Table A7:
Study Results—Mortality and Stroke
| Author, Year N (TAVI/SAVR) | All-Cause Mortality or Disabling Stroke | All-Cause Mortality | Stroke and TIA | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 30 Days | 1 Year | 2 Years | 30 Days | 1 Year | 2 Years | 30 Days | 1 Year | 2 Years | |
| Full Cohort | |||||||||
| Reardon et al, 201719 SURTAVI 1,746 (879/867) |
Percentagea TAVI: 2.7 SAVR: 3.2 95% Crl for difference: −2.2 to 1.1 |
Percentagea TAVI: 8.3 SAVR: 8.8 95% Crl for difference: −3.3 to 2.2 |
Percentagea TAVI: 13.2 SAVR: 14.1 95% Crl for difference: −4.7 to 2.7 P < .001 for noninferiority |
Percentagea TAVI: 2.0 SAVR: 1.3 95% Crl for difference: −0.5 to 1.9 |
Percentagea TAVI: 7.0 SAVR: 6.8 95% Crl for difference: −2.3 to 2.7 |
Percentagea TAVI: 12.0 SAVR: 11.6 95% Crl for difference: −3.2 to 3.9 |
PercentageaAny stroke TAVI: 2.6 SAVR: 4.8 95% Crl for difference: −4.0 to −0.4 |
PercentageaAny stroke TAVI: 5.5 SAVR: 6.8 95% Crl for difference: −3.7 to 1.1 |
Percentagea Any stroke TAVI: 6.1 SAVR: 8.5 95% Crl for difference: −5.1 to 0.3 |
| Disabling stroke TAVI: 1.1 SAVR: 2.2 95% Crl for difference: −2.3 to 0.2 |
Disabling stroke TAVI: 2.2 SAVR: 3.7 95% Crl for difference: −3.2 to 0.2 |
Disabling stroke TAVI: 2.6 SAVR: 4.6 95% Crl for difference: −4.0 to 0 |
|||||||
| TIA TAVI: 0.9 SAVR: 0.7 95% Crl for difference: −0.7 to 1.1 |
TIA TAVI: 3.4 SAVR: 2.0 95% Crl for difference: −0.2 to 3.0 |
TIA TAVI: 4.4 SAVR: 3.0 95% Crl for difference: −0.6 to 3.5 |
|||||||
| Leon et al, 201610 PARTNER 2 2,032 (1,011/1,021) |
KM estimateb, n (%) TAVI: 62 (6.1) SAVR: 80 (8.0) P = .11 |
KM estimateb, n (%) TAVI: 145 (14.5) SAVR: 160 (16.4) P = .24 |
KM estimateb, n (%) TAVI: 192 (19.3) SAVR: 202 (21.1) P = .33 HR (95% CI) 0.89 (0.73–1.09) P = .25 RR (95% CI) 0.92 (0.77–1.09) P = .001 for noninferiority |
KM estimateb, n (%) TAVI: 39 (3.9) SAVR: 41 (4.1) P = .78 |
KM estimateb, n (%) TAVI: 123 (12.3) SAVR: 124 (12.9) P = .69 |
KM estimateb, n (%) TAVI: 166 (16.7) SAVR: 170 (18.0) P = .45 HR (95% CI) 0.92 (0.74; 1.13) P = .42 |
KM estimateb, n (%) Any stroke TAVI: 55 (5.5) SAVR: 61 (6.1) P = .57 Disabling stroke TAVI: 32 (3.2) SAVR: 43 (4.3) P = .20 TIA TAVI: 9 (0.9) SAVR: 4 (0.4) P = .17 |
KM estimateb, n (%) Any stroke TAVI: 78 (8.0) SAVR: 79 (8.1) P = .88 Disabling stroke TAVI: 49 (5.0) SAVR: 56 (5.8) P = .46 TIA TAVI: 23 (2.4) SAVR: 16 (1.8) P = .38 |
KM estimateb, n (%) Any stroke TAVI: 91 (9.5) SAVR: 85 (8.9) P = .67 Disabling stroke TAVI: 59 (6.2) SAVR: 61 (6.4) P = .83 HR (95% CI) 0.93 (0.65; 1.33) P = .70 TIA TAVI: 34 (3.7) SAVR: 20 (2.3) P = .09 |
| Transfemoral Cohort | |||||||||
| Leon et al, 201610 PARTNER 2 1,550 (775/775) |
KM estimateb, n (%) TAVI: 38 (4.9) SAVR: 59 (7.7) P = .02 |
KM estimateb, n (%) TAVI: 94 (12.3) SAVR: 118 (15.9) P = .04 |
KM estimateb, n (%) TAVI: 128 (16.8) SAVR: 149 (20.4) P = .07 HR (95% CI) 0.79 (0.62–1.00) P = .05 |
KM estimateb, n (%) TAVI: 23 (3.0) SAVR: 31 (4.1) P = .24 |
KM estimateb, n (%) TAVI: 77 (10.0) SAVR: 90 (12.3) P = .17 |
KM estimateb, n (%) TAVI: 108 (14.2) SAVR: 124 (17.2) P = .11 HR (95% CI) 0.80 (0.62–1.04) P = .09 |
KM estimateb, n (%) Any stroke TAVI: 32 (4.2) SAVR: 48 (6.3) P = .06 Disabling stroke TAVI: 18 (2.3) SAVR: 32 (4.2) P = .04 TIA TAVI: 7 (0.9) SAVR: 2 (0.3) P = .10 |
KM estimateb, n (%) Any stroke TAVI: 52 (6.9) SAVR: 63 (8.5) P = .24 Disabling stroke TAVI: 32 (4.3) SAVR: 44 (6.0) P = .13 TIA TAVI: 19 (2.6) SAVR: 12 (1.8) P = .33 |
KM estimateb, n (%) Any stroke TAVI: 62 (8.4) SAVR: 67 (9.2) P = .60 Disabling stroke TAVI: 39 (5.3) SAVR: 48 (6.7) P = .28 HR (95% CI) 0.77 (0.50–1.17) P = .22 TIA TAVI: 27 (3.8) SAVR: 14 (2.1) P = .07 |
| Transthoracic Cohort | |||||||||
| Leon et al, 201610 PARTNER 2 482 (236/246) |
KM estimateb, n (%) TAVI: 24 (10.2) SAVR: 21 (8.7) P = .57 |
KM estimateb, n (%) TAVI: 51 (22.0) SAVR: 42 (18.2) P = .31 |
KM estimateb, n (%) TAVI: 64 (27.7) SAVR: 53 (23.4) P = .29 HR (95% CI) 1.21 (0.84–1.74) P = .31 |
KM estimateb, n (%) TAVI: 16 (6.8) SAVR: 10 (4.2) P = .21 |
KM estimateb, n (%) TAVI: 46 (19.9) SAVR: 34 (15.0) P = .17 |
KM estimateb, n (%) TAVI: 58 (25.2) SAVR: 46 (20.7) P = .26 HR (95% CI): 1.26 (0.86–1.86) P = .24 |
KM estimateb, n (%) Any stroke TAVI: 23 (9.8) SAVR: 13 (5.4) P = .07 Disabling stroke TAVI: 14 (6.0) SAVR: 11 (4.5) P = .35 TIA TAVI: 2 (0.9) SAVR: 2 (0.8) P = .97 |
KM estimateb, n (%) Any stroke TAVI: 26 (11.3) SAVR: 16 (6.8) P = .09 Disabling stroke TAVI: 17 (7.5) SAVR: 12 (5.0) P = .27 TIA TAVI: 4 (1.9) SAVR: 4 (1.9) P = .99 |
KM estimateb, n (%) Any stroke TAVI: 29 (12.9) SAVR: 18 (7.9) P = .09 Disabling stroke TAVI: 20 (9.1) SAVR: 13 (5.6) P = .16 HR (95% CI): 1.57 (0.78–3.16) P = .20 TIA TAVI: 7 (3.5) SAVR: 6 (3.0) P = .79 |
Abbreviations: CI, confidence interval; CrI, credible interval; HR, hazard ratio; KM, Kaplan–Meier; RR, risk ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve replacement; TIA, transient ischemic attack.
a
Calculated by means of Bayesian analyses.
b
The percentages provided are Kaplan–Meier estimates at the specific time point and do not necessarily equal the number of patients who experienced the event divided by the total number of patients in the treatment group at the given time point.