A randomized comparison study assessing the impact of cilostazol on the heart rate and arrhythmias by 24-hour ambulatory holter electrocardiographic monitoring after drug-eluting stent implantation for coronary artery disease - Results from the CILOHA (The randomized prospective impact of CILOstazol associated with Heart rate and arrhythmias after percutaneous coronary intervention) trial

Aims: Cilostazol may have a positive chronotropic or pro-arrhythmic effect. However, there have been no randomized trials to confirm these effects. Methods: This randomized prospective trial compared dual (DAT, aspirin and clopidogrel, n=114) versus triple antiplatelet therapy (TAT, DAT plus cilostazol, n= 113) at baseline and after six months in patients receiving intracoronary drug-eluting stents (DES). The primary endpoint was the 24-hour heart rate (24h-HR) at six months determined using 24h-Holter ECG monitoring. The secondary endpoints were the 24h-HR ≥70 bpm, 24h-HR increase ≥5 bpm and the counts or presence of arrhythmias. Results: At six months after DES implantation, the 24h-HR (73 [68-83] vs. 68 [62-75] bpm, p< 0.001), presence of a 24h-HR ≥70 bpm (71.4 vs. 47.1%, p<0.001) and presence of a 24h-HR increase ≥5 bpm (44.8 vs. 24.5%, p=0.002) were significantly higher for the TAT group than for the DAT group. A multivariate analysis showed that the use of cilostazol (OR: 3.10, p=0.035) and a baseline 24h-HR <70 bpm (OR: 4.60, p<0.001) were strong predictors of a 24h-HR increase ≥5 bpm. However, there were no significant intergroup differences in arrhythmias. Conclusions: Cilostazol appears to result in an increase in the 24h-HR after DES implantation. Therefore, some caution should be exercised regarding the use of cilostazol in patients with tachycardia, when planning DES implantation.