CORONARY STENTS

- Bare Metal - Passive Coated - Drug Eluting - Covered

PERIPHERAL STENTS


Commited to conducting clinical trials, Vascular Concepts has completed various trials and registries with Pronova in 2078 patients both in India and abroad. Following are the details of the clinical trials:



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Abstracts

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Indian Heart Journal
Honorary Editor: Dr. V.K Bahl
All India Institute of Medical Sciences, New Delhi, India.

An Angiographic Follow-up Study of Prolink TM Bare Metal Stents

Madhu Sreedharan, N Sreenivas, B Barooah, PK Dash
Sri Sathya Sai Institute of Higher Medical Sciences, Bangalore

Bare metal stents which are hand-crimped on to balloon delivery system are infrequently used worldwide due to difficulty in its deployment and the antecedent risk of stent dislodgement. However they come at a fraction of the cost of the pre-mounted stents. We prospectively evaluated patients who had coronary stenting with ProlinkTM (Vascular Concepts Ltd, Sussex, UK) stent in our Institute between May 2001 and December 2003. The patients were reviewed regarding major adverse cardiac events (MACE) death, myocardial infarction (MI) and target lesion revascularization (TLR) and also by angiographic evaluation. Quantitative coronary angiographic (QCA) end points included binary restenosis (>50% diameter stenosis), reference vessel diameter, minimum lumen diameter, percent diameter stenosis and late lumen loss. Out of 158 patients who had a Prolink stent implanted during this period only 86 patients (92 stents) came for follow-up and consented for the angiographic restudy at a mean of 8.4±3.2 months following the procedure. There were 69 males and 17 females. Of these, 34.8% were diabetic, 51.1% had hypertension (HTN), 27.2% were current smokers and 78.3% had dyslipidemia. 62% of the patients had MI and 20.6% had moderate left ventricular (LV) dysfunction. The left interior descending artery (LAD) was involved in 57.6%, left circumflex (LCx) in 17.4% and right coronary artery (RCA) in 25%.The mean HDL, LDL and TG levels were 33.5 mg/dl, 92.6 mg/dl and 186.83 mg/dl respectively. Direct stenting was done in 19.6% of cases. There was only one case of stent dislodgment among the 158 cases (0.63%).



The instent restenosis (defined as >50% stenosis within the stent) rate was 34.8% and it was significantly associated with current smoking, vessel diameter and length of the stent (p< 0.01). There was no significant association with other demographic variables or type of lesion. We conclude that PCI/ stent with ProlinkTM bare metal stent gives immediate- and long-term results comparable to the published literature of premounted stents at a significantly reduced cost.