Table 3. Clinical outcomes after TAVR.
Overall (n=189) | Sapien XT (n=94) | Sapien 3 (n=95) | p value* | HR (95% CI) | p value | ||
---|---|---|---|---|---|---|---|
In-hospital | |||||||
Disabling stroke or all-cause mortality | 8 (4.2) | 4 (4.3) | 4 (4.2) | 1.000 | - | - | |
All-cause mortality | 7 (3.7) | 3 (3.2) | 4 (4.2) | 1.000 | - | - | |
Cardiovascular mortality | 4 (2.1) | 3 (3.2) | 1 (1.1) | 0.368 | - | - | |
Disabling stroke | 2 (1.1) | 1 (1.1) | 1 (1.1) | 1.000 | - | - | |
1-month follow-up | |||||||
Disabling stroke or all-cause mortality | 9 (4.8) | 5 (5.4) | 4 (4.3) | 0.731 | 0.460 (0.094–2.244) | 0.337 | |
All-cause mortality | 8 (4.3) | 4 (4.3) | 4 (4.3) | 0.998 | 0.523 (0.099–2.761) | 0.445 | |
Cardiovascular mortality | 5 (2.7) | 4 (4.3) | 1 (1.1) | 0.182 | 0.079 (0.005–1.303) | 0.076 | |
Disabling stroke | 3 (1.7) | 2 (2.2) | 1 (1.1) | 0.564 | 0.074 (0.001–7.248) | 0.265 | |
NYHA>2 | 1/153 (0.7) | 0/81 (0.0) | 1/72 (1.4) | 0.471 | - | - | |
CCS>2 | 1/153 (0.7) | 0/81 (0.0) | 1/72 (1.4) | 0.471 | - | - | |
1-year follow-up | |||||||
Disabling stroke or all-cause mortality | 21 (12.9) | 12 (13.6) | 9 (11.7) | 0.783 | 1.055 (0.376–2.960) | 0.919 | |
All-cause mortality | 18 (11.1) | 10 (11.3) | 8 (10.5) | 0.931 | 0.977 (0.326–2.934) | 0.967 | |
Cardiovascular mortality | 6 (3.3) | 5 (5.4) | 1 (1.1) | 0.107 | 0.031 (0.001–0.951) | 0.047 | |
Disabling stroke | 5 (3.0) | 3 (3.5) | 2 (2.3) | 0.715 | 1.394 (0.107–18.196) | 0.800 | |
NYHA>2 | 2/99 (2.0) | 2/73 (2.7) | 0/26 (0.0) | 1.000 | - | - | |
CCS>2 | - | - | - | - | - | - |
Values are presented as number of patients (%) or mean±standard deviation. Covariates for multivariable Cox regression analysis were age, sex, body mass index, diabetes mellitus, hypertension, chronic lung disease, peripheral arterial occlusive disease, bicuspid aortic valve, extent of coronary artery disease, atrial fibrillation, advanced chronic kidney disease (stage>3), device generation, and in-hospital moderate or severe paravalvular leakage.
CCS = Canadian Cardiovascular Society grade of angina pectoris; CI = confidence interval; HR = hazard ratio; NYHA = New York Heart Association; TAVR = transcatheter aortic valve replacement.
*Events rates regarding mortality or stroke were estimated with Kaplan-Meier analysis. The p values were derived from the log-rank test.