Clinical and angiographic results with the beStent: The Registry for Optimal beStent Evaluation (ROSE) trial

H. Suryapranata, J. L. Boland, M. Pieper, V. L. Legrand, J. J R M Bonnier, J. M. Juliard, M. C M Vrolix, R. Seabra-Gomes, J. N. Hamburger, A. Roguin, C. Oosterwijk, G. A. Van Es, R. Beyar, P. W. Serruys

Research output: Contribution to journalArticlepeer-review

8 Scopus citations


BACKGROUND: Although safety and efficacy of the beStent (Medtronic Inc., Santa Rosa, CA, USA) have been described, the long-term angiographic and clinical outcomes have yet to be investigated. The ROSE (Registry for Optimal beStent Evaluation) trial was designed to assess the procedural safety of single 15 mm beStent implantation, and the six-month angiographic and 12- month clinical outcomes of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery of ≥2.75 mm diameter were included in this multicenter, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary end-point included major adverse cardiac events (death, myocardial infarction and target lesion revascularization), major bleeding complications, and thrombotic occlusions at one-month follow-up. Secondary end-points were major cardiac-event-free survival at six- and 12-month follow-up and angiographic restenosis at six months. A total of 120 patients (80% male, mean age 58.6 ± 10.6 years) with stable (48%) or unstable (44%) angina pectoris were allocated. The target vessel reference diameter pre-procedure was 2.85 ± 0.52 mm. RESULTS: Minimal lumen diameter pre/post and at follow-up was 0.97 ± 0.28 mm, 2.53 ± 0.40 mm and 1.86 ± 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six-month follow-up was 21.5%. At 12 months, the event-free survival rate was 75% (no deaths, two Q-wave and seven non-Q- wave infarctions, five bypass surgery interventions and 16 target lesion revascularizations), whilst 87% of the patients were free of angina pectoris. CONCLUSION: Despite the relatively high percentage of small vessels, the outcome of the ROSE trial is comparable to those observed in previous stent trials, indicating that the coronary beStent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris.

Original languageEnglish (US)
Pages (from-to)21-28
Number of pages8
JournalInternational Journal of Cardiovascular Interventions
Issue number1
StatePublished - 2000
Externally publishedYes


  • Angioplasty
  • BeStent
  • Coronary disease
  • Stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging


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