Abstract
Background
The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor ...before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors—ticagrelor and prasugrel—currently recommended by the guidelines.
Study design
DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings.
Conclusions
The DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed.
Trial registration
ClinicalTrials.gov
NCT02618837
. Registered on 1 December 2015.
The ABSORB III study Summaria, Francesco; Giannico, Maria Benedetta; Masiero, Giulia ...
Giornale italiano di cardiologia (2006)
17, Številka:
11
Journal Article
Differently from many European and non-European countries, currently in Italy there is not an official, well-defined process for training, evaluation and certification for interventional ...cardiologists. Interventional Cardiology is an important branch of Cardiology with peculiarities such as to need specific theoretical and practical training. The lack of standardization of training criteria may result in disparities in the quality of care offered to patients in different locations. The Italian Society of Interventional Cardiology (SICI-GISE) has therefore developed an independent certification process for Italian interventional cardiologists. This is a first step towards the implementation of a well-defined training and certification process for both coronary and structural interventions, and for regular re-certification of established operators.The certification will be issued by SICI-GISE and will be based on the recognition of the skills attained by interventional cardiologists in the setting of coronary diagnostic and interventional procedures. This document describes the minimum eligibility criteria for the training centers, which have the task of recording and validating the training activity carried out by each interventional cardiologist, and the minimum competence requirements that should be attained by the operators to obtain the certification.
Drug-eluting stents (DES) are the current gold standard for percutaneous treatment of coronary artery disease. However, DES are associated with a non-negligible risk of long-term adverse events ...related to persistence of foreign material in the coronary artery wall. In addition, DES implantation causes permanent caging of the native vessel, thus impairing normal vasomotricity and the possibility of using non-invasive coronary imaging or preforming subsequent bypass surgery. On the contrary, coronary bioresorbable stents (BRS) may provide temporary mechanical support to coronary wall without compromising the subsequent recovery of normal vascular physiology, and have the potential to prevent late adverse events related to permanent elements. Several types of BRS have been introduced into clinical practice in Europe or are being tested. However, most of available clinical data relate to a single BRS, the Absorb bioresorbable Vascular Scaffold (Absorb BVS) (Abbott Vascular, Santa Clara, CA). Despite encouraging clinical results, no societal guidelines are available on the use of BRS in clinical practice.A panel of Italian expert cardiologists assembled under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim to provide recommendations on the use of bioresorbable stents in terms of clinical indications, procedural aspects, post-percutaneous coronary angioplasty pharmacologic treatment and follow-up. Based on current evidence and BRS availability in Italian cath-labs, the panel decided unanimously to provide specific recommendations for the Absorb BVS device. These recommendations do not necessarily extend to other BRS, unless specified, although significant overlap may exist with Absorb BVS, particularly in terms of clinical rationale.
Although oral P2Y
inhibitors are key in the management of patients with non-ST-segment elevation acute coronary syndrome, the optimal timing of their administration is not well defined.
The purpose ...of this study was to compare downstream and upstream oral P2Y
inhibitors administration strategies in patients with non-ST-segment elevation acute coronary syndrome undergoing invasive treatment.
We performed a randomized, adaptive, open-label, multicenter clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was the superiority of the downstream versus the upstream strategy on the combination of efficacy and safety events (net clinical benefit).
We randomized 1,449 patients to downstream or upstream oral P2Y
inhibitor administration. A pre-specified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes; nonfatal myocardial infarction or nonfatal stroke; and Bleeding Academic Research Consortium type 3, 4, and 5 bleeding through day 30, did not differ significantly between the downstream and upstream groups (percent absolute risk reduction: -0.46; 95% repeated confidence interval: -2.90 to 1.90). These results were confirmed among patients undergoing percutaneous coronary intervention (72% of population) and regardless of the timing of coronary angiography (within or after 24 h from enrollment).
Downstream and upstream oral P2Y
inhibitor administration strategies were associated with low incidence of ischemic and bleeding events and minimal numeric difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of 1 strategy over the other. (Downstream Versus Upstream Strategy for the Administration of P2Y
Receptor Blockers In Non-ST Elevated Acute Coronary Syndromes With Initial Invasive Indication DUBIUS; NCT02618837).
The implementation of the latest medical innovations can vary widely within the same geographic area. This study aimed to describe the current status of recent innovations in the field of coronary ...interventional cardiology in 4 regions of Northern Italy.
From April to May 2014, 4 regional delegations of the Italian Society of Invasive Cardiology (SICI-GISE) have promoted a multicenter survey. By means of a web-based methodology, a focused questionnaire was administered to head physicians of 97 cath-labs in 4 Italian regions within the "GISE TOLOVE" area (Lombardy, Veneto, Tuscany, Emilia-Romagna).
Pharmacological and technological innovations in coronary interventional cardiology appear to be widely used in the area covered by this survey, with uniformity in application and availability of therapeutic devices and drugs within the 4 regions involved. The main limiting factors to the adoption of new technologies and drugs were economic factors or lack of scientific evidence for some specific devices or drugs.
This survey showed widespread and consistent application of the main latest innovations in coronary interventional cardiology across 4 Italian regions of Northern Italy.
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