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Vol. 65. Issue 7.
Pages 670-671 (July 2012)
Vol. 65. Issue 7.
Pages 670-671 (July 2012)
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Safety and Efficacy of Endothelial Progenitor Cell Capture Stent in ST-Elevation Acute Myocardial Infarction. GENIA Study
Seguridad y eficacia del stent capturador de células progenitoras de endotelio en el infarto agudo de miocardio con elevación del ST. Estudio GENIA
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Melisa Santas-Alvareza,
Corresponding author
melisasantas@hotmail.com

Corresponding author: melisasantas@hotmail.com
, Diego Lopez-Oteroa, Ana B. Cid-Alvareza, Pablo Souto-Castroa, Ramiro Trillo-Nouchea, Jose R. Gonzalez-Juanateya
a Departamento de Cardiología Intervencionista, Hospital Clínico de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain
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To the Editor,

The Genous® stent (OrbusNeich, Fort Lauderdale, Florida, United States) is made of stainless steel coated with murine anti-CD34 monoclonal antibodies, an antigen present on the surface of endothelial progenitor cells. Because of this characteristic, circulating cells of this type are attracted to the stent and attach to the struts, resulting in prompt formation of a layer of functional endothelium in less than 2 weeks.1 In a highly prothrombotic clinical situation such as ST segment elevation acute myocardial infarction (STEAMI), fast endothelialization of the stent could hypothetically reduce the risk of thrombosis and the need for new target vessel revascularization (TVR)..

The aim of our study is to evaluate the safety and efficacy of the Genous® stent in patients with STEAMI undergoing primary angioplasty..

This is a prospective observational study carried out between June 2008 and July 2010, including 139 consecutive patients undergoing primary angioplasty with implantation of one or more Genous® stents. Patients who were hospitalized in cardiogenic shock, those in recovery from cardiac arrest, and patients with a formal contraindication for dual antiplatelet therapy for at least 1 month were excluded. The regimen for antithrombotic and anticoagulant therapy followed the recommendations of European guidelines for the management of acute myocardial infarction. Patients were followed up by telephone contact..

Cardiac death was defined as death due to a cardiac cause, an unknown cause, or a procedure-related cause. Clinical restenosis was established on the presence of anginal symptoms associated with >50% stenosis in the segment covered by the stent and the adjacent 5mm..

The patients’ baseline characteristics and the procedure-related characteristics are summarized in Table 1, Table 2..

Table 1. Baseline Characteristics of Patients With ST Segment Elevation Acute Myocardial Infarction Treated With a Genous® Stent.

Age, years 64±13.5
Males 104 (74.8)
Smokers 67 (58.2)
Hypertension 69 (49.6)
Hyperlipidemia 66 (47.5)
Diabetes mellitus 24 (17.3)
Previous AMI 13 (9.4)
Chronic renal failure 10 (7.3)
Previous revascularization surgery 1 (0.7)
Previous PCA 14 (10.1)
Maximum TpI, ng/mL 93.1±87
Multivessel disease 28 (20.1)
Ejection fraction 52.3±10.8

AMI, acute myocardial infarction; PCA, percutaneous coronary angioplasty; TpI, troponin I.
Data are expressed as mean±standard deviation or no. (%).

Table 2. Procedure-Related Characteristics.

Radial access 124 (89.2)
Culprit artery  
Anterior descending 52 (37.4)
Right coronary 66 (47.5)
Circumflex 20 (14.4)
Baseline TIMI  
TIMI 0-1 115 (82.7)
TIMI 2-3 24 (17.3)
Total lesion length, mm 22.6±8.7
Number of stents per patient  
1 106 (76.3)
2 28 (20.1)
3 5 (3.6)
Maximum lesion diameter, mm 3.1±0.4
Direct stent 75 (54)
Thrombus aspiration 80 (57.6)
Final TIMI  
TIMI 3 134 (96.5)
TIMI 1-2 4 (3.6)
No reflux 9 (6.5)
Angiographic complications * 18 (12.9)

TIMI, thrombolysis in myocardial infarction.
Data are expressed as mean±standard deviation or no. (%).

* Distal embolization, lateral branch occlusion, dissection, or perforation.

All patients received dual antiplatelet therapy, which lasted for 1 year in 88 patients (65.2%). Mean follow-up was 538·(334.72) days. Five patients died during follow-up (3.6%): one death was due to noncardiac cause related to gastric neoplasm at 2 years following the procedure (cardiac mortality 2.9%, noncardiac mortality 0.7%), 2 patients died suddenly at home at 1 year and 2 years of follow-up, and 2 patients died during hospitalization (1 due to cardiac rupture and 1 due to cardiogenic shock and multiorgan failure)..

Based on the criteria of the Academic Research Consortium, there were 2 definite cases of thrombosis during follow-up (1.4%), one occurring during hospitalization and the other at 7 months following the procedure in a patient who had temporarily discontinued antiplatelet therapy..

Clinical restenosis occurred in 5% of cases, a new TVR was required in 5.8%, and target lesion revascularization (TLR) was needed in 3.8%..

Primary angioplasty is the treatment of choice in patients with STEAMI. Nonetheless, the choice of stent type remains controversial. Although it has been demonstrated that drug-eluting stents (DESs) effectively reduce restenosis, they can delay remodeling, a factor that has been related to thrombosis, particularly in high-risk situations, such as STEAMI.2 In a study by Planas et al.,3 8.6% of the patient group treated with DESs required TLR, a higher rate than was documented in our study. This difference may be related to the fact that the patients in that study underwent angiographic follow-up studies at 6 and 12 months, which could increase the indication for coronary interventions..

Few studies have been performed with the Genous® stent in primary angioplasty. In the registry carried out by Lee et al.,4 which contained 321 patients, definite thrombosis was reported in 0.9% and the total mortality rate was 5.8%. The most relevant finding of Lee's study was that there was no increase in the number of late thrombosis cases despite the use of dual antiplatelet therapy for 1 month. More recently, Low et al.5 reported a binary restenosis rate of 28% and lumen loss of 0.82 mm in a study including 95 patients with angiographic follow-up at 6 and 12 months. These values are higher than those obtained in our study and, again, can be related to a higher indication for coronary interventions in patients under angiographic follow-up..

In a comparison with other devices used in STEAMI cases, a study by Chong et al.6 showed that the Genous® stent was a comparable alternative to conventional stents and DESs; no significant differences were found in terms of TVR, non-fatal myocardial infarction, or long-term major cardiac events..

The Genous® stent seems to be a safe, effective option in STEAMI patients because of low associated rates of thrombosis and TLR. However, additional comparative studies with currently available devices are needed..

.

Corresponding author: melisasantas@hotmail.com

Bibliography
[1]
Mioglionico M, Patti G, D’Ambrosio A, Di Sciascio G..
Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: A prospective single-centre registry in high-risk patients..
Catheter Cardiovasc Interv. , 71 (2008), pp. 600-604
[2]
Saia F, Lemos PA, Lee CH, Arampatzis CA, Hoye A, Degertekin A, et al..
Sirolimus-eluting stent implantation in ST-elevation acute myocardial infarction: a clinical an angiographic study..
Circulation. , 108 (2003), pp. 1927-1929
[3]
Planas-del Viejo AM, Pomar-Domingo F, Vilar-Herrero JV, Jacas-Osborn V, Nadal-Barangé M, Pérez-Fernández E..
Resultados clínicos y angiográficos tardíos de stents liberadores de fármacos en pacientes con infarto agudo de miocardio con elevación del ST..
Rev Esp Cardiol. , 61 (2008), pp. 360-368
[4]
Lee YP, Tay E, Lee CH, Low A, Teo SG, Poh KK, et al..
Endotelial progenitor cell capture stent implantation in patients with ST-segment elevation acute myocardial infarction: one year follow-up..
Eurointervention. , 5 (2010), pp. 698-702
[5]
Low A, Lee CH, Teo SG, Chan M, Tay E, Lee YP, et al..
Effectiveness and safety of the Genous endothelial progenitor cell-capture stent in acute ST-elevation myocardial infarction..
Am J Cardiol. , 108 (2011), pp. 202-205
[6]
Chong E, Poh KK, Liang S, Lee RCH, Low A, Teo S-G, et al..
Two-year clinical registry follow-up endothelial progenitor cell capture stent versus sirolimus-eluting bioabsorbable polymer-coated stent versus bare metal stent in patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction..
J Interv Cardiol. , 23 (2010), pp. 101-108
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Revista Española de Cardiología (English Edition)

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