CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Direct stenting of native de novo coronary artery lesions with the sirolimus-eluting stent
A post hoc subanalysis of the pooled E- and C-SIRIUS trials
Michael Schlüter, PhD*,
Joachim Schofer, MD*,*,
Anthony H. Gershlick, MD ,
Erick Schampaert, MD ,
William Wijns, MD ,
Günter Breithardt, MD, FACC|| for the E- and C-SIRIUS Investigators
* Center for Cardiology and Vascular Intervention, Hamburg, Germany
Glenfield Hospital, Leicester, United Kingdom
Hôpital du Sacré-Coeur de Montréal, Montréal, Canada
Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
|| Department of Cardiology and Angiology, Hospital of the University of Münster, Münster, Germany
Manuscript received June 21, 2004;
revised manuscript received September 1, 2004,
accepted September 13, 2004.
* Reprint requests and correspondence: Dr. Joachim Schofer, Othmarscher Kirchenweg 168, D-22763 Hamburg, Germany
(Email: schofer{at}center-for-cardiology.de).
OBJECTIVES: We sought to assess the impact of direct stenting (DS) using the sirolimus-eluting stent (SES) on angiographic and clinical outcomes.
BACKGROUND: The SES is superior to bare-metal stents in the treatment of native de novo coronary artery lesions in randomized, controlled trials.
METHODS: A post hoc analysis was performed on 225 patients (158 men; 62 ± 11 years old) who received SES in the pooled cohorts of the European and Canadian Sirolimus-Eluting Stent in Coronary Lesions (E-SIRIUS and C-SIRIUS, respectively) trials. Of these patients, 57 (25%) had undergone DS at the investigator's discretion. Lesion predilation preceded SES implantation in the remaining 168 patients.
RESULTS: Patient and lesion characteristics were no different between the two subgroups, except for a lower prevalence of moderate to severe lesion calcification (5% vs. predilation 19%, p = 0.017) and a lower baseline diameter stenosis (61.6% vs. predilation 68.1%, p < 0.001) in the DS subgroup. At eight months, in-lesion late loss (0.10 vs. 0.19 mm at predilation, p = 0.14) and in-lesion binary restenosis (2.0% vs. 6.1% at predilation, p = 0.46) tended to be lower after DS. Clinical follow-up at one year revealed non-significantly reduced incidences of target lesion revascularization (1.8% vs. 5.4% at predilation, p = 0.46) and major adverse cardiac events (5.3% vs. 8.9% at predilation, p = 0.57).
CONCLUSIONS: Direct SES deployment performed at the investigator's discretion was as safe and efficacious at mid-term follow-up as stenting preceded by lesion predilation.
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Abbreviations and Acronyms
| | CI = confidence interval | | C-SIRIUS = Canadian Sirolimus-Eluting Stent in Coronary Lesions trial | | DS = direct stenting | | E-SIRIUS = European Sirolimus-Eluting Stent in Coronary Lesions trial | | MACE = major adverse cardiac events | | MI = myocardial infarction | | MLD = minimum lumen diameter | | SES = sirolimus-eluting stent(s) | | SIRIUS = Sirolimus-Eluting Stent in Coronary Lesions trial | | TLR = target lesion revascularization |
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