Nuove tecnologie e applicazioni per il pallone medicato nel 2017

Nuove tecnologie e applicazioni per il pallone medicato nel 2017

A new pubblication about “Nuove tecnologie e applicazioni per il pallone medicato nel 2017” has been published on G Ital Cardiol 2017.

Authors: Bernardo Cortese (1,2), Gaetano Di Palma (1), Roberto Nerla (3), Antonio Micari (3)

(1) Cardiologia Interventistica, ASST Fatebenefratelli – Sacco, Milano
(2) U.O. Cardiologia Diagnostica e Interventistica, Fondazione “Gabriele Monasterio”-Regione Toscana – CNR, Massa
(3) Laboratorio di Cardio-Angiologia Diagnostica e Interventistica, Maria Cecilia Hospital, Cotignola (RA)

CONCLUSIONS
I DCB sono in grado di superare alcune importanti limitazioni degli stent senza perdere la capacità di inibizione della proliferazione neo-intimale, ma deve essere chiaro che questi costituiscono una componente della strategia di rivascolarizzazione ottimale per i nostri pazienti, sempre più complessi, piuttosto che un’alternativa ai DES. Mentre il loro ruolo nella ISR è ormai ben defnito, il trattamento di lesioni de novo, specie nel distretto coronarico, è la nuova frontiera e presenta ad oggi dati incoraggianti, ancorché preliminari. In ambito periferico, tali risultati sembrano non subire effetto di catch-up a 2-3 anni e si possono estendere sia a lesioni TASC A/B sia alle più complesse TASC C/D, così come alle sottopopolazioni di pazienti con lesioni severamente calcifche, dove l’aterectomia costituisce un valido alleato del DCB, o la ISR.
I diversi DCB attualmente in commercio differiscono per la tecnologia che ne è alla base e, pertanto, hanno fornito risultati differenti in termini di effcacia a lungo termine, il che suggerisce l’assenza di un “effetto di classe” per i DCB in generale. Ogni differente tecnologia ha l’obbligo di dimostrare la sua effcacia e sicurezza in studi di adeguata ampiezza, qualità e rigore che possano confermare l’utilità nella pratica clinica dei dispositivi che entreranno in commercio da qui in avanti.

Here is the full article:
9 DCB review GIC 2017

Cangrelor With and Without Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention – JACC Publication May 2017

Cangrelor With and Without Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention – JACC Publication May 2017

A new pubblication about Cangrelor With and Without Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention has been published on JACC.

BACKGROUND
Cangrelor, an intravenous, reversible P2Y12 antagonist, is approved for use in patients undergoing percutaneous coronary intervention (PCI).
OBJECTIVES This study sought to evaluate the efficacy and safety of cangrelor compared with clopidogrel in subgroups that did and did not receive glycoprotein IIb/IIIa inhibitors (GPIs).
METHODS This pooled, patient-level analysis of the 3 CHAMPION (Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) trials analyzed all randomized patients who underwent PCI and received the study drug (n ¼ 24,902). Only bailout/rescue GPI use was permitted, except in CHAMPION PCI, in which routine or bailout/rescue GPI use was at the site investigator’s discretion. The primary efficacy endpoint was the composite of all-cause mortality, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 h after randomization.

RESULTS
Overall, 3,173 patients (12.7%) received a GPI, most commonly eptifibatide (69.4%). Despite variation in indications for GPIs, baseline characteristics were well balanced between the cangrelor and clopidogrel arms in subsets receiving and not receiving GPIs. Rates of the primary composite endpoint were lower with cangrelor compared with clopidogrel in patients who did (4.9% vs. 6.5%; odds ratio [OR]: 0.74; 95% confidence interval [CI]: 0.55 to 1.01) or did not receive a GPI (3.6% vs. 4.4%; OR: 0.82; 95% CI: 0.72 to 0.94; Pint ¼ 0.55). Cangrelor did not increase the primary safety endpoint, GUSTO-defined severe/life-threatening bleeding, in patients who did (0.4% vs. 0.5%; OR: 0.71; 95% CI: 0.25 to 1.99) or did not receive GPIs (0.2% vs. 0.1%; OR: 1.56; 95% CI: 0.80 to 3.04; Pint ¼ 0.21). GPI use was associated with increased risk of bleeding in both treatment arms.

CONCLUSIONS
Cangrelor’s efficacy in reducing ischemic complications in patients undergoing PCI was maintained irrespective of GPI administration. GPI use was associated with substantially higher bleeding rates, regardless of the randomization to cangrelor or clopidogrel. (A Clinical Trial to Demonstrate the Efficacy of Cangrelor [PCI]: NCT00305162; Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition [PLATFORM]: NCT00385138; A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary
Intervention [PCI] [CHAMPION PHOENIX] [CHAMPION]: NCT01156571) (J Am Coll Cardiol 2017;69:176–85)
© 2017 by the American College of Cardiology Foundation.

Here is the full article:
8 Cangrelor without GPI JACC 17

BIVAL – EURO PCR 2017 Publication May 2017

BIVAL – EURO PCR 2017 Publication May 2017

A pubblication about BIVAL Study has been published on EURO PCR 2017 Late Breaking Trials.

Abstract
Aims: The aim of the study was to investigate whether bivalirudin versus unfractionated heparin (UFH) reduces infarct size (IS) for primary percutaneous coronary intervention (PPCI) in large acute myocardial infarction (AMI).

Methods and results
This multicentre open-label trial randomised 78 patients undergoing PPCI for large AMI to bivalirudin or UFH. The primary endpoint was IS, assessed by cardiac magnetic resonance (CMR) five days after PPCI. Secondary endpoints included index of microcirculatory resistance (IMR), CMRassessed microvascular obstruction (MVO) and ejection fraction, and biomarkers for thrombin activity and cell injury. No difference was observed in mean IS at five days (25.0±19.7 g for bivalirudin vs. 27.1±20.7 g for UFH; p=0.75). Early MVO was numerically lower with bivalirudin (5.3±5.8 g vs. 7.7±6.3 g; p=0.17), with no significant difference in ejection fraction at 90 days (54.6±12.0% vs. 49.1±12.1%; p=0.11). In the biomarkers, thrombin-antithrombin complexes were reduced by 4.8 ug/L over the first day for bivalirudin versus an increase of 1.9 ug/L in the heparin arm (p=0.0003). Acute IMR was lower (43.5±21.6 vs. 68.7±35.8 mmHg×s, espectively; p=0.014). In a planned interim analysis, an approximate 11% reduction in IS was observed with bivalirudin; the trial was discontinued for futility.

Conclusions
This study did not achieve its primary endpoint of significant infarct size reduction in PPCI by prolonged bivalirudin infusion compared to UFH, even though complete thrombin inhibition was
achieved in the acute phase, with a lower myocardial microcirculation resistance at the end of the procedure.

Here is the full article:
7 BIVAL 2017