A randomized trial of aspirin versus cilostazol therapy after successful coronary stent implantation

Percutaneous transluminal coronary angioplasty (PTCA) is widely used to treat patients with ischemic heart disease, but the procedure involves a number of problems, including acute coronary occlusion and restenosis. Although stents have proved useful for preventing post-PTCA restenosis, especially elastic recoil during the acute phase, no method has yet been established to prevent restenosis caused by vascular smooth muscle cell proliferation in the late phase. Cilostazol selectively inhibits the 3'5'-cyclic-nucleotide phosphodiesterase (PDE) III (cyclic guanosine monophosphate-inhibited PDE) of the cyclic adenosine monophosphate PDE family; it also has antithrombotic and vasodilating effects, as well as an inhibitory effect on vascular smooth muscle cell proliferation through PDE III inhibition. From November 1995 to March 1997, the usefulness of cilostazol versus aspirin in preventing subacute thrombosis and restenosis was studied in 70 patients (55 men and 15 women; 82 total lesions) who had undergone successful elective Palmaz-Schatz stent implantation. Patients were randomly allocated to receive aspirin 81 mg/d (40 patients with 45 lesions) or cilostazol 200 mg/d (30 patients with 37 lesions) alone. There was no difference in patients or angiographic characteristics between these groups. No subacute thrombosis, acute complications (ie, death, emergent coronary artery bypass grafting, or hemorrhagic complications), or drug side effects were found in the cilostazol group. The minimal lumen diameter (mean +/- SD) at follow-up was 1.89 +/- 1.08 mm in the aspirin group (41 lesions, 5.63 +/- 1.74 months after stent implantation) and 2.34 +/- 0.74 mm in the cilostazol group (35 lesions, 5.14 +/- 1.91 months after stent implantation), revealing statistically significant dilatation in the cilostazol group. The restenosis rate was 26.8% in the aspirin group, compared with 8.6% in the cilostazol group; this difference was statistically significant. Administration of cilostazol alone after the implantation of intracoronary Palmaz-Schatz stents was useful for the prevention of subacute thrombosis and restenosis.