Vita Registry 3.7.05

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 Age (yr) Male sex (%) Previous myocardial infarction (%) Diabetes mellitus (%) Treated hypercholesterolemia (%) Treated hypertension (%) Current smoker (%) Angina pectoris (%) Unstable Stable Silent ischemia (%)

Vita Stent n:113

59,6 ± 10 83 29 20 31 59 30 80 18 2 Sirian Congress, July 2005

VITA STENT REGISTRY PROCEDURAL CHARACTERISTICS Characteristics

Vita Stent n:113

Target coronary artery (%) LAD RCA LCX Left MT SVG

52 30 13 1 4

Lesion type (%) A B1 B2 C

15 39 19 24

Reference diameter vessel (mm) Length of lesion (mm) Use of glycoprotein IIb/IIIa inhibitors Angiographic success Number of study stents

2,73 ± 0,53 13,9 ± 6,3 4% 99% 1,08

Sirian Congress, July 2005

VITA STENT REGISTRY PROCEDURAL CHARACTERISTICS Characteristics

Vita Stent n:113

Target coronary artery (%) LAD RCA LCX Left MT SVG Lesion type (%) A B1 B2 C Reference diameter vessel (mm) Length of lesion (mm)

52 30 13 1 4 15 39 19 24 2,73 ± 0,53 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 Use of glycoprotein IIb/IIIa inhibitors Target Artery Left Main & SVG Composite major adverse events

80% 4% 4,4% 13,3%

100% 59% 0% 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