Author + information
- Received April 14, 1994
- Revision received August 12, 1994
- Accepted August 25, 1994
- Published online February 1, 1995.
- David P. Faxon, MD, FACC∗,
- Multicenter American Research Trial With Cilazapril After Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MARCATOR) study group
- ↵∗Address for correspondence: Dr. David P. Faxon, Division of Cardiology, University of Southern California School of Medicine, 1355 San Pablo Street, AHC-117, Los Angeles, California 90033.
Objectives. We conducted a randomized, double-blind, placebo-controlled trial to assess the effect of low and high dose angiotensin-converting enzyme inhibition with cilazapril on angiographic restenosis prevention after percutaneous transluminal coronary angioplasty.
Background. Angiotensin-converting enzyme inhibitors possess antiproliferative effects in animal models of vascular injury. However, a recent clinical trial using low dose cilazapril, a long-acting angiotensin-converting enzyme inhibitor, failed to prevent restenosis.
Methods. Patients received either cilazapril (1 or 2.5 mg in the evening after successful coronary angioplasty, then 1, 5 or 10 mg twice daily for 6 months) or matched placebo. All patients received aspirin for 6 months. Coronary angiograms before and after angioplasty and at 6-month follow-up were quantitatively analyzed. In addition, the clinical, procedural and angiographic factors associated with restenosis were determined with the use of stepwise logistic analysis.
Results. A total of 1,436 patients with a successful coronary angioplasty were recruited. As assessed by an intention-to-treat analysis, the mean difference in minimal coronary lumen diameter (mean ± 1 SD) between the postangioplasty and follow-up angiogram at 6 months (primary end point) was −0.35 ± 0.51 for the placebo group and −0.37 ± 0.52, −0.45 ± 0.52 and −0.412 ± 0.53, respectively, for the 1-, 5- and 10-mg twice daily cilazapril groups (p = NS). Clinical events during follow-up did not differ among the four study groups. Multivariate analysis revealed only six variables as independent predictors of the loss of minimal lumen diameter: duration of angina <6 months, history of myocardial infarction, minimal lumen diameter before and after angioplasty as well as a proximal lesion location and reference diameters. Traditional risk factors for atherosclerosis did not relate to restenosis.
Conclusions. Long-term angiotensin-converting enzyme inhibition with cilazapril in high as well as low dosages does not prevent restenosis and does not favorably influence the overall clinical and angiographic outcome after coronary angioplasty. Few factors are predictive of restenosis.
☆ This study was sponsored by F. Hoffmann-La Roche Ltd., Basel and Cardiologique, Geneva, Switzerland. A complete list of the principal investigators and clinical sites of the MARCATOR study appears in the Appendix.
- Received April 14, 1994.
- Revision received August 12, 1994.
- Accepted August 25, 1994.