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procedure. Deaths were classified as cardiac or non-cardiac.
Deaths from undetermined causes were reported as cardiac.
Myocardial infarction was diagnosed on the basis of the
development of new Q waves of more than 0.04 seconds in two or
more contiguous leads, accompanied by a significant increase in
the creatine kinase or MB isoform or troponin I or T levels; non-Q
wave infarction was diagnosed as an increase in the creatine kinase
level to more than three times the upper limit of the normal range
with an accompanying elevation in the MB isoform or troponin I or T
levels without development of new Q waves. Stent thrombosis was
classified as acute when it occurred within 24 hours of the index
procedure, sub-acute when it occurred between one and 30 days,
and late when it occurred beyond 30 days. Stent thrombosis was
considered ‘definite’ when confirmed angiographically. Stent
thrombosis was considered ‘probable’ when the patient had a target
vessel–related MI or died of a coronary event, possibly caused by
stent thrombosis, within 30 days of the index procedure. All
reported re-interventions inside the stent implanted during the
index procedure or within 5 mm proximal or distal to the stent were
classified as TLR. Other repeated PCI in the same vessel were
recorded as TVR. Renal insufficiency was defined according to
serum creatinine values of ≥1.5 mg/dl during hospitalisation. Left
ventricular function was diagnosed by either ventriculography or
using cardiac echocardiography during hospitalisation. The cardiac
function measure was available in 380/515 (77%) of treated
patients. Two senior cardiologists and an experienced research
coordinator adjudicated all events.
Angiogram assessment
Quantitative coronary angiograms obtained before and after the
procedure were analysed at our core laboratory (Rabin Medical
Centre, Petach Tikva, Israel) by the Medcon-McKesson Horizon™
system (Tel Aviv, Israel). Baseline angiographic variables included
reference vessel diameter (RVD), minimal luminal diameter (MLD),
percent diameter stenosis, lesion length and lesion complexity as
defined by the American Heart Association/American College of
Cardiology (AHA/ACC) classification. Type B2 and C were
considered complex lesions. In-stent diameter stenosis, RVD, MLD,
acute gain (final MLD-pre MLD) and the presence of dissection
were noted post-procedure. No systematic angiographic follow-up
was scheduled for this study. However, all performed repeat
angiographic procedures were analysed by the same core
laboratory. Thrombolysis in myocardial infarction (TIMI) flow grade
(0 to 3) was measured prior to and at completion of procedure.
Follow-up
All patients underwent a clinical follow-up for six months. They were
scheduled to have a six-month telephone contact. Study patients
were enrolled in two hospitals (Beilinson Hospital and Hasharon
Hospital, both belong to the Rabin Medical Centre). Telephone
contact rates and source document adjudication was 100% at six
month time points. At the time of follow-up contact, data were
collected pertaining to current clinical status, prior hospitalisation
and occurrence of any of the aforementioned adverse events.
Statistical plan
Statistical analysis was done by using STATISTICA™ software in
order to calculate the categorical demographic and clinical outcome
variables. MACE rates were calculated as hierarchical in case of
multiple events (e.g. MI, TVR or death) occurring in individual
patients. TVR and TLR events were calculated twice: per patient
and per treated vessel, accordingly.
Results
Patient’s demographics
The analysis includes 515 patients treated for 540 coronary lesions
using the PRO-Kinetic stent alone. Patient’s demographics are given
in Table 1. Of note, 223 (43%) patients were diagnosed as diabetics
and 46 patients (8.9%) needed insulin treatment. Also, 87 (17%) of
the treated patients had some degree of renal insufficiency defined
as Creatinine ≥1.5 mg/dl. Otherwise, patients’ demographics are
representative of a contemporary PCI practice. Clinical indications
for PCI are presented as well in Table 1. Of note, acute coronary
syndrome event was the cause in about half of the patients. Fifty-one
(9.9%) were treated during the course of ST elevation acute
myocardial infarction (STEMI) and additional 78 (15%) patients
sustained a recent infarction event (STEMI or non-STEMI) within six
to 24 hours prior to undergoing PCI. Overall, the majority of patients
(67%) had prior MI, either acute or recent or “remote” (>7 days
before PCI) event. Accordingly, 79 patients (15%) had moderate LV
dysfunction and 43 (8.3%) patients had severe LV dysfunction
defined by either left ventriculogram or echocardiographic
examination performed during the index hospitalisation.
Clinical research
Table 1. Clinical characteristics and indications for intervention.
Patients =515/Lesions=540
Age (years)
65.8±11.7 [30-95]
Men
384 (74%)
Smoking
144 (28%)
Diabetes mellitus
223 (43%)
Insulin dependent DM
46 (8.9%)
Hypertension
355 (69%)
Hypercholesterolaemia
368 (71%)
Renal dysfunction (Creat. ≥1.5 mg/dl)
4 87 (17%)
Prior angioplasty
192 (37%)
Prior CABG
82 (16%)
Stable AP
122 (24%)
Silent ischaemia
33 (6.4%)
Acute coronary syndrome
274 (53%)
Total MI
346 (67%)
STEMI (0-6 h)
51 (9.9%)
MI (6-24 hours)
78 (15%)
MI (1 - 7 days)
107 (21%)
Remote MI (> 7 days)
110 (21%)
Moderate LVEF dysfunction
79 (15%)
Severe LVEF dysfunction
43 (8.3%)