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PCI vs Isolated CABG Numbers (UK)
Data from BCIS and SCTS Registry
50000
45000
40000
35000
30000
BCIS
25000
SCTS
20000
15000
10000
5000
0
'91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02
Ratio PCI:CABG
1.3 1.5
?
1.7
PCI and CABG rates per million
(Europe 2000)
2500
2.3
Ratio
PCI:CABG
2000
4.1 5.4
1500
2.8
2.4
3.0
1.7
1.4
1000
3.3
PCI
2.0
CABG
0.9
1.8 1.4 4.2
500
0.7
1.3
2.0
0
Pol
Gre
Spa Hun Por
Fin
UK
Ita
Bel
Cze Nor Lux
Fra
Ice
Swi Aus Ger
The problem of restenosis
Results from ARTS trial,
NEJM 2001
Survival
Event free survival
excluding target vessel
revascularisation
Event free survival
including target vessel
revascularisation
Issues of Drug Elution
 Is drug elution effective?
 Is the effect sustained?
 Are there any adverse effects?
 Are there other down sides?
 Is it being used in most patients? If not, why?
 Can it be used in all patients?
 Are there subgroups where it should be
avoided?
Is Drug Elution Effective?
TAXUS IV
TAXUS IV
Issues of Drug Elution

 Is drug elution effective?
 Is the effect sustained?
 Are there any adverse effects?
 Are there other down sides?
 Is it being used in most patients? If not, why?
 Can it be used in all patients?
 Are there subgroups where it should be
avoided?
Is this effect sustained or merely delayed?
Virmani et al. Heart 2003
Neointimal growth with bare
metal stents
Neointimal growth with drug
eluting stents
Issues of Drug Elution

 Is drug elution effective?

 Is the effect sustained?
 Are there any adverse effects?
 Are there other down sides?
 Is it being used in most patients? If not, why?
 Can it be used in all patients?
 Are there subgroups where it should be
avoided?
BCIS Website Sept ‘03
UK report of 3 cases of Cypher stent
thrombosis
Subacute Thombosis
Data from >100,000 patients
Drug Eluting Stents
Other potential down sides!
 More prolonged use of anti-platelet therapy
Addition of clopidogrel for 3-6 months in line with
trend in anti-platelet therapy for ACS
 Cost
Cost analysis flawed
Patients have different perspective on cost versus
benefit
Ability to treat many more lesions with DES
Impact in reducing need for surgical
revascularisation – long term cost benefit issues
Issues of Drug Elution

 Is drug elution effective?

 Is the effect sustained?
 Are there any adverse effects? 
 Are there other down sides?

 Is it being used in most patients? If not, why?
 Can it be used in all patients?
 Are there subgroups where it should be
avoided?
Southampton Usage - 2003
1400
1200
93%
1000
800
73%
600
400
200
0
PCI
Stents
Drug Eluting
League Table
Reasons for bare metal stent usage
 Limited availability of different types of stent
Deliverability
 Limitation on available lengths and sizes
Lesion suitability
Graft disease
 NICE guidance
NICE Guidance – Drug Eluting Stents
TAXUS IV
TAXUS IV
TAXUS IV
Cypher stents in AMI
 96 patients with ST elevation AMI
 12 patients with cardiogenic shock
 Primary PCI in 89 (92.7%)
 TIMI 3 flow in 93.3%
 1 patient with reinfarction and TLR
 Follow up mean of 218 (+ 75) days
 1 death during follow up
Saia et al. Circulation 2003
Cypher stents in AMI
Rapamycin-Eluting Stent Evaluated At
Rotterdam Cardiology Hospital (RESEARCH)
Registry
 508 consecutive patients treated with
Sirolimus eluting stent
 Compared to preceding 450 patients with
bare metal stents
 SES group had more patients with
multivessel disease, more type C lesions,
more bifurcation lesions and received more
stents
Serruys group – Circulation, NEXT week
RESEARCH Registry
30 day outcome
RESEARCH Registry
1 year outcome
Issues of Drug Elution

 Is drug elution effective?

 Is the effect sustained?
 Are there any adverse effects? 
 Are there other down sides?

 Is it being used in most patients? If not, why? 
 Can it be used in all patients? 
 Are there subgroups where it should be 
avoided?
Drug Eluting Stents
Q. Use them in all patients?
A. Use them on all patients!
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