Impact of calcium on procedural and clinical outcomes in lesions treated with bioresorbable vascular scaffolds - A prospective BRS registry study

Background: There is limited data on the impact of calcium (Ca) on acute procedural and clinical outcomes in patients with lesions treated with bioresorbable vascular scaffolds (BRS). We sought to evaluate the effect of calcium on procedural and clinical outcomes in a 'real world' population. Methods: Clinical outcomes were compared between patients with at least 1 moderately or heavily calcified lesion (Ca) and patients with no/mild calcified lesions (non-Ca) enrolled in our institutional BRS registry. Results: 455 patients (N) with 548 lesions (L) treated with 735 BRS were studied. Patients in the Ca group (N = 160, L = 200) had more complex (AHA B2/C lesion: 69.0% in Ca vs 14.9% in non-Ca, p. <. 0.001) and significantly longer lesions (27.80. ±. 15.27 vs 19.48. ±. 9.92. mm, p. <. 0.001). Overall device success rate was 99.1% with no significant differences between the groups. Despite more aggressive lesion preparation and postdilation compared to non Ca, acute lumen gain was significantly less in Ca lesions (1.50. ±. 0.66 vs 1.62. ±. 0.69. mm, p = 0.040) with lower final MLD (2.28. ±. 0.41 vs 2.36. ±. 0.43, p = 0.046). There were no significant differences in all-cause mortality, total definite scaffold thrombosis (ST), target lesion revascularization and myocardial infarction between the 2 groups. Late ST was more frequent in the Ca group compared to non Ca group (late ST: 2.1 vs 0%, p = 0.02). Conclusions: Clinical outcomes after BRS implantation in calcified and non-calcified lesions were similar. A remarkable difference in timing of thrombosis was observed, with an increased rate of late thrombosis in calcified lesions

Political Parties and Political Foundations in Italy. Their Changing Landscape of Structure and Financing

This book, published with research funds from the University of Rome La Sapienza, aims at disseminating knowledge about the Italian system of political parties and political foundations among non-Italian scholars, in the light of the recent legislative reforms in this field. Due to their nature as free associations of citizens under art. 49 Cost., political parties are supposed to enjoy a full autonomy in determining their own purposes, internal organisation and financial management. However, the recent regulation on the funding of political parties contains provisions aimed at influencing the contents of party statutes, imposing upon them several organisational obligations. Moreover, some draft laws concerning the internalfunding have been proposed, with the idea of making intra-party democracy not only a prerequisite for obtaining funds, but also for competing in elections. However, many argue that a law should be the least invasive possible, and parties should instead proceed to self-reformation. The stronger the erosion process of party organisations and of political cultures is, the more strongly affirmed will be the personalised models of political organisation, in which even the funding of the organisation’s own public viability is managed autonomously. This is why ever more frequently some political leaders make use of think tanks for fund-raising, by virtue of the broad degree of autonomy that they enjoy

Progress in treatment by percutaneous coronary intervention: The stent of the future

First generation drug-eluting stents have considerably reduced in-stent restenosis and broadened the applications of percutaneous coronary interventions for the treatment of coronary artery disease. The polymer is an integral part of drug-eluting stents in that, it controls the release of an antiproliferative drug. The main safety concern of first generation drug-eluting stents with permanent polymers - stent thrombosis - has been caused by local hypersensitivity, delayed vessel healing, and endothelial dysfunction. This has prompted the development of newer generation drug-eluting stents with biodegradable polymers or even polymer-free drug-eluting stents. Recent clinical trials have shown the safety and efficacy of drug-eluting stents with biodegradable polymer, with proven reductions in very late stent thrombosis as compared to first generation drug-eluting stents. However, the concept of using a permanent metallic prosthesis implies major drawbacks, such as the presence of a foreign material within the native coronary artery that causes vascular inflammation and neoatherosclerosis, and also impedes the restoration of the vasomotor function of the stented segment. Bioresorbable scaffolds have been introduced to overcome these limitations, since they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. This update article presents the current status of these new technologies and highlights their future perspectives in interventional cardiology

Treatment of Coronary Atherosclerotic Lesions with Bioresorbable Vascular Scaffolds

The present thesis represents a journey through our initial experience with the bioresorbable scaffold up to the implementation of this technology in complex scenarios such as unstable patients with acute thrombotic lesions, calcified plaques, coronary bifurcations, and even complex chronic total occlusions thus resembling as much as possible the entire spectrum of our daily clinical practice

Reducing Microvascular Dysfunction in Revascularized Patients with ST-Elevation Myocardial Infarction by Off-Target Properties of Ticagrelor versus Prasugrel. Rationale and Design of the REDUCE-MVI Study

Microvascular injury is present in a large proportion of patients with ST-elevation myocardial infarction (STEMI) despite successful revascularization. Ticagrelor potentially mitigates this process by exerting additional adenosine-mediated effects. This study aims to determine whether ticagrelor is associated with a better microvascular function compared to prasugrel as maintenance therapy after STEMI. A total of 110 patients presenting with STEMI and additional intermediate stenosis in another coronary artery will be studied after successful percutaneous coronary intervention (PCI) of the infarct-related artery. Patients will be randomized to treatment with ticagrelor or prasugrel for 1 year. FFR-guided PCI of the non-infarct-related artery will be performed at 1 month. Microvascular function will be assessed by measurement of the index of microcirculatory resistance (IMR) in the infarct-related artery and non-infarct-related artery, immediately after primary PCI and after 1 month. The REDUCE-MVI study will establish whether ticagrelor as a maintenance therapy may improve microvascular function in patients after revascularized STEMI

Recommendations for the use of bioresorbable vascular scaffolds in percutaneous coronary interventions

Background To eliminate some of the potential late limitations of permanent metallic stents, the bioresorbable coronary stents or ‘bioresorbable vascular scaffolds’ (BVS) have been developed. Methods We reviewed all currently available clinical data on BVS implantation. Results Since the 2015 position statement on the appropriateness of BVS in percutaneous coronary interventions, several large randomised trials have been presented. These have demonstrated that achieving adequate 1 and 2 year outcomes with these first-generation BVS is not straightforward. These first adequately powered studies in non-complex lesions showed worse results if standard implan- tation techniques were used for these relatively thick scaffolds. Post-hoc analyses hypothesise that outcomes similar to current drug-eluting stents are still possible if aggressive lesion preparation, adequate sizing and high-pressure postdilatation are implemented rigorously. As long as this has not been confirmed in prospective studies the usage should be restricted to experienced centres with continuous outcome monitoring. For more complex lesions, results are even more disappointing and usage should be discouraged. When developed, newer generation scaffolds with thinner struts or faster resorption rates are expected to improve outcomes. In the meantime prolonged dual antiplatelet therapy (DAPT, beyond one year) is recommended in an individu-alised approach for patients treated with current generation BVS. Conclusion The new 2017 recommendations downgrade and limit the use of the current BVS to experienced centres within dedicated registries using the updated implantation protocol and advise the prolonged usage of DAPT. In line with these recommendations the manufacturer does not supply devices to the hospitals without such registries in place

Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction

Aims: Limited data are currently available on midterm outcomes after implantation of everolimus-eluting bioresorbable vascular scaffolds (BVS) for treatment of acute ST-elevation myocardial infarction (STEMI). Methods and results: Patients presenting with STEMI and undergoing primary percutaneous coronary intervention in the initial experience with BVS were evaluated and compared with patients treated with everolimus-eluting metal stents (EES) by applying propensity matching. Quantitative coronary angiography analysis, and 18-month clinical follow-up were reported. A total of 302 patients were analysed, 151 with BVS and 151 with EES. Baseline clinical characteristics were similar between groups. Final TIMI 3 flow was 87.4% vs. 86.1%, p=0.296. At 18-month follow-up, all-cause mortality was 2.8% vs. 3.0% in the BVS and EES groups respectively, p=0.99; the MACE rate was higher in the BVS group (9.8% vs. 3.6%, p=0.02); target lesion revascularisation was 5.7% vs. 1.3%, p=0.05. The 30-day MACE rate in BVS patients without post-dilatation was 6.8%, while in patients with post-dilatation it was 3.6%. Scaffold thrombosis (ST) occurred primarily in the acute phase (acute ST 2.1% vs. 0.7%, p=0.29; subacute 0.7% vs. 0.7%, p=0.99; late 0.0% vs. 0.0%; very late 1.5% vs. 0.0%, p=0.18). All three BVS cases with acute ST had no post-dilatation at the index procedure. Conclusions: STEMI patients treated during the early experience with BVS had similar acute angiographic results as compared with the EES group. Clinical midterm follow-up data showed a higher clinical events rate compared with metal stents. The majority of clinical events occurred in the early phase after implantation and mainly in cases without post-dilatation. Optimisation of the implantation technique in the acute clinical setting is of paramount importance for optimal short and mid-term outcomes

Are BVS suitable for ACS patients? Support from a large single center real live registry

Objectives To investigate one-year outcomes after implantation of a bioresorbable vascular scaffold (BVS) in patients presenting with acute coronary syndrome (ACS) compared to stable angina patients. Background Robust data on the outcome of BVS in the setting of ACS is still scarce. Methods Two investigator initiated, single-center, single-arm BVS registries have been pooled for the purpose of this study, namely the BVS Expand and BVS STEMI registries. Results From September 2012-Octob

Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study

AimsWe evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI).Methods and resultsThe present investigation is a prospective, single-arm, single-centre study, reporting data after the BVS implantation in STEMI patients. Quantitative coronary angiography and optical coherence tomography (OCT) data were evaluated. Clinical outcomes are reported at the 30-day follow-up. The intent-to-treat population comprises a total of 49 patients. The procedural success was 97.9%. Pre-procedure TIMI-flow was 0 in 50.0% of the patients; after the BVS implantation, a TIMI-flow III was achieved in 91.7% of patients and the post-procedure percentage diameter stenosis was 14.7 ± 8.2%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography analysis performed in 31 patients showed that the post-procedure mean lumen area was 8.02 ± 1.92 mm2, minimum lumen area 5.95 ± 1.61 mm2, mean incomplete scaffold apposition area 0.118 ± 0.162 mm2, mean intraluminal defect area 0.013 ± 0.017 mm2, and mean percentage malapposed struts per patient 2.80 ± 3.90%. Scaffolds with >5% malapposed struts were 7. At the 30-day follow-up, target-lesion failure rate was 0%. Non-target-vessel revascularization and target-vessel myocardial infarction (MI) were reported. A non-target-vessel non-Q-wave MI occurred. No cases of cardiac death or scaffold thrombosis were observed.ConclusionIn the present series, the BVS implantation in patients presenting with acute MI appeared feasible, with high rate of final TIMI-flow III and good scaffold apposition. Larger studies are currently needed to confirm these preliminary data