RESUMEN

INTRODUCTION: Percutaneous coronary intervention (PCI) of bifurcation lesions is technically challenging and associated with higher rates of complications such as stent thrombosis or in-stent restenosis. In this paper, we present the clinical outcomes of BiOSS LIM C (Balton, Poland), a dedicated bifurcation stent. METHODS: In this retrospective single-center study we analyzed the outcome of patients with bifurcation coronary artery disease treated with the BiOSS LIM C stent system. The primary endpoint was the cumulative rate of major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR) at the longest available follow-up. RESULTS: The study population consisted of 25 patients (mean age 73.6 ± 9.7 years, 25 % females). In 80 % of the cases (n = 20) BiOSS LIM C stent was implanted in the left main coronary artery. Intravascular imaging was used in 70 % of the cases and an additional regular drug-eluting stent (DES) was deployed in the side branch in 24 % of the cases. The device success rate was 100 % and we observed no in-hospital adverse events. At a median follow-up of 15 ± 6 months, the MACE rate was 56 %, cardiac death was 4 %, and clinically driven TLR was 55 %. One patient died in the LM subgroup, 5 months after the index PCI, due to NSTEMI complicated by cardiogenic shock. Two patients died due to non-cardiac causes. CONCLUSIONS: In this consecutive series of patients treated with BiOSS LIM C in major coronary bifurcation lesions, mostly in the left main stem, the mid-term clinical outcomes demonstrated a high incidence of major adverse events, mainly caused by TLR, despite an adequate implantation technique.

Asunto(s)

Enfermedad de la Arteria Coronaria , Estenosis Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Femenino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Estenosis Coronaria/terapia , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Estudios Retrospectivos , Resultado del Tratamiento , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Stents , Muerte , Angiografía Coronaria/métodos

RESUMEN

Introduction: Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-in-man registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods: In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results: The study population consisted of 95 patients (mean age: 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in 4 (4.2%) cases. At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions: Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.

RESUMEN

BACKGROUND: The optimal approach to coronary bifurcation treatment by percutaneous coronary intervention (PCI) is still a subject of debate, and dedicated bifurcation stents are one of the proposed solutions. AIM: The aim of this report was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM C® (Balton, Poland) at the first three months of a 12-month registry. METHODS: This is a two-centre registry, which enrolled patients with non-ST elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting is the obligatory strategy of the treatment. Angiographic control is planned at 12 months. The primary endpoint is the cumulative rate of cardiac death, myocardial infarction (MI), and target lesion revas-cularisation (TLR) at 12 months. RESULTS: A total of 48 patients with lesions in coronary bifurcations were enrolled (mean age 67.9 ± 8.9 years, 14.6% female). There were 20.8% of patients with NSTE-ACS, 93.8% with hypertension, 35.4% with diabetes, 52.1% had previous MI, and 47.9% and 14.6% underwent prior PCI and coronary artery bypass grafting, respectively. The device success rate was 100%. The side branch was treated with an additional classical drug-eluting stent implantation in 18.8% of cases. The periprocedural MI (MI type 4a) was observed in two (4.2%) cases. At three months there was one (2.1%) case of TLR. No death, MI, or stent thrombosis were observed in the follow-up period. CONCLUSIONS: Bifurcation treatment with a single dedicated bifurcation stent (BiOSS LIM C®) is feasible and highly successful (100% implantation success rate). The short-term clinical outcomes are very promising, also in distal left main stenosis. The 12-month observations are pending.

Asunto(s)

Estenosis Coronaria/cirugía , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/tratamiento farmacológico , Síndrome Coronario Agudo/cirugía , Anciano , Angina Estable/tratamiento farmacológico , Angina Estable/cirugía , Cromo , Cobalto , Estenosis Coronaria/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polonia , Sistema de Registros , Sirolimus/uso terapéutico , Resultado del Tratamiento

RESUMEN

BACKGROUND: In the distal left main (LM) atherosclerosis mainly develops within bifurcation or trifur-cation. The aim of this study was to analyze the strategy of distal LM stenosis treatment and associated clinical outcomes in a large hospital in Northern Poland. METHODS: The study population consisted of consecutive patients with stable coronary artery disease or acute coronary syndrome (ACS) and distal LM stenosis who were hospitalized between June 2012 and June 2013. Patients were treated with regular drug-eluting stents (rDES), including bioresorbable vascular scaffolds, or dedicated bifurcation stents (BiOSS LIM®). Clinical outcomes were analyzed at 12, 24 and 36 months. Primary endpoint was cumulative major adverse cardiovascular events (MACE) inducing rate of cardiac death, myocardial infarction, and target lesion revascularization (TLR) after 36 months. RESULTS: One hundred and two patients were identified, 90 of whom were treated with percutaneous coronary intervention (56 rDES, including 9 Absorb, and 34 BiOSS) with no stent implantation fail-ure. In 15 (16.7%) patients rDES was required within side branch (SB). After 36 months MACE rate was 19.0% (BiOSS: 18.8% vs. rDES 19.2%), whereas TLR rate was 10.7% (BiOSS 12.5% vs. rDES 9.6%). In logistic regression for 36-month TLR rate proximal optimization technique (OR 0.311, 95% CI 0.211-0.644) was a prognostic factor of better clinical outcome, whereas non-ST-elevation ACS (OR 2.211, 95% CI 1.642-5.110), ST-elevation myocardial infarction (OR 2.771, 95% CI 1.325-7.209) and SB stenting (OR 1.141, 95% CI 1.002-1.881) were risk factors of poor outcome. CONCLUSIONS: Regular drug-eluting stents as well as dedicated bifurcation BiOSS LIM® stents enabled a simple and fast distal LM treatment option with a single stent. Both resulted in comparable MACE and TLR rates.

Asunto(s)

Estenosis Coronaria/cirugía , Stents Liberadores de Fármacos , Paclitaxel/farmacología , Intervención Coronaria Percutánea/métodos , Complicaciones Posoperatorias/epidemiología , Sirolimus/farmacología , Andamios del Tejido , Anciano , Antineoplásicos Fitogénicos/farmacología , Angiografía Coronaria/métodos , Estenosis Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/farmacología , Incidencia , Masculino , Polonia/epidemiología , Diseño de Prótesis , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Resultado del Tratamiento

RESUMEN

INTRODUCTION: Percutaneous coronary interventions (PCIs) involving coronary bifurcation lesions are associated with adverse outcomes compared with non-bifurcation lesions. The Tryton Side Branch Stent has been developed to improve clinical outcomes after bifurcation PCI. Areas covered: We will discuss observational data (clinical registries and intravascular imaging studies) and randomized data from the TRYTON trial (comparing Tryton [used in combination with a main branch drug-eluting stent (DES)] with side branch balloon angioplasty [in combination with a main branch DES; also referred to the provisional strategy]). Expert commentary: The published data showed that the use of Tryton was feasible (successful stent placement in ~95%) and safe (stent thrombosis rates ~0.5% at 9-12 months; no cardiac deaths in the TRYTON trial). Its use resulted in excellent acute angiographic results. However, the TRYTON trial also showed that due to neo-intimal tissue growth, luminal dimension at 9 months were similar between Tryton and the provisional strategy. Furthermore, the trial showed an increased risk of peri-procedural myocardial infarction when Tryton was used in small side branches. Based on all data available, the provisional strategy should still be considered as the default strategy in the majority of bifurcation cases, although the use of Tryton may be considered in complex bifurcation anatomies with extensive disease in large side branches, especially when the device will be further improved by a drug-coating.

Asunto(s)

Angioplastia Coronaria con Balón/métodos , Stents Liberadores de Fármacos , Diseño de Prótesis , Angioplastia Coronaria con Balón/efectos adversos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/patología , Stents Liberadores de Fármacos/efectos adversos , Humanos , Complicaciones Intraoperatorias/etiología , Infarto del Miocardio/etiología , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo , Resultado del Tratamiento

RESUMEN

BACKGROUND: Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions. The aim of this study was to analyze the strategy of coronary bifurcation treatment and associated angiographic as well as clinical outcomes in a large hospital in Northern Poland. METHODS: Between January 2012 and January 2014 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome (NSTE-ACS) were treated with regular drug-eluting stents (rDES) or dedicated bifurcation stents (BiOSS Expert® or BiOSS LIM®). Clinical and angiographic controls were planned at 12 months. The primary endpoint was major adverse cardiovascular events (MACE) rate composed of cardiac death, myocardial infarction, and target lesion revascularization (TLR) at 12 months. RESULTS: In total, 152 patients were enrolled in whom 158 stents were deployed (99 BiOSS stents and 59 rDES). Left anterior descending artery (50%) was the dominant target vessel followed by left circum¬flex (25%). There was no stent implantation failure. In 10 (6.3%) patients rDES was required within the side branch. At 12 months MACE rate was 11.2%, whereas TLR rate was 7.9%. In the logistic regression analysis final kissing balloon technique was the prognostic factor for better clinical outcome, whereas NSTE-ACS and true bifurcations were risk factors of a poor outcome. CONCLUSIONS: Percutaneous coronary bifurcation treatment is a safe and effective procedure, and pro¬visional T-stenting is the preferred technique. Both rDES as well as dedicated bifurcation stents enabled a simple and fast bifurcation treatment option with comparable MACE and TLR rates. (Cardiol J 2017; 24, 6: 589-596).

Asunto(s)

Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/cirugía , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/métodos , Causas de Muerte/tendencias , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/epidemiología , Vasos Coronarios/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Polonia/epidemiología , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Tasa de Supervivencia/tendencias , Factores de Tiempo

RESUMEN

INTRODUCTION: Coronary bifurcation lesions pose therapeutic challenges during percutaneous coronary interventions. Dedicated bifurcation stents are one of the treatment options available. Areas covered: This paper will analyze the results of the BiOSS (Bifurcation Optimization Stent System) Clinical Program with a special focus on the cobalt-chromium BiOSS LIM C stent which has recently been introduced into the market (CE 2016). The stent is characterized by a strut thickness of 70 µm and sirolimus concentration of 1.4 µg/mm2. Expert commentary: The first BiOSS stent was a bare metal one, but shortly after a paclitaxel-eluting version was introduced - BiOSS Expert stent (CE 2010). After acceptable results of BiOSS Expert stent were obtained in registries as well as in the randomized clinical trial POLBOS I, a way for improvement was to change paclitaxel into the - olimus drug. Sirolimus has been chosen and the BiOSS LIM stent was developed (CE 2012). BiOSS LIM is the dedicated bifurcation stent with stainless steel platform that releases sirolimus (1.4 µg/mm2) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids. Nevertheless, the idea to reduce late lumen loss and as a result TLR rate by using thinner struts appeared. Therefore, presently first-in-man registry with BiOSS LIM C is ongoing.

Asunto(s)

Cromo , Cobalto , Enfermedad Coronaria/terapia , Stents Liberadores de Fármacos , Enfermedad Coronaria/patología , Diseño de Equipo , Humanos , Sirolimus/administración & dosificación , Resultado del Tratamiento

RESUMEN

AIMS: The optimal treatment strategy for coronary bifurcation lesions is still unknown. The aim of the study was to assess applicability of the new cobalt-chromium version of the sirolimus-eluting dedicated bifurcation BiOSS® LIM C stent in comparison with regular sirolimus-eluting Orsiro®  stent in a porcine coronary model. METHODS: A total of 13 BiOSS® LIM C stents and 6 Orsiro® stents were implanted in normal nonatherosclerotic porcine straight coronary arteries of six animals using 1.2:1.0 stent-to-artery ratio. Stent geometry and morphology were evaluated by Faxitron imaging. Vascular response was assessed by quantitative coronary angiography (QCA), optical coherence tomography (OCT), and histological analyses. RESULTS: OCT performed at 28 days confirmed that all stents were patent with no signs of thrombus. In morphometric analysis, no differences between groups regarding stent diameter (P=.141), neointima area (P=.247), % area stenosis (P=.293), or % diameter stenosis (P=.069) were observed. Also, no significant differences were noted between groups regarding their histopathology scores. The injury and inflammation scores were low (mean grade<1) in all groups. CONCLUSIONS: The novel BiOSS® LIM C stent demonstrates good short-term vascular effects in a porcine coronary bifurcation model which are comparable with Orsiro® stents.

Asunto(s)

Vasos Coronarios/fisiología , Stents Liberadores de Fármacos , Angiografía , Animales , Aleaciones de Cromo , Angiografía Coronaria , Vasos Coronarios/efectos de los fármacos , Corazón/diagnóstico por imagen , Inmunosupresores/administración & dosificación , Inmunosupresores/uso terapéutico , Ensayo de Materiales , Miocardio/citología , Sirolimus/administración & dosificación , Sirolimus/uso terapéutico , Porcinos , Tomografía de Coherencia Óptica

RESUMEN

OBJECTIVES: To assess the anatomical and functional impact of final kissing balloon inflation (FKBI) after implantation of a dedicated bifurcation stent system. BACKGROUND: Current evidence suggests clinical benefit of FKBI in patients undergoing bifurcation dilatation using the Tryton side branch stent (Tryton-SBS). We hypothesized that FKBI improves anatomical reconstruction and functional results of bifurcation treated by Tryton-SBS. METHODS: An unselected group of patients with complex bifurcation coronary lesions undergoing percutaneous coronary intervention (PCI) with Tryton-SBS underwent paired anatomical assessment with two- and three-dimensional quantitative coronary analysis (2D- and 3D-QCA), and optical coherence tomography (OCT), including 3D reconstruction before and after FKBI. Functional assessment by fractional flow reserve (FFR) was performed in the main branch (MB) and side branch (SB) before and after FKBI. RESULTS: Paired pre- and post-FKBI data were obtained in 10 patients. By OCT imaging, FKBI increased both the SB ostial area (4.93 ± 2.81 vs. 7.43 ± 2.87 mm2 , P < 0.001) and the SB maximum diameter (3.12 ± 0.98 vs. 3.82 ± 1.10 mm, P = 0.003). These findings were associated with a significant increase in FFR in the SB (0.90 ± 0.05 vs. 0.94 ± 0.03; P = 0.011), with no significant change in the MB (0.91 ± 0.05 vs. 0.92 ± 0.04; P = 0.470). CONCLUSIONS: In patients with complex bifurcation stenosis undergoing PCI with a dedicated bifurcation system, FKBI is associated with improved anatomical and functional results at the SB level, without compromising the result at the MB. © 2016 Wiley Periodicals, Inc.

Asunto(s)

Angioplastia Coronaria con Balón/instrumentación , Cateterismo Cardíaco , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Reserva del Flujo Fraccional Miocárdico , Imagenología Tridimensional , Interpretación de Imagen Radiográfica Asistida por Computador , Stents , Tomografía de Coherencia Óptica , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/efectos adversos , Enfermedad de la Arteria Coronaria/fisiopatología , Estenosis Coronaria/fisiopatología , Vasos Coronarios/fisiopatología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , Resultado del Tratamiento

RESUMEN

BACKGROUND: In a number of coronary bifurcation lesions, both the main vessel and the side branch (SB) need stent coverage. OBJECTIVES: To analyze the procedural performance and the impact on radiation times (RT) and contrast medium consumption (CMC) of the Axxess™ stent system (Biosensors, Switzerland) treating de novo bifurcation lesions (DBL). METHODS: One hundred and ten consecutive prospectively enrolled cases (Axxess Group) and 110 age, sex, and lesion location matched controls undergoing mandatory (Group A, n = 56) or provisional (Group B, n = 54) SB intervention were analyzed. RESULTS: Although more pre-dilatation was performed in the Axxess Group (92.7% vs. 46.4% [Group A] vs. 24.1% [Group B]), and more stents were used (2.4 vs. 1.2 vs. 1.05), RT and CMC were significantly lower in the Axxess Group [7.9 min/129 ml vs. 14.2 min/209 ml vs. 7.8 min/152 ml; P < 0.001]. Final Thrombolysis In Myocardial Infarction three flow in both branches was significantly more frequent in the Axxess Group (98.2% vs. 94.6% vs. 88.9%; P = 0.02), and post-interventional troponin T elevations were the lowest in the Axxess Group. Eighty one percent of the Axxess-stents could be implanted without technical difficulties. Difficult implantations procedures were mainly related to coronary anatomy. There was no safety concerns (cardiac death, stent-thrombosis) compared to controls. Cumulative 6-months MACE rates were 11% versus 23% versus 25%. TLR rates at 6-months were 5%, 18%, and 15%, respectively. CONCLUSIONS: Axxess bifurcation stent system procedures were associated with significantly less RT and CMC compared to conventional DBL therapy strategies. Difficult coronary anatomy may hinder successful implantation and a learning curve has to be considered. © 2016 Wiley Periodicals, Inc.

Asunto(s)

Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Sirolimus/análogos & derivados , Anciano , Anciano de 80 o más Años , Fármacos Cardiovasculares/efectos adversos , Estudios de Casos y Controles , Medios de Contraste/administración & dosificación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Trombosis Coronaria/etiología , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Dosis de Radiación , Exposición a la Radiación , Radiografía Intervencional , Sistema de Registros , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/etiología , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Factores de Tiempo , Resultado del Tratamiento

RESUMEN

OBJECTIVES: The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). BACKGROUND: The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled. METHODS: The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT. RESULTS: Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint. CONCLUSIONS: The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.

Asunto(s)

Angioplastia Coronaria con Balón/instrumentación , Enfermedad de la Arteria Coronaria/terapia , Estenosis Coronaria/terapia , Vasos Coronarios , Stents , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Biomarcadores/sangre , Aleaciones de Cromo , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Estenosis Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Forma MB de la Creatina-Quinasa/sangre , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/sangre , Infarto del Miocardio/etiología , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos

RESUMEN

The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.

Asunto(s)

Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/efectos de los fármacos , Stents Liberadores de Fármacos , Infarto del Miocardio sin Elevación del ST/terapia , Paclitaxel/administración & dosificación , Sirolimus/administración & dosificación , Ultrasonografía Intervencional , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Fármacos Cardiovasculares/efectos adversos , Proliferación Celular , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neointima , Infarto del Miocardio sin Elevación del ST/diagnóstico por imagen , Paclitaxel/efectos adversos , Valor Predictivo de las Pruebas , Diseño de Prótesis , Sistema de Registros , Sirolimus/efectos adversos , Factores de Tiempo , Resultado del Tratamiento

RESUMEN

There is growing evidence that optimally performed two-stent techniques may provide similar or better results compared with the simple techniques for bifurcation lesions, with an observed trend towards improvements in clinical and/or angiographic outcomes with a two-stent strategy. Yet, provisional stenting remains the treatment of choice. Here, the author discusses the evidence - and controversies - concerning when and how to use complex techniques.

Asunto(s)

Enfermedad de la Arteria Coronaria/cirugía , Stents , Anciano , Femenino , Humanos , Masculino , Diseño de Prótesis , Procedimientos Quirúrgicos Vasculares/métodos

RESUMEN

The Bifurcation Optimisation Stent System (BiOSS®) (Balton®, Poland) is a coronary, dedicated bifurcation, balloon-expandable stent made of 316 litre stainless steel tube with strut thickness of 120 micrometre (µm). It is covered with a mixture of a biodegradable polymer and an antiproliferative substance - paclitaxel (BiOSS Expert version) or sirolimus (BiOSS Lim version). The stent consists of two parts (the proximal with a larger diameter in relation to the distal one) connected with two connection struts (average 1.2 mm in length) at the step-up middle zone. The stent is crimped on a bottle-shaped semi-complaint balloon (Bottle®, Balton, Poland). Our intravascular ultrasound (IVUS) study revealed that the construction of the BiOSS stent assures an easy access to the side branch and is comparable to the classic stent lumen enlargement with less injury to the area adjacent to the most sensitive part of the bifurcation. A total number of 65 lesions in 63 consecutive patients were enrolled in the First-In-Man (FIM) registry for BiOSS Expert, where we achieved a 100 % device success rate. The long-term clinical results were satisfactory and closely related to the high-risk profile of the treated population. Our data demonstrated that simple and fast bifurcation treatment with a single dedicated bifurcation paclitaxel-eluting stent (BiOSS Expert) is feasible and highly successful. Based on the data collected in animal experiments and preliminary data in humans with BiOSS Lim, releasing sirolimus from the surface of the biodegradable coating, one may presume that this version will provide even better clinical results compared with the paclitaxel one.