Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome

AbstractBackgroundWe compared efficacy of bare-metal stent (BMS) and drug-eluting balloon (DEB) combination vs BMS alone, in patients with non-ST elevation acute coronary syndrome treated with percutaneous coronary intervention (PCI).MethodsPatients with non-ST elevation myocardial infarction (NSTEMI) or unstable angina (UA) were randomized to BMS only or BMS+DEB group. Angiographic follow-up was performed after 6 months. The primary endpoints were binary in-stent restenosis (ISR) and late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR), stent thrombosis (ST), and new acute coronary syndrome (ACS).ResultsA total of 85 patients were enrolled, 44 (BMS) and 41 (BMS+DEB). The median age was 67 (36–84) years and 68 (80%) were male. Fifty-two patients (61.2%) had NSTEMI and 33 patients (38.8%) UA. There was no difference in patient demographics, risk factors, and clinical characteristics, except for more smokers in the BMS+DEB group 18/41 (43.9%) vs 9/44 (20.5%). At follow-up, no significant difference in binary ISR was found; p=0.593, but LLL was significantly lower in the BMS+DEB group 0.68 (0.00–2.15) mm vs 0.22 (0.00–2.35) mm; p=0.002. The difference in major adverse cardiac events (MACE) rate combining TLR, ST, and ACS, between the groups was also non-significant, 29.5% (BMS) vs 24.4% (BMS+DEB); p=0.835. One patient had a subacute ST (BMS+DEB) due to clopidogrel resistance.ConclusionPatients treated with BMS+DEB combination for non-ST elevation acute coronary syndrome had significantly less LLL in comparison to patients treated with BMS alone but without an impact on patient clinical outcomes

Global and regional myocardial function and outcomes after transcatheter aortic valve implantation for aortic stenosis and preserved ejection fraction.

AIM: To investigate the effects of transcatheter aortic valve implantation (TAVI) on early recovery of global and segmental myocardial function in patients with severe symptomatic aortic stenosis and preserved left ventricular ejection fraction (LVEF) and to determine if parameters of deformation correlate with outcomes. METHODS: The echocardiographic (strain analysis) and outcome (hospitalizations because of heart failure and mortality) data of 62 consecutive patients with preserved LVEF (64.54 ± 7.97%) who underwent CoreValve prosthesis implantation were examined. RESULTS: Early after TAVI (5 ± 3.9 days), no significant changes in LVEF or diastolic function were found, while a significant drop of systolic pulmonary artery pressure (PAP) occurred (42.3 ± 14.9 vs. 38.1 ± 13.9 mmHg, P = 0.028). After TAVI global longitudinal strain (GLS) did not change significantly, whereas significant improvement in global mid-level left ventricular (LV) radial strain (GRS) was found (-16.71 ± 2.42 vs. -17.32 ± 3.25%; P = 0.33; 16.57 ± 6.6 vs. 19.48 ± 5.97%, P = 0.018, respectively). Early significant recovery of longitudinal strain was found in basal lateral and anteroseptal segments (P = 0.038 and 0.048). Regional radial strain at the level of papillary muscles [P = 0.038 mid-lateral, P < 0.001 mid-anteroseptum (RSAS)] also improved. There was a significant LV mass index reduction in the late follow-up (152.42 ± 53.21 vs. 136.24 ± 56.67 g/m, P = 0.04). Mean follow-up period was 3.5 ± 1.9 years. Parameters associated with worse outcomes in univariable analysis were RSAS pre-TAVI, LV end-diastolic diameter after TAVI, relative wall thickness, and mitral E and E/A after TAVI. CONCLUSION: Global and regional indices of myocardial function improved early after TAVI, suggesting the potential of myocardium to recover with a reduced risk for clinical deterioration

A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial

Background: Despite primary PCI (PPCI), STEMI can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signal for reduction in IS in anterior STEMI. Aims: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to primary PCI (PPCI) in conscious patients with anterior ST-elevation myocardial infarction (STEMI) without cardiac arrest. Methods: Hypothermia was induced using ZOLL® Proteus™ Intravascular Cooling System. After randomization of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischemic delay in hypothermia group (232 vs 188 minutes; p <0.001). Results: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular mass (IS/LV) by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in hypothermia group and 20.0% in control group (p=0.540). Major adverse cardiac events (MACE) at 30 days were non significantly increased in hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in hypothermia group. Conclusion: Intravascular ZOLL TM Proteus Cooling System reduced temperature to 33.3oC before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in longer ischemic delay, did not reduce IS/LV mass and was associated with increased adverse events