Raisuke Iijima

BACKGROUND: A combined strategy of atherectomy followed by intravascular lithotripsy (dual-prep strategy) for severely calcified lesions may optimize stent deployment, but mechanistic evidence from prospective optical coherence tomography (OCT) imaging is limited. This study was designed to comprehensively characterize patterns of calcium modification during a dual-preparation strategy and to explore imaging determinants of calcium fracture and stent expansion using serial and 3-dimensional OCT assessment. METHODS: This was a prespecified, multicenter, single-arm OCT substudy of the DUAL-PREP (atherectomy Devices and intravascUlAr Lithotripsy for the PREParation of heavy calcified coronary lesions) registry, enrolling patients with severely calcified lesions for whom combined treatment with atherectomy and intravascular lithotripsy was deemed preferable based on imaging findings. OCT was analyzed by an independent core laboratory. Multivariable models examined predictors of fracture and stenting performance, including calcium thickness, length, angle, calcified nodules, and morphology (circumferential, eccentric spiral, and eccentric straight types). RESULTS: OCT images were available for 114 of 118 patients (116 lesions; age, 75.9±9.1 years; 69.3% male). All lesions had an OCT calcium score of 4. Calcium fractures were uncommon after atherectomy (2/106 lesions [1.9%]) but markedly increased following intravascular lithotripsy (89/106 lesions [84.0%]; 2.05±1.59 fractures per lesion), with a further increase after stent implantation (101/109 lesions [92.7%]; 2.89±1.67 fractures per lesion). Final stent expansion index was 0.81±0.15 (eccentricity, 0.72±0.09; asymmetry, 0.39±0.15). Eccentric straight-type calcification was associated with a lower likelihood of fracture at final OCT (odds ratio, 0.07 [95% CI, 0.00–0.77]; P =0.029), whereas eccentric spiral and circumferential types showed higher fracture occurrence. CONCLUSIONS: This OCT analysis demonstrated a stepwise increase in calcium fracture during a dual-preparation strategy, with minimal fracture after atherectomy, a marked increase following intravascular lithotripsy, and a further increase after stent implantation. Calcium morphology may provide additional insight into fracture occurrence, supporting the potential value of 3-dimensional assessment in severely calcified lesions. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: jRCT1032230384.

Background: Combination therapy with atherectomy and intravascular lithotripsy (IVL) has emerged as a promising strategy for the treatment of severely calcified occlusive coronary lesions, which potentially enhances procedural efficacy without increasing complication risk. Methods: The Dual-Prep Registry is a multicenter, prospective registry designed to evaluate the safety and efficacy of IVL after atherectomy in severely calcified lesions. Combined use was selectively applied when the risk of complications was anticipated to be high with a larger atherectomy burr size, or when it was deemed non-beneficial due to unfavorable guidewire bias. All adverse events were adjudicated by a clinical events committee. Kaplan-Meier analysis was performed to evaluate the primary endpoint of major adverse cardiovascular events (MACE; composite endpoint of cardiac death, myocardial infarction, and target vessel revascularization [TVR]) at 1 year. Results: A total of 118 cases (120 lesions) were enrolled across 20 facilities. Significant comorbidities included diabetes in 56.8% of patients and hemodialysis-dependence in 25.4%. Calcification score after atherectomy was 4.0 in all cases, and calcified nodules were present in 56.4% (core-lab analysis) of cases. One-year follow-up was complete in 99.2% patients. MACE occurred in 7.6% patients at one year (cardiac death 2.5%, myocardial infarction 5.1%, TVR 5.1%) and stent thrombosis was observed in 1 case. Conclusions: Atherectomy followed by IVL resulted in low 1-year rates of MACE, TVR, and stent thrombosis in patients with severely calcified coronary lesions. This approach may be considered for lesions where an “IVL-first” strategy is difficult to apply. Japan Registry of Clinical Trials: jRCT1032230384. URL: https://jrct.mhlw.go.jp A Clinical Perspective: 1) What Is New? Elective combined use of IVL and atherectomy resulted in low 1 year MACE and TLR. The incidence of MACE was higher in cases with greater residual stenosis after the procedure and a larger baseline reference vessel diameter. 2) What Are the Clinical Implications? Combining IVL with atherectomy may serve as an effective treatment strategy in cases where IVL-first approaches are difficult to apply. Severe calcified lesions that are presumed to be unresponsive to RA/OA treatment or carry a high risk of RA/OA complications may be good candidates for this strategy.

Background: Despite limited clinical evidence, the use of drug-coated balloons (DCB) in percutaneous coronary intervention for de novo coronary lesions is expanding and increasing. Furthermore, recent randomized trial demonstrated that imaging guided DCB improves angiographic outcomes. Methods: ALLIANCE is a prospective, multicenter, all-comer registry designed to evaluate the efficacy and safety of the paclitaxel-DCB in an expanded real-world clinical setting. A calculated sample size of 1500 patients was expected to provide 95% power to detect non-inferiority against a performance goal of 7.5% target lesion failure (TLF) at 1 year with a 3.0% absolute non-inferiority margin. Cases in which DCB was performed after successful lesion preparation were consecutively enrolled. The Primary endpoint was TLF, a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization (cd-TLR) at 1 year. An independent clinical events committee adjudicated all primary endpoint events. Results: Between July 2023 and February 2024, 1794 patients (with 1984 lesions) were enrolled at 57 sites in Japan. Mean age was 71 years, 76% of patients were male, 45% had diabetes mellitus, and 29% presented with acute coronary syndromes. Among lesion characteristics, 31% were calcified lesions, 25% showed diffuse disease, 26% were bifurcations, and 38% were treated a greater than 3 mm DCB balloon. Intravascular imaging was used in 88.5% (1755/1984) of lesions. Lesion preparation was performed with modified balloons in 68% of cases and by atherectomy in 19%. Bail-out stenting after DCB was required in 1.1% of patients. The rate of TLF at 1 year was 4.7% overall (95%CI 3.8-5.8%, p _{non-inferiority} <0.001), and cd-TLR 2.9%. Thrombotic events during the follow-up period were limited to one case Conclusions: Paclitaxel DCB has proven effective and safe in the current expanding daily clinical practice. Utilizing imaging modalities during DCB procedure may improve DCB treatment outcomes. What is Known?: Clinical applications of paclitaxel DCBs are being explored for a variety of lesion subsets and clinical presentations; however, their expanded clinical use has not been validated in large-scale prospective studies. Guidance from imaging devices may enhance the potential of DCBs in routine clinical practice; however, no data demonstrate clinical benefit from the combined use of DCBs and imaging modality. What the study adds?: Paclitaxel DCB was effective and safe in various coronary artery lesion and clinical settings in real world practice. The use of an imaging modality may enable optimal preparation of lesions, increasing the inherent potential of DCB in daily practice.

Background: Optimal medical therapy (OMT) is increasingly recognized as a cornerstone in managing chronic coronary syndrome (CCS), offering a non-invasive alternative to percutaneous coronary intervention (PCI). Case Presentation: A 38-year-old male with diabetes, dyslipidemia, and hypertension was treated with early and comprehensive OMT, including statins, ezetimibe, sodium-glucose cotransporter 2 inhibitors (SGLT2i), pioglitazone, and renin-angiotensin system inhibitors. Insulin was introduced during the acute phase to stabilize glycemic control. His HbA1c decreased to 6.3% within 4 months. Results: Over 8 months, the patient experienced a reduction in coronary plaque burden and an improvement in fractional flow reserve (FFR) from 0.75 to 0.90, indicating enhanced coronary blood flow. Plaque volume burden decreased from 85% to 52% in key coronary segments. Conclusions: This case highlights the effectiveness of OMT, including statins, ezetimibe, SGLT2i, and pioglitazone, in achieving outcomes comparable to PCI. FFR-computed tomography follow-up is critical in guiding treatment decisions. Continued OMT is recommended if plaque stabilization is observed. If no improvement is observed, OMT should be intensified, and PCI considered as appropriate.

Background We investigated whether drug-coated balloon (DCB) treatment is effective for all de novo cases of coronary artery disease (CAD) in patients with diabetes mellitus. Furthermore, we also investigated the relationship between the degree of diabetes mellitus and clinical outcomes after DCB treatment. Methods In this study, we included 516 consecutive patients with de novo CAD who were treated with DCB. The patients were divided into the diabetic and non-diabetic groups. Patients with diabetes mellitus were further classified into non-insulin-treated diabetes mellitus (NITDM) and insulin-treated diabetes mellitus (ITDM). The primary endpoints were major adverse cardiovascular ischemic events (MACE) and clinically driven target lesion revascularization (CD-TLR). Results Within a mean clinical follow-up period of 2.5 years, the incidence of MACE among patients with diabetes mellitus (22.1%) was almost twice that of non-diabetic patients (11.9%) with a relative risk of 1.86 (95% CI 1.24–2.79, p = 0.002). The 3-year CD-TLR occurred in 28 patients with diabetes mellitus (10.6%) and 13 non-diabetic patients (5.1%, p = 0.02). ITDM patients had a significantly higher rate of MACE compared with non-diabetic patients with a relative risk of 2.86 (95% CI 1.76–4.63, p = 0.0002). ITDM remained an independent predictor of 3-year MACE with an odd ratio of 1.96 (95% CI 1.00–3.83, p = 0.05). Conclusion In patients undergoing DCB, the presence of DM was associated with a higher risk of MACE and CD-TLR. Particularly in DCB, treatment was still inadequately effective for ITDM patients.

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Background: Thrombocytopenia poses a risk of bleeding in patients with chronic coronary syndrome after coronary intervention. However, whether thrombocytopenia also increases the bleeding risk in patients with atrial fibrillation and chronic coronary syndrome remains unclear. Methods and Results: This study evaluated the AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial. Thrombocytopenia was defined as platelet count 3 level at enrollment. Primary end points included incidence of major bleeding based on the International Society on Thrombosis and Hemostasis criterion and major adverse cardiovascular ischemic events (cardiac death, myocardial infarction, and stroke). A total of 2133 patients were classified into the thrombocytopenia (n=70) and nonthrombocytopenia (n=2063) groups. Major bleeding was significantly higher in the thrombocytopenia group than in the nonthrombocytopenia group (10.0% versus 4.1%, P =0.027). The thrombocytopenia group tended to have a higher risk of major adverse cardiovascular ischemic events (11.4% versus 6.2%, P =0.08). The bleeding incidence was significantly higher in patients with thrombocytopenia receiving combination therapy with rivaroxaban and a single antiplatelet drug (thrombocytopenia group, 14.3%, versus nonthrombocytopenia group, 5.0%; hazard ratio, 3.18 [95% CI, 1.27–7.97], P =0.014). Thrombocytopenia was an independent predictor of major bleeding (hazard ratio, 2.57 [95% CI, 1.19–5.56], P =0.017). Conclusions: Among patients with atrial fibrillation and chronic coronary syndrome, thrombocytopenia was significantly associated with increased risk of major bleeding. Selecting drugs for patients with thrombocytopenia continuing antithrombotic therapy should be given special consideration. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02642419. https://www.umin.ac.jp/ctr/ ; Unique identifier: UMIN000016612.

Access full-text academic articles: J-STAGE is an online platform for Japanese academic journals.

Access full-text academic articles: J-STAGE is an online platform for Japanese academic journals.