Background and Objectives: Chronic total occlusion (CTO) affects 30% of patients undergoing coronary angiography rendering poorer outcomes. While percutaneous coronary intervention (PCI) can be technically successful, RCTs show no survival benefit. Cardiovascular Magnetic Resonance (CMR) provides comprehensive myocardial phenotyping, offering prognostic insights in this high-risk cohort. Materials and Methods: Fifty-six patients with angiographically confirmed CTO underwent stress perfusion CMR with late gadolinium enhancement. Myocardial function, ischaemia and scar burden were quantified and compared across CTO territory and viability subgroups. Results: In patients with CTO, 27% of patients (15/56) had no viability. In patients with viable myocardium, 66% (27/41) demonstrated reversible ischaemia. Viable myocardium was associated with significantly higher LV stroke volumes (93.6 ± 20.1 mL vs. 80.9 ± 18.4 mL, p = 0.039), along with lower LV scar mass (18.7 ± 13.5g vs. 32.3 ± 12.8g; p = 0.002) and scar percentage (14.9 ± 8.3% vs. 25.9 ± 7.5%; p = 0.001). Viable myocardium showed more ischaemia both globally (11.6 ± 14.3g vs. 0.2 ± 9.3g; p = 0.005) and within the CTO territory (10.3 ± 10.3% vs. 2.3 ± 2.7%; p = 0.01). Non-viable myocardium was associated with significantly higher CTO-territory scar mass (9.4 ± 6.5 g vs. 5.1 ± 6.9 g; p = 0.046) and scar percentage (21.8 ± 13.3% vs. 11.7 ± 12.8%; p = 0.01), indicating extensive fibrosis. A scar burden threshold of 11.18% in CTO territory predicted non-viability with 80% sensitivity and 65.85% specificity (AUC = 0.701 [95% CI 0.54–0.87], p = 0.019). Conclusions: Among CTO patients, 27% harbour no viability, while patients with viable myocardium typically exhibit reversible ischaemia—representing a phenotype with preserved viability and inducible ischaemia. These findings support the use of multiparametric CMR to phenotype CTO territories prior to considering CTO-PCI.

Primary percutaneous coronary intervention (PCI) is the established gold-standard treatment for ST-elevation myocardial infarction (STEMI), but stent implantation confers an appreciable long-term failure rate driven by impaired vasomotion, neoatherosclerosis and late stent thrombosis. Drug-coated balloons (DCB) allow a leave-nothing-behind strategy that may optimise short- and long-term outcomes in this high-risk population, but no adequately powered randomised trial has compared a DCB-only strategy with drug-eluting stents (DES) in STEMI using an all-comers design with randomisation prior to diagnostic angiography. The STEMI DCB trial is an investigator-initiated, multi-centre, prospective, open-label, 1:1 randomised non-inferiority trial conducted across 15 United Kingdom sites (ISRCTN16341009), recruiting 700 patients presenting for primary angioplasty who will be randomised to a DCB-only strategy (SeQuent Please Neo) or DES prior to diagnostic angiography. An emergency consent process, followed by formal written consent before discharge, allows near-complete enrolment of this acute population. The primary endpoint is Target Vessel Failure (TVF), a composite of cardiovascular death and target vessel myocardial infarction or revascularisation, assessed for non-inferiority at 1 year with superiority testing if non-inferiority is met; patients will be followed to 8 years. By randomising before coronary anatomy is known, the STEMI DCB trial avoids the selection bias inherent in trials that randomise after angiography and restoration of flow, providing a true all-comers comparison of these strategies. This trial will provide the first adequately powered evidence on whether a DCB-only strategy is non-inferior to DES for STEMI, with potential to materially change primary PCI practice worldwide.

BACKGROUND:Drug-coated balloons (DCBs) are increasingly adopted in percutaneous coronary intervention. Bail-out drug-eluting stent (DES) implantation due to suboptimal immediate results after DCB angioplasty is not infrequent, and the clinical outcomes of percutaneous coronary intervention with DCB angioplasty followed by bail-out DES implantation remain unexplored. The aim of this study was to evaluate the safety of bail-out DES implantation following DCB angioplasty in percutaneous coronary intervention. METHODS:The BAILOUT registry included consecutive patients undergoing bail-out DES implantation after DCB angioplasty at 17 European centers between 2011 and 2024. The primary end point was target lesion failure (TLF) at 1 year, defined as the composite of target lesion revascularization, target vessel myocardial infarction, and cardiac death. The TLF rate was compared with a performance goal of 7.0% for an upfront DES-only strategy, derived from a meta-analysis of contemporary randomized controlled trials. RESULTS:A total of 733 patients were included, accounting for 5.5% of all DCB-based percutaneous coronary interventions. At 1 year, the cumulative TLF incidence in the overall population was 7.0% (95% CI, 5.2%-9.3%), which was comparable to the performance goal (P=0.916). This was mainly driven by target lesion revascularization (4.1%), while cardiac death and target vessel myocardial infarction occurred both in 1.9% of patients. The incidence of stent thrombosis was 0.6%. Independent predictors of 1-year TLF included lesion length (hazard ratio, 1.02 per mm increase [95% CI, 1.01-1.03]; P<0.001), moderate-to-severe calcification (hazard ratio, 2.82 [95% CI, 1.48-5.40]; P=0.002), and the use of paclitaxel- versus sirolimus-coated balloons (hazard ratio, 1.99 [95% CI, 1.01-4.05]; P=0.048). CONCLUSIONS:In cases of suboptimal angiographic results after DCB angioplasty, bail-out DES implantation is safe, with no increased risk of TLF at 1 year compared with the expected performance goal for an upfront DES-only strategy.

Atherosclerotic cardiovascular disease (CVD) remains a leading cause of worldwide morbidity and mortality, despite well-established/effective pharmacological therapies. A substantial component of the residual risk is inflammatory. The importance of inflammation and immune mediators in the pathophysiology has been recognised over the past two decades and, importantly, treatment with percutaneous coronary intervention (PCI) also results in an inflammatory response and associated adverse outcomes. Multiple biochemical pathways have been implicated with various identified biomarkers, such as high-sensitivity C-reactive protein which is now recognised as a marker of cardiovascular risk. Proteins such as interleukins (IL) IL-1 and IL-6 or larger protein complexes such as the NLRP3 inflammasome all play a key role in both the pathophysiology of atherosclerosis and inflammation relating to PCI. This knowledge has led to advances in pharmacological therapies and multiple pre-clinical and clinical trials, but to date, colchicine is the only treatment with sufficiently robust evidence from large-scale clinical trials to be recommended in multinational guidelines. Other therapies at present lack this level of evidence, and identification of other potential therapies is an important next step in treating inflammation post-PCI. Furthermore, the potential routine use of colchicine periprocedurally for PCI and its biochemical and clinical effects in this context are not yet fully established, requiring further investigation to identify its effect on specific inflammatory mediators and whether this translates to clinical outcomes.

Percutaneous coronary intervention (PCI) using drug-coated balloons (DCBs) may provide outcomes comparable to drug-eluting stents (DESs) due to the absence of a permanent implant and improved coronary artery remodelling. This study compared clinical outcomes of DCB-only angioplasty with DESs in a real-world setting. All patients undergoing PCI with DCBs or DESs for de novo disease were included in a propensity score-matched analysis using prospective and retrospective collected data from a single centre. The primary outcome was target lesion revascularisation (TLR) at 12 months. The secondary outcomes were major adverse cardiac events (MACEs) defined as a composite of all-cause death, myocardial infarction, or TLR at 12 months. Propensity matching produced 904 DCB lesions (719 patients) matched to 1424 DES lesions (1271 patients). The DCB group had smaller coronary arteries, shorter treated segments, and more bifurcation lesions. The mean age was 65 years, 22% of patients had prior MI, 16% had diabetes, and 58% had acute coronary syndromes. The rate of TLR at 12 months was as follows: 2.3% with DCBs; 2.5% with DESs (OR 0.86, p = 0.726, 95% CI 0.37-2.02). MACE was 8.2% with DCBs and 7.3% for DESs (OR 1.04, 95% CI 0.73-1.47). Results suggest comparable outcomes in patients who received paclitaxel DCBs compared to DESs without excess MACE, highlighting the need for randomised controlled trials.

BACKGROUND:Drug-eluting stents (DES) are associated with a 2% annual failure rate and have worse outcomes at coronary bifurcations. Recent randomized control data have shown the noninferiority of drug-coated balloons (DCB) vs stents at 1 year. Possible benefits of DCBs include the lack of a metal prosthesis, absence of stent malapposition, lack of obligate antiplatelet treatment, and maintenance of vessel geometry and function. HYPOTHESIS:The use of DCBs in the treatment of nonleft main bifurcation disease is noninferior to a DES strategy for Target Bifurcation Failure at 1 year. STRATEGY DESIGN:The EBC DCB trial is a nonblinded, investigator-initiated, randomized control trial that will recruit 750 patients with nonleft main bifurcations requiring revascularization. Both main vessel and side branch must have significant atheroma. Subacute (NSTEMI and unstable angina) and elective presentations will be eligible for inclusion. Patients will be randomized to either a step-wise provisional DES or a DCB strategy. Major exclusion criteria include STEMI in the previous 48 hours, chronic total occlusions, and in-stent restenosis. The primary endpoint of Target Bifurcation Failure is a composite of cardiovascular death, target bifurcation myocardial infarction, or target bifurcation revascularization. Patients will be followed up at 6 months, 1, 3, 5, and 8 years. If noninferiority is met, superiority will be tested. SUMMARY:EBC DCB is an open-label, multicenter, international randomized control trial comparing the use of DCB and DES in the treatment of coronary artery bifurcation disease. The trial is registered at clinicaltrials.gov (NCT06822322).

Objectives:To identify patient factors associated with poor transthoracic echocardiographic image quality and to evaluate whether a simple pre-test triage model could improve imaging efficiency. Design:Retrospective cohort study with derivation and independent validation cohorts, together with a model-based cost-effectiveness analysis. Setting:Single large UK tertiary centre using routinely collected data from 2010 to 2020. Participants:70,597 adult transthoracic echocardiograms, divided into a derivation cohort (n = 40,000) and an independent validation cohort (n = 30,597). Main outcome measures:Poor image quality (limited or non-diagnostic vs good or adequate), model discrimination, sensitivity, specificity and comparative imaging costs. Results:Of 70,597 studies, 24,213 (34.3%) were poor quality, including 8582 (12.2%) non-diagnostic and 15,631 (22.1%) limited studies. Lung disease was the strongest predictor (OR 2.04, 95% CI 1.59 to 2.61), followed by suspected heart failure, inpatient status, arrhythmia, prior cardiac surgery and permanent pacemaker (all p < 0.01). Validation performance was modest (AUC 0.58; sensitivity 67.3%; specificity 45.7%). In a model-guided simulation using 2024/25 NHS tariffs, total imaging costs were lower than with standard care (£11.85 million vs £12.16 million), yielding an estimated saving of £317,331. Conclusions:Several routinely available clinical factors influence transthoracic echocardiographic image quality. Although individual-level prediction is modest, pre-test triage may help direct higher-risk patients to contrast echocardiography or alternative imaging, reducing repeat testing and improving efficiency.

BACKGROUND:Implantation of drug eluting stents (DESs) is currently the default approach for percutaneous coronary interventions, but long-term adverse events still exist. An approach with minimal stenting deserves to be assessed in a randomized trial. We studied a novel sirolimus-eluting balloon (SEB) that elutes sirolimus over a 90-day period using a biodegradable polymer microreservoir technology. METHODS:In a multicenter, open-label, randomized trial, we compared an SEB-based strategy with provisional DES with one of systematic DES for de novo lesions in coronary arteries between 2 and 5 mm in diameter. Subjects were randomized 1:1 before percutaneous coronary intervention. The primary end point was target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. It was tested for noninferiority at 1 year with the use of an absolute margin equal to 50% of the combined event rate at a significance level of 0.025. The primary analysis population included all randomized subjects with completed or attempted percutaneous revascularization, analyzed according to the intention-to-treat principle. A sensitivity analysis was performed on the per-protocol population. RESULTS:Between August 27, 2021, and July 29, 2024, 3323 participants were randomized and treated in 62 sites. Among 1661 participants in the SEB strategy group, bailout stenting was performed in 343 (20.7%). Target vessel failure occurred over 365 days in 88 (5.3%) and 73 (4.4%) participants in the SEB and the systematic DES strategy groups, respectively (risk difference, 0.91% [95% CI -0.55% to 2.38%]; 1-sided P=0.02 for noninferiority with a 2.44% noninferiority margin). Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group (3.3% versus 2.1%; risk difference, 1.22% [95% CI, 0.11%-2.33%). Safety events, including lesion thrombosis, were low and similar in both groups. Although the results of the per-protocol population (3194 participants, 96%) did not confirm noninferiority (upper boundary of the 95% CI, 2.63; P=0.04), they were similar to the intention-to-treat results in both magnitude and direction. CONCLUSIONS:At 1 year, in the primary intention-to-treat analysis population, a strategy of percutaneous coronary intervention with SEB and provisional DES was noninferior to the systematic use of DES for the primary end point of target vessel failure. The per-protocol population sensitivity analysis did not confirm noninferiority. Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group. At 5 years, target vessel failure will be tested again for noninferiority and for superiority if noninferiority is achieved. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04859985.

We aimed to investigate the safety of drug-coated balloon (DCB)-only percutaneous coronary intervention compared to drug-eluting stent (DES) for de novo lesions in large vessels. To pursue this goal, we conducted a systematic review and meta-analysis following the PRISMA guidelines. The analysis included studies that utilized DCB-only or hybrid angioplasty for de novo lesions in large coronary vessel (> 2.75 mm). The primary outcome was to assess the target lesion revascularization (TLR) rate, while secondary outcomes included cardiac death, myocardial infarction (MI), and the composite of these. A total of 15 studies, comprising 3975 patients (of whom 2114 treated with DCB) were included. Median age was 62 ± 1.5 years, with 77.4% being male. Overall, 26.9% had diabetes, and 67.6% were diagnosed with acute coronary syndrome. Over a pooled follow-up of 20.6 ± 1.9 months, the incidence of TLR was 4% in the pooled DBC group. Additionally, over a pooled follow-up of 25.8 ± 2.7 months, no significant differences were observed in incidence of TLR between the DCB group and the DES group (4.3% vs. 6.9%, odds ratio 0.71, 95% confidence interval 0.50-1.01, p = 0.059). Furthermore, there were no differences in incidence of cardiac death and MI. DCB angioplasty treatment of de novo lesions in large coronary vessels could be a safe and effective strategy in both acute and chronic coronary settings. The incidence of target lesion revascularization appears to be similar to that of contemporary DES.

The Drug-Coated Balloon (DCB) Academic Research Consortium project originated from the need to overcome the lack of standardization and comparability among studies focusing on drug-coated balloon treatment. The DCB Academic Research Consortium represents a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focusing on percutaneous coronary intervention in Europe, the United States, and Asia. The present consensus document provides a classification of DCB technologies, antiproliferative drugs, and types of elution and coatings. Moreover, by reviewing the available evidence on the use of DCBs for several lesion (restenosis, de novo small and large vessels, bifurcations) and clinical (acute coronary syndromes, diabetes mellitus, multivessel disease, high bleeding risk) settings, it seeks to provide reasonable suggestions for their clinical use. Last, this paper outlines the processes involved in optimal "lesion preparation" before the use of DCBs and the criteria used for assessing results following their use.

There is increasing use of drug-coated balloons (DCBs) in de novo coronary disease, supported by an ever-expanding evidence base. However, DCB-only angioplasty requires a slightly modified lesion preparation strategy to ensure an optimal angioplasty result and minimise the risk of vessel-threatening dissection. In this article, we discuss the importance of optimal lesion preparation and vessel safety based on clinical and angiographic findings, as well as the selection and deployment of appropriate DCB. We outline a new and simplified classification of dissections: those that are safe to leave untreated (type 1) and those that require modification or stenting (type 2). We also present this classification in a simple graphical format. Finally, we provide a checklist for the complete process. This review article aims to accelerate the learning curve for DCB-only percutaneous coronary intervention (PCI), highlighting the importance of lesion preparation and dissection assessment while ensuring patient safety throughout the procedure. We hope this will facilitate the adoption of safe DCB-only PCI.

BACKGROUND:The treatment of coronary bifurcation lesions (CBL) remains complex and associated with a higher rate of long-term adverse cardiovascular events due to anatomical and procedural complexity. AIMS:We compared procedural outcomes between a drug coated balloon (DCB) only approach and a 2nd generation drug eluting stent (DES) for treating de novo CBLs. METHODS:We retrospectively identified all patients with CBL treated with either a DCB only or DES only strategy, including all coronary bifurcations and compared a bifurcation-oriented composite endpoint (BOCE) of cardiovascular death, target bifurcation-related myocardial infarction (TB-MI), and clinically driven target bifurcation revascularization (TBR) using nationally obtained clinical outcome measures from 2015 to 2019. A propensity score matched analysis was undertaken. RESULTS:Of 2113 patients, 1030 patients were treated with a DCB and 1083 with a DES. There was higher lesion complexity in the DCB group, and propensity score-matched analysis was utilized. This included a total of 2052 patients (1026 in each arm). The median age was 68 (59-75), and all clinical presentations were included. The median follow-up time was 3.6 (2.5-4.8) years with 501 (48.8%) patients having follow-up available at 5 years. Propensity matched analysis showed a significant increase in events (14.0% vs. 9.9% respectively) (HR: 1.39 [1.08-1.79], p = 0.01) when using DES compared to DCB, driven predominantly by an increase in TBR (8.9% vs. 5.0%) (HR: 1.79 [1.27-2.50], p ≤ 0.001) and TB-MI (3.0% vs. 1.6%) (HR: 1.92 [1.05-3.57], p 0.03). CONCLUSIONS:The use of DCB-only in a coronary bifurcation is a safe alternative in treating CBL, within the limitations of a retrospective single center analysis. An appropriately designed RCT is now required.

INTRODUCTION:Drug-eluting stent (DES) angioplasty is the gold standard treatment for coronary lesions. Drug-coated balloon (DCB) is an option for in-stent restenosis, and has also shown promise for small-calibre coronary artery disease. We evaluated the 3-year effectiveness of a decision algorithm for percutaneous coronary intervention (PCI) that favoured a stent-less strategy (SLS) in primary angioplasty. METHODS:All patients who underwent angioplasty during 1 year were included in a prospective observational study. Patients eligible for SLS first underwent scoring balloon followed by DCB angioplasty or DES in case of mandatory bailout. Patients not eligible for SLS were unstable patients who underwent conventional drug-eluting stenting. The metal index, stent burden, was calculated by stent length divided by the total lesion length. A 36-month follow-up recorded target lesion revascularization (TLR). RESULTS:Patients eligible for SLS represented 85% (n = 840) of patients who underwent PCI. TLR was required in 2.6% and 6% of patients in the DCB-only and bailout-DES groups, respectively. Median metal index was 0.25 (IQR: 0.5) in patients with TLR. There was a difference between TLR-free survival distributions in the DCB-only and bailout-DES groups (p = 0.016). CONCLUSIONS:The SLS based on a combination of scoring balloon and DCB was effective at 3 years with a low rate of TLR. This rate was higher in patients with stent burden. TRIAL REGISTRATION:This study was registered with clinicaltrials. gov (NCT03893396, first posted on March 28, 2019).

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-coated balloons is presented for reference. Overall, this article aims to provide clinicians and researchers with a comprehensive understanding of the current state of drug-coated balloon technology and its implications in clinical practice.