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Background: The BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and the NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) randomized clinical trials showed noninferiority of the ridaforolimus-eluting stent (RES) compared with the zotarolimus-eluting stent (ZES) with respect to 1-year target-lesion failure and 6-month angiographic late lumen loss. We aimed to evaluate clinical outcomes between treatment groups over a 5-year follow-up., Methods and Results: Patient-level data from the BIONICS (n=1919) and NIREUS (n=302) were pooled, comparing the outcomes of patients implanted with RES and ZES. The primary end point was the 5-year rate of target-lesion failure. A total of 2221 patients (63.2±10.3 years, 79.7% men) undergoing percutaneous coronary intervention with RES (n=1159) or ZES (n=1062) were included. Most clinical and angiographic characteristics were similar between groups. At 5 years, the primary end point of target-lesion failure was similar between treatment groups (12.2% RES versus 11.3% ZES, P =0.52). Rates of TLR (7.6% RES versus 6.8% ZES, P =0.42) target-vessel-related myocardial infarction (4.8% RES versus 4.9% ZES, P =0.95) and stent thrombosis (0.9% RES versus 0.9% ZES, P =0.87) also did not differ between groups. Target-vessel revascularization and cardiac death were higher among the RES group (12.3% versus 9.5% P =0.037, and 3.6% versus 2.2% P =0.042, respectively). However, after correction for baseline characteristics, there was no significant difference in cardiac death between groups., Conclusions: In a pooled analysis of 2 randomized trials, 5-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of patients with coronary artery disease.

Introduction: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI., Methods: Net adverse cardiovascular events (NACE: all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions., Results: Among 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR: 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR: 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group., Conclusions: SCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background and Aims: Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial., Methods: ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions., Results: A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P < .0001) and proximal edge dissection (hazard ratio 1.77, 95% confidence interval 1.20-2.62, P = .004). The independent predictors of cardiac death or TV-MI were smaller minimal stent area and longer stent length; of ID-TLR were smaller intra-stent flow area and proximal edge dissection; and of stent thrombosis was smaller minimal stent expansion., Conclusions: In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

We aimed to assess the factors affecting patient outcomes in multiple stent placements over a 10-year period. The single-center study included 1,200 patients who had multiple stents implanted at least twice or more. Participants were divided into the adverse outcomes as endpoints (n = 204 [17%]) and control groups. Univariate and multivariate analyses of stent-related adverse events risk during 10 years and logistic regression analysis of the adverse outcomes risk factors were performed. Univariate analysis revealed the impact of acute coronary syndrome (ACS), diabetes mellitus, hypertriglyceridemia, cumulative lesions in the left anterior descending (LAD) and left circumflex (LCX) arteries, number of stents in the LAD, LCX, and right coronary artery (RCA), presence of multiple coronary artery lesions, total number of stents used, and intervals between the first and second and between the fourth and fifth implantations. For secondary stent implantation, significant factors in univariate analysis included the number of LAD and LCX lesions, stents in LAD, LCX, and RCA, extent of coronary lesions, ACS, hypertension, diabetes, and total stent count. Many factors affect the outcomes in this patient group over time. Reducing the need for frequent percutaneous coronary intervention and considering the number of stents implanted are essential to improving outcomes., Competing Interests: Declarations Competing interests The authors declare no competing interests., (© 2024. The Author(s).)

Introduction: Polymer-free sirolimus-eluting stent (PF-SES) possess multiple properties improving targeted drug elution and in-stent reendothelialization without the presence of polymers. The long-term clinical performance comparison between PF-SES and the latest generation polymer-coated sirolimus-eluting stents (SES), particularly regarding intravascular imaging assessment and in the type 2 diabetes mellitus (DM) population, remains unexplored., Methods: We conducted a retrospective study involving 2646 diabetes patients meeting coronary artery disease (CAD) criteria underwent coronary stents in the real-world. All patients were divided into the PF-SES group and the SES group. Optical coherence tomography (OCT) was used to evaluate the imaging characteristics of in-stent reendothelialization. Patient information between the two groups was systematically compared in hospital and at 5-year follow-up., Results: In terms of basic characteristics, the proportion of current smoker and stable angina patients in the PF-SES group was significantly higher than that in the SES group. The PF-SES group exhibited significantly higher rate of left anterior descending (LAD) lesion and more stents per patients compared to the SES group. The value of minimum lumen area (MLA), neointimal area (NA) and neointimal thickness (NT) were higher in the PF-SES group. Additionally, the occurrence rates of heterogeneous, lipid layer, intimal tears, thrombi, and micro-vessels were notably lower in the PF-SES group compared to the SES group. A higher all-cause mortality was observed in the SES cohort., Discussion: PF-SES could effectively improve in-stent reendothelialization in patients with type 2 DM, with positive effects on survival rate and may, therefore, be considered as an alternative treatment option for improving clinical long-term outcomes., Competing Interests: All authors report no conflicts of interest in this work., (© 2024 Yang et al.)

Background: Severe aortic stenosis (AS) coexists with coronary artery disease (CAD) in approximately 50% of patients. The preferred treatment is combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG). However, transcatheter aortic valve replacement (TAVR) along with percutaneous coronary intervention (PCI) has emerged as a viable alternative., Objectives: This study sought to compare the outcomes of PCI + TAVR vs CABG + SAVR., Methods: This national multicenter retrospective study in Spain involved patients with severe AS and CAD treated between 2018 and 2021. Patients underwent either PCI + TAVR or CABG + SAVR and were compared. The primary endpoint was all-cause mortality and stroke at 1 year. Propensity score analysis was performed to mitigate baseline differences., Results: Of the 1,342 included patients, 625 (46.6%) underwent PCI + TAVR, and 713 (53.1%) underwent CABG + SAVR. Patients in the percutaneous arm were older (age 81.6 ± 5.8 years vs 72.1 ± 7 years; P < 0.001), had a higher prevalence of chronic kidney disease (40.6% vs 14.9%; P < 0.001), and had higher Society of Thoracic Surgeons risk scores (4.3% [interquartile range (Q1-Q3): 2.8-6.4] vs 2.2% [Q1-Q3: 1.4-3.3]; P < 0.001). Technical success rates were 96% for PCI + TAVR and 98.4% for CABG + SAVR (P = 0.008), with similar periprocedural mortality (0.8% vs 0.7%; P = 0.999). However, the mortality + stroke rate at 30 days was higher in the CABG + SAVR group compared with PCI + TAVR, both in the unmatched (12.2% vs 4.7%; P = 0.005) and matched cohorts (8.8% vs 4.5%; P = 0.002), persisting at the 1-year follow-up., Conclusions: Despite a lower baseline risk, CABG + SAVR in patients with severe AS and CAD was associated with a higher rate of death and stroke compared with PCI + TAVR, highlighting the necessity for a large, randomized analysis., Competing Interests: Funding Support and Author Disclosures Dr Amat-Santos is a proctor for Medtronic, Meril Life, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Lipoprotein(a) [Lp(a)] has demonstrated its association with atherosclerosis and myocardial infarction. However, its role in the development of in-stent restenosis (ISR) after percutaneous coronary intervention (PCI) is not clearly established. The aim of this study is to investigate the association between Lp(a) and ISR., Methods and Results: A retrospective study of adult patients who underwent successful PCI between January 2006 and December 2017 at the three Mayo Clinic sites and had a preprocedural Lp(a) measurement was conducted. Patients were divided into two groups according to the serum Lp(a) concentration [high Lp(a) ≥ 50 mg/dL and low Lp(a) < 50 mg/dL]. Univariable and multivariable analyses were performed to compare risk of ISR between patients with high Lp(a) vs. those with low Lp(a). A total of 1209 patients were included, with mean age 65.9 ± 11.7 years and 71.8% were male. Median follow-up after baseline PCI was 8.8 [interquartile range (IQR) 7.4] years. Restenosis was observed in 162 (13.4%) patients. Median serum levels of Lp(a) were significantly higher in patients affected by ISR vs. non-affected cases: 27 (IQR 73.8) vs. 20 (IQR 57.5) mg/dL, P = 0.008. The rate of ISR was significantly higher among patients with high Lp(a) vs. patients with low Lp(a) values (17.0% vs. 11.6%, P = 0.010). High Lp(a) values were independently associated with ISR events (hazard ratio 1.67, 95% confidence interval 1.18-2.37, P = 0.004), and this association was more prominent after the first year following the PCI., Conclusion: Lipoprotein(a) is an independent predictor for long-term ISR and should be considered in the evaluation of patients undergoing PCI., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Non-valvular atrial fibrillation (NVAF) is the most common sustained arrhythmia worldwide, and is associated with significant morbidity and mortality. Increasing life expectancy, coupled with a surge in comorbidity burden, has resulted in a sharp increase in NVAF prevalence over the last three decades. Coronary artery disease (CAD) is an important and clinically relevant risk factor of AF. Concomitant CAD has significant implications for AF management and is a major determinant of the overall outcomes. Shared risk factors, a common pathophysiological basis, and heightened thrombogenesis culminating in cardiovascular adverse events, highlight the close association between the two. The clinical course of AF is worse when associated with CAD, resulting in poor heart rate control, increased propensity to develop stroke and myocardial infarction, increased likelihood of acute presentation with hemodynamic collapse and pulmonary edema, increased bleeding tendencies, and poor response to ablation therapies. Emerging research highlighting the significant role of underlying CAD as an independent predictor of thromboembolic risk has paved the way for the adoption of CAD beyond prior myocardial infarction into the symbol "V" of the CHA2DS2-VASc score. In our opinion, elderly patients aged >65 years with AF, with a history of one or more cardiovascular comorbidities, or evidence of atherosclerosis in other vascular beds should warrant a closer look and a dedicated effort to look for associated CAD. This would allow for a more holistic and comprehensive approach to patients with AF and ultimately help reduce the disease burden and improve the overall outcomes., Competing Interests: The author(s) report no conflicts of interest in this work., (© 2024 Batta et al.)

Backgrounds: High-intensity statin is recommended for patients undergoing percutaneous coronary intervention (PCI), and ezetimibe is recommended to be added in patients not achieving low-density lipoprotein cholesterol (LDL-C) targets. Moderate-intensity statin plus ezetimibe can reduce LDL-C levels similar to high-intensity statin. The aim of this study is to examine the long-term efficacy and safety of moderate-intensity statin plus ezetimibe as the first-line strategy compared to high-intensity statin in patients undergoing PCI., Method: Data was obtained from the Health Insurance Review and Assessment Service database of South Korea. Patients who underwent PCI from 2012 to 2017 were included. The primary efficacy endpoint was major adverse cardiac cerebrovascular events (MACCEs), a composite of all-cause death, revascularization, or ischemic stroke. The safety endpoint was new-onset diabetes mellitus (DM)., Results: A total of 45,501 patients received high-intensity statin (n = 38,340) or moderate-intensity statin plus ezetimibe (n = 7,161). Among propensity-score-matched 7,161 pairs, MACCEs occurred in 1,460 patients with high-intensity statin and 1,406 patients with moderate-intensity statin plus ezetimibe (33.8% vs. 31.9%, hazard ratio 0.96, 95% confidence interval 0.89-1.03, P = 0.27) at a median follow-up of 2.7 years. DM was newly diagnosed in 398 patients with high-intensity statin and 342 patients with moderate-intensity statin plus ezetimibe (12.5% vs. 10.7%; hazard ratio 0.84, 95% confidence interval 0.73-0.97, P = 0.02)., Conclusion: In patients undergoing PCI, moderate-intensity statin plus ezetimibe demonstrated a similar risk of MACCEs but a lower risk of new-onset DM than high-intensity statin. Early combination treatment of moderate-intensity statin and ezetimibe may be a useful and safe lipid-lowering strategy after PCI., (© 2024. The Author(s).)

Background: The evidence for optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) in improving the prognosis of individuals with in-stent restenosis (ISR) is lacking., Methods and Results: This retrospective study enrolled 588 consecutive individuals with drug-eluting stent ISR undergoing PCI from March 2010 to March 2022. Two hundred seven (35.2%) underwent OCT guidance, and 381 (64.8%) underwent angiography guidance. Clinical outcomes were analyzed using survival curves. The primary clinical endpoint was 2-year major adverse cardiovascular events (MACEs), a composite of all-cause death, myocardial infarction, and target-vessel revascularization. Compared with angiography guidance, OCT guidance demonstrated a higher frequency of drug-coated balloon use and adjunctive therapeutic modalities, including predilation, postdilation, nonslip element balloons, and noncompliant balloons ( P <0.05). Following PCI, the OCT-guided group achieved a significantly larger minimum lumen diameter (2.36 versus 2.15 mm, P <0.001) and a lower percentage diameter stenosis (17% versus 20%, P <0.001) than the angiography-guided group. Survival analysis revealed significantly lower 2-year MACEs in the OCT-guided group compared with the angiography-guided group (7% versus 15%, P =0.007), validated in the propensity matching analysis (7% versus 15%, P =0.001). Multiple sensitivity analyses showed that OCT-guided PCI treatment was an independent protective factor for 2-year MACEs in individuals with drug-eluting stent ISR., Conclusions: Compared with angiography guidance, OCT guidance is associated with a lower 2-year MACE risk among individuals with drug-eluting stent ISR. Therefore, OCT should be actively considered for guiding PCI treatment in individuals with drug-eluting stent ISR., Registration: Url: clinicaltrials.gov. Identifier: NCT03809754.

Background: Despite improvement in devices, in-stent restenosis remains a frequent and challenging complication of percutaneous coronary interventions., Methods and Results: The RESTO (Morphological Parameters of In-Stent Restenosis Assessed and Identified by OCT [Optical Coherence Tomography]; study NCT04268875) was a prospective multicenter registry including patients presenting with coronary syndromes related to in-stent restenosis. All patients underwent preintervention OCT analysis, which led to analysis of in-stent restenosis phenotype, number of strut layers, and presence of stent underexpansion. The primary end point was the in-stent restenosis type according to the OCT morphological classification. The 1-year incidence of target vessel failure (a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) was assessed. The study included 297 patients. The culprit stent was a drug-eluting stent in 74.2% of cases. OCT analysis revealed the presence of neoatherosclerosis in 57% (52% calcified), neointimal hyperplasia in 43% (58% homogeneous), stent underexpansion (minimal stent area <4.5 mm 2 ) in 43%, and multiple stent layers in 30%. The prepercutaneous coronary intervention OCT analysis modified the operator's strategy for management in 30% of cases. Treatment involved drug-eluting stent implantation in 61.6% and drug-eluting balloon angioplasty in 36.1% of cases with only 63.2% optimal results. The 1-year target vessel failure incidence was 11% (95% CI, 9%-13%). Residual postpercutaneous coronary intervention stent underexpansion was associated with significantly higher target vessel failure incidence (19% [95% CI, 14%-24%] versus 7% [95% CI, 5-9], P =0.01)., Conclusions: OCT identified neoatherosclerosis and neointimal hyperplasia in comparable proportions. Stent underexpansion was frequent and favored subsequent adverse clinical outcomes.

Background: The impact of high-risk coronary artery plaques identified using optical coherence tomography on late luminal narrowing and clinical events remains poorly understood., Methods and Results: This multicenter prospective study included 176 patients who underwent percutaneous coronary intervention and serial optical coherence tomography at baseline and 1-year follow-up to investigate nontarget regions with angiographically intermediate stenosis. At 1 year after percutaneous coronary intervention, the coronary artery lumen area decreased significantly from 6.06 (95% CI, 5.60-6.53) mm 2 to 5.88 (95% CI, 5.41-6.35) mm 2 (difference, -0.18; 95% CI, -0.22 to -0.14 mm 2 ; P <0.001), particularly in thin-cap fibroatheromas, thick-cap fibroatheromas, mixed plaques, and fibrous plaques. The prevalence of fibroatheroma decreased from 38% to 36% ( P <0.001), whereas calcified plaque increased from 31% to 34% ( P <0.001), accompanied by a significant increase in calcium thickness and angle. Diabetes and current smoking habits were independently associated with increasing calcium prevalence. Patients with thin-cap fibroatheroma had a significantly higher 3-year risk of ischemia-driven nontarget vessel revascularization (hazard ratio, 2.42 [95% CI, 1.03-5.71]; P =0.04), primarily due to revascularization in the imaged region. No significant association was observed between coronary artery calcium prevalence and clinical outcomes within 3 years., Conclusions: The coronary artery lumen area significantly decreased over a 1-year interval, particularly in thin-cap fibroatheromas, thick-cap fibroatheromas, mixed plaques, and fibrous plaques. Although thin-cap fibroatheroma prevalence was associated with higher risk of ischemia-driven nontarget vessel revascularization, no significant association was noted between coronary artery calcium prevalence and clinical outcomes within 3 years. The interaction between calcium progression and long-term clinical events necessitates further investigation., Registration: URL: https://www.umin.ac.jp/ctr/; Unique Identifier: UMIN000031937.

Background: The association between left ventricular ejection fraction (LVEF) change (ΔLVEF) following percutaneous coronary intervention (PCI) and the long-term mortality rate in patients with coronary artery disease is incompletely investigated. We aimed to assess the impact of PCI on LVEF and the association of ΔLVEF after PCI with the long-term mortality rate., Methods and Results: This observational study included 8181 patients with paired angiographic LVEF measurements performed at baseline and 6 to 8 months following the index PCI. ΔLVEF was defined as LVEF measured on the 6- to 8-month angiography minus LVEF measured on the baseline angiography. LVEF change was classified according to the following categories: reduced (ΔLVEF <0), mildly improved (ΔLVEF >0% to <10%) and largely improved (ΔLVEF ≥10%). The primary outcome was the 5-year mortality rate. In patients with baseline LVEF <40%, 40% to <50% and ≥50%, ΔLVEF (median [25th-75th percentiles]) was 6.0% [0.0% to 14.0%], 4.0% [-1.0% to 11.0%] and 0.0% [-4.0% to 3.0%], respectively ( P <0.001). In patients with reduced, mildly improved, and largely improved ΔLVEF, the 5-year mortality rate (n=712) was 29.1%, 23.1%, and 16.5%, respectively, in patients with baseline LVEF <40%; 17.0%, 12.2% and 9.8%, respectively, in patients with baseline LVEF 40% to <50%; and 7.8%, 7.1%, and 5.6%, respectively, in patients with baseline LVEF ≥50% (adjusted hazard ratio [HR], 0.91 [95% CI, 0.86-0.96]; P <0.001) for all-cause death and adjusted (HR, 0.86 [95% CI, 0.81-0.92]; P <0.001) for cardiac death, calculated for 5% higher ΔLVEF., Conclusions: In patients with coronary artery disease undergoing PCI, improvement of LVEF following PCI was associated with a reduced long-term mortality rate in patients with reduced LVEF but not in patients with preserved LVEF before intervention.

The aspects of extracorporeal cardiopulmonary resuscitation critical for reestablishing an organized rhythm and subsequent functional survival are unclear. This study characterizes the impact of reperfusion with extracorporeal membrane oxygenation (ECMO) and percutaneous coronary interventions (PCI) on achieving an organized rhythm in patients with refractory shockable out-of-hospital cardiac arrest (OHCA)., Methods and Results: Two hundred eighty-nine consecutive patients in refractory shockable OHCA were placed on ECMO followed by coronary angiogram (n=289) and PCI (n=165). Patients were grouped based on the extracorporeal cardiopulmonary resuscitation stage where a sustained organized rhythm was achieved. Survival outcomes were evaluated by using the Cerebral Performance Category. Logistic regression analysis was performed to determine the relationship between Cerebral Performance Category and timing of organized rhythm. Standard advanced cardiac life support before hospital arrival resulted in 148 of 289 (51%) patients attaining an organized rhythm while 87 of 289 (30%) achieved an organized rhythm post ECMO cannulation but before PCI, and 37 of 289 (13%) achieved an organized rhythm following PCI. Obstructive coronary artery disease was observed in 192 of 289 (66%) patients. A total of 144 of 192 (75%) patients with obstructive coronary artery disease converted to an organized rhythm before PCI and 37 of 192 (19%) following PCI. Cerebral Performance Category score 1 or 2 was significantly more likely in patients with cardiac arrest and obstructive coronary artery disease who achieved an organized rhythm before PCI (odds ratio [OR], 3.9 [95% CI, 1.2-12.0], P =0.024)., Conclusions: Most patients undergoing extracorporeal cardiopulmonary resuscitation for refractory OHCA due to shockable rhythms achieved an organized rhythm before PCI independent of coronary artery disease burden. Also, neurologically favorable survival was more prevalent in those attaining an organized rhythm before PCI.

Background: Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR)., Aims: We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR., Methods: Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR)., Results: A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES., Conclusions: Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.

Despite the use of conventional dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), the risk of adverse events remains high among patients with increased thrombotic risk. Until recently, the optimal antiplatelet strategy to balance the ischaemic and bleeding risks in patients who are undergoing complex high-risk PCI has been unclear. The TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP) trial is an investigator-initiated, multicentre, prospective randomised trial to evaluate the efficacy and safety of a time-dependent tailored antiplatelet therapy with an early (<6 months post-PCI) escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin) and a late (>6 months post-PCI) de-escalation (clopidogrel monotherapy) in patients undergoing complex high-risk PCI as compared with standard DAPT (clopidogrel plus aspirin for 12 months). Eligible patients had to have at least one high-risk anatomical or procedural feature or clinical characteristic associated with an increased risk of ischaemic or thrombotic events. The primary endpoint was the net clinical outcome, a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, or clinically relevant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 12 months after randomisation. (ClinicalTrials.gov: NCT03465644).

Background: Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive., Aims: This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions., Methods: To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints., Results: Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths)., Conclusions: The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

Background: Calcified nodules (CNs) are an increasingly important, high-risk lesion subset., Aims: We sought to identify the emergence of new CNs and the relation between underlying plaque characteristics and new CN development., Methods: Patients who had undergone two optical coherence tomography (OCT) studies that imaged the same untreated calcified lesion at baseline and follow-up were included. New CNs were an accumulation of small calcium fragments at follow-up that were not present at baseline. Cardiac death, myocardial infarction (MI), or clinically driven revascularisation related to OCT-imaged, but untreated, calcified lesions were then evaluated., Results: Among 372 untreated calcified lesions, with a median of 1.5 (first and third quartiles: 0.7-2.9) years between baseline and follow-up OCTs, new CNs were observed in 7.0% (26/372) of lesions at follow-up. Attenuated calcium representing residual lipid (odds ratio [OR] 3.38, 95% confidence interval [CI]: 1.15-9.98; p=0.03); log 10 calcium volume index (length×maximum arc×maximum thickness; OR 2.76, 95% CI: 1.10-6.95; p=0.03); angiographic Δangle between systole and diastole, per 10° (OR 2.30, 95% CI: 1.25-4.22; p=0.01); and time since baseline OCT, per year (OR 1.36, 95% CI: 1.05-1.75; p=0.02) were all associated with new CN development. Clinical events were revascularisation and/or MI and were more frequent in lesions with versus without a new CN (29.3% vs 15.3%; p=0.04)., Conclusions: New CNs developed in untreated, lipid-containing, severely calcified lesions with a larger angiographic hinge motion (between systole and diastole), compared with lesions without CNs, and were associated with worse clinical outcomes.

Coronary artery disease (CAD) is characterized by narrowing and subsequent blockade of coronary arteries, and imposes a significant health and economic burden. Stent and scaffold devices are introduced in advanced CAD to improve vascular stability and restore blood flow. Although in vitro flow systems like the Chandler loop have been developed to enhance the understanding of interactions between device materials, their coatings, and vascular cells, imaging-based in vitro analysis of device performance is limited. In this study, we established a novel stent flow chamber system designed to assess the thrombogenicity of bioresorbable magnesium scaffold (RMS) and stent materials in vitro. Additionally, we compared the thrombogenicity - an important clinical parameter in stent performance - of the Magmaris-316 L stainless steel stent with its predecessors, Magmaris RMS and a prototype of the third-generation RMS (DREAMS 3G). Analysis of platelet adhesion and coverage of the different devices under flow conditions demonstrated that the Magmaris RMS exhibits reduced thrombogenicity compared to the Magmaris-316 L stainless steel stent. Moreover, thrombogenicity of the DREAMS 3G prototype, composed of BIOmag material, is further decreased compared to its predecessors. The observed reduction in thrombogenicity of the DREAMS 3G prototype in vitro suggests additional improvements in clinical safety and efficacy, highlighting its promise for treating CAD. Future research on this prototype may thus open avenues for analyzing other blood components and patient-derived endothelial cells. In line with the 3R principles, this approach may also help reduce the need for animal testing., (© 2024. The Author(s).)

Background: Since 2010, all non-VA hospitals performing cardiac surgeries and percutaneous interventions in Washington State have participated in the Cardiac Care Outcomes Assessment Program (COAP), a data-driven, physician-led collaborative quality improvement (QI) collaborative. Prior literature has demonstrated QI programs such as COAP can avert avoidable utilization such as hospital readmissions. However, it is unknown whether such improvements translate into economic benefits., Hypothesis: This study compared downstream healthcare costs between patients undergoing cardiac interventions for coronary artery disease (CAD) at hospitals that were and were not participating in COAP., Methods: Post hoc analysis of Medicare administrative and claims data examined 2.5 million randomly selected deidentified beneficiaries receiving a percutaneous coronary intervention or coronary artery bypass grafting between 2013 and 2020. Total costs were defined as all reimbursements paid by Medicare for up to 5 years following cardiac intervention. Because all non-VA hospitals in Washington State participated in COAP, we compared respective groups of patients receiving intervention in Washington State with all non-Washington states, adjusting for patient demographics and comorbidity. To model costs, we applied a multipart estimator, which distinguishes the impact of QI program participation due to survival and utilization while accounting for censoring., Results: Total 5-year downstream costs were $3861 lower (95% confidence interval [CI] = $1794 to $5741) among patients receiving cardiac intervention at COAP-exposed hospitals. Lower costs were largely driven by lower utilization during calendar quarters where death was not observed., Conclusions: Participation in this state-wide cardiac quality improvement program was associated with economic benefits in patients receiving intervention for CAD., (©2024 Noridian Healthcare Solutions and The Author(s). Clinical Cardiology published by Wiley Periodicals LLC.)

Abstract: The aim of this study was to explore the relationship between in-stent neoatherosclerosis (ISNA) and the neutrophil-to-lymphocyte ratio (NLR) in patients with in-stent restenosis (ISR) following drug-eluting stent (DES) implantation. We divided 216 patients into 3 groups based on the NLR tertile. We performed a comparative analysis of baseline, angiographic, and features of optical coherence tomography (OCT) between the NLR groups and performed univariate and multivariate logistic regression analyses to assess the association of the NLR with ISNA and in-stent thin-cap fibroatheroma (TCFA). Patients in the third tertile NLR group had a higher incidence of ISNA and in-stent TCFA compared with those in the first tertile. Multivariate logistic regression analysis showed that the hazard ratios and 95% confidence intervals for ISNA and TCFA were 2.673 (1.257-5.684; P = 0.038) and 4.272 (1.740-10.488; P = 0.004), respectively, for patients in the highest tertile compared with those in the lowest tertile. Our study showed that an increased NLR was associated with ISNA and in-stent plaque fragility in patients with ISR following DES implantation., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: While the survival benefits of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) are firmly established in the general population, their efficacy within patient undergoing dialysis with coronary artery disease (CAD) remains controversial., Methods: Between January 2015 and June 2021, 1168 patients undergoing dialysis with CAD were assessed from 30 tertiary medical centers. The primary outcome was all-cause death, and the secondary outcome was cardiovascular death. Inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were performed to account for between-group differences., Results: Overall, ACEI or ARB were prescribed to 518 patients (44.3%) upon discharge. After a median follow-up of 22.2 months, 361 (30.9%) patients died, including 243 cardiovascular deaths. The use of ACEI or ARB was associated with a significantly lower risk of all-cause (25.3% vs 35.4%, hazard ratio [HR] 0.65, 95% confidence interval [CI] 0.52-0.82, p  < 0.001) and cardiovascular death (17.0% vs 23.8%; HR 0.64, 95% CI 0.48-0.83, p  = 0.001). These findings remained consistent across IPTW and PSM analyses. Sensitivity analyses for ACEI and ARB use separately yielded similar results., Conclusions: Our findings suggested that among patients undergoing dialysis with CAD, ACEI or ARB use was associated with a lower risk of all-cause and cardiovascular death.

Failure to close the side branches of the internal mammary artery can result in ischemia due to coronary steal through a patent mammary artery side branch after coronary artery bypass grafting. The authors present the case of a 56-year-old man with recurrent angina after 6 month surgical myocardial revascularization underwent coronary angiography that showed patent left branch of the internal mammary artery. After demonstration of inducible ischemia, effective percutaneous treatment was performed using coil embolization, improving blood flow and clinical symptoms., (© 2024 Wiley Periodicals LLC.)

Background: The same-day discharge (SDD) program after elective percutaneous coronary intervention (PCI) is a safe strategy that allows for the optimization of hospital resources. However, the lack of adequate infrastructure and a specially targeted care model may limit its implementation. Our center developed an outpatient care model based on an area designed for percutaneous procedures called radial lounge (RL)., Aims: Evaluate the efficacy and safety of the RL care model: (1) SDD rate, (2) patient experience, (3) major adverse cardiac events (MACEs) (in-hospital, 30-day, and 1-year mortality and intervention), and (4) vascular access complication., Secondary Objective:  Impact of RL SDD rate on total elective SDD-PCI volume., Methods: We conducted a retrospective observational cohort study at a cardiovascular hospital, including consecutive patients undergoing elective PCI between 2015 and 2022 who were admitted to the conventional hospitalization area (CHA) or the RL about the stated objectives. Patient experience was assessed using the Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey., Results: A total of 5466 elective PCI procedures were included: 2102 in the RL and 3364 in the CHA. The SDD rate was 85.2% in the RL group and 54% in the CHA. After the implementation of RL, a significant increase in the volume of elective SDD-PCI was observed and patient satisfaction improved significantly (p < 0.005) with CHA. Finally, a greater amount of MACEs were not observed in the RL., Conclusions: The PCI program in RL proved to be safe and effective. It showed a higher rate of SDD and a significant improvement in patient experience was observed without affecting safety., (© 2024 Wiley Periodicals LLC.)

Background: Percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or drug-eluting stents (DES) are well-established treatments for in-stent restenosis, however little is known about the impact of vessel size on the outcomes. The study aimed to evaluate the efficacy and safety profile of DCB versus DES in DES in-stent restenosis depending on the vessel size., Methods: Consecutive patients with DES in-stent restenosis who underwent PCI between January 2010 and February 2018 entered the registry with a long-term follow-up. Patients who received DCB at the index procedure were compared with those who received DES in three subgroups depending on the vessel size (≤2.5 mm; 2.5-3.5 mm; >3.5 mm). Data were analyzed using propensity score matching and Kaplan-Meier estimator plots., Results: Among 1,374 patients with DES in-stent restenosis, 615 were treated with DES and 759 with DCB. After propensity score matching, we analyzed 752 patients in the DES and DCB groups at a long-term follow-up. The risk of DOCE did not differ significantly between the DES and DCB groups, both in the overall population (HR 0.85; 95%CI [0.58; 1.26], log-rank p = 0.41) and when divided into small (HR 0.84; 95%CI [0.36; 1.95], log-rank p = 0.70), medium-sized (HR 0.90; 95%CI [0.49; 1.65], log-rank p = 0.73), and large-sized (HR 0.81; 95%CI [0.42; 1.53], log-rank p = 0.50) coronary arteries. The incidence of all-cause death was significantly higher in the overall DES population (HR 4.03; 95%CI [2.40; 6.79], log-rank p < 0.001) and subgroup of small (HR 5.54; 95%CI [1.80; 17.02], log-rank p = 0.003), medium-sized (HR 4.37; 95%CI [1.92; 9.94], log-rank p = 0.009) and large-sized coronary arteries (HR 3.26; 95%CI [1.35; 7.86], log-rank p = 0.02)., Conclusions: DES and DCB strategies are comparable methods of treating ISR regardless of the diameter of the treated vessel in a long-term follow-up., (© 2024 Wiley Periodicals LLC.)

Aims: We conducted a prespecified subanalysis of the POEM trial to assess the association between sex and clinical outcomes following a short 1-month dual-antiplatelet-therapy (DAPT) period after percutaneous coronary intervention (PCI) with bioresorbable polymer everolimus-eluting stent (BP-EES) among patients at high bleeding risk (HBR)., Background: Shortening the DAPT period after PCI is an effective bleeding avoidance strategy with contemporary drug-eluting stents. Whether sex affects the risk of adverse events following PCI is still debated., Methods: Patients at HBR undergoing PCI with BP-EES were enrolled and treated with 1-month DAPT. If anticoagulation was needed, study participants received an oral anticoagulant (OAC) in addition to a P2Y 12 inhibitor for 1 month, followed by OAC only thereafter. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. We report sex-based outcomes of patients included in the POEM study., Results: We enrolled 129 (29.1%) women and 314 (70.9%) men. Women were older, with lower hemoglobin levels, and worse renal function. Accordingly, they had a trend for a greater number of HBR criteria fulfilled and a higher PARIS bleeding score. However, they were not at a significantly higher risk for the primary endpoint (men vs. women: 5.17% vs. 3.94%; HR 1.30; 95% CI: 0.48-3.54, p = 0.61), or any of the hemorrhagic and ischemic secondary endpoints., Conclusions: This prespecified subanalysis of the POEM trial suggests that 1-month DAPT following PCI with BP-EES may be a safe and effective therapeutic strategy for women at HBR., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Sirolimus-coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long-term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de-novo lesions from a real-world practice., Aims: To report long-term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions., Methods and Results: We analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high-volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE). During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty-two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST-segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions ( ≥ 20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67). During the median follow-up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure., Conclusions: The results from this long-term follow-up in a real-world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term., (© 2024 Wiley Periodicals LLC.)

Purpose of Review: This review evaluates the emerging role of the pullback pressure gradient (PPG) as a standardized metric for assessing coronary artery disease (CAD) patterns and its implications for clinical decision-making when managing patients undergoing percutaneous coronary interventions (PCIs). By integrating PPG with existing physiological assessments, this review highlights the potential benefits of PPG in predicting treatment outcomes and refining therapeutic strategies for CAD., Recent Findings: Recent studies, particularly the PPG Global study have demonstrated a strong correlation between PPG values and post-PCI outcomes, revealing that focal disease is associated with improved fractional flow reserve (FFR) and lower rates of adverse events than vessels with diffuse disease (low PPG). Additionally, PPG has been linked to specific atherosclerotic plaque characteristics, indicating its utility in identifying high-risk plaques. The integration of PPG with advanced imaging techniques further enhances the understanding of CAD patterns and their implications for treatment planning., Summary: The PPG represents a significant advancement in the management of CAD, providing a reproducible and objective assessment of coronary artery disease patterns that can inform clinical decision-making. As research continues to explore the relationship among PPG, atherosclerotic characteristics, and patient outcomes, its integration into routine practice is expected to improve the effectiveness of PCI and optimize patient management strategies. Future studies are warranted to establish specific PPG thresholds and further investigate its potential in identifying vulnerable plaques and guiding treatment decisions., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Angiography-derived fractional flow reserve (virtual FFR) has shown excellent diagnostic performance compared with wire-based FFR. However, virtual FFR pullback curves have not been validated yet., Objectives: To validate the accuracy of virtual FFR pullback curves compared to wire-based FFR pullbacks and to assess their clinical utility using patient-reported outcomes., Methods: Pooled analysis of two prospective studies, including patients with hemodynamically significant (FFR ≤ 0.80) coronary artery disease (CAD). Virtual and wire-based FFR pullbacks were compared to assess the accuracy of virtual pullbacks to characterize CAD as focal or diffuse. Pullbacks were analyzed visually and quantitatively using the pullback pressure gradient (PPG). Patients underwent PCI, and the Seattle Angina Questionnaire (SAQ) was administered at 3-month follow-up., Results: A total of 298 patients (300 vessels) with both virtual and wire-based pullbacks who underwent PCI were included in the analysis. The mean age was 61.8 ± 8.8, and 15% were female. The agreement on the visual adjudication of the CAD pattern was fair (Cohen's Kappa: 0.31, 95% confidence interval: 0.18-0.45). The mean PPG were 0.65 ± 0.18 from virtual pullbacks and 0.65 ± 0.13 from wire-based pullbacks (r = 0.68, mean difference 0, limits of agreement -0.27 to 0.28). At follow-up, patients with high virtual PPG (>0.67) had higher SAQ angina frequency scores (i.e., less angina) than those with low virtual PPG (SAQ scores 92.0 ± 14.3 vs. 85.5 ± 23.1, p = 0.022)., Conclusion: Virtual FFR pullback curves showed moderate agreement with wire-based FFR pullbacks. Nonetheless, patients with focal disease based on virtual PPG reported greater improvement in angina after PCI., (© 2024 Wiley Periodicals LLC.)

Background: Coronary artery dissections are caused by a tear in the vessel endothelium, resulting in blood extravasation into the subintimal space, with subsequent intramural hematoma (IMH). One potential technique to deal with this complication is the use of cutting balloons, however, a significant number of cases experienced distal propagation of the hematoma. We describe a novel technique that enhances the possibility of creating intimal tears between the false and true lumen, aiding in hematoma drainage and restoring distal coronary flow., Methods: We conducted a retrospective analysis of seven consecutive patients who underwent percutaneous coronary intervention complicated by flow-limiting intramural hematomas. All patients were treated using the "Cuttering Technique," based on the operators' preference. Procedural success was defined as achieving a distal thrombolysis in myocardial infarction 3 (TIMI 3) flow., Results: In five out of seven patients treated with "Cuttering Technique" we observed a complete restoration of TIMI 3 flow into the dissected segment., Conclusions: Our cases show the effectiveness of the "Cuttering Technique" as a viable approach for managing IMHs. This technique enhances the possibility of creating intimal tears between the false and true lumens, aiding in hematoma drainage and restoring distal coronary flow., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

The steady development of same-day discharge (SDD) PCIs in recent years means that, by 2024, we will be able to tackle increasingly complex lesions, including those of the left main artery. This strategy is supported by the literature, but requires an appropriate patient selection (based on medical and social criteria) and precise assessment of the anatomical complexity of the lesion and the foreseeable risks of the PCI. Strict adherence to pre-established service protocols for patient preparation and follow-up, as well as the establishment of clinical and paraclinical criteria for discharge to a conventional hospital unit, are essential to the success of an SDD PCI program., Competing Interests: Déclaration de liens d'intérêts Les auteurs déclarent n'avoir aucun lien d'intérêt., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

Background: Percutaneous coronary intervention of calcified aorto-ostial lesions (AOL) pose unique challenges due to anatomical propensity for recoil, leading to poorer outcomes compared to non-AOL. Although intravascular lithotripsy (IVL) has shown excellent success and safety in heavily calcified plaques, evidence specific to AOL is limited. This study aims to evaluate the efficacy and safety of IVL in AOL versus non-AOL., Methods: Patients treated with IVL between 2019 and 2023 from an ongoing prospective multicenter registry were eligible for inclusion. Patients were therefore classified in AOL and non-AOL groups, based on anatomical location. The primary technical endpoint was device success, defined as the ability to deliver the IVL catheter and pulses at the target lesion, without angiographic complications. Secondary technical endpoint encompassed procedural success <30%, consisting of device success with residual stenosis <30%, final thrombolysis in myocardial infarction grade 3 flow, and no in-hospital major adverse cardiovascular events (MACE). The primary clinical endpoint was in-hospital MACE, including cardiac death, nonfatal myocardial infarction, or target lesion revascularization., Results: A total of 321 patients underwent IVL, including 48 with AOL. Device success showed no significant difference between AOL and non-AOL groups (100% vs. 98.2%; p = 0.35). A nonsignificant trend toward worse procedural success with residual stenosis <30% was observed in the AOL arm (AOL 81.3% vs. non-AOL 90.5%, p = 0.06). In-hospital MACE was significantly higher in AOL (4.2% vs. 0.7%, p = 0.048), attributed entirely to cardiac deaths. At 6-month follow-up, the incidence of MACE (AOL 8.3% vs. non-AOL 4.0%, p = 0.19), and cardiac deaths (AOL 4.2% vs non-AOL1.1%, p = 0.11) were comparable between groups., Conclusion: IVL treatment for heavily calcified AOL demonstrates comparable procedural and 6-month clinical outcomes when compared to non-AOL, despite a higher incidence of in-hospital MACE., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Optimal lesion preparation for coronary lesions has been reappraised in the interventional community, given the increasing use of drug-coated balloons for de novo lesions; however, whether multiple ballooning could achieve more favorable angiographic results compared with single ballooning remains unknown. We aimed to investigate the incremental effect of multiple ballooning on de novo coronary lesions over single ballooning as assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS) among patients undergoing percutaneous coronary intervention (PCI)., Methods: Patients with chronic coronary syndrome (CCS) undergoing PCI were enrolled. Ballooning before stent implantation was repeatedly performed for three times using the same semi-compliant balloon. OCT and IVUS were performed after each balloon dilatation. Primary outcome measure was the difference in the mean lumen area between post-1st ballooning (1B) and post-3rd ballooning (3B) as assessed by OCT., Results: A total of 32 lesions in 30 patients undergoing PCI between May 2021 and August 2022 were analyzed. Major plaque types of the lesions were fibrous (68.8%) and lipid (28.1%). Mean lumen area by OCT was significantly increased from 1B to 3B (5.9 ± 2.9 mm 2 vs. 6.0 ± 2.9 mm 2 , difference: 0.2 ± 0.4 mm 2 , p = 0.040). There were significant increases from 1B to 3B in minimum lumen area by OCT (3.1 ± 1.5 mm 2 vs. 3.6 ± 1.7 mm 2 , difference: 0.5 ± 0.6 mm 2 , p < 0.001) and mean dissection angle by OCT (65.6 ± 24.9° vs. 95.2 ± 34.0°, difference: 29.6 ± 25.5°, p < 0.001). Additionally, mean plaque area by IVUS was significantly decreased (8.0 ± 4.2 mm 2 vs. 7.8 ± 4.1 mm 2 , difference: -0.2 ± 0.2 mm 2 , p < 0.001)., Conclusions: Among CCS patients with mainly non-calcified lesions, multiple ballooning significantly increased the lumen area and dissection angle compared with single ballooning., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Progress in coronary angioplasty has enabled outpatients treatment with rates of immediate complications below 1%. This shows a clear improvement in patient's comfort and it represents an important medical and economic gain. Considering the demographic evolution of the population, there is an increasing number of calcified coronary lesions which represent, according to the series, up to a quarter of angioplasties. However, their care is more delicate with a greater risk of complications and procedural failure. In fact, with the difficulties of crossing and with the vascular intrusions related to pre-dilation or sub-dilation stent deployment, the complication risk increases by almost 10% in these cases of angioplasties. Similarly, the death rate at 30 days goes from 4.7% in angioplasty in general up to 24.4% in calcified lesions. Several devices for atherectomy and plaque preparation have been developed in order to better overcome the lesions and better prepare the stent installation at the cost of a risk of complications between 2 and 10%. The three most frequent complications are dissection (1.8 to 7%), slow/no-flow (0.1 to 3%) and coronary perforation (0.2 to 4%). Nevertheless, despite this procedural increased risk, ambulatory angioplasty of calcified complex lesions can become a reality subject to 4-6 hours monitoring in a specialized unit with dedicated protocols., Competing Interests: Déclaration de liens d'intérêts Les auteurs déclarent n'avoir aucun lien d'intérêt., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

Eruptive calcified nodules (CNs) are a manifestation of severely calcified plaques, which exist in acute coronary syndrome (ACS), non-ACS lesions. Optical coherence tomography is crucial for diagnosing and treating eruptive CNs in clinical practice. Management of eruptive CNs is still a challenge for interventional cardiologists. There have been significant advances in the treatment of eruptive CNs such as intravascular lithotripsy, excimer laser coronary atherectomy, rotational atherectomy, and orbital atherectomy. We find a range of treatment modalities to be effective under different conditions. The selection of these devices should be considered based on guidewire position, lesion characteristics, clinical manifestations, and operator's experiences., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined., Methods: 262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years., Results: At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices., Conclusions: In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495)., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Percutaneous coronary intervention (PCI) can provide benefits for anatomically suitable left main coronary artery (LMCA) lesions. When compared to traditional coronary angiography (CAG) -guided PCI, the use of intravascular ultrasound (IVUS) guidance has shown significant long-term prognostic improvements in LMCA PCI. Optical coherence tomography (OCT) offers a higher axial resolution than IVUS. However, there is currently a lack of relevant randomized controlled trials investigating the use of OCT specifically for left main distal bifurcation lesions., Methods: The ISOLEDS trial is an ongoing multicenter study that aims to compare IVUS-guided PCI with OCT-guided PCI for patients with true LMCA distal bifurcation lesions. This prospective, randomized, controlled, non-inferiority trial will enroll a total of 664 patients with visually-defined Medina 1,1,1 or 0,1,1 classification of left main distal bifurcation lesions. The patients will be randomly assigned in a 1:1 ratio to either IVUS-guided or OCT-guided PCI. The primary endpoint is to assess the occurrence of target lesion failure (TLF) within 12 months after the procedure. After undergoing PCI, patients are required to visit the hospital for a 12-month clinical follow-up. During this clinical assessment, CAG can be performed to evaluate the status of target lesions., Discussion: The ISOLEDS trial represents the first attempt to compare two distinct intracoronary imaging techniques for guiding PCI in patients with true LMCA distal bifurcation lesions. By evaluating and comparing the outcomes of these two imaging techniques, the trial results will aid operators in selection of the most effective approach for guiding PCI in these patients., Competing Interests: Declaration of competing interest All authors declare that they have no competing interests., (Copyright © 2024. Published by Elsevier Inc.)

Background: The role of intra-coronary imaging in patients with stent failure undergoing intravascular lithotripsy (IVL) is unclear. We aimed to assess clinical outcomes in patients undergoing IVL treatment for stent failure stratified according to the use of intra-coronary imaging and lesion complexity., Methods: This is a pre-specified subgroup analysis of patients who were included in the coronary intravascular lithotripsy in patients with stent failure (COIL) registry (international multi-centre study assessing IVL treatment for stent failure in 6 European centres). A complex lesion was defined if IVL treatment was used in the left main, true bifurcation, long lesion, or coupled with athero-ablative therapy. The primary endpoint was the composite of cardiac death, spontaneous myocardial infarction, or target vessel revascularization (TVR) at 12 months., Results: There were 102 patients analyzed, of whom 27 (26%) patients had complex anatomy. The use of intra-coronary imaging following IVL in stent failure was more frequent in patients with complex versus Noncomplex anatomy (56% vs. 31%, p = 0.022). IVL treatment was effective in both groups, however, patients with complex anatomy had worse clinical outcomes (30% vs. 11%, p = 0.02), driven by a higher rate of TVR (26% vs. 8%, p = 0.017). In the complex group, patients who underwent intracoronary imaging post intervention had lower event rate compared to those without imaging (13% vs. 50%, p = 0.038)., Conclusions: In patients undergoing IVL treatment for stent failure with complex coronary anatomy, the use of intra-coronary imaging was associated with fewer adverse events compared to angiography guided intervention., (© 2024 Wiley Periodicals LLC.)

Background: Fractional flow reserve (FFR) has emerged as the invasive gold standard for assessing vessel-specific ischemia. However, FFR measurements are influenced by the hydrostatic effect, which might adversely impact the assessment of ischemia., Aims: This study aimed to investigate the impact of hydrostatic pressure on FFR measurements by correcting for the height and comparing FFR with [ 15 O]H 2 O positron emission tomography (PET)-derived relative flow reserve (RFR)., Methods: The 206 patients were included in this analysis. Patients underwent coronary computed tomography angiography (CCTA), [ 15 O]H 2 O PET, and invasive coronary angiography with routine FFR in every epicardial artery. Height differences between the aortic guiding catheter and distal pressure sensor were quantified on CCTA images. An FFR ≤ 0.80 was considered significant., Results: The study found a reclassification in 7% of the coronary arteries. Notably, 11% of left anterior descending (LAD) arteries were reclassified from hemodynamically significant to nonsignificant. Conversely, 6% of left circumflex (Cx) arteries were reclassified from nonsignificant to significant. After correcting for the hydrostatic pressure effect, the correlation between FFR and PET-derived RFR increased significantly from r = 0.720 to r = 0.786 (p = 0.009). The average magnitude of correction was +0.05 FFR units in the LAD, -0.03 in the Cx, and -0.02 in the right coronary artery., Conclusion: Hydrostatic pressure has a small but clinically relevant influence on FFR measurements obtained with a pressure wire. Correcting for this hydrostatic error significantly enhances the correlation between FFR and PET-derived RFR., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Purpose of Review: We review the limited available evidence informing coronary revascularization decisions in women and minorities, and introduce the RECHARGE trial program, which consists of two separate but integrated parallel multicenter, randomized trials comparing coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI), one exclusively enrolling women (RECHARGE:Women) and one exclusively enrolling Black or Hispanic patients (RECHARGE:Minorities)., Recent Findings: The extensive evidence base supporting coronary revascularization suffers from under-representation of women, minorities and minoritized populations, and the use of heterogeneous primary composite outcomes whose components have varying strengths of association with prognosis and quality-of-life (QOL). In RECHARGE, participants will be followed for up to 10 years, with QOL assessments at baseline, 30 days, 3 months, every 6 months for 3 years, and annually thereafter. The primary endpoint is the hierarchical composite of time to all-cause mortality, time-averaged change from baseline in the physical component of the SF-12v2 physical summary score, and time-averaged change from baseline in the mental component of the SF12v2 summary score, evaluated using a win ratio. Independently adjudicated major adverse cardiovascular and noncardiovascular events and disease-specific QoL will be secondary endpoints., Summary: The RECHARGE trials are the first revascularization trials to enroll exclusively women and minority patients and to use patient-centered outcomes as their primary outcome., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The aim of this study is to describe resources and outcomes of coronary computed tomography angiography plus Stress CT perfusion (CCTA ​+ ​Stress-CTP) and stress cardiovascular magnetic resonance (Stress-CMR) in symptomatic patients with suspected or known CAD., Methods: Six hundred and twenty-four consecutive symptomatic patients with intermediate to high-risk pretest likelihood for CAD or previous history of revascularization referred to our hospital for clinically indicated CCTA ​+ ​Stress-CTP or Stress-CMR were enrolled. Stress-CTP scans were performed in 223 patients while 401 patients performed Stress-CMR. Patient follow-up was performed at 1 year after index test performance. Endpoints were all cardiac events, as a combined endpoint of revascularization, non-fatal MI and death, and hard cardiac events, as combined endpoint of non-fatal MI and death., Results: Twenty-nine percent of patients who underwent CCTA ​+ ​Stress-CTP received revascularization, 7% of subjects assessed with Stress-CMR were treated invasively, and a low number of non-fatal MI and death was observed with both strategies (hard events in 0.4% of patients that had CCTA ​+ ​Stress-CTP as index test, and in 3% of patients evaluated with Stress-CMR). According to the predefined endpoints, CCTA ​+ ​Stress-CTP group showed high rate of all cardiac events and low rate of hard cardiac events, respectively. The cumulative costs were 1970 ​± ​2506 Euro and 733 ​± ​1418 Euro for the CCTA ​+ ​Stress-CTP group and Stress-CMR group, respectively., Conclusions: The use of CCTA ​+ ​Stress-CTP strategy was associated with high referral to revascularization but with a favourable trend in terms of hard cardiac events and diagnostic yield in identifying individuals at lower risk of adverse events despite the presence of CAD., Competing Interests: Declaration of competing interest All authors have nothing to disclose., (Copyright © 2024 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Background: The association of coronary computed tomography angiography (CTA) and left ventricular (LV) myocardium measurements with cancer therapy-related cardiac dysfunction (CTRCD) is limited., Objectives: In this study, the authors sought to evaluate the changes in coronary arteries and LV myocardium in patients with left breast cancer (BC) receiving anthracycline with or without radiotherapy, with the use of coronary CTA., Methods: Participants with left BC receiving anthracycline with or without radiotherapy were prospectively included. All participants underwent coronary CTA before and after treatment, including nonenhanced calcium-scoring scan, computed tomography angiography, and dual-energy late enhancement scan. Computed tomographic fractional flow reserve (CT-FFR), pericoronary adipose tissue (PCAT) CT attenuation, and LV segments' extracellular volume (ECV) before and after treatment were compared. Logistic regression analysis was used to assess the association between baseline coronary CTA parameters and CTRCD., Results: Eighty participants receiving anthracycline and 59 participants receiving anthracycline with radiotherapy were included. CT-FFR decreased and PCAT CT attenuation and LV global and segments' ECV increased after treatment (all P < 0.05). After chemoradiotherapy, CT-FFR was lower and PCAT CT attenuation and LV myocardial ECV were higher than after chemotherapy. Twenty-four participants developed CTRCD. After adjustment by Heart Failure Association-International Cardio-Oncology Society risk in multivariable logistic regression analysis, baseline stenosis of the left anterior descending artery (LAD) (OR: 1.987 [95% CI: 1.322-2.768]; P = 0.021), left circumflex artery (LCX) (OR: 1.895 [95% CI: 1.281-2.802]; P = 0.031), and right coronary artery (RCA) (OR: 1.920 [95% CI: 1.405-2.811]; P = 0.028), and baseline CT-FFR of the LAD (OR: 3.425 [95% CI: 1.621-9.434]; P < 0.001), LCX (OR: 2.058 [95% CI: 1.030-5.076]; P = 0.006), and RCA (OR: 2.469 [95% CI: 1.232-6.944]; P = 0.004) were associated with CTRCD., Conclusions: Multiparameter coronary CTA contributes to comprehensive assessment of the coronary arteries and myocardium in patients with left BC receiving anthracycline with or without radiotherapy. Baseline coronary artery stenosis and CT-FFR might be imaging markers for predicting CTRCD in these patients., Competing Interests: Funding Support and Author Disclosures This study has received funding from the National Natural Science Foundation of China (grant number 82071883), the Chongqing University Cancer Hospital Scientific Research Capacity Improvement Project (grant number 2023nlts004), the Chongqing Natural Science Foundation (grant number cstc2021jcyj-msxmX0398), the 2023 SKY Imaging Research Fund of the Chinese International Medical Exchange Foundation (grant number Z-2014-07-2301), the Natural Science Foundation of Chongqing municipality (grant number CSTB2023NSCQ-MSX0787), the Chongqing Shapingba District 2023 Technology Innovation and Application Development Project (grant number 202388), and the Chongqing medical research project of a combination of science and medicine (grant number 2024MSXM096). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI)., Methods: The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients., Summary: The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population., Competing Interests: Conflict of interest Dr. Erlinge reports consulting/speaker fees from AstraZeneca, Bayer, Novartis, Amgen, Ciesi, InfraredX, NovoNordisk, and Sanofi. Dr. James reports institutional research grants/support from AstraZeneca, Novartis, Novo Nordisk, Janssen, and Amgen, participates in the DSMB/ advisory board New Amsterdam (Cardialysis) and valve proctoring fees from Medtronic. Dr. Fröbert reports consulting fees from GSK and participates at DSMB/ Advisory board of the Ischemia CTO study and the NOTION-3-TAVI study. Dr Böhm reports institutional research grants from Abbott and Boston Scientific, speaker fees from Pfizer, Abbott, Boston Scientific and Amarin, and advisory board participation for Amarin. Dr. Oldgren reports institutional research grants/support from Amgen, AstraZeneca, Bayer, Novartis, and Roche Diagnostics. Dr Claes Held reports consulting/speaker fees from AstraZeneca, Boehringer Ingelheim, Bayer, Novo Nordisk, Amarin, and Coala Life and institutional research grants from Pfizer. Candace Elek and Motasim Sirhan are employees of and hold stock/ stock options of Elixir Medical. The other authors have no conflict of interest to declare., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

This study was conducted to develop and validate a deep learning model for delineating intravascular ultrasound (IVUS) images of coronary arteries.Using a total of 1240 40-MHz IVUS pullbacks with 191,407 frames, the model for lumen and external elastic membrane (EEM) segmentation was developed. Both frame- and vessel-level performances and clinical impact of the model on 3-year cardiovascular events were evaluated in the independent data sets. In the test set, the Dice similarity coefficients (DSC) were 0.966 ± 0.025 and 0.982 ± 0.017 for the lumen and EEM, respectively. Even at sites of extensive attenuation, the frame-level performance was excellent (DSCs > 0.96 for the lumen and EEM). The model (vs. the expert) showed a better temporal consistency for contouring the EEM. The agreement between the model- vs. the expert-derived cross-sectional and volumetric measurements was excellent in the independent retrospective cohort (all, intra-class coefficients > 0.94). The model-derived percent atheroma volume > 52.5% (area under curve 0.70, sensitivity 71% and specificity 67%) and plaque burden at the minimal lumen area site (area under curve 0.72, sensitivity 72% and specificity 66%) best predicted 3-year cardiac death and nonculprit-related target vessel revascularization, respectively. In the stented segment, the DSCs > 0.96 for contouring lumen and EEM were achieved. Applied to the 60-MHz IVUS images, the DSCs were > 0.97. In the external cohort with 45-MHz IVUS, the DSCs were > 0.96. The deep learning model accurately delineated vascular geometry, which may be cost-saving and support clinical decision-making., Competing Interests: Declarations Informed consent The authors declare that this report does not contain any personal information that could lead to the identification of the patients. Commercial plans There has not been ongoing or planned commercialization efforts based on the developed model. Competing interests Kim H & Lee G is an employee of Mediwhale Inc., Seoul, Korea. Min D is an employee of and Ingradient Inc., Seoul, Korea. Other authors report no conflicts of interest regarding this manuscript., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Background: About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown., Study Design: The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy "angiography-guided complete revascularization after (within 1-45 days) TAVI" is noninferior to the strategy "angiography-guided complete revascularization before (within 1-45 days) TAVI" using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year., Conclusions: The TAVI PCI trial tests the hypothesis that the strategy "PCI after TAVI" is noninferior to the strategy "PCI before TAVI" in patients with severe aortic stenosis and concomitant coronary artery disease., Competing Interests: Declaration of competing interest TAVI PCI is supported as investigator-initiated research by Edwards Lifesciences (THV-I20-061)., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Lithotripsy has been used for decades in the treatment of kidney stones and gallstones, in which ultrasound shock waves generated outside of the body are used to physically break up hardened masses. In the past decade, intravascular lithotripsy (IVL), a technology developed by Shockwave Medical Inc. (Santa Clara, CA), has emerged as a novel therapy for the treatment of vascular calcification. In the coronary blood vessels, IVL modifies arterial calcium and enables percutaneous coronary interventions to be performed in a safe and consistent manner, and in the peripheral blood vessels, IVL can be used as a standalone therapy in the treatment of calcified plaque in patients with peripheral artery disease (PAD). Due to the success of the Disrupt CAD and Disrupt PAD clinical trials, IVL is now FDA-approved in the United States for use in both patients with coronary artery disease (CAD) and PAD. The widespread adoption of IVL for PAD is likely to mirror the swift uptake seen in CAD. Although questions remain regarding IVL's high cost and performance compared directly to other technologies such as atherectomy, its ease of use, speed, and safety makes its future extremely promising for the treatment of complex, heavily calcified lesions in both peripheral and coronary vessels. Despite this, more studies are certainly needed to determine in what clinical scenarios IVL should be considered as opposed to atherectomy and if there are types of calcified lesions where IVL is best utilized (ie, concentric vs eccentric)., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: Various devices and techniques have been used for plaque modification in the treatment of severe coronary artery calcification. This prospective, multicenter, randomized, open-label study aims to evaluate the safety and efficacy of cutting balloon angioplasty using a novel bioabsorbable polymer-coated everolimus-eluting coronary stent for treating various degrees of calcified coronary lesions., Methods: We outline the trial design aimed at assessing whether the cutting balloon (Wolverine™) is non-inferior to the non-compliant balloon in treating patients with calcified lesions, encompassing both de novo and in-stent restenosis (ISR) lesions. We aim to enroll 250 patients who have undergone bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™) implantation. The primary endpoint is the minimal stent cross-sectional area at the calcium site as determined by intravascular ultrasonography. The secondary endpoints include major adverse cardiac events and target lesion revascularization at 12 months, alongside procedural convenience and operator-centric parameters, such as the number of balloons used, procedure time, and total contrast medium volume used., Discussion: In this study, we will evaluate the efficacy and safety of Wolverine™ and non-compliant balloon in patients with calcified coronary lesions and provide a rationale for which type of balloons will optimally modify calcium lesions. In addition, we will attempt to expand the indications of the cutting balloon for treating mild-to-severe calcified coronary lesions. As the scope of insurance coverage for cutting balloons remains limited in some countries, this study may provide evidence for extending insurance coverage to the treatment of de novo calcified and ISR lesions., Trial Registration: ClinicalTrials.gov NCT06177808. Registered on January 1, 2024., (© 2024. The Author(s).)

Aims: The optimal revascularization strategy for patients with acute myocardial infarction (AMI), cardiogenic shock (CS), and multivessel disease remains controversial. The CULPRIT-SHOCK trial compared culprit lesion-only vs. immediate multivessel percutaneous coronary intervention (PCI), providing important data but leaving efficacy questions unresolved. To address lingering uncertainties and gain deeper insights, we performed a Bayesian reanalysis of the CULPRIT-SHOCK trial data., Methods and Results: We conducted a Bayesian re-analysis of the CULPRIT-SHOCK trial data using non-informative, sceptical, and enthusiastic priors. Relative risks (RRs) with 95% highest posterior density (HPD) intervals were calculated. We defined the minimal clinically important difference (MCID) as RR < 0.84. We performed subgroup analyses for key patient characteristics and assessed secondary outcomes and safety endpoints. Probabilities of benefit, achieving MCID, and harm were computed. Results are presented as median RR with probabilities of effect sizes. Bayesian reanalysis showed a median RR of 0.82 (95% HPD 0.66-1.04) with a non-informative prior, indicating a 95% probability of benefit and 59% probability of achieving MCID. Subgroup analyses revealed potentially stronger effects in males (RR 0.78, 73% probability of MCID), patients without diabetes (RR 0.76, 79% probability of MCID), and those with non-anterior ST-segment elevation MI (STEMI; RR 0.74, 76% probability of MCID). Secondary outcomes suggested potential benefits in mortality (RR 0.85) and need for renal replacement therapy (RR 0.72) but increased risks of recurrent MI (RR 2.84) and urgent revascularization (RR 2.88)., Conclusion: Our Bayesian reanalysis provides intuitive insights by quantifying probabilities of treatment effect sizes, offering further evidence favouring the culprit lesion-only PCI strategy in AMI patients with CS and multivessel disease. The analysis demonstrates a high probability of overall benefit, with a notable chance of achieving a minimally clinically important difference, particularly in specific subgroups. These findings not only support the consideration of culprit lesion-only PCI in certain patient populations but also underscore the need for careful risk-benefit assessment. Furthermore, our hypothesis-generating subgroup analyses, which show varying probabilities of achieving MCID, illuminate promising avenues for future targeted investigations in this critical patient population., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)