Calcified Coronary Lesions Research Articles

Single centre registry: Acute outcomes of coronary orbital atherectomy in calcified coronary arteries

The DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) is a catheter-based system designed for optimising PCI results in calcified coronary artery lesions. Calcification of coronary arteries remains one of the last frontiers in interventional cardiology. Interventions in these lesions are consistently associated with increased adverse acute and chronic outcomes e.g. Death, MI and TVR. These are attributed to failed stent delivery, stent malapposition, vessel dissection, stent thrombosis and in-stent restenosis.

Abstract 13828: Lesion Length and Left Ventricular Function Predict Outcome in Patients Undergoing Orbital Atherectomy Prior to Stenting for Severely Calcified Coronary Lesions

Introduction: Orbital atherectomy prior to stenting (OAptS) of severely calcified coronary lesions may improve procedural outcomes. However, there is little data identifying specific procedural/clinical factors influencing these outcomes. In this study, we examined the hypothesis that both lesion length and left ventricular ejection (LVEF) influence overall clinical outcomes for OAptS. Methods: Between November 1, 2015 and December 31, 2019, clinical data and coronary angiograms for all patients undergoing OAptS for severely calcified coronary lesions at our institution were retrospectively reviewed. Patients were first grouped by lesion length (focal ≤24mm and diffuse >24mm), then subdivided into normal (≥50%) and reduced (<50%) LVEF groups. Demographics, procedural variables and clinical outcomes for all four groups were then analyzed and compared. Results: In total, 213 lesions were analyzed (74 focal and 139 diffuse). There was no significant difference in demographics between all four patient groups. Average target lesion stent lengths were longer for diffuse compared to focal lesions (38.1±1.7mm vs. 17.2±0.8mm; p<0.001). Fluoroscopy time was longer in patients with diffuse lesions (p< 0.05), with no significant difference in contrast volumes between all groups (p=NS). The baseline LVEF was lower in patients with diffuse lesions (50.6±13% vs. 54.8±12%; p<0.05). Thirty-day time-to-event analysis (Mantel-Cox) demonstrated earlier and more frequent death/MACE/bleeding in the patient group with both diffuse lesions and reduced LVEF (p<0.01). Death, MACE and bleeding was not statistically different between the other three subgroups. Conclusions: In conclusion, our single center, retrospective analysis demonstrates the general safety of OAptS for treating severely calcified coronary lesions of different lengths in patients with normal and reduced LVEF. In addition, it identifies a high-risk patient subgroup (diffuse lesion length and reduced LVEF) at increased risk for a worse procedural outcome.

Primary Angioplasty of Calcified Coronary Lesions Using Coronary Lithotripsy in Acute ST-Segment Elevation Myocardial Infarction.

This study reports procedural and short-term clinical outcomes from a real-world series with the use of coronary lithotripsy in the context of primary angioplasty in ST-segment elevation myocardial infarction (STEMI). This was a prospective registry conducted at 2 hospitals, which included 10 patients who presented a culprit calcified lesion within acute STEMI and underwent coronary lithotripsy during primary angioplasty, between July 2019 and July 2020. Mean age was 69.2 ± 11.8 years, and there was a high proportion of hypertension (70%) and dyslipidemia (60%). All lesions (type B/C) were predilated with a semicompliant balloon. Coronary lithotripsy was performed in all cases once macroscopic thrombus was successfully retrieved by thrombus aspiration catheter. Before lithotripsy, rotational atherectomy was used in 1 case and cutting balloon was used in 2 cases. On average, coronary lithotripsy required the use of 1 lithotripsy balloon (range, 1-2) delivering a mean of 70 pulses. Two lithotripsy balloons were ruptured during lithotripsy therapy without any adverse event. Successful coronary lithotripsy was achieved in 90%. There were no periprocedural cardiac complications. Coronary lithotripsy seems to be a safe and effective technique in patients with STEMI and a culprit calcified lesion undergoing primary angioplasty for calcium modification in the absence of angiographic thrombus, and a suitable option to achieve adequate stent expansion and apposition.

Pourquoi et comment j'utilise l'athérectomie orbitale ?

Severe coronary artery calcification, too often underestimated, increases the complexity of percutaneous coronary interventions. Atherectomy is one of preferred approach for the preparation of calcified lesions before stent placement. Orbital atherectomy (OA) is a new method that has proven to be safe and effective in the preparation of calcium plaques (ORBIT I and ORBIT II studies). The OA is made up of a crown mounted with diamonds that abrades the endoluminal calcium plaque by centrifugal force and creates pulsatile forces on the wall that fractures the deep calcified plaques in the media. The OA Diamondback 360 ™ consists of a tableside electric powered motor handle connected to a drive shaft mounted with an eccentric crown. The OA specific 0.012" coronary guidewire made of Nitinol (ViperWire ™) has 3 qualities; the torquability, the ease of navigation and the support. Compared to rotational atherectomy, AO is associated with a lower rate of MACE at 1 year, with less revascularization of the target vessel and reduced fluoroscopy time but at the cost of an increased rate of coronary dissection and perforation. AO is a new, quite attractive, safe and effective tool to consider in the preparation of calcified coronary lesions.

TCT-120 Optical Coherence Tomography Characterization of Shockwave Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD OCT Substudies

TCT-120 Optical Coherence Tomography Characterization of Shockwave Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD OCT Substudies

Deep learning reconstruction algorithm for coronary CT angiography in assessing obstructive coronary artery disease caused by calcified lesions: the clinical application value

Objective: To investigate the image quality of coronary CT angiography (CCTA) subjected to deep learning-based reconstruction algorithm (DLR) method and its diagnostic performance for stenosis caused by coronary calcified lesions. Methods: We enrolled 33 consecutive patients with known or suspected coronary artery disease (CAD) who underwent CCTA and subsequently invasive coronary angiography (ICA) within 1 month in the department of radiology, Peking Union Medical College Hospital between February 2020 and February 2021. Among them, there are 26 males and 7 females, age range from 45 to 86 (61.9±9.0) years. The CCTA images were reconstructed with DLR and hybrid iterative reconstruction (HIR). Image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were calculated on the aorta root, left main artery, proximal left anterior descending, left circumflex, and right coronary artery of the CCTA images and were used to evaluate the objective image quality (IQ). Subjective IQ score was graded using Likert four-point scale (1 for excellent and 4 for poor). The diagnostic performance of obstructive coronary artery disease caused by calcified lesions on CCTA subjected to DLR and HIR methods were evaluated using ICA as the reference standard. Results: A total of 123 lesions in 33 patients were included in the analysis. Image noise of DLR image was significantly lower than that on HIR image(defined as the standard deviation of the attenuation values in the aortic root: 18.12±3.66 vs 24.19±5.71, P<0.001), CNR and SNR of DLR image in the aortic root were higher (CNR:43.83±23.73 vs 26.38±9.69, P<0.001,SNR:26.66±7.83 vs 21.23±8.65, P<0.001). Subjective scores of DLR was better than HIR image (1.12±0.41 vs 1.46±0.60,P<0.001). The sensitivity, specificity and accuracy of DLR and HIR images for diagnosing obstructive coronary artery disease caused by calcified lesions were 100.0%, 77.4%, 78.9% and 100.0%, 63.5%, 65.9%%, respectively. The number of false positive cases on DLR image decreased by 38% compared with HIR. Conclusions: Artificial intelligence based DLR can significantly reduce the image noise and improve the image quality of CCTA. DLR helps to improve the diagnostic performance of CCTA in assessing obstructive coronary artery disease caused by calcified lesions, which may have good clinical application value.

Physiological and angiographic outcomes of PCI in calcified lesions after rotational atherectomy or intravascular lithotripsy

Abstract Background Percutaneous coronary interventions (PCI) in calcified coronary artery lesions is associated with impaired stent expansion, higher rate of periprocedural complications and cardiac mortality. Lesion preparation using dedicated calcium modifying techniques such as RA or IVL has been advocated. Studies comparing these technologies are lacking. Objectives To compare the in-stent pressure gradient, evaluated by virtual fractional flow-reserve, in calcific lesions treated using either rotational atherectomy (RA) or intravascular lithotripsy (IVL). Methods Patients undergoing either RA- or IVL-assisted PCI from two European centers were included. Propensity score matching (1:2) was performed to control for potential bias. Primary outcome was post- PCI in-stent pressure gradient calculated by virtual fractional flow reserve (vFFRgrad, calculated as the difference between the vFFR at the proximal minus distal edge of the stent). Secondary outcomes included the proportion of patients with complete functional revascularization defined as of distal vFFR post PCI (vFFRpost) ≥0.90. Results From a cohort of 210 patients, 105 matched patients (70 RA and 35 IVL) were included. Pre-PCI vFFR did not differ between groups (0,65±0,13 RA and 0,67±0,11 IVL). After PCI, in-stent pressure gradient was significantly lower in the IVL group (0.032±0.026 vs 0.043±0.026 in the RA group, p=0.024). The proportion of vessels with functional complete revascularization was similar between the two groups (32.9% vs. 37.1% in the RA and IVL group, respectively; p=0.669) Conclusions Calcific lesions preparation with IVL is effective and resulted in improved in-stent pressure gradient compared to RA. Approximately one third of the patients undergoing PCI for a severely calcified lesion achieved functional revascularization with no difference between rotational RA and IVL. Funding Acknowledgement Type of funding sources: None. In stent gradients after RA and IVL

Comparison of cardiovascular outcomes of moderate to severely calcific de novo coronary lesion preparation for stent implantation using rotational atherectomy in conjunction with cutting balloon versu

Abstract Background Previous studies showed the combined rotational atherectomy (RA) and cutting balloon angioplasty (CBA) strategy was associated with favourable cardiovascular outcomes compared to RA and plain balloon angioplasty (PBA) for adequate lesion preparation before stent implantation in moderate to severely calcified coronary lesions. However, these studies were limited by small sample size. Purpose To assess clinical outcomes in a large group of patients with moderate to severely calcified de novo severe coronary artery stenoses using RA followed by CBA (RA+CBA) compared to RA followed by PBA (RA+PBA) before 2.5–3.5 mm diameter stent implantation. Methods We conducted a retrospective analysis of 1852 patients with moderate to severely calcified de novo severe coronary artery stenosis who underwent RA+CBA (n=372) or RA+PBA (n=1480) before 2.5–3.5 mm stent implantation. Death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST), and major adverse cardiovascular events (MACE) were calculated at 1-year. Standard multivariable covariate adjusted hazard ratios (HR) were performed. Results At 1-year follow-up, the unadjusted MACE [HR: 1.58 (1.14–2.21); p=0.007] was significant in RA+CBA group compared to RA+PBA group, even after adjusted for multiple variables [HR: 1.61 (1.11–2.35); p=0.013] (Figure 1A). This was mainly driven by TVR [Unadjusted HR: 1.76 (1.16–2.68); p=0.008 and adjusted HR: 1.64 (1.01–2.67); p=0.045] (Figure 1B). However, other adjusted outcomes including death [HR: 1.25 (0.63–2.50); p=0.521], MI [HR: 1.71 (0.77–3.77); p=0.188], and ST [HR: 2.11 (0.64–6.95); p=0.221] were not significant between both groups. There was no significant difference in complications including coronary artery dissection, side branch closure, coronary perforation, slow flow/no flow, abrupt vessel closure, post procedure MI, blood transfusion or bleeding in between the two groups. Conclusion In moderate to severely calcific de novo severe coronary artery stenosis lesion preparation before 2.5–3.5 mm stent implantation, RA+CBA strategy is associated with a higher risk of major adverse cardiovascular events compared to RA+PBA strategy at 1-year follow-up. Funding Acknowledgement Type of funding sources: None. Figure 1

Radial versus femoral approach for rotational atherectomy – technical aspects and procedural outcomes

Abstract Background Rotational atherectomy (RA) is a well-established therapy for the treatment of heavily calcified coronary lesions. While the radial approach has evolved into the gold-standard for standard percutaneous coronary intervention (PCI), RA is still often performed via a femoral approach. Concerns over guiding size, sheath size, the delivery of the burr as well as the need for a temporary pacemaker play a role in that decision. Methods This retrospective analysis includes all patients undergoing RA from 03/2013 to 06/2019 at one institution. We sought to investigate the procedural outcome and the influence of the percutaneous approach. Results A total of 228 patients were planned to undergo RA. Based on operator preference, RA was attempted via the radial approach (RAD) in 78 (34.2%) patients and via the femoral approach (FEM) in 150 (65.8%) patients. The procedure failed in 2.6% (RAD 1.3% vs. FEM 3.3%, p=0.359) due to crossing failure of either the RotaWire (n=5) or the burr (n=1). The left anterior descending was the most frequently treated vessel in the radial group and significantly more often targeted in comparison to the femoral group (LAD: RAD 44.6% vs. FEM 26.5%, p=0.004). All other vessels were similarly often treated in both groups (LM: RAD 13.3% vs. FEM 17.3%, p=0.414; LCX: RAD 15.7% vs. FEM 23.5%, p=0.155; RCA: RAD 25.3% vs. FEM 31.5%, p=0.315; Bypass: RAD 1.2% vs. FEM 1.2%, p=0.984). RAD-RA was significantly more often performed with a 6F sheath in comparison to FEM-RA (RAD 47.4% vs. FEM 16.7%, p&amp;lt;0.001). A 7F sheath was used in 52.6% of the cases for RAD-RA (men: 85.4%, women: 14.6%, p=0.176) and is therefore the most frequently chosen sheath size within that group. A 7F or 8F sheath was used in 75.3%, respectively 8.0% of the cases in the FEM group (7F: p&amp;lt;0.001; 8F: p=0.010 compared to RAD). There were no significant differences regarding the burr sizes (RAD 1.43±0.17mm vs FEM 1.41±0.18mm, p=0.442). Whereas the placement of a temporary pacemaker was equal in both groups (RAD 20.8% vs. FEM 30.8%, p=0.110), the femoral group showed a higher number of patients with any back-up pacing, permanent or temporary (RAD 24.7% vs. FEM 39.0%, p=0.031). There were no significant differences in terms of fluoroscopy time (RAD 00:24:65±00:12:48 vs. FEM 00:28:33±00:17:05, p=0.180) and the volume of contrast medium (RAD 217.2±96.3ml vs. FEM 192.9±86.0ml, p=0.118). Moreover, procedural complications (RAD 17.9% vs. FEM 18.0%, p=0.992) and access site related complications (RAD 6.4% vs. FEM 10.0%, p=0.363) occurred equivalently in both groups. Conclusion This analysis shows that RA via radial access is as safe and successful as via femoral access. Despite the more frequent use of 6F sheaths, burr sizes did not differ. Additionally, neither fluoroscopy time nor contrast volume indicated a higher complexity of the RAD approach. Funding Acknowledgement Type of funding sources: None.

Planned Versus Bailout Rotational Atherectomy: A Systematic Review and Meta-Analysis

Background/purposeRotational atherectomy (RA) plays a central role in the treatment of heavily calcified coronary artery lesions. Our aim was to compare periprocedural characteristics and outcomes of planned (PA) vs. bailout (BA) rotational atherectomy. MethodsWe conducted a systematic review and performed a meta-analysis on studies which compared PA vs. BA strategy. ResultsFive studies fulfilled the inclusion criteria, pooling a total of 2120 patients. There was no difference in procedural success, PA vs. BA risk ratio (RR) 1.03 and 95% confidence interval (95% CI) 0.99–1.07. Compared to BA, PA was associated with a shorter procedural time [mean difference (MD) -25.88 min, 95% CI -35.55 to −16.22], less contrast volume (MD -43.71 ml, 95% CI -69.17 to −18.25), less coronary dissections (RR 0.50, 95% CI 0.26–0.99), fewer stents (MD -0.20, 95% CI -0.29 to −0.11), and a trend favouring less periprocedural myocardial infarctions (MI) (RR 0.77, 95% CI 0.54–1.11). There was no difference in major adverse cardiovascular events on follow-up (RR 1.04, 95% CI 0.62–1.74), death (RR 0.98, 95% CI 0.59–1.64), MI (RR 1.16, 95% CI 0.62–2.18), target vessel revascularization (RR 1.40, 95% CI 0.83 to 2.36), stroke (RR 1.50, 95% CI 0.46–4.86) or stent thrombosis (RR 0.82, 95% CI 0.06–10.74); all PA vs. BA comparisons. ConclusionsCompared to bailout RA, planned RA resulted in significantly shorter procedural times, less contrast use, lesser dissection rates and fewer stents used. The bailout RA approach appears to enhance periprocedural risk, but there is no difference on mid-term outcomes.

Coronary orbital atherectomy using a five-French guiding catheter.

Recently, the efficacy was demonstratedof the Diamondback 360® Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc., St. Paul, MN, USA) for treating calcified coronary lesions in percutaneous coronary intervention (PCI). The safety and feasibility of OAS application through a 5-Fr guiding catheter (GC) which is less invasive and reduces access site complications were validated. This sequential, retrospective, observational study was conducted in a single center from September 2018 to May 2020. The primary endpoint was a successful PCI with the OAS. Secondary endpoints were major adverse complications related to PCI with the OAS, including coronary dissection, perforation, side branch loss, need for an unexpected cardiac assist device, access site complications, and major adverse cardiac and cerebrovascular events. 33 PCIs in 30 patients (mean age 72 ± 11years; male, 83.3%) were surveyed. All PCIs were successfully completed with OAS application through a 5-Fr GC. Coronary perforation after the OAS procedure occurred in one case (3.0%). Severe coronary dissection occurred in three cases (9.1%), and procedural myocardial infarction in two cases (6.1%). Regarding PCIs performed with the 5-Fr GC, the OAS is a safe and feasible strategy for calcified plaque modification.

Optical coherence tomography findings on intima healing reaction using drug-coated balloon after orbital atherectomy for a heavily calcified coronary artery lesion.

Optical coherence tomography findings on intima healing reaction using drug-coated balloon after orbital atherectomy for a heavily calcified coronary artery lesion.

Characteristics and hospital outcomes of coronary atherectomy within the United States: a multivariate and propensity-score matched analysis

ABSTRACT Background Suboptimal stent delivery and deployment in calcified coronary lesions are associated with a poor clinical outcome. Methods Using the National Inpatient Sample database, we identified patients undergoing percutaneous coronary intervention (PCI). Comparison between procedural and hospital outcomes between patients who underwent atherectomy and those who did not. Results A total of 2,035,039 patients underwent PCI, of which 50,095 (2.4%) underwent lesion modification using atherectomy. After adjustment for baseline differences, patients who underwent atherectomy were found to have higher rates of in-hospital mortality (3.3% vs 2.2% adjusted Odds Ratio, aOR, 1.39; 95% confidence interval [CI], 1.31–1.46, P < 0.001), coronary artery dissection (1.7% vs 1.1%, aOR, 1.56; 95%, 1.45–1.67, P < 0.001) vascular complications (1.6% vs 1.0%, aOR, 1.52; 95%, 1.42–1.64, P < 0.001), major bleeding (6.3% vs 4.7%, aOR, 1.24; 95%, 1.18–1.28, P < 0.001), and acute kidney injury (AKI) (10.9%vs 9.1%, aOR, 1.07; 95%, 1.04–1.11, P < 0.001) when compared with non-atherectomy patients. Concomitant intravascular ultrasound (IVUS) imaging improved mortality, while other complication rates were not affected by imaging. Conclusion Coronary atherectomy was performed in patients with multiple comorbidities and was associated with higher in-hospital mortality and complications than the non-atherectomy group.

Real-world outcomes in treatment of highly calcified coronary lesions with intravascular shockwave lithotripsy

Real-world data regarding the efficacy and safety of coronary intravascular lithotripsy (IVL) are lacking. We conducted a study of 50 consecutive patients (64 lesions) who underwent IVL. 3 patients suffered in-hospital mortality unrelated to the IVL; there was no other occurrence of MACE up to 30 days. Angiographic success was nearly universal (98% of patients with residual stenosis <50%, 96% of patients with TIMI 3 flow) and complication was rare, including among patients undergoing IVL for in-stent restenosis or left main coronary artery lesions. In a high-risk real-world cohort, IVL was a safe and effective treatment for highly-calcified coronary lesions.

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective

Regulatory approval processes for medical devices in Japan and the United States of America (US) often require similar clinical trials to establish safety and effectiveness. The Harmonization by Doing (HBD) program provides a collaborative environment for communication between regulators, academics and industry, facilitating the design and conduct of US/Japanese clinical trials supporting approval in both countries.

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept

Effective treatment strategies and medical devices continue to be needed in Japan and the United States of America (US) to mitigate the growing burden of cardiovascular disease and coronary heart disease. Unfortunately, there can be a delay in gaining cardiovascular device approval in Japan after a device has already been approved and is in use in the US. The Harmonization by Doing (HBD) program; however, can eliminate this delay and reduce the cost of completing a clinical trial in Japan. The HBD proof-of-concept study, COAST, resulted in approval of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown simultaneously in Japan and the US on the same day. Subsequently, the Diamondback 360® Coronary OAS Classic Crown also received approval in Japan. The COAST study provides further evidence that global clinical trials via HBD for medical devices are practical and advantageous.

Emergence of a new technique to treat calcified coronary lesions

Emergence of a new technique to treat calcified coronary lesions

Effect of smoking on clinical outcomes in patients receiving rotational atherectomy in calcified coronary lesions: from the ROCK Registry, South Korea.

BACKGROUND: Tobacco smoking and its harmful health effects also increase economic burdens globally. Surprisingly, despite the detrimental health consequences of smoking, some studies have shown better survival among smokers compared with non-smokers, a phenomenon called “smoker's paradox”. However, the impact of smoking status on clinical outcomes in severe calcified coronary artery disease (CAD) patients has yet to be reported.OBJECTIVES: Investigate the impact of smoking on clinical outcomes in calcified CAD receiving rotational atherectomy (RA).DESIGN: Retrospective review of medical records.SETTING: Multicenter registry in South Korea.PATIENTS AND METHODS: This multicenter registry included consecutive patients with calcified CAD who underwent RA at nine tertiary centers in Korea between January 2010 and October 2019.MAIN OUTCOME MEASURES: Target-vessel failure (TVF) which included the composite of cardiac death, target-vessel myocardial infarction (TVMI), and target-vessel revascularization (TVR).SAMPLE SIZE: 583 lesions in 540 patients followed for a median of 16.1 months.RESULTS: Lesions were divided into two groups: non-smokers (n=472, 81.0%) and smokers (n=111, 19.0%). TVF in the smoker group was significantly more frequent than in non-smoker group (log rank P=.016). The inverse probability of treatment weighting analysis also showed that smoking was significantly associated with a higher incidence of the primary outcome (HR: 1.617; 95% CI: 1.127–2.320; P=.009), cardiac death (HR 1.912; 95% CI: 1.105-3.311; P=.021), myocardial infarction (HR: 3.914; 95% CI: 1.884-8.132; P<.001), TVMI (HR: 3.234; 95% CI: 1.130-9.258; P=.029), and TVR (HR: 1.661; 95% CI: 1.043-2.643; P=.032). However, any bleeding was significantly observed less in the smokers.CONCLUSION: Smoking is significantly associated with adverse clinical outcomes in CAD patients requiring RA.LIMITATIONS: Retrospective design.CONFLICTS OF INTEREST: None.

Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial.

The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied. We sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon. In this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomised to predilation with either a super high-pressure balloon or a scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success. OCT data after DES implantation were available for 70 out of 74 patients (94.6%) enrolled. Lesion preparation with a super high-pressure balloon versus a scoring balloon led to a comparable stent expansion index (0.72±0.12 vs 0.68±0.13; p=0.22). Compared with the scoring balloon, the super high-pressure balloon increased the minimum lumen diameter (2.83±0.34 mm vs 2.65±0.36 mm; p=0.03) and reduced the diameter stenosis (11.6±4.8% vs 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% vs 97.3%; p>0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon. In patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance. Visual summary. A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.

Feasibility and safety of minimal-contrast IVUS-guided rotational atherectomy for complex calcified coronary artery disease.

To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. Mean glomerular filtration rate was 32 ± 17ml/min/1.73m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.