Bernardo Cortese

Harrington Heart & Vascular Center · Coronary Center

Drug-coated balloons (DCBs) have emerged as an increasingly valuable option for the treatment of coronary artery disease (CAD). Percutaneous coronary intervention (PCI) with DCBs enables the localized delivery of antiproliferative drugs directly to the target coronary lesion, avoiding the need for permanent scaffold implantation. Historically, pacl...

Background The-long term outcomes of patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. Purpose This study aims to investigate the outcomes of patients with drug-eluting stents (DES)-ISR presenting with CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB)...

Background Drug coated balloon (DCB) is a treatment option for a lesion in a small coronary artery. The effect of DCB is proven in mechanistic and clinical outcomes, however, its influence on the microvascular function has not been elucidated. In addition, because there are differences in the types of drugs and coatings among different DCBs, their...

Background Despite the improvements in drug eluting stents (DES) technology, suboptimal results have been observed in certain higher‐risk subsets of patients, as in diabetes mellitus (DM). Drug‐coated balloons (DCB) could represent an alternative to DES in complex populations and anatomies, as in DM. Aims The present meta‐analysis aimed at assessi...

Key points The usage of drug coated balloon (DCB) is escalating globally, but the data mainly exists for certain lesion and patient subsets; in‐stent restenosis, small vessel disease, high bleeding risk patients and bifurcation lesions. As of now there is lack of data on the use of DCB in large vessels and we are sceptical whether we can prove supe...

Background Percutaneous coronary intervention (PCI) with drug‐coated balloons (DCB) or drug‐eluting stents (DES) are well‐established treatments for in‐stent restenosis, however little is known about the impact of vessel size on the outcomes. The study aimed to evaluate the efficacy and safety profile of DCB versus DES in DES in‐stent restenosis de...

Drug-coated balloons have emerged as a promising therapeutic option in the treatment of cardiovascular disease. This review article provides an overview of the concept of drug-coated balloons and their clinical applications in both de novo and treated coronary artery disease. A summary of key clinical trials and registry studies evaluating drug-coa...

The Magic Touch sirolimus-coated balloon (SCB) was recently introduced in Europe and features robust clinical technology different from other devices on the market. This device is able to deliver a sufficient sirolimus dose to the target segment to reduce neointimal proliferation with very little exposure downstream and no apparent adverse effects...

Background: The rate of in-stent restenosis (ISR) is decreasing; however, it is still a challenge for contemporary invasive cardiologists. Therapeutic methods, including drug-eluting balloons (DEBs), intravascular lithotripsy, excimer laser coronary atherectomy, and imaging-guided percutaneous coronary intervention (PCI) with drug-eluting stents (D...

BACKGROUND Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. METHODS All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Ba...

Introduction Recent studies have shown gender differences in cardiovascular outcomes after left atrial appendage closure (LAAC), highlighting different complication rates and adverse events, particularly in short-term assessments. As a result, there remains a significant knowledge gap on how these differences directly impact the efficacy and safety...

In patients on oral anticoagulant (OAC) therapy undergoing percutaneous coronary intervention with stent (PCI), international guidelines endorse the use of direct oral anticoagulants (DOAC) rather than vitamin K antagonists (VKA) and dual antithrombotic therapy (DAT) rather than triple antithrombotic therapy (TAT). Aim of this study was to evaluate...

Background: The long-term outcomes for patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. Aims: We aimed to investigate the outcomes for patients with drug-eluting stents (DES)-ISR and CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-D...

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Background International guidelines recommend a dual antithrombotic therapy (DAT) with direct oral anticoagulant (DOAC) for patients on chronic oral anticoagulant therapy (OAT) undergoing percutaneous coronary intervention with stent implantation (PCI–S). However, the implementation of practice Guidelines in the “real world” is often a complex exer...

Purpose of Review Acute coronary syndromes (ACS) are a major global health concern. Percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES) has been endorsed as safe and effective in the management of culprit and non-culprit lesions of ACS. However, permanent metallic implants may have drawbacks, including the need fo...

Background: Coronary bifurcation lesions are associated with less favourable outcome as compared to other lesion subsets. The role of drug-coated balloons (DCB) for bifurcation lesions has been only investigated in small studies so far, which reported encouraging results. We here describe the results of EASTBOURNE-BIF prospective registry, in whic...

Background Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited. Aims Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries. Methods We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling p...

Background The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons. Aims To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch...

Aims The use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) as a new class of drug in treating type 2 diabetes has expanded beyond its original framework. Positive results have been achieved in reducing symptoms in patients with cardiovascular disease (CVD). The aim of this article is to present an in-depth review of the basic principles of...

Background. Coronary bifurcation lesions (CBL) are associated with impaired outcome. The role of drug-coated balloons (DCB) in this setting has been only investigated in small studies so far. Aim. We here describe the design of PRO-DAVID study, aiming at investigating the clinical outcomes of a “provisional DCB” versus a "standard" approach (provis...

Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) represents the treatment of choice for the majority of patients with coronary artery disease. While currently available DES, in addition to physiological support, has failed to show the non-inferiority to coronary artery bypass grafting (CABG) in terms of cumulative incidence o...

Introduction and objectives: The PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (...

Drug‐coated balloons (DCB) offer an excellent alternative to stents as the antiproliferative drugs are delivered via balloons and hence there is no permanent implant of metal or polymer. This rationale applies perfectly in in‐stent restenosis (ISR) as we want to avoid another layer of metal in a previously failed stent. However, their use has also...

Objectives We sought to understand the clinical outcomes of dissections left untreated after sirolimus drug‐coated balloon (DCB) angioplasty. Background DCB may be a valuable alternative to stents for the treatment of native coronary lesions, but the risk of having a dissection after DCB‐angioplasty is not negligible. While type A and B dissection...

European Society of Cardiology (ESC) guidelines gave class I A indication for use of DCB in in‐stent restenosis. However, no indication exists for the usage of DCB in de novo lesions. Although the current generation DES offer excellent results, as we embark more complex lesions such as calcified lesion and chronic total occlusion, restenosis and st...

Background Drug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Biolimus A9™ (BA9), a sirolimus analogue with enhanced lipophilicity, may facilitate enhanced local drug delivery into vascular tissue (figure 1). A novel DCB coated with Biolimus A9 represents an alte...

Objective The role of coronary calcification on clinical outcomes among different revascularization strategies in patients presenting with acute coronary syndromes (ACS) has been rarely investigated. The aim of this investigation is to evaluate the role of coronary calcification, detected by coronary angiography, in the whole spectrum of patients p...

The present study investigates the prognostic value of the Syntax Score II 2020 corrected for flow-limiting lesions and its ability to better address treatment by benefit prediction among patients with left main or multivessel disease. We analyzed 1274 patients from the HALE-BOPP cohort and integrated the Syntax Score II 2020 with the result of the...

Background: It is still unclear the impact of diabetes mellitus (DM) in complex coronary lesions treated with percutaneous coronary intervention (PCI) which themselves are at increased incidence of adverse events. Methods: BIFURCAT registry encompassed patients treated with PCI for coronary bifurcation lesion from the COBIS III and the RAIN regi...

Background: Although Medina 0.0.1 bifurcation lesions are often treated by percutaneous coronary intervention (PCI) in real-world practice, the optimal revascularization strategy for this lesion is uncertain. Objectives: The current study aimed to compare the clinical outcomes between 1-stent and 2-stent strategies in patients treated with PCI f...

Background: A simple, contemporary risk score for the prediction of contrast-associated acute kidney injury (CA-AKI) after percutaneous coronary intervention (PCI) was recently updated, although its external validation is lacking. Objectives: The aim of this study was to validate the updated CA-AKI risk score in a large cohort of acute coronary...

Introduction: Percutaneous coronary intervention (PCI) of bifurcation lesions is technically challenging and associated with higher rates of complications such as stent thrombosis or in-stent restenosis. In this paper, we present the clinical outcomes of BiOSS LIM C (Balton, Poland), a dedicated bifurcation stent. Methods: In this retrospective...

Background The impact of complete revascularization (CR) on the development of heart failure (HF) in patients with acute coronary syndrome and multivessel coronary artery disease undergoing percutaneous coronary intervention remains to be elucidated. Methods and Results Consecutive patients with acute coronary syndrome with multivessel coronary ar...

Drug-coated balloons (DCB) have emerged as a valid alternative for drug-eluting stents in the treatment of in-stent restenosis and de-novo lesions in small vessels. In the past years, a significant effort has been made to investigate the role of this strategy in larger vessel disease, with promising preliminary results being reported for several cl...

Background: Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications. Objectives: This study sought to understand the ro...

Background: Drug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Biolimus A9™ (BA9), a sirolimus analogue with enhanced lipophilicity, may facilitate enhanced local drug delivery into vascular tissue. A novel DCB coated with Biolimus A9™ represents an alternative...

Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shock...

Key Points This study brings new important insights on the role of drug‐coated balloons for calcific lesions management in peripheral interventions, being this therapeutic option less performant in longer calcifications, as assessed by PACSS methodology. The role of intravascular imaging and atherectomy devices, and if these rules can be applied al...

Background: Native vessel coronary artery disease represents 1 of the most attractive fields of application for drug-coated balloons (DCBs). To date, several devices have been compared with drug-eluting stents (DESs) in this setting with different outcomes. Objectives: The authors sought to compare the short- and long-term performance of the pac...

The management of coronary artery disease by means of percutaneous approach have been focused initially to overcome the recoil and acute occlusion after vessel ballooning; therefore, to develop and improve metallic stent platforms, and later drug-eluting technologies. Contemporarily, the necessity emerged to optimize interventional procedures using...

Background Recently, questions around the efficacy and effectiveness of Fractional Flow Reserve (FFR) have arisen in various clinical settings. Methods The Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) study is an investigator-initiated, multicentre, international prospective study enrolling patients who...

Background The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing. Aims To assess the preliminary efficacy and safety profile of PF...

Objectives: To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population. Background: IVL is a relatively new but promising modality for treating coronary calcified lesions, but there is a dearth of long-term outcome data from real-world patients. Methods: This...

Background The impact of complete revascularization (CR) on survival and occurrence of heart failure (HF) after ACS is still unsettled. Goal of this study was to evaluate the impact of CR on HF hospitalization and adverse outcomes in patients with ACS and multivessel coronary artery disease undergoing PCI. Methods Consecutive ACS patients with mul...

Background There are currently some doubts about the efficacy of fractional flow reserve (FFR)-guided revascularization in different clinical settings. Aim To evaluate the long-term outcome of an FFR-deferred strategy in daily practice. Methods The Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) is an inv...

QUESTION: What is the evidence available on the use of drug-coated balloons (DCB) in the de novo lesion setting? ANSWER: The use of DCB to treat de novo lesions is the most compelling argument regarding this technology, an area that has advanced significantly over the last 5 years. Only recently, investigators and companies have begun to understand...

PREGUNTA: ¿Qué evidencias existen para el uso de los balones liberadores de fármaco (BLF) en el contexto de las lesiones de novo? RESPUESTA: El uso del BLF para el tratamiento de lesiones de novo es el argumento más convincente en torno a esta tecnología, un campo que ha experimentado un importante avance durante los últimos 5 años. No ha sido hast...

This chapter examines the role of intravascular imaging guidance for percutaneous left main (LM) intervention, focusing on optical coherence tomography (OCT) to improve clinical outcomes in this setting, along with the initial scientific evidence through clinical trials and meta-analyses.The chapter includes, in detail, an explanation of the patien...

Left main (LM) coronary artery disease is a pathological condition of great clinical relevance due to its significant impact on both morbidity and mortality of patients with ischemic heart disease. An accurate assessment of the extent and characteristics of LM disease is often challenging due to the two-dimensional nature of angiography. For this r...

There is a paucity of data on the contemporary use of non-drug-eluting devices (balloon angioplasty or bare-metal stents) in contemporary percutaneous coronary intervention (PCI) in the United States. We utilized the Nationwide Readmissions Database to identify patients hospitalized to undergo PCI with non-drug-eluting devices from 2016 to 2019. Th...

Left main (LM) coronary artery disease is a high-risk lesion subset, with important prognostic implications for the patients. Recent advances in the field of interventional cardiology have narrowed the gap between surgical and percutaneous approach of this complex lesion setting. However, the rate of repeat revascularization remains higher in the c...

Left main (LM) stem has different structural and anatomical characteristics compared to all of the other segments of the coronary tree, thus its management through percutaneous coronary intervention (PCI) is a challenge and is associated with worse clinical outcome and higher need for revascularization as compared to other lesion settings. Intravas...

Background The presence of calcium in atherosclerotic plaques is a challenge for successful angioplasty and is an independent risk factor for restenosis and stent thrombosis. Despite conventional tools (non-compliant, scoring and cutting balloons and rotational atherectomy), cracking calcium can still be challenging and incomplete. Intra-vascular l...

Background Previous studies investigating predictors of Heart Failure (HF) after acute coronary syndrome (ACS) were mostly conducted during fibrinolytic era or restricted to baseline characteristics and diagnoses prior to admission. We assessed the incidence and predictors of HF hospitalizations among patients treated with percutaneous coronary int...

Objectives The UEFA 2020 European Football Championship held in multiple cities across Europe from June 11 to July 11, 2021, was won by Italy, providing an opportunity to examine the relationship between emotional stress and the incidence of acute cardiovascular events (ACE). Methods and results Cardiovascular hospitalizations in the Cardiac Care...

Aim: Percutaneous coronary intervention with stent implantation (PCI-S) in patients requiring chronic oral anticoagulant therapy (OAC) is associated with an increased risk of bleeding and ischemic complications. Different randomized studies showed a significant advantage of a double antithrombotic therapy and superiority of direct oral anticoagula...

Background: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as...