Drug Eluting Stents

The Wrong therapy for Vulnerable Plaque

RS SchwartzMinneapolis Heart Institute

A 3-Part Argument

There are no data yet

VP Detection and Economics

The Strategy is wrong

FACT

Drug Eluting stents appear to form a healthy neointima

The restenosis rate may be 8-10%

FACT

Long term results are pending

We have no data for mild disease or Vulnerable lesions

Argument #1

There is simply no evidence that the drug eluting stent will fix the vulnerable plaque problem.

FACT

Drug Eluting stents will initially cost about $3,000 each.

FACT

Sensitivity and Specificity for Detection are unknown but will likely be poor

??40%- 50%

FACT

If a typical patient has 3-4 such plaques, a single session will cost $12,000 in stents alone

FACT

Including all asymptomatic patients, there may be 2,000,000 candidates. At $12,000 each, this will be

$24,000,000,000

in stents alone

Argument #2

Stenting every vulnerable plaque will break the National Budget.

Which Lesions to stent and which to ignore?

Fact

Vulnerable Plaque is a multifocal and possibly diffuse disease

Fact

Vulnerable Plaque is a systemic disease

Multicentric inflammation in epicardial coronary arteries of patients dying of acute myocardial infarction.Spagnoli LG, Bonanno E, Mauriello A, Palmieri G, Partenzi A, Sangiorgi G, Crea F.

J Am Coll Cardiol 2002 Nov 6;40(9):1579-88

Spagnoli et al3 Groups, Autopsy pts

Acute MIOld MINo CAD

Cell Suspensions of all 3 coronary arteries

Spagnoli et alFlow Cytometry

LymphocytesSMCCD3/CD68

Spagnoli et alResults

Diffuse lymphoctye activation in all 3 arteries of Acute MI patients

11

5.6

0

3

6

9

12

Percent

Acute MI Old MI No CAD

Patient 4, Stable, NZPatient 4, Stable, NZMaxT Difference Map of RCAMaxT Difference Map of RCA

0

.05

.1

.15

.2

.25

Max

Tdiff

Distal MID Prox

Fact

We just spent 12 years developing Drug Eluting Stents as a LOCAL therapy

Fact

Rox’s own data argues against stents

The 1 year recurrent MACE in Acute Coronary Syndromes with PCI may be as high as 20%

Rhetoric

Treating a systemic disease with a local therapy makes no sense.

Argument #3

It is folly to treat a diffuse problem with a focal therapy.

We must instead develop simple therapies for the entire coronary tree.

“Shoot’em all boys, the Devil will sort them out…”Clint Eastwood, 1972

Strategy

Rearrange the cellular mileu of the entire coronary tree.

Treat the disease, not the lesions.

Summary

1. No efficacy data in mild/minimal disease

2. We can’t afford to treat with Drug Eluting Stents

3. It is folly to treat a diffuse problem with a focal therapy.

Axiom

In any debate, present your case simply and cogently.

Then personally savage your opponent.

Positions

Photographs

Motherhood

Lennox Hill Hosp

Iranian