TY - JOUR
T1 - Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy
T2 - Results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial
AU - Di Sciascio, Germano
AU - Patti, Giuseppe
AU - Pasceri, Vincenzo
AU - Colonna, Giuseppe
AU - Mangiacapra, Fabio
AU - Montinaro, Antonio
N1 - Funding Information:
One-month clinical follow-up was obtained by office visits in all study patients. Each patient gave informed consent to the study. The study complies with the Declaration of Helsinki and was approved by the Institutional Review Boards of the Institutions involved. The trial was not funded by the industry or other external sources, including grants; funding was derived entirely from internal sources of Campus Bio-Medico University.
PY - 2010/6
Y1 - 2010/6
N2 - Aims To evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy undergoing percutaneous coronary intervention (PCI). Methods and results Five hundred and three patients on >10 days clopidogrel therapy (41 with non-ST-segment elevation acute coronary syndrome, ACS) randomly received 600 mg clopidogrel loading 4-8 h before PCI (n = 252) or placebo (n = 251). Primary endpoint was 30-day incidence of major adverse cardiac events (MACE). In the overall population primary endpoint occurred in 6.7 of patients in the reload vs. 8.8 in the placebo arm [odds ratios (OR) 0.75, 95 confidence intervals (CI) 0.37-1.52; P = 0.50]. In stable angina patients, 1-month MACE were not significantly different (7.0 vs. 3.9; OR 1.84, 0.60-5.88; P = 0.36), whereas ACS patients had significant clinical benefit with reloading (6.4 vs. 16.3; OR 0.34, 95 CI 0.32-0.90, P = 0.033 at multivariable analysis; interaction test: P = 0.01). There was no excess bleeding in the reload arm (6 in both groups). Conclusion ARMYDA-4 RELOAD reveals no overall benefit from reloading patients on chronic clopidogrel therapy prior to PCI; the benefit observed in ACS patients is a hypothesis-generating finding that needs to be confirmed by larger studies.
AB - Aims To evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy undergoing percutaneous coronary intervention (PCI). Methods and results Five hundred and three patients on >10 days clopidogrel therapy (41 with non-ST-segment elevation acute coronary syndrome, ACS) randomly received 600 mg clopidogrel loading 4-8 h before PCI (n = 252) or placebo (n = 251). Primary endpoint was 30-day incidence of major adverse cardiac events (MACE). In the overall population primary endpoint occurred in 6.7 of patients in the reload vs. 8.8 in the placebo arm [odds ratios (OR) 0.75, 95 confidence intervals (CI) 0.37-1.52; P = 0.50]. In stable angina patients, 1-month MACE were not significantly different (7.0 vs. 3.9; OR 1.84, 0.60-5.88; P = 0.36), whereas ACS patients had significant clinical benefit with reloading (6.4 vs. 16.3; OR 0.34, 95 CI 0.32-0.90, P = 0.033 at multivariable analysis; interaction test: P = 0.01). There was no excess bleeding in the reload arm (6 in both groups). Conclusion ARMYDA-4 RELOAD reveals no overall benefit from reloading patients on chronic clopidogrel therapy prior to PCI; the benefit observed in ACS patients is a hypothesis-generating finding that needs to be confirmed by larger studies.
KW - Acute coronary syndromes
KW - Clopidogrel
KW - Percutaneous coronary intervention
KW - Stent
UR - https://www.scopus.com/pages/publications/77953178780
U2 - 10.1093/eurheartj/ehq081
DO - 10.1093/eurheartj/ehq081
M3 - Article
SN - 0195-668X
VL - 31
SP - 1337
EP - 1343
JO - European Heart Journal
JF - European Heart Journal
IS - 11
ER -