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Randomized comparative trial of a thin‐strut bare metal cobalt‐chromium stent versus a sirolimus‐eluting stent for coronary revascularization
Author(s) -
Ortolani Paolo,
Marzocchi Antonio,
Marrozzini Cinzia,
Palmerini Tullio,
Saia Francesco,
Taglieri Nevio,
Aquilina Matteo,
Baldazzi Federica,
Silenzi Simona,
Cooke Robin M.T.,
Reggiani MariaLetizia Bacchi,
Branzi Angelo
Publication year - 2007
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.21011
Subject(s) - medicine , restenosis , stent , bare metal stent , sirolimus , coronary artery disease , cardiology , randomized controlled trial , revascularization , surgery , coronary arteries , bare metal , percutaneous coronary intervention , artery , radiology , drug eluting stent , myocardial infarction
OBJECTIVES: To see whether use of a sirolimus‐eluting stent (SES) is superior to a third‐generation thin‐strut, cobalt‐chromium stent (CCS) in terms of in‐segment late loss at 9 months in patients with symptomatic coronary artery disease. BACKGROUND: Stent‐strut thickness has been shown to be strictly related with risk of in‐stent restenosis, but available demonstrations of the angiographic efficacy of SES have been based on comparisons with thick‐strut bare metal control stents. METHODS: The primary outcome measure of this single‐center, single‐blind randomized comparative trial was 9‐month in‐segment late loss. Eligibility criteria were symptomatic coronary artery disease and target vessel diameter appropriate for implantation a 3‐mm stent. Based on a power calculation, 104 patients were randomly assigned to receive a SES (Cypher™) or a CCS (Vision™). RESULTS: In‐segment late loss was significantly lower in the SES group (0.18 ± 0.40 mm vs 0.58 ± 0.51 mm, P < 0.001). Regarding subsidiary outcome measures, in‐segment restenosis (at 9 months) was recorded in 10% (5/50) patients treated with SES and 23% (11/48) receiving CCS ( P = 0.14). No clinical difference between the two groups was apparent at 12 months. Freedom from target vessel failure at 12 months was 72% for SES patients and 68% for CCS patients ( P = 0.65). CONCLUSIONS: In patients with de‐novo coronary lesions at medium risk of restenosis the anti‐proliferative effect of SES is greater than that of a thin‐strut CCS. Nevertheless, the angiographic results of the CCS were rather good. It remains to be seen whether the angiographic superiority of SES can translate into clinical superiority. © 2007 Wiley‐Liss, Inc.