Author + information
- Received June 1, 1995
- Revision received September 6, 1995
- Accepted September 15, 1995
- Published online February 1, 1996.
- Carlos Macaya, MD,
- Patrick W. Serruys, MD FACC*,
- Peter Ruygrok, MD,
- Harry Suryapranata, MD,
- Gijs Mast, MD,
- Silvio Klugmann, MD,
- Philippe Urban, MD,
- Peter den Heijer, MD,
- Karel Koch, MD,
- Rudiger Simon, MD,
- Marie-Claude Morice, MD,
- Peter Crean, MD,
- Hans Bonnier, MD,
- William Wijns, MD,
- Nicolas Danchin, MD,
- Claude Bourdonnec, MD,
- Marie-Angèle Morel, MSc,
- Benestent Study Group
- ↵*Address for correspondence: Dr. Patrick W. Serruys, Catheterization Laboratory, Thorax Center, Erasmus University Rotterdam, P.O. Box 1738, 3000 DR Rotterdam, The Netherlands.
Objectives. This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial.
Background. The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations.
Methods. To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion.
Results. After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up.
Conclusions. These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.
This study was supported in part by a grant from Johnson & Johnson Interventional Systems, Warren, New Jersey, Schneider and Co., Bülach, Switzerland; and Lorex Pharmaceutica BV, Maarsen, The Netherlands. A list of the principal investigation and participating institutions appears in the Appendix.
- Received June 1, 1995.
- Revision received September 6, 1995.
- Accepted September 15, 1995.