Calcium Modification After Orbital Atherectomy and Balloon Angioplasty in Severely Calcified Lesions: The ECLIPSE OCT Substudy.

Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial.

We sought to assess plaque modification and stent expansion following orbital atherectomy (OA) for calcified lesions using optical coherence tomography (OCT). The efficacy of OA for treating calcified lesions is not well studied, especially using intravascular imaging in vivo. OCT was performed preprocedure, post-OA, and post-stent (n = 58). Calcium modification after OA was defined as a round, concave, polished calcium surface. Calcium fracture was complete discontinuity of calcium. Comparing pre- vs post-OA OCT (n = 29), calcium area was significantly decreased post-OA (from 3.4 mm2 [2.4-4.7] to 2.9 mm2 [1.9-3.9], P < 0.001). Poststent percent calcium fracture (calcium fracture length/calcium length) correlated with post-OA percent calcium modification (calcium modification length/calcium length) (r = 0.31, P = 0.01). Among 75 calcium fractures in 35 lesions, maximum calcium thickness at the fracture site was greater with vs without calcium modification (0.58 mm [0.50-0.66] vs 0.45 mm [0.38-0.52], P = 0.003). Final optimal stent expansion, defined as minimum stent area ≥6.1 mm2 or stent expansion ≥90% (medians of this cohort) at the maximum calcium angle site, was observed in 41 lesions. Larger post-OA lumen area (odds ratio 2.64; 95% CI 1.21-5.76; P = 0.02) and the presence of calcium fracture (odds ratio 6.77; 95% CI 1.25-36.6; P = 0.03) were independent predictors for optimal stent expansion. Calcium modification by OA facilitates poststent calcium fracture even in thick calcium. Greater calcium modification correlated with greater calcium fracture, in turn resulting in better stent expansion.

Intravascular Imaging vs Angiography Guidance for PCI of Severely Calcified Lesions: The ECLIPSE Trial.

Mechanisms of balloon angioplasty and repeat stenting in patients with drug-eluting in-stent restenosis

We aimed to compare coronary artery disease (CAD) at the time of a first acute coronary syndrome (ACS) in type II diabetic and non-diabetic patients by coronary angiography and by optical coherence tomography (OCT). Two different patient populations with a first ACS were enrolled for the angiographic (167 patients) and the OCT (72 patients) substudy. Angiographic CAD severity was assessed by Bogaty, Gensini, and Sullivan scores, whereas collateral development towards the culprit vessel was assessed by the Rentrop score. Optical coherence tomography plaque features were evaluated at the site of the minimum lumen area (MLA) and of culprit segment. In the angiographic substudy, at multivariate analysis, diabetes was associated with both the stenosis score and the extent index (P = 0.001). Furthermore, well-developed collateral circulation (Rentrop 2-3) towards the culprit vessel was more frequent in diabetic than in non-diabetic patients (73% vs. 16%, P = 0.001). In the OCT substudy, at MLA site lipid quadrants were less and the lipid arc was smaller in diabetic than in non-diabetic patients (2.3 ± 1.3 vs. 3.0 ± 1.2; P = 0.03 and 198° ± 121° vs. 260° ± 118°; P = 0.03). Furthermore, the most calcified cross-section along the culprit segment had a greater number of calcified quadrants and a wider calcified arc in diabetic than in non-diabetic patients (1.7 ± 1.0 vs. 1.2 ± 0.9; P = 0.03 and 126° ± 95° vs. 81° ± 80°; P = 0.03). Superficial calcified nodules were more frequently found in diabetic than in non-diabetic patients (79 vs. 54%, P = 0.04). In spite of potent pro-inflammatory, pro-oxidant and pro-thrombotic stimuli operating in type II diabetes, diabetic patients exhibit substantially more severe coronary atherosclerosis than non-diabetic patients at the time of a first acute coronary event. Better collateral development towards the culprit vessel, a predominantly calcific plaque phenotype and, probably, yet unknown protective factors operating in diabetic patients may explain these intriguing paradoxical findings.

Backgrounds Calcified lesions limit stent expansion and are associated with poor clinical outcomes. Atherectomy devices, including rotational atherectomy (RA) and orbital atherectomy (OA), can reduce calcium volume and potentially improve clinical outcomes. We previously conducted the DIRO trial, a prospective randomized study comparing RA (n=50) vs OA (n=50) for calcified lesions using optical coherence tomography (OCT) guidance. The trial showed that RA achieved greater tissue modification and stent expansion than OA. However, 8-month clinical outcomes did not differ between the 2 groups. The long-term clinical impact of these devices remains unclear. Purpose This study aimed to evaluate the long-term clinical outcomes of RA and OA followed by drug-eluting stents implantation. Methods In the DIRO trial population, the long-term incidence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR), was assessed and compared between RA and OA groups using a log-rank test. Results Figure 1 presents patient demographics, lesion and procedural characteristics, and OCT findings. Stent expansion was significantly larger in the RA group than in the OA group. The medium follow-up period was 1095 days. The 3-year TLF rate was 13% in RA group vs 11% in OA group. Figure 2 shows Kaplan-Meier curves of TLF and its individual components. Conclusions Long-term TLF rate was low following adequate atherectomy under OCT guidance and was comparable between the 2 groups.

IntroductionIntravascular lithotripsy (IVL) is a novel calcium modification technique. Its safety and efficacy have been shown in non-randomized studies. The effect of IVL on varying calcium patterns has not been...

Benefit of Long-Term Dual Anti-Platelet Therapy in Patients Treated With Drug-Eluting Stents: From the NHLBI Dynamic Registry

Background and Objectives:Sirolimus-eluting stents (SESs) have a considerably lower optimal minimal stent area (MSA) threshold compared to bare metal stents (BMSs). In the SIRIUS IVUS sub study, the absolute optimal stent expansion (OSE) of SESs was described as ≥5.0 mm. The purpose of this study was to evaluate the impact of the OSE on long-term outcomes following SES implantation using absolute IVUS criteria. Subjects and Methods:The study included 157 patients (BMS: 57; SES; 100), who underwent 6-month follow-up angiography and 18-month clinical follow-up after bare metal stent or drug-eluting stent (DES) implantation. According to the absolute measurement IVUS criteria, patients were divided into two groups: OSE and non-OSE. The IVUS criteria for OSE were MSA ≥6.5 mm for BMS implantation and MSA ≥5.0 mm for SES implantation. Results:Angiographic binary restenosis was higher in the non-OSE than the OSE group with BMS (33.3% vs. 11.4%; p<0.039), but the rates were similar between the two groups with SES (4.5% vs. 3.2%; p=1.00). With the BMS, the MACE rates were 5.7% and 30% in the OSE and non-OSE group, respectively (p=0.017). However, with the SES, the MACE rates were similar between the two groups (OSE group, 3.2% vs. non-OSE group, 4.5%, p=1.00). Conclusion: After SES implantation, there were no significant differences in the late outcomes in relation to the achievement of absolute OSE. A variety of restenosis related factors should be considered for better outcomes after DES implantation. Therefore, the concept of OSE in the era of DESs might need to be revisited. (Korean Circulation J 2007;37:244-250)

Although the outcomes of various treatments for in-stent restenosis (ISR) after drug-eluting stent (DES) implantation have been reported, the optimal treatment of recurrent ISR lesions after DES implantation for ISR lesions was unknown. This study compared the efficacy between DES implantation and balloon angioplasty (BA) for recurrent ISR lesions after DES implantation. From 2003 to 2010, DES were implanted in 1,101 ISR lesions, of which 148 recurrent ISR lesions (142 patients) were treated with BA (76 lesions, 72 patients) and DES implantation (72 lesions, 70 patients). Clinical outcomes were evaluated for major adverse cardiac events (MACE), including a composite of death, myocardial infarction, and target lesion revascularisation (TLR). Angiographic outcomes were evaluated by follow-up angiography at six to eight months after procedure. At angiographic follow-up (94.4% of all patients), the binary restenosis rate was significantly lower in DES implantation (25.0%) than in BA (64.4%, p<0.001), whereas late lumen loss was similar between DES implantation and BA (0.80±0.78 mm vs. 0.87±0.79 mm, p=0.60). The incidence of four-year MACE was significantly higher in BA (75.2%) than in DES implantation (45.8%, p<0.001), mainly because of the lower TLR rate in DES implantation (60.5% vs. 27.6%, p<0.001). Multivariate analysis revealed that BA is an independent predictor of TLR, followed by non-focal lesion, non-intravascular ultrasound guidance, and dyslipidaemia. In the treatment of recurrent ISR lesions, DES implantation is markedly more effective with a lower incidence of TLR compared to BA.

Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy.

This study evaluated the impact of optical coherence tomography (OCT)-derived low-backscattered tissue on mid-term coronary endothelial function after drug-eluting stent (DES) implantation. Although OCT enables detailed in vivo evaluation of neointimal tissue characterization after DES implantation, its association with physiological vascular healing response is unclear. Thirty-three stable angina pectoris patients underwent OCT examination and endothelial function testing with intracoronary infusion of incremental doses of acetylcholine 8-month after DES implantation in a single lesion of the left anterior descending artery. Neointimal tissue was classified into two patterns based on the predominant OCT light backscatter: high backscatter and low backscatter. Although the presence of uncovered or malapposed stent strut was not associated with the degree of vasoconstriction, the degree of vasoconstriction was significantly greater in the DES with low-backscattered neointima than in the DES without low-backscattered neointima (- 32.1 ± 25.7 vs. - 4.1 ± 20.1%, p = 0.003). Moreover, there was an inverse linear relationship between low backscatter tissue index and degree of vasoconstriction after acetylcholine infusion (r = 0.50 and p = 0.003). The endothelium-dependent vasomotor response after 8-month of DES was impaired in patients with low neointimal tissue backscatter on OCT imaging. OCT assessment of low-backscattered tissue may be used as surrogate markers for impairment of endothelial function after DES.

<h3>Introduction</h3> Coronary artery calcification (CAC) is associated with poor outcomes in patients undergoing percutaneous coronary intervention (PCI).¹Rotational atherectomy (RA) and orbital atherectomy (OA) are two ways to manage CAC.² <h3>Methods</h3> A systematic review and meta-analysis were conducted in accordance with PRISMA 2020 guidelines. PubMed was searched from January 2000 to July 2025. Eligible studies reported comparisons between OA and RA in the management of patients with severe CAC. Data was synthesised quantitatively and narratively. The Newcastle-Ottawa scale was used to assess risk of bias in observational studies, and the Cochrane Risk of Bias Tool was used for randomised controlled trials. <h3>Results</h3> No significant differences were found in short-term major adverse cardiovascular events (MACE), cardiac mortality, long-term non-fatal myocardial infarction (MI), or short-term target vessel revascularisation (TVR). RA was associated with higher long-term MACE (OR: 1.52, 95% CI: 1.02–2.27), long-term TVR (OR: 2.55, 95% CI: 1.14–5.71), short-term non-fatal MI (OR: 1.75, 95% CI: 1.05–2.92), and short- and long-term all-cause mortality (OR: 1.61 and 3.98, respectively). However, RA showed lower rates of coronary dissection (OR: 0.36, 95% CI: 0.29–0.45) and cardiac tamponade (OR: 0.34, 95% CI: 0.25–0.46). No differences were found in slow-flow/no-reflow, device-induced perforation, fluoroscopy time, or contrast volume. <h3>Conclusion</h3> OA is associated with superior long-term outcomes, while RA demonstrated fewer procedural complications, highlighting the need for individualised device selection based on patient and lesion characteristics. <h3>References</h3> Virmani R, Burke AP, Farb A, Kolodgie FD. Pathology of the vulnerable plaque. <i>J Am Coll Cardiol.</i> 2006;<b>47</b>(8 Suppl):C13-C18. Khan MH, Ahmed Z, Fatima B, <i>et al</i>. Rotational versus orbital atherectomy for treating heavily calcified coronary lesions: a meta-analysis. <i>Catheter Cardiovasc Interv.</i> 2020;<b>96</b>(6):1242–1249.

BackgroundOrbital atherectomy (OA) is a known alternative to other atherectomy devices. However, some complex patient demographics (eg, left ventricular ejection fraction <25%) were excluded from the first‐in‐human trial (ORBIT I) and the pivotal FDA device approval trial (ORBIT II) which evaluated the safety and efficacy of OA in severely calcified de novo coronary lesions. This single‐operator cohort study aimed to examine the impact of OA on a real‐world complex Veterans Affairs patient subset.MethodsRetrospective analysis was completed on 40 consecutive patients with severely calcified coronary lesions who underwent OA prior to drug‐eluting stent placement at the Atlanta Veterans Affairs Medical Center from January 2015 to June 2017.ResultsOrbital atherectomy plus drug‐eluting stent placement was successful in all 40 cases. Chocolate focal force balloon angioplasty was the most commonly used post‐atherectomy balloon (N = 34, 85%). Few complications were observed, including one case (2.5%) of perforation and one case (2.5%) of no‐reflow. Neither acute stent thrombosis nor emergent coronary artery bypass grafting was observed. The intravascular ultrasound (IVUS)‐determined median [IQR] pre‐procedure minimum lumen area and post‐procedure minimum stent area (MSA) were 2.8 [2.2, 3.0] mm2 and 8.7 [7.7, 10.0] mm2, respectively (P < 0.0001, Mann‐Whitney test). Major adverse cardiovascular events, including all‐cause mortality, at 30 days and at a median [IQR] follow‐up of 197.5 [35.5, 461.3] days, was 5% and 10%, respectively. During that period, one target vessel revascularization (2.5%) was observed.ConclusionsThis study indicates that OA is a useful tool in performing high‐risk percutaneous coronary intervention effectively in VA patients with severely calcified coronary lesions. OA plaque modification in combination with a high utilization rate of IVUS and Chocolate focal force angioplasty facilitates stent delivery and optimal stent expansion, resulting in a large MSA.

Treatment of in-stent restenosis (ISR) remains a significant challenge. Current options include repeat stenting or drug-coated balloons. However, there is a paucity of data regarding vascular healing after these strategies. We, aimed to compare optical coherence tomography (OCT)-based vessel healing after treatment with paclitaxel-coated balloons (PCB) or everolimus-eluting stents (EES). An OCT substudy (baseline and 6-9 months) of patients from RIBS IV and RIBS V, two prospective multicenter, randomized controlled clinical trials comparing PCB vs. EES in patients with ISR was performed. Sixty-four patients were included (30 PCB and 34 EES). There were no differences in the baseline or angiographic characteristics between groups. Both groups had the same proportion of drug-eluting and bare-metal stent (BMS) ISR. Baseline OCT analysis did not show differences in the qualitative characteristics of the ISR nor the restenotic tissue burden. Follow-up OCT showed a larger mean lumen area in the EES group (6.03 ± 1.5 vs. 5.24 ± 1.3 mm 2 ; P = 0.043) but no difference in angiographic restenosis ( P = 0.66). Percentage tissue coverage was higher with PCB vs. EES (26 ± 13 vs. 19 ± 11%; P = 0.031). EES-treated ISR more frequently had uncovered struts at follow-up [21 (72%) vs. 12 (44%); P = 0.034]. Tissue covering struts more frequently had a high backscatter structure after PCB [21 (78%) vs. 16 (55%); P = 0.07]. Compared with EES, ISR treated with PCB demonstrated more strut coverage with mainly high backscattering tissue. Larger OCT-defined neointimal proliferation in PCB-treated ISR did not translate into higher angiographic restenosis rates.