Multicentre experience with MGuard™net protective stent in ST-elevation Myocardial Infarction: long-term results. Federico Piscione, MD, FESC Department of Clinical Medicine, Cardiovascular Sciences and Immunology Cardiology Division “Federico II” University Naples - Italy Disclosure Statement of Financial Interest I, Federico Piscione, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. New coronary stent for high thrombus burden Embolisation of atherothrombotic material is common during percutaneous coronary intervention (PCI) in acute myocardial infarction (MI), resulting in distal vessel occlusion, impaired myocardial perfusion, larger infarct size and increased mortality. MGuard™net protective stent (InspireMD Corporation, Tel Aviv, Israel) is a new device for PCI that, through an ultra-thin polymer mesh sleeve attached to the external surface of a bare-metal stent, aims to protect the microcirculation, by minimizing distal embolisation. Stent Strut 8080-100 μ Net size 150 x 180 μ Journ Inv Card, 2007, Card Revasc Med 2008, Cath Card Intv 2009, Cath Card Intv 2009, Clin Res Card 2010, Adapted from Jaffe, R et al. Circulation 2008 Thirty-day results All death Cardiac death 7% 4%* Myocardial Infarction 2% Target vessel revascularization 2% Stent thrombosis 3%** * Heart rupture with cardiac tamponade not related with procedural aspects (n=1); severe right or left ventricular function impairment at admission (n=3). ** Three in-hospital definite stent thromboses occurred: in a case a clear image of type B dissection at the distal edge of the stent was identified as culprit; in the other cases, abrupt vessel closure occurred as a consequence of devices undersizing. Five out of seven deaths occurred among cardiogenic shock patients. ts Long-term results at two-year follow-up Overall population (n=105) Patients W/o shock (n=89) MACE§ 13.3% 7.9% All death Cardiac death* 13.3% 6.7% 9% 2.2% Target Vessel Revascularization 6.7% 3.4% Myocardial Infarction 9.5% 5.6% Stent thrombosis (ARC)** Definite Acute Subacute Late 7.6% 4.8% 1% 3.8% 2.9% 3.4% 1.1% 3.4% § Cardiac Death, Myocardial Infarction, TVR * Possible stent thrombosis 2.9% vs 2.2%, respectively ** Definite/Probable/Possible Piscione F et al., unpublished data 92,1% Log Rank p<.0001 91% Log Rank p<.0001 62,5% 56,2% 97,8% Log Rank p<.0001 68,8% Piscione F et al., unpublished data Log Rank p<.0001 94,4% 68,8% 96,6% Log Rank p=.001 96,6% Log Rank p<.0001 75% 68,8% Cox regression analysis showed that shock presentation and CKD were the only independent predictors of MACE at follow-up. Moreover, cardiogenic shock at admission resulted as the most powerful predictor of MACE occurrence (p<.0001; HR 10.4). Piscione F et al., unpublished data A step forward. MGUard vs bAre-metal-stents plus manual thRombectomy in real worlD STEMI pAtieNts. GUARDIAN: A Prospective Multicentre Randomized Trial. GUARDIAN Trial: I/E Criteria and Study flow-chart Primary end-points Open Label 1:1 • ≥18 years-old patients. • Female not pregnant or potentially child-bearing. • ECG evidence of persistent ST-segment elevation ≥0.1 mV in two or more contiguous ECG leads for any myocardial infarction. • Myocardial infarction lasting ≥30 minutes and <12 hours. • De novo myocardial infarction event in the infarct related area. • Reverence vessel diameter of the infarct related artery ≥2.5 mm. • Patient must be candidate to coronary stenting according to target vessel and lesion features. • No Cardiogenic shock. • No “true” bifurcation lesions. Randomization before angiography “IntentionIntention-toto-treat” treat” basis MGuard net protective stent 2-3 TIMI antegrade coronary blood flow (TIMI); <23-24 corrected TIMI frame count (cTFC); 2-3 Myocardial Blush Perfusional Grade (MBG) of the infarct related area. Complete ST segment resolution at 60 minutes after PCI. Vs Manual thrombectomy + BMS Secondary end-points Major adverse cardiac event (MACE) - cardiac death, myocardial infarction, target vessel failure (TVR) at 1, 6 and 12 months after PCI. Infarct-size area reduction and left ventricular function evaluation with non invasive tests at 6 months after PCI. Conclusions 1. STEMI patients still represent the most challenging scenario for interventional cardiologists. In this clinical setting, it must be paid attention not only for vessel flow restoration, but for myocardial perfusion also, that is crucial for limiting events rate at follow-up. 2. Distal embolization during PCI in STEMI is responsible for adverse outcomes, and there is still much more to do for avoiding this phenomenon in the acute as well as the late phase after PCI (i.e. late plaque and debris prolapse through stent struts). 3. According to the reported data, MGuardTM net protective stent could represent a safe and feasible option, option both at short and long-term follow-up, for STEMI patients undergoing PCI with huge thrombus burden evidence at coronary angiography. 4. Nevertheless, data confirmed the significant worse prognosis for STEMI patients complaining cardiogenic shock at admission both in terms of safety and efficacy end-points occurrence. 5. More data will be available after the GUARDIAN randomized trial completion: this trial will help to ascertain if a strategy of manual thrombectomy plus bare-metal stenting is superior with respect to a strategy of MGuard stenting for patients undergoing PCI for STEMI. Thank You.
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