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VITA STENT REGISTRY

Dr. Miguel Miceli, Buenos Aires, Argentina

Sirian Congress, July 2005


VITA STENT REGISTRY

OBJECTIVE:
To assess the safety and
efficacy of routine Tretinoin
eluting stent (Vita Stent from
Aachen Resonance)
implantation for unselected
patients treated in daily
practice. Sirian Congress, July 2005
Dr.
VITA STENT REGISTRY

DESIGN & PATIENT POPULATION:


Prospective, single centre registry. To
include a patient population
representative of the “real world,” we
have adopted since July 3, 2003, a
policy of using Vita Stent as the default
strategy for every percutaneous
coronary intervention, except in
patients with an AMI.
Sirian Congress, July 2005
VITA STENT REGISTRY

DESIGN & PATIENT POPULATION:


In the first 6 months enrollment, a total of
113 patients with de novo lesions were
treated exclusively with Vita Stent and
were included in the present report. (68%
of the 166 patients treated with stents in
during the period). Patients treated with
bare stents and Vita Stent in the same
procedure (15 patients) and those treated
only with bare stents (38 patients) were
not included in the present report.
Sirian Congress, July 2005
VITA STENT REGISTRY

DESIGN & PATIENT POPULATION:


Unavailability of an appropriate Vita
Stent size was still the reason for non
utilization of Vita Stent in 55% of cases.
Moreover, 10% of cases were included
in the other study and were not enrolled
in the Vita Stent Registry. In the
remaining patients not included, Vita
Stent were not used for operator’s
personal choice.
Sirian Congress, July 2005
VITA STENT REGISTRY

PROCEDURES & POSTINTERVENTION


MEDICATIONS
Angiographic success was defined as residual
stenosis 30% by visual analysis in the
presence of TIMI 3 grade flow. Periprocedural
glycoprotein IIbIIIa inhibitors and
antithrombotic medications were used
according to the operator’s decision. All
patients were advised to maintain lifelong
aspirin. Clopidogrel was prescribed for at
least 3 months.
Sirian Congress, July 2005
VITA STENT REGISTRY
END POINT DEFINITIONS & CLINICAL FOLLOW-UP
The primary outcome was the occurrence of major adverse
cardiac events

Death
Nonfatal myocardial infarction
Target vessel revascularization

Myocardial infarction was diagnosed by a rise in the creatine


kinase level to more than twice the upper normal limit with
an increased creatine kinase-MB. Target lesion
revascularization was defined as a repeat intervention.
During follow-up, coronary angiography was obtained
as clinically indicated by symptoms or documentation
of myocardial ischemia.

Sirian Congress, July 2005


VITA STENT REGISTRY
BASELINE CHARACTERISTICS
Characteristics Vita Stent
n:113
Age (yr) 59,6 ± 10
Male sex (%) 83
Previous myocardial infarction (%) 29
Diabetes mellitus (%) 20
Treated hypercholesterolemia (%) 31
Treated hypertension (%) 59
Current smoker (%) 30
Angina pectoris (%)
Unstable 80
Stable 18
Silent ischemia (%) 2
Sirian Congress, July 2005
VITA STENT REGISTRY

PROCEDURAL CHARACTERISTICS
Characteristics Vita Stent
n:113
Target coronary artery (%)
LAD 52
RCA 30
LCX 13
Left MT 1
SVG 4
Lesion type (%)
A 15
B1 39
B2 19
C 24
Reference diameter vessel (mm) 2,73 ± 0,53
Length of lesion (mm) 13,9 ± 6,3
Use of glycoprotein IIb/IIIa inhibitors 4%
Angiographic success 99%
Number of study stents 1,08

Sirian Congress, July 2005


VITA STENT REGISTRY

PROCEDURAL CHARACTERISTICS
Characteristics Vita Stent
n:113
Target coronary artery (%)
LAD 52
RCA 30
LCX 13
Left MT 1
SVG 4
Lesion type (%)
A 15
B1 39
B2 19
C 24
Reference diameter vessel (mm) 2,73 ± 0,53
Length of lesion (mm) 13,9 ± 6,3

Sirian Congress, July 2005


VITA STENT REGISTRY

CLINICAL OUTCOMES

Complete follow-up information


was available for 99,1% of
patients (mean follow-up period,
425 days).

Sirian Congress, July 2005


VITA STENT REGISTRY

CLINICAL OUTCOMES 1 year

Death 4.4%
Myocardial Infarction 1.8%
Target vessel revascularization 7.1%.

Composite major adverse events


13.3%
Sirian Congress, July 2005
VITA STENT REGISTRY

COMPARISON WITH OTHER DES

JACC Vol. 45, No. 8, 2005 April 19, 2005:1165–71


Sirian Congress, July 2005
VITA STENT REGISTRY

COMPARISON WITH OTHER DES


VITA STENT REGISTRY TAXUS-IV Trial
Unstable Angina 80% 100%
Use of glycoprotein IIb/IIIa inhibitors 4% 59%
Target Artery Left Main & SVG 4,4% 0%
Composite major adverse events 13,3% 11,1% P value: 0,54

Sirian Congress, July 2005


VITA STENT REGISTRY

CONCLUSION

The results of the VITA STENT REGISTRY


shows that the implantation of the
Tretinoin eluting stent (Vita Stent) was
safe, without increased rates of
cardiac death, MI, or target vessel
revascularization compared to other
DES implantation.
Sirian Congress, July 2005