Editorial: Is the axiom of balloon angioplasty, "the more you gain the more you lose", still true in the era of DCB with paclitaxel?

Balloon angioplasty achieves luminal enlargement by fracturing the atherosclerotic intima at its point of least resistance, thereby creating a dissection plane and space with dehiscence of the intima from the media. This barotraumatic dissection triggers an inflammatory and proliferative reaction, resulting in a restenosis process at medium-term. In the era of plain old balloon angioplasty, quantitative angiographic studies at follow-up demonstrated that - the greater the acute luminal gain was after balloon angioplasty, the greater the late luminal loss was at follow-up. The interventional cardiologists coined the following motto "the more you gain, the more you lose". However, in the current era of drug coated balloon (DCB), it appears that this vexing conundrum could have been abrogated. A recently published DCB study in small de novo vessel has demonstrated that there was a slightly negative correlation between the volume of dissection assessed by optical coherence tomography and the angiographic late luminal loss (now gain) after Paclitaxel coated balloon treatment. In other words, the barotraumatic dissection does not necessarily herald a restenosis process in the era of DCB. This article revisits the mechanism of balloon angioplasty and explores how DCB with Paclitaxel may change the paradigm of balloon angioplasty as default treatment in CAD percutaneous treatment.

Chronic total occlusion in non-ST elevation myocardial infarction - A multi-centre observational study.

OBJECTIVES: To evaluate the characteristics and outcomes of patients with a chronic total occlusion (CTO) in a Non-ST Elevation Myocardial Infarction (NSTEMI) cohort. BACKGROUND: There is limited data on the clinical characteristics, revascularisation strategies and outcomes of patients presenting with a NSTEMI and a CTO. METHODS: Retrospective analysis of a six-centre percutaneous coronary intervention (PCI) registry in the UK between January 2015 and December 2020 was performed. Patients with a NSTEMI with and without a CTO were compared for baseline characteristics and outcomes. RESULTS: There were 17,355 NSTEMI patients in total of whom 1813 patients had a CTO (10.4 %). Patients with a CTO were more likely to be older (CTO: 67.8 (±11.5) years vs. no CTO: 67.2 (±12) years, p = 0.04), male (CTO: 81.1 % vs.71.9 %, p < 0.0001) with a greater prevalence of cardiovascular risk factors. All-cause mortality at 30 days: HR 2.63, 95 % CI 1.42-4.84, p = 0.002 and at 1 year: HR: 1.87, 95 % CI 1.25-2.81, p = 0.003 was higher in the CTO cohort. CTO patients who underwent revascularisation were younger (Revascularisation 66.4 [±11.7] years vs. no revascularisation 68.4 [±11.4] years, p = 0.001). Patients with failed CTO revascularisation had lower survival (HR 0.21, 95 % CI 0.10-0.42, p < 0.0001). The mean time to revascularisation was 13.4 days. There was variation in attempt at CTO revascularisation between the 6 centres for (16 % to 100 %) with success rates ranging from 65 to 100 %. CONCLUSIONS: In conclusion, the presence of a CTO in NSTEMI patients undergoing PCI was associated with worse in-hospital and long-term outcomes.

How to perform a successful drug-coated balloon angioplasty? Tips and tricks.

Drug-coated balloons (DCB) offer an excellent alternative to stents as the antiproliferative drugs are delivered via balloons and hence there is no permanent implant of metal or polymer. This rationale applies perfectly in in-stent restenosis (ISR) as we want to avoid another layer of metal in a previously failed stent. However, their use has also been extended to de novo lesions especially in patients and lesion subsets where stents are not ideal. There is an increased desire toward expanding this further and studies are now being done which are testing DCB in large-caliber vessels. As the use of DCB is escalating, we felt the importance of writing this article whereby we aim to provide important tips and tricks when using DCB especially for the operators who are in the early phase or have the desire of embarking this technology. From our experience, the DCB-angioplasty substantially differs on several aspects from DES-angioplasty. We have provided several case bases examples including algorithm when using DCB in ISR and de novo lesions.

The evolution and revolution of drug coated balloons in coronary angioplasty: An up-to-date review of literature data.

European Society of Cardiology (ESC) guidelines gave class I A indication for use of DCB in in-stent restenosis. However, no indication exists for the usage of DCB in de novo lesions. Although the current generation DES offer excellent results, as we embark more complex lesions such as calcified lesion and chronic total occlusion, restenosis and stent thrombosis are higher and tend to increase within the years. There is increasing desire to leave nothing behind to abolish the risk of restenosis and stent thrombosis and hence the absorbable scaffolds were introduced, but with disappointing results. In addition, they take several years to be absorbed. Drug coated balloons offer an alternative to stents with no permanent implant of metal or polymer. They are already in use in in Europe and Asia and they have been approved for the first time in the United States for clinical trials specifically for restenotic lesions. There is emerging data in de novo lesions which have shown that DCB are noninferior and in some studies maybe even superior to current generation DES especially in small vessels. In this article, we provide a comprehensive review of the literature on this expanding technology focussing on the evidence in both re-stenotic and de novo lesions.

A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small Vessels.

BACKGROUND: There are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de novo small vessel disease (SVD). OBJECTIVES: This study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB. METHODS: This prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to treatment with an SCB or PCB, with balloon sizing determined using optical coherence tomography. The primary endpoint was noninferiority for the 6-month angiographic net lumen gain. RESULTS: Angiographic follow-up was completed in 109 (90.1%) patients in the per-protocol analysis. The mean ± SD angiographic net gains were 0.25 ± 0.40 mm with SCBs vs 0.48 ± 0.37 mm with PCBs, resulting in SCBs failing to meet the 0.30 mm criterion for noninferiority (Pnoninferiority = 0.173), with an absolute difference of -0.23 mm (95% CI: -0.37 to -0.09) secondary to a smaller late loss (0.00 ± 0.32 mm vs 0.32 ± 0.47 mm; P < 0.001) and more frequent late lumen enlargement (53.7% vs 30.0%; OR: 2.60; 95% CI: 1.22-5.67; P = 0.014) with PCBs. Binary restenosis rates were 32.8% and 12.5% following treatment with SCBs and PCBs, respectively (OR: 3.41; 95% CI: 1.36-9.44; P = 0.012). The mean angiography-derived fractional flow ratio at follow-up was 0.86 ± 0.15 following treatment with SCBs and 0.91 ± 0.09 following PCBs (P = 0.026); a fractional flow ratio ≤0.80 occurred in 13 and 5 vessels after treatment with SCBs and PCBs, respectively. CONCLUSIONS: The SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo.

The estimation of coronary artery calcium thickness by computed tomography angiography based on optical coherence tomography measurements.

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. A total of 68 patients who had CCTA for suspected coronary artery disease and subsequently went on to have OCT were included in the study. 238 lesions of them divided into derivation and validation dataset at 2:1 ratio (47 patients with 159 lesions and 21 with 79, respectively) were analyzed. A new method was developed to estimate calcium thickness from the maximum CT density within the calcification and compared with calcium thickness measured by OCT. 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 < 0.001). The estimated calcium thickness derived from this equation showed strong agreement with measured calcium thickness in validation and derivation dataset (r2 = 0.481 and 0.527, 95% CI 0.609-0.842 and 0.497-0.782, p < 0.001 in both, respectively), more accurate than the estimation by full width at half maximum and inflection point method. In conclusion, this novel method provided the estimation of calcium thickness more accurately than conventional methods.

Which predilatation balloons provide the best lesion preparation prior to use of drug coated balloons in de-novo lesions? Results from the PREPARE study.

BACKGROUND: 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 predilatation balloons: semi-compliant (SB), non-compliant (NB) and scoring balloons (ScB) used when preparing de-novo lesions prior to the use of DCB. METHODS: 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. RESULTS: 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. Predilatation 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; P<0.001). 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; P<0.001). During the median follow-up duration of 547-days, there were no differences in the hard-clinical endpoints, 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). CONCLUSIONS: The PREPARE study results do not suggest routine use of ScB prior to DCB in de-novo lesions.

Long-term outcomes following intravascular lithotripsy (IVL) for calcified coronary lesions: A Real-World Multicenter European Study.

OBJECTIVES: To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population. BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

"RotaTripsy" for Severe Calcified Coronary Artery Lesions: Insights From a Real-World Multicenter Cohort.

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.

Is a high calcific burden an indication, or a contraindication for Drug Coated Balloon?

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.

Epidemiological findings on interventional cardiology procedures during the COVID-19 pandemic: A multi-center study.

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.

Long-term Outcome following Percutaneous Intervention of Intra-stent Coronary Occlusion and Evaluating the Different Treatment Modalities.

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.

Intravascular lithotripsy in calcified-coronary lesions: A real-world observational, European multicenter study.

BACKGROUND: The recently introduced intravascular lithotripsy (IVL) appears promising and relatively safer than conventional approaches when dealing with calcified lesions. Although there are published reports on this novel technology, data from the real world are limited. In this study, we aim to report on the experience of IVL from a real-world population derived from six European centers that undertake high-volume complex coronary interventions. METHODS AND RESULTS: We enrolled all patients treated with IVL between November 2018 and February 2020 at six centers. Procedural success and complications were assessed along with clinical outcomes, which included: cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR), and major adverse cardiac event (MACE) (composite of cardiac death, TVMI, and TLR). Hundred and ninety patients (200 lesions) with a mean age of 72 years were treated using IVL. Diabetes and chronic kidney disease were present in 50% (n = 95) and 16% (n = 30) of cases, respectively. Acute-coronary syndromes accounted for 91 (48%) of the cases. Most were de-novo lesions (77%; n = 154). Upfront use of IVL occurred in 26% of cases, while the rest were bail-out procedures due to inadequate predilatation with conventional balloons. Adjuvant rotational atherectomy was needed in 17% of cases. Procedural success was achieved in 99% of cases with a complication rate of 3%. During the median follow-up of 222 days, there was two cardiac deaths (1%), one case of TVMI (0.5%), 3 TLR (1.5%) taking the MACE rate to 2.6%. CONCLUSION: Use of IVL appears to be safe and effective in dealing with calcified-coronary lesions. A high success rate was observed with low procedural complications and event rates.

Mid-term clinical outcomes from use of Sirolimus coated balloon in coronary intervention; data from real world population.

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.

Should Technical and Anatomical Difficulties Discourage Operators From Embarking on Transradial Access for Percutaneous Coronary Intervention?

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.