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TAXUS Perseus Core Data Elements: Qualitative and Quantitative Angiography. Jeffrey J. Popma, MD Alexandra Almonacid, MD Brigham and Women’s Hospital St. Elizabeth Medical Center Tufts University School of Medicine Boston, MA. Angiographic Core Laboratory.

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Jeffrey J. Popma, MD Alexandra Almonacid, MD Brigham and Women’s Hospital

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Jeffrey j popma md alexandra almonacid md brigham and women s hospital

TAXUS PerseusCore Data Elements:Qualitative and Quantitative Angiography

Jeffrey J. Popma, MD

Alexandra Almonacid, MD

Brigham and Women’s Hospital

St. Elizabeth Medical Center

Tufts University School of Medicine

Boston, MA

AngiographicCore Laboratory


Core lab lessons beyond late lumen loss

Core Lab Lessons: Beyond Late Lumen Loss

  • After 15 years, substantial observer variabilities are still found with qualitative angiographic interpretations  independent Core Laboratory analyses have become standard for FDA DES studies

  • Discrepancies noted with Clinical Site Observations:

    • Baseline % diameter stenosis (e.g., NASCET Carotid)

    • Lesion Length and Reference Vessel Diameter

    • Final Angiographic Result

    • Binary restenosis (? 50-70% threshold for revascularization)

    • “Oculostenotic reflex”


Core lab lessons beyond late lumen loss1

Core Lab Lessons: Beyond Late Lumen Loss

  • Our initial focus with QCA was to determine the late term lumen dimensions, and relate them to the early angiographic results and late clinical events

    • Balloon angioplasty – less acute gain; less late loss

    • DCA – more acute gain; more lumen loss; better net gain

    • Continuous measures replaced binary criteria

    • Loss index (LL/AG) provided relative benefit --> drugs failed

  • With stents, LL was attributable to intimal hyperplasia.

    • Acute gains and late loss was similar (essentially) for all bare metal stents

    • ? Possible exception related to strut thickness

    • Late loss replaced loss index as a surrogate


Beyond late lumen loss

Beyond Late Lumen Loss

  • Clinical indices were further refined to determine those events that directly related to failure of the stent

    • TLR replaced “any” revascularization and TVF (in some studies)

    • Early (< 30 d) stent thrombosis was not included in the criteria for “restenosis” or calculations for late lumen loss but was placed in the early clinical failure category alone

    • To lower sample sizes, “surrogate” markers were sought to identify was to lower sample sizes required for device approval

  • In-Lesion (Segment) late lumen loss became the preferred endpoint for many device trials


Qca methodology

in-segment

in-stent

(all stents used to treat the target lesion)

QCA methodology

5 mm

5 mm

stented segment

proximal

edge

distal

edge


Bms restenosis was near gaussian allowing expression with mean sd

Angio Restenosis is any late loss over 1.5 mm (50% DS)

Clinical TLR correlates with late loss over 2.1 (70% DS)

Pts. with angio restenosis

Pts. with

clinical restenosis

BMS Restenosis was Near Gaussianallowing expression with mean±SD

Example: 3.0 mm Bare Metal Stent

Mean late loss = 1.0 ± 0.5 mm

Mean late loss

1.0

Pts. w/o restenosis

0.8

0.6

Distribution Density

0.4

0.2

0.0

-0.50

-0.25

0.00

0.25

0.50

0.75

1.00

1.25

1.50

1.75

2.00

2.25

2.50

Late loss (mm)

Donald Baim, Summer in Seattle, 2006.


Des have different late loss distributions

DES Have Different Late Loss Distributions

Mean late loss = 0.2 mm

Clinical restenosis

What % of patients are above that line?

0.4 mm

0.6 mm

1.0 mm (BMS)

Mauri et al. Circulation. 2005;111:3435


Angiographic predictors of tlr

TAXUS-IV

Angiographic predictors of TLR

Follow-up % Diameter Stenosis is a Better Predictor

ROC Analysis combining all patients

1.0

Late Loss

AUC = 0.918

MLD

AUC = 0.940

0.5

Sensitivity

Diameter Stenosis

AUC = 0.944

0.0

0.0

0.5

1.0

1 - Specificity


Surrogate angiographic endpoints

Surrogate Angiographic Endpoints

LL and % DS vs. TLR - A curvilinear relationship

11 RCTs with Cypher, Taxus, Endeavor, and BMS (5381 pts)

All patientsRVD <2.5mmRVD 2.5-3.0mmRVD > 3.0mm

All patients

Probability of TLR

Probability of TLR

In-stent late loss

In-segment %DS

Pocock S et al ACC 2006


Sidebranch compromise with overlapping stents taxus v multiple stent analysis

Sidebranch Compromise With Overlapping StentsTAXUS V Multiple Stent Analysis

Blinded core lab analysis of all multiple stent patients

  • Main Vessel Analysis:

    • Main vessel No Reflow, TIMI flow, Dissection, Distal Embolization, Abrupt Closure

  • Side Branch Analysis (for branches >1 mm):

    • Branch occlusion (total occlusion)

    • Branch narrowing (Δ≥70%  100%)

    • Branch TIMI flow


Taxus v sb analysis with multiple stents

TAXUS V: SB Analysis With Multiple Stents


Side branch analysis in multiple stenting

Sidebranch Occlusion

Side Branch Narrowing (Δ ≥ 70%  100%)

TIMI Flow Reduction

Side Branch Analysis in Multiple Stenting


Impact of the overlap region per side branch

Control

TAXUS

p=0.74

p=1.00

p=0.10

p=0.025

p=0.23

p=1.00

37/203

51/203

56/203

21/48

12/48

8/48

34/207

58/207

68/207

24/55

15/55

26/55

Non-overlap

region

Non-overlap

region

Non-overlap

region

Overlap

region

Overlap

region

Overlap

region

Impact of the Overlap Region(per side branch)

Any Sidebranch

Occlusion

Any Sidebranch

Narrowing

Any TIMI Flow

Reduction


Definitions used for stent fracture

Definitions Used for Stent Fracture

1 Allie et al Endovascular Today 2004; July/August: 22-34

2 Scheinert et al J Am Coll Cardiol 2005; 45:312-315

* Type 5 implies

spiral fracture of stent


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Stent Fractures

Type 4

Stent Fractures

Stent Fracture with 3 mm of Stent Overlap


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Incidence of TAXUS-Express Stent Fracture

Detailed angiographic review of TAXUS IV and VI

Core Lab remains blinded due to ongoing adjudication

Taxus IV: 7 FracturesTAXUS VI: 3 Factures

-Type 1N=3- Type 1 N=1

-Type 2 N=1- Type 2 N=1

-Type 3 N=1-Type 3 N=1

-Type 4N=2

- Of the 10 fractures, 5 cases had overlapping stents (all overlaps were longer thatn 3 mm). In 4 of 5 cases, the stent fracture was within 5 mm of the overlap

* Preliminary Analysis


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Incidence of TAXUS Stent Fracture

In patients assigned to angiographic FU

0.85%

0.81%

0.71%

N=819

N=420

N=1239

Taxus IV

Taxus VI

Overall


Taxus express type i fractures

Taxus IV

145-247

24.9mm Stented Segment

Overlap >3mm

TAXUS-Express Type I Fractures


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Fundamental “Pitfalls” for the Seasoned Professional Interventionalist

  • Forget the angiographic inclusion and exclusion criteria, the patient really needs the Taxus Perseus stent

  • “I don’t really see a stenosis, but it must be tight behind that diagonal branch” or “Who needs two views, it looks pretty tight in this one”

  • I’m sure the Core Lab can measure that tip of the injection catheter

  • Who needs documentation, I’ll remember all the views I took when the patient comes back for at follow-up

  • I can’t believe that this lesion isn’t causing symptoms, I going to fix it anyway


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Pitfalls in QCA

  • Make certain that all patients meet the angiographic inclusion and exclusion criteria with respect to lesion length, vessel size, and lesion complexity

  • A “Friendly Feedback” sheet will give you a 20 point score for the film quality

  • Dr. Almonacid and I will provide “personal” feedback if we disagree with the patient being enrolled in the study. Remember, we’re colleagues and friends, but . . . .


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Pitfalls in QCA

  • An accurate calibration source (the injection catheter filled with contrast) is the only way that we can identify the absolute changes in the MLD, edges, and within the stent between the final and the follow-up

  • We need to see the very distal, nontapered portion of the catheter and document the size of the catheters on the Technician’s

  • Nitroglycerin with the final stent placement and at FU is essential to control vasomotor tone for the calculations of late lumen loss


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Pitfalls in QCA

  • “Who needs the documentation, I will remember the views I took when the patient comes back for follow-up”

Please Use the Worksheet


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Pitfalls in QCA

  • At the time of follow-up angiography, you see and intermediate stenosis (50-60%) and say

    “I can’t believe that this lesion isn’t causing symptoms, I going to fix it anyway”


Summary

Summary

  • Core QCA data elements should include conventional morphologic and quantitative angiographic parameters in order to classify “tested” and “untested” therapies

    -Newer analysis methods are needed for bifurcations

  • Late lumen loss is a reason index (% diameter stenosis may be better) for the late angiographic outcome but its ability to predict TLR (and MACE) may be limited in DES v. DES studies

  • Core QCA elements should add sidebranch patency (for overlapping stents), stent fracture, aneurysms, and stent thrombosis to assess long-term safety


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

Slides posted on http://www.clinicaltrialresults.org


Jeffrey j popma md alexandra almonacid md brigham and women s hospital

  • Technologist Worksheet or detailed catheterization report with sequential angiographic views

  • Dicom3 Compatible CDs or 35 mm film

  • Please don’t forget the nitroglycerin

  • Follow Image Acquisition Guidelines

  • Match 2 Pre, Final, and Follow-up

  • Document everything on cine, particularly in the radiation studies

  • Near 100% angiographic follow-up is essential

Simple

QCA

Requests


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