TY - JOUR
T1 - DRainage Or Pericardiocentesis alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention
T2 - rationale and design of the DROP trial, a randomized, open-label, multicenter study
AU - Imazio, Massimo
AU - Belli, Riccardo
AU - Beqaraj, Federico
AU - Giammaria, Massimo
AU - Lestuzzi, Chiara
AU - Hoit, Brian
AU - LeWinter, Martin
AU - Spodick, David H.
AU - Adler, Yehuda
PY - 2014/6/1
Y1 - 2014/6/1
N2 - OBJECTIVES: Evidence to support the use of pericardial drainage instead of simple pericardiocentesis for nonmalignant pericardial effusions refractory to medical therapy is based on observational studies and experts' opinions, rather than randomized trials. The aim of the present trial is to fill this knowledge gap and to provide a stronger base of evidence to support a specific interventional treatment in this setting.METHODS: DRainage Or Pericardiocentesis (DROP) alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention is a randomized, open-label and multicenter study. The primary efficacy endpoints are the incidence of recurrent pericardial effusion, and the need for additional pericardiocentesis or cardiac surgery at 12 months. Secondary endpoints are hospital length stay, disease-related admission and overall mortality. Safety and complications rates of each intervention will be also assessed.IMPLICATIONS AND CONCLUSION: The DROP trial will be the first multicenter randomized trial to evaluate the efficacy and safety of pericardiocentesis versus pericardiocentesis and extended pericardial drainage for recurrent nonmalignant, nonbacterial pericardial effusions refractory to medical therapy and requiring interventional treatments (ClinicalTrials.gov Identifier: NCT01665495).
AB - OBJECTIVES: Evidence to support the use of pericardial drainage instead of simple pericardiocentesis for nonmalignant pericardial effusions refractory to medical therapy is based on observational studies and experts' opinions, rather than randomized trials. The aim of the present trial is to fill this knowledge gap and to provide a stronger base of evidence to support a specific interventional treatment in this setting.METHODS: DRainage Or Pericardiocentesis (DROP) alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention is a randomized, open-label and multicenter study. The primary efficacy endpoints are the incidence of recurrent pericardial effusion, and the need for additional pericardiocentesis or cardiac surgery at 12 months. Secondary endpoints are hospital length stay, disease-related admission and overall mortality. Safety and complications rates of each intervention will be also assessed.IMPLICATIONS AND CONCLUSION: The DROP trial will be the first multicenter randomized trial to evaluate the efficacy and safety of pericardiocentesis versus pericardiocentesis and extended pericardial drainage for recurrent nonmalignant, nonbacterial pericardial effusions refractory to medical therapy and requiring interventional treatments (ClinicalTrials.gov Identifier: NCT01665495).
UR - http://www.scopus.com/inward/record.url?scp=84925231390&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84925231390&partnerID=8YFLogxK
U2 - 10.2459/JCM.0b013e3283621d26
DO - 10.2459/JCM.0b013e3283621d26
M3 - Article
C2 - 23867908
AN - SCOPUS:84925231390
VL - 15
SP - 510
EP - 514
JO - Journal of Cardiovascular Medicine
JF - Journal of Cardiovascular Medicine
SN - 1558-2027
IS - 6
ER -