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DRUG ELUTION FOR ALL? THE CASE AGAINST. Jim McLenachan Yorkshire Heart Centre, Leeds. DRUG ELUTING STENTS. DO WE REALLY NEED THEM ? DO THEY WORK ? CAN WE SELECT “AT RISK” PATIENTS ? ARE THEY SAFE ?. Stenting and procedures for restenosis (2000 data from 40 centres).

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Drug elution for all the case against

DRUG ELUTION FOR ALL? THE CASE AGAINST

Jim McLenachan

Yorkshire Heart Centre,

Leeds


Drug eluting stents
DRUG ELUTING STENTS

  • DO WE REALLY NEED THEM ?

  • DO THEY WORK ?

  • CAN WE SELECT “AT RISK” PATIENTS ?

  • ARE THEY SAFE ?


Stenting and procedures for restenosis 2000 data from 40 centres
Stenting and procedures for restenosis (2000 data from 40 centres)

BCIS AUDIT


Repeat pci in ravel
REPEAT PCI IN RAVEL

Event

Free

Survival

(%)

Days after implantation

N Engl J Med 2002;346:1773-80


Cardiac events at one year ravel study
CARDIAC EVENTS AT ONE YEARRAVEL STUDY

N Engl J Med 2002;346:1773-80


Timing of events in ravel
TIMING OF EVENTS IN RAVEL

Event

Free

Survival

(%)

REPEAT

ANGIOGRAPHY

Days after implantation

N Engl J Med 2002;346:1773-80


Sirius clinical events
SIRIUS : Clinical events

Holmes et al ACC 2003


Sirius clinical events1
SIRIUS : Clinical events

Holmes et al ACC 2003


Drug eluting stents1
DRUG ELUTING STENTS

  • DO WE REALLY NEED THEM ?

  • DO THEY WORK ?

  • CAN WE SELECT “AT RISK” PATIENTS ?

  • ARE THEY SAFE ?


Drug eluting stents2
DRUG ELUTING STENTS

  • DO WE REALLY NEED THEM ?

  • DO THEY WORK ?

  • CAN WE SELECT “AT RISK” PATIENTS ?

  • ARE THEY SAFE ?


Prediction of restenosis
PREDICTION OF RESTENOSIS (%)

KEREIAKES Am J Cardiol 2000;86:336


Drug eluting stents3
DRUG ELUTING STENTS

  • DO WE REALLY NEED THEM ?

  • DO THEY WORK ?

  • CAN WE SELECT “AT RISK” PATIENTS ?

  • ARE THEY SAFE ?


SCORE Trial

Binary Restenosis (%)

p<0.001 83%

Binary Restenosis (%)


SCORE Trial

MACE (6 months)

SAT (%)

AMI (%)

Death (%)


Subacute thrombosis and drug eluting stents is there a link
Subacute thrombosis and drug eluting stents Is there a link?



Fda alert 29 th october 2002
FDA ALERT 29th October, 2002

  • FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents

  • FDA has received more than 290 reports of thrombosis (clotting) occurring one to 30 days after the procedure to implant the device. In more than 60 of these reports, use of the device was associated with the death of the patient;

  • FDA has also received more than 50 reports, including some deaths, that Cordis considers to be possible hypersensitivity reactions.


E-Sirius (male 59 yrs)

Two Cypher Stents (3.0 x 18mm + 2.5 x 18mm)

Virmani R, Guagliumi G, Farb A


Marked Chronic Inflammation and Medial Destruction

Distal

Stent

Proximal

Stent

Aneurysm

Prominent eosinophils

Inflammation within and surrounding stent strutsand in adventitia


Inflammatory sequelae to what?

Long Term Human Pathology: 18 Months

Eosinophils in adventitia (red colored cells, Luna stain)

Giant cells surrounding foreign material in aneurysm

Polymer coating around stent strut

Virmani R, Guagliumi G, Farb A





Cardiac events at two years ravel study
CARDIAC EVENTS AT TWO YEARSRAVEL STUDY

MORICE et al ACC 2003


Cypher mortality from randomized trials
CYPHERMortality from Randomized trials


“Selective use of drug eluting stents

can further improve the already

excellent outcome seen with

regular stent technology.”

Spencer B King III,

Circulation 2003;108:248-249


“ As to diseases,

make a habit of two things –

to help, or at least do no harm.”

HIPPOCRATES


“I think there is

something to this

inflammation story”

K. DAWKINS, LONDON, 5/12/03


Drug eluting stents4
DRUG ELUTING STENTS

  • DO WE REALLY NEED THEM ?

  • DO THEY WORK ?

  • CAN WE SELECT “AT RISK” PATIENTS ?

  • ARE THEY SAFE ?


IAIN SIMPSON

AND

SOUTHAMPTON


Dr Liam Penny

V.

Dr Alison Calver

PRIMARY PCI FOR AMI DEBATE,

BRIGHTON 24 th October. 2003



“In no other walk of life does the cloven hoof

so quickly display itself. Golf is the infallible test.

The man who can go into a patch of rough alone,

with the knowledge that only God is watching him,

and play his ball where it lies, is the man who will

serve you faithfully and well. But the man who is

hasty, unbalanced and violent on the links, will display

the same qualities in the wider field of everyday life.”

PG Wodehouse


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