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

Abstract 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.

Abstract 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.

Abstract 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 (<3.0 mm) accounted for 72% (n=48) of cases. Non-compliant balloons and scoring balloons to prepare the lesion was used in 51% (n=34) and 13% (n=9) of cases respectively. The mean diameter and length of SCBs were 2.6±0.4 mm and 23.2±7.3 mm respectively. 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.