Davide Piraino

Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection.

OBJECTIVES The authors sought to understand the clinical and angiographic outcomes of dissections left after drug-coated balloon (DCB) angioplasty. BACKGROUND Second-generation DCB may be an alternative to stents in selected populations for the treatment of native coronary lesions. However, the use of these devices may be hampered by a certain risk of acute vessel recoil or residual coronary dissection. Moreover, stenting after DCB has shown limited efficacy. Little is known about when a non-flow-limiting dissection is left after DCB angioplasty. METHODS This was a prospective observational study whose aim was to investigate the outcome of a consecutive series of patients with native coronary artery disease treated with second-generation DCB and residual coronary dissection at 2 Italian centers. We evaluated patient clinical conditions at 1 and 9 months, and angiographic follow up was undertaken at 6 months. RESULTS Between July 2012 and July 2014, 156 patients were treated with DCB for native coronary artery disease. Fifty-two patients had a final dissection, 4 of which underwent prosthesis implantation and 48 were left untreated and underwent angiographic follow-up after 201 days (interquartile range: 161 to 250 days). The dissections were all type A to C, and none determined an impaired distal flow. Complete vessel healing at angiography was observed in 45 patients (93.8%), whereas 3 patients had persistent but uncomplicated dissections, and 3 had binary restenosis (6.2%). Late lumen loss was 0.14 mm (-0.14 to 0.42). Major adverse cardiovascular events occurred in 11 patients in the entire cohort and in 4 of the dissection cohort (7.2% vs. 8.1%; p = 0.48). We observed 8 and 3 target lesion revascularizations, respectively (5.3% vs. 6.2%; p = 0.37). CONCLUSIONS In this cohort of consecutive patients treated with new-generation DCB and left with a final dissection, this strategy of revascularization seemed associated with the sealing of most of dissections and without significant neointimal hyperplasia.

Treatment of bifurcation lesions with drug-coated balloons: A review of currently available scientific data

Bifurcation lesion management still represents a challenge for interventional cardiologists and currently there is a number of different approaches/techniques involving coronary stents. The use of a drug-coated balloon for native coronary vessel management is emerging as an alternative treatment, although in selected patient populations only. In particular, this technology has been tested for the treatment of bifurcations, both for the main vessel and the side branches. Several studies have evaluated this treatment as an alternative or as a therapeutic option complementary to stents, with conflicting and debatable results. However, the perspective of leaving lower metallic burden in this type of lesions is highly appealing and should be deeply investigated. We review here the currently available scientific data and future perspectives on drug-coated balloon use for bifurcation lesions.

Coronary bifurcation lesions: Some questions need an answer to make bioresorbable vascular scaffold technology more "coronary bifurcation-friendly"

In the last years, the use of bioresorbable vascular scaffold (BVS) has been increasing in daily interventional practice, especially in the setting of patients considered off-label until a few years ago as coronary bifurcation lesions (CBL). In these complex lesions, although the introduction of drug eluting stent (DES) has reduced the rate of complications, the incidence of instent restenosis (ISR) and/or stent thrombosis (ST) is still high in both provisional and double strategy [1]. According to the fully resorbable poly-L-lactide (PLLA) structure of BVS, this device might represent an optimal choice to revascularize CBL overcoming the limits of metallic DES struts, because of its temporary scaffold support without permanent metal layers allowing a bifurcation anatomy and vasomotion restoration, a normal flow pattern due to the resorption of the struts across the side branch (SB) with a natural remodeling. However the other side of the coin is the high thickness of its struts and the large profile that decreases the deliverability andmay induce an alteration of flow pattern with an anomalous endothelial shear stress and an unnatural alteration of the bifurcation integrity, due to the formation of tissue bridge called “neo-carina” after struts resorption [2].

Recurrent in-stent restenosis, certainty of its origin, uncertainty about treatment

Treatment of recurrent in-stent restenosis is a real brainteaser for the interventional cardiologist who cannot resort to the guidelines to have indications about the type of treatment to be preferred. The use of intracoronary imaging may provide insights into the underlying mechanisms of this complication and use of drug-coated balloons may be a valid alternative and especially a thoughtful treatment when the repeated and perseverant use of drug-eluting stents clearly fails. In this setting, we present a review of the literature about this interesting topic, going deep into the heart of the problem, its origin and possible treatment options.

STEMI patients and nonculprit lesions: To treat or not to treat? and when? A review of most recent literature.

Patients with ST segment elevation myocardial infarction and multivessel disease represent a high percentage of ischemic patient with a worse outcome than patient with single coronary artery disease. Therefore, initial management of these patients is of high importance, but unfortunately this is not clarified yet. We analyze the available literature trying to afford current doubts to determine which way of revascularization is to be preferred.

Coronary artery fistulas as a cause of angina: How to manage these patients?

Coronary artery fistulas represent the most common hemodynamically significant congenital defect of the coronary arteries and the clinical presentation is mainly dependent on the severity of the left-to-right shunt. We describe a case of a 55-year-old man with history of chest pain and without history of previous significant chest wall trauma or any invasive cardiac procedures. A coronary multislice computed tomography showed two large coronary fistulas arising from the left anterior descending coronary artery and ending in an angiomatous plexus draining into the common pulmonary trunk. Coronary angiography confirmed the CT finding and showed a third fistulous communication arising from the sinus node artery. Although coronary fistulas are infrequent, they are becoming increasingly important because their management and treatment could prevent serious complications. The latest guidelines of the American College of Cardiology/American Heart Association indicate as Class I recommendation the percutaneous or surgical closure for large fistulas regardless of symptoms. In this manuscript, we provide a detailed review of the literature on this topic, focusing on the clinical management of these patients.

Clinical outcomes of overlapping versus non-overlapping everolimus-eluting absorb bioresorbable vascular scaffolds: An analysis from the multicentre prospective RAI registry (ClinicalTrials.gov identifier: NCT02298413)

To compare clinical outcomes of patients treated with overlapping versus non‐overlapping Absorb BVS. Background: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. Methods: We compared outcomes of patients receiving overlapping or non‐overlapping Absorb BVS in the multicenter prospective RAI Registry. Results: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non‐overlap group. The most frequent overlap configuration was the marker‐to‐marker type (48%), followed by marker‐over‐marker (46%) and marker‐inside‐marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow‐up of 368 days, no difference was observed between overlap and non‐overlap groups in terms of a device‐related composite endpoint (cardiac death, TV‐MI, ID‐TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient‐related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device‐ or patient‐related composite endpoints. Conclusions: Outcomes of patients with or without overlapping BVS were comparable at mid‐term follow‐up despite higher angiographic complexity of the overlap subset.

Score System Approach to Diagnose and Manage Spontaneous Coronary Artery Dissection

We have read with great interest the publication by Lezcano Gort et al. The authors have kindly reported their experience in which a 40-year-old postpartum woman with no relevant coronary risk factors was admitted for non–ST-segment elevation myocardial infarction in which optical coherence tomography and intravascular ultrasound images showed a multivessel spontaneous coronary artery dissection (SCAD).

TCT-437 Clinical outcome of coronary bifurcation management with a “fully bioresorbable” technique. Results of the multicentre BBS study

TCT-436 Multi-Center, Post-marketing Evaluation of the Elixir DESolve Novolimus Eluting Bioresorbable Coronary Stent System: 6-month Results from the DESolve PMCF Study Holger Nef, Karl Eugen Hauptmann, Azeem Latib, Lynn Morrison, Sara Toyloy, Lynn Vandertie, Antonio Colombo Universitaetsklinikum Giessen, Giessen, Germany; Trier, Germany; EMO-GVM Centro Cuore Columbus, Milan, Italy; Elixir Medical, sunnyvale, California, United States; Elixir Medical Corporation, Sunnyvale, California, United States; Medical Devices Consultancy, Christchurch, New Zealand; San Raffaele Scientific Institute, Milan, Italy

TCT-425 Bioresorbable vascular scaffold technology for small vessel coronary artery disease: results from the Italian multicenter RAI Registry

RESULTS A total of 207 patients with at least one SV were included in this analysis. Mean follow-up time was 22.4 months 14.9 with 85.8 % of patients having at least 1 year of follow-up. Clinical presentation of pts. (72.4% male, mean age 58.5 11.7 years, 16.4% diabetics, 25.6% with previous PCI and/or CABG) was ACS in 55.1%. Multivessel treatment was perfomed in 17,9% (37 pz). Mean lesion length by QCA was 23.7 11.0 mm and mean RVD was 2.2 0.3 mm with 14.5% of moderate/sever calcification lesions and 19.8 % of bifurcation treatment. Pre-dilatation was performed in 93.2% and post-dilatation in 57.9%. The mean scaffold length was 28.1 15.0 mm with 30.9% of cases using overlapping scaffolds. OCT or IVUS was used in 26.0%. Device success was 99.0% (failure to deliver in 2 pts). Over the entire follow-up period, death occurred in 3.4 % (7/207), myocardial infarction (MI) in 5.3% (11/207), target lesion revascularization in 7.2 % (15/207), target vessel revascularization (TVR) in 8.2% (17/207), non-target vessel revascularization in 2.9 (6/207) %. Overall MACE (death, MI, TVR) rate was 12.0% (25/207). Definite stent thrombosis (ST) occurred in 6 pts. (2.9%), of whom early ST occurred in 4 pts and late ST in 2 pts.