Incidence and Outcomes of Sirolimuseluting Stent Thrombosis 8 Years After
Implantation in Unrestricted Clinical Practice
Alfonso Ielasi¹, Azeem Latib¹,², Maria Angela Gullace¹, John Cosgrave¹,², Giedrius
Davidavicius¹, Cosmo Godino¹,², Alaide Chieffo¹, Mauro Carlino¹,
Matteo Montorfano¹, and Antonio Colombo¹,²
(1) Interventional Cardiology Unit San Raffaele Hospital (IRCCS), and
(2) EMO-GVM Centro Cuore Columbus Milan, Italy
BACKGROUND
1. DES have been widely adopted in clinical practice after results of the
first Pivotal randomized trials (RAVEL, SIRIUS, TAXUS II, TAXUS IV)
2. However even more so than with BMS, the long-term safety and
efficacy of DES has been recently questioned, especially in higher
risk patients and lesions.
3. Little is known about the very long-term (>5 years) incidence of
Academic Research Consortium (ARC) defined stent thrombosis (ST)
and the related clinical outcomes after sirolimus-eluting stent (SES)
implantation
AIM
To assess the incidence of SES ST and the clinical
consequences related to this event .
METHODS
All consecutive patients with significant coronary artery stenosis
treated with implantation of at least one SES between December 2001
and February 2003 were analyzed in order to assess the incidence
(estimated by the Kaplan-Meier method) of ST and the consequences
related to this event.
According with guidelines at the time of implantation, dual antiplatelet
therapy (DAT) was prescribed for at least 3-6 months after the index
procedure.
1st December 2001
POBA/BMS
1769 pts
3547 lesions
Successful PCI
2272 pts
4604 lesions
BMS/DES
25 pts
63 lesions
SES
447 patients
954 lesions
28th February 2003
DES
478 pts
994 lesions
PES
29 pts
40 lesions
BASELINE CLINICAL CHARACTERISTICS
Patients
n= 447 (%)
Age (years)
61.9±10.4
Ejection Fraction (%)
52.9±9.3
Male
History of CAD
399 (89.3)
152 (34.0)
Hypertension
261 (58.4)
Hypercholesterolemia
310 (69.4)
Current Smoker
59 (13.2)
Diabetes mellitus
99 (22.1)
Insulin-dependent
18 (18.1)
Oral hypoglycemics
60 (60.6)
Diet
21 (21.2)
Previous MI
205 (45.9)
Previous CABG
Previous PCI
106 (23.7)
225 (50.3)
Unstable Angina at admission
99 (22.1)
Multivessel disease
356 (79.6)
Three-vessel disease
204 (57.3)
Two-vessel disease
152 (42.7)
BASELINE LESION/PROCEDURAL CHARACTERISTICS
Lesions
Target Vessel
Left anterior descending
Right coronary artery
Left Circumflex
Lesion Type and Characteristics
Lesion length, mm
Reference Vessel Diameter, mm
ACC/AHA Lesion B2 or C
Calcification
Thrombus
Ostial Lesion
BMS Restenotic Lesion
Bifurcation
Chronic Total Occlusion
Left Main
Saphenous Vein Graft
Procedural Characteristics
Rotational coronary atherectomy
Directional coronary atherectomy
Cutting balloon
Intravascular ultrasound
Intra-aortic balloon pump
Glycoprotein IIb-IIIa inhibitors
n= 954 (%)
296 (31.0)
191 (20.0)
142 (14.9)
17.1 ± 10.8
2.67 ± 0.55
771 (80.8)
57 (6.0)
12 (1.3)
186 (19.5)
155 (16.2)
177 (18.6)
94 (9.9)
87 (9.1)
19 (2.0)
9 (0.9)
9 (0.9)
56 (5.9)
114 (11.9)
17 (1.8)
508 (53.2)
Mean n°SES/patient: 2.0±1.4
Total stent length/patient:
27.7±13.4 mm
FOLLOW-UP
Median follow-up time was 7.9 (IQR 7.5-8.2) years;
Clinical follow-up information were obtained at:
-1 year in 443 eligible patients (99.1%),
- 2 years in 429 eligible patients (96%),
- 4 years in 425 eligible patients (95.1%)
- 8 years in 403 patients eligible (90.2%).
Angiographic follow-up: 753/954 of the lesions treated (78.9%) at a
median of 268 days (IQR 178-303) from the index procedure.
TARGET LESION REVASCULARIZATION
Ischemic-Driven TLR (ID-TLR)
repeat revascularization secondary to a stenosis ≥ 50% within the stent or within the 5 mm proximal or
distal to the stent edge associated with symptoms or objective signs of ischemia.
82.6
64.1
30.9
26.0 24.6
16.6
21.4
19.5
31.4
23.5
16.5
13.0
10.4
Incidence estimated by the Kaplan-Meier method
TARGET VESSEL REVASCULARIZATION
41.2
30.9
26.0
19.5
Incidence estimated by the Kaplan-Meier method
CARDIAC DEATH/TARGET VESSEL-MI
12.1
82.6
72.6
83.4
24.6
64.1
30.9
77.2
21.4
7.8
26.0
3.7
2.3
16.6
19.5
72.9
Cumulative Incidence of Events Estimated with
the Kaplan-Meier Method
Death
Cardiac death
MI
TV-MI
Cardiac death/TV-MI
TLR per patient
TLR per lesion
TVR per patient
MACE
Any ST
ARC Definite/probable ST
1 Year
2 Years
N° events,
N° events,
(Incidence %)
(Incidence %)
1282.6
(2.7)
18 (4.1)
7 (1.2)72.6
12 (2.8)
83.4
24.6
64.1
30.9
7 (1.2)
11 (2.5)
77.2
21.4 7.8 10 (2.3)
6 (1.2)
26.0
72.9
10 (2.3)
16 (3.7)
3.7
16.6
7219.5
(16.6)
92 (21.4)
2.3
117 (12.6)
143 (15.6)
85 (19.5)
112 (26)
95 (21.4)
125 (28.4)
6 (1.2)
9 (2.1)
3 (0.7)
4 (0.9)
4 Years
N° events,
(Incidence %)
12.1
31 (7.2)
20 (4.7)
19 (4.5)
16 (3.8)
29 (7.8)
105 (24.6)
162 (17.8)
132 (30.9)
157 (35.9)
17 (4%)
8 (1.9)
8 Years
N° events,
(Incidence %)
65 (15.7)
34 (8.3)
32 (7.9)
25 (6.2)
50 (12.1)
130 (31.4)
204 (23.0)
170 (41.2)
211 (49.3)
29 (7.4)
12 (3.1)
STENT THROMBOSIS
Median DAT duration was 253 (IQR 162-1197) days
1 year: 216 patients (48.3%) on DAT;
2 years: 151 (33.8%) on DAT;
last clinical contact: 101 (22.6%) patients on DAT.
82.6
72.6
83.4
77.2
21.4
26.0
24.6
64.1
30.9
72.9
16.6
19.5
Bern-Rotterdam 8,146 pts (81%SES): ARC def/prob 5.7% at 4-year
RECIPE Registry 1,124 pts (100% SES): ARC def 2.0% at 4-year
estimated
the Kaplan-Meier
method
DESIRE RegistryIncidence
1,010 pts
(81%by
SES):
ARC def/prob
1.7% at 5-year
DEFINITE/PROBABLE STENT THROMBOSIS
82.6
72.6
83.4
Rate
0.4%
2 pts
77.2
21.4
24.6
64.1
30.9
26.0
0.2%
19.5
116.6
pt
Early
Late
<30 days 30 day-1year
72.9
2.5%
9 pts
Very Late
>1-year
2/12 patients on DAT
12/12 presented as MI
9/12 successfully managed
3.1%
LIMITATIONS
1. No control group and no comparison;
82.6
2. Results reflects the initial72.6
single center experience during everyday clinical
83.4 of DES24.6
practice at the beginning
era;
64.1
30.9
77.2
21.4
26.0
72.9
3. Relatively small number
of STs did
not permit to evaluate independent
predictors for these worrying
events;
16.6
19.5
CONCLUSIONS
1. SES implantation for severe CAD resulted in an acceptable 8-year rate of
cardiac death and TV-MI;
82.6
72.6
2. Very late definite/probable
the “Achille’s heel” for SES because it
83.4 ST remains
24.6
64.1 low, rate up to 8-years after the index
continues to occur at a steady,30.9
albeit
77.2
21.4
procedure;
26.0
72.9
16.6
3. The annual incidence
of ARC definite/probabale ST after 1-year from SES
19.5
implantation was relatively low (0.2%-0.5%) and in most of cases (75%)
successfully managed.