mechanism | treatment | Demonstrated benefit and harm | k | | | |
---|
cholesterol lowering intervention | atorvastatin | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
SALTIRE, 2005 | atorvastatin vs placebo | | | CV detah, aortic replacement, hospitalization for severe aortic stenosis 0.63 [0.34; 1.16] CV death 1.01 [0.21; 4.86] Aortic-valve replacement 0.59 [0.30; 1.15] Death from any cause 0.61 [0.15; 2.46] Hospitalization for severe aortic stenosis 0.61 [0.15; 2.46] |
Trial | Treatments | Patients | Method |
---|
SALTIRE, 2005 | atorvastatin 80mg daily (n=77) vs. placebo (n=78) | patients with calcific aortic stenosis | double blind Parallel groups Sample size: 77/78 Primary endpoint: aortic-jet velocity and aortic-valve calcium score FU duration: 25 mo (7-36) |
|
cholesterol lowering intervention | rosuvastatin | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
ASTRONOMER, 2010 | rosuvastatin vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
ASTRONOMER, 2010 | rosuvastatin 40 mg daily (n=134) vs. placebo (n=135) | asymptomatic patients with mild to moderate aortic stenosis and no clinical indications for cholesterol lowering | double blind Parallel groups Sample size: 134/135 Primary endpoint: FU duration: 3.5 y |
|
cholesterol lowering intervention | simvastatin | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
SEAS, 2008 | ezetimibe+simvastatin vs placebo | | | CV detah, aortic replacement, hospitalization for severe aortic stenosis 0.92 [0.82; 1.04] Death from any cause 1.03 [0.80; 1.34] Aortic-valve replacement 0.95 [0.82; 1.09] CV death 0.83 [0.57; 1.20] |
Trial | Treatments | Patients | Method |
---|
SEAS, 2008 | simvastatin 40mg plus ezetimibe 10 mg daily (n=944) vs. placebo (n=929) | patients with mild-tomoderate,
asymptomatic aortic stenosis | double blind Parallel groups Sample size: 944/929 Primary endpoint: aortic-valve and cardiovascular events FU duration: 52.2 mo |
|
transcatheter aortic-valve implantation (TAVI) | TAVI | versus no TAVI No demonstrated result for efficacy transcatheter aortic valve implantation inferior to standard therapy in terms of Stroke or TIA in PARTNER, 2010 | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
PARTNER, 2010 | transcatheter aortic valve implantation vs standard therapy | death from any cause 0.62 [0.47; 0.81] Death from any cause or major stroke 0.66 [0.51; 0.85] | Stroke or TIA 2.38 [1.07; 5.28] | major stroke 2.00 [0.83; 4.84] | PARTNER cohort A, 2011 | transcatheter aortic valve implantation vs surgical valve replacement | | | |
Trial | Treatments | Patients | Method |
---|
PARTNER, 2010 | transcatheter aortic-valve
implantation (TAVI)with Edwards SAPIEN Transcatheter Heart Valve
(n=179) vs. standard therapy (n=179) | patients with severe aortic stenosis considered
not to be suitable candidates for surgery | open Parallel groups Sample size: 179/179 Primary endpoint: death from any cause FU duration: 1.6 y (at least1 year) | PARTNER cohort A, 2011 | percutaneous valve implantation (Sapien device) (n=699) vs. surgical valve replacement
(n=0) | high risk, symptomatic patients with severe aortic stenosis | Parallel groups Sample size: 699/0 Primary endpoint: FU duration: |
|