AIMS: This study assessed safety and efficacy of a third-generation distal protection device, MedNova CardioShield Bare Wire Myocardial Protection System, for treating Saphenous Vein Graft (SVG) disease.Treatment of SVG disease remains difficult, with increased adverse cardiac events (MACE) primarily manifested as no reflow and periprocedural infarction. Even with approved embolic protection devices, 30-day MACE rates are approximately 10%. METHODS AND RESULTS: A multicentre randomized clinical trial evaluated a third-generation distal protection device MedNova CardioShield vs Percusurge GuardWire in 652 patients undergoing treatment of SVG disease, using a primary endpoint of 30-day death, Q-wave, non-Q-wave infarction, or target vessel revascularisation (MACE).The primary endpoint occurred in 11.4% with CardioShield vs 9.1% with GuardWire (P=.37). Intention-to-treat analysis showed a strong trend for noninferiority (P=.057). Secondary modified intention-to-treat analysis including only patients receiving treatment device and no protocol deviation (defined as treatment of another lesion not using embolic protection) supported noninferiority of CardioShield (P=.022). CONCLUSION: Analysis of outcomes of treatment strategies for SVG disease is difficult. In this trial, final results depended on whether a patient actually received the device according to protocol. With 30-day MACE as primary endpoint, CardioShield was not demonstrated to be noninferior to GuardWire.
RCT Entities:
AIMS: This study assessed safety and efficacy of a third-generation distal protection device, MedNova CardioShield Bare Wire Myocardial Protection System, for treating Saphenous Vein Graft (SVG) disease.Treatment of SVG disease remains difficult, with increased adverse cardiac events (MACE) primarily manifested as no reflow and periprocedural infarction. Even with approved embolic protection devices, 30-day MACE rates are approximately 10%. METHODS AND RESULTS: A multicentre randomized clinical trial evaluated a third-generation distal protection device MedNova CardioShield vs Percusurge GuardWire in 652 patients undergoing treatment of SVG disease, using a primary endpoint of 30-day death, Q-wave, non-Q-wave infarction, or target vessel revascularisation (MACE).The primary endpoint occurred in 11.4% with CardioShield vs 9.1% with GuardWire (P=.37). Intention-to-treat analysis showed a strong trend for noninferiority (P=.057). Secondary modified intention-to-treat analysis including only patients receiving treatment device and no protocol deviation (defined as treatment of another lesion not using embolic protection) supported noninferiority of CardioShield (P=.022). CONCLUSION: Analysis of outcomes of treatment strategies for SVG disease is difficult. In this trial, final results depended on whether a patient actually received the device according to protocol. With 30-day MACE as primary endpoint, CardioShield was not demonstrated to be noninferior to GuardWire.