IMPROVE HF clinical trial results presented at annual HFSA meeting

Sep 15 2009

A process improvement program significantly improved the quality of care on six of seven guideline-recommended care measures in the largest U.S. outpatient heart failure clinical study. Twenty-four month findings from IMPROVE HF, (The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting), funded by Medtronic, Inc. (NYSE: MDT), demonstrated that clinics using the process improvement program increased adherence to evidence-based, guideline-recommended care by 82 and 62 percent, respectively, for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) use, and 80 percent for aldosterone antagonist use, all relative to baseline results. Use of angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARB), beta blockers and heart failure education also showed significant improvement.

IMPROVE HF is the first of its kind, large-scale, prospective study involving approximately 35,000 heart failure patients from 167 U.S. cardiology practices. All study data were collected and analyzed by an independent clinical research organization. Results were presented today as a late breaking clinical trial at the 13^th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Boston.

“These compelling results serve as a call to action for the need to transform heart failure care delivery in the outpatient practice setting,” said Gregg C. Fonarow, M.D., co-chair of the IMPROVE HF Scientific Steering Committee and Professor of Cardiovascular Medicine at the University of California at Los Angeles. “By monitoring care and applying a practice-specific performance improvement system to better meet guideline recommendations, cardiology practices can markedly increase the quality of care for their heart failure patients.”

With a primary endpoint of 20 percent relative improvement on at least two of the seven quality measures (of which four were on drug therapy, two on device therapy and another on heart failure education), IMPROVE HF 24-month data showed significant improvement on six of the seven measures. Full results include:

• Greater than 60 percent relative improvement on three quality measures (CRT utilization increased 82 percent, aldosterone antagonist use increased 80 percent, ICD utilization increased 62 percent); and
• Significant improvement on three other guideline-recommended care measures (ACE inhibitors and ARB use increased 8 percent, beta blocker use increased 9 percent and heart failure education use increased 15 percent); and
• No significant increase in the use of anticoagulation for atrial fibrillation.

The quality measures apply only to patients documented to be eligible for treatment according to current guidelines and without any recorded contraindications, intolerance, or other rationale for not treating.

IMPROVE HF baseline data, collected prior to any performance improvement intervention, demonstrated inconsistencies in care for women and elderly and underutilization of lifesaving device therapies for heart failure patients. Specifically, of those patients eligible, only 38 percent received a CRT device, 49 percent received an ICD, and 34 percent received aldosterone antagonist drug therapy. The 24-month data, which were gathered after implementing the practice-specific performance improvement interventions, showed higher utilization with CRT therapy increasing to 69 percent, ICD use increasing to 79 percent and aldosterone antagonist drug therapy increasing to 62 percent utilization. ACE inhibitors/ARB use increased to 87 percent, beta blocker use increased to 94 percent and heart failure education use increased to 71 percent.

“We are proud to support research that helps physicians provide more consistent, guideline-driven care for the 22 million heart failure patients worldwide,” said Marshall Stanton M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “The 167 clinical sites participating in IMPROVE HF are paving the way for practice improvement efforts that will have a meaningful impact on improving the quality of care for heart failure patients.”