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Suryapranata H, Boland JL, Pieper M, et al. Clinical and angiographic results with the beStent: the Registry for Optimal beStent Evaluation (ROSE) trial. Int J Cardiovasc Intervent. 2000;3(1):21-28doi: 10.1080/14628840050516271.
Suryapranata, H., Boland, J. L., Pieper, M., Legrand, V. L., Bonnier, J. J., Juliard, J. M., Vrolix, M. C., Seabra-Gomes, R., Hamburger, J. N., Roguin, A., Oosterwijk, C., Van Es, G. A., Beyar, R., & Serruys, P. W. (2000). Clinical and angiographic results with the beStent: the Registry for Optimal beStent Evaluation (ROSE) trial. International journal of cardiovascular interventions, 3(1), 21-28. https://doi.org/10.1080/14628840050516271
Suryapranata, Harry, et al. "Clinical and angiographic results with the beStent: the Registry for Optimal beStent Evaluation (ROSE) trial." International journal of cardiovascular interventions vol. 3,1 (2000): 21-28. doi: https://doi.org/10.1080/14628840050516271
Suryapranata H, Boland JL, Pieper M, Legrand VL, Bonnier JJ, Juliard JM, Vrolix MC, Seabra-Gomes R, Hamburger JN, Roguin A, Oosterwijk C, Van Es GA, Beyar R, Serruys PW. Clinical and angiographic results with the beStent: the Registry for Optimal beStent Evaluation (ROSE) trial. Int J Cardiovasc Intervent. 2000 Mar;3(1):21-28. doi: 10.1080/14628840050516271. PMID: 12470383.
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Int J Cardiovasc Intervent. 2000 Mar;3(1):21-28. doi: 10.1080/14628840050516271.

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

International journal of cardiovascular interventions

Harry Suryapranata, Jean L Boland, Michael Pieper, Victor L Legrand, Johannes JRM Bonnier, Jean-Michel Juliard, Matty CM Vrolix, Ricardo Seabra-Gomes, Jaap N Hamburger, Ariel Roguin, Cor Oosterwijk, Gerrit-Anne Van Es, Rafael Beyar, Patrick W Serruys

Affiliations

  1. Isala Klinieken, Zwolle, The Netherlands.

PMID: 12470383 DOI: 10.1080/14628840050516271

Abstract

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.

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