Table 2. Clinical Outcomes at 1 Year.
| Outcomea | Patients with event, No. (%)b | Hazard ratio (95% CI) | P value for noninferiorityc | |
|---|---|---|---|---|
| 1- to 2-mo DAPT (n = 2058) | 12-mo DAPT (n = 2078) | |||
| Primary end point | ||||
| A composite of cardiovascular death, myocardial infarction, definite stent thrombosis, ischemic/hemorrhagic stroke, or TIMI major/minor bleeding | 65 (3.2) | 58 (2.8) | 1.14 (0.80-1.62) | .06 |
| Major secondary end points | ||||
| Cardiovascular end point: a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic/hemorrhagic stroke | 56 (2.7) | 38 (1.9) | 1.50 (0.99-2.26) | NA |
| Bleeding end point: TIMI major/minor bleeding | 11 (0.5) | 24 (1.2) | 0.46 (0.23-0.94) | NA |
| Other secondary end points | ||||
| Death | 28 (1.4) | 19 (0.9) | 1.49 (0.83-2.67) | NA |
| Death from cardiac causes | 9 (0.4) | 7 (0.3) | 1.30 (0.48-3.49) | NA |
| Death from cardiovascular causes | 10 (0.5) | 10 (0.5) | 1.01 (0.42-2.43) | NA |
| Sudden cardiac death | 3 (0.2) | 3 (0.2) | 1.01 (0.20-5.02) | NA |
| Death from noncardiovascular causes | 18 (0.9) | 9 (0.4) | 2.02 (0.91-4.50) | NA |
| Myocardial infarction | 32 (1.6) | 17 (0.9) | 1.91 (1.06-3.44) | NA |
| Large MI (CK-MB ≥ 10×ULN) | 6 (0.3) | 4 (0.2) | 1.53 (0.43-5.43) | NA |
| Small MI (CK-MB) < 10×ULN) | 17 (0.8) | 8 (0.4) | 2.65 (0.93-5.00) | NA |
| MI without CK-MB elevation | 9 (0.5) | 4 (0.2) | 2.28 (0.70-7.41) | NA |
| MI without measurement of CK-MB | 0 | 1 (0.1) | NA | NA |
| Spontaneous MI | 30 (1.5) | 15 (0.8) | 2.03 (1.09-3.78) | NA |
| Procedural MI | 2 (0.1) | 2 (0.1) | 1.01 (0.14-7.20) | NA |
| MI related to the target lesion | 13 (0.7) | 10 (0.5) | 1.32 (0.58-3.01) | NA |
| Definite stent thrombosis | 9 (0.5) | 4 (0.2) | 2.29 (0.70-7.42) | NA |
| Definite or probable stent thrombosis | 10 (0.5) | 4 (0.2) | 2.54 (0.80-8.10) | NA |
| Stroke | 15 (0.7) | 11 (0.5) | 1.38 (0.63-3.00) | NA |
| Ischemic | 13 (0.6) | 10 (0.5) | 1.32 (0.58-3.00) | NA |
| Hemorrhagic | 2 (0.1) | 1 (0.1) | 2.02 (0.18-22.28) | NA |
| Bleeding | ||||
| TIMI major | 7 (0.3) | 13 (0.6) | 0.54 (0.22-1.36) | NA |
| TIMI minor | 4 (0.2) | 13 (0.6) | 0.31 (0.10-0.95) | NA |
| BARC 3/5 | 11 (0.5) | 27 (1.3) | 0.41 (0.20-0.83) | NA |
| BARC 5 | 1 (0.1) | 0 | NA | NA |
| BARC 3 | 10 (0.5) | 27 (1.3) | 0.37 (0.18-0.77) | NA |
| GUSTO moderate/severe | 10 (0.5) | 24 (1.2) | 0.42 (0.20-0.88) | NA |
| GUSTO severe | 7 (0.3) | 12 (0.6) | 0.59 (0.23-1.50) | NA |
| GUSTO moderate | 3 (0.2) | 13 (0.6) | 0.23 (0.07-0.82) | NA |
| Intracranial bleeding | 5 (0.2) | 3 (0.2) | 1.68 (0.40-7.04) | NA |
| Gastrointestinal bleeding | 5 (0.2) | 19 (0.9) | 0.21 (0.07-0.62) | NA |
| Any coronary revascularization | 114 (5.7) | 74 (3.7) | 1.58 (1.18-2.13) | NA |
| TLR | 46 (2.3) | 32 (1.6) | 1.46 (0.93-2.30) | NA |
| Clinically driven TLR | 38 (1.9) | 26 (1.3) | 1.49 (0.90-2.45) | NA |
| Non-TLR | 81 (4.1) | 50 (2.5) | 1.67 (1.17-2.38) | NA |
| CABG | 7 (0.4) | 3 (0.2) | 2.36 (0.61-9.12) | NA |
| Death or myocardial infarction | 60 (3.0) | 36 (1.8) | 1.69 (1.12-2.56) | NA |
| Cardiovascular death or myocardial infarction | 42 (2.1) | 27 (1.3) | 1.58 (0.97-2.56) | NA |
| Major adverse cardiac eventsd | 64 (3.1) | 40 (2.0) | 1.63 (1.10-2.42) | NA |
Abbreviations: BARC, Bleeding Academic Research Consortium; CABG, coronary artery bypass grafting; CK-MB, creatine kinase–MB fraction; DAPT, dual antiplatelet therapy; GUSTO, Global Use of Strategies to Open Occluded Arteries; MI, myocardial infarction, NA, not applicable; TIMI, Thrombolysis in Myocardial Infarction; TLR, target-lesion revascularization; ULN, upper limit of normal.
Definitions of the end points were described in eAppendix 3 in Supplement 2.
Percentages are Kaplan-Meier estimates at 365 days.
P for noninferiority was derived from Cox hazard model with prespecified relative 50% margin of noninferiority in the hazard ratio scale.
Major adverse cardiac events were defined as composite of cardiac death, myocardial infarction, and clinically driven TLR.