Michael JB Kutryk,
Alexander J Wardeh, Arie HM Knook, David
P Foley, Willem J van der Giessen, Jaap
H Hamburger, Marcel van den Brand, Pim J
de Feyer, Gary J Becker and Patrick W Serruys
BACKGROUND
:
Coronary stents have been used with increasing
frequency and in increasing complex coronary
disease. A new 316 LVM stainless steel coronary
stent, the R stent™, has been designed
to provide maximum flexibility for tracking
and high radial strength post-deployment.
PURPOSE
:
To assess the clinical feasibility of the
R stent™ in a tertiary referral population
of patients with coronary heart disease.
Specific objectives are to assess the R
stent™'s deployment success, angiographic
and procedural success (<20% residual
stenosis and > TIMI 2 flow), safety (absence
of complications), and 30-day clinical success
(angiographic/procedural success plus no
major adverse coronary events).
METHODS
:
Between April and November 1998, stent deployment
was attempted in 27 patients with stable
(46%) or unstable (54%) agina pectoris who
qualified for percuteneous transluminal
coronary angioplasty. Eighty percent of
patients had a pre-existing history of myocardial
infarction, coronary bypass surgery or percutaneous
transluminal coronary angioplasty, and several
of the lesions were anatomically complex
(totally occluded, n=2; thrombus present,
n=2; heavily calcified, n=3; ostial, n=1;
>20mm long, n=9; angulation >45 degrees,
n=7). Lesions in aortocoronary saphenous
vein grafts were excluded. Adjunctive medical
management included intraprocedural aspirin
and heparin and post-procedural aspirin
and ticlopidine. After deployment, patients
were followed up in the hospital and at
30 days post procedure.
RESULTS
:
Stent deployment was achieved in 32 of 33
attempts (26 of 27 patients). There was
one deployment failure in a long, calcified
ostial and proximal left coronary lesion.
In the 26 successful deployments, TIMI 3
flow was achieved. One other patient experienced
a painless increase in creative kinase to
375 (CK-MB of 59) at 12 h without ECG changes.
At 30 days, there were no deaths, no mycardial
infarction, no subacute thromboses, no repeat
interventions, no bypass surgeries, and
no bleeding complications. Only the patient
with post-procedural CK-MB elevation experience
recurrence of CCS class 2 angina within
the 30 days.
CONCLUSION
:
The R stent™ is a promising new device
for the treatment of complex coronary heart
disease. A larger, more broadly based study
is warranted. (Int J Cardiovascular Interventions
1999; 2: 163-169)
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