TY - JOUR
T1 - Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)
AU - Serruys, Patrick W.
AU - Van Hout, Ben
AU - Bonnier, Hans
AU - Legrand, Victor
AU - Garcia, Eulogio
AU - Macaya, Carlos
AU - Sousa, Eduardo
AU - Van Giessen, Wim Der
AU - Colombo, Antonio
AU - Seabra-Gomes, Ricardo
AU - Kiemeneij, Ferdinand
AU - Ruygrok, Peter
AU - Ormiston, John
AU - Emanuelsson, Hakan
AU - Fajadet, Jean
AU - Haude, Michael
AU - Klugmann, Silvio
AU - Morel, Marie Angèle
PY - 1998/8/29
Y1 - 1998/8/29
N2 - Background. The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. Methods. 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. Findings. Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p = 0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p = 0.0002), which corresponds to restenosis rates (diameter stenosis ≤ 50%) of 16% and 31% (p = 0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p = 0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. Interpretation. Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.
AB - Background. The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. Methods. 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. Findings. Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p = 0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p = 0.0002), which corresponds to restenosis rates (diameter stenosis ≤ 50%) of 16% and 31% (p = 0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p = 0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. Interpretation. Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.
UR - https://www.scopus.com/pages/publications/0032578319
U2 - 10.1016/S0140-6736(97)11128-X
DO - 10.1016/S0140-6736(97)11128-X
M3 - Article
C2 - 9728982
AN - SCOPUS:0032578319
SN - 0140-6736
VL - 352
SP - 673
EP - 681
JO - The Lancet
JF - The Lancet
IS - 9129
ER -
