ArticlesRandomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)
Introduction
After the publication of Benestent-11 and STRESS2, two randomised trials that compared elective stenting with balloon angioplasty, there was concern3 about the risk of subacute occlusion, bleeding, and vascular complications associated with intensive antithrombin therapy, as well as about cost increases stemming from stents, adjunctive balloons, and longer hospital stays, although no prospectively collected data on costs were available in these trials. In addition, the homogeneous cohort of patients with stable disease tested in Benestent-I was not representative of the unselected patients treated in routine practice.
The design of this study, Benestent-II, aimed to address these various issues. Attention was directed to coating the stent with a material that would lower the risk of abrupt stent closure and obviate the need for anticoagulant therapy, thereby reducing bleeding complications as well as the duration of hospital stay. A heparin-coated stent was tested in the Benestent-II pilot study, in which anticoagulation with a coumadine analogue was replaced by antiplatelet therapy in a stepwise manner.4 This pilot study confirmed that anticoagulant therapy could be withdrawn safely and showed that the heparin-coated stent in combination with two-pronged antiplatelet treatment virtually eliminated the risk of subacute stent thrombosis and resulted in a favourable event-free survival (86%) after 6 months. Gawaz and colleagues5 have shown that anticoagulation with anti-vitamin K and heparin does not prevent the activation of the IIB/IIIA receptors on the platelets, whereas the combination of ticlopidine and aspirin achieves this goal, thereby greatly reducing the incidence of subacute occlusion, a thrombotic event triggered mainly by platelet aggregation. Furthermore, full deployment of the stent by high-pressure balloon inflation under intravenous ultrasonographic guidance has reduced the risk of subacute occlusion.6
The Benestent-II study was designed to test the hypothesis that use of a heparin-coated stent plus antiplatelet therapy would result in better event-free survival at 6 months than that resulting after standard balloon angioplasty. Secondary analyses were planned to compare restenosis rate at 6 months and cost-effectiveness at 12 months for the two interventions. Although savings can be expected if there is a reduction in repeat revascularisation procedures, there are still questions of whether these savings will compensate for the higher initial costs and, if this is not the case, how the additional benefits weigh against the additional costs.7, 8
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Selection of patients
Eligible patients were those scheduled to undergo coronary angioplasty, who had one or more de-novo lesions due to stable angina or unstable angina (Braunwald class IB, IIB, IC, IIC),9 who had no contraindication to platelet therapy with aspirin and ticlopidine, and who were suitable candidates for coronarybypass surgery. The protocol required that all the target lesions (if multiple) were suitable for stent implantation (< 18 mm in length and located in a vessel of diameter >3·00 mm, supplying
Characteristics of patients
Between September, 1995, and March, 1996, 827 patients were randomly assigned stent implantation (414 patients) or balloon angioplasty (413 patients) at 50 participating centres (figure 1). Four patients were excluded from the intention-to-treat analysis because they did not undergo coronary revascularisation; their lesions were shown to be physiologically non-significant during on-line quantitative coronary angiography at the time of the intended intervention. The 1-year follow-up of these
Discussion
This study confirms that stenting has a preventive effect on restenosis. It also confirms that the combined use of two antiplatelet drugs, aspirin and ticlopidine, is safe and effective in preventing stent thrombosis.22
Although this trial was not specifically designed to investigate the value of the heparin coating, among the 721 patients (with various ischaemic syndromes including acute myocardial infarction23) who have received heparin-coated stents, only one patient has so far presented with
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