En el Centro de Estudios en Cardiología Intervencionista (CECI) somos un grupo independiente de investigadores clínicos entrenados para brindar soluciones integrales para la realización de Investigación Clínica de fase IIIb y IV.

Como Contract Research Organization (CRO), en el CECI contamos con una gran experiencia en el campo de la cardiología. Desde hace 25 años venimos capacitándonos y perfeccionándonos para brindar un servicio completo, desde el diseño del protocolo, organización y coordinanción logísitica, management, evaluación de centros, análisis estadísitico, redacción de manuscritos y presentación en congresos y revistas arbitriradas. Como un grupo boutique sabemos que nuestra fuerza es mantener la independencia y la veracidad de los datos para lograr un análisis correcto de la información médica que se desprende de ellos. Para ello trabajamos con pasión y profesionalismo.

# El Fenomeno de early Recoil y el proceso de Reestenosis post balon.

En los años 1993, 1995 se describió por primera vez a un subgrupo de pacientes que se podía detectar precozmente post angioplastia con balon,POBA, cuales tienen alta posibilidad de hacer reestenosis coronaria temprana debido al fenómeno de retracción elástica de la pared del vaso que se denominó early recoil.

Estos trabajos observacionales algunos, y randomizados otros se publicaron en el Am J Cardiol 1993 y 1995; Circulation en 1995 y en el JACC 1998.

Fueron referencia obligada durante la década de los 90 y utilizado para justificar el uso del stent metálico para prevenir este recoil elástico.

De hecho uno de estos trabajos publicado en Circulation y realizado por el grupo CECI y el Dr Alfredo Rodriguez en Argentina, Coronary stenting decreases restenosis in lesions with early loss in luminal diameter 24 hours after successful PTCA. Circulation 1995;91:1397–402,fue una de las referencias usadas por la compañía que fabricaba el stent de Gianturco Roubin II, Cook Inc, para lograr que la FDA de USA aprobará que el stent de Gianturco-Roubin sea el primer stent balón- expandible aprobado en USA para su uso clínico un año antes que el stent de Palmaz-Schatz.

Acá están las referencias incluyendo las de Gary Roubin quien fue el inventor del stent Gianturco-Roubin.

# Rodrıguez A, Santaera O, Larribau M, Sosa MI, Palacios IF. Early decrease in minimal luminal diameter after successful percutaneous transluminal coronary angioplasty predicts late restenosis. Am J Cardiol 1993;71:1391–5

# Rodrıguez A, Palacios I, Ferna´ndez M, Larribau M, Giraudo M, Ambrose J. Time course and mechanism of early luminal diameter loss after percutaneous transluminal coronary angioplasty. Am J Cardiol 1995;76:1131–4. 9.

# Rodrıguez A, Santaera O, Larribau M, et al. Coronary stenting decreases restenosis in lesions with early loss in luminal diameter 24 hours after successful PTCA. Circulation 1995;91:1397–402.

# Rodriguez  A , Ayala F, Bernardi V et al  Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results J Am Coll Cardiol. 1998 Nov;32(5):1351-7  —

#  Roubin GS, Cannon AD, Agrawal SK, et al. Intracoronary stenting for acute and threatened closure complicating percutaneous transluminal coronary angioplasty.Circulation. 1992;85:916–927

#  The First Balloon-Expandable Coronary Stent: An expedition that Changed Cardiovascular Medicine. Roubin, Gary: University of Queensland Press 2014. (Amazon.com).

# Roubin Gary S  The coronary stent: the rocket engine that launched contemporary cardiac and vascular intervention.

# Revista Argentina de Cardioangiología Intervencionista 2023;14(4):156-159. https://doi.org/10.30567/RACI/202304/0156-0159

Algunos de los estudios que diseñamos, organizamos, analizamos y realizamos el manuscrito final, actuando como CRO de punta a punta.

ERACI I

Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary artery bypass surgery in multivessel disease (ERACI): in-hospital results and 1-year follow-up.ERACI Group.J Am Coll Cardiol. 1993 Oct;22(4):1060-7.

Three-year follow-up of the Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease (ERACI).J Am Coll Cardiol. 1996 Apr;27(5):1178-84

ERACI II

Coronary stenting versus coronary bypass surgery in patients with multiple vessel disease and significant proximal LAD stenosis: results from the ERACI II study. Heart. 2003 Feb;89(2):184-8.

Five-year follow-up of the Argentine randomized trial of coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II). J Am Coll Cardiol. 2005 Aug 16;46(4):582-8.

ERACI III

Coronary stent thrombosis in the current drug-eluting stent era: insights from the ERACI III trial. J Am Coll Cardiol. 2006 Jan 3;47(1):205-7.

Revascularization strategies of coronary multiple vessel disease in the Drug Eluting Stent Era: one year follow-up results of the ERACI III Trial. EuroIntervention. 2006 May;2(1):53-60.

Late loss of early benefit from drug-eluting stents when compared with bare-metal stents and coronary artery bypass surgery: 3 years follow-up of the ERACI III registry. Eur Heart J. 2007 Sep;28(17):2118-25

Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: a meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials. Circulation. 2008 Sep 9;118(11):1146-54

Percutaneous coronary intervention with drug-eluting stents versus coronary artery bypass surgery for multivessel coronary artery disease: a meta-analysis of data from the ARTS II, CARDia, ERACIIII, and SYNTAX studies and systematic review of observational data. EuroIntervention. 2010 Jun;6(2):269-76

ERACI IV

Second versus first generation DES in multiple vessel disease and unprotected left main stenosis: insights from ERACI IV Study. Minerva Cardioangiol. 2015 Aug;63(4):317-27

Modifying angiographic syntax score according to PCI strategy: lessons learnt from ERACI IV Study Cardiovasc Revasc Med. 2015 Oct-Nov;16(7):418-20.

Second vs. First Generation Drug Eluting Stents in Multiple Vessel Disease and Left Main Stenosis: Two-Year Follow-Up of the Observational, Prospective, Controlled and Multicenter ERACI IV Registry.» Accepted article ahead of-print.

ORAR I

Pilot study of oral rapamycin to prevent restenosis in patients undergoing coronary stent therapy: Argentina Single-Center Study (ORAR Trial). J Invasive Cardiol. 2003 Oct;15(10):581-4.

Role of oral rapamycin to prevent restenosis in patients with de novo lesions undergoing coronary stenting: results of the Argentina single centre study (ORAR trial). Heart. 2005 Nov;91(11):1433-7

ORAR II

Oral rapamycin after coronary bare-metal stent implantation to prevent restenosis: the Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study. J Am Coll Cardiol. 2006 Apr 18;47(8):1522-9

ORAR III

Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study. EuroIntervention. 2009 Jun;5(2):255-64.

Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial. Catheter Cardiovasc Interv. 2012 Sep 1;80(3):385-94

Comparison of cost-effectiveness of oral rapamycin plus bare-metal stents versus first generation of drug-eluting stents (from the Randomized Oral Rapamycin in Argentina [ORAR] 3 trial). Am J Cardiol. 2014 Mar 1;113(5):815-21.

GRAMI TRIAL

In-hospital and late results of coronary stents versus conventional balloon angioplasty in acute myocardial infarction (GRAMI trial). Gianturco-Roubin in Acute Myocardial Infarction.Am J Cardiol. 1998 Jun 1;81(11):1286-91.

OCBAS TRIAL

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results. J Am Coll Cardiol. 1998 Nov;32(5):1351-7.

The role of acute wall recoil and late restenosis: results of the OCBAS trial (Optimal Coronary Balloon Angioplasty with Provisional Stenting versus Primary Stent). Int J Cardiovasc Intervent. 2001 Jun;4(2):99-106

LASMAL I

Latin American randomized trial of balloon angioplasty vs coronary stenting for small vessels (LASMAL): immediate and long-term results. Am J Med. 2005 Jul;118(7):743-51.

LASMAL II

Latin American randomized trial of balloon angioplasty versus coronary stenting in diabetic patients with small vessel reference size (Latin American Small Vessel [LASMAL II] Trial): immediate and long-term results. Am Heart J. 2005 Jul;150(1):188.

EUCATAX

Efficacy and safety of a double-coated paclitaxel-eluting coronary stent: the EUCATAX trial. Catheter Cardiovasc Interv. 2011 Feb 15;77(3):335-42

CAMOUFLAGE

New coating stent design for patients with high-risk coronary lesions for thrombotic events: early and long-term results of the Camouflage registry. J Invasive Cardiol. 2009 Aug;21(8):378-82.

DEAR

One-year outcome of patients with diabetes mellitus after percutaneous coronary intervention with three different revascularization strategies: results from the Diabetic Argentina Registry (DEAR). Cardiovasc Revasc Med. 2012 Sep-Oct;13(5):265-71.

La extensa experiencia en la conducción de estudios clínicos tanto a nivel nacional como internacional permite a los clientes tener acceso a importantes expertos alrededor del mundo y al CECI brindar las mejores opciones costo efectivas para lograr los objetivos propuestos.