Promising, but still a matter of debate.
Several trials failed to demonstrate the efficacy of plaque modification device in patients with severely calcified coronary lesions. Safety and efficacy of the Diamondback 360® Coronary OAS have been demonstrated by the ORBIT II trial. The 2-year follow-up of the ORBIT II trial extends the favorable results previously shown at 30-day and 1-year follow-up. The single arm, non-randomized character of the trial with indirect historical comparison may restrict the results to hypothesis generating and entail further prospective randomized trials.
Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Yohei
Y
Sotomi
NHLI, Imperial College London, London, United Kingdom. patrick.w.j.c.serruys@gmail.com.
Patrick W
PW
Serruys
D017225:Atherectomy, Coronary / Q000295:instrumentation*; D003324:Coronary Artery Disease; D006801:Humans; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011446:Prospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D061205:Vascular Calcification