Table 2. Prespecified Clinical Outcomes Through 1 Year.
| Clinical outcomesa | No. % | Difference (95% CI), % | HR (95% CI) | Log-rank P value | |
|---|---|---|---|---|---|
| Paclitaxel-coated balloon (n = 406) | Uncoated balloon (n = 194) | ||||
| Primary outcome | |||||
| Target lesion failureb | 71 (17.9) | 54 (28.6) | −10.7 (−18.2 to −3.2) | 0.59 (0.42 to 0.84) | .003 |
| Additional prespecified outcomes | |||||
| Target lesion revascularizationc | |||||
| Overall | 51 (13.0) | 46 (24.7) | −11.6 (−18.7 to −4.5) | 0.50 (0.34 to 0.74) | .001 |
| PCI | 39 (10.0) | 43 (22.8) | −12.9 (−19.6 to −6.1) | 0.41 (0.26 to 0.63) | <.001 |
| CABG | 13 (3.3) | 8 (4.5) | −1.2 (−4.8 to 2.4) | 0.77 (0.32 to 1.86) | .56 |
| Target vessel revascularizationc | |||||
| Overall | 56 (14.3) | 49 (26.2) | −11.8 (−19.1 to −4.6) | 0.51 (0.35 to 0.75) | .001 |
| PCI | 44 (11.3) | 46 (24.4) | −13.1 (−20.0 to −6.2) | 0.43 (0.28 to 0.64) | <.001 |
| CABG | 14 (3.6) | 8 (4.5) | −0.9 (−4.5 to 2.7) | 0.83 (0.35 to 1.98) | .68 |
| Target vessel revascularization not in target lesionc,d | |||||
| Overall | 20 (5.1) | 13 (6.9) | −1.8 (−6.0 to 2.4) | 0.72 (0.36 to 1.46) | .36 |
| PCI | 17 (4.3) | 11 (5.8) | −1.5 (−5.3 to 2.4) | 0.73 (0.34 to 1.55) | .41 |
| CABG | 4 (1.0) | 3 (1.6) | −0.6 (−2.6 to 1.5) | 0.64 (0.14 to 2.85) | .55 |
| Target vessel failuree | 73 (18.4) | 57 (30.1) | −11.7 (−19.3 to −4.1) | 0.57 (0.40 to 0.81) | .001 |
| Myocardial infarction | 29 (7.5) | 23 (12.1) | −4.7 (−10.0 to 0.7) | 0.58 (0.34 to 1.01) | .05 |
| Related to target vessel | 23 (5.8) | 21 (11.1) | −5.3 (−10.3 to −0.2) | 0.51 (0.28 to 0.92) | .02 |
| Q-wave myocardial infarction | 1 (0.3) | 1 (0.5) | −0.3 (−1.4 to 0.9) | 0.48 (0.03 to 7.64) | .59 |
| Related to target vessel | 0 | 1 (0.5) | −0.5 (−1.5 to 0.5) | NA | .15 |
| Non–Q-wave myocardial infarction | 28 (7.2) | 22 (11.6) | −4.4 (−9.7 to 0.9) | 0.59 (0.34 to 1.03) | .06 |
| Related to target vessel | 23 (5.8) | 20 (10.6) | −4.8 (−9.7 to 0.2) | 0.54 (0.30 to 0.98) | .04 |
| Related to target vessel-unknownf | 11 (2.8) | 4 (2.2) | 0.7 (−2.0 to 3.3) | 1.32 (0.42 to 4.16) | .63 |
| Not related to target vessel | 5 (1.4) | 2 (1.1) | 0.4 (−1.5 to 2.3) | 1.19 (0.23 to 6.12) | .84 |
| All deathg | 16 (4.1) | 7 (3.7) | 0.4 (−3.0 to 3.7) | 1.09 (0.45 to 2.65) | .85 |
| Cardiac | 11 (2.9) | 3 (1.6) | 1.3 (−1.2 to 3.7) | 1.75 (0.49 to 6.28) | .38 |
| Noncardiac | 5 (1.3) | 4 (2.2) | −0.9 (−3.3 to 1.5) | 0.60 (0.16 to 2.22) | .43 |
| Stent thrombosisg | 1 (0.4) | 7 (3.7) | −3.3 (−6.1 to −0.5) | 0.07 (0.01 to 0.55) | .001 |
| Definite or probable | 0 | 6 (3.2) | −3.2 (−5.7 to −0.7) | NA | <.001 |
| Definite | 0 | 6 (3.2) | −3.2 (−5.7 to −0.7) | NA | <.001 |
| Probable | 0 | 0 | 0.0 (0.0 to 0.0) | NA | Undefined |
| Possible | 1 (0.4) | 1 (0.5) | −0.2 (−1.4 to 1.1) | 0.48 (0.03 to 7.63) | .59 |
Abbreviations: CABG, coronary artery bypass graft surgery; HR, hazard ratio; NA, not available; PCI, percutaneous coronary intervention.
Rates of outcomes with their associated HRs and 95% CIs were calculated using survival methodology.
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death. If it could not be determined with certainty whether the myocardial infarction was related to the target vessel, it was considered a target lesion failure.
The numbers may not equal the overall totals because patients could have multiple events.
Refers to lesions more than 5 mm from the stent borders, but within the same major coronary vessel.
Defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death. If it could not be determined with certainty whether the myocardial infarction was related to the target vessel by the clinical events committee, it is considered a target vessel failure.
All unknown non–Q-wave myocardial infarction counted as related to target vessel.
As defined by the Academic Research Consortium.18