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Safety of downstream high-dose tirofiban bolus among 1578 patients undergoing percutaneous coronary intervention: the Sant'ANna TIrofiban Safety study

Schiariti, Michele; Saladini, Angela; Missiroli, Bindo; Papalia, Francesco; Cuturello, Domenico; Puddu, Paolo Emilio; Gaudio, Carlo

Journal of Cardiovascular Medicine: April 2010 - Volume 11 - Issue 4 - p 250–259
doi: 10.2459/JCM.0b013e328334c7b9
Original articles

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.

aSant'Anna Hospital, Catanzaro, Italy

bDepartment of the Heart and Great Vessels ‘A. Reale’, University ‘La Sapienza’, Rome, Italy

* On leave from Broomfield Hospital, Chelmsford, Essex, UK.

Received 3 August, 2009

Revised 26 October, 2009

Accepted 30 October, 2009

Correspondence to P.E. Puddu, MD, FESC, FACC, Dipartimento del Cuore e Grossi Vasi ‘Attilio Reale’, UOC Biotecnologie Applicate alle Malattie Cardiovascolari, Università degli Studi di Roma ‘La Sapienza’, Viale del Policlinico, 155, Rome 00161, Italy Tel: +39 06 4455291; fax: +39 06 4441600; e-mail: paoloemilio.puddu@uniroma1.it

© 2010 Italian Federation of Cardiology. All rights reserved.