PORTO Trial

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PORTO Trial
PORTuguese prospective, non-randomised,
multicenter Outcomes Trial of the Sirolimus
eluting stent in small native coronary arteries
of diabetic (PORTO I) and non-diabetic (PORTO II)
patients
R. Seabra-Gomes on behalf of the PORTO
Investigators
I have no conflict of interest to declare
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PORTO Trial
Organization Sponsor - Portuguese Society of
Cardiology Scientific Committee - R.
Seabra-Gomes (PI), J. Eduardo de Sousa (co-PI),
A. Sousa (IDPC), H. Pereira (PCI WG), L.
Gonçalves (CNCDC) Steering Committee - Scientific
Committee 1 representative from each
participating Hospital (9 Portuguese H. Santa
Cruz, H. Garcia de Orta, H. Fernando Fonseca, H.
Pulido Valente, C.H. Coimbra, C.H. Vila Nova de
Gaia, H. S. Bernardo, H. Curry Cabral, SMIC 1
Brazilian - IDPC, S. Paulo) Data Collection
Eminent-PPD (electronic CRF) QCA Core Lab -
Cardialysis Monitoring and Data Analysis
KeyPoint (Portugal) Unrestricted Grant - From
Cordis, Johnson Johnson
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PORTO Trial

• Objectives
• Assess the effectiveness and safety of the
  CYPHER Sirolimus-eluting Stent in de novo native
  coronary lesions in small vessels (? 2.50 mm)
• Primary endpoint
• In-stent Late Lumen Loss at 6-month angiographic
  follow-up
• Secondary endpoints
• MACE at 30 days, 6 months and 12 months follow-up
• In-stent MLD, Binary Restenosis / In-segment LLL,
  MLD, BR
• TLR and TVR
• Compare Diabetic insulin-treated vs oral Long
  vs short stents

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PORTO Trial

• Inclusion Criteria
• Target de novo native lesion stenosis ?50,
  vessel size
• ?2.5mm, lesion length ?33mm, TIMI ? II
• Informed consent
• Exclusion Criteria
• Acute STE or NSTE MI and persistent elevated
  biochemical markers
• Documented left ventricular ejection fraction
  ?30
• Impaired renal function (creatinine gt 3.0 mg/dl)
• Angiographic evidence of thrombus within target
  lesion
• Heavily calcified lesion which cannot be
  successfully predilated

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PORTO Trial Flow chart
Between Jan 03 and Sep 04
274 Patients
120 Diabetic PORTO I
154 Non-Diabetic PORTO II
4 Deaths 2 LTFU
1 Death 3 LTFU
6 m Clinical F-U
264 (96)
114 (95)
150 (97)
9 Refused
10 Refused
F-U Angio
140 (91)
245 (89)
105 (88)
(225.4?69.8 days)
233 (85)
QCA Analysis
135 (88)
98 (82)
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PORTO Trial Patient data
p lt 0.05 p lt 0.01
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PORTO Trial Patient data
p ns
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PORTO Trial PCI data
p lt 0.05 p lt 0.001
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PORTO Trial QCA data
p lt 0.05
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PORTO Trial In-stent Late Loss
0.10?0.38
pns
0.07?0.38
0.05?0.38
non-diabetic n141
n262
diabetic n121
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PORTO Trial In-stent Binary Restenosis
pns
6.6
5.3
4.3
n262
non-diabetic n141
diabetic n121
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PORTO Trial Events at 6 m
SAT, day 9, after APT discontinuation
LT, day 44, on APT
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PORTO Trial MACE at 6 m(Cardiac Death
Non-fatal AMI TVR)
5.0
pns
2.9
1.3
n274
diabetic n120
non-diabetic n154
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PORTO Trial

• Conclusions
• QCA results for In-stent Late Lumen Loss and
  Binary Restenosis were similar between diabetic
  and non-diabetic patients.
• Within this small vessel population (RVD 2.09
  mm) MACE rate at 6 months was only 2.9.
• In routine clinical practice the CYPHER
  Sirolimus-eluting Stent proved to be safe and
  efficient in small vessels.

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PORTO Trial

• Acknowledgment to the Investigators
• H. Santa Cruz R. Seabra-Gomes, R. Teles, M.
  Almeida, F.P. Machado
• I. Dante Pazzanese (Brazil) J.E. Sousa, A.
  Sousa, Aurea Chaves
• H. Garcia de Orta Helder Pereira, Rui Caria
• H. Fernando Fonseca Pedro Farto e Abreu, José
  Loureiro
• H. Pulido Valente Manuela Adão, Pedro Cardoso
• C. H. Coimbra A. Leitão Marques, Hilário
  Oliveira, V. Matos
• C. H. Vila Nova de Gaia V. G. Ribeiro, M.
  Gonçalves, P. Braga
• H. Curry Cabral L. Mourão, Ramiro Sá de
  Carvalho, L. Brizida
• H. S. Bernardo Ricardo Santos
• SMIC Henrique Carvalho, Paulino Sousa

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Reserved Slides
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PORTO Trial PCI data
p lt 0.05
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PORTO Trial PCI data
p lt 0.001
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PORTO Trial Patient data
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PORTO Trial Patient data
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PORTO Trial
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PORTO Trial