Coronary artery disease
Comparison of Triple Versus Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation (from the DECLARE–Long Trial)

https://doi.org/10.1016/j.amjcard.2007.05.032Get rights and content

To evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation for long coronary lesions, we performed a randomized multicenter prospective study comparing triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol; triple group, n = 250) and dual antiplatelet therapy (aspirin and clopidogrel; standard group, n = 250) for 6 months in patients with long lesions (≥25 mm) requiring a long DES (≥32 mm). The primary end point was in-stent late loss at 6-month angiography. The 2 groups had similar baseline clinical and angiographic characteristics. In-stent late loss (0.22 ± 0.48 mm vs 0.32 ± 0.51 mm, p = 0.031) and in-segment late loss (0.34 ± 0.49 mm vs 0.51 ± 0.49 mm, p = 0.001) at 6-month follow-up angiography were significantly lower in the triple group versus the standard group. There was a trend toward lower rates of in-segment restenosis in the triple group versus the standard group (6.7% vs 11.2%, p = 0.104). Target lesion revascularization (TLR; 2.8% vs 6.8%, p = 0.036) and major adverse cardiac events (2.8% vs 7.6%, p = 0.016), including death, myocardial infarction, and TLR at 9 months were significantly lower in the triple group than in the standard group. At 9 months, the 2 groups had similar rates of stent thrombosis (0.4% vs 0.4%, p = 0.999), death (0% vs 0.8%, p = 0.499), and myocardial infarction (0.4% vs 0.4%, p = 0.999). In conclusion, cilostazol significantly reduced late loss at 6 months after DES implantation and the occurrence of TLR and major adverse cardiac events in patients with long coronary lesions.

Section snippets

Patient selection

The detailed Drug-Eluting stenting followed by Cilostazol treatment reduces LAte REstenosis in patients with Long native coronary lesions (DECLARE–Long) protocol has been published,12 including study design, organization, clinical measurement, and angiographic measurement. This prospective randomized study involved 500 patients ≥18 years of age with angina pectoris and/or positive stress test findings and a native coronary lesion. The study involved 5 cardiac centers in Korea between August

Baseline characteristics of the patients

Table 1 lists the baseline clinical characteristics of the 2 groups. There were no significant differences between groups in baseline clinical characteristics and risk factors.

Procedural results and in-hospital outcomes

Table 2 lists angiographic characteristics and procedural results. The 2 groups have similar anatomic and procedural characteristics. All stents were successfully implanted, and the angiographic success rate was 99.2% in both groups. No in-hospital events occurred in either group, including stent thrombosis, Q-wave MI,

Discussion

The major finding of this study is that cilostazol treatment for 6 months is associated with reduction of late loss after DES implantation in long coronary lesions. This translates into a trend toward less angiographic restenosis (p = 0.104) and significant reduction of TLR and major adverse cardiac events.

Cilostazol is a potent oral antiplatelet agent with a rapid onset of action that selectively inhibits phosphodiesterase III and leads to a higher level of cyclic adenosine monophosphate

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    This study was supported by the Cardiovascular Research Foundation of Korea, grant 0412-CR02-0704-0001 from the Korean Ministry of Health and Welfare as part of the Korea Health 21 Research and Development Project, and a grant from Cordis (a Johnson & Johnson Company), Miami, Florida.

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