MADIT-CRT: CRT-D more effective in women than men
Arshad A. J Am Coll Cardiol. 2011;57:813-820.
Women in the randomized MADIT-CRT trial had significantly greater reductions in death or HF, HF alone and all-cause mortality with cardiac resynchronization therapy using defibrillator than men.
Researchers of the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) enrolled 1,820 patients (24.9% women) and analyzed sex-specific outcomes comparing the effect of cardiac resynchronization therapy with defibrillator (CRT-D) against implantable cardioverter defibrillator therapy.
They found better results with CRT-D for female patients, culminating with a 70% reduction in HF (P<.001) and a 69% reduction in death or HF (P<.001), which were significantly lower when compared with men (P<.01 for each).
Also reported was a 72% reduction of all-cause mortality in women (P<.02), as well as an 82% reduction in mortality for those with QRS of at least 150 ms and 78% reduction in those with left bundle branch block (LBBB) conduction disturbance. However, for female patients with non-LBBB, rates of death or HF (HR=1.97; 95% CI, 0.40-9.64), as well as HF alone (HR=1.95; 95% CI, 0.40-9.53), were nearly two times greater.
Significant differences in baseline characteristics between women and men, the researchers wrote, could explain part of the observed findings because a greater proportion of women had a substrate of nonischemic cardiomyopathy and an underlying LBBB pattern.
“It is possible that among patients with heart disease, the risk of HF is greater for women than for men, resulting in a greater benefit from preventive CRT-D therapy in women,” they said.
Cardiology Today’s initial coverage of MADIT-CRT can be viewed here. – by Brian Ellis
Dr. Arshad and her colleagues report that women in the MADIT-CRT trial obtained significantly greater reductions in death or HF, HF alone, and all-cause mortality with CRT-D therapy than men. Although these findings were associated with greater echocardiographic evidence of reverse remodeling in women compared with men, the differences were small. Furthermore, female patients were more likely to have nonischemic cardiomyopathy and LBBB and less likely to have renal dysfunction than men; these factors are known to be associated with improved outcomes. Conversely, men had more ischemic heart disease, prior revascularization and renal dysfunction. Thus, the overall findings are not surprising.
On the other hand, it is notable that women with ICDs rather than CRT-Ds had worse outcomes than men, and women had a significantly overall higher likelihood of device-related adverse events than men. Despite these findings, just as in the case of atrial fibrillation and age, male gender should not be taken to mean that men should not receive CRT-D therapy, since the subset is less likely to respond. Patients who are male, the elderly and those with atrial fibrillation simply have blunting of beneficial responses, not absent response. Why women with nonischemic cardiomyopathy seem to be more responsive to CRT than are men remains unknown.
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LEAPS: Locomotor training not superior to home-based therapy post-stroke
International Stroke Conference 2011
Results from the LEAPS trial have indicated that a locomotor training program featuring body weight-supported treadmill training did not produce superior outcomes in patients post-stroke when compared with a rigorous home-based physical therapy, although both did produce improvements in mobility at 1 year.
“The important message [of this study] is that patients do change and they improve over time. What we found is that the more high-tech intervention didn’t help them walk any better [and that] the home-based exercise program works as well,” Pamela W. Duncan, PhD, professor and research fellow at Duke University School of Medicine, Durham, North Carolina, and investigator on the trial, said in an interview with Cardiology Today.
The Multi-site Phase III Randomized Trial of Physical Therapy Interventions to Improve Walking Recovery Post-stroke (LEAPS) was the largest randomized controlled trial performed in rehab, including 408 patients following stroke. The patients were randomly assigned to three groups: early locomotor training program (LTP; n=139) at two months post-stroke, late LTP (n=143) at 6 months post-stroke and home-based therapy (n=126) 2 months post-stroke.
At 1 year following stroke, the researchers found that functional outcome did not differ significantly between groups, with improved functional walking ability reported in 50.4% of the early-LTP group, 53.8% of the late-LTP group and 51.6% of the home-based therapy arm. Additionally, those in the early LTP group did not have improved change in comfortable walking speed at 1 year when compared with the late-LTP group (0.23 ± 0.20 m/s vs. 0.24 ± 0.23 m/s).
In the study’s secondary outcome, Duncan and fellow colleagues found that when compared to usual care at 6 months, those who received more structured, progressive interventions recovered twice as well.
“So, in stroke as in heart disease, exercise and maintaining your strength and mobility is extremely important and we have to figure out ways to do this more effectively,” Duncan said. – by Brian Ellis
We know that recovery and rehabilitation post-stroke is very important. We are looking for new approaches to improve outcomes in our stroke survivors. Walking and mobility are two of the biggest things that affect quality of life in a stroke survivor.
Although [the LEAPS researchers] hoped that this innovative approach to improving walking would be beneficial they weren’t able to show that. However, they were able to show that if you do home-based physical therapy at 2 months post the usual time period for rehab you had some very important recovery in terms of walking and mobility at 6 months and a year. This is important to us because sometimes the early acute rehab period passes and both patients and physicians neglect the longer-term importance of physical therapy and rehab. I try to emphasize it to my patients but sometimes insurance doesn’t cover it and other things kick in. I think this implies that home-based physical therapy started two months after stroke could still be very important for improving long-term outcomes.
So I think this shows us that sometimes the more innovative, possibly more costly approach isn’t always better than old-fashioned home-based physical therapy which I think that this trial shows is a very important rehabilitation opportunity for us to improve outcomes.
I think the LEAPS result is a transformative result. It shows us that intensive and prolonged therapy to improve gait is better than our usual care of only short and modest intensity therapy. It didn’t really matter which way we delivered the intensive and prolonged therapy, whether it was home-based physical therapy or a sophisticated locomotor weight elevation program. But we didn’t know for the lower extremity and for gait whether intensive therapy was better than standard care. We knew that for upper extremity before and this means that we need to change the way we’re taking care of patients. We need to have them engage much more often in prolonged therapy so that they can gain all the benefit they can while their brain is plastic and responsive to change after a stroke