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


RESULTS
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 > or =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.


CONCLUSIONS
Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.
Serruys
P W
PW
University Hospital Rotterdam Dijkzigt, Thorax Center, Rotterdam, The Netherlands. serruys@card.azr.nl
van Hout
B
B
Bonnier
H
H
Legrand
V
V
Garcia
E
E
Macaya
C
C
Sousa
E
E
van der Giessen
W
W
Colombo
A
A
Seabra-Gomes
R
R
Kiemeneij
F
F
Ruygrok
P
P
Ormiston
J
J
Emanuelsson
H
H
Fajadet
J
J
Haude
M
M
Klugmann
S
S
Morel
M A
MA
D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000401:mortality / Q000628:therapy*; D000789:Angina, Unstable / Q000401:mortality / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D017023:Coronary Angiography; D004867:Equipment Design; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D015607:Stents; D016019:Survival Analysis; D013988:Ticlopidine / Q000627:therapeutic use; D016896:Treatment Outcome
D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D006493:Heparin; D013988:Ticlopidine; D001241:Aspirin