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...
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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–

Nontarget vessel

71/1313 (5.4)

39/677 (5.8)

0.94 (0.64–1.37)

ischemia-driven 8/1313 (0.6) 5/677 (0.7) BVSNotversus Everolimus Eluting Stent (RCT) 0.82 (0.27–2.51) Target lesion

2/677 (0.3)

0.77

0.52 (0.07–3.65)

0.61

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

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