Boland, J.L., Corbeji, H.A.M., van der Giessen, W., Seabra-Gomex, R., Suryapranata, H., Wijns, W., Hanet, C., Suttorp, M.J., Buller, C., Bonnier, J.J.R.M., Colombo, A., van Birgelen, C., Pieper, M., Mangioni, J.A., Londero, H., Carere, R.G., Hamm, C.W., Bonan, R., and Bartorelli, A.
AIMS: The BiodivYsio™ stent (Biocompatibles Ltd, Farnham, UK) is coated with a phosphorylcholine (PC)-containin copolymer to confer biocompatibility. The SOPHOS (Study Of PHosphorylcholine coating On Stents) study was designed to assess the safety and efficacy of this novel coronary stent and by indirect comparison to indicate equivalence with other formal stent studies. METHODS AND RESULTS: Patients with angina and a single short (⩽12 mm) de novo lesion in a native coronary artery of ≥ 2.75 mm diameter were included. A total of 425 patients were allocated in 24 centers. Clinical data were collected at one-, six- and nine-month follow-up. Angiography was performed before and after the stent implantation. In addition, in the first 200 patients (SOPHOS A) angiography was routinely performed at six months. The following 225 patients (SOPHOS B) were merely followed up clinically. The primary end-point of the study, the six-month MACE-rate (MACE = Major Adverse Cardiac Events) was 13.4% (two cardiac death; five Q-wave/nine non-Qwave myocardial infarctions (MI); nine CABG and 32 target lesion revascularization (TLR), which is similar to the calculated 15% MACE-rate in comparable reference studies. Secondary end-points included among others restenosis at six months in the SOPHOS A population. The target vessel diameter was 2.98 ± 0.48 mm. Minimal lumen diameter pre/post procedure and at follow-up was 1.00 ± 0.32, 2.69 ± 0.37, 1.91 ± 0.71mm, respectively. The binary restenosis rate (≥50% diameter stenosis at follow-up) was 17.7%. CONCLUSION: The coronary BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with stable or unstable angina pectoris. Clinical and angiographic results are in the statistical range of equivalence with comparable studies with other current stents. (Int J Cardiovasc Intervent 2000; 3: 215-225) [ABSTRACT FROM AUTHOR]