Abstract 12994: Sarpogrelate Use and Clinical Outcomes After Drug-Eluting Stent in Patients With Diabetes Mellitus(s-code), a Single Center Trial
Introduction: Diabetes mellitus (DM) still remains a strong risk factor for the early restenosis and target lesion revascularization (TLR) after implanting drug-eluting stent (DES).
5-Hydroxytryptamine (5-HT) is known to induce platelet aggregation, proliferation of vascular smooth muscle cells and vasoconstriction. Sarpogrelate is the selective 5-HT2A receptor antagonist, which has been used clinically to prevent atherosclerosis.
Hypothesis: We assessed the hypothesis that adding sarpogrelate with standard dual antiplatelet therapy (DAPT) would lower restenosis after DES implantation in the CAD patients with DM or impaired glucose tolerance (IGT).
Methods: We undertook a prospective, open-label randomized trial in 148 patients with DM or IGT, who were planned for elective percutaneous coronary intervention (PCI) using DES for de-novo native coronary artery lesions. Patients were assigned to receive standard DAPT (aspirin 100mg daily and clopidogrel 75mg daily or ticlopidine 200mg daily) or sarpogrelate 300mg daily in addition with DAPT. Restenosis was determined by quantitative coronary angiography at 1 year.
Results: There was no significant difference in clinical baseline characteristics, reference-vessel diameter and minimum luminal diameter at pre-PCI and post-PCI between 2 groups. The minimum luminal diameter at 1 year for sarpogrelate-treated patients was 2.49 +- 0.47 mm compared with 2.33 +- 0.59 mm in the control group (p=0.08). The late loss for sarpogrelate-treated patients was 0.08+- 0.39mm compared with 0.23+- 0.59 mm in the control group (p=0.03). There was no significant difference in death, myocardial infarction, stroke, bleeding and TLR.
Conclusion: We demonstrated for the first time that addition of sarpogrelate to the standard DAPT is associated with reduction of late loss after DES implantation in patients with DM. The results demonstrated here provides the concept of novel therapeutic option for PCI in high risk patients. Further large-scale studies are warranted.
Author Disclosures: K. Fukuchi: None. T. Inada: None. F. Hayashi: None. K. Nagao: None. N. Takahashi: None. M. Tokunaga: None. H. Ito: None. M. Tanaka: Research Grant; Modest; Japan Vascular Disease Research Foundation.
- © 2014 by American Heart Association, Inc.