Comparison of clinical outcomes regarding the use of titanium-nitride-oxide-coated stents (Titan) versus zotarolimus-eluting stents (Endeavor) in patients with ST-segment elevation myocardial infarction (STEMI): An experience from a Cardiac Center-Third care level / Comparación de los resultados clínicos con respecto al uso de stents recubiertos de óxido de titanio (Titan) versus stents liberadores de zotarolimus (Endeavor) en pacientes con infarto de miocardio por elevación del segmento ST (STEMI): Una experiencia de un centro cardiaco de Tercer nivel de atención

Abstract: Introduction: Internationally, the Titan bioactive stent efficacy and safety have been evaluated against second-generation drug-eluting stents (DES) in patients with acute coronary syndrome. In our field, however, there is not enough information about its short-term or one-year follow-up outcomes when compared with a second-generation drug-eluting stent in ST-segment elevation myocardial infarction (STEMI). Objective: To evaluate and compare immediate, in-hospital and one-year use clinical outcomes of the Titan stent versus Endeavor stent in patients with ST-segment elevation myocardial infarction. Material and methods: A descriptive, comparative, longitudinal, retrospective, observational study was performed in patients with ST-segment elevation myocardial infarction type acute coronary syndrome who were subjected to primary, pharmacoinvasive and rescue angioplasties, using a Titan stent against Endeavor stent. Primary points: major adverse cardiac events (MACEs), death, myocardial infarction, need for target lesion revascularization (TLR), target vessel revascularization (TVR), cerebrovascular event (CVE) and stent thrombosis. Secondary points: Dual antiplatelet therapy (DAPT) usage time. Results: 256 patients with ST-segment elevation myocardial infarction were examined from January 2011 to December 2014. They were treated with a Titan bioactive stent (135 patients) or Endeavor stent (121 patients). There were no significant differences related to major adverse cardiac events, death, myocardial infarction, stent thrombosis or cerebrovascular event, either in-hospital or one-year follow-up. More patients were observed in the Killip-Kimball 3-4 classification in Endeavor stent group versus patients in Titan stent group (62.2% versus 42.2%, respectively, p = 0.010). A greater pre-PTCA (Percutaneous Transluminal Coronary Angioplasty) TIMI (Thrombolysis in Myocardial Infarction) 0-1 flow rate was also observed (90.9% in Endeavor stent group versus 79.3% in Titan stent group, p = 0.010). However, the Titan stent was considerably more used in elderly patients (62.36 ± 12.95 years old versus 57.59 ± 10.42 years old in Endeavor stent group, p = 0.001); in more complex type C lesions (62.4% in Titan stent group versus 40.5% in Endeavor stent group, p = 0.010); and small vessels (28.9% in Titan stent group versus 18.2% in Endeavor stent group, p = 0.045). Target lesion revascularization and target vessel revascularization rates were similar: 0% versus 2.5%, p = 0.066 and 0% versus 0.8%, p = 0.290, in Titan stent and Endeavor stent groups, respectively. There were no significant differences on the major adverse cardiac events-free survival analysis (Log-rank Mantel-Cox 0.764 test). There were significant differences on dual antiplatelet therapy usage time (6.46 ± 4.11 months in Titan stent group versus 10.98 ± 2.51 months in Endeavor stent group, p ≤ 0.0001). Conclusions: There was no superiority registered in use of a second-generation drug-eluting stent such as the Endeavor stent versus Titan bioactive stent (titanium-nitride-oxide-coated stent) in patients with ST-segment elevation myocardial infarction regarding immediate, in-hospital and one-year follow-up clinical outcomes. The Titan stent seems to be a good choice for this kind of ST-segment elevation acute coronary syndrome in both efficacy and safety against new drug-eluting stents, and it could be used in elderly patients and/or patients with high bleeding risk requiring less time of dual antiplatelet therapy.(AU)

Resumen: Introducción: A nivel internacional, la eficacia y la seguridad de los stents bioactivos Titan se han evaluado en comparación con los stents liberadores de fármacos (su sigla en inglés es DES) de segunda generación en pacientes con síndrome coronario agudo. Sin embargo, en nuestro campo, no hay suficiente información acerca de sus resultados de seguimiento a corto plazo o de un año cuando se compara con una endoprótesis liberadora de fármacos de segunda generación en el infarto de miocardio por elevación del segmento ST (STEMI). Objetivo: Evaluar y comparar los resultados clínicos inmediatos, en el hospital y a un año de uso del stent Titan frente a stent Endeavor en pacientes con infarto de miocardio por elevación del segmento ST. Material y métodos: Se realizó un estudio observacional descriptivo, comparativo, longitudinal, retrospectivo y observacional en pacientes con el síndrome coronario agudo de infarto de miocardio por elevación del segmento ST que fueron sometidos a angioplastias primarias, farmacoinvasivas y de rescate, utilizando un stent Titan contra el stent Endeavor. Puntos primarios: eventos cardiacos adversos mayores (MACE), muerte, infarto de miocardio, necesidad de revascularización de la lesión objetivo (TLR). Revascularización del vaso objetivo (TVR), evento cerebrovascular (CVE) y trombosis del stent. Puntos secundarios: Tiempo de uso de la terapia antiplaquetaria dual (DAPT). Resultados: De enero de 2011 a diciembre de 2014 se examinaron 256 pacientes con infarto de miocardio por elevación del segmento ST. Fueron tratados con un stent bioactivo de Titan (135 pacientes) o un stent de Endeavor (121 pacientes). No hubo diferencias significativas relacionadas con los eventos cardiacos adversos mayores, muerte, infarto de miocardio, trombosis de stent o evento cerebrovascular, ni en el hospital ni en el seguimiento de un año. Se observaron más pacientes en la clasificación Killip-Kimball 3-4 en el grupo de stent Endeavor versus pacientes en el grupo de stent Titan (62.2% versus 42.2%, respectivamente, p = 0.010). También se observó una mayor tasa de flujo 0-1 antes de la PTCA (angioplastia coronaria transluminal percutánea) TIMI (trombólisis en el infarto de miocardio) (90.9% en el grupo de stent Endeavor frente a 79.3% en el grupo de stent Titan, p = 0.010). Sin embargo, la endoprótesis Titan se utilizó considerablemente más en pacientes de edad avanzada (62.36 ± 12.95 años frente a 57.59 ± 10.42 años en el grupo de endoprótesis Endeavor, p = 0.001); en las lesiones tipo C más complejas (62.4% en el grupo de stent Titan versus 40.5% en el grupo de stent Endeavor, p = 0.010); y en pequeños vasos (28.9% en el grupo de stent Titan versus 18.2% en el grupo de stent Endeavor, p = 0.045). La revascularización de las lesiones objetivo y las tasas de revascularización de los vasos objetivo fueron similares: 0% versus 2.5%, p = 0.066 y 0% versus 0.8%, p = 0.290, en los grupos de stent Titan y stent Endeavor, respectivamente. No hubo diferencias significativas en el análisis de supervivencia sin eventos cardiacos adversos mayores (ensayo de Mantel-Cox 0.764 del rango de logos). Hubo diferencias significativas en el tiempo de uso del tratamiento antiplaquetario dual (6.46 ± 4.11 meses en el grupo con stent Titan versus 10.98 ± 2.51 meses en el grupo con stent Endeavor, p ≤ 0.0001). Conclusiones: No se registró una superioridad en el uso de un stent liberador de fármacos de segunda generación como el stent Endeavor versus el stent bioactivo Titan (stent recubierto de titanio-nitrurado) en pacientes con infarto de miocardio por elevación del segmento ST con respecto a los resultados clínicos de seguimiento inmediato, hospitalario y de un año. El stent Titan parece ser una buena opción para este tipo de síndrome coronario agudo por elevación del segmento ST, tanto en eficacia como en seguridad frente a nuevos stents liberadores de fármacos, y podría utilizarse en pacientes ancianos y/o pacientes con alto riesgo de hemorragia que requieran menos tiempo de tratamiento antiplaquetario dual.(AU)

[Experience with the use of the bio-active stent coated with titanium nitric oxide compared with zotarolimus-eluting stent: experience of a unit medical high specialty]. / Experiencia con el uso del stent bioactivo cubierto con titanio-óxido nítrico comparado con stent liberador de zotarolimus: experiencia de una unidad médica de alta especialidad.

UNLABELLED: The use of coronary stents in coronary angioplasty has evolved dramatically in its design, type materials, polymers, and a variety of drugs, the use of coronary stents covered nitric oxide have shown satisfactory results in practice, however compared to the results reported drug-eluting stents, there is little information. OBJECTIVES: The aim of this study was to compare clinical outcomes of a stainless steel stent Bioactive nitric oxide coated titanium (BAS) and a drug-eluting stent zotarolimus (DES) in daily clinical practice. METHODS: A retrospective, analytical, descriptive and comparative study aimed at evaluating the safety and efficacy of two devices with different characteristics in our population. The primary endpoints were: death, acute infarction (AMI), and re intervention injury Treated (RLT). RESULTS: A total of 759 patients were included in the study which was performed angioplasty to a single vessel. Were divided into two arms 382 with DES and 377 patients with BAS, the one year follow up was carried in 95%. After this follow-up period, primary points (cardiovascular death, myocardial infarction, TLR and stent thrombosis) for arm DES vs BAS; 9.5% vs 8.5% P=NS but with shorter periods of dual antiplatelet therapy for arm BAS 6.9±4.1 vs 11.1±2.5 months DES P=.0001. The results were independent of the clinical syndrome of presentation. CONCLUSIONS: After one year of follow no statistically significant difference in major clinical events, there was a trend in favour of BAS vs SM with respect to revascularization of the target lesion without reaching statistical significance.

A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

INTRODUCTION AND OBJECTIVES: Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. METHODS: A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). RESULTS: Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). CONCLUSIONS: The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis.