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PRO-Kinetic registry
Lesion characteristics
QCA data were available for all 540 lesions (100%). Main lesion
characteristics are presented on Table 2. The vast majority of
patients (95%) underwent a single vessel intervention. Almost two-
third of lesions were categorised as B2 and C type. The left anterior
descending artery (LAD) was treated in only 21% of patients as a
predominant proportion of LAD diseased patients were treated
using DES at our institution. Due to a similar reason, there were only
4% of the stented lesions that involved a true bifurcation lesion.
Prior to intervention, the TIMI flow was 3 in only 73% of patients as
the remaining patients (27%) sustained acute or recent MI and
manifested sub-optimal flow (i.e. TIMI 0-2) into the culprit vessel.
The mean reference vessel diameter was 2.81 mm and the average
lesions length was 12.6 mm (range 3 to 62 mm) according to QCA
data. The total stent length and diameter was 21.2 and 2.98 mm,
respectively (Table 2). The final TIMI flow was 3 in 99.8% of the
treated vessels as was the rate of angiographic success.
Clinical follow-up
During six month follow up (Table 3), the cumulative MACE rate was
8.7%. Mortality rate was 3.5% and cardiac mortality rate was
verified in 1.9% of patients. Seven patients (1.4%) sustained MI
during follow-up, the same number of patients needed coronary
bypass surgery (1.4%) and TVR and TLR rates (calculated per
treated patient) were 6.4% and 5.2%, respectively. Importantly,
there were only two cases (0.4%) of confirmed early or sub-acute
stent thrombosis and not a single case of later (>30 days) definite
thrombosis event. A graphic summary of the study main outcomes
is shown in Figure 2.
Diabetics and non-diabetics subgroup analysis
The MACE rate was 10.7% among the 224 diabetic patients
(233 lesions) that participated in the registry. Total mortality was
4.5%, MI rate was 2.7% and TVR and TLR rates (calculated per
treated patient) were 7.6% and 7.1%, respectively (Figure 3). The
corresponding figures were lower among the non-diabetic patients
with an overall MACE rate of 5.8% during six months follow-up.
Discussion
The main findings of our study are as follow: 1) the PRO-Kinetic
clinical data shows very good results on a large group of coronary
patients treated consecutively, 2) very few stent thrombosis events
Figure 2. Cumulative (hierarchical) six months results of the study
cohort.
MACE
8.7%
3.5%
1.4% 1.4%
6.4%
5.2%
0.4%
Death MI
CABG TVR TLR ST
Table 2. Vessels and lesions data.
Patients = 254/Lesions = 264
2 treated arteries/ patients
20 (3.9%)
3 treated arteries/ patients
3 (0.6%)
LM
13 (2.5%)
LAD
107 (21%)
Diagonal
27 (5.2%)
LCx
177 (34%)
RCA
189 (37%)
SVG
27 (5.2%)
Lesion Type
A
53 (9.8%)
B1
148 (27%)
B2
211 (39%)
C
115 (21%)
B2/C
326 (60%)
TIMI flow pre-procedure
0/1
100 (18%)
2
44 (8.1%)
3
396 (73%)
Lesion length (mm)
12.6±5.9
Total stent length per lesion (mm)
21.17±12.33
Mean stent diameter (mm)
2.98±0.61
Pre-procedure
Reference vessel diameter (mm)
2.81±0.6
Minimal luminal diameter (mm)
0.42±0.36
Diameter stenosis (%)
87.8±10.97
Post-procedure
Reference vessel diameter (mm)
3.1±0.62
Minimal luminal diameter (mm)
2.89±0.65
Diameter stenosis (%)
6.35±5.06
Final TIMI flow 3
539 (99.8%)
Table 3. Clinical outcomes.
Patients = 515/Lesions = 540
Six months outcomes
Cumulative MACE
45 (8.7%)
Death
18 (3.5%)
Cardiac mortality
10 (1.9%)
Myocardial infarction
7 (1.4%)
CABG
7 (1.4%)
TVR (per patient)
33 (6.4%)
TLR (per patient)
27 (5.2%)
TVR (per Lesion)
36 (6.7%)
TLR (per Lesion)
30 (5.5%)
Stent thrombosis*
2 (0.4%)
* 2 events within 30 days