Clinical evaluation of new balloon mountable coil stent: in-hospital and follow-up results.

ABSTRACT

The purpose of this study was to determine the feasibility, safety and efficacy of elective deployment of a new coil-stent (KR stent) in patients with coronary artery disease. KR stent deployment was attempted in 100 patients (135 lesions) enrolled prospectively at a single centre from December 1996 to March 1997. Ten, 15, 18, 24, and 32 mm long KR stents were manually crimped onto balloons and deployed in native coronary artery lesions. Majority of the patients had recent acute coronary syndromes (unstable angina 30% and post-myocardial infarction angina 56%). Diabetes was present in 34 percent of the patients. Fifty-six percent had single-vessel and 44 percent multi-vessel disease. In 38 percent, the lesions were located in proximal segments and 40 percent of lesions were long. KR stents were successfully deployed in 98 percent of patients. Mean minimal luminal diameter increased by 2.89 +/- 0.63 mm (from 0.57 +/- 0.38 mm before to 3.45 +/- 0.56 mm after the procedure). Mean percent diameter stenosis decreased from 83.33 +/- 10.84 percent before to 3.38 +/- 5.74 percent after the stent deployment. Mean reference vessel diameter was 3.45 +/- 0.56 mm. There were occasional technical complications including balloon rupture (1), stent migration (2) and distal embolisation of atheromatous material (1). One patient developed subacute stent thrombosis. There were no other major in-hospital cardiovascular events. At the end of six-month follow-up, there were no myocardial infarction or death. Six patients presented with recurrence of symptoms within six-months of the procedure, four of whom underwent target vessel revascularisation procedure. In conclusion, the in-hospital and six-month follow-up clinical results were highly encouraging with KR stent. Successful deployment rates were high despite unfavourable clinical and angiographic background. Low clinical events on follow-up will make it suitable for elective stenting.