The PARAGON stent study: A randomized trial of a new martensitic nitinol stent versus the Palmaz-Schatz stent for treatment of complex native coronary arterial lesions

A new martensitic nitinol stent with improved flexibility and radiopacity w as tested to evaluate whether these differences improve initial or long-ter m outcome. Patients who underwent percutaneous revascularization of a discr ete native coronary lesion were randomly assigned to the new stent (PARAGON , n = 349) or to the first-generation Palmaz-Schatz (PS) stent in = 339). T he primary end point was target vessel failure at 6 months (a composite of cardiac or noncardiac death, any infarction in the distribution of the trea ted vessel, or clinically indicated target vessel revascularization). Secon dary end points were, among others, device and procedural success and angio graphic restenosis. Mean age was 62 years; diabetes was present in 21% of p atients, prior bypass surgery in 6%, and recent infarction in 22% Ip = NS f or comparison between the 2 randomized arms). The PARAGON stent group had s maller reference vessels (2.97 vs 3.05 mm, p = 0.05), more prior restenosis (8.0% vs 4.5%, p = 0.07), and a longer overage stent length (21.3 vs 19.4 mm, p <0.05). Device success was significantly higher in the PARAGON arm (9 9.1% vs 94.3%, p <0.05). Death and infarction at 6-month follow-up were inf requent in both groups. There was no significant difference in death (2.0% vs 1.2%, p 0.546), but a higher rate of infarction for the PARAGON cohort ( 9.2% vs 4.7%, p = 0.025). Although target vessel failure (20.3% vs 12.4%, p = 0.005) and target lesion revascularization (12.0% vs 5.9%, p = 0.005) we re higher in the PARAGON group, there was no significant difference in 6-mo nth follow-up in in-stent minimal lumen diameter or in the rate of binary a ngiographic restenosis. Both PARAGON and PS stents are safe and associated with infrequent adverse events. The PARAGON stent can be delivered more fre quently than the first-generation PS stent. Although there was no significa nt difference in in-stent minimal lumen diameter or the frequency of angiog raphic restenosis, clinical restenosis was more frequent in the PARAGON gro up. (C) 2000 by Excerpta Medico, Inc.