title: The fate of patients with clinical recurrence after sirolimus-eluting stent implantation (a two-year follow-up analysis from the SIRIUS trial).
abstract: Although clinical outcomes after sirolimus-eluting stents (SESs) have been previously described ("primary" success rates), the fate of patients whose SES implantation fail and who require ischemia-driven target lesion revascularization is poorly understood. The SIRIUS trial is a prospective, randomized, clinical trial that includes 533 evaluable patients with SESs. Twenty-two of these patients had adjudicated ischemia-driven target lesion revascularization (4.1%) within the first year of follow-up and comprised the study population of this analysis. Of these patients, 11 (50%) had diabetes, and restenotic lesions were focal and located at the proximal stent edge in 91% and 73% of patients, respectively. Restenosis was treated with bare metal stent implantation, balloon dilatation, or intravascular brachytherapy in 82%, 13.5%, and 4.5% of patients, respectively. At 1-year follow-up after the first recurrence (2-year follow-up after the index procedure), only 5 of these patients (23%) required a second repeat revascularization procedure. Risk factors for a second recurrence after treatment of SES restenosis were female gender, long lesions that required long stents at the index procedure, and an early first recurrence. In conclusion, SES failure treated with traditional percutaneous coronary intervention yielded good outcome at 1-year follow-up (secondary failure rate only 23%), perhaps due to the focal nature of the SES restenotic lesion. Future studies should evaluate other methods, including drug-eluting stents, to further optimize the outcome of treatment of SES failures.
authors.affiliation: Columbia University Medical Center-New York Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York, USA. imoussa@crf.org
authors.forename: Issam D
authors.initials: ID
authors.lastname: Moussa
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Richard E
authors.initials: RE
authors.lastname: Kuntz
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: S Chiu
authors.initials: SC
authors.lastname: Wong
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000401:mortality*; D023921:Coronary Stenosis / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000494:pharmacology*; D015607:Stents; D015996:Survival Rate; D017211:Treatment Failure
chemical_list: D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D020123:Sirolimus