Alfredo Marchese

A Randomized Multicenter Study Comparing a Paclitaxel Drug-Eluting Balloon With a Paclitaxel-Eluting Stent in Small Coronary Vessels: The BELLO (Balloon Elution and Late Loss Optimization) Study

OBJECTIVES The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel-eluting stents (PES) for the reduction of restenosis in small vessels. BACKGROUND DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de novo disease. METHODS BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicenter trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary endpoints were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. RESULTS Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter <2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference -0.21; 95% CI: -0.34 to -0.09; p(noninferiority) < 0.001; p(superiority) = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (10% vs. 14.6%; p = 0.35), [corrected] target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (10% vs. 16.3%; p = 0.21). [corrected]. CONCLUSIONS Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES. (Balloon Elution and Late Loss Optimization [BELLO]; Study NCT01086579).

Analysis of microvascular integrity, contractile reserve, and myocardial viability after acute myocardial infarction by dobutamine echocardiography and myocardial contrast echocardiography

The purpose of this study was to evaluate, in postinfarction dysfunctioning myocardium, the relative potential of myocardial contrast and low-dose dobutamine echocardiography in detecting myocardial viability, and the relation between microvascular integrity, contractile reserve, and functional recovery at follow-up. Twenty-four patients with recent myocardial infarction were studied before hospital discharge with low-dose dobutamine and myocardial contrast echocardiography. In the dysfunctioning infarct area, wall motion score index was calculated at baseline, during low-dose dobutamine, and at 3-month follow-up. Revascularization of the infarct-related artery was performed if clinically indicated. Eighteen patients (group A) had myocardial enhancement of the dysfunctioning infarct area at myocardial contrast echocardiography of >50%, whereas the remaining patients (group B) had an increase of < or = 50%. Wall motion score index was similar at baseline in groups A and B (2.6 +/- 0.4 and 2.8 +/- 0.2; p = NS), but it improved during low-dose dobutamine and at follow-up only in group A (1.9 +/- 0.9 and 1.9 +/- 0.7, respectively; p <0.001 vs baseline). In group B, wall motion score index was 2.7 +/- 0.4 with low-dose dobutamine and 2.8 +/- 0.2 at follow-up (p = NS vs rest). In identifying viable myocardial segments, myocardial contrast echo had 100% sensitivity and 46% specificity, whereas low-dose dobutamine echo had 71% sensitivity and 88% specificity. Thus, microvascular integrity after acute myocardial infarction is a fundamental prerequisite for ensuring myocardial contractile reserve and regional functional recovery. Myocardial contrast and low-dose dobutamine echocardiography have different, but complementary, diagnostic characteristics in detecting myocardial viability.

Clinical Evaluation of a Paclitaxel-Eluting Balloon for Treatment of Femoropopliteal Arterial Disease: 12-Month Results From a Multicenter Italian Registry

OBJECTIVES This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. BACKGROUND Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. METHODS This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤ 15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. RESULTS The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. CONCLUSIONS PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.

2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry.

OBJECTIVES This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. BACKGROUND Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. METHODS Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months. RESULTS A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%). CONCLUSIONS PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization.

A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study.

BACKGROUND/OBJECTIVES A prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. METHODS A total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n=92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. RESULTS Two-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p=0.08). TLR rates in the DEB group were acceptable at 6 months, 1 year and 2 years and did not differ significantly from the PES group (4.4% vs. 7.6%, p=0.37; 6.7% vs. 12.1%, p=0.23; 6.8% vs. 12.1%, p=0.25, respectively). CONCLUSIONS Our results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2 years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.

Incidence and outcome of switching of oral platelet P2Y12 receptor inhibitors in patients with acute coronary syndromes undergoing percutaneous coronary intervention: the SCOPE registry

AIMS In patients with acute coronary syndromes (ACS) undergoing a percutaneous coronary intervention (PCI), switching of oral P2Y12 receptor inhibitors may frequently occur. We aimed to assess the current incidence of switching of oral P2Y12 receptor inhibitors and its safety in consecutive ACS patients undergoing PCI over a three-month period. METHODS AND RESULTS The SCOPE registry was a multicentre, observational, prospective study. A total of 1,363 consecutive patients were enrolled in 39 PCI centres across Italy. Switching of oral antiplatelet therapies occurred in 2.3% in the cathlab, 3.3% at discharge and 5.1% at follow-up. The cumulative incidence of major adverse cerebrovascular events (MACE) and net adverse cerebrovascular events (NACE: a combination of MACE and bleeding events) was 1.6% and 5.6%, respectively. Among patients receiving an upgrade switching (change from old to novel P2Y12 receptor inhibitors), no ischaemic or bleeding events occurred during the whole study period. On the other hand, downgrade switching (from novel to old P2Y12 receptor inhibitors) was an independent predictor of NACE (OR 5.3; CI: 2.1-18.2; p=0.04). CONCLUSIONS Switching of oral antiplatelet therapies is not uncommon among ACS patients undergoing PCI. Notably, switching from clopidogrel to novel P2Y12 receptor inhibitors appears safe, while a downgrade switching in early phases of ACS is associated with adverse clinical events.

Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients – results from the BELLO (balloon elution and late loss optimization) trial

OBJECTIVES To evaluate the impact of diabetes on the efficacy of drug-eluting balloon (DEB) as compared to paclitaxel-eluting stent (PES) for the reduction of restenosis in small vessels according to the presence of diabetes in patients enrolled in the BELLO (Balloon Elution and Late Loss Optimization) trial. BACKGROUND Small vessel disease is common in diabetic patients but currently there are no available data regarding DEB in these patients. METHODS In the BELLO trial, 182 patients with lesions in small vessels were randomized 1:1 to receive DEB or PES. In the current sub analysis, patients were stratified according to the presence of diabetes. The diabetic group consisted of 74 patients (DEB=39, PES=35) and the nondiabetic group of 108 patients (DEB=51, PES=57). Angiographic endpoints examined were in-stent/in-balloon and in-segment late loss and binary restenosis at 6 months. Clinical endpoints were major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 1 year. RESULTS In-stent/in-balloon late loss was significantly less with DEB as compared to PES in both diabetic (0.05±0.41 vs. 0.30±0.51mm, p=0.033) and nondiabetic patients (0.10±0.36 vs. 0.29±0.40mm, p=0.015). In patients with diabetes, angiographic restenosis and in-segment late loss were significantly lower with DEB as compared to PES (respectively, 6.3% vs. 25.0%; p=0.039 and -0.013±0.39 vs. 0.25±0.53; p=0.023), with no differences noted in nondiabetic patients. The cumulative MACE rate at 1 year was similar between DEB and PES in both the diabetic (13.2% vs. 25%, p=0.194) and nondiabetic groups (11.8% vs. 14.3%, p=0.699). CONCLUSIONS Diabetes does not appear to have a negative impact on the efficacy of DEB in small vessels, which were associated with better angiographic outcomes at 6 months in this complex subgroup. Larger studies are needed to confirm these findings.

Documento di posizione SICI-GISE: Utilizzo di Absorb BVS nella pratica clinica

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.

Doppler continuous-wave analysis of grafted mammary artery as a non-invasive technique for static and dynamic assessment of coronary flow in man

SummaryIn this paper, Doppler continuous-wave analysis of blood velocity in the internal mammary artery, anastomosed to the left coronary vascular bed in humans who have undergone myocardial revascularization, is proposed as a non-invasive technique to study coronary blood flow during physiological procedures which cause it to change. Blood velocity curves obtained in normal and anastomosed internal mammary arteries were compared during hyperventilation and the Valsalva manoeuvre. During hyperventilation, blood velocity increased in the normal mammary but not in the anastomosed artery. During the expiratory effort of the Valsalva manoeuvre, the mean blood velocity decreased in the normal mammary artery but it did not change significantly in the anastomosed artery. Variations in the mean velocity were largely prevented by simultaneous and well-balanced increases and decreases in the diastolic and systolic velocities, respectively.

A propensity score matched comparative study between paclitaxel-coated balloon and everolimus-eluting stents for the treatment of small coronary vessels

To compare the long‐term clinical outcomes of paclitaxel drug‐coated‐balloons (DCB) and everolimus‐eluting‐stents (EES) following the treatment of de novo small vessel coronary artery disease.