Background
Left ventricular assist device (
LVAD
) thrombosis is clinically devastating and impacts the cost effectiveness of
LVAD
therapy for advanced heart failure. Anticoagulation and antiplatelet therapies represent the standard of care to mitigate
LVAD
thrombosis. Phosphodiesterase type 5 inhibitors (
PDE
‐5is) exhibit hemodynamic, antiplatelet, and antithrombotic effects. Using a national registry, we examined the relationship of
PDE
‐5i use on thrombotic events in patients with continuous‐flow
LVAD
s.
Methods and Results
We obtained data from 13 772 patients with continuous flow
LVAD
s participating in a national registry. Patients implanted with primary
LVADs
from 2012 to 2017 were included in the analysis. The primary end point was a composite of
LVAD
thrombosis and ischemic stroke. Patients were analyzed according to any use of
PDE
‐5i after LVAD implantation (
PDE
‐5i group) versus no use after
LVAD
implantation (no
PDE
‐5i group). The primary end point was significantly lower in the
PDE
‐5i group compared with the no
PDE
‐5i group (hazard ratio [HR], 0.84; 95%
CI,
0.77–0.91;
P
<0.001) at 48 months. The components of the primary end point (
LVAD
thrombosis: HR, 0.82; 95%
CI
, 0.74–0.90;
P
<0.001; and ischemic stroke: HR, 0.85; 95%
CI,
0.75–0.97;
P
=0.019), as well as the secondary end point all‐cause mortality (HR, 0.86; 95%
CI
, 0.79–0.93;
P
<0.001) were lower in the
PDE
‐5i group versus the no
PDE
‐5i at 48 months post
LVAD
. The favorable results observed with postimplant
PDE
‐5i use were consistent with both axial and centrifugal flow devices.
Conclusions
The postimplant use of
PDE
‐5i was associated with fewer thrombotic events and improved survival in
LVAD
patients. A randomized clinical trial is warranted to confirm these findings.
BackgroundHeavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking.AimTo assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice.Design and settingA pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands.MethodIn total, 571 women aged 25–50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen–progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety.ResultsAt 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = −0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events.ConclusionLarge improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.