Table 2.
Procedural Net Adverse Clinical Events
| Gender | Unadjusted | Adjustedd | ||||
|---|---|---|---|---|---|---|
| Female (n = 285) | Male (n = 480) | OR (95% CI) | p Value | OR (95% CI) | p‐Value | |
| Net adverse clinical events (NACE) | 42 (15%) | 42 (9%) | 1.80 (1.14 − 2.84) | 0.010 | 1.81 (1.04 − 3.13) | 0.037 |
| MACE | 10 (4%) | 24 (5%) | 0.70 (0.35 − 1.42) | 0.333 | 0.71 (0.29 − 1.73) | 0.455 |
| Complication | 36 (13%) | 29 (6%) | 2.24 (1.35 − 3.76) | 0.002 | 2.32 (1.21 − 4.46) | 0.011 |
| MACE components: | ||||||
| Death | 3 (1%) | 13 (3%) | 0.38 (0.11 − 1.35) | 0.122 | ||
| Stroke | 3 (1%) | 1 (0.2%) | 5.10 (0.53 − 49.22) | 0.117 | ||
| Myocardial infarction | 4 (1%) | 10 (2%) | 0.67 (0.21 − 2.15) | 0.587 | ||
| TVR | 1 (0.4%) | 1 (0.2%) | 1.69 (0.11 − 27.07) | 0.709 | ||
| Complications: | ||||||
| Major Vascular Injurya | 2 (1%) | 0 (0%) | 8.47 (0.41 − 177.15) | 0.066 | ||
| Tamponade (Perforation) | 6 (2%) | 2 (0.4%) | 5.14 (1.03 − 25.64) | 0.026 | ||
| Any Coronary Perforationb | 12 (4%) | 10 (2%) | 2.07 (0.88 − 4.85) | 0.089 | ||
| Coronary Dissection | 13 (5%) | 6 (1%) | 3.78 (1.42 − 10.05) | 0.004 | ||
| No Reflow/Slow Flow | 1 (0.4%) | 4 (0.8%) | 0.42 (0.05 − 3.77) | 0.423 | ||
| Bleed (BARC 2 or greater)c | 15 (5%) | 11 (2%) | 2.37 (1.07 − 5.23) | 0.028 | ||
| Minor Vascular Injurya | 4 (1%) | 4 (1%) | 1.69 (0.42 − 6.83) | 0.454 | ||
| Arrhythmia | ||||||
| Arrest: VF/VT/PEA | 3 (1%) | 6 (1%) | 0.84 (0.21 − 3.39) | 0.807 | ||
| Bradycardia (TPL) | 1 (0%) | 5 (1%) | 0.33 (0.04 − 2.88) | 0.295 | ||
| Other | 2 (1%) | 3 (1%) | 1.12 (0.19 − 6.77) | 0.902 | ||
All events independently adjudicated and occurring within 24 hours of procedure. NACE was defined as major adverse cardiac events (MACE: all‐cause death, MI, stroke, target vessel revascularization) plus any prespecified procedural complication. Periprocedural MI: Type IV myocardial infarction according to the third universal definition. Bradycardia (TPL): Severe bradycardia requiring insertion of temporary pacing line. OR: odds ratio. TVR: target vessel revascularization. Significance determined by Pearson‐Chi square test.
Vascular injury defined according to Valve Academic Research Consortium (VARC) minor and major criteria.
Coronary perforation (Ellis classification 1‐5).
Bleeding Academic Research Consortium (BARC) criteria. Other complications include contrast allergy and stent dislodgement requiring retrieval.
Adjustment incorporating propensity score only performed for NACE events, small sample bias precludes adjustment for MACE individual components.