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A Randomized Comparison of a Sirolimus-elutingStent with Biodegradable Polymer versus an
Everolimus-eluting Stent with a Durable Polymerfor Percutaneous Coronary Revascularization
Thomas Pilgrim, MDSwiss Cardiovascular CenterBern University Hospital, Switzerland
Overall (I-squared = 0·0%, p=0·92)
LEADERS 4 years fup
ISAR-TEST 4 3 years fup
ISAR-TEST 3 2 years fup
20/857
9/1299
1/202
32/850
9/652
2/202
0·58 (0·37, 0·93)
0·62 (0·36, 1·08)
0·50 (0·20, 1·26)
0·50 (0·05, 5·47)
10·1 0·2 2 50·5
Favours biodegradable polymer DES
Favours durable
polymer SES
BP-DES DP-SES RR (95% CI)
Definite ST
A Meta-Analysis of Biodegradable Polymer DES versus Durable Polymer Sirolimus Eluting Stents
Stefanini G et al. Lancet 2011; 378:1940-8
Overall (I-squared = 0·0%, p=0·79)
LEADERS 4 years fup
ISAR-TEST 4 3 years fup
ISAR-TEST 32 years fup
88/857
168/1299
17/202
111/850
95/652
21/202
0·84 (0·71, 0·99)
0·79 (0·60, 1·02)
0·89 (0·70, 1·12)
0·81 (0·44, 1·49)
TLR
Favours biodegradable polymer DES
Favours durable
polymer SES
10·1 0·2 2 50·5
BP-DES DP-SES RR (95% CI)
Biodegradable Polymer Based DES Platforms
Sirolimus – ISAR TESTBiolimus A9 – BioMatrixNobori, Axxess, XTENT
Sirolimus – ORSIRO
Sirolimus – GenousBioengineered R Stent
Everolimus - SYNERGY Myolimus – ELIXIR
Orsiro1 Hybrid Sirolimus Eluting Stent System
Passive component: PROBIO• Silicon carbide2 layer that encapsulates the
stent surface, reducing ion release
Active component: BIOlute• PLLA3 bioabsorbable polymer matrix• Sirolimus (1.4 µg/mm2)
• Controlled drug release out to 3 months• Asymmetric coating with greater
drug dose on abluminal side (Ablumial thickness 7.4 µm)
Stent platform: PRO-Kinetic Energy• Cobalt Chromium, L-605• 60 µm struts
1 Manufactured and distributed by BIOTRONIK2 aSiC:H amorphous silicon carbide3 Poly-L-lactide
In vivo drug release in minipig coronary arteries
0
10
20
30
40
50
60
70
80
90
100
0 10 20 30 40 50 60 70 80 90 100
% D
rug
Rele
ase
Time (days)
Source: Data on file at BIOTRONIK
BIOSCIENCE Trial NCT01443104
Primary endpoint: Target lesion failure defined as the composite of cardiac death, target vessel
myocardial infarction, and clinically-driven target lesion revascularization at 12 months
2100 Patients
Orsiro® Stent system Sirolimus-eluting stent with a
biodegradable polymer
Xience PRIME® stent Everolimus-eluting stent with a
durable polymer
1:1
Prospective multi-center randomized “all-comers” trial with a non-inferiority design
Inclusion Criteria
1 Age ≥18 years;
2 Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS;
3 Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with one or multiple stents;
4 No limitation on the number of treated lesions, and vessels, and lesion length
Exclusion Criteria
1 Pregnancy;
2 Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Everolimus or contrast material;
3 Inability to provide informed consent;
4 Currently participating in another trial before reaching first endpoint;
5 Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
Primary Endpoint
Target lesion failure (TLF) in the overall population, defined as the composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI) (i.e., Q-wave MI that cannot be attributed to a non-target vessel), clinically driven target lesion revascularization (TLR) and emergent coronary artery bypass grafting (CABG) within 12 months.
Secondary Endpoints Clinically indicated and not clinically indicated target lesion revascularization (TLR) at 30 days, 1, 2 and 5 years.
Clinically indicated and not clinically indicated target vessel revascularization (TVR) at 30 days, 1, 2, and 5 years.
TLF composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI) (i.e., Q-wave MI that cannot be attributed to a non-target vessel), clinically driven target lesion revascularization (TLR) and emergent coronary artery bypass grafting (CABG)at 30 days, 2, and 5 years.
Target Vessel Failure (TVF) at 30 days, 1, 2, and 5 years.
Cardiac death at 30 days, 1, 2, and 5 years.
All deaths (cardiac and non-cardiac) at 30 days, 1, 2, and 5 years.
Myocardial infarction (Q-wave and NQWMI) at 30 days, 1, 2, and 5 years.
Definite stent thrombosis at 30 days, 1, 2, 3and 5 years.
Definite or probable stent thrombosis at 30 days, 1, 2, and 5 years.
Device success, lesion success and procedural success (see definitions).
Time ScheduleEvent Screen Procedur
ePost -Procedure to Hospital D/c
30 Days 1 Yr 2 Yrs 5 Yrs
Type of contact Phone Visit Phone PhoneInclusion/
exclusion Criteria
X
Informed consent XPhysical examination
X
Medical and Cardiac history
X
Anginal Status X X X X X XCBC, blood chemistry, lipids,
X
CK, CK-MB X XTroponin X X12 lead ECG X XMedication regimen
X X X X X X X
Adverse event and Severe Adverse Event monitoring
X X X X X X
Contacts
Dr. med. Thomas Pilgrim
Invasive Kardiologie, Inselspital Bern
076 548 44 11