Table 3. Clinical Outcomes by 1 Yeara.
| Analysis | No. of Events (%)b | Unadjusted | Adjusted | |||||
|---|---|---|---|---|---|---|---|---|
| Intervention (n = 6135) |
Usual Care (n = 3967) | Observed Difference, % (95% CI)c | HR (95% CI) | P Value | Adjusted Difference, % (95% CI)c | HR (95% CI) | P Value | |
| Primary Outcome (Death, MI, or Stroke) | ||||||||
| MACE | ||||||||
| Intention-to-treat | 614 (10.2) | 415 (10.6) | −0.5 (−2.2 to 1.3) | 0.96 (0.80 to 1.15) | .65 | 0.7 (−0.7 to 2.1) | 1.07 (0.93 to 1.25) | .35 |
| As-treated | 327 (7.5) | 415 (10.6) | −3.0 (−4.6 to −1.5) | 0.70 (0.58 to 0.84) | <.001 | −0.7 (−2.1 to 0.7) | 0.90 (0.76 to 1.08) | .25 |
| Secondary Outcomes | ||||||||
| Death | ||||||||
| Intention-to-treat | 237 (3.9) | 154 (3.9) | 0.0 (−1.0 to 1.0) | 1.00 (0.76 to 1.31) | .98 | 0.4 (−0.5 to 1.2) | 1.11 (0.88 to 1.39) | .39 |
| As-treated | 103 (2.3) | 154 (3.9) | −1.5 (−2.4 to −0.7) | 0.60 (0.44 to 0.81) | .001 | −0.6 (−1.4 to 0.2) | 0.82 (0.63 to 1.07) | .14 |
| Recurrent MI | ||||||||
| Intention-to-treat | 413 (6.9) | 280 (7.3) | −0.3 (−1.6 to 0.9) | 0.96 (0.79 to 1.15) | .64 | 0.5 (−0.7 to 1.6) | 1.08 (0.90 to 1.29) | .40 |
| As-treated | 235 (5.4) | 280 (7.3) | −1.7 (−2.9 to 0.6) | 0.74 (0.61 to 0.90) | .003 | 0.0 (−1.2 to 1.2) | 0.98 (0.80 to 1.20) | .83 |
| Stroke | ||||||||
| Intention-to-treat | 33 (0.8) | 19 (1.0) | −0.1 (−0.5 to 0.2) | 0.88 (0.59 to 1.31) | .53 | 0.0 (−0.3 to 0.3) | 0.98 (0.68 to 1.42) | .91 |
| As-treated | 29 (0.7) | 19 (1.0) | −0.3 (−0.6 to 0.1) | 0.71 (0.44 to 1.15) | .16 | −0.1 (−0.4 to 0.2) | 0.86 (0.57 to 1.31) | .48 |
| Cardiovascular death | ||||||||
| Intention-to-treat | 187 (3.1) | 117 (3.0) | 0.1 (−0.8 to 1.0) | 1.03 (0.77 to 1.38) | .82 | 0.5 (−0.2 to 1.2) | 1.18 (0.92 to 1.52) | .19 |
| As-treated | 80 (1.8) | 117 (3.0) | −1.1 (−1.9 to −0.4) | 0.61 (0.45 to 0.84) | .003 | −0.3 (−0.9 to 0.4) | 0.89 (0.66 to 1.21) | .46 |
| BARC type 2 or higher bleeding | ||||||||
| Intention-to-treat | 259 (4.4) | 157 (4.1) | 0.3 (−0.6 to 1.2) | 1.06 (0.87 to 1.30) | .56 | 0.6 (−0.3 to 1.5) | 1.15 (0.94 to 1.41) | .17 |
| As-treated | 184 (4.3) | 157 (4.1) | 0.1 (−0.8 to 1.0) | 1.00 (0.81 to 1.23) | .95 | 0.6 (−0.3 to 1.5) | 1.13 (0.91 to 1.40) | .26 |
Abbreviations: BARC, Bleeding Academic Research Consortium; HR, hazard ratio; MACE, major adverse cardiovascular events; MI, myocardial infarction.
a
Primary analysis used an intention-to-treat approach in which outcomes were compared regardless of whether the intervention group patient used the study voucher. Prespecified secondary analyses of the as-treated population excluded intervention group patients who never used the study voucher during the 1 year after index MI discharge.
b
Unadjusted Kaplan-Meier event rates.
c
Negative differences denote better outcomes for patients in the intervention group.