Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH)
Condition: Cardiovascular Diseases; Heart Diseases; Heart Failure; Heart Failure, Congestive
MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To conduct a randomized, unblinded clinical trial comparing the left ventricular assist
      device (LVAD) with maximum medical management in patients with end-stage heart failure who
      were not candidates for heart transplantation.
    

Detailed description: 
      BACKGROUND:

      Mortality rates for heart failure are high, with five year survival rates approximating 30 to
      40 percent in patients with mild to moderate symptoms and 0 to 20 percent survival in
      patients with severe symptoms. The patient with class IV heart failure has a one year
      survival rate of only 40 to 50 percent. This is despite advances in medical therapy and the
      availability of ACE inhibitors. While cardiac transplantation is the most viable form of
      treatment for these patients, it is limited by complications of chronic immunosuppression,
      the development of graft coronary artery disease and the serious shortage of donor organs. As
      many as 16,500 patients per year may be suitable candidates for heart transplantation. The
      actual number of donor hearts procured over the past few years, however, has remained
      relatively constant at 2,000. Thus, there is a strong rationale for the therapeutic
      application of left ventricular assist devices (LVADs) as an alternative to cardiac
      transplantation.

      With respect to LVAD efficacy, patients have been supported for periods as long as 344 days
      on the pneumatic system and 503 days with the electromechanical device. Experience with the
      TCI pneumatic system in 75 LVAD patients show improved one year survival after
      transplantation in the LVAD patients as opposed to patients who did not receive the LVAD
      despite the same selection criteria. Experience with the vented electric LVADs in bridge
      patients show a transplant and survival rate that is similar to the pneumatic device. LVADs
      have also been shown to have a favorable effect on circulatory hemodynamics and exercise
      capacity. Among 53 patients who survived the TCI LVAD procedure, 90 percent improved to New
      York Heart Association (NYHA) functional class I and 10 percent to functional class II.

      With respect to safety, the principal adverse effects associated with the LVADs include
      bleeding, hemolysis, and organ dysfunction, thromboembolism, infection, right heart failure,
      and mechanical failure. Thromboembolic complications are low in the TCI device despite the
      lack of systemic anticoagulation. The overall mechanical failure rate is small, less than 1
      percent in 26 patient years of use. The vented electric and pneumatic device experience to
      date indicates that the devices are similar with respect to adverse event rates. Thus, in
      1997 there was a strong rationale for a randomized controlled trial that compared the
      benefits and cost of vented electric LVADs to medical treatment. The need to perform a
      randomized controlled study was further emphasized by the lack of rigorous data on survival,
      quality of life, and cost effectiveness comparing LVAD support with medical therapy.

      DESIGN NARRATIVE:

      Unblinded, randomized, multicenter. Patients were randomized to either the Thermo
      Cardiosystems, Inc. (TCI) vented electric (VE) LVAD or optimal medical therapy (OMM) and
      followed for at least two years. If randomized to LVAD therapy, patients received a LVAD
      implantation within 12 hours of randomization. If randomized to medical therapy, patients
      received optimal medical management including the use of digoxin, diuretics, and ACE
      (Angiotensin Converting Enzyme) inhibitors in maximally tolerated doses. The primary endpoint
      was all-cause mortality. Secondary endpoints included cardiovascular mortality, exercise
      capacity (six-minute walk test) and health-related quality of life, adverse effects, and the
      relative cost-effectiveness of LVADs versus medical management. Recruitment ended in June,
      2001.
    

Intervention name(s): Left ventricular assist device; Optimal medical therapy
Intervention type(s): Device; Device
Intervention description(s): A type of implantable heart pump; (non-experimental) One possibility in handling Heart failure effectively is optimal medicine therapy. The most popular treatment medications at present are ACE Inhibitors and Beta Blockers. The result is the heart being able to pump more effectively and allowing blood to circulate freely.
Other intervention name(s): LVAD; OMM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment