Ioannis Merinopoulos

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.

Background: There are limited data about the use of drug-coated balloon (DCB)-only angioplasty for multivessel coronary disease. Objectives: The aim of this study was to assess the safety and efficacy of DCB-only angioplasty as compared with second-generation drug-eluting stents (DESs) in patients undergoing multivessel angioplasty. Methods: We compared major adverse cardiovascular events (MACEs) in all patients undergoing multivessel angioplasty in our institution from 1 January 2015 until 15 November 2019, with either the DCB-only or DES-only strategy. The primary endpoint of our study was a MACE, including cardiovascular mortality, acute coronary syndrome, target lesion revascularisation, stroke, or major bleeding. Data were analysed using Cox regression models, Kaplan–Meier estimator plots, and propensity score matching. Results: A total of 159 consecutive patients treated with DCB-only angioplasty and 222 consecutive patients treated with DES-only angioplasty were identified. The majority of the vessels treated were large vessels (>3 mm). After a median follow-up of 4 years, a total of 52 (33%) patients in the DCB and 73 (33%) patients in the DES group encountered a MACE (p = 0.97). The results did not change following propensity score matching. On multivariate Cox regression analysis in the propensity score-matched cohort, atrial fibrillation [HR = 2.37, CI: (1.22–4.61), p = 0.011] and diabetes [HR = 1.71, CI: (1.13–2.60), p = 0.011] were the only independent adverse predictors of MACE. Conclusions: DCB-only angioplasty appears to be safe and efficient when compared to DES for multivessel angioplasty in terms of MACEs after a follow-up of 4 years.

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.

Background and Aims: A randomized trial has previously demonstrated that neointimal modification with a scoring balloon improves the anti‐restenotic effect of drug‐coated balloon (DCB) in patients with drug‐eluting stent restenosis. There are very limited data about the safety and efficacy of using scoring balloons as part of lesion preparation in patients with STEMI, especially in patients with de novo disease treated with DCB‐only angioplasty. Methods: We undertook an analysis of the SPARTAN Norwich Registry to address this question. We compared the composite endpoint of cardiovascular mortality or unplanned target lesion revascularization in the DCB‐only cohort stratified based on the use or not of scoring balloon as part of the lesion preparation. Furthermore, we undertook a propensity score‐matched analysis of the DCB‐only cohort. Results: A total of 452 consecutive patients were treated with DCB‐only angioplasty and scoring balloon was used in 121 patients as part of the lesion preparation. Scoring balloon was not a significant predictor of the composite endpoint even after propensity score‐matched analysis. Chronic obstructive pulmonary disease was the only significant predictor of the composite endpoint after propensity score‐matched analysis. Conclusion: This is the first study demonstrating the safety and efficacy of scoring balloon as part of lesion preparation in patients with STEMI due to de novo disease treated with DCB‐only angioplasty. Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04482972 ; Unique identifier: NCT04482972.

Background: There are no data regarding the outcomes of patients with stent thrombosis (ST) being treated with drug-coated balloon (DCB) angioplasty. Our aim was to compare the outcomes of patients with ST treated with DCB vs. a drug eluting stent (DES). Methods: In this registry analysis, we identified all patients treated for ST in our institution from June 2011 until November 2019. We excluded patients who died in the cath lab, patients with uncrossable lesions, and patients treated with thrombectomy only. Patient outcomes were obtained from Hospital Episodes Statistics from NHS England. The primary endpoint of this study was the composite of cardiovascular mortality, acute coronary syndrome, or target lesion revascularisation. The data were analysed with Cox regression and Kaplan–Meier estimator plots. Results: A total of 173 patients were identified; 92 treated with DCB-only, 36 with balloon angioplasty (BA), 26 with DES, and 19 with a combination of DES and DCB. We compared the outcomes of 92 patients with DCB versus 20 patients with DES, all of which had presented with late or very late ST. There was no difference between DCB and DES in terms of the primary endpoint (p = 0.06). Multivariate analysis identified diabetes (adverse) and the use of GPIIbIIIa inhibitor (favourable) as the only independent predictors of the primary endpoint. Implantation of a DES was independently associated with worse cardiovascular mortality. Conclusions: This is the first study assessing the outcomes of patients with ST treated with DCB only. It has demonstrated that DCBs are an attractive therapeutic option with a tendency towards favourable outcomes when compared to DESs.

Background/Objectives: The need to determine the safest duration of dual antiplatelet therapy duration after elective angioplasty to reduce bleeding events without an adverse effect on major adverse cardiovascular events (MACE) remains a challenge. Methods: In this investigator-initiated, single-centre cohort study, we identified all patients who underwent PCI for de novo coronary disease for stable angina between January 2015 and November 2019. We compared 1-month and 12-month durations of dual antiplatelet therapy (DAPT) to determine if there was any difference in the primary outcome of major bleeding. The secondary outcome was a patient-oriented composite endpoint of all-cause mortality; any myocardial infarction, stroke, or revascularisation; and the individual components of this composite endpoint. Data were analysed using Cox regression models and cumulative hazard plots. Results: A total of 1025 patients were analysed, of which 340 received 1 month of DAPT and 685 received 12 months of DAPT. There was no difference in major bleeding between the two groups (2.6% vs. 2.5% respectively). On univariable cox regression analysis, no characteristics were predictors of major bleeding. A proportion of 99.7% of patients in the 1-month DAPT arm were treated with a DCB strategy, whilst 93% in the 12-month DAPT group were treated with a DES. There was no difference between the two groups with regards to the composite patient-oriented MACE (11% vs. 12%, respectively) or any individual component of this. These results were unchanged after propensity score matched analysis. Conclusions: A 1-month duration of DAPT, for which 99.7% of patients were treated with a DCB strategy, appears safe and effective when compared with a 12-month duration of DAPT with no difference in major bleeding or MACE.

Background: Recent data have suggested that global longitudinal strain (GLS) could be useful for risk stratification of patients with severe aortic stenosis (AS). In this study, we aimed to investigate the prognostic role of GLS in patients with AS and also its incremental value in relation to left ventricular ejection fraction (LVEF) and late gadolinium enhancement (LGE). Methods: We analysed all consecutive patients with AS and LGE-CMR in our institution. Survival data were obtained from office of national statistics, a national body where all deaths in England are registered by law. Death certificates were obtained from the general register office. Results: Some 194 consecutive patients with aortic stenosis were investigated with CMR at baseline and followed up for 7.3 ± 4 years. On multivariate Cox regression analysis, only increasing age remained significant for both all-cause and cardiac mortality, while LGE (any pattern) retained significance for all-cause mortality and had a trend to significance for cardiac mortality. Kaplan–Meier survival analysis demonstrated that patients in the best and middle GLS tertiles had significantly better mortality compared to patients in the worst GLS tertiles. Importantly though, sequential Cox proportional-hazard analysis demonstrated that GLS did not have significant incremental prognostic value for all-cause mortality or cardiac mortality in addition to LVEF and LGE. Conclusions: Our study has demonstrated that age and LGE but not GLS are significant poor prognostic indicators in patients with moderate and severe AS.

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.

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.

While the use of drug-eluting stents (DES) has become the first-line strategy for treating coronary artery disease, there are still drawbacks with their use. As our understanding of coronary artery anatomy and physiology evolves, growing evidence supports the use of drug-coated balloons (DCB) not only in the treatment of in-stent restenosis but also in de novo lesions. The aim of this systematic review and meta-analysis is to determine if there is a difference in outcomes when DCBs are used versus when stents are used. PubMed, Cochrane and Web of Science databases were systematically searched. The primary outcome of the meta-analysis was acute vessel closure and the secondary outcomes were stent complications including major adverse cardiovascular events (MACE) and all-cause mortality. Eleven studies with a total of 2349 patients were included. No significant difference was found in terms of acute vessel closure between DCBs and all stents (2.6% vs. 1.0%, OR: 2.13 (0.74–6.44), I²: 4%, p = 0.16). Furthermore, there was no difference in MACE (6.8% vs. 10.1%, OR: 0.53 (0.27–1.04), I²: 48%, p = 0.06), all-cause mortality and target lesion revascularisation. This meta-analysis suggests that the use of DCBs is a safe alternative to stents when treating coronary artery disease.