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Clinical Trial Commentary. MUSTT. PACT. Dr Eric Topol Chairman and Professor, Department of Cardiology Director of the Joseph J Jacobs Center for Thrombosis and Vascular Biology at the Cleveland Clinic Dr Robert Califf Professor of Cardiology Associate Vice Chancellor for

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Clinical Trial Commentary


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clinical trial commentary

Clinical Trial Commentary

MUSTT

PACT

Dr Eric Topol

Chairman and Professor, Department of Cardiology Director of the Joseph J Jacobs Center for Thrombosis and Vascular Biology at the Cleveland Clinic

Dr Robert Califf

Professor of Cardiology

Associate Vice Chancellor for

Clinical Research at Duke University

slide2

PACT trial

Ross AM, et al. J Amer Coll Cardiol 1999;34:1954-1962

slide3

PACT trial

Reperfusion and LV function: rtPA vs placebo

Ross AM, et al. J Amer Coll Cardiol 1999;34:1954-1962

slide4

PACT trial

Adverse clinical outcomes: rtPA vs placebo

Ross AM, et al. J Amer Coll Cardiol 1999;34:1954-1962

slide5

PACT trial

“The bottom line is that the combination therapy did not improve LV function or change outcome…Enhancing reperfusion by 10, 15, or 20 minutes hasn’t proven to be an added benefit. So why would you adopt that type of therapy?”

Dr Cindy Grines

William Beaumont Hospital, Detroit

PACT trial ignites clash of opinions… heartwire. theheart.org. December 2, 1999.

mustt trial eligibility criteria
MUSTT trial eligibility criteria
  • EF < 40%
  • CAD
  • spontaneous nonsustained

ventricular tachycardia (VT-NS)

  • Eligible patients randomized to
  • electrophysiologic (EP)-guided
  • antiarrhythmic therapy
  • no antiarrhythmic therapy

Buxton AE, et al. N Engl J Med 1999;341:1882-1890

mustt protocol
MUSTT:protocol

Electrophysiologic studies

Registry (n=1435)

sustained VT not inducible

Randomization(n=704)

sustained VT inducible

Conservative therapy (n=353)

ACE-inhibitors and beta-blockers

EP-guided therapy (n=351)

ACE-inhibitors and beta-blockers

Buxton AE, et al. N Engl J Med 1999;341:1882-1890

mustt results
MUSTT results
  • EP guided therapy showed a reduction in primary endpoints
  • 27% reduction in arrhythmic death and cardiac arrest
  • trend toward overall reduction in mortality (20% risk reduction)
  • entire benefit derived from EP-guided therapy was due to treatment with implantable defibrillators

Buxton AE, et al. N Engl J Med 1999;341:1882-1890

mustt and implantable defibrillators
MUSTT and implantable defibrillators

Benefit was derived from implantable defibrillators, however:

  • trial was not designed to test efficacy of

ICD therapy

  • patients were not randomized to receive

ICD implantation

  • ICD was only undertaken after patients

failed antiarrhythmic drug therapy

A second look at the Multicenter UnSustained Tachycardia Trial (MUSTT). Clinical trials. theheart.org. December 7, 1999.

sudden cardiac death in heart failure trial scd heft randomization
Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT): randomization

Control group Heart failure Rx Blinded placebo

Amiodarone group Heart failure Rx Blinded amiodarone

ICD group Heart failure Rx Single-lead, pectoral ICD

scd heft eligibility criteria
SCD-HeFT eligibility criteria
  • EF < 35%
  • CHF treatment with ACE-I > 3 months
  • NYHA II and III, ischemic or nonischemic
  • Age > 18 years
  • projected enrollment 2 500
  • minimum 2.5 year follow-up
scd heft endpoints
SCD-HeFT endpoints
  • Primary endpoint:
  • overall mortality
  • Secondary endpoints:
      • arrhythmic vs nonarrhythmic cardiac mortality
      • comparison of morbidity
      • comparison of quality of life
      • analysis of cost effectiveness
      • categorizing arrhythmias in ICD arm
slide13

MUSTT trial

“…it is an implantable device. But if we had these results in a study looking at aspirin, do you really think we'd be sitting here arguing over would I withhold aspirin therapy from a defined sub-risk group…what we're really talking about here is economics, that's the bottom line.”

Dr Eric Prystowski

St Vincent Hospital

A second look at the Multicenter UnSustained Tachycardia Trial (MUSTT). Clinical trials. theheart.org. December 7, 1999.

cabg patch trial eligibility criteria
CABG Patch trial eligibility criteria
  • EF < 36%
  • scheduled for CABG
  • abnormalities on signal averaged ECG’s
  • Age < 80 years
  • patients (n=900) randomly assigned to ICD vs control
  • average follow-up 32 + 16 months

Bigger J, et al. New Engl J Med 1997;337:1569-75.

cabg patch results
CABG Patch results

Mortality by treatment arm in the CABG Patch trial

Bigger J, et al. New Engl J Med 1997;337:1569-75.