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BERLIN, ET AL.
a new generation coronary stent that combines three
important characteristics: It has a double helix design,
silicon carbide coating, and thin struts (0.0024 for
2–3 mm diameter, 0.0031 for 3.5–4.0 mm, and
0.0047 for 4.4–5.0 mm diameter stents). We hypothe-
sized that this combination would translate into favor-
able clinical results. Therefore, in the present study we
retrospectively investigated the primary and long-term
outcome of Prokinetic BMS stents in patients present-
ing with ACS.
Methods
The first Prokinetic stent was used in our laboratory
in October 30, 2005. During the following 2 years,
the Prokinetic stent became a prevalent stent for coro-
nary implantation in our laboratory both in routine and
challenging cases. Use of any stent at our laboratory
was at the discretion of the operators. Stent lengths
available during the study were: 8, 10, 13, 15, 18, 22,
and 30. For longer lesions, we overlapped two to three
stents. For statistical purposes, overlapping stents were
considered as a single long stent.
Inclusion Criteria.
All consecutive patients who
had coronary percutaneous coronary intervention
(PCI) and were treated with Prokinetic stents between
October 30, 2005 and December 3, 2007 identified in
our catheterization laboratory computerized database
were included.
Exclusion Criteria.
Excluded from the study
group were patients who received additional types of
stents other than Prokinetic, presented with cardio-
genic shock, underwent PCI to left main coronary
artery (LM), lost to follow-up, or refused interview-
ing. Patients who died without being interviewed an-
tecedently were not excluded to avoid underestimation
of an important major adverse cardiac event (MACE).
Information on mortality was derived from the hospital
computerized demographic database, which is updated
monthly by the Ministry of Interior Affairs. These pa-
tients’ data were derived from their last hospitalization
summary letter.
Clinical Data.
Included gender, age, cardiac risk
factors, cardiac history, and indications for PCI. PCI
data included lesion location, type and characteristics,
and delivery data.
The Primary End-Point.
This registry was
MACE at 6 and 12 months after stent implantation.
MACE was defined as any death, myocardial infarc-
tion, target lesion revascularization (TLR) due to ei-
ther restenosis (PCI or coronary artery bypass graft-
Table 1.
Baseline Clinical Characteristics
%
Risk factors
Hypertension
53.0
Hyperlipidemia
69.5
Diabetes mellitus
29.9
Smoking
33.9
Premature coronary artery disease
27.4
in first-degree relative
∗
Cardiac history
Prior MI
22.2
Prior PCI
24.8
Prior CABG
6.8
Indications for PCI
Unstable angina
31.6
STEMI
32.5
NSTEMI
35.9
∗
First-degree relatives with premature coronary artery disease were
defined as male relatives
<
55 years of age and female relatives
<
65 years of age.
ing [CABG]). MACE was presented in a hierarchical
fashion (patients count only once for the most serious
event) as done previously.
9
,
10
Follow-up information
was obtained by phone interview, approved by our local
Institution Ethical Committee. The interview included
questions about angina class, change in symptoms, and
rehospitalization after cardiac catheterization.
Secondary End-Points.
Included immediate
technical and clinical success and complications.
Results
Three hundred thirty-two patients underwent percu-
taneous coronary stenting with a Prokinetic stent dur-
ing the study period. In 285 of these patients, the pro-
cedure was performed during hospitalization for ACS.
Excluded from the study group were 124 patients who
received additional types of stents other than Proki-
netic, three patients who presented with cardiogenic
shock, one patient who underwent PCI to LM, and
40 patients of Arabic origin who live in rural areas with
deficient communications and were lost to follow-up.
The remaining 108 patients and another nine patients
who died during the study period comprised the study
group of 117 patients. A total of 140 coronary lesions
were treated in these 117 patients.
Patients’ Demographics.
Patients’ age was 64
±
13.0 years and 78% of them were men. Baseline char-
acteristics of the enrolled patients and indications for
PCI are shown in Table 1.
378
Journal of Interventional Cardiology
Vol. 23, No. 4, 2010