心脏再同步化治疗临床应用：COMPANION研究和CARE-HF研究分析解析

• One procedure-related death in each group
May 2005
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Possible remission
"I think we see a substantial proportion of patients who become asymptomatic and whose cardiac function is normalized by this therapy." • Possibility of HF "remission"
May 2005
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Significant reductions
"This study showed in a large population of patients that resynchronization therapy improves survival and reduces hospitalization." • Survival benefit limited to those with CRT and ICD
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COMPANION and CARE-HF
Eric Prystowsky MD Director, Clinical Electrophysiology Laboratory St Vincent Hospital Indianapolis, IN Hugh Calkins MD Director, Electrophysiology Lab Johns Hopkins University Medical Center Baltimore, MD John Cleland MD Professor of Cardiology Hull University Kingston upon Hull, UK
May 2005
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Cardiac Resynchronization Heart Failure
CARE-HF
May 2005
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CARE-HF
Rationale
• Cardiac dyssynchrony a problem in a large number of patients with HF and left ventricular systolic dysfunction • Previous studies have suggested that CRT can improve symptoms, quality of life, and exercise capacity • No conclusive evidence of an effect on hospitalizations or mortality
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CARE-HF
• Patients with a QRS duration <150 ms were required to have echocardiographic confirmation of ventricular dyssynchrony • Primary end point was all-cause mortality/unplanned hospitalization for CV event
• Dramatic improvements at 18 months in levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP)
May 2005
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Problems encountered
Lead problems • 27 lead-related problems, such as fracture or displacement, in the 409 patients randomized to CRT • Number of cases of coronary sinus dissection, none of which caused death
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Results
Primary end point • Combination of all-cause death and allcause hospitalizations reduced 19% in the CRT study arm and 20% in the CRTD study arm • Death from or hospitalization for HF reduced 34% in CRT group and 40% in CRT-D group
• New era of biventricular pacing to improve HF symptoms
• COMPANION and CARE-HF
May 2005
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Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure
May 2005
Calkins
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Other issues
Morbidity There is the possibility of inappropriate shocks from the ICD in healthy patients who might not stand to benefit from its addition In studies using older devices, the morbidity from the defibrillator was unacceptable
May 2005
Calkins
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CRT challenges
Implanting the coronary sinus lead • Difficulty involves not getting the lead in, but getting it in the right place • To achieve effective resynchronization, the lead needs to be implanted in a lateral branch of the coronary sinus • Requires experienced implanter
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Results
Secondary end point • CRT alone associated with a nonsignificant trend toward a 24% reduction in all-cause mortality, a secondary end point of the study • CRT with a defibrillator reduced allcause mortality 36%, a highly significant result
May 2005
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Use of cardiac resynchronization therapy (CRT) in COMPANION and CARE-HF
May 2005
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Brief history
• Large group of patients in need of ICDs for primary prevention
<0.0001 0.0019 <0.0001
Cleland JGF et al. N Engl J Med 2005; 352:1539-1549
May 2005
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Other improvements
• CRT group also benefited significantly with improved LVEF, NYHA class, endsystolic volume, mitral-valve function, blood pressure, and quality-of-life indices
May 2005
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Treating patients
"It's a fairly easy decision."
• Real difference comes down to cost, but the added protection of the ICD warrants the use of CRT with a defibrillator
May 2005
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If money were not an issue . . .
May 2005
Cleland
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What thBaidu Nhomakorabearapy?
No question to the value of CRT, but candidates for CRT are also candidates for ICD therapy
The question then becomes, which treatment do they receive?
May 2005
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Primary and secondary outcomes in CARE-HF
Outcomes All-cause mortality/unplanned hospitalization for CV event All-cause mortality All-cause mortality/HF hospitalization Hazard ratio (95% CI) 0.63 (0.51-0.77) 0.64 (0.48-0.85) 0.54 (0.43-0.68) p
May 2005
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CARE-HF
Design • Randomized, controlled, open-label, blinded-end-point study • Randomized patients to continue with medical therapy or to receive CRT • Included 813 patients with NYHA class 3-4 HF despite standard drug therapy, an LVEF <35%, and QRS duration of at least 120 ms
COMPANION
May 2005
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COMPANION
Design
• Parallel, randomized clinical trial in 1600 patients with moderate or severe heart failure with QRS >120 ms and PR interval >150 ms (Bristow MR et al. N Engl J Med 2004; 350: 2140-2150) • Patients randomized in a 1:2:2 fashion to optimal medical therapy; optimal drug therapy plus CRT; or optimal drug therapy plus CRT with an ICD (CRT-D)
May 2005
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Strengths of CARE-HF
Study details
• Large control group • Implant success rate 96% • Long-term follow-up, with an average of 2.5 years • Average age of patient 67 years • Only 40% of patients taking >80 mg furosemide (most common dose was 40 mg daily)