Vita Registry 3.7.05

8/14/2019 Vita Registry 3.7.05

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VVITAITA SSTENTTENT RREGISTRY EGISTRY

Dr. Miguel Miceli, Buenos Aires, ArgentinaDr. Miguel Miceli, Buenos Aires, Argentina

Sirian Congress, July 2005Sirian Congress, July 2005




OBJECTIVE:OBJECTIVE:

To assess To assess the safety andefficacy of routine Tretinoinroutine Tretinoineluting stent (Vita Stent fromeluting stent (Vita Stent from

Aachen Resonance)Aachen Resonance)implantation for unselectedimplantation for unselectedpatientspatients treated in dailypractice.

VVITAITA SS TENT TENT RREGISTRYEGISTRY

Dr.




DDESIGNESIGN & P& PATIENTATIENT PPOPULATIONOPULATION::

Prospective, single centre registry.Prospective, single centre registry. To To

include a patient populationinclude a patient population

representative of the “real world,” werepresentative of the “real world,” we

have adopted since July 3, 2003, ahave adopted since July 3, 2003, a

policy of using Vita Stent as the defaultpolicy of using Vita Stent as the defaultstrategy for every percutaneousstrategy for every percutaneous

coronary intervention, except incoronary intervention, except in

patients with an AMI.patients with an AMI.





DDESIGNESIGN & P& PATIENTATIENT PPOPULATIONOPULATION:: In the first 6 months enrollment, a total of

113 patients with de novo lesions weretreated exclusively with Vita Stent andwere included in the present report. (68%of the 166 patients treated with stents induring the period). Patients treated with

bare stents and Vita Stent in the sameprocedure (15 patients) and those treatedonly with bare stents (38 patients) werenot included in the present report.





DDESIGNESIGN & P& PATIENTATIENT PPOPULATIONOPULATION:: Unavailability of an appropriate Vita

Stent size was still the reason for nonutilization of Vita Stent in 55% of cases.Moreover, 10% of cases were includedin the other study and were not enrolled

in the Vita Stent Registry. In theremaining patients not included, VitaStent were not used for operator’spersonal choice.





PROCEDURES & POSTINTERVENTION

MEDICATIONS

Angiographic success was defined as residualstenosis 30% by visual analysis in thepresence of TIMI 3 grade flow. Periproceduralglycoprotein IIbIIIa inhibitors and

antithrombotic medications were usedaccording to the operator’s decision. Allpatients were advised to maintain lifelongaspirin. Clopidogrel was prescribed for atleast 3 months.





END POINT DEFINITIONS & CLINICAL FOLLOW-UP

The primary outcome was the occurrence of major adversecardiac events

DeathNonfatal 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 withan increased creatine kinase-MB. Target lesionrevascularization was defined as a repeat intervention.During follow-up, coronary angiography was obtainedas clinically indicated by symptoms or documentationof myocardial ischemia.





BASELINE CHARACTERISTICS


Characteristics Vita Stentn:

Age (yr) 59,6 ± 10Male sex (%) 83

Previous myocardial infarction (%) 29

Diabetes mellitus (%) 20

Treated hypercholesterolemia (%) 31

Treated hypertension (%) 59

Current smoker (%) 30Angina pectoris (%)

Unstable 80

Stable 18

Silent ischemia (%) 2




Characteristics Vita Stent

n:113

Target coronary artery (%)

LAD 52RCA 30

LCX 13

Left MT 1

SVG 4

Lesion type (%)

A 15

B1 39

B2 19C 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

PROCEDURAL CHARACTERISTICS





CLINICAL OUTCOMES

Complete follow-up informationwas available for 99,1% of patients (mean follow-up period,

425 days).





CLINICAL OUTCOMES 1 year

Death 4.4%

Myocardial Infarction 1.8% Target vessel revascularization 7.1%.

Composite major adverse events13.3%






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

COMPARISON WITH O THER DES




COMPARISON WITH O THER 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




CONCLUSION

The results of the VITA S TENT REGISTRYshows that the implantation of the

Tretinoin eluting stent (Vita Stent) wassafe, without increased rates of

cardiac death, MI, or target vesselrevascularization compared to other

DES implantation.


Vita Registry 3.7.05

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