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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.

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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