Transcript Synergy SCAAR Registry 12Mos Outcomesx

Real-world clinical experience with an everolimus
eluting platinum chromium stent with an
abluminal biodegradable polymer – a report from
the Swedish Coronary Angiography and
Angioplasty Registry (SCAAR)
Giovanna Sarno, MD, PhD
Uppsala University Hospital
and Uppsala Clinical Research Center
Uppsala, Sweden
Giovanna Sarno, MD, PhD
Istitutional research support from Boston Scientific Corporation
BACKGROUND
• Time-dependent effects for polymers used in drug-eluting
stent (DES) technology have been previously described with
an early protective effect against stent thrombosis and a late
pro-inflammatory and pro-thrombotic effect.
• The local reaction to the polymer coating can exacerbate the
inflammatory reaction caused by stent implantation, impair
endothelialization and lead to increased risk of late ST
compared to bare metal stents.
Finn AV, Joner M, Nakazawa G, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization.
Circulation 2007;115:2435– 41. Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J
Am Coll Cardiol 2006;48:193–202. Joner et al. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol.
2008 Jul 29;52(5):333-42. Drug-eluting stents and late adverse clinical outcomes lessons learned, lessons awaited. J Am Coll Cardiol 2006;47:2112–5
Higher risk of Stent thrombosis in old-generation DES
after 1 year
Stents implanted 1st Jan 2007 to 8th Jan 2014
N= 84266 and 72294
N= 18535 and 17238
N= 74645 and 46104
Cumulative risk of ST (%)
BMSN=
N=84266
84266and
and 72294
72294
BMS
Old
DES
N=18577
and
17238
Old DES N= 18535 and 17238
New DES N= 74645 and
New DES N= 74645 and 46104
46104
o-DES vs BMS: adjusted RR 1.81 (1.44-2.28), p<0.001)
n-DES vs BMS: adjusted RR 1.17 (0.88-1.56), p=ns
BMS= bare metal stent
DES= drug eluting stent
SAT= stent thrombosis
o-DES=old generation drug eluting stents, n-DES=new generation drug eluting stents, BMS=bare metal stents, RR=risk ratio, ns=non significant
AIM
To describe the initial real-world experience
with a novel everolimus eluting platinum
chromium
stent
with
an
abluminal
biodegradable polymer (SYNERGY)
SYNERGY Stent Technology Design
Platform
Platinum chromium
• 74μm (0.0029in)
• Increased Visibility
Bioabsorbable Polymer Coating
PLGA
• Abluminal
• 4 µm thick
• < 4 month absorption time
Drug
Everolimus
• 100μg/cm2
• 3 month release time
METHODS
• The SCAAR records consecutive patients from all centers (n=29)
performing coronary angiography and PCI in Sweden. Information on
restenosis or stent thrombosis in any previously implanted stent anywhere
in Sweden is requested for all patients undergoing any subsequent
coronary angiography for any clinical indication
• All implanted SYNERGY stents were compared to all new generation DES
(n-DES) with more than 1000 implantations in Sweden between March
2013 and October 2015 for all indications including acute coronary
syndromes (ACS)
• Restenosis, ST, death rates were assessed using propensity score and Cox
regression analyses. A subgroup analysis for ST up to 1 year was
performed in patients with acute coronary syndromes (ACS) including
Non-ST elevation myocardial infarction (NSTEMI), ST-elevation myocardial
infarction (STEMI), unstable angina (UA)
STENT CLASSIFICATION
• SYNERGY stent group, N= 7,886
• Other n-DES, N=69,429








BioMatrix, N=1,953
Orsiro, N= 4,946
Promus Element Plus, N= 2,543
Promus Premier, N= 20,414
Xience/ Xpedition, N= 7,971
Resolute/Resolute Integrity, N=19,021
Ultimaster, N=1,156;
Resolute Onyx, N=6,425
Clinical Characteristics
N Patients
Age, years, mean
Women (%)
Diabetes (%)
Clinical presentation
NSTEMI ‡ (%)
STEMI § (%)
SA (%)
UA (%)
Other indications
Clinical history
Hypertension (%)
Hyperlipidemia (%)
Prior MI† (%)
Smoker (%)
Prior CABG* (%)
Prior PCI (%)
SYNERGY
n-DES
p
4247
68.0 ± 10.8
1191(28.0)
981 (23.1)
38110
67.6 ± 10.8
9697 (25.4)
8346 (21.9)
<0.01
0.02
<0.01
<0.01
1582 (37.2)
1017 (23.9)
1031 (24.3)
412 (9.7)
205 (4.8)
14384 (37.7)
9261 (24.3)
9300 (24.4)
3751 (9.8)
1414 (3.7)
NS
NS
NS
NS
<0.01
2818 (66.4)
2305 (54.3)
1276 (30.0)
795 (18.7)
414 (9.7)
1324 (31.2)
24107 (63.3)
20428 (53.6)
10606 (27.8)
7057 (18.5)
3589 (9.4)
11117 (29.2)
<0.01
<0.01
<0.01
NS
NS
0.02
Procedural Characteristics
SYNERGY
n-DES
p
N
3 VD¶ (%)
LM disease (%)
Treated vessel
RCA║ (%)
LM (%)
LAD† (%)
4247
1705 (21.6)
651 (8.3)
38110
11824 (20.4)
4277 (7.4)
<0.01
<0.01
<0.01
1390 (32.7)
222 (5.2)
1841 (43.3)
12247 (32.1)
1810 (4.7)
16905 (44.4)
NS
NS
<0.01
LCX‡ (%)
660 (15.5)
6129 (16.1)
NS
Vengraft (%)
Arterial graft (%)
CTO* (%)
Restenotic lesions (%)
127 (3.0)
7 (0.2)
133 (3.1)
191 (4.5)
981 (2.6)
41 (0.1)
1059 (2.8)
1382 (3.6)
NS
NS
NS
<0.01
Bifurcation lesions (%)
610 (14.4)
5010 (13.1)
<0.01
Stent Diameter, mm, mean±SD
2.95 ± 0.52
3.00 ± 0.51
<0.01
Stent Length, mm, mean±SD
22.32 ± 8.72
20.32 ± 7.84
<0.01
Stent number per patient, mean±SD
2.52 ± 1.48
2.28 ± 1.32
<0.01
Procedural success (%)
4169 (98,2)
37485 (98.4)
NS
RESTENOSIS
Cumulative Rate of restenosis
2,0
1.2% vs. 1.0%, adjusted HR: 1.24 95% CI: 0.88-1.75; p=0.21).
(1.2% vs. 1.0%, adjusted HR: 1.24 95% CI: 0.88-1.75; p=0.21
n-DES, N=64429
Synergy, N=7886
1,5
1,0
0,5
0,0
0
2
4
6
8
10
12
Time after PCI (months)
Restenosis occurred in 525 cases in the total population up to 1 year
DEFINITE STENT THROMBOSIS
0.2% vs. 0.5%, adjusted HR: 0.68; 95% CI: 0.38-1.19; p=0.17
n-DES, N=64429
Synergy, N=7886
Stent thrombosis occurred in 282 cases in the total population up to 1 year
DEFINITE STENT THROMBOSIS
in Acute coronary syndromes
0,6
0.3% vs. 0.5%; adjusted HR: 0.69; 95% CI: 0.37-1.37; p=0.29
Cumulative Rate of stent thrombosis
n-DES, N=44845
Synergy, N= 5294
0,5
0,4
0,3
0,2
0,1
0,0
0
2
4
6
8
Time after PCI (months)
10
12
ALL CAUSE MORTALITY
5.1% vs. 4.9%, adjusted HR: 1.08; 95% CI: 0.89-1.32; p=0.42
CONCLUSIONS
• In a large real-world population the SYNERGY stent appears to be
safe and effective with a low risk of restenosis and ST comparable
with other n-DES. The risk of ST up to 1 year is similarly low also in
patients with ACS.
• The advantages of stent devices with bioabsorbable polymer may
become more evident in the longer term follow-up1
• A longer term follow-up in this population might show a larger
difference in the risk of the very late stent thrombosis between the
SYNERGY stent and the other n-DES
Serruys, JACC Interv 2013; 6: 777-89