Die letzten relevanten Studien, praktische Umsetzung: Interventionen (KHK + VHK)
Die letzten relevanten Studien, praktische Umsetzung: Interventionen (KHK + VHK) Herbsttagung der SGK 2015 „Kardiologie im Netz“ PD Dr. med. Lukas Alt...
Die letzten relevanten Studien, praktische Umsetzung: Interventionen (KHK + VHK) Herbsttagung der SGK 2015 „Kardiologie im Netz“ PD Dr. med. Lukas Altwegg Kardiologie, St. Claraspital Basel
Nov 12 2015
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Nov 12 2015
Herbsttagung der SGK: „Kardiologie im Netz“
Don’t Get Entangled…
PubMed search for interventional studies 2015: - „PCI“: - TAVI/TAVR:
8’241 757
http://www.bund.net Nov 12 2015
Herbsttagung der SGK: „Kardiologie im Netz“
My Stent – my Life Choice of Stent in 2015: which one do you choose most?
A)Bare metal stent (BMS)? B) Drug eluting Stent (DES)? C)Bioresorbable vascular scaffold (BVS)?
Nov 12 2015
Herbsttagung der SGK: „Kardiologie im Netz“
BVS versus Everolimus Eluting Stent (RCT)
Target-Lesion Failure (%)
T h e n e w e ng l a n d j o u r na l o f m e dic i n e ABSORB III Trial: Non-Inferiority regarding TLF at 1 Year
100
20
80
15
60
10 Absorb scaffold
0
20
0
1
2
Absorb= 1322
7.7
Xience= 686
6.0
5
40
0
Hazard ratio, 1.30 (95% CI, 0.91–1.87) P=0.15
Xience stent
1
0
3
2
4
4
3
5
5
6
6
7
7
8
9
8
10
9
11
10
12
13
11
12
13
Months since Index Procedure No. at Risk Absorb Xience
1322 686
1254 661
1230 651
1218 643
1205 638
Ellis SG et al. NEJM Oct 12 2015
Figure 1. Target-Lesion Failure at 1 Year. Data for the primary outcome are shown through 13 months, outside limit of the 1-year follow-up window, for Nov 12 2015 Herbsttagung der SGK: „Kardiologie imthe Netz“ patients who received an everolimus-eluting bioresorbable vascular (Absorb) scaffold or an everolimus-eluting cobalt–
Target vessel No significant difference 3/1313 (0.2) (0.4) 0.52 ABSORB III Trial: in device3/677 thrombosis at 1(0.10–2.55) Year
0.42
Nontarget vessel
2/1313 (0.2)
0.74
5/1313 (0.4)
2/677 (0.3)
1.29 (0.25–6.63)
1.00
238/1302 (18.3)
125/678 (18.4)
0.99 (0.82–1.21)
0.93
20/1301 (1.5)
5/675 (0.7)
2.08 (0.78–5.51)
0.13
14/1315 (1.1)
5/686 (0.7)
1.46 (0.53–4.04)
0.46
2/1320 (0.2)
4/686 (0.6)
0.26 (0.05–1.42)
0.19
12/1315 (0.9)
1/686 (0.1)
6.26 (0.82–48.04)
0.04
6/1299 (0.5)
0/675
NA
0.10
Definite
18/1301 (1.4)
5/675 (0.7)
1.87 (0.70–5.01)
0.21
Probable
2/1301 (0.2)
0/675
NA
0.55
Patient-reported angina Definite or probable device thrombosis Early: 0 to 30 days Acute: ≤24 hr Subacute: >24 hr to 30 days Late: 31 days to 1 yr
* One-year follow-up includes a window of ±28 days. NA denotes not applicable.
tive vascular responses, which may result in butes, they are likely to become evident only in chronic inflammation, neoatherosclerosis, or de- the longer term. The ongoing ABSORB IV trial vice fracture.5,6,10-12 Thus, bioresorbable vascular (ClinicalTrials.gov number, NCT02173379), which scaffolds were developed to improve long-term will enroll approximately 5000 patients, has a outcomes with contemporary metallic drug-elut- powered primary end point of improved rates of ing stents. Imaging studies support the novel at- target-lesion failure at 1 to 5 years after implanet al. NEJMtoOct 12 2015 tributes of bioresorbable scaffolds, with restoration tation, an outcome thatEllisisSGdesigned address of cyclic pulsatility at the device site 6 months after this question. Nov 12 2015 Herbsttagung der SGK: „Kardiologie implantation, restored vasomotion by 12 months,im Netz“Rates of target-lesion failure at 1 year were
Bioresorbable Scaffolds for Coronary Disease BVS versus Everolimus Eluting Stent (RCT)
ABSORB III Trial: Subgroup analysis Subgroup
Absorb (N=1322)
Xience (N=686)
P Value for Interaction
Risk Ratio (95% CI)
no. of events/total no. (%) All patients Age ≥64 yr