Design of the ß3-Adrenergic Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure Trial.

Combined pre-and post-capillary hypertension (CpcPH) is a relatively common complication of heart failure (HF) associated with a poor prognosis. Currently, there is no specific therapy approved for this entity. Recently, treatment with beta-3 adrenergic receptor (ß3AR) agonists was able to improve pulmonary hemodynamics and right ventricular (RV) performance in a translational, large animal model of chronic PH. The authors present the design of a phase II randomized clinical trial that tests the benefits of mirabegron (a clinically available ß3AR agonist) in patients with CpcPH due to HF. The effect of ß3AR treatment will be evaluated on pulmonary hemodynamics, as well as clinical, biochemical, and advanced cardiac imaging parameters. (Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure [SPHERE-HF]; NCT02775539).

Does manual thrombus aspiration help optimize stent implantation in ST-segment elevation myocardial infarction?

AIM: To evaluate the impact of thrombus aspiration (TA) on procedural outcomes in a real-world ST-segment elevation myocardial infarction (STEMI) registry. METHODS: From May 2006 to August 2008, 542 consecutive STEMI patients referred for primary or rescue percutaneous coronary intervention were enrolled and the angiographic results and stent implantation characteristics were compared according to the performance of manual TA. RESULTS: A total of 456 patients were analyzable and categorized in TA group (156 patients; 34.2%) and non-TA (NTA) group (300 patients; 65.8%). Patients treated with TA had less prevalence of multivessel disease (39.7% vs 54.7%, P = 0.003) and higher prevalence of initial thrombolysis in myocardial infarction flow < 3 (P < 0.001) than NTA group. There was a higher rate of direct stenting (58.7% vs 45.5%, P = 0.009), with shorter (24.1 ± 11.8 mm vs 26.9 ± 15.7 mm, P = 0.038) and larger stents (3.17 ± 0.43 mm vs 2.93 ± 0.44 mm, P < 0.001) in the TA group as compared to NTA group. The number of implanted stents (1.3 ± 0.67 vs 1.5 ± 0.84, P = 0.009) was also lower in TA group. CONCLUSION: In an "all-comers" STEMI population, the use of TA resulted in more efficient procedure leading to the implantation of less number of stents per lesion of shorter lengths and larger sizes.

Edge vascular response after polymer-free vs. polymer-based paclitaxel-eluting stent implantation.

BACKGROUND: It is unknown if lack of polymer can provoke a different edge response in drug-eluting stents. The aim of this study was to compare edge vascular response between polymer-free paclitaxel-eluting stent (PF-PES) and polymer-based paclitaxel-eluting stents (PB-PES). METHODS AND RESULTS: A total of 165 eligible patients undergoing percutaneous coronary intervention were prospectively randomized 1:1 to receive either PF-PES or PB-PES. Those patients with paired intravascular ultrasound (IVUS) after procedure and at 9-month follow-up were included in this analysis.Seventy-six patients with 84 lesions, divided into PB-PES (38 patients, 41 lesions) and PF-PES groups (38 patients, 43 lesions) had paired post-procedure and 9-month follow-up IVUS and were therefore included in this substudy. There was a significant lumen decrease at the proximal edge of PF-PES (from 9.02±3.06 mm(2)to 8.47±3.05 mm(2); P=0.040), and a significant plaque increase at the distal edges of PF-PES (from 4.39±2.73 mm(2)to 4.78±2.63 mm(2); P=0.004). At the distal edge there was a significant plaque increase in the PF-PES compared to PB-PES (+8.0% vs. -0.6%, respectively; P=0.015) with subsequent lumen reduction (-5.2% vs. +6.0%, respectively; P=0.024). CONCLUSIONS: PF-PES had significant plaque increase and lumen reduction at the distal edge as compared to PB-PES, probably due to difference in polymer-based drug-release kinetics between the 2 platforms.

Randomized comparison between polymer-free versus polymer-based paclitaxel-eluting stent: two-year final clinical results.

BACKGROUND: Most drug-eluting stents currently in use are coated with a polymer carrying the drug that is released for several weeks. However, a durable polymer may provoke hypersensitive reaction, delayed artery healing, and eventually stent thrombosis. The aim of this study was to investigate the safety and efficacy of a polymer-free paclitaxel-eluting stent (PF-PES) versus a polymer-based PES (PB-PES). METHODS AND RESULTS: Eligible patients undergoing percutaneous coronary intervention were randomized 1:1 to receive either PF-PES or PB-PES. The primary end point was late loss at 9 months. Intravascular ultrasound analysis at 9 months and final 2-year clinical follow-up were also performed. From October 2007 to April 2009, 164 patients were enrolled and randomized into 2 groups (PF-PES: n = 84; PB-PES: n = 80). Mean in-stent lumen loss was 0.90 ± 0.59 mm for PF-PES and 0.49 ± 0.52 mm for PB-PES (P < 0.001). Mean neointimal area by intravascular ultrasound was higher in PF-PES than in PB-PES (1.42 ± 1.09 versus 0.51 ± 0.61 mm(2); P < 0.001). At 2 years, a composite end point of all-cause death, any myocardial infarction, and target vessel revascularization occurred in 36.9% for PF-PES and 16.3% for PB-PES (P = 0.004), mainly driven by a higher rate of target vessel revascularization (PF-PES: 35.7%; PB-PES: 13.8%; P = 0.001). One late stent thrombosis was observed in PF-PES. CONCLUSIONS: Compared with PB-PES, PF-PES was associated with increased neointimal proliferation and subsequent clinical restenosis. Polymer plays an essential role in the performance of drug-eluting stents. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01375855.

Utilidad del catéter Tornus ® en las oclusiones coronarias crónicas no dilatables / Usefulness of the Tornus ® catheter in nondilatable coronary chronic total occlusion

El tratamiento percutáneo de las oclusiones coronarias crónicas (OCC) representa un desafío. La segunda causa del fracaso de la técnica es la imposibilidad de dilatarlas con un balón. Describimos nuestra experiencia con el nuevo catéter Tornus® (Asahi Intecc; Aichi, Japón), diseñado específicamente para facilitar el tratamiento de OCC «no dilatables». Desde noviembre de 2008 hasta marzo de 2010, hemos tratado a 17 pacientes (media de edad, 62 años; el 88% varones, el 82% dislipémicos, el 52% hipertensos, el 29% diabéticos) en los que no se consiguió dilatar la lesión con ningún catéter balón tras haber cruzado la lesión con una guía de angioplastia. El catéter se utilizó con éxito en 15 casos, sin complicaciones, y se consiguió finalizar la revascularización del vaso. Durante el seguimiento clínico (mediana, 573 días), no se registraron eventos de importancia. El uso del catéter Tornus® es seguro y factible en las OCC de lesiones previamente no dilatables de manera convencional (AU)

The treatment of coronary chronic total occlusions (CTO) remains a challenge for the interventional cardiologist. Failure of balloon angioplasty is the second more common cause of an unsuccessful procedure. We describe our experience with the use of the new Tornus® catheter (Asahi Intecc, Aichi, Japan) designed specifically for the treatment of “nondilatable” CTO. Between November 2008 and March 2010, 17 patients (age 62 years, 88% men, 82% dyslipidemia, 52% hypertension, 29% diabetes) were treated in whom balloon dilatation had failed after crossing the lesion with the guide. The use of Tornus® catheter was successful without complications in 15. All patients underwent clinical follow-up (median, 573 days) with no documented major adverse events. The use of the Tornus® catheter is safe and feasible in those patients with CTO lesions in whom balloon angioplasty has been unsuccessful (AU)

[Usefulness of the Tornus® catheter in nondilatable coronary chronic total occlusion]. / Utilidad del catéter Tornus(®) en las oclusiones coronarias crónicas no dilatables.

The treatment of coronary chronic total occlusions (CTO) remains a challenge for the interventional cardiologist. Failure of balloon angioplasty is the second more common cause of an unsuccessful procedure. We describe our experience with the use of the new Tornus® catheter (Asahi Intecc, Aichi, Japan) designed specifically for the treatment of "nondilatable" CTO. Between November 2008 and March 2010, 17 patients (age 62 years, 88% men, 82% dyslipidemia, 52% hypertension, 29% diabetes) were treated in whom balloon dilatation had failed after crossing the lesion with the guide. The use of Tornus® catheter was successful without complications in 15. All patients underwent clinical follow-up (median, 573 days) with no documented major adverse events. The use of the Tornus® catheter is safe and feasible in those patients with CTO lesions in whom balloon angioplasty has been unsuccessful.