Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

Patrick W. Serruys, Ben Van Hout, Hans Bonnier, Victor Legrand, Eulogio Garcia, Carlos Macaya, Eduardo Sousa, Wim Der Van Giessen, Antonio Colombo, Ricardo Seabra-Gomes, Ferdinand Kiemeneij, Peter Ruygrok, John Ormiston, Hakan Emanuelsson, Jean Fajadet, Michael Haude, Silvio Klugmann, Marie Angèle Morel

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)673-681
Number of pages9
JournalLancet
Volume352
Issue number9129
Publication statusPublished - Aug 29 1998

ASJC Scopus subject areas

  • Medicine(all)

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