C
2010, Wiley Periodicals, Inc.
DOI: 10.1111/j.1540-8183.2010.00550.x
CORONARY ARTERY DISEASE
Six- and Twelve-Month Clinical Outcomes after Implantation of Prokinetic
BMS in Patients with Acute Coronary Syndrome
TATIANA BERLIN, M.D., ELIEZER ROZENBAUM, M.D., JOEL ARBEL, M.D., ORNA REGES, M.P.H.,
JACOB EREL, M.D., ISRAEL SHETBOUN, M.D., MORTON LEIBOVITCH, M.D.,
and MORRIS MOSSERI, M.D.
From the Cardiology Division, Meir Medical Center, Kfar Saba, Israel
Aims:
To evaluate the Prokinetic bare metal stent implanted in patients presenting with acute coronary syndrome
(ACS).
Methods:
We retrospectively studied ACS patients who underwent percutaneous coronary intervention (PCI) with
a Prokinetic stent implantation. Excluded were patients presenting with cardiogenic shock, undergoing PCI to left
main coronary artery (LM), or having implantation of additional stents other than Prokinetic. Six and 12 months
clinical follow-up was obtained by phone.
Results:
A total of 140 Prokinetic stents were implanted in 117 patients (age 64
±
13.0 years, 78% men). Thirty two
percent of the patients had unstable angina, 36% had non ST-elevation myocardial infarction (NSTEMI) and 33%
had ST-elevation myocardial infarction (STEMI). Forty two percent of lesions were categorized as B2 and 21% as
C type. Procedural success was achieved in 99.1% of lesions. Clinical success was achieved in 97.4% of patients.
Major adverse cardiac events (MACE) rate was 8.5% and 11.1% at 6 and 12 months follow-up, respectively. The
incidence of cardiac death, MI and TLR was 2.6%, 3.4% and 2.6%, respectively at 6 months, and 4.3%, 4.3%,
2.6% respectively at 12 months.
Conclusions:
Clinical outcomes at 6 and 12 months after Prokinetic stent implantation are excellent and may be
attributable to its unique combination of composition, design and coating.
(J Interven Cardiol 2010;23:377–381)
Background
Angiographic in-stent restenosis occurs in 20–30%
of patients undergoing Bare Metal Stent (BMS) im-
plantation and is caused entirely by neointimal pro-
liferation.
1
,
2
Stent design plays a key role in resteno-
sis. Recent studies have shown that thinner-strut stents
significantly reduce angiographic and clinical resteno-
sis after coronary interventions.
3
,
4
Improvements in
three-dimensional geometrical structure and innova-
tive delivery systems have enhanced flexibility and
tracking properties while optimizing scaffolding of
the atherosclerotic plaque. Helical design has theoreti-
Address for reprints: Tatiana Berlin, M.D., Cardiology Division,
Meir Medical Center, Kfar Saba, Israel. Fax: 972-97410704; e-mail:
tatiana.berlin@clalit.org.il
cal advantages and has been patented as superior with
these aspects,
5
but comparative studies are lacking.
Stent coating is also an important factor for stent
design, influencing both angiographic and clinical out-
comes. The actual biological effect of nickel ion release
from stents in the setting of an arterial wall is not com-
pletely solved. In one study, higher frequency of in-
stent restenosis was found in patients with delayed-type
hypersensitivity to metals, particularly nickel, com-
pared to patients without sensitization to metals.
6
In
addition, in-stent thrombosis is a small but real con-
cern in every patient who undergoes stent implantation
and possibly even more in patients with acute coronary
syndrome (ACS).
7
Silicon carbide is a semiconduc-
tor considered to be biologically inert that proved to
induce less inflammation and thrombogenicity when
used as a stent coating.
8
The Prokinetic CoCr stent is
Vol. 23, No. 4, 2010
Journal of Interventional Cardiology
377