It’s a great pleasure to announce that CERC board has welcomed 3 brilliant new members: Drs Thomas Cuisset (France), Darren Mylotte (Ireland) and Peter Smits (The Netherlands). Their arrival will enhance even more CERC’s global reach. Click here to discover all of the CERC...
Investigating the risk balance of thrombotic and bleeding events after percutaneous coronaryintervention (PCI) is especially relevant for patients at high bleeding risk (HBR). In 2019, the Academic Research Consortium for HBR (ARC-HBR) proposed a consensus definition of HBR in an effortto standardize the patient population involved. CERC organized the meetings of the ARC-HBR group. This finally led to the presentation of the consensus document at EuroPCR 2019 and to the simultaneous publication in Circulation and the European Heart Journal. The second initiative from the ARC-HBR is to produce a second consensus document and thus propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. Two meetings of the ARC-HBR group took place in Washington, DC, USA, in April 2019, and Paris, France, in October 2019, once again organized by CERC and attended by the same experts from Europe, the USA and Asia, as well as representatives from the US FDA, the Japanese PMDA, a European Notified Body (DEKRA Certification BV, Arnhem, the Netherlands), and observers from the cardiovascular device and pharmaceutical industries. The output of the meetings will be published soon. The authors hope that this second document will promote consistency in trial design across a potential spectrum of applications in HBR patients, including evaluation of novel technologies and iterations of existing devices. This context is particularly important for the ARC-HBR definitions, which are intended for use in patients who have historically been under-represented in device and drug studies, and for whom there is a need for further understanding of both device and drug benefit/risk. ...
Recent studies have proven the benefit of single stenting in the treatment of bifurcation lesions. However, the debate is still ongoing about the added value of SB interventions in the setting of a provisional stenting approach when conducted according to European Bifurcation Club (EBC) recommendations, namely with systematic use of proximal optimization technique (POT) in order to adjust stent deployment to the two diameters of the main vessel as established by the fractal nature of coronary tree. Studies evaluating the potential benefit of kissing balloon have been conducted before the systematic use of POT. In the treatment of bifurcation lesions, the KISS (Keep sIngle Stenting Simple) study will evaluate the non-inferiority of no side branch (SB) intervention versus side branch ballooning (with or without kissing balloon inflation), in the setting of single stenting with systematic proximal optimization technique (POT). Patients will be randomized after main vessel stenting and POT if the SB is patent with a normal flow and no signs of ischemia. Read more in the CERC...
CERC is proud to announce that the recruitment of 4,300 patients in the MASTER-DAPT study was achieved before the end of last year! The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with Sirolimus-eluting bioresorbable polymer-coated stent implantation Terumo). Pr Marco Valgimigli This investigator-initiated study compares an abbreviated versus a prolonged duration of antiplatelet therapy after bioresorbable polymer-coated SES implantation (Ultimaster Tansei, Terumo, Tokyo, Japan) in 137 interventional cardiology centers. MASTER DAPT is powered to assess the non-inferiority of the abbreviated regimen with respect to the net adverse clinical and MACCE composite endpoint and the superiority in terms of major and clinically relevant bleedings. Patients from 3 continents (Europe, Asia, Oceania) have been enrolled in the study and the three best country-recruiters were the Netherlands, France and Switzerland. In addition, 5 sites reached the 100th patient’s milestone including Bern (CH) Dr. Aris Moschovitis having randomized more than 350 patients in the trial! The results of the MASTER DAPT study are planned to be presented at the EuroPCR Meeting in...
Discover our new study CRUZ HBR Registry ! The first patient enrollment was announced on LinkedIn and Twitter by our partner SMT. Clic on the picture below to discover their...
Marie-Claude Morice with CERC team members @ High Tech Cardio 2020 in...