Comparison of pharmacokinetics between sarpogrelate hydrochloride immediate-release formulation and controlled-release formulation.

BACKGROUND

Efficacy of carotid endarterectomy (CEA) in prevention of stroke in patients with carotid artery stenosis has been confirmed in randomised trials. Carotid artery stenting (CAS) is a routine clinical practice and recent results of CAS are not worse than CEA. Moreover, percutaneous transluminal angioplasty (PTA) techniques allow other cephalad arteries to be dilated.

AIM: To assess early and long-term outcome of PTA of cephalad arteries and to determine risk factors of early and late major adverse cardiovascular and cerebral events (MACCE).

METHODS

The study group consisted of 223 consecutive patients (151 males, 67.7%, mean age 65.3+/-8.6) in whom 256 PTA procedures of cephalad arteries were performed. Two hundred and forty-two internal carotid, 7 common carotid and 15 vertebral arteries were dilated. Thirty-four patients underwent one-stage carotid and coronary procedures, while in 46 patients one-stage carotid and peripheral procedures were performed. Neuroprotection with a distal protection device was used in 51.5% of cases. The procedures were divided into two groups: with high (n=181) and low (n=75) risk of cardiovascular events. Early and late events were recorded and analysed subsequently.

RESULTS

In hospital 30-day MACCE occurred in 12 (4.6%) patients, including 7 (2.7%) strokes, 3 (1.1%) myocardial infarctions and two (0.8%) deaths. Transient ischaemic attacks were observed in 8 patients, pulmonary oedema in 3 cases, as well as a single episode of retinal artery embolisation and acute renal insufficiency. The incidence of 30-day MACCE was not significantly higher in the high-risk group (6.07 vs. 1.33%; NS), but the risk of any adverse event was significantly higher (p=0.03). There was no difference in stroke incidence between procedures with or without neuroprotection (2.27 vs. 3.22%; NS). There was no difference in risk of MACCE between angioplasty of cephalad artery and one-stage cephalad and coronary artery angioplasty procedure (3.6 vs. 5.5%; NS). During 50.3+/-20 months of follow-up there were 16 (7.1%) deaths, 9 (3.5%) strokes and 6 (2.3%) re-stenoses confirmed angiographically. One-year total survival and one-year MACCE-free survival rates according to the Kaplan-Meier analysis were 94.9% and 89.0%, showing a trend towards better outcome in the low-risk group (F-Cox=2.46; p=0.19 and F-Cox=2.17; p=0.09 respectively).

CONCLUSIONS

Percutaneous transluminal angioplasty of cephalad arteries is safe and feasible, with a low periprocedural complication rate and good late outcome. Carotid artery stenting is an alternative method to CEA.