Comparação da performance clínica de dois tipos de stents farmacológicos com recobrimento polimérico abluminal biodegradável: resultados de cinco anos do estudo randomizado DESTINY
Guy F.A. Prado Jra,b, Alexandre A.C. Abizaidc, George C. Meirelesd, Rogério Sarmento-Leitee, Mauricio Prudentef, Marcelo Cantarellig, Adriano D. Douradoh, Jose Mariani Jra,b,i, Marco A. Perinj, Costantino Costantinik, Ricardo Costac, J. Ribamar Costac, Daniel Chamiec, Carlos M. Camposa,b, Expedito E. Ribeiroa, Pedro A. Lemosa,b,
a Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil
b Hospital Israelita Albert Einstein, São Paulo, SP, Brazil
c Instituto Dante Pazzanese de Cardiologia, São Paulo, SP, Brazil
d Hospital do Servidor Público Estadual – IAMSPE, São Paulo, SP, Brazil
e Institute of Cardiology/Fundação Universitária de Cardiologia de Porto Alegre, Porto Alegre, RS, Brazil
f Hospital Encore, Aparecida de Goiania, GO, Brazil
g Hospital Bandeirantes, São Paulo, SP, Brazil
h Hospital Santa Izabel, Salvador, BA, Brazil
i Faculdade de Ciências Médicas da Santa Casa de São Paulo, São Paulo, SP, Brazil
j Hospital Santa Marcelina, São Paulo, SP, Brazil
k Hospital Cardiológico Costantini, Curitiba, PR, Brazil
Introduction and Objectives
The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions – DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure.
A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization.
At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group.
The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.