Table 2.
Severity/Location Combination | “Bleed-Level” Analysis
|
Sensitivity “Patient-Level” Analyses*
|
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---|---|---|---|---|---|---|---|---|---|---|---|---|
First Most Severe Bleed
|
Random Most Severe
|
First Bleed
|
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HR | 95% CI | Rank | HR | 95% CI | Rank | HR | 95% CI | Rank | HR | 95% CI | Rank | |
Severe, surgical | 5.27 | 3.80–7.29 | 1 | 6.31 | 4.56–8.72 | 1 | 6.23 | 4.47–8.69 | 1 | 6.01 | 4.17–8.68 | 1 |
Severe, systemic | 4.48 | 2.98–6.72 | 2 | 4.83 | 3.15–7.40 | 2 | 5.52 | 3.66–8.31 | 2 | 3.70 | 2.21–6.18 | 2 |
Severe, access site | 3.57 | 2.35–5.40 | 3 | 3.88 | 2.56–5.89 | 3 | 3.98 | 2.62–6.03 | 3 | 2.97 | 1.78–4.95 | 3 |
| ||||||||||||
Mild/moderate, surgical | 2.52 | 2.16–2.94 | 4 | 2.58 | 2.18–3.06 | 4 | 2.82 | 2.39–3.32 | 4 | 2.58 | 2.18–3.06 | 4 |
Mild/moderate, systemic | 1.40 | 1.16–1.69 | 5 | 1.70 | 1.37–2.12 | 5 | 1.69 | 1.35–2.11 | 5 | 1.74 | 1.40–2.16 | 5 |
Mild/moderate, superficial | 1.17 | 0.97–1.40 | 6 | 1.32 | 1.06–1.63 | 6 | 1.41 | 1.13–1.76 | 6 | 1.41 | 1.15–1.73 | 6 |
Mild/moderate, access site | 0.96 | 0.82–1.12 | 7 | 1.08 | 0.91–1.28 | 7 | 1.13 | 0.95–1.34 | 7 | 1.11 | 0.94–1.31 | 7 |
Sensitivity analyses conducted on the patient level. For patients with multiple bleeding events, the “first severe” bleed categorizes each patient by the first GUSTO severe bleed reported, but when no severe bleeding is reported, the patient is categorized by the first GUSTO mild/moderate bleed. “First bleed” categorizes each patient by the first reported bleeding event regardless of severity.
CI = confidence interval; GUSTO = Global Use of Strategies To Open Occluded Coronary Arteries; HR = hazard ratio; MI = myocardial infarction.