Reddy N K, Raju P R, Kapoor S, Reddy R P, Rao M S, Kumar D N, Sastry B K, Prasad S G, Raju B S
Division of Cardiology, CARE Hospital, Hyderabad.
Indian Heart J. 1998 Jan-Feb;50(1):40-4.
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.
本研究的目的是确定在冠心病患者中选择性植入一种新型线圈支架（KR支架）的可行性、安全性和有效性。1996年12月至1997年3月，在单一中心前瞻性纳入了100例患者（135处病变），尝试植入KR支架。将10、15、18、24和32毫米长的KR支架手动压接到球囊上，并植入天然冠状动脉病变处。大多数患者近期患有急性冠状动脉综合征（不稳定型心绞痛占30%，心肌梗死后心绞痛占56%）。34%的患者患有糖尿病。56%的患者为单支血管病变，44%为多支血管病变。38%的病变位于近端节段，40%的病变为长病变。98%的患者成功植入了KR支架。平均最小管腔直径增加了2.89±0.63毫米（从术前的0.57±0.38毫米增加到术后的3.45±0.56毫米）。平均直径狭窄百分比从支架植入前的83.33±10.84%降至植入后的3.38±5.74%。平均参考血管直径为3.45±0.56毫米。偶尔会出现技术并发症，包括球囊破裂（1例）、支架移位（2例）和动脉粥样硬化物质远端栓塞（1例）。1例患者发生亚急性支架血栓形成。没有其他主要的院内心血管事件。在六个月随访结束时，没有发生心肌梗死或死亡。6例患者在术后六个月内出现症状复发，其中4例接受了靶血管血运重建手术。总之，KR支架的院内和六个月随访临床结果非常令人鼓舞。尽管临床和血管造影背景不利，但成功植入率很高。随访时临床事件发生率低，使其适用于选择性支架植入。
