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Background Drug coated balloons (DCBs) in Europe are mainly used in restenotic lesions as endorsed by the European Society of Cardiology, with a class IA recommendation. However, some of the recent data suggest, it can also be considered in a subset of denovo lesions, especially in small vessels. Most DCBs used, are coated with Paclitaxcel. There is no data on the efficacy of Sirolimus in DCBs, the drug of choice in drug eluting stents. In this study, we report outcomes from the use of a Sirolimus coated balloon (SCB) in de novo small-vessel coronary lesions, from a single high yield centre. Methods A retrospective analysis was conducted on all patients treated with an SCB between March 2018 and October 2020. Follow-up was achieved with clinic visits, telephone calls and admission records. The outcomes measured include cardiac death, target-vessel myocardial-infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target-vessel MI and TLR). Results During the study period, 279-patients (with 332-lesions) with de novo lesions were treated with an SCB. The mean age of patients was 65±12 years, 219 (79%) were male, 36% (n=100) had diabetes, 16% (n=45) had chronic kidney disease and 61% were in the setting of acute coronary syndrome (n=169). Predilatation was performed in 96% (320-lesions). Bailout stenting (with DES) was required in 5% of lesions (n=18) of which 16 were due to dissections and 2 were due to recoil >30% following DCB use. The mean diameter and length of DCBs were 2.35 mm and 26 mm respectively. During a median follow-up of 584-days (19-months) cardiac death was reported in 8 patients (3%). Target vessel MI was in 3% (n=9), TLR per lesion was 8% (n=26) and the MACE rate was 11% (n=31). There were no documented cases of acute vessel closure. Conclusion The long-term outcome from the first ever study on sirolimus eluting balloons in de novo small vessel lesions appears promising with low rates of hard endpoints, and acceptable repeat rates of TLR despite a complex group of patients (50% ACS, 36% diabetics and 19% CKD) and lesion subsets (small vessel and diffuse disease). Implanting stents in these subsets renders them vulnerable to restenosis, making treatment challenging and resulting in high rates of recurrence. Funding Acknowledgement Type of funding sources: None.

Aims The use of scoring balloon prior to drug coated balloon has been proven to be effective in restenotic lesions. However, their effect in de novo lesions has not been tested. Logic tells that the use of scoring balloons should enhance the drug uptake into the vessel wall. In this study, we evaluated this concept of scoring balloon prior to DCB in de novo lesions and compared to those who were treated with a conventional approach (semi-compliant and/or non-compliant balloons). Methods and results We evaluated all de novo lesions treated with DCB between March 2018 and October 2020 at our centre. The results are reported as cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target vessel MI and TLR). During the study period 348 patients with de novo lesions were treated with DCB. Of those, 49 were predilated with scoring balloon prior to use of DCB and the remaining 299 were predilated with non-scoring balloons (semi-compliant and/or non-compliant). The majority of the baseline characteristics had no statistically significant differences (table 1), with the exception of the mean diameter of the lesions were larger in the scoring balloon group than non-scoring balloon group: 2.7±0.5 vs. 2.49±0.4; p=0.003 and mean length of lesions were longer in the non-scoring balloon group: 26±8.8 vs. 23±7.7; p=0.02. During the median follow-up of 660 days, clinical outcomes between the scoring and non-scoring balloons were; cardiac death: 0 vs. 8 (3%); p=0.5, TVMI: 2 (4%) vs. 8 (3%); p=0.9, TLR: 3 (6%) vs. 25 (8.4%); p=0.8, MACE: 4 (8%) vs. 34 (11%) p=0.7 Conclusion There were no differences in the clinical outcomes between the two groups indicating that use of scoring balloon prior to DCB may not offer additional benefit, although this needs to be confirmed in a larger patient group. Funding Acknowledgement Type of funding sources: None.

Introduction Use of drug coated balloons (DCBs) in coronary intervention is escalating and the guidelines recommend its use in restenotic lesions. However, recent data suggest it can also be considered in a subset of denovo lesions especially; small vessels, ostium of an important side-branch and in patients unable to tolerate dual antiplatelet therapy for a prolonged period. Most DCBs used elute Paclitaxcel, but there is no data on Sirolimus eluting DCB, which is the drug of choice in currently available drug eluting stents. In this study, we report outcomes from the use of a Sirolimus coated balloon (SCB) in de novo coronary lesions. Methods We retrospectively analysed all patients treated with an SCB between April and December 2018. Results are reported as cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR), target vessel revascularisation (TVR) and MACE (combination of cardiac death, target vessel MI and TLR). Results During the study period, 351 patients (with 414 lesions) with de novo lesions were treated with an SCB. The mean age of patients was 65.6±11.5 years, 275 (78%) were male and 39% (n=212) had diabetes. Most lesions treated were in the LAD/diagonal system (n=173, 42%). Predilatation was performed in 98% (405 lesions). Bailout stenting (with a drug eluting stent) was required in 7% lesions (n=30), of which 11 were due to dissections and 19 were due to recoil >50% following DCB use. The mean diameter and length of DCBs were 2.47 mm and 26 mm respectively. During a median follow-up of 322-days (11-months) cardiac death was reported in 8 patients (2.3%). Target vessel MI was in 3%; n=10, TLR and TVR per lesion were 8% (n=34) and 9% (n=37) respectively. The MACE rate was 11%. There were no documented cases of acute vessel closure. Conclusion The mid-term outcome from the first ever study on sirolimus coated balloons in de novo lesions appears promising with low rates of hard endpoints with no documented cases of acute vessel closure. The MACE rates appear promising, although we need longer follow-up which is ongoing and we will be able to report outcomes from even longer follow-up during the presentation. Funding Acknowledgement Type of funding sources: None.

Introduction Provisional stenting is the preferred strategy even in true bifurcations, however, to minimise the need for repeat revascularization of side-branches, the use of drug coated balloons has been suggested. Most of the data available in the literature are on Paclitaxel coated balloons, a drug which is almost obsolete in stents due to its cytotoxic properties. There is limited data on Limus coated balloons (SCB), a drug which is the default for all the currently available drug eluting stents. In this study, we explore the clinical outcomes following use of SCB in side-branches during provisional stent technique in true bifurcations. Methods and results We evaluated all de novo lesions treated with DCB for true bifurcations between March 2018 and October 2020 at our centre. The results are reported as cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target vessel MI and TLR). During the study period 110 patients with de novo lesions were treated with SCB for bifurcation lesions. Of them; 66 were in true bifurcations. The mean age of patients were 66.3±10.7 years, 75% (n=50) were male, 40 (61%) were in the setting of acute coronary syndrome, 52% (n=34) had diabetes and 32% (n=21) had CKD. Pre-dilatation was performed in all cases and none of them needed bailout stenting. Small vessels ( During a median follow-up of 729 days (2-years); there were no cardiac deaths, TVMI occurred in one case (2%), TLR in 3% (n=2) and the overall MACE rate was 3% (n=2). There were no documented cases of acute vessel closure Conclusion The results from long term follow-up with this relatively new technology of DCB in treatment of side-branch in true bifurcation is encouraging. We have demonstrated low rates of hard endpoints, TLR and MACE rates despite complex group of patients (61% ACS, 52% diabetics and 32% CKD). These results are encouraging, but going forward, we need more data from larger patient trials. In the meanwhile our data should instil confidence to adopt this technology in clinical practice. Funding Acknowledgement Type of funding sources: None.

Background Drug coated balloons (DCBs) in Europe are mainly used in restenotic lesions as endorsed by the European Society of Cardiology, with a class IA recommendation. However, some of the recent data suggest, it can also be considered in a subset of denovo lesions, especially in small vessels. Most DCBs used are coated with Paclitaxcel. There is no data on the efficacy of Sirolimus in DCBs, the drug of choice in drug eluting stents. In this study, we report outcomes from the use of a Sirolimus coated balloon (SCB) in de novo small-vessel coronary lesions, from a single high yield centre. Methods A retrospective analysis was conducted on all patients treated with an SCB between March 2018 and October 2020. Follow-up was achieved with clinic visits, telephone calls and admission records. The outcomes measured include cardiac death, target-vessel myocardial-infarction, target lesion revascularisation and MACE (combination of cardiac death, target-vessel MI and TLR). Results During the study period, 279-patients (with 332-lesions) with de novo lesions were treated with an SCB. The mean age of patients was 65 ± 12 years, 219 (79%) were male, 36% (n=100) had diabetes, 16% (n=45) had chronic kidney disease and 61% were in the setting of acute coronary syndrome (n=169). Predilatation was performed in 96% (320-lesions). Bailout stenting (with DES) was required in 5% lesions (n=18) and of which 16 were due to dissections and 2 were due to recoil >30% following DCB use. The mean diameter and length of DCBs were 2.35 mm and 26 mm respectively. During a median follow-up of 584-days (19-months) cardiac death was reported in 8 patients (3%). Target vessel MI was in 3% (n=9), TLR per lesion was 8% (n=26) and the MACE rate was 11% (n=31). There were no documented cases of acute vessel closure. Conclusion The long-term outcome from the first ever study on sirolimus eluting balloon in de novo small vessel lesions appears promising with low rates of hard endpoints, and acceptable repeat rates of TLR despite a complex group of patients (50% ACS, 36% diabetics and 19% CKD) and lesion subsets (small vessel and diffuse disease). Implanting stents in these subsets renders them vulnerable to restenosis, making it difficult to treat, making treatment challenging and resulting in high rates of recurrence. Conflict of Interest None to declare

Background The use of drug coated balloons (DCBs) in coronary intervention is escalating. There are two drugs of choice for coating either DCBs or drug eluting stents: Paclitaxel or Sirolimus. Most available DCBs are coated with Paclitaxcel, due to pre-existing, extensive data that support good clinical outcomes. With drug eluting stents both the literature and hence clinical practice favour Sirolimus over Paclitaxcel. This is due the cytostatic properties and wide therapeutic window of Sirolimus. However, there is very limited data on Sirolimus coated balloons (SCBs). We report a long-term follow-up with this relatively new technology from our centre. Methods A retrospective analysis was conducted on all patients treated with an SCB between March 2018 and October 2020. Follow-up was achieved with clinic visits, telephone calls and admission records. The outcomes measured include cardiac death, target-vessel myocardial-infarction, target lesion revascularisation and MACE (combination of cardiac death, target-vessel MI and TLR). Results 533 patients (690-lesions) with a mean age of 65.4 (range; 37-90) were treated with an SCB. 79% (n=419) were male, 314 (59%) were in the setting of acute coronary syndrome, 40% (n=211) had diabetes and 60% (n=414) had DCB in de-novo lesions. Small vessels accounted for 59% of cases (n=406). Pre-dilatation was performed in 97% (n=670) of cases. Bailout stenting (with a drug eluting stent) was required in 6.5% lesions (n=45), of which 11 were due to dissections and 34 were due to >50% recoil following DCB use. The mean diameter and length of DCBs were 2.8 mm and 26.3 mm respectively. During a median follow-up of 572 days (IQR: 381 - 868); cardiac death occurred in 15 patients (3%). Target vessel MI was in 4%; n=21, TLR per lesion and per patient were 10% (n=72 and n=55 respectively). The overall MACE rate was 12%. There were no documented cases of acute vessel closure. Conclusions The results from long term follow-up with this relatively new technology DCB are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite complex group of patients (59% ACS and 40% diabetics) and lesion subsets (40% restenotic lesions and 59% small vessels). This suggests that SCBs can be used in both restenotic and de novo small vessel lesions with acceptable clinical outcomes. However, in order to further inform clinical practice, more longer-term data on SCBs compared with Paclitaxel coated balloons is needed. Conflict of Interest None to declare

Highlights • Limited data on intra-stent CTO. • We explored the long-term outcomes in patients undergoing PCI to intra-stent CTO. • Acceptable rates of hard endpoints (cardiac death; 5.8%, TVMI; 4%). • High rates of TLR (45.6%). • PCI should only be undertaken if symptomatic or if there is inducible ischaemia. • If PCI is undertaken, DCB and DES should be considered over POBA., Background Angioplasty for ISR remains a challenge with relatively high rates of recurrence. Although there is a plethora of data on ISR, there is relatively less data on intra-stent-CTO. In this study, we explore the long-term clinical outcomes following angioplasty to intra-stent CTO and study the differences in clinical outcomes between three treatment-arms: POBA vs. DES vs. DCB. Methods and results We evaluated all patients who underwent PCI to intra-stent CTO between 2011 and 2017. The endpoints used were: cardiac-death, TVMI, TLR, TVR, and MACE. During the study period, 403-patients with a mean age of 69.2 years had successful PCI to intra-stent CTO. 50% were diabetic, 38% had CKD and 32% had left ventricular dysfunction. 93% of cases were stable angina. 22% (n = 88) received only POBA, 28% (n = 113) received DCB and 50% (n = 202) received DES. During the median follow-up of 48-months, cardiac-death occurred in 5.8% (n = 23), TVMI in 4% (n = 16), TLR in 45.6% (n = 182), TVR in 48.7% (n = 194) and MACE of 46%. There were no differences in the hard endpoints between the 3treatment arms. However, the TLR and overall MACE were better in DCB and DES-groups as compared to POBA (TLR: 33%vs.42%vs.49%; p = 0.06); MACE (34% vs. 45% vs. 52%; p = 0.05). Conclusion This is the first study that has focussed on the outcomes following angioplasty to intra-stent CTOs with a very long-term follow-up. The hard endpoints were low, although the TLR rates were high. In regards to treatment strategy, the DCB and DES provide relatively better outcomes than POBA.

Introduction Bailout stenting post-Paclitaxcel drug coated balloon use (DCB) is done with Limus eluting stent as we don’t use Paclitaxcel eluting stent anymore. However, when using Sirolimus DCB, bailout stenting is done with Limus eluting stent, but this raises the issue of drug toxicity with double dose of Limus to the vessel wall. In this study, we evaluate all patients treated with Limus DCB that required bailout stenting for safety and clinical outcomes. Methods and Results We evaluated all patients who were treated with MagicTouch Sirolimus eluting DCB (Concept Medical limited, India) March 2018-June 2019. Bailout stenting per lesion were identified and studied for endpoints which included cardiac death, target vessel MI, stent thrombosis, target lesion revascularisation and MACE. Between the study period; 406 patients (477-lesions) with a mean age of 66 ± 11.2 years (range; 37-90) were treated with MagicTouch DCB. Bailout stenting was required in 39 lesions (8%) and of which 22 were due to dissections and 17 were due to >50% recoil following DCB use. During a median follow-up of 302 days; there were no cases of cardiac death, 1-case of target vessel MI (2.6%) and 3-cases (7%) of TLR. The MACE rate was 7%. There were no cases of stent thrombosis as per the ARC definition. Conclusion One of the highlighting features of our study is low-rates of bailout stenting (9%). This may be due to our criteria of not stenting mild dissections (unless they are flow limiting) and not to expect stent like results. The outcomes in the bailout stenting group is excellent with very low hard clinical endpoints indicating there may not be any toxic effect from double dose of Limus drug (DCB + DES). Conflict of Interest None

Aims The bailout stenting post-drug coated balloon (DCB) is performed with second generation drug eluting stents (DES). For paclitaxel DCBs (PCB), it will result in delivery of 2 different drugs to the vessel wall (Paclitaxel from DCB + Limus from DES), on the contrary for sirolimus DCBs (SCB) it will result in double dose of a same drug (Limus from DCB + Limus from DES). In this study, we study the differences in the clinical outcomes between the two groups (PCB + Limus stent vs. SCB + Limus stent) assessing for either a synergistic or a toxic-effects. Methods and Results We evaluated patients treated with DCB between January 2016 and June 2019 at our centre. Results are reported as death, cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, TVMI and TLR). During the study period; 890 lesions (766-patients) were treated with DCB. Of them; 433 were treated with PCB and 477 with SCB. Total of 81-lesions (9%) needed bailout stenting for either dissection and/or recoil of >50%. This included; 42-lesions in PCB group and 39-lesions in SCB group. There were no significant differences in the baseline characteristics between the two groups. During the median follow-up period of 18-months, the clinical outcomes between PCB and SCB group were; death: 3 (7%) vs. 0; p=0.3, cardiac death: 2 (5%) vs. 0; p=0.5, TVMI: 0 vs. 1 (2.6%); p=0.4, TLR: 1 (2.4%) vs. 3 (7.7%); p=0.5, MACE: 3 (7%) vs. 3 (7.7%); p=0.7. There were no reported cases of stent thrombosis in either group. Conclusions The bailout stenting rate was relatively low in our group (9%) as compared to previously published studies. No significant differences were observed between the two-bailout stenting groups, although numerically PCB + limus stent group had lower rates of TLR, but had higher mortality rates as compared to SCB + limus stent, implying potential synergistic effect, but maybe at the cost of toxicity? This needs to be confirmed with larger patient group with multi-centre experience. Conflict of Interest None

Background Use of drug coated balloons (DCBs) in coronary intervention is escalating. There is a plethora of data on Paclitaxcel-DCB. However, when it comes of stents, Limus-drugs are preferred over Paclitaxel. There is very limited data on Sirolimus coated balloons (SCB). MagicTouch-SCB (Concept Medical, FL) elutes Sirolimus via nano-technology and have been used in our centers since March 2018. We report a mid-term follow-up with this relatively novel-technology. Methods and results We retrospectively analyzed all patients treated with MagicTouch-SCB between March-2018 and February-2019. Results are reported as cardiac-death, target-vessel myocardial-infarction (TVMI), target lesion revascularization (TLR) and Major Adverse Cardiac Events (MACE). During the study period, 288-patients (373-lesions) with a mean age of 65.8 were treated with MagicTouch-SCB. 84% (n = 241) were male, 155 (54%) were in the setting of acute coronary syndrome, 38% (n = 110) had diabetes and 62% (n = 233) were in de-novo lesions. Most lesions treated were in the LAD/diagonal-system (n = 170; 46%). Pre-dilatation was performed in 92% (n = 345) of cases. Bailout stenting was required in 9% lesions (n = 35). The mean diameter and length of SCBs were 2.64 ± 0.56 mm and 24 ± 8.9 mm respectively. During a median follow-up of 363 days (IQR: 278-435), cardiac death and TVMI occurred in 5-patients (1.7%) and 10-patients (3.4%) respectively, TLR per-lesion was 12%. The MACE rate was 10%. There were no documented cases of acute vessel closure. Conclusions The results from mid-term follow-up with this relatively new technology SCB is encouraging with a low rates of hard endpoints and acceptable MACE rates despite complex group of patients and lesion subsets.

BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden. The ERIC-PPCI trial was funded by a British Heart Foundation clinical study grant (grant number CS/14/3/31002) and a University College London Hospitals/University College London Biomedical Research Centre clinical research grant. The CONDI-2 trial was funded by Danish Innovation Foundation grants (grant numbers 11-108354 and 11-115818), Novo Nordisk Foundation (grant number NNF13OC0007447), and TrygFonden (grant number 109624). DJH was supported by the British Heart Foundation (grant number FS/10/039/28270), the National Institute for Health Research (NIHR) Biomedical Research Centre at University College London Hospitals, the Duke-National University Singapore Medical School, the Singapore Ministry of Health’s National Medical Research Council under its Clinician Scientist-Senior Investigator scheme (grant number NMRC/CSA-SI/0011/2017) and its Collaborative Centre Grant scheme (grant number NMRC/CGAug16C006), and the Singapore Ministry of Education Academic Research Fund Tier 2 (grant number MOE2016-T2-2-021). HEB was supported by the Novo Nordisk Foundation (grant numbers NNF14OC0013337, NNF15OC0016674). RKK is supported by the Oxford NIHR Biomedical Centre. The research was also supported by the NIHR infrastructure at Leeds. The views expressed are those of the author(s) and not necessarily those of the National Health Service, the NIHR, or the Department of Health. This article is based on the work of COST Action EU-CARDIOPROTECTION (CA16225) and supported by COST (European Cooperation in Science and Technology). We thank all study personnel for their invaluable assistance. Sí

Bailout stenting post–paclitaxel drug-coated balloon use (DCB) is done with a limus-eluting stent, as we no longer use the paclitaxel-eluting stent. However, when using sirolimus DCB, bailout stenting is done with a limus-eluting stent, but this raises the issue of drug toxicity with a double dose

Use of drug-coated balloon (DCB) in de novo lesions is usually preferred in small vessels, and the recently reported Basket small 2 trial showed that DCBs were noninferior to second-generation DES. All the available data DCBs in de novo lesions have been extrapolated from paclitaxel-eluting balloons

Use of drug-coated balloons (DCBs) in coronary intervention is escalating. Most available DCBs elute paclitaxel, and there is a plethora of data on them. However, we prefer limus-eluting over paclitaxel-eluting stents. There is very limited data on sirolimus-eluting DCBs. MagicTouch (Concept Medical

A 77-year-old Caucasian female presented with central chest pain and an electrocardiogram showing anterior and inferior ST segment elevation. The patient had discrepancy of the blood pressure measurement and unequal radial pulses of the upper limbs. Urgent CT thorax and aorta showed no evidence of aortic dissection, but it showed a large mass in the left lung lower lobe, which involved the adjacent structures including the left ventricular. The patient refused to have a bronchoscopy or any further investigations and was discharged to the community with palliative care support.

A 71-year-old man who had had rheumatic fever as a child presented with prosthetic-valve endocarditis. A mitral valvotomy had been performed 37 years before, and 21 years later, his mitral valve was replaced with a Starr–Edwards prosthesis. Lateral chest radiography showed complete calcification of the left atrial wall (Panel A, arrows). A transesophageal echocardiogram showed calcification of the interatrial septum (Panel B, arrow). This rare condition was first described in 1898, in association with chronic rheumatic mitral disease, and is more common in women, most of whom have symptoms for more than 20 years. The condition is assumed to be . . .