Five year clinical follow-up of the
PASSION-trial
Five Year Follow-up after Primary PCI with a
Paclitaxel-Eluting Stent versus a Bare-Metal Stent in
Acute ST-Elevation Myocardial Infarction
Maarten A. Vink,
Maurits T. Dirksen, Maarten J. Suttorp, Jan G.P.
Tijssen, GertJan Laarman
on behalf of the PASSION investigators
OLVG Hospital,
Amsterdam, The Netherlands
ACC/i2 2010 Late-breaking clinical trial session, March 16, 2010
Disclosure information
Maarten A. Vink, M.D.:
Nothing to disclose
Background
DES in primary PCI
• Several RCTs showed a variable reduction in the
need for repeat revascularization of infarct-related
artery in favour of DES.
• No differences in survival rates or recurrent MI
Laarman et al N Engl J Med 2006; Kastrati et al Eur Heart J 2007;
Stone et al N Engl J Med 2009
Background
DES and stent thrombosis
• HORIZONS-AMI showed similar rates of stent
thrombosis with DES and BMS at one year1.
• However, concern has arisen about the occurrence of
(very) late stent thrombosis after implantation of
DES2.
• Available data suggest a higher rate of (very) late
stent thrombosis after the use of DES in primary PCI,
compared to stenting for stable angina3.
1Stone
et al N Engl J Med 2009; 2Pfisterer et al J Am Coll Cardiol 2006;
3Leibundgut e al Am Heart J 2009;
Background
DES and stent thrombosis in primary PCI
• In the absence of long-term outcome of RCTs, this
issue remains unresolved.
• Therefore, guidelines do not uniformly support the
use of DES in primary PCI for STEMI.
• ACC/AHA 2009 IIa B indication
• ESC 2008 not defined
PASSION 5-year clinical follow-up
• Clinical follow-up at 5 years
• To elucidate a possible sustained benefit of DES in
the occurrence of MACE
• To address the concern of late and very late stent
thrombosis
PASSION-trial
• Prospective, two-center, randomized, single-blind
trial
• Enrollment March 2003 - December 2004
– OLVG Hospital, Amsterdam, The Netherlands
– St. Antonius Hospital, Nieuwegein, The Netherlands
• 619 consecutive patients with STEMI, eligible for
primary PCI with stenting
• Representative of real world population owing to
limited exclusion criteria
• No routine angiographic follow-up
• Clinical follow-up at: 6, 12, 24, and 60 months
Limited exclusion criteria
• Cardiogenic shock prior to randomization
• Mechanical ventilation
Procedure
• Stent diameter and length decided before
randomization
• Randomization to:
paclitaxel-eluting stent (Taxus/Express2) or
bare metal stent (Express2 or Liberté)
• Additional stents according to assigned stent type
• Thrombus aspiration and direct stenting at the
discretion of the operator
Concomitant medication
• GP IIb/IIIa receptor blocker at the discretion of the
operator
• Post-PCI:
– Clopidogrel 300 mg, followed by 75 mg od for at
least 6 months
– Aspirin 100 to 500 mg, followed by 80-100 mg od
indefinitely
Baseline Clinical Characteristics
PES
N=310
BMS
N=309
Age (years)
61 ± 12
61 ± 13
Male (%)
74
78
Diabetes Mellitus (%)
10
12
Hypertension (%)
31
32
Hypercholesterolemia (%)
23
28
Family History of CAD (%)
40
36
Smoking (%)
53
50
Previous MI (%)
4.5
5.8
Symptom to balloon (hours)
3.0
3.0
∑ST segment elevation (mm)
11
11
Baseline Angiographic and Procedural Characteristics
PES
N=310
BMS
N=309
LAD
50
50
Cx
6
10
RCA
42
38
TIMI flow 0/1 (%)
74
78
Multivessel disease (%)
42
47
Visible thrombus (%)
69
66
Stent size (mm)
3.2
3.3
Stent length (mm)
19
19
Thrombus aspiration (%)
50
50
GP IIB/IIA receptor blockers (%)
73
74
Procedural success (%)
93
96
Infarct related artery (%)
Clinical Outcome at 1 year
PES
N=310
BMS
N=309
HR (95% CI)
P
Composite of cardiac death,
re-MI, or TLR no. (%)
27 (8.8) 39 (12.8)
0.69 (0.43-1.10)
0.12
Cardiac death no. (%)
12 (3.9)
19 (6.2)
0.63 (0.31-1.27)
0.20
Recurrent MI no. (%)
5 (1.7)
6 (2.0)
0.83 (0.13-5.34)
0.74
TLR no. (%)
16 (5.3)
23 (7.8)
0.69 (0.37-1.27)
0.23
Laarman et al N Engl J Med 2006
Long-term Follow-up
• Complete follow-up available at 5 years:
• vital status: 98.5% (9 patients lost to FUP)
• clinical events: 95.8%
Composite of Cardiac death,
Recurrent MI, or TLR
Cardiac death
Recurrent myocardial infarction
Target-lesion revascularization
Stent Thrombosis
Definite
PES
N=310
BMS
N=309
10 (3.6%)
5 (1.7%)
HR (95% CI)
P
1.98 (0.67 - 5.79) 0.20
Definite or probable 11 (3.9%)
10 (3.4%) 1.09 (0.46 - 2.57) 0.85
Possible
19 (6.7%) 1.03 (0.55 - 1.93) 0.93
20 (6.8%)
Incidences were estimated from the Kaplan-Meier curves
Late and Very Late Stent Thrombosis
PES
BMS
N=310 N=309
HR (95% CI)
P
Definite ST
30 days – 1 year
1 (0.3%)
0 (0.0%)
1 year – 5 years
7 (2.5%)
2 (0.7%)
Total
8 (2.9%)
2 (0.8%)
30 days – 1 year
2 (0.7%)
0 (0.0%)
1 year – 5 years
7 (2.5%)
3 (1.1%)
Total
9 (3.2%)
3 (1.1%)
3.95 (0.81 – 18.61) 0.06
Definite or Probable ST
Incidences were estimated from the Kaplan-Meier curves
2.97 (0.80 – 12.97) 0.09
Definite Stent Thrombosis
Conclusions
PASSION 5-year follow-up
PES compared to BMS in primary PCI
• The PASSION-trial is the first RCT to report
very long-term follow-up.
• No significant difference in the occurrence of
the composite endpoint of cardiac death,
recurrent MI, or TLR
• No significant differences in the occurrence of
individual major adverse cardiac events
Conclusions
PASSION 5-year follow-up
PES compared to BMS in primary PCI
• 5-year follow-up of the PASSION-trial
confirms small risk of (very) late stent
thrombosis.
• Comparable incidence of definite or probable
stent thrombosis
• However, the rate of definite stent thrombosis
in the PES-group was two-fold as compared
to the BMS-group (P = 0.20).
Conclusions
DES in primary PCI for STEMI
• The risk of stent thrombosis appears to
persist for several years after stent
implantation.
• We have to outweigh the possible advantage
of DES in TLR against the potential risk of
(very) late stent thrombosis.
Thanks to:
The PASSION Investigators
MT Dirksen, MJ Suttorp, JGP Tijssen, J van Etten,T
Slagboom, M Patterson, F Kiemeneij, GJ Laarman
And to all patients and co-workers of the PASSION trial
at
OLVG Hospital, Amsterdam
St. Antonius Hospital, Nieuwegein