Drugeluting stents and Multivessel disease PCI

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Drug-eluting stents and Multi-vessel disease PCI

Tony Gershlick University Hospitals
of Leicester
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Milestones in the development PCI
?
X
Thrombosis Restenosis
1980s 1990s 1990s 1990s
2000 -
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• Multi-vessel disease and Drug Eluting Stents
  (?)
• What do we know about POBA and MVD excess risk
  ?
• How does this risk apply to stenting and why ?
• Can DES help ?
• Current status DES
• Higher risk DES
• Do DES help us to treat all patients ?
• Selecting cases ?
• 6. Can we afford it ?

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• POBA and MVD
• OKeefe JH Jr, Rutherford BD, McConohay DR et al.
  Multivessel coronary angioplasty from 1980 to
  1989 procedural results and long-term outcome. J
  Am Coll Cardiol 1990161097-102.
• Bell MR, Bailey KR, Reeder GS, Lapeyres AC III,
  Holmes DR Jr. Percutaneous angioplasty in
  patients with multivessel coronary disease how
  important is complete re-vascularization for
  cardiac event-free survival? J Am Coll Cardiol
  199016553-62.
• Deligonul U, Vandormael MG, Kern MJ, Zelman R,
  Galan K, Chaitman BR. Coronary angioplasty a
  therapeutic option for symptomatic patients with
  two and three vessel disease. J Am Coll Cardiol
  1988111173-9.
• Hartzler GO, Rutherford BD, McConahay DR, Johnson
  WL, Giorgi LV. High-risk percutaneous
  transluminal coronary angioplasty. Am J Cardiol
  19881158-13.
• Thomas ES, Most AS, Williams DO. Coronary
  angioplasty for patients with multivessel
  coronary artery disease follow-up clinical
  status. Am Heart J 19881158-13.
• Cowley MJ, Vetrovec GW, DiSciasco G, Lewis SA,
  Hirsh PD, Wolfgang TC. Coronary angioplasty of
  multiple vessels short-term outcome and
  long-term results. Circulation 1985721314-20.
• Dorros G, Lewin RF, Janke L. Multiple lesion
  transluminal coronary angioplasty in single and
  multivessel coronary artery disease acute
  outcome and long-term effect. J Am Coll Cardiol
  1987101007-13.

Recoil, negative re-modelling, intimal hyperplasia
Recoil, negative re-modelling, intimal hyperplasia
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MVD and stenting
Predictors of Restenosis After Coronary Stent
Implantation Bauters C et al JACC 1998 31
1291-1298
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MVD risk restenosis
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With stenting (remove 2/3 variables) why is no.
stents important ? does this influence
performance versus surgery ?
Different patients do worse with multiple
stents Different stented lesions do worse
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What do we mean by MVD ? Does it matter ?
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ARTS Trial 2000
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Wientraub WS et al JACC 1998 31 10-19
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Variable outcome in MVD (stenting) due to
variability risk different lesions that make up
MVD Can DES help ? Can we then compete with
surgery ?
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MVD and MVD
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68 yr non-insulin dependant diabetic
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To what extent do trials DES reflect real life ?
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SIROLIMUS
RAVEL 0 v 26 (lt18 mm de novo)
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PACLITAXEL
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Drug eluting stents (Sirolimus and Paclitaxel)
have a potent biological effect on intimal
hyperplastic tissue Is it enough ?
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RAVEL SIRIUS ELUTES/ASPECT TAXUS II
Short lesions Type A-B2 Single vessel
(multi-stent) ? Small vessel ? diabetic
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To what extent do trials DES reflect real life
? Are there any up-coming trials ?
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SIROLIMUS
FREEDOM trial  Diabetic MVD randomised - Cypher
or CABG
E-SIRIUS 250 patients De novo single
vessel,15mm-35mm long, 2.5 - 3.5mm diameter
reporting Q4/ACC
Cypher Registry real life cases 10 000
Web based
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Where do the trials fit ?

• DELIVER II
• TAXUS III
• TAXUS VI

• E-SIRIUS
• TAXUS IV

• DELIVER I
• SIRIUS
• TAXUS II

Complexity

• ELUTES
• ASPECT
• RAVEL

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DELIVER II Lesion characteristics(n 500)
PACLITAXEL
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The A.R.T.S. II Study Arterial Revascularization
Therapies Study part II of the Sirolimus drug
eluting Bx velocity balloon-expandable stent in
the treatment of patients with de novo coronary
artery lesions.  
Multicenter non-randomized, open, stratified
trial in which a total of 600 legible patients
will be enrolled (in 45-50 centers). All
patients will be followed over a period of 5
years.   Effectiveness is measured in terms of
Major Cardiac and Cerebrovascular Events (MACCE)
free survival at 30 days, 6 months and at one
year
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2003
ARTS II ve
No difference in MVD stenting versus surgery
- Sub-group analyses ..which patients Are DES
applicable to all patients with MVD ?
No difference in MVD stenting versus surgery
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Treatment Strategy for Stable Angina n 2316
Euro Heart Survey on Coronary Revascularization N.
Mercado, on behalf of the Investigators and
Expert Committee
Poor LV function
Normal LV or mildly impaired n 2223 (96 )
Left Main
3 VD
2 VD
1 VD
7.4 18 18 64
32 21 26 53
32 20 56 24
36 27 66 7
Medical R PCR CABG
No difference in treatment options between
diabetics and non diabetics
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Dealing with MVD may be as much about
technology and technique as about DES
availability (high risk lesions apart)
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What is
the extra cost of MV stenting
N1024 patients (1492 stents) Single vessel
Multi-vessel Single vessel
Multi-vessel single stent single
stent multi stent multi stent 216
650 17 150 157
150 131 250 928 500
73 500 673 500
562 500 711 850 56 350 516 350
431 250
R DES
768 200 1 199 450 431 250
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1. DES will increase the number of patients in
whom MV stenting could be proposed instead of
CABG 2. DES will decrease the number of patients
in whom we could afford MV stenting 3. Select
lesions better
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Size versus importance Restenosis benefit
versus risk (3.5 v 2.2)
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Optimum Revascularization Strategy for
Multivessel Disease THE TAILORED APPROACH
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Drug Eluting stents are a major breakthrough
! Multi vessel stenting . ARTS I Composed
different lesions with different risk(s) Trials
to date simple lesions ( in the future ?)
Registries DES may not be the panacea MVD
stenting ? surgery Surgical disease -
technique equipment skill Lesion selection
highest risk or most important/both Non
invasive /Pressure wire help ? Bifurcation
overlap, dosing, expense Watch this space

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MIBI data
Dobutamine versus dipyridamole magnetic
resonance tomography safety and sensitivity in
the detection of coronary stenosesArticle in
GermanBaer FM, Theissen P, Smolarz K,
Z Kardiol 1993 Aug82(8)494-503
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Grzegorz Kaluza / Al Raisner Core Lab
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SIRIUS vs. DELIVER IILesions and Patient
Characteristics

• Total patient
• population