Circulating intermediate monocytes CD14++CD16+ are increased after elective percutaneous coronary intervention.

AIM: Inflammation plays a central role in the pathogenesis of atherosclerosis and in the sequelae of percutaneous coronary intervention (PCI). Previous work demonstrated that intermediate monocytes (CD14++CD16+) are associated with adverse cardiovascular events, yet monocyte subset response following elective PCI has not been described. This article explores the changes in monocyte subset and humoral response after elective PCI. METHODS: This prospective study included 30 patients without inflammatory diseases being referred for elective PCI. We included patients treated with drug coated balloons or 2nd generation drug eluting stents. Patients underwent blood tests at baseline (prior to PCI), four hours, two weeks and two months later. Analyses were performed in terms of monocyte subsets (classical CD14++CD16-, intermediate CD14++CD16+ and non-classical CD14+CD16++), gene expression of CD14+ leucocytes and humoral biomarkers. RESULTS: Intermediate monocytes decreased significantly four hours after PCI, were recovered at two weeks, and increased significantly at two months post elective, uncomplicated PCI. They remain significantly elevated in the DES group but not in the DCB group. Gene expression analysis of CD14+ leucocytes showed IL18 had decreased expression at two weeks, CXCR4 and IL1ß decreased at two months, while pentraxin 3 increased at two weeks and two months. In terms of humoral biomarkers, hsTnI remains elevated up to two weeks post PCI while IL6 and TNFα remain elevated till two months post PCI. CONCLUSION: Intermediate monocytes increase significantly two months following elective, uncomplicated PCI. They remain significantly elevated in the DES group but not in the DCB group suggesting that the PCI strategy could be one of the ways to modulate the inflammatory response post PCI.

Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease.

AIMS: We aimed to perform a cost analysis of drug coated balloon (DCB)-only angioplasty versus drug eluting stent (DES), for de novo disease of all vessel sizes and all clinical indications. BACKGROUND: DCB angioplasty is an emergent technology for the treatment of coronary artery disease. There is lack of data regarding the cost-effectiveness of DCB-only angioplasty for treatment of de novo coronary artery disease as compared with second generation DES. METHODS: We compared total costs of patients treated with DCB or DES for first presentation of ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or stable angina due to de novo disease between January 1, 2018 and November 15, 2019. We defined total cost as the sum of (1) procedural devices-cost, (2) procedural staff-cost, (3) post-percutaneous coronary intervention hospital stay cost, and (4) antiplatelet regime cost. A cost minimization analysis was performed to compare the costs of DCB and DES. RESULTS: We present 1952 all-comer, consecutive patients; 902 (1064 lesions) treated with DCB and 1050 (1236 lesions) treated with DES for de novo coronary artery disease. The cost per patient was estimated to be £9.02 more expensive in the DCB group (£3153.00 vs. £3143.98). However, the cost per lesion treated was calculated to be £15.51 cheaper in the DCB group (£3007.56 vs. £3023.07). The results were consistent irrespective of duration of long-term antiplatelet medications. CONCLUSION: We have compared the cost-effectiveness of DCB-only angioplasty to DES-angioplasty and showed that the per patient and per lesion results were not different and hence cost should not be implicated in the decision to choose DCB or DES.

Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI.

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).

Drug-Coated Balloon vs. Drug-Eluting Stents for De Novo Unprotected Left Main Stem Disease: The SPARTAN-LMS Study.

The objective of this study is to compare the outcomes of patients treated with drug-coated balloons (DCBs) or second-generation drug-eluting stents (DESs) for de novo unprotected left main stem (LMS) disease. Previous studies comparing the treatment of LMS disease suggest that the mortality for DES PCI is not worse than CABG. There are limited data from studies investigating the treatment of de novo LMS disease with DCB angioplasty. We compared the all-cause and cardiac mortality of patients treated with paclitaxel DCB to those with second-generation DES for de novo LMS disease from July 2014 to November 2019. Data were analysed using Kaplan-Meier analyses and propensity-matched analyses. A total of 148 patients were treated with either a DCB or DES strategy. There was no significant difference in all-cause mortality in the DCB group (19.5%) compared to the DES group (15.9%) (HR 1.42 [0.61-3.32], p = 0.42). Regarding cardiac mortality, 2 (4.9%) were recorded for the DCB group and 7 (6.5%) for the DES group (HR 1.21 [0.31-4.67], p = 0.786); for target vessel myocardial infarction, there were 0 (0%) for the DCB group and 7 (6.5%) for the DES group; and for target lesion revascularisation, there were 3 (7.3%) in the DCB group and 9 (8.3%) in the DES group (HR: 0.89 [0.24-3.30]). p = 0.86. These remained not significant after propensity score matching. We found no difference in the mortality outcomes with DCB angioplasty compared to second-generation DES, with a median follow-up of 33 months. DCB can therefore be regarded as a safe option in the treatment of LMS disease in suitable patients.

Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial.

BACKGROUND: Drug eluting stents (DES) are associated with a 2% to 4% annual rate of target lesion failure through 5-to-10-year follow-up. The presence of a metallic protheses is a trigger for neo-atherosclerosis and very late stent thrombosis. A "leave nothing behind" strategy using Drug Coated Balloons has been suggested; however, paclitaxel coated balloons are only recommended in selected indications. Recently a novel sirolimus eluting balloon, the SELUTION SLR TM 014 PTCA balloon (SEB) (M.A. MedAlliance SA, Nyon, Switzerland) has been developed. HYPOTHESIS: A strategy of percutaneous coronary intervention (PCI) with SEB and provisional DES is non-inferior to a strategy of systematic DES on target vessel failure (TVF) at one and five years. If non-inferiority is met at 5 years, superiority will be tested. DESIGN: SELUTION DeNovo is a multi-center international open-label randomized trial. Subjects meeting eligibility criteria are randomized 1:1 to treatment of all lesions with either SEB and provisional DES or systematic DES. Major inclusion criteria are PCI indicated for ≥1 lesion considered suitable for treatment by either SEB or DES and clinical presentation with chronic coronary syndrome, unstable angina or non-ST segment elevation myocardial infarction (NSTEMI). There is no limitation in the number of lesions to be treated. Target lesions diameters are between 2 and 5 mm. Major exclusion criteria are lesions in the left main artery, chronic total occlusions, ST segment elevation myocardial infarction and unstable non-ST segment elevation myocardial infarction. Three thousand three hundred twenty six patients will be included in 50 sites in Europe and Asia. TVF rates and their components will be determined at 30 days, 6 months and annually up to 5 years post-intervention. Among secondary endpoints, bleeding events, cost-effectiveness data and net clinical benefits will be assessed. SUMMARY: SELUTION DeNovo trial is an open-label, multi-center international randomized trial comparing a strategy of PCI with SEB and provisional DES to a strategy of PCI with systematic DES on TVF at one and five years. Non-inferiority will be tested at one and five years. If non-inferiority is met at five years, superiority will be tested.

CT angiography compared to invasive angiography for stable coronary disease as predictors of major adverse cardiovascular events- A systematic review and meta-analysis.

BACKGROUND: Computational tomography coronary angiography (CTCA) is increasingly the diagnostic test of choice for investigating patients with stable anginal symptoms. OBJECTIVES: We sought to conduct a systematic review and meta-analysis comparing CTCA with invasive coronary angiography (ICA) with regards to major adverse cardiovascular events (MACE), procedural complications and rates of revascularisation. METHODS: We conducted a systematic review and meta-analysis in line with the PRISMA statement. A literature search was conducted using PubMed, MEDLINE Ovid and Embase, with three studies included in meta-analysis. Statistical analysis was undertaken using Review Manager 5.3 for MacOS software and outcomes expressed as odds ratio, with 95% confidence intervals and sensitivity analysis was conducted. RESULTS: A total of 5662 patients were included in this study level meta-analysis. There was no difference in MACE between CT and angiography [2.97% v 3.45%, fixed-effect model, OR: 0.84 (0.62-1.14), p = 0.26, I2 0%] and no difference found in rates of myocardial infarction, death or stroke. CTCA was associated with a reduced rate of revascularisation [12.6% v 18.3%, fixed-effects model, OR: 0.64 (0.55-0.75), p<0.00001, I2 =0%]. However, CTCA was not associated with a significantly lower complication rate [0.5% v 1.72%, random effects model, OR: 0.52 (0.06-4.38), p = 0.55, I2 52%]. CONCLUSION: CTCA is a safe strategy for investigating patients with stable angina with no associated increase in MACE but a reduction in revascularisation rates.

The role of inflammation in percutaneous coronary intervention, from balloon angioplasty to drug eluting stents.

The role of inflammation in percutaneous coronary intervention (PCI) has been investigated in numerous studies. Both pre-PCI and post-PCI inflammatory status have been demonstrated to be linked with patient outcomes. C-reactive protein continues to be the most studied inflammatory biomarker, while a growing number of additional biomarkers, including cytokines and immune cells, are being assessed. As insights are gained into the complexities of the inflammatory response to PCI, it becomes evident that a targeted approach is necessary to ensure optimal patient outcomes. Here, we review the biomarkers that can predict patient outcomes following PCI and specifically how they differ for balloon angioplasty, bare metal stents and drug eluting stents. A specific focus is given to human studies and periprocedural inflammation rather than inflammation associated with myocardial infarction.

Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice.

OBJECTIVE: We aimed to investigate the safety of drug-coated balloon (DCB)-only angioplasty compared to drug-eluting stent (DES), as part of routine clinical practice. BACKGROUND: The recent BASKETSMALL2 trial demonstrated the safety and efficacy of DCB angioplasty for de novo small vessel disease. Registry data have also demonstrated that DCB angioplasty is safe; however, most of these studies are limited due to long recruitment time and a small number of patients with DCB compared to DES. Therefore, it is unclear if DCB-only strategy is safe to incorporate in routine elective clinical practice. METHODS: We compared all-cause mortality and major cardiovascular endpoints (MACE), including unplanned target lesion revascularisation (TLR) of all patients treated with DCB or DES for first presentation of stable angina due to de novo coronary artery disease between 1st January 2015 and 15th November 2019. Data were analysed with Cox regression models and cumulative hazard plots. RESULTS: We present 1237 patients; 544 treated with DCB and 693 treated with DES for de novo, mainly large-vessel coronary artery disease. On multivariable Cox regression analysis, only age and frailty remained significant adverse predictors of all-cause mortality. Univariable, cumulative hazard plots showed no difference between DCB and DES for either all-cause mortality or any of the major cardiovascular endpoints, including unplanned TLR. The results remained unchanged following propensity score-matched analysis. CONCLUSION: DCB-only angioplasty, for stable angina and predominantly large vessels, is safe compared to DES as part of routine clinical practice, in terms of all-cause mortality and MACE, including unplanned TLR.

Drug coated balloons for coronary artery bifurcation lesions: A systematic review and focused meta-analysis.

OBJECTIVES: We sought to systematically review the evidence supporting the role of drug coated balloons (DCBs) in the treatment of coronary bifurcation lesions. BACKGROUND: DCBs are emerging as an attractive alternative treatment strategy for treating coronary bifurcations due to simplifying the approach and reducing rates of stent related complications. We systematically reviewed the evidence for DCB use in coronary bifurcations and conducted a focused meta-analysis on late lumen loss in the side branch comparing DCB and plain old balloon angioplasty (POBA). METHODS: This study was conducted in line with the PRISMA statement. All studies (including both RCTs and observational studies, excluding case reports) using DCB as part of a bifurcation strategy were included in this review. A literature search identified a total of ten studies for inclusion. A focused meta-analysis was undertaken for the use of DCB in side-branch compared with POBA. Mean late lumen loss was used with a random effects model due to heterogeneity. RESULTS: DCB was found to be superior to POBA for side branch treatment in bifurcations (p = 0.01). There are four studies that investigated the use of DCB for main branch treatment in a bifurcation, with evidence supporting its safety in main branches of bifurcation lesions, while prospective observational studies have demonstrated favourable target lesion revascularisation rates. CONCLUSION: Although there is a lack of robust RCTs comparing DCBs with current generation DES, DCBs appear safe in main branch bifurcation lesions with improved side branch late lumen loss when compared with DES or POBA.

Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study.

OBJECTIVES: We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI). BACKGROUND: Safety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel. METHODS: We compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel second-generation drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan-Meier curves and Cox regression statistical models. RESULTS: We present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES (p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis. CONCLUSION: We found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.

Endothelial Dysfunction and Coronary Vasoreactivity - A Review of the History, Physiology, Diagnostic Techniques, and Clinical Relevance.

The fervency for advancement and evolution in percutaneous coronary intervention has revolutionised the treatment of coronary artery disease. Historically, the focus of the interventional cardiologist was directed at the restoration of luminal patency of the major epicardial coronary arteries, yet whilst this approach is evolving with much greater utilisation of physiological assessment, it often neglects consideration of the role of the coronary microcirculation, which has been shown to clearly influence prognosis. In this review, we explore the narrative of the coronary circulation as more than just a simple conduit for blood but an organ with functional significance. We review organisation and physiology of the coronary circulation, as well as the current methods and techniques used to examine it. We discuss the studies exploring coronary artery endothelial function, appreciating that coronary artery disease occurs on a spectrum of disorder and that percutaneous coronary intervention has a latent effect on the coronary circulation with long-term consequences. It is concluded that greater recognition of the coronary artery endothelium and mechanisms of the coronary circulation should further guide revascularisation strategies.

Diagnostic Applications of Ultrasmall Superparamagnetic Particles of Iron Oxide for Imaging Myocardial and Vascular Inflammation.

Cardiac magnetic resonance (CMR) is at the forefront of noninvasive methods for the assessment of myocardial anatomy, function, and most importantly tissue characterization. The role of CMR is becoming even more significant with an increasing recognition that inflammation plays a major role for various myocardial diseases such as myocardial infarction, myocarditis, and takotsubo cardiomyopathy. Ultrasmall superparamagnetic particles of iron oxide (USPIO) are nanoparticles that are taken up by monocytes and macrophages accumulating at sites of inflammation. In this context, USPIO-enhanced CMR can provide valuable additional information regarding the cellular inflammatory component of myocardial and vascular diseases. Here, we will review the recent diagnostic applications of USPIO in terms of imaging myocardial and vascular inflammation, and highlight some of their future potential.

Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group.

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.

Drug-coated Balloons or Drug-eluting Stents - Determining an Optimum Strategy for Patients with High Bleeding Risk.

he management of patients who require percutaneous coronary intervention and are at high risk of bleeding continues to be challenging; balancing thrombotic risk versus bleeding risk to determine the safest duration of dual antiplatelet therapy (DAPT). With recent efforts to determine the safety of 1 month of DAPT after implantation of a drug-eluting stent, drug-coated balloons (DCBs) have also been explored, as both have been shown superior to bare-metal stents, which have historically been used for patients with high bleeding risk. We sought to review the literature surrounding the safety profile and bleeding events with both DCBs and drug-eluting stents, and conclude that while both offer safety of cessation of DAPT after 1 month, DCBs offer lower major adverse cardiovascular events.

Day case discharge of patients treated with drug coated balloon only angioplasty for de novo coronary artery disease: A single center experience.

OBJECTIVE: To report our initial experience with drug coated balloon (DCB) only angioplasty and propose a protocol to achieve this safely. BACKGROUND: There are no articles published in the literature currently regarding the safety of same day discharge in patients treated with DCB-only angioplasty. METHODS: Retrospective review of all our patients treated with DCB-only angioplasty from September 2017 to April 2018 with identification of potential complications relating to same day discharge. RESULTS: A total of 100 consecutive patients who underwent elective DCB-only angioplasty for de novo coronary artery disease and were discharged on the same day as the procedure were included. In 99% no cardiac symptoms relating to the procedure requiring urgent hospitalization or urgent investigations were identified. One patient was readmitted the next day requiring stenting of the previously treated lesion. Our 30-day mortality was zero. Some 97 hospital bed days were saved with 100 patients treated. CONCLUSION: Elective day-case DCB-only angioplasty according to our local protocol is safe and cost-effective and should be considered for the majority of the patients.

Duration of dual antiplatelet therapy in elective drug-coated balloon angioplasty.

OBJECTIVES: We sought to answer whether 1-month duration of dual antiplatelet therapy (DAPT) is safe after elective drug-coated balloon only (DCB) angioplasty. BACKGROUND: The duration of DAPT after elective DCB was called into question after the ESC Focused DAPT Update of 2017. Until then, a 1-month duration of DAPT was considered safe by national consensus groups (German, Italian, and Chinese) supported by data from prospective worldwide registries. The ESC Guidelines recommended a 6-month duration of DAPT based on evidence from in-stent restenosis randomized controlled trials only. METHODS: Retrospective, real-world population, single-center analysis conducted from January 1, 2012 to March 31, 2017 in a high-volume, tertiary PCI center. Consecutive patients receiving 1-month duration of DAPT after elective DCB angioplasty were included. We identified a primary composite outcome of cardiac death, myocardial infarction and target lesion revascularization at 6-months. RESULTS: A total of 303 patients (78.5% male) with mean age of 67 ± 12.5 were included. This incorporated 86.1% de novo lesions and 56.5% nonsmall (≥3 mm diameter) coronary arteries treated. There were no reported outcomes of lesion thrombosis, target vessel MI, target lesion revascularization or cardiac death at 6-months. There were two (0.6%) nontarget vessel MIs and one (0.3%) noncardiac death. CONCLUSION: One-month duration of DAPT appears safe after elective DCB-only angioplasty, highlighting this strategy for patients at high-risk of bleeding. These results also show favorable clinical outcomes for de novo coronary artery disease and nonsmall coronary arteries treated with DCB-only angioplasty. A 1-month duration of DAPT appears a safe and attractive option.

Cardiovascular magnetic resonance: Stressing the future.

Non-invasive cardiac stress imaging plays a central role in the assessment of patients with known or suspected coronary artery disease. The current guidelines suggest estimation of the myocardial ischaemic burden as a criterion for revascularisation on prognostic grounds despite the lack of standardised reporting of the magnitude of ischaemia on various non-invasive imaging methods. Future studies should aim to accurately describe the relationship between myocardial ischaemic burden as assessed by cardiovascular magnetic resonance imaging and mortality.

Percutaneous Coronary Intervention Versus Medical Therapy for Chronic Total Occlusion of Coronary Arteries: A Systematic Review and Meta-Analysis.

PURPOSE OF REVIEW: Chronic total occlusion (CTO) of the coronary arteries is a significant clinical problem and has traditionally been treated by medical therapy or coronary artery bypass grafting. Recent studies have examined percutaneous coronary intervention (PCI) as an alternative option. RECENT FINDINGS: This systematic review and meta-analysis compared medical therapy to PCI for treating CTOs. PubMed and Embase were searched from their inception to March 2019 for studies that compared medical therapy and PCI for clinical outcomes in patients with CTOs. Quality of the included studies was assessed by Newcastle-Ottawa scale. The results were pooled by DerSimonian and Laird random- or fixed-effect models as appropriate. Heterogeneity between studies and publication bias was evaluated by I2 index and Egger's regression, respectively. Of the 703 entries screened, 17 studies were included in the final analysis. This comprised 11,493 participants. Compared to PCI, medical therapy including randomized and observational studies was significantly associated with higher risk of all-cause mortality (risk ratio (RR) 1.99, 95% CI 1.38-2.86), cardiac mortality (RR 2.36 (1.97-2.84)), and major adverse cardiac event (RR 1.25 (1.03-1.51)). However, no difference in the rate of myocardial infarction and repeat revascularization procedures was observed between the two groups. Univariate meta-regression demonstrated multiple covariates as independent moderating factors for myocardial infarction and repeat revascularization but not cardiac death and all-cause mortality. However, when only randomized studies were included, there was no difference in overall mortality or cardiac death. In CTO, when considering randomized and observational studies, medical therapy might be associated with a higher risk of mortality and myocardial infarction compared to PCI treatment.

Coronary artery treatment with a urea-based paclitaxel-coated balloon: the European-wide FALCON all-comers DCB Registry (FALCON Registry).

AIMS: The aim of this study was to investigate the use of a drug-coated balloon (DCB) in daily clinical practice and provide further evidence on the safety and efficacy of paclitaxel-coated balloon treatment using urea as an inert excipient. METHODS AND RESULTS: Between December 2013 and December 2015, 757 patients treated for coronary lesions with the IN.PACT Falcon balloon were enrolled in this prospective real-world all-comers registry. The primary outcome was the clinically driven target lesion revascularisation (TLR) rate at 12 months. The secondary outcome was major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction, TLR and target vessel revascularisation (TVR). Out of 805 lesions, 43.1% were de novo, and 53.2% drug-eluting stent (DES) or bare metal stent (BMS) in-stent restenosis (ISR). TLR at 12 months was 6.2% and TVR 8.3%. MACE occurred in 9.7% of patients with a composite of cardiac death in 0.8% and myocardial infarction in 2.7% plus TLR/TVR. Subgroup analysis confirmed a TLR rate of 7.5% for ISR (2.1% BMS and 9.5% DES) and 4.9% for de novo lesions. CONCLUSIONS: The IN.PACT Falcon urea-based paclitaxel-coated balloon is safe and efficient in de novo and ISR lesions with low rates of TLR/TVR. The high proportion of treatment of de novo lesions indicates that a DCB-only strategy is nowadays common.