DES or maybe BMS - escardio.org · Boehringer Ingelheim Bristol Myers-Squibb Correvio Daiichi-Sankyo ... Interview at ACC 2003, ... Presentation Title

DES or maybe BMS ?

Prof. Dr. Helmut Schühlen, FESC, FACC

Vivantes Auguste-Viktoria-Klinikum

Berlin, Germany

Conflict of Interest Statement


Research support, speaker‘s or consulting honoraria from:

Astra Zeneca Abbott

Bayer Biotronik

Boehringer Ingelheim Bristol Myers-Squibb

Correvio Daiichi-Sankyo

Lilly Novartis


Rationale for StentsWhich Problems Did We Want to Solve With Stents ?

• mechanically scaffold the artery

• (re)create a larger circular lumen

• prevent abrupt vessel closure

• prevent late restenosis

S Goldberg, TCT 2004Prof. Dr. Helmut Schühlen, FESC, FACC

Abrupt Vessel Closure

Early Data with POBA:

• frequency 5-10%

• consequences:MI ~35%mortality ~8-20%emergency CABG ~30%

• stents for abrupt closureas bridge to bypass surgery

• stents as definite treatmentfor abrupt vessel closure

• routine surgical back-up became obsolete


Quantitative Coronary Analysis ofStents versus POBA

STRESS n=410 BENESTENT n=520

P Serruys et al., N Engl J Med 1994

1,72

0,74

0,98

1,23

0,38

0,80

0

0,5

1

1,5

2

acute lumen gain

late lumen loss

net gain

mm P<.001

DL Fishman et al., N Engl J Med 1994

P<.001 p=0.01

1,40

0,650,75

0,97

0,32

0,65

0

0,5

1

1,5

2

acute lumen gain

late lumen loss

net gain

mm P<.001 P<.001 p=0.09

POBA

Stent


Clinical Results & Longterm OutcomeStents versus POBA

19,5

10,2

31,6

23,8

15,2

42,1

0

10

20

30

40

50

MACE TLR restenosis

% p=0.16 p=0.06 p=0.046

20,1

13,5

22

29,6

23,3

32

0

10

20

30

40

50

MACE TLR restenosisat 12 mo. at 7 mo.

p=0.02 p=0.001 p=0.02%

STRESS n=410 BENESTENT n=520

P Serruys et al., N Engl J Med 1994DL Fishman et al., N Engl J Med 1994

POBA

Stent


Randomized Trials Stent versus POBA


J Al Suwaidi et al., JAMA 2000

Analysis of 12 randomized trials with 6300 patients

Metaanalysis of Stent versus POBA Trials

AJ Nordmann et al.,

Eur Heart J 2004

19 randomized trials with 8004 patients- Analysis of lives saved per 1000 patients at 12 mo. -


Initial Experience with DES


JE Sousa et al., Circulation 2001

The real target isnot BMS vs. DES,

it‘s surgery.

Interview at ACC 2003, www.theheart.org


Early Data for DES & BMS in Subgroups

17,6

0

10

20

30

40

50

%50.5

SIRIUSdiabetes subgroup

Velocity CypherAn

gio

grap

hic

rest

en

osi

sat

6 m

o.

J Moses, ACC 2003

20,5

44,7

0

10

20

30

40

50

%

VelocityMULTI-LINK

ISAR-STEREO-2diabetes subgroup

J Pache et al., J Am Coll Cardiol 2003

Metaanalysis of Trials with DES versus BMS

11 trials with 5103 patients

mortality TLRMN Babapulle et al.,

Lancet 2004

The Debate at ESC 2006


Mechanistic Insights into the Excess Risk ofLate Stent Thrombosis After 1G DES

AquiredMalapposition

Incomplete Endothelializationand Chronic Inflammation

Guagliumi et al., JACC Interv 2012

Guagliumi et al, Circulation 2003

18 mo. after implantation


Continuous Risk for Stent Thrombosis with 1st Gen. DES

Stent Thrombosis (%)

Registry of18,334 pts

with BMS or DES

246 definite SAT

T Tada et al., JACC Intv 2013

years

0

0.5

1.0

2.0

3.0

0 1 2 3

1.5

2.5

BMS

1st Gen. DES


Longterm Outcome with 1st-gen. DES vs. BMS


SK James et al., N Engl J Med 2009

Incidence of death or MI

SCAAR Registry

47967 pts.

BMS n=18659DES n=10294

ACS ~80%STEMI ~30%

DAPT Duration in Pivotal Trials of 1G-DES

RAVEL 8 wks.SIRIUS 3 mo.E- & C-SIRIUS 2 mo.

TAXUS I, II, IV-VI 6 mo.

Cypher ®

sirolimus-eluting, permanent polymer

Taxus ®

paclitaxel-eluting, permanent polymer


ESC Guidelines on DAPT after PCI in stable CAD 2005 - 2014

E Kedhi et al., Lancet 2010

Taxus

Stent thrombosis

Xience

TVR for restenosis

COMPARE Trial: 1800 patients, 60% with ACS

More Favorable Results with 2nd-Gen. DES


Is Late Stent Thrombosis Still a Relevant Issue After 2nd-Gen. DES ?

GG Stefanini et al., Eur Heart J 2012

Metaanalysis of ISAR-TEST 3 + 4 & LEADERS

4062 pts. randomized to Yukon, Biomatrix or Cypher

Endeavor

PROTECT trial 8709 pts. randomized to Cypher or Endeavor

Cypher

Yukon & Biomatrix

Cypher

E Camenzind et al., Lancet 2012


Late Stent Thrombosis with BMS, 1st-Gen. & 2nd-Gen. DES

1st-G. DES

BMS

2nd-G. DES

Registry of18,334 pts

with BMS or DES

246 definite SAT

T Tada et al., JACC Intv 2013


2nd-Gen. DES vs. BMS - The NORSTENT Trial


KH Bønaa et al., N Engl J Med 2016

9013 patients randomized to BMS or DES; both >9 mo. DAPT; ~60% ACS (DES group: Promus/Xience 82.3%, Endeavor 11.9%, Cypher/Taxus 5.1%)

All-Cause Mortality Revascularization(PCI or CABG)

Stent Thrombosis(definite)

DES vs. BMS in Patients with DAPT for 1 Mo.

Stent Thrombosisdefinite or probable

Death, MI or TVR

BMS

DES (Endeavor)

828 patients randomized to BMS or Endeavor

S Ariotti et al.,JACC Intv 2016


Cardiac Death, MI or Stent Thrombosis TLR

P Urban et al., N Engl J Med 2015


DES vs. BMS in Patients with DAPT for 1 Mo.

2466 patients randomized to BMS or BioFreedom

Metaanalysis 2nd-gen. DES vs. BMS in STEMI


M Sabaté et al., JACC Intv 2014

EXAMINATION & COMFORTABLE-AMI with 2665 pts.

(Xience or Biomatrix versus BMS)

All-Cause Death Revascularization Stent Thrombosis(definite)

Network Metaanalysis DES vs. BMS in STEMI


T Palmerini et al., JACC 2013

22 trials with 12453 patients

Cardiac Death or MI per 100 patient-yrs.

Stent Thrombosisper 100 patient-yrs. (definite)

TVRper 100 patient-yrs.

Summary

Mortality is better perceived as the target for themandatory & well-established longterm medical therapy.

Stents have revolutionized & simplified PCI.

Stents (BMS) increase the proliferative response to PTCA.

1st-gen. DES diminished this proliferative response at thecost of deficient healing & a continuous thrombotic risk.

“3rd“gen. DES are safer than BMS, even with 1 mo. DAPT.



Our opinion of these data is that there is a clearbenefit from DES… and that this benefit is inde-pendent of the clinical indication. …In 2016 implantation of BMS is no longer justified. We suggest that BMS should be honourably retiredand added to the history books that document theevolution of interventional therapies.


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DES or maybe BMS - escardio.org · Boehringer Ingelheim Bristol Myers-Squibb Correvio Daiichi-Sankyo ... Interview at ACC 2003, ... Presentation Title