1. TAXUS II: Slow Release Formula An International, Randomized, Multicenter, Blinded Trial of TAXUSTM NIRxTM SR Stent
Presented at TCT 2002

2. TAXUS II: Study Overview
Randomized 1:1
Triple-blind
536 Patients
TAXUSTM NIRxTM SR (n=267)
TAXUSTM NIRxTM MR (n=269)
30 day, 6 month, 1-5 year F/U
Primary endpoint: % in-stent net volume obstruction (IVUS) at 6 m
Inclusion Criteria
Standard risk de novo lesions
Length <12 mm
RVD >3.0 mm & <3.5 mm
Antiplatelet Regimen
ASA >75 mg (loading dose and maintained indefinitely)
Clopidogrel (loading dose 300mg and 75 mg q.d. for 6 months)
TCT 2002

3. TAXUS II: Two Consecutive Cohorts, Slow and Moderate Release
Slow Release (SR)
Moderate Release (MR)
Cohort I
SR = 267
DMC
Cohort II
MR = 269
TAXUS
n = 131
Control
n = 136
TAXUS
n = 135
Control
n = 134
30 Day Follow-up
SR Follow-up
Clinical: >99%
Angiographic: >98%
IVUS: >90%
MR Follow-up
Clinical: >96%
Angiographic: >95%
IVUS: >87%
6 Month Follow-up
Annually
1-5 Years
TCT 2002

4. TAXUS II: Patient Demographics
TAXUS SR (%) Control (%) p-value
(n=131) (n=136)
Male
Mean Age (years)
Prior MI
Prior Intervention
Diabetes
Unstable Angina
Hypertension
Smoker
Lecture Notes
The dosing of the thrombolytic agent TNK is shown here. After giving informed consent, patients were randomly assigned, through a central computerized telephone system, to a body weight-adjusted single bolus of tenecteplase with either enoxaparin or with abciximab plus low-dose unfractionated heparin or with unfractionated heparin. Each patient was given a unique study number that corresponded with the number of a treatment kit. Study treatments were given on an open-label basis.
Tenecteplase (TNK) was administered over 5 seconds according to body weight: patients allocated to enoxaparin or unfractionated heparin were given 30 mg if body weight was 60 kg, 35 mg if body weight was 60 to 70 kg; 40 mg if body weight was 70 to 80 kg; 45 mg if body weight was 80 to <90 kg and 50 mg if body weight was 90 kg.
In patients allocated to combination treatment with abciximab, half-dose tenecteplase was given with doses ranging from 15 mg to 25 mg according to the same weight categories as with full dose. TNK-tPA is available as a lyophilized powder and should be reconstituted with Sterile Water for Injection, USP. The simple weight-based dosing regimen is designed to balance efficacy with safety. The dosing categories are about 22 lb wide (10 kg = 22 lb) which minimizes the possibility of dosing errors. The dosing schedule is as shown below:
< 60 kg  6 mL
kg  7 mL
kg  8 mL
kg  9 mL
> 90 kg  10 mL
References
ASSENT 2 Investigators. Lancet. 1999;354:
1. The ASSENT 3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT 3 randomised trial in acute myocardial infarction. Lancet 2001;358:
TCT 2002

5. TAXUS II: Baseline Lesion Characteristics
TAXUS SR Control p-value
(n=131) (n=136)
RVD (mm)
MLD (mm)
Diameter Stenosis (%)
Lesion Length (mm)
Lecture Notes
The dosing of the thrombolytic agent TNK is shown here. After giving informed consent, patients were randomly assigned, through a central computerized telephone system, to a body weight-adjusted single bolus of tenecteplase with either enoxaparin or with abciximab plus low-dose unfractionated heparin or with unfractionated heparin. Each patient was given a unique study number that corresponded with the number of a treatment kit. Study treatments were given on an open-label basis.
Tenecteplase (TNK) was administered over 5 seconds according to body weight: patients allocated to enoxaparin or unfractionated heparin were given 30 mg if body weight was 60 kg, 35 mg if body weight was 60 to 70 kg; 40 mg if body weight was 70 to 80 kg; 45 mg if body weight was 80 to <90 kg and 50 mg if body weight was 90 kg.
In patients allocated to combination treatment with abciximab, half-dose tenecteplase was given with doses ranging from 15 mg to 25 mg according to the same weight categories as with full dose. TNK-tPA is available as a lyophilized powder and should be reconstituted with Sterile Water for Injection, USP. The simple weight-based dosing regimen is designed to balance efficacy with safety. The dosing categories are about 22 lb wide (10 kg = 22 lb) which minimizes the possibility of dosing errors. The dosing schedule is as shown below:
< 60 kg  6 mL
kg  7 mL
kg  8 mL
kg  9 mL
> 90 kg  10 mL
References
ASSENT 2 Investigators. Lancet. 1999;354:
1. The ASSENT 3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT 3 randomised trial in acute myocardial infarction. Lancet 2001;358:
TCT 2002

6. TAXUS II: Primary Endpoint, In-stent Net Volume Obstruction at 6 Month IVUS
62% reduction
p <
% In-stent Net Volume Obstruction
n=118
n=125
TAXUS SR
Stent
Control
Stent
TCT 2002

7. TAXUS II: Clinical Events Through 6 Months
Target Lesion Revascularization
MACE*
*Defined as cardiac death, MI, TVR
p=0.013
p=0.043
TAXUS SR
Stent
Control
Stent
TAXUS SR
Stent
Control
Stent
TCT 2002

8. TAXUS II: 6 Month Angiographic Restenosis
Proximal Edge (5 mm)
p=1.000
Stented Segment
p=0.0002
Distal Edge (5 mm)
p=0.685
Restenosis (%)
n=127
n=134
TAXUS SR
Stent
Control
Stent
TAXUS SR
Stent
Control
Stent
TAXUS SR
Stent
Control
Stent
TCT 2002

9. TAXUS II: 6 Month Angiographic MLD
Proximal Edge
p=0.009
Stented Segment
p<0.0001
Distal Edge
p=0.039
(mm)
n=127
n=134
TAXUS SR
Stent
Control
Stent
TAXUS SR
Stent
Control
Stent
TAXUS SR
Stent
Control
Stent
TCT 2002

10. TAXUS II: Late Loss and Loss Index in Stented Segment
p<0.0001
p<0.0001
(mm)
n=127
n=134
n=125
n=134
TAXUS SR
Stent
Control
Stent
TAXUS SR
Stent
Control
Stent
TCT 2002