was 16.7% in the short DAPT regimen group compared with 7.3% in the long DAPT regimen group (p = 0.034). This is principally due to a lower occurrence of death and MI in the long DAPT regimen group as compared to the short DAPT regimen group (6.5% vs. 15.5%; p = 0.03). There was no difference in the occurrence of bleeding complications between long and short DAPT regimen. CONCLUSIONS: Our study offers preliminary evidence that patients receiving a new PCI procedure for ISR may benefit from long-term administration of aspirin plus clopidogrel. (Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention [PRODIGY]; NCT00611286).
RCT Entities:
OBJECTIVES: This study sought to investigate the clinical outcome of patients treated with percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) randomized to short (6 months) versus long (24 months) dual antiplatelet therapy (DAPT) regimen. BACKGROUND: It is still unclear if patients treated for ISR may benefit from a long DAPT regimen. METHODS: For the present purpose, we selected 224 patients undergoing the PCI procedure for ISR enrolled in the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial and randomized to short (6 months) versus long (24 months) DAPT regimen. The primary objective was the cumulative incidence of death, nonfatal myocardial infarction (MI), or cerebrovascular accident at 24 months. Safety endpoints were moderate and major bleeding complications. RESULTS: Overall, 114 patients were allocated to short DAPT regimen, whereas 110 patients were allocated to long DAPT regimen. Twenty-seven patients reached the primary endpoint (19 in short DAPT regimen vs. 8 in long DAPT regimen; p = 0.02). The cumulative incidence of the primary endpoint at 24 months was 16.7% in the short DAPT regimen group compared with 7.3% in the long DAPT regimen group (p = 0.034). This is principally due to a lower occurrence of death and MI in the long DAPT regimen group as compared to the short DAPT regimen group (6.5% vs. 15.5%; p = 0.03). There was no difference in the occurrence of bleeding complications between long and short DAPT regimen. CONCLUSIONS: Our study offers preliminary evidence that patients receiving a new PCI procedure for ISR may benefit from long-term administration of aspirin plus clopidogrel. (Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention [PRODIGY]; NCT00611286).
Authors: Patrizia Natale; Suetonia C Palmer; Valeria M Saglimbene; Marinella Ruospo; Mona Razavian; Jonathan C Craig; Meg J Jardine; Angela C Webster; Giovanni Fm Strippoli Journal: Cochrane Database Syst Rev Date: 2022-02-28
Authors: Simone Biscaglia; Elisabetta Tonet; Rita Pavasini; Matteo Serenelli; Giulia Bugani; Paolo Cimaglia; Francesco Gallo; Giosafat Spitaleri; Annamaria Del Franco; Giorgio Aquila; Francesco Vieceli Dalla Sega; Matteo Tebaldi; Carlo Tumscitz; Roberto Ferrari; Gianluca Campo Journal: PLoS One Date: 2017-08-23 Impact factor: 3.240
Authors: Raphaela Lohaus; Jonathan Michel; Katharina Mayer; Anna Lena Lahmann; Robert A Byrne; Annabelle Wolk; Jurrien M Ten Berg; Franz-Josef Neumann; Yaling Han; Tom Adriaenssens; Ralph Tölg; Melchior Seyfarth; Michael Maeng; Bernhard Zrenner; Claudius Jacobshagen; Jochen Wöhrle; Sebastian Kufner; Tanja Morath; Tareq Ibrahim; Isabell Bernlochner; Marcus Fischer; Heribert Schunkert; Karl-Ludwig Laugwitz; Julinda Mehilli; Adnan Kastrati; Stefanie Schulz-Schüpke Journal: Sci Rep Date: 2016-09-14 Impact factor: 4.379