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(0.4%) were observed and/or confirmed up to six months, 3) the
TVR/TLR rates were very low overall and acceptable even among
diabetic patients, 4) in a public system and clinical setting, with
~40% of patients treated using DES and 60% of the remaining
patients receiving BMS, the data should emphasise the
encouraging safety and clinical performance of the PRO-Kinetic
coronary stent system among patients with a wide variety of clinical
characteristics and syndromes. Additional findings of our study are
related to the excellent angiographic performance (99.8%
angiographic success rate) and clinical safety and efficacy profiles
of the PRO-Kinetic stent in the intermediate-term follow-up period
(i.e. MACE rates at six months was 8.7%). Thus, the PRO-Kinetic
registry emphasises the need for ongoing discussion concerning the
role of contemporary non-DES platforms, in the modern
interventional cardiology practice. Also, our results reassure the
important role of BMS utilisation in patients faced with the hazards
of receiving long-term clopidogrel treatment following DES due to
advanced age, bleeding risks, planned surgery, or if they are on
concurrent warfarin treatment
3
.
Comparative data
Our results are in accordance with a previous report by Dahm et al
4
.
They recently reported on 145 patients and 161 lesions treated
using the PRO-Kinetic stent. Diabetic patients were 28% of the
study population and the mean reference vessel diameter was
2.67 mm with an average lesion length of 12.8 mm. The six month
TLR rate was 4.9%, the overall MACE rate was 5.6% and the
average angiographic late loss was 0.75 mm. Interesting, an
in vitro
sub-study showed a favourable and rapid rate of endothelisation
associated with the silicon carbide coating as compared to an
uncoated stent platform. Thus, it is possible that the PROBIO silicon
carbide passive stent coating contributed to the favourable clinical
results in the PRO-Kinetic studies
2,4
.
It is difficult to compare our registry results with other historical stent
registries. Nonetheless, we should focus on some of the most recent
ones. The MATSURI multicentre registry using the TSUNAMI
stainless steel stent, had 1,437 patients and 1,792 lesions with
25% diabetics, 49% type B2/C lesions and 39% located in the
LAD
5
. Lesions length was 10.6 mm and the mean reference vessel
diameter was 2.96 mm. The cumulative MACE rate at six months
was 7.3% and a TLR rate of 4.5% and 0.2% suspected rate of stent
thrombosis.
The Driver cobalt chromium US stent registry
6
had 298 coronary
patients and lesions (28% diabetics), 45% LAD lesion and 51%
type B2/C lesions, with a mean reference vessel diameter of
3.07 mm and a mean lesion length of 11.04 mm. The cumulative
MACE was 5.7% and TLR was 3.4% at six months and no sub-
acute stent thromboses events were observed. The Multi-Link
Vision cobalt chromium coronary US stent registry
7
had
267 coronary patients and lesions (23% diabetics), 39% LAD and
40% type B2/C lesions, with a mean reference vessel diameter of
2.94 mm and a mean lesion length averaging 10.6 mm. The
cumulative incidence of MACE was 6.2%, TLR was 4.3% and TVR
was 5.1% at six months. The mean in-stent late loss was 0.83 mm
and no sub-acute stent thrombosis events were reported. The
multicentre NIRtop study examined the results of the stainless-steel
NIRflex stent in 305 patients suffering from a native coronary
disease
8
. One hundred and fifty-eight (n=158) patients participated
in the non-gold plated NIRflex arm of the study, with 191 lesions
treated and 19% of the patients had diabetes. The average
diameter of the arteries was 2.74 mm, the average length of the
stenoses was 10.3 mm and 65% of the stenoses were of a complex
angiographic morphology (B2/C). The angiographic data gathered
during the 6-month follow-up period showed a late-loss parameter
averaging 0.65 mm. The clinical results at six months were as
follows: no mortality TLR of 2.5% and a total MACE rate of 7.0%
during the six month follow-up.
Figure 4 summarises the MACE and TLR results in those studies
and in relation to the main drivers of restenosis outcomes in each
study as well as in the context of our study findings. It should be
acknowledged that most patients included in these registries
might have been of mild to moderate risk profile from a standpoint
Clinical research
Figure 3. Cumulative (hierarchical) six months results of the total
study population (red bars) and the diabetic sub-group (grey bars).
MACE Death MI
CABG TVR TLR ST
8.7%
4.5%
1.4% 1.4%
0.4%
0.8%
1.8%
6.4%
7.6%
5.2%
7.1%
2.7%
10.7%
3.5%
Figure 4. MACE and TRL rates in BMS reported studies.
N=Pts/Lesions 515/540 145/161 1437/1792 298/298 267/267 158/191
DM (%)
43
28
25
28
23
19
LAD (%)
21
30
39
45
39
37
B2/C type (%)
60
59
49
51
40
65
RVD (mm)
2.81
2.67
2.96
3.07
2.94 2.74
Length (mm)
12.6
12.8
10.6
11.04 10.6 10.3
MACE/TLR (%)
MACE
TLR
PRO-Kinetic
(RMC)
PRO-Kinetic
(Dahm)
TSUNAMI
(MATSURI)
DRIVER
(US)
VISION
(US)
NIRFlex
(NIRTOP)
10
8
6
4
2
0