Impact of baseline hemorrhagic risk on the benefit of bivalirudin versus unfractionated heparin in patients treated with coronary angioplasty: a meta-regression analysis of randomized trials.

BACKGROUND: Bivalirudin significantly reduces 30-day major and minor bleeding compared with unfractionated heparin (UFH), while resulting in similar or lower rates of ischemic events in both patients with stable and unstable coronary disease undergoing percutaneous coronary intervention. We performed a meta-analysis of randomized trials to evaluate the impact of bivalirudin compared with UFH, with or without glycoprotein IIb/IIIa receptor inhibitors (GPI), on the rates of mortality, myocardial infarction (MI), and major bleeding. METHODS: We searched electronic databases for randomized controlled trials with >100 patients comparing bivalirudin (±provisional GPI) with UFH with either routine or provisional GPI in patients undergoing percutaneous coronary intervention. The principal efficacy end points were mortality and MI within 30 day, whereas major bleeding was the principal safety end point. We assessed the benefit of bivalirudin for each efficacy end point relative to the baseline bleeding risk, using the control (UFH) major bleeding rate as proxy for that risk. RESULTS: A total of 12 randomized trials that enrolled 33,261 patients were included. Overall, there was no significant difference in mortality and MI between bivalirudin monotherapy and UFH (±GPI), whereas major bleeding was significantly lower with bivalirudin. Bivalirudin reduced major and minor bleeding across the entire bleeding risk spectrum. CONCLUSIONS: Bivalirudin significantly reduces major and minor bleeding regardless of the estimated baseline hemorrhagic risk.

[Drug-eluting stents in contemporary interventional practice: the STENT PANORAMA project (Part I)]. / Gli stent coronarici a rilascio di farmaco nella pratica interventistica contemporanea: progetto STENT PANORAMA (Parte I).

STENT PANORAMA is a project carried out by the Young Interventional Cardiologists of Triveneto coordinated by the Italian Society of Interventional Cardiology (GISE) Veneto delegation. The project includes two parts: the first, here reported, is aimed at describing in a standardized and easily usable way the main technological characteristics of the latest generation of the drug eluting stents (DES) that are most widely used in the Italian cath-labs. The second, to follow, will aim to summarize the main scientific evidence regarding the performance of individual devices with particular reference to subgroups of clinical interest. The ambitious goal of the STENT PANORAMA working group is to provide the interventional cardiologist with a thorough, practical, and functional knowledge of the DES currently available in the modern therapeutic armamentarium to promote a therapeutic strategy tailored to the patient.

"Cardiac allograft vasculopathy: Pathogenesis, diagnosis and therapy".

Cardiac allograft vasculopathy (CAV) is a unique form of accelerated atherosclerosis that represents the main late cause of morbidity and mortality, affecting almost half patients at ten years after heart transplantation (HTx). Unless the pathogenesis of CAV is still not completely understood, it seems to be the result of a complex interplay between immunological and non-immunological factors that induce endothelial injury. Histologically epicardial and intramural vessels present a concentric circumferential intimal thickening caused by smooth muscle cell proliferation, inflammatory cells, and lipid deposition. Coronary angiography is still considered the gold-standard diagnostic tool for CAV detection but has reduced sensibility due to its inability to visualize beyond the arterial lumen. Intravascular ultrasound (IVUS) allows detecting early intimal thickening with high sensitivity. Plaque composition and vulnerability, detectable with virtual histology (VH/IVUS), and optical coherence tomography (OCT) seem to relate to adverse clinical events. Treatment approaches continue to evolve, but prevention and early detection remain the focus. Mammalian target of rapamycin inhibitors can significantly delay the development and the progression of CAV, but their optimal use remains to be established. New encouraging results come from monoclonal autoantibodies. At present percutaneous revascularization procedures seem to have only a palliative meaning, with no clear evidence of survival advantage over medical therapy and should be considered in case of a focal disease. Drug-eluting stents have proven to reduce in-stent restenosis, with a potential role of imaging-guided intervention in this setting. Heart re-transplantation is the only resolutive therapy and is considered in the case of CAV associated with graft dysfunction.

Physiological Versus Angiographic Guidance for Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation.

Background Management of coronary artery disease in patients undergoing transcatheter aortic valve implantation is uncertain. Fractional flow reserve (FFR) has never been clinically validated in aortic stenosis. The study aim was to analyze the clinical outcome of FFR-guided revascularization in patients undergoing transcatheter aortic valve implantation. Methods and Results Patients with severe aortic stenosis and coronary artery disease at coronary angiography were included in this retrospective analysis and divided in 2 groups: angiography guided (122/216; 56.5%) versus FFR-guided revascularization (94/216; 43.5%). Patients were clinically followed up and evaluated for the occurrence of major adverse cardiac and cerebrovascular events at 2-year follow-up. Most lesions in the FFR group resulted negative according to the conventional 0.80 cutoff value (111/142; 78.2%) and were deferred. The FFR-guided group showed a better major adverse cardiac and cerebrovascular event-free survival compared with the angio-guided group (92.6% versus 82.0%; hazard ratio, 0.4; 95% CI, 0.2-1.0; P=0.035). Patients with deferred lesions based on FFR presented better outcome compared with patients who underwent angio-guided percutaneous coronary intervention (91.4% versus 68.1%; hazard ratio, 0.3; 95% CI, 0.1-0.6; P=0.001). Conclusions FFR guidance was associated with favorable outcome in this observational study in patients undergoing transcatheter aortic valve implantation. Randomized trials are needed to investigate the long-term effects of FFR-guided revascularization against angiographic guidance alone in patients with aortic stenosis.

Impella-protected PCI: the clinical results achieved so far.

The ability of interventional cardiologists to identify high-risk percutaneous coronary intervention (PCI) patients, requires the integration of different features belonging to medical history, organ damage, coronary anatomy and the nature of the acute event. The selection of a subgroup of patients that could benefit from mechanical support during interventions is a key feature to success. The introduction of the Impella percutaneous axial pump have added an easy-to-set-up, less invasive and time-consuming active-support device to the interventional toolbox. Up to date, only few (four) randomized clinical trials (RCTs) have tried to address the clinical efficacy of Impella assistance for the treatment of this very high-risk population, but several large registries and multiple observational studies have demonstrated its safety, feasibility and hemodynamic performance. Although the largest RCT (PROTECT II) have been prematurely stopped due to the risk of futility despite the evidence of more complete revascularization in the Impella arm, the need for an adequate operator's learning curve must be considered. More recent insights suggest an effect of the device in optimizing end-organ perfusion and improving crucial parameters like renal function. Furthermore, available data suggest that vary early Impella support may improve patient's outcome in case of cardiogenic shock.