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JACC. Cardiovascular Interventions Jun 2020Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent a novel alternative... (Review)
Review
Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent a novel alternative therapeutic strategy in certain anatomic conditions. The effect of DCBs is based on the fast and homogenous transfer of antiproliferative drugs into the vessel wall during single balloon inflation by means of a lipophilic matrix without the use of permanent implants. Although their use is established for in-stent restenosis of both bare-metal and drug-eluting stents, recent randomized clinical data demonstrate a good efficacy and safety profile in de novo small-vessel disease and high bleeding risk. In addition, there are other emerging indications (e.g., bifurcation lesions, large-vessel disease, diabetes mellitus, acute coronary syndromes). Because the interaction among the different delivery balloon designs, doses, formulations, and release kinetics of the drugs used is important, there seems to be no "class effect" of DCBs. On the basis of the amount of recently published data, the International DCB Consensus Group provides this update of previous recommendations summarizing the historical background, technical considerations such as choice of device and implantation technique, possible indications, and future perspectives.
Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Clinical Decision-Making; Consensus; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Equipment Design; Humans; Risk Factors; Treatment Outcome
PubMed: 32473887
DOI: 10.1016/j.jcin.2020.02.043 -
Journal of the American College of... Mar 2020Percutaneous coronary intervention with a drug-eluting stent is the most common mode of revascularization for coronary artery disease. However, restenosis rates remain... (Review)
Review
Percutaneous coronary intervention with a drug-eluting stent is the most common mode of revascularization for coronary artery disease. However, restenosis rates remain high. Non-stent-based local drug delivery by a drug-coated balloon (DCB) has been investigated, as it leaves no metallic mesh. A DCB consists of a semicompliant balloon coated with antiproliferative agents encapsulated in a polymer matrix, which is released into the wall after inflation and contact with the intima. DCB have demonstrated effectiveness in treating in-stent restenosis. Clinical studies using DCB in de novo coronary artery disease have shown mixed results, with a major benefit in small-vessel disease. Differences in study results are not only due to variations in DCB technology but also to disparity in procedural approach, "leave nothing behind" or "combination therapy," and vessel size. This review focuses on the available evidence from randomized trials and proposes a design for future clinical trials.
Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus
PubMed: 32138967
DOI: 10.1016/j.jacc.2019.12.046 -
JACC. Cardiovascular Interventions Apr 2023Primary percutaneous coronary intervention (pPCI) with drug-eluting stents (DES) has emerged as the standard of care, but stent-related events have persisted.... (Clinical Trial)
Clinical Trial
BACKGROUND
Primary percutaneous coronary intervention (pPCI) with drug-eluting stents (DES) has emerged as the standard of care, but stent-related events have persisted. Drug-coated balloon (DCB)-only angioplasty is an emerging technology, although it is not fully evaluated compared with DES in the context of pPCI.
OBJECTIVES
The aim of this study was to investigate the safety of DCB-only angioplasty compared with second-generation DES in pPCI.
METHODS
All-cause mortality and net adverse cardiac events (cardiovascular mortality, acute coronary syndrome, ischemic stroke or transient ischemic attack, major bleeding, and unplanned target lesion revascularization [TLR]) were compared among all patients treated with DCBs only or with second-generation DES only for first presentation of ST-segment elevation myocardial infarction (STEMI) due to de novo disease between January 1, 2016, and November 15, 2019. Patients treated with both DCBs and DES were excluded. Data were analyzed using Cox regression models, Kaplan-Meier estimator plots and propensity score matching.
RESULTS
Among 1,139 patients with STEMI due to de novo disease, 452 were treated with DCBs and 687 with DES. After a median follow-up period of >3 years, all-cause mortality was 49 of 452 and 62 of 687 in the DCB and DES groups, respectively (P = 0.18). On multivariable Cox regression analysis, there was no difference in mortality between DCBs and DES in the full and propensity score-matched cohorts. Age, frailty risk, history of heart failure, and family history of ischemic heart disease remained significant independent predictors of mortality. There was no difference in any of the secondary endpoints, including unplanned TLR.
CONCLUSIONS
DCB-only angioplasty appears safe compared with DES for STEMI in terms of all-cause mortality and all net adverse cardiac events, including unplanned TLR. DCB may be an efficacious and safe alternative to DES in selected patient groups. (Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty; NCT04482972).
Topics: Humans; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Drug-Eluting Stents; Paclitaxel; ST Elevation Myocardial Infarction; Treatment Outcome
PubMed: 37045498
DOI: 10.1016/j.jcin.2023.01.380 -
JACC. Cardiovascular Interventions Sep 2022The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied.
OBJECTIVES
This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT).
METHODS
Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization.
RESULTS
Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups.
CONCLUSIONS
In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Treatment Outcome; Vascular Calcification
PubMed: 36137691
DOI: 10.1016/j.jcin.2022.07.034 -
The Journal of Invasive Cardiology May 2020Accordion effect or concertina effect - also known as "crumpled coronary" - is an uncommon occurrence during coronary angioplasty. It usually has no major clinical...
Accordion effect or concertina effect - also known as "crumpled coronary" - is an uncommon occurrence during coronary angioplasty. It usually has no major clinical sequelae and should be differentiated from spasm, dissection, and thrombosis, which require special management.
Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Humans
PubMed: 32357138
DOI: No ID Found -
JACC. Cardiovascular Interventions Dec 2020This 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... (Randomized Controlled Trial)
Randomized Controlled 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).
Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Germany; Humans; Pharmaceutical Preparations; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome
PubMed: 33248978
DOI: 10.1016/j.jcin.2020.08.035 -
Catheterization and Cardiovascular... Nov 2020Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the...
BACKGROUND
Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison.
METHODS
The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice.
RESULTS
An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques ("provisional" and "inverted provisional") and (b) 2-stent techniques ("T/TAP," "culotte," and "DK-crush").
CONCLUSIONS
The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice.
Topics: Angioplasty, Balloon, Coronary; Clinical Decision-Making; Coronary Artery Disease; Humans; Stents; Treatment Outcome
PubMed: 32579300
DOI: 10.1002/ccd.29071 -
Cardiovascular Diabetology Feb 2022Restenosis, defined as the re-narrowing of an arterial lumen after revascularization, represents an increasingly important issue in clinical practice. Indeed, as the... (Review)
Review
Restenosis, defined as the re-narrowing of an arterial lumen after revascularization, represents an increasingly important issue in clinical practice. Indeed, as the number of stent placements has risen to an estimate that exceeds 3 million annually worldwide, revascularization procedures have become much more common. Several investigators have demonstrated that vessels in patients with diabetes mellitus have an increased risk restenosis. Here we present a systematic overview of the effects of diabetes on in-stent restenosis. Current classification and updated epidemiology of restenosis are discussed, alongside the main mechanisms underlying the pathophysiology of this event. Then, we summarize the clinical presentation of restenosis, emphasizing the importance of glycemic control in diabetic patients. Indeed, in diabetic patients who underwent revascularization procedures a proper glycemic control remains imperative.
Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Diabetes Mellitus; Humans; Stents; Treatment Outcome
PubMed: 35164744
DOI: 10.1186/s12933-022-01460-5 -
Cardiovascular Intervention and... Apr 2023Drug-coated balloon (DCB) technology was developed to deliver the antiproliferative drugs to the vessel wall without leaving any permanent prosthesis or durable... (Review)
Review
Drug-coated balloon (DCB) technology was developed to deliver the antiproliferative drugs to the vessel wall without leaving any permanent prosthesis or durable polymers. The absence of foreign material can reduce the risk of very late stent failure, improve the ability to perform bypass-graft surgery, and reduce the need for long-term dual antiplatelet therapy, potentially reducing associated bleeding complications. The DCB technology, like the bioresorbable scaffolds, is expected to be a therapeutic approach that facilitates the "leave nothing behind" strategy. Although newer generation drug-eluting stents are the most common therapeutic strategy in modern percutaneous coronary interventions, the use of DCB is steadily increasing in Japan. Currently, the DCB is only indicated for treatment of in-stent restenosis or small vessel lesions (< 3.0 mm), but potential expansion for larger vessels (≥ 3.0 mm) may hasten its use in a wider range of lesions or patients with obstructive coronary artery disease. The task force of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) was convened to describe the expert consensus on DCBs. This document aims to summarize its concept, current clinical evidence, possible indications, technical considerations, and future perspectives.
Topics: Humans; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Consensus; Coronary Artery Disease; Coronary Restenosis; Percutaneous Coronary Intervention; Treatment Outcome
PubMed: 36847902
DOI: 10.1007/s12928-023-00921-2 -
EuroIntervention : Journal of EuroPCR... Aug 2022The European Bifurcation Club (EBC) supports a continuous review of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion...
The European Bifurcation Club (EBC) supports a continuous review of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The recent focus of meetings and consensus statements has been on the technical issues in bifurcation stenting, recognising that the final result of a bifurcation procedure and the long-term outcome for our patients are strongly influenced by factors, including preprocedural strategy, stenting technique selection, performance of optimal procedural steps, the ability to identify and correct complications and finally, and most important, the overall performance of the operator. Continuous refinement of bifurcation stenting techniques and the promotion of education and training in bifurcation stenting techniques represent a major clinical need. Accordingly, the consensus from the latest EBC meeting in Brussels, October 2021, was to promote education and training in bifurcation stenting based on the EBC principle. Part II of this 16th EBC consensus document aims to provide a step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the second stent either in the provisional stenting (PS) strategy or in upfront 2-stent techniques (e.g., 2-stent PS pathway and double kissing crush stenting). Finally, a detailed overview and discussion of the numerous modalities available to provide continuous education and technical training in bifurcation stenting techniques are discussed, with consideration of their future application in enhancing training and practice in coronary bifurcation lesion treatment.
Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Humans; Percutaneous Coronary Intervention; Stents; Treatment Outcome
PubMed: 35570753
DOI: 10.4244/EIJ-D-22-00166