Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis.
OBJECTIVE
The objective of this study was to assess the non-inferiority, in terms of anti-restenotic efficacy, of both biodegradable-polymer (BP) and polymer-free (PF) stents compared with permanent-polymer rapamycin-eluting (PP; Cypher) stent.


RESULTS
Patients with de novo coronary lesions in native vessels were randomly assigned to receive a BP stent, a PF stent or a PP stent. The primary endpoint was in-stent late lumen loss at follow-up angiogram. A total of 605 patients were enrolled: 202 patients received BP stents, 202 were treated with PP stents, and 201 received PF stents. Repeat angiography was available for 492 patients (81.3%). Mean late lumen loss at 6-8-month angiographic follow-up was 0.17 +/- 0.45 mm in the BP stent group, 0.23 +/- 0.46 mm in the PP cohort, and 0.47 +/- 0.56 mm in the PF stent group. The BP stent met pre-specified criteria for non-inferiority (P < 0.001), whereas the PF stent did not (P = 0.94). There were no differences in safety outcomes.


CONCLUSIONS
Both BP and PF stents have a 1-year safety profile similar to that of the PP stent. Whereas the PF stent provided an inferior efficacy, the BP stent is at least as effective as the PP stent in terms of anti-restenotic efficacy.
Deutsches Herzzentrum and 1. Medizinische Klinik rechts der Isar, Technische Universität, Lazarettstrasse 36, 80636 Munich, Germany.
Julinda
J
Mehilli
Robert A
RA
Byrne
Anna
A
Wieczorek
Raisuke
R
Iijima
Stefanie
S
Schulz
Olga
O
Bruskina
Jürgen
J
Pache
Rainer
R
Wessely
Albert
A
Schömig
Adnan
A
Kastrati
D000368:Aged; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000188:drug therapy; D054855:Drug-Eluting Stents / Q000592:standards; D005260:Female; D006801:Humans; D008297:Male; D011108:Polymers; D011446:Prospective Studies; D011859:Radiography; D020123:Sirolimus / Q000627:therapeutic use*; D015607:Stents / Q000592:standards*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000627:therapeutic use*
D020099:Coated Materials, Biocompatible; D011108:Polymers; D050257:Tubulin Modulators; D020123:Sirolimus