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2021, Number 3

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Rev Cubana Cardiol Cir Cardiovasc 2021; 27 (3)

Effectiveness at three year of paclitaxel eluting coronary stent implant with off-label use

Aroche AR, Rodríguez NÁY, Naranjo-Dominguez A, Obregón SÁG, Aldama PL, Amador GR

Language: Spanish
References: 23
Page: 1-10
PDF size: 560.20 Kb.


ABSTRACT

Introduction: Drug-eluting stents have expanded their utility to clinical and angiographic situations more complex than the initial ones.
Objective: To evaluate the effectiveness of paclitaxel-eluting stents Active™ and Active Small™ models (Iberhospitex, Barcelona, Spain), in patients with an off-label indication versus patients with an on-label indication.
Method: Prospective sub study (2007 - 2018) at CIMEQ, Havana, Cuba, in 159 patients treated with paclitaxel eluting stent, 88 with an off-label indication and 77 on-label indication. Death, heart attack, revascularization and their combination were considered, as well as stent restenosis and thrombosis. Frequency distribution, χ2 test, Fisher's test and T-Test of difference between means, Kaplan-Meier curve and Logarithmic Range Test (Mantel-Cox) were used, with statistical significance (α <0.05). Research in line with the Helsinki declaration approved by the Scientific Council, without conflict of interest.
Results: Infarction in three years of follow-up on label: 1 (1.4%) vs. off label 2 (2.3%), death 2.3% vs. 4.2%, new revascularization due to restenosis 15.9% vs. 15.5 % and late or very late thrombosis 3.4% vs. 0. 34 major combined cardiac events were recorded without significant difference between the on-label group with respect to the off-label group, 21.1% vs. 21.6% respectively; p = 0.94).
Conclusions: The stents evaluated are effective and safe in patients with off-label and on-label indications, with similar incidence of death, infarction, need for new target lesion revascularization and combined mayor cardiac events, after three years of follow-up, with a low frequency of late or very late thrombosis.


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