Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial.

OBJECTIVES: This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions. BACKGROUND: Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes. METHODS: The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months. RESULTS: Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm. CONCLUSIONS: In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Role of optical coherence tomography for distal left main stem angioplasty.

OBJECTIVE: The objective is to analyze the acute and midterm angiographic outcome of percutaneous treatment of left main coronary stem (LM-PCI) guided by optical coherence tomography (OCT). BACKGROUND: LM-PCI is a complex procedure, and several anatomical factors may impair its outcome. Intravascular imaging is emerging as a useful tool to guide the procedure. METHODS: We conducted a retrospective analysis of patients undergoing LM-PCI at three European centers between 2014 and 2017 with a control angiography at 6-12 months. Patients were divided into two groups: OCT-guidance (pre- and post-PCI) and control group (standard angiographic guidance with/out intravascular ultrasound [IVUS]). A blinded core lab analyzed all angiographic images. Primary endpoint was late lumen loss (LLL) after 6 months. RESULTS: A total of 112 patients entered the study, 55 in the OCT group and 57 in the control group (10 IVUS). Baseline and procedural characteristics were similar between groups. Overall, reference vessel diameter of the LM was 3.98 ± 0.65 mm. OCT guidance detected four cases of stent underexpansion (7.2%) and six cases of acute malapposition (10.9%). After a median of 207 ± 23 days, LLL of LM tended to be lower in the OCT group (0.12 ± 0.41 vs. 0.26 ± 0.52 mm, p = .10), and was significantly reduced in the distal portion of the main vessel (0.03 ± 0.45 vs. 0.24 ± 0.53 mm, p = .025). Percent diameter stenosis was also lower (14 ± 9 vs. 19 ± 16%, p = .05). Adverse event rates were similar in the two groups. CONCLUSIONS: In this study, systematic OCT guidance during LM-PCI allowed a timely detection and correction of acute stent underexpansion and malapposition, and was associated with signs of improved angiographic outcome at midterm, compared to standard practice.

Clinical performance of a dedicated self-apposing stent for the treatment of left main stem disease. Results of the left Main AngioplasTy wIth a Self-apposing StEnt - the MATISSE study.

BACKGROUND: In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease. METHODS AND RESULTS: MATISSE is a retrospective, multicenter registry, which enrolled 151 patients treated with the device at 17 international centers. Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE), a composite endpoint of cardiac death, target lesion revascularization (TLR) and target-vessel myocardial infarction, at 9months clinical follow-up. Secondary endpoints included procedural success, the single determinants of MACE and stent thrombosis. Lesions were located in distal LM bifurcation in 84% of the patients. Procedural success was achieved in 150 patients. The average follow-up length was 348±52days. MACE occurred in 14 (9.3%) patients with 2 (1.3%) cardiac deaths. TLR occurred in 8 patients (5.3%). There were 2 cases of definite stent thrombosis, 1 acute and 1 very late. CONCLUSIONS: A self-apposing stent, when used for LM PCI in a real world, high risk population, showed good immediate procedural results with low rates of adverse events at mid-term follow-up.

One-year clinical outcomes after unrestricted implantation of the Absorb bioresorbable scaffold (RAI registry).

AIMS: The aim of this study was to assess outcomes following Absorb bioresorbable scaffold (BVS) implantation in an unrestricted clinical practice according to an "on-label" versus "off-label" indication. METHODS AND RESULTS: RAI is a prospective registry, investigating BVS performance in different lesion subsets. No specific exclusion criteria were applied. Co-primary endpoints were target lesion revascularisation (TLR) and definite/probable scaffold thrombosis (ScT) at one year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients, BVS was implanted in at least one off-label subset according to the manufacturer's instructions for use. Predilatation was performed in 98.5% of the cases, and post-dilatation in 96.8%. At one-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% vs. 2.2%, HR 1.8, 95% CI: 1.0-3.4; p=0.05) while a trend towards a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%, HR 2.7, 95% CI: 0.9-8.2; p=0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR. CONCLUSIONS: Our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcomes when meticulously implanted. However, a higher rate of adverse events was observed when this device was used in off-label lesions.

First experience of drug-coated balloons for treatment of bioresorbable vascular scaffold restenosis.

OBJECTIVES: The aim of this study is to evaluate the role of drug-coated balloons (DCB) for the management of bioresorbable vascular scaffold (BVS) restenosis. METHODS AND RESULTS: In a series of 25 BVS restenosis discovered during systematic angiographic follow up of 246 consecutive BVS implantations at our institution, DCB was used as a primary therapeutic tool in 9 patients and 3 different types of DCB were used. Follow-up coronary angiography at 12months after DCB treatment was performed to all the patients. Among the 9 patients treated with DCB, angiographic follow up revealed failure in two patients that experienced type III restenosis (both of them treated with the same type of DCB). Both patients were treated with drug eluting stent implantation. CONCLUSIONS: In this case series of consecutive patients with BVS restenosis, the use of certain types of DCB is safe and effective in order to maintain vessel patency at mid-term follow up. Despite the small sample size and the study limitations, DCB can provide therefore an alternative treatment option in this setting, avoiding the implantation of further metallic stents in a patient where a different strategy was initially planned.

Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry.

BACKGROUND AND PURPOSES: Drug-coated balloons (DCB) currently represent an alternative to drug-eluting stents (DES) for the treatment of in-stent restenosis and they are also variably used for small coronary vessel and bifurcation lesion management. All DCB variably elute paclitaxel as an anti-proliferative drug. The first sirolimus coated balloon (SCB) received the CE mark in 2016, but its clinical performance has not been shown yet. METHODS AND RESULTS: FASICO in an all-comer registry of the first consecutive patients with at least one lesion treated with SCB between March and July 2016 at the first European centre that used this device. All patients were prospectively enrolled in a dedicated database. Primary endpoint was procedural success; co-primary endpoint was the rate of major adverse cardiac events at short-term follow-up. The 32 patients (34 lesions) enrolled had at least 6-month clinical follow up available. Forty-five percent had diabetes and indication to PCI was ISR in 47% of the cases. Lesions were always pre-dilated and device deployment was successful in all the cases. Procedural success was achieved in 100% of patients. We observed 3 cases of TLR at follow-up. CONCLUSIONS: SCB shows high immediate technical performance and adequate short-term efficacy and safety. The ongoing EASTBOURNE registry will shed light on mid-and long-term performance of this device in an adequately powered population.

Stress-induced cardiomyopathy and psychological wellbeing 1 year after an acute event.

Stress cardiomyopathy (SCM) typically presents similar symptoms to acute myocardial infarction (AMI). However, these symptoms differ when it comes to a transient and completely reversible myocardial dysfunction, which is frequently precipitated by acute stressful events, occurring in the absence of plaque rupture and coronary thrombosis. The purpose of this study was to investigate health-related quality of life (HRQL) and emotional burden subsequent to cardiac events in SCM patients. Thirty-seven SCM patients were compared with 37 matched AMI patients. All selected patients were assessed for HRQL and psychological distress at baseline and 1-year after the acute event. After controlling for covariates, scores on the Psychological General Well Being Index indicated that depressed mood had increased in both groups, but the increase for SCM patients was greater than for AMI patients. The AMI group displayed greater decreases than the SCM in physical quality of life and in total cardiac-related health quality of life. The percentage of patients with psychological distress increased significantly more in the SCM group than in the AMI group, and it made no difference whether the triggering event was emotional or physical. Our results suggest that, despite the more favorable medical prognosis of SCM patients, their cardiac condition being transient and resolving completely in few weeks, the psychological impact associated with their condition is more negative 1 year later than in the case of AMI patients whose medical prognosis is less favorable, and this difference is independent of type of trigger event.

Type D personality is associated with the development of stress cardiomyopathy following emotional triggers.

BACKGROUND: Stress cardiomyopathy (SCM) can be triggered by emotional events. Recently, type D personality has been established as an independent predictor of acute cardiac adverse events. PURPOSE: We sought to examine whether type D personality can be identified in SCM patients. METHODS: A case-control study with 37 SCM patients, 37 myocardial infarction (AMI) patients, who both experienced emotional triggering, and 37 SCM patients without emotional triggers was performed. The DS14 and Interview for Recent Life Events were administered. RESULTS: Twenty-eight (76 %) SCM emotional trigger patients were categorized as type D compared with 13 (43 %) SCM patients without emotional trigger and 12 (32 %) AMI patients (p < 0.001). SCM patients with emotional triggers had higher scores on the social inhibition subscale than the other patient groups. CONCLUSIONS: The present study highlights the possible link between type D, with a specific key role for social inhibition component, and increased biological reactivity to acute emotional stress.

Clinical impact of thrombectomy in acute ST-elevation myocardial infarction: an individual patient-data pooled analysis of 11 trials.

AIMS: Thrombectomy in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) is associated to better myocardial reperfusion. However, no single trial was adequately powered to asses the impact of thrombectomy on long-term clinical outcome and to identify patients at higher benefit. Thus, we sought to assess these issues in a collaborative individual patient-data pooled analysis of randomized studies (study acronym: ATTEMPT, number of registration: NCT00766740). METHODS AND RESULTS: Individual data of 2686 patients enrolled in 11 trials entered the pooled analysis. Primary endpoint of the study was all-cause mortality. Major adverse cardiac events (MACE) were considered as the occurrence of all-cause death and/or target lesion/vessel revascularization and/or myocardial infarction (MI). Subgroups analysis was planned according to type of thrombectomy device (manual or non-manual), diabetic status, IIb/IIIa-inhibitor therapy, ischaemic time, infarct-related artery, pre-PCI TIMI flow. Clinical follow-up was available in 2674 (99.6%) patients at a median of 365 days. Kaplan-Meier analysis showed that allocation to thrombectomy was associated with significantly lower all-cause mortality (P = 0.049). Thrombectomy was also associated with significantly reduced MACE (P = 0.011) and death + MI rate during the follow-up (P = 0.015). Subgroups analysis showed that thrombectomy is associated to improved survival in patients treated with IIb/IIIa-inhibitors (P = 0.045) and that the survival benefit is confined to patients treated in manual thrombectomy trials (P = 0.011). CONCLUSION: The present large pooled analysis of randomized trials suggests that thrombectomy (in particular manual thrombectomy) significantly improves the clinical outcome in patients with STEMI undergoing mechanical reperfusion and that its effect may be additional to that of IIb/IIIa-inhibitors.

Individual patient-data meta-analysis comparing clinical outcome in patients with ST-elevation myocardial infarction treated with percutaneous coronary intervention with or without prior thrombectomy. ATTEMPT study: a pooled Analysis of Trials on ThrombEctomy in acute Myocardial infarction based on individual PatienT data.

BACKGROUND: Available data from randomized trials on thrombectomy in patients with ST-elevation myocardial infarction (STEMI) have shown favorable trends in myocardial reperfusion. However, few data are available on the effect of thrombectomy on clinical outcome. Thus we have designed a collaborative individual patient-data meta-analysis which aimed to assess the long-term clinical outcome in STEMI patients randomized to percutaneous coronary intervention (PCI) with or without thrombectomy. METHOD: After a thorough database search, the principal investigators of randomized trials comparing thrombectomy with standard PCI in patients with STEMI were contacted. Principal investigators as authors of 11 randomized studies agreed to participate and were asked to complete a structured database by providing a series of key pre-PCI clinical and angiographic data as well as the longest available clinical outcome of the patients enrolled in the corresponding trial. The primary end-point of this pooled analysis is the comparison of overall survival rates between patients randomized to PCI with thrombectomy or PCI without thrombectomy. The secondary end-points are survival free from myocardial infarction (MI), target lesion revascularization (TLR), major adverse coronary events (MACE: death + MI + TLR) and death + MI between patients randomized to PCI with thrombectomy or PCI without thrombectomy. A pre-defined subgroup analysis is planned considering the following variables: type of thrombectomy device used, diabetes, rescue PCI, IIb/IIIa-inhibitors use, time-to-reperfusion, infarct-related artery, and pre-PCI TIMI flow. IMPLICATIONS: This study will provide useful data on the effect of the reported improved myocardial perfusion associated with thrombectomy on the long-term clinical outcome in patients with STEMI.

Functional derangement and cardiac innervation in the apical ballooning syndrome: a 123I-meta-iodobenzylguanidine scintigraphic and dobutamine stress echocardiographic study.

Several cases of transient left ventricular apical ballooning syndrome have already been described, but the pathophysiological mechanisms of this syndrome still remain unclear. We report the case of a patient evaluated in the acute phase of apical ballooning by coronary angiography and echocardiography who was submitted to I-meta-iodobenzylguanidine (MIBG) myocardial scintigraphy and dobutamine stress echocardiography one month after the discharge. MIBG scintigraphy demonstrated a decreased tracer uptake in the apical and periapical anterior regions, whilst myocardial perfusion at rest was normal. Dobutamine induced an increased left ventricular outflow tract gradient and hypokinesis in the apical and periapical segments, mimicking the findings that occurred in the acute phase, and in agreement with the location of MIBG abnormalities. After a two-month treatment with carvedilol, MIBG uptake increased in the apical and periapical anterior regions.

Relation of terminal QRS distortion to left ventricular functional recovery and remodeling in acute myocardial infarction treated with primary angioplasty.

The association between admission electrocardiogram and 6-month change in left ventricular function and volume was assessed in 200 patients who had acute myocardial infarction that was treated with primary percutaneous coronary intervention. Logistic regression analysis indicated peak creatine phosphokinase-MB, number of Q-wave leads, QRS interval distortion, wall motion score index, and angiographic Thrombolysis In Myocardial Infarction flow grade as predictors of no functional recovery and QRS interval distortion and Thrombolysis In Myocardial Infarction flow grade as predictors of left ventricular remodeling.

Distal protection in native coronary arteries during primary angioplasty in acute myocardial infarction: single-center experience.

Distal embolization of plaque or thrombotic debris is one of the mechanisms involved in the ischemia/reperfusion injury during primary percutaneous intervention for acute occlusion of a native coronary artery. We tested the clinical application of maximal antiplatelet therapy with abciximab combined with one of two different systems of mechanical distal protection: balloon occlusion and aspiration (PercuSurge) in 24 cases and a distal filter (FilterWire Ex) in 10 cases. Feasibility, technical limitations, and pitfalls are described.