Table 4.
Summary of trials comparing 30-day major bleeding events based on the primary study definition in patients randomized to bivalirudin vs. heparin with provisional and routine GPI use.
| Study | Reference | Primary major bleeding definition | N | Indication | RR [95% CI]: p-value |
|---|---|---|---|---|---|
| BIVALIRUDIN VS. HEPARIN + PROVISIONAL GPI | |||||
| ARMYDA-7 BIVALVE 2012 | Patti et al., 2012 | TIMI | 401 | SA, UA, NSTEMI | 0.49 [0.04, 5.34]: 0.0001 |
| BRIGHT 2015 | Han et al., 2015 | BARC | 1464 | NSTEMI, STEMI | 0.54 [0.35, 0.83]: < 0.001 |
| EUROMAX 2013 | Steg et al., 2013 | ACUITY trial | 2198 | STEMI | 0.43 [0.28, 0.66]: < 0.001 |
| HEAT-PPCI 2014 | Shahzad et al., 2014 | BARC | 1812 | STEMI | 1.15 [0.70, 1.89]: 0.59 |
| HIRULOG 1995 | Bittl et al., 1995 | TIMI | 4098 | UA, Post-infarction Angina | 0.39 [0.30, 0.50]: 0.001 |
| ISAR-REACT 3 2008 | Kastrati et al., 2008 | REPLACE 2 trial | 4570 | UA, SA | 0.50 [0.25, 0.99]: 0.008 |
| MATRIX 2015 | Valgimigli et al., 2015 | BARC | 7213 | NSTEMI, STEMI | 0.56 [0.39, 0.79]: < 0.001 |
| BIVALIRUDIN VS. HEPARIN + ROUTINE GPI | |||||
| ACUITY 2006 | Stone et al., 2006 | ACUITY trial | 9207 | UA, NSTEMI | 0.93 [0.78, 1.10]: < 0.001 |
| BRIGHT 2015 | Han et al., 2015 | BARC | 1465 | NSTEMI, STEMI | 0.33 [0.22, 0.49]: < 0.001 |
| HORIZON-AMI 2008 | Stone et al., 2008 | ACUITY trial | 3602 | STEMI | 0.61 [0.44, 0.84]: < 0.001 |
| ISAR-REACT 4 2011 | Kastrati et al., 2011 | REPLACE 2 trial | 1721 | NSTEMI | 0.55 [0.33, 0.92]: 0.02 |
| NAPLES 2009 | Tavano et al., 2009 | ACUITY trial | 335 | SA, UA | 0.25 [0.03, 2.23]: 0.371 |
| REPLACE-2 2003 | Lincoff et al., 2003 | REPLACE 2 trial | 6002 | SA, UA, MI | 0.58 [0.43, 0.77]: 0.001 |
TIMI, Thrombolysis in Myocardial Infarction; BARC, Bleeding Academic Research Consortium; REPLACE-2, Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events; ACUITY, Acute Catheterization and Urgent Intervention Triage Strategy.