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.

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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.

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7 BIVAL 2017

AKI-MATRIX – JACC Publication 20 May 2017

AKI-MATRIX – JACC Publication 20 May 2017

The 20th of May 2017, a new pubblication about AKI Matrix has been published on JACC.

BACKGROUND
It remains unclear whether radial access (RA), compared with femoral access (FA), mitigates the risk of acute kidney injury (AKI).

OBJECTIVES
The authors assessed the incidence of AKI in patients with acute coronary syndrome (ACS) enrolled in the MATRIX-Access (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial.

METHODS
Among 8,404 patients, 194 (2.3%) were excluded due to missing creatinine values, no or an incomplete coronary angiogram, or previous dialysis. The primary AKI-MATRIX endpoint was AKI, defined as an absolute (>0.5 mg/dl) or a relative (>25%) increase in serum creatinine (sCr).

CONCLUSIONS
In ACS patients who underwent invasive management, RA was associated with a reduced risk of AKI compared with FA. (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]

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6 AKI MATRIX

GIC – Documento di posizione SICI-GISE: Utilizzo di Absorb BVS nella pratica clinica

GIC – Documento di posizione SICI-GISE: Utilizzo di Absorb BVS nella pratica clinica

This is the article published in G ITAL CARDIOL, VOL17, SUPPL 1 AL N 10 2016.

Documento di posizione SICI-GISE: Utilizzo di Absorb BVS nella pratica clinica

Giuseppe Tarantini (1), Francesco Saia (2), Piera Capranzano (3), Bernardo Cortese (4),
Marco Mojoli (1), Giacomo Boccuzzi (5), Andrea Cuculo (6), Salvatore Geraci (7), Alessio Mattesini (8),
Jacopo Oreglia (9), Francesco Summaria (10), Luca Testa (11), Sergio Berti (12), Giovanni Esposito (13), Caterina Maria Gandolfo (14), Alessio La Manna (3), Ugo Limbruno (15), Alfredo Marchese (16),
Ciro Mauro (17), Fabio Tarantino (18), Alessandro Salvi (19), Gennaro Santoro (20), Ferdinando Varbella (21), Roberto Violini (22), Giuseppe Musumeci (23)
(1) Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari, Policlinico Universitario, Padova
(2) Dipartimento Cardio-Toraco-Vascolare, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna
(3) Dipartimento Cardiovascolare, Ospedale Ferrarotto, Università degli Studi, Catania
(4) Cardiologia Interventistica, A.O. Fatebenefratelli, Milano
(5) Cardiologia Interventistica, Azienda Sanitaria Locale Torino 2, Torino
(6) Dipartimento di Cardiologia, A.O. Ospedali Riuniti, Foggia
(7) Cardiologia Interventistica, Ospedale S. Giovanni di Dio, Agrigento
(8) Cardiologia Interventistica, Ospedale Moriggia Pelascini, Gravedona (CO)
(9) Emodinamica, ASST Grande Ospedale Metropolitano Niguarda, Milano
(10) Dipartimento di Cardiologia, Policlinico Casilino, Roma
(11) Dipartimento di Cardiologia, IRCCS Policlinico S. Donato, S. Donato Milanese (MI)
(12) U.O. Cardiologia Diagnostica ed Interventistica, Fondazione Toscana “Gabriele Monasterio”, Ospedale del Cuore, Massa
(13) Dipartimento di Scienze Biomediche Avanzate, Università degli Studi “Federico II”, Napoli
(14) Cardiologia Interventistica, Ospedale Civico, Palermo
(15) U.O.C. Cardiologia, Azienda USL Toscana Sudest, Grosseto
(16) U.O.C. Cardiologia Interventistica, Anthea Hospital, GVM Care & Research, Bari
(17) Dipartimento Cardiovascolare, Ospedale Cardarelli, Napoli
(18) Laboratorio di Emodinamica, U.O. Cardiologia, Ospedale G.B. Morgagni-L. Pierantoni, Forlì
(19) Dipartimento Cardiovascolare, Ospedali Riuniti, Università degli Studi, Trieste
(20) Cardiologia Interventistica, AOU Careggi, Firenze
(21) Dipartimento di Cardiologia, Ospedale degli Infermi, Rivoli (TO)
(22) Cardiologia Interventistica, Ospedale S. Camillo-Forlanini, Roma
(23) Dipartimento Cardiovascolare, ASST Papa Giovanni XXIII, Bergamo

Riassunto

Il “gold standard” nel trattamento percutaneo della coronaropatia è costituito dagli stent a rilascio di farmaco (DES). Tuttavia, i DES si associano a un rischio non trascurabile di eventi avversi a
lungo termine correlati alla permanenza di un “corpo estraneo” nella parete coronarica. Inoltre, i DES comportano il “caging” permanente del vaso nativo con compromissione della normale vasomotricità oltre alla mancata possibilità di utilizzare imaging coronarico non invasivo o di impiantare successivi graft chirurgici. Al contrario, gli stent coronarici riassorbibili (bioresorbable stents, BRS) consentono di ottenere un transitorio supporto meccanico senza compromettere il successivo recupero della normale fisiologia vascolare e hanno la potenzialità di prevenire eventi avversi tardivi legati a elementi permanenti. Numerosi tipi di BRS sono stati introdotti nella pratica clinica in Europa o sono in via di sperimentazione. Tuttavia, la maggior parte dei dati clinici si riferisce a un singolo BRS, l’Absorb Bioresorbable Vascular Scaffold (Abbott Vascular, Santa Clara, CA). Nonostante la disponibilità
di dati clinici incoraggianti, non sono disponibili linee guida di società internazionali sulle indicazioni all’utilizzo dei BRS nella pratica clinica.
Un panel di cardiologi esperti si è radunato sotto l’egida della Società Italiana di Cardiologia Interventistica (SICI-GISE) per discutere l’argomento e sviluppare un documento di posizione
contenente raccomandazioni sull’utilizzo degli stent riassorbibili in termini di indicazioni cliniche, aspetti procedurali, trattamento farmacologico post-impianto e follow-up. Alla luce dei dati
scientifici e della disponibilità nell’attuale pratica clinica italiana, il panel ha deciso unanimemente di fornire raccomandazioni specifiche per il dispositivo Absorb BVS (o semplicemente BVS). Tali raccomandazioni non si estendono necessariamente ad altri BRS, salvo laddove indicato specificamente nel testo, benché vi possano essere significative sovrapposizioni con Absorb BVS soprattutto in termini di razionale clinico.

documento GISE su utilizzo BVS

International Journal of Cardiology – Treatment of bifurcation lesions with drug-coated balloons: A review of currently available scientificdata

International Journal of Cardiology – Treatment of bifurcation lesions with drug-coated balloons: A review of currently available scientificdata

This is the article published in the International Journal of Cardiology 220 (2016) 589–594.

International Journal of Cardiology – Treatment of bifurcation lesions with drug-coated balloons: A review of currently available scientificdata

Bernardo Cortese (a,b,⁎), Davide Piraino (c), Dario Buccheri (a,c), Fernando Alfonso(d)
(a) Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy
(b) Fondazione Monasterio CNR-Regione Toscana, Italy
(c) Interventional Cardiology,“P.Giaccone”Universitary Hospital of Palermo, Italy
(d) Interventional Cardiology, Hospital Universitario de La Princesa, Spain
(⁎) Corresponding author at: Interventional Cardiology, A.O. Fatebenefratelli Milano, Bastioni di Porta Nuova 21, 20100 Milano, Italy. E-mail address:bcortese@gmail.com (B. Cortese)

Conclusion

DCB use for bifurcation lesion management remains very attractive indeed as a complement of a provisional stenting strategy. However, currently available scientific evidence remains scarce and we still require additional data to refine its real clinical value. However, an indiscriminate use of stents in this setting (complex stenting or any 2-stent technique) is associated with suboptimal Clinical and angiographic results. The use of a novel generation DES in the MB remains the strategy of choice for most patients that can be managed with a provisional stenting strategy. It is possible that newer technologies such as DCB and biovascular scaffolds might improve the short and long-term outcome of bifurcation lesions, allowing a limited use of permanent prosthesis, especially at the SB

DCB bifurcation review 16