Table 2. Adverse Event Rates Cumulative Through 5 Years.
| Adverse Event | Events, No. (%)a | HR (95% CI) | P Value | |
|---|---|---|---|---|
| BVS (n = 2161) | EES (n = 1223) | |||
| TLF | 308 (14.9) | 135 (11.6) | 1.26 (1.03-1.54) | .03 |
| POCE | 550 (26.4) | 267 (22.7) | 1.15 (0.99-1.33) | .07 |
| All-cause mortality | 119 (5.9) | 64 (5.6) | 1.02 (0.75-1.38) | .92 |
| Cardiac | 44 (2.2) | 31 (2.8) | 0.79 (0.50-1.25) | .31 |
| Noncardiacb | 75 (3.8) | 33 (2.9) | 1.23 (0.81-1.85) | .33 |
| All MI | 221 (10.7) | 92 (7.9) | 1.30 (1.02-1.66) | .03 |
| TV-MI | 184 (8.8) | 64 (5.5) | 1.55 (1.16-2.06) | .003 |
| Non-TV-MI | 51 (2.5) | 35 (3.1) | 0.78 (0.51-1.20) | .26 |
| All revascularization | 378 (18.4) | 189 (16.3) | 1.10 (0.92-1.31) | .28 |
| ID-TLR | 172 (8.4) | 67 (5.8) | 1.41 (1.06-1.87) | .02 |
| ID-TVR | 268 (13.1) | 112 (9.8) | 1.32 (1.06-1.65) | .01 |
| Device thrombosis, definite/probable | 53 (2.5) | 10 (0.8) | 2.87 (1.46-5.65) | .002 |
| Definite | 48 (2.3) | 8 (0.7) | 3.14 (1.48-6.64) | .003 |
| Probable | 5 (0.2) | 2 (0.2) | 1.73 (0.33-9.09) | .52 |
Abbreviations: BVS, bioresorbable vascular scaffold; EES, everolimus-eluting stents; HR, hazard ratio; ID-TLR, ischemia-driven target lesion revascularization; ID-TVR, ischemia-driven target vessel revascularization; MI, myocardial infarction; POCE, patient-oriented composite end point (all death, all MI, or all revascularization); TLF, target lesion failure (cardiac death, TV-MI, or ID-TLR); TV-MI, target vessel–related MI.
a
Event rates are Kaplan-Meier time to first event estimates.
b
Includes noncardiac vascular deaths.