Coronary Angioplasty and Drug-Eluting Stents - Applications of Biotechnology in Cardiovascular Therapeutics - page 271

Drug-Eluting Stents

DES is the term is applied to coated stents which elute drugs to prevent restenosis.
Bare stents now are being coated with a number of different agents in an attempt to
inhibit restenosis. Drugs that have been investigated include the following:

• ABT-578 (zotarolimus)

• Angiopeptin

• AP23573 (mTOR inhibitor)

• Cytochalasin A

• Dexamethasone

• Estradiol

• Everolimus

• Heparin

• Latrunculin D

• Nanotechnology-based DES

• Nitric oxide

• Paclitaxel

• Prostaglandin E

• Radioactive compounds, for example, P³² beta-emitter

• Sirolimus

• Tacrolimus (FK506)

Various Types of DES

CYPHER ® Sirolimus-Eluting Coronary Stent

The CYPHER ® sirolimus-eluting coronary stent (Cordis) provides a scaffold to
open the artery and slowly elutes sirolimus, an antirejection medication, that helps
limit the overgrowth of normal cells while the artery heals. The procedure to place
a CYPHER ® stent is the same as for an uncoated stent. In a single-blind, multi-
center, prospectively randomized trial on selected patients with acute myocardial
infarction, the use of sirolimus-eluting stents significantly reduced the rate of tar-
get-vessel revascularization at 1 year (Spaulding et al. 2006 ).
In 2006, the FDA approved revised instructions for use for the CYPHER ®
Sirolimus-eluting Coronary Stent. The label retains its current precaution state-
ments for multiple CYPHER ® Stents but now reflects FDA's review of clinical trial
data that suggests there is no increased risk of myocardial infarction (heart attack)
with the use of overlapping CYPHER ® Stents in comparison to bare metal stents.
Overlapping stents are most often used in patients with complex coronary artery
disease in which the blockage is too long for a single stent. Today, approximately
25% of stenting procedures involve the use of overlapping coronary stents. The
CYPHER ® Stent is the only drug-eluting stent with this new label. The revised
labeling can be found at: www.cypherusa.com . This labeling change is based on a
retrospective analysis of several prospective randomized controlled clinical studies