Search

Objectives The aim of this study is to assess the feasibility, efficacy and safety of the “RotaTripsy” approach in severe calcified coronary artery lesions. Background Coronary lesions with a high calcium content represent a challenging scenario in interventional cardiology , requiring a proper lesion preparation. In this light, very little is known about the possibility to combine the benefits of rotational atherectomy and intravascular lithotripsy . Methods We retrospectively enrolled 34 patients from a real-word, multicenter, cohort of patients affected by severe calcified coronary artery lesions, which required the “RotaTripsy” to obtain a proper lesion preparation. In all the cases, rotational atherectomy and then intravascular lithotripsy were performed as a bail-out strategy following sub-optimal non-compliant balloon expansion. In 53% of the cases, the procedure was guided by intracoronary imaging findings. Results Procedural success was reported in all the cases, without any in-hospital major complication. Few major adverse clinical events were reported at mid-term follow-up. Conclusions “RotaTripsy” can represent a valid therapeutic option for undilatable heavily calcified coronary artery lesions. Our findings demonstrate the feasibility, safety and efficacy of this approach.

There is a lack of data on the clinical outcomes following the use of different strategies for lesion preparation prior to the use of drug-coated balloons (DCB). In this study, we have explored the clinical outcomes between different types of pre-dilatation balloons: semicompliant (SB), non-compliant (NB) and scoring balloons (ScB) used when preparing denovo lesions prior to the use of DCB.We retrospectively evaluated all patients who underwent treatment with DCB for de-novo lesions between 2011-2019 at 4 high-volume European centres. The measured study endpoints were: cardiac-death, TV-MI, TLR and MACE.During the study period, 553 patients were treated with DCB for de-novo lesions, 327 with SB only, 172 with NB and 54 with ScB. There were some differences in the procedural characteristics between the 3 groups. Pre-dilatation balloons were significantly larger in the ScB and NB groups as compared to the SB (2.7 mm and 2.6 mm vs. 2.3 mm; p0.001). The reference vessel diameter was significantly larger in the NB group as compared to the ScB and SB (2.6 mm vs. 2.2 mm and 2.3 mm; p0.001). During the median follow-up duration of 547-days, there were no differences in the hard-clinical end-points, however, TLR was significantly higher in the ScB as compared to SB and NB group (11% vs. 3.4% and 4.7%; p=0.02).The PREPARE study results do not suggest routine use of ScB prior to DCB in de novo lesions.

Purpose Optical coherence tomography (OCT) is recommended to be the most appropriate modality in assessing calcium thickness, however, it has limitations associated with infrared attenuation. Although coronary computed tomography angiography (CCTA) detects calcification, it has low resolution and hence not recommended to measure the calcium size. The aim of this study was to devise a simple algorithm to estimate calcium thickness based on the CCTA image. Methods Consecutive patient who had CCTA for suspected coronary artery disease and subsequently went on to have OCT were included in the study. Calcium CT density was collected from CT profile curve. The method to estimate calcium thickness was devised from maximum CT density within the calcification and compared to the measured calcium thickness by OCT. The accuracy of this method was compared to full width at half maximum (FWHM) or inflection point (IP) method. Results A total of 68-patients (238-lesions) divided into derivation and validation dataset at 2:1 ratio (47 patients with 159 lesions and 21 with 79, respectively) were analyzed. Maximum Calcium density and measured calcium-border CT density had a good correlation with a linear equation of y = 0.58x + 201 (r = 0.892, 95% CI: 0.855–0.919, p 2 = 0.481 and 0.527, 95% CI: 0.609–0.842 and 0.497–0.782, p

To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population.IVL is a relatively new but promising modality for treating coronary calcified lesions, but there is a dearth of long-term outcome data from real-world patients.This was a multicenter, observational study in which we enrolled all patients treated with IVL from November 2018 to February 2021 from eight centers in Europe and the United Kingdom. Procedural success, complications, and clinical outcomes (cardiac death, target vessel myocardial infarction [TVMI], target lesion revascularization [TLR], and MACE [major adverse cardiac events, the composite of cardiac death, TVMI, and TLR]) were assessed.In total, 273 patients with a mean age of 72 ± 9.1 years were treated with IVL. Major comorbidities included diabetes mellitus (n = 110, 40%) and chronic kidney disease (n = 45, 16%). Acute coronary syndrome accounted for 48% (n = 132) of patients, while 52% (n = 141) had stable angina. De novo lesions and in-stent restenosis accounted for 79% and 21% of cases, respectively. Intravascular imaging was used in 33% (n = 90) of patients. An upfront IVL strategy was adopted in 34% (n = 92), while the rest were bailout procedures. Adjuvant rotational atherectomy ("RotaTripsy") was required in 11% (n = 31) of cases. The procedural success was 99%. During a median follow-up of 687 days (interquartile range: 549-787), cardiac death occurred in 5% (n = 14), TVMI in 3% (n = 8), TLR in 6% (n = 16), and MACE rate was 11% (n = 30).This is the largest multicenter registry with a long-term follow-up showing the remarkably high procedural success of IVL use in calcified coronary lesions with low rates of hard endpoints and MACE.

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.

Drug coated balloons (DCB) are increasingly being used in coronary intervention. Most of their use is currently restricted to in stent restenosis, however, they are also being used to treat some de novo lesion subsets (especially small vessels) and in patients unable to take dual antiplatelet therapy beyond a month. Calcified lesions pose a significant challenge to coronary intervention from lesion preparation to the delivery of drug to the vessel wall. There are limited data on the use of DCB in calcified lesions. In this article, we have provided a detailed literature review on calcified lesions and the use of DCB including a case example.

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

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

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.

Background The rates of in-hospital mortality following percutaneous interventional procedures (PIP) during the COVID-19 pandemic period compared to the non-pandemic period has not been reported so far. Methods We retrospectively enrolled all consecutive patients admitted for PIP across five centers from February 2020 to May 2020. Results A total of 4092 PIP were performed during the reference periods. The total number of procedures dropped from 2380 to 1712 (28.0% reduction). Overall in-hospital mortality increased from 1.1% in 2019, to 2.6% in 2020 (63% relative increase). Conclusion During the COVID-19 pandemic, in-hospital all-cause mortality significantly increased in patients admitted for cardiological PIP.

Introduction Sub-optimal stent expansion due to coronary calcification augments the risk of restenosis and stent thrombosis. Calcium modification is generally achieved by rotational atherectomy or specialized balloons (scoring and cutting balloons), which carries risk of complications. Intravascular lithotripsy (IVL) appears safe and also aids in cracking deep seated adventitial calcium. Although, there are reported studies on this novel technology, there is a lack of real-world data. In this study, we report the experience from 4 centres that undertake high-volume complex coronary interventions. Methods We enrolled all patients treated with IVL between September 2018 and October 2019 at 4 centres (1 in UK and 3 in Italy). Procedural success and complication were assessed. The clinical outcomes evaluated were; cardiovascular death, target vessel MI (TVMI), target lesion revascularisation (TLR) and MACE (composite of cardiovascular death, TVMI and TLR). Results During the study period, 100 lesions (in 94 patients) with a mean age of 71±9.7 years (range;30 - 88) were treated using IVL. 70% (n=70) were male, 85% (n=80) had hypertension, 51% (n=48) had diabetes and 20% (n=19) had chronic kidney disease. Acute coronary syndromes accounted for 40% of patients (n=38). De-novo lesions accounted for 66% of cases (n=66) and the remaining 34% (n=34) were restenotic lesions. Left anterior descending artery (56%) accounted for most cases followed by right coronary artery (22%), left circumflex artery (21%), left main (17%) and saphenous vein grafts (3%) procedures. Upfront use of IVL occurred in 18% of cases whilst the rest were bail-out procedures due to inadequate pre-dilatation with conventional balloons. Adjuvant rotational atherectomy (Rota-tripsy) was used in 10 cases (10%) prior to the use of IVL. The mean diameter of IVL balloon was 3.3 ± 0.5mm. Intravascular imaging (IVUS) was used in 19% of cases. Procedural success was achieved in 100% of cases with a complication rate of 2% (2-cases of coronary perforation and one of them resulted in in-hospital mortality). During the median follow-up of 150 days, there were no clinical events including cardiac death, TVMI and TLR. Conclusion Initial experience and short-term clinical follow-up from IVL use appears safe and effective PCI strategy for dealing with calcified coronary lesions. A high success rate was observed with low event rates and procedural complications. We are enrolling more patients from other centres as part of a larger multi-centre registry and will be able to report this with higher numbers and longer follow-up at BCS 2020. Conflict of Interest nil

The impact of chronic kidney disease (CKD) and potential pharmacologic intervention on clinical outcomes after percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) remains unknown. A total of 1,463 patients underwent successful CTO-PCI between August 2004 and December 2014. Major adverse cardiovascular events (MACE) defined as the composite of all-cause death, myocardial infarction and target lesion revascularization, cardiac death, and stent thrombosis were compared between patients with and without CKD (555 and 908 patients, respectively). The results demonstrated higher risks of MACE (log-rank p = 0.015), all-cause death (log-rank p

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 The incidence of bailout stenting post-drug coated balloon use (DCB) in the literature has been more than 10%; ranging up-to 21% in Bello trial and this variation could be due to the different criteria used to consider bailout stenting and may also reflect aggressive pre-dilatation. Our eyes are trained to expect stent like result and anything less is considered sub-optimal and this could be one of the reasons for high incidence of bailout stenting. The current recommendation is to use drug eluting stent (DES) for bailout stenting and hence raising in the possibility of drug toxicity or maybe even synergistic effect from combination of Paclitaxel (DCB) and limus (DES). Aim We have evaluated the incidence and outcomes of patients needing bailout stenting in our centre. Methods and results We evaluated all patients who were treated with DCB between January 2016-August 2017. Bailout stenting per lesion were identified and studied for endpoints which included cardiac death, target vessel MI, stent thrombosis, target lesion revascularization and target vessel revascularisation. Between the study period; 468 lesions (in 364 patients) were treated with paclitaxel DCB (Sequent Please, B Braun, Germany). Bailout stenting was required in 23 lesions (4.9%) and of which 12 (52%) was for flow limiting dissections (type C or more) and the remaining 11 was for recoil of more than 50%. Majority of the lesions were de novo (18; 78%). All bailout stenting was performed with third generation limus eluting stents. During a median follow-up of 18.14 months; range; 7–33 months, there was no cardiac death and target vessel MI occurred in 1 patient (4.3%), TLR and TVR were in 3 lesions (13%). MACE rate (combination of cardiac death, target vessel MI and TVR) was 13%. There were no cases of stent thrombosis as per the ARC definition. Conclusion One of the highlighting features of our study is very low-rates of bailout stenting. This may be due to our criteria of not stenting mild dissections (unless they are flow limiting) and also to accepting recoil of up-to 50% post-DCB use. The outcome in bailout stenting group is acceptable especially with hard endpoints (cardiac death, target vessel MI and stent thrombosis) although TLR and TVR rates were higher indicating synergistic effect of paclitaxel and limus may not offer additional benefits.

AIMS Bindarit (BND) is a selective inhibitor of monocyte chemotactic protein-1 (MCP-1/CCL2), which plays an important role in generating intimal hyperplasia. Our aim was to explore the efficacy and safety of bindarit in preventing restenosis following percutaneous coronary intervention. METHODS AND RESULTS A phase II, double-blind, multicentre randomised trial included 148 patients randomised into three arms (BND 600 mg, n=48; BND 1,200 mg, n=49; PLB, n=51). Bindarit was given following PCI and continued for 180 days. Monthly clinical follow-up and six-month coronary angiography were conducted. The primary endpoint was in-segment late loss; the main secondary endpoints were in-stent late loss and major adverse cardiovascular events. Efficacy analysis was carried out on two populations, ITT and PP. There were no significant differences in the baseline characteristics among the three treatment groups. In-segment and in-stent late loss at six months in BND 600, BND 1,200 and PLB were: (ITT 0.54 vs. 0.52 vs. 0.72; p=0.21), (PP 0.46 vs. 0.53 vs. 0.72; p=0.12) and (ITT 0.74 vs. 0.74 vs. 1.05; p=0.01), (PP 0.66 vs. 0.73 vs. 1.06; p=0.003), respectively. The MACE rates at nine months among treatment groups were 20.8% vs. 28.6% vs. 25.5% (p=0.54), respectively. CONCLUSIONS This was a negative study with the primary endpoint not being met. However, significant reduction in the in-stent late loss suggests that bindarit probably exerts a favourable action on the vessel wall following angioplasty. Bindarit was well tolerated with a compliance rate of over 90%. A larger study utilising a loading dose and targeting a specific patient cohort may demonstrate more significant results.

Use of the radial approach for PCI procedures is increasing due to lower rates of access-site complications/bleeding, and patient preference. However, femoral operators switching may be discouraged by the learning curve and by anatomical issues that may complicate the procedure. We aimed to define the frequency of anatomic variants and success rates during transradial access for PCI.We retrospectively analyzed 2588 cases of PCI attempted by the radial route; radial/brachial and subclavian angiography was performed when obstructions were encountered. Presence of anatomical variants, spasm, and ability to complete the procedure were noted.Radial procedures were successfully completed in 2741/2588 cases (98.2%); in the remainder, switching to femoral approach was necessary. Local arteriography was performed in 221/2588 cases (8.5%) due to difficulties encountered; of these, 131/221 difficulties (59%) were due to problems at the radial arterial level, 58/221 (26%) were due to problems at the subclavian level, and 32/221 (15%) were due to problems at brachial arterial sites. Extreme radial tortuosity (18%) and radial loop (20%) had relatively lower rates of success followed by subclavian tortuosity (73%). Females had significantly higher incidences of radial spasm (6% vs 1.9% in men; P.001), radial tortuosity (3.4% vs 1.7% in men; P=.01), and subclavian tortuosity (3.8% vs 1.8% in men; P.01).Inability to successfully complete invasive procedures via the radial approach is uncommon. Even when encountered, most difficulties can be overcome with the use of vasodilators and hydrophilic wires. These data provide reassurance for would-be radial converts that the learning curve may not be as steep as envisaged.

Objectives To compare drug-eluting balloons (DEBs) versus second-generation DES in the treatment of drug-eluting stent restenosis (DES-ISR). Background The optimal treatment of DES-ISR remains unclear. Several modes of treatment ranging from plain-old balloon angioplasty to repeated use of DES have yielded disappointing results. DEBs are increasingly been used in restenotic lesions; however, their use in DES-ISR is less established. Methods We evaluated all procedures between 2009 and 2011, involving DES-ISR that were treated either with DEB or second-generation DES. The measured end-points during the follow-up period were cardiac-death, target-vessel MI, TLR, TVR, and MACE defined as composite of cardiac-death, TV-MI, and TVR. Results Two hundred and forty-seven patients (302 lesions) with DES-ISR were treated with either DEB (81 patients; 104 lesions) or second-generation DES (166 patients; 198 lesions). The mean age of patients was 66.1 ± 9.4 years. There were higher numbers of patients with diabetes in the DEB group (DEB 47% vs DES 33%; p = 0.03). The mean length of DEB was significantly longer than the DES (35.4 vs 19.8 mm; p

OBJECTIVES To report a single-center experience of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) and de novo coronary artery disease. BACKGROUND DEB are emerging as an alternative treatment for coronary stenosis especially when metal scaffolding is undesirable (in-stent restenosis and small-vessel de novo disease). Although there are various randomized trials and registry studies, the data from real-world cohorts are lacking. METHODS Consecutive patients treated with the In.Pact Falcon™ (Medtronic Inc., Minneapolis, MN, USA) paclitaxel-eluting balloon between January 2009 and December 2011 were retrospectively studied. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TVR. RESULTS A total of 275 lesions were successfully treated in 184 patients. The mean age was 66.2 ± 9.6 years, and 87% were males. The predominant indication for DEB use was ISR (62%), with de novo lesions accounting for the remainder (38%). A mean of 1.48 ± 0.9 DEB were used per patient. Bailout stenting was required in 24% of lesions. The median clinical follow-up was 14.6 months (IQR 12-23). The overall rates of cardiac death, MI, TLR, TVR, and MACE were 3.8%, 1.6%, 16.8%, 17.9%, and 21.7%, respectively. The overall rate of stent thrombosis was 0.5% (n = 1). CONCLUSION Our results suggests that DEB can be considered in lesions where the use of stents is not desirable, especially restenotic lesions. Further long-term follow-up of these patients will provide us more insights on the long-term outcomes.