Background: The Sant'ANna TIrofiban Safety study (SANTISS) is an open-label investigator-initiated single-centre registry launched to assess the combination of bleeding and access site in-hospital complications (primary end-point) in patients undergoing percutaneous coronary intervention (PCI) by femoral approach only.
Methods: We compared patients who were on oral single antiaggregating drug (AAD) and received, just prior to PCI, high-dose tirofiban and a second oral antiplatelet agent (triple AAD: group 1, n = 970) with those who were already on an oral double AAD regimen and did not receive tirofiban (double AAD: group 2, n = 608).
Results: Group 2 patients were slightly older, presented less frequently with unstable angina and had chronic renal failure more frequently. They were more than twice as frequently on rescue PCI, being more than three-fold less frequently on primary PCI (all: 0.01>P < 0.001). Overall, there were 87 in-hospital (average 4.7 days of stay) complications: 51 (5.3%) in group 1 and 36 (5.9%) in group 2 (not significant). Haemotransfusions were needed in 34 patients: 21 (2.2%) in group 1 and 13 (2.1%) in group 2 (not significant). Of the 16 hospital deaths, eight (0.8%) were seen in group 1 and eight (1.3%) in group 2 (not significant). Multivariate prediction showed a high predictive accuracy (areas under the curve >0.700) of female sex, rescue PCI and chronic renal failure to index complications, with highly significant odds ratios. The presence of high-dose tirofiban did not increase complication risk.
Conclusion: In the real world, high-dose tirofiban is well tolerated by patients on elective, primary or rescue PCI, and the in-hospital complication rate, including major bleeding, is low. This may have pharmacoeconomic consequences.