ISAR-CABG: Randomized, Superiority Trial of Drug-Eluting-Stent and - - PowerPoint PPT Presentation

▶

Jun 07, 2023 491 likes •769 views

ISAR-CABG: Randomized, Superiority Trial of Drug-Eluting-Stent and Bare Metal Stent in Safenous Vein Graft Lesions J. Mehilli, MD , G. Richardt, F-J. Neumann, S. Massberg, K-L. Laugwitz, J. Pache, J. Hausleiter, I. Ott, M. Fusaro, T. Ibrahim,

SLIDE 1

J. Mehilli, MD,
G. Richardt, F-J. Neumann, S. Massberg, K-L. Laugwitz, J. Pache,
J. Hausleiter, I. Ott, M. Fusaro, T. Ibrahim, S. Schulz, R. A. Byrne,
A. Schömig,
A. Kastrati

Deutsches Herzzentrum & 1st Med. Klinik rechts der Isar, Technische Universität Munich,

Germany

ISAR-CABG:

Randomized, Superiority Trial of Drug-Eluting-Stent and Bare Metal Stent in Safenous Vein Graft Lesions

SLIDE 2

Disclosure Statement

f Financial Interest

Lecture fees from Abbott Vascular

SLIDE 3

Background

Years After Randomization

Patients at Risk SES BMS 2486 2472 1891 1639 1099 902 921 773 682 621 491 395

10 20 30 40 50

Sirolimus-eluting stent

1 2 3 4 5

Bare metal stent

Probability of Death, MI and Reintervention, %

HR 0.43 (0.34, 0.54) 14 Trials, 4958 pts

DES are more effective and as safe as their BMS predecessors in native coronary artery lesions

Kastrati …Schömig, NEJM 2007

HR 0.46 (0.38, 0.55) 5 Trials, 3513 pts

Stone …Leon, NEJM 2007

SLIDE 4

DES vs. BMS in Saphenous Vein Graft Lesions

Vermeersch et al., JACC 2007

DELAYED RRISC Trial N=75

months

24 30 10 20 30 40 50

TLR

P=.55

Survival SES BMS

SLIDE 5

All-cause Death Target Lesion Revascularization

Cardiac death 7% (PES) vs. 13% (BMS) HR 0.62 [0.15-2-6]; P=0.51

DES vs. BMS in Saphenous Vein Graft Lesions

Brilakis et al., JACC Intv 2011

SOS Trial N=80

SLIDE 6

Objective of the of ISAR-CABG Trial:

…to compare the efficacy of drug-eluting stents against bare metal stents – in a trial powered for clinical events

Participating Centers

Deutsches Herzzentrum Munich 1.

Med. Klinik, Klinikum

rechts der Isar, Munich Herzzentrum Bad Krozingen, Bad Krozingen Bad Segeberger Kliniken, Bad Segeberg Germany

SLIDE 7

Inclusion criteria Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50 % de novo stenosis located in saphenous vein grafts Informed, written consent Exclusion criteria Cardiogenic shock Target lesion located in arterial grafts Malignancies with life expectancy <1 year Allergies to study medication

Patient Selection

SLIDE 8

Composite

death, myocardial infarction ischemia-related target lesion revascularization at 1-year post index PCI

Primary Endpoint

SLIDE 9

Secondary Endpoints

All cause mortality Myocardial infarction Ischemia-related target lesion revascularization Incidence

f definite/probable

stent thrombosis at 1-year post index PCI

SLIDE 10

Sample Size Calculation

Hypothesis: Drug-eluting stent (DES) is superior to bare metal stent (BMS) in terms of major adverse cardiac events Assumptions: Incidence of primary endpoint in BMS group of 30% Reduction of MACE with DES of 33% Power of 80% -level of 0.05 Total number of patients needed: 600

(accounting for possible losses at follow-up)

SLIDE 11

DES (Cypher/Taxus/BP Sirolimus) n=303 BMS n=307

610 patients with de novo SVG lesions

Is Drug-Eluting Stenting Associated With Improved Results in Coronary Artery Bypass Grafts?

ISAR-CABG

6 to 8-month repeat angiogram (encouraged) 12-month clinical follow-up

SLIDE 12

serial CK + CKMB measurements 600 mg Clopidogrel

PCI

ASS 500 mg repeat angiography clinical follow-up

6-8 mo. 12 mo.

Follow-Up Protocol

30 d

clinical follow-up Clopidogrel 2x75 mg/day until discharge 75 mg at least 6 months after index PCI Aspirin 200 mg/d indefinitely

SLIDE 13

DES n=303 BMS n=307 Age, years 71.4±9.0 71.5±9.3 Female, % 13 16

Art. hypertension, %

71 73 Diabetes, % 37 35 Current smoker, % 8 6 Hyperlipidemia, % 88 86 SVG age, years 13.8±5.5 13.5±5.1 History of MI, % 56 55

Baseline clinical characteristics

SLIDE 14

DES n=303 BMS n=307 Clinical presentation, % acute MI 17 13 unstable angina 21 27 stable angina 62 60 Multivessel disease, % 98 99 Multilesion PCI, % 24 22 >1 SVGs treated/patient, % 4.0 3.6 LV ejection fraction, % 49.2±12.2 49.5±13.8

Baseline clinical characteristics, II

SLIDE 15

Angiographic characteristics

DES n=386 BMS n=385 Recipient vessel, % LAD/diagonal 32.0 31.0 LCx/marginal 35.0 36.0 RCA/PDA 33.0 33.0 Vessel size, mm 3.36±0.67 3.38±0.73 Total stented length, mm 26.8±15.4 27.5±17.7

SLIDE 16

36 26 20 18 DES % 3 2 1

Distribution of SVG Degeneration Score

34 27 20 19 BMS %

SLIDE 17

16 12 26 28 14 4 DES % medial proximal coronary

Distribution of Lesion Location within the SVGs

aortal BMS % distal diffuse 18 10 23 26 17 6

SLIDE 18

5 5 3 4

17 17 75 74

93 90

100 60 20

Distribution of TIMI Flow Rates

DES BMS DES BMS

Prior to PCI After PCI

TIMI 3 TIMI 2 TIMI 1 TIMI 0

SLIDE 19

30-Day Clinical Outcomes

0.7 0.3 2.0 2.6 1.0 0.6 4.6 5.9 5 10 15 20 %

BMS DES

P=.57 P=.66 P=.07 P=.05

Cardiac death Myocardial infarction

* No TLR occurred and only 1 pt (DES) died suddenly (probable stent thrombosis) during 30-day follow-up

MACE* All-cause death

SLIDE 20

Months After Randomization Cumulative Incidence (%) 10 20 30 40 50 1 2 3 4 5 6 7 8 9 10 11 12

Primary Endpoint: Death/MI/TLR

22.1% 15.4% P=.03 RR 0.65 [0.45-0.96] BMS DES

SLIDE 21

All-cause Death

Months After Randomization 10 20 30 40 50 1 2 3 4 5 6 7 8 9 10 11 12 Cumulative Incidence (%) 4.7% 5.2% P=.82 RR 1.09 [0.52-2.25] BMS DES

SLIDE 22

Months After Randomization 10 20 30 40 50 1 2 3 4 5 6 7 8 9 10 11 12 Cumulative Incidence (%)

Myocardial Infarction

6.0% 4.2% P=.27 RR 0.66 [0.32-1.37] BMS DES

SLIDE 23

Death

Myocardial Infarction

Cumulative Incidence (%) P=.27 RR 0.75 [0.45-1.26] BMS DES Months After Randomization 10 20 30 40 50 1 2 3 4 5 6 7 8 9 10 11 12 10.9% 8.5%

SLIDE 24

Definite/Probable Stent Thrombosis

Months After Randomization 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 Cumulative Incidence (%) P=.99 RR 1.01 [0.14-7.18] BMS DES 0.7% 0.7%

SLIDE 25

Target Lesion Revascularization

10 20 30 40 50 1 2 3 4 5 6 7 8 9 10 11 12 Cumulative Incidence (%) P=.02 RR 0.52 [0.30-0.90] BMS DES 13.1% 7.2% Months After Randomization

SLIDE 26

Target Vessel Revascularization

7.2 13.1 5 10 15 20

BMS DES

TLR

11.5 17.8 10 20

TVR

P=.02 RR 0.52 [0.30-0.90] P=.03 RR 0.61 [0.39-0.95]

SLIDE 27

Summary

Out to 12 months drug-eluting stents are superior to bare metal stents in a large-scale study powered for clinical endpoints. The need for repeat revascularizations was reduced by ~50% with DES as compared to BMS. DES were comparable to BMS regarding safety parameters – stent thrombosis, death or MI.