Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial.

BACKGROUND: The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions. METHODS: REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing. FINDINGS: Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; pnon-inferiority=0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group. INTERPRETATION: In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years, which indicates that DES should remain the preferred treatment for this patient population. FUNDING: Xijing Hospital and Shenqi Medical. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.

[Successful percutaneous treatment of complex heart disease in a stage IV non-small cell lung cancer survivor]. / Trattamento percutaneo di successo di una cardiopatia complessa in un sopravvissuto a carcinoma polmonare non a piccole cellule in stadio IV.

The presence of metastatic cancer represents a high-risk condition for the treatment of heart disease requiring surgical or percutaneous procedures. We present the case of a 58-year-old man with pulmonary adenocarcinoma and renal metastases surviving more than 3 years after chemotherapy and immunotherapy suffering dyspnea and chest pain on minimal exertion due to 99% anterior coronary artery stenosis associated with severe aortic stenosis of a bicuspid valve. We treated the cardiac lesions in two steps by coronary angioplasty with drug-eluting stent implantation followed by percutaneous prosthetic aortic valve replacement. The procedures were successful with resolution of the symptoms and recovery of the usual ECOG-PS 0-1 functional capacity which persists 24 months after cardiac procedures. This case demonstrates that the multidisciplinary collaboration between oncologists and cardiologists with a personalized patient-centered approach allows to treat complex clinical situations successfully in the emerging category of patients surviving with metastatic cancer.

Uncommon culprit artery leading to atypical de winter electrocardiographic changes: a case report.

BACKGROUND: A subset of patients with acute coronary artery occlusion requiring emergency revascularization, does not present with the typical ECG features of ST-segment elevation myocardial infarction (STEMI).Timely identification of these atypical presentations is crucial. CASE PRESENTATION: This report describes a 55-year-old male patient who was admitted to the emergency department with chest pain. The electrocardiogram (ECG) recorded atypical de Winter electrocardiographic changes and their evolution. RESULTS: Coronary angiography confirmed the occlusion of the second diagonal branch (D2). The patient's condition improved after D2 balloon angioplasty. CONCLUSION: De Winter electrocardiographic changes can also be observed in D2 occlusions and may present with milder manifestations. Timely recognition of these changes holds significant clinical value.

Management of adult focal nasolacrimal duct stenosis: long-term outcomes of 3D CT-DCG-assisted and endoscopically guided coronary catheter balloon dacryoplasty.

The purpose was to evaluate the use of 3D CT-DCG-assisted and endoscopically guided coronary catheter balloon dacryoplasty (CC-BDCP) in adults with focal stenosis of the nasolacrimal duct (NLD) and report their long-term outcomes. A prospective, non-randomized, single-center clinical study was performed, and the patients underwent endoscopy-guided CC-BDCP using percutaneous transluminal coronary angioplasty (PTCA) balloon catheters. 25 patients were enrolled in the study. The CC-BDCP procedure was performed in 21 of 25 (84%) patients, and the remaining 4 (16%) patients had significant procedural difficulties due to unfavorable anatomical conditions. Of the 21 patients, 10 (47.6%) were procedurally assessed as "easy" (eCC-BDCP) and in 11 (52.4%) as procedurally "difficult" (dCC-BDCP). Values on Munk's epiphora intensity scale changed overall from 4.0 preoperatively to 1.4 ± 1.6 (p = 0.00001) postoperatively overall. FDDT changed overall from 2.9 ± 0.3 to 1.1 ± 1.2 after treatment (p = 0.00008) (from 2.8 ± 0.4 to 0.3 ± 0.6 in the eCC-BDCP group and from 2.9 ± 0.3 to 1.4 ± 1.2 in the dCC-BDCP group (p = 0.01352). The anatomical and functional success rate was 77% overall, 90% in the eCC-BDCP group, and 64% in the dCC-BDCP group. The CC-BDCP led to a statistically significant decrease in epiphora in a particular group of adult patients with demonstrable focal stenosis of the NLD.

Long-Term Results of Bioresorbable Vascular Scaffolds in Patients With In-Stent Restenosis: The RIBS VI Study.

BACKGROUND: In patients with in-stent restenosis (ISR) bioresorbable vascular scaffolds (BVS) provide similar results to drug-coated balloons (DCBs) but are inferior to drug-eluting stents (DES) at 1 year. However, the long-term efficacy of BVS in these patients remains unknown. OBJECTIVES: This study sought to assess the long-term safety and efficacy of BVS in patients with ISR. METHODS: RIBS VI (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment; NCT02672878) and RIBS VI Scoring (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon; NTC03069066) are prospective multicenter studies designed to evaluate the results of BVS in patients with ISR (N = 220). The inclusion and exclusion criteria were identical to those used in the RIBS IV (ISR of DES) (Restenosis Intra-stent of Drug-eluting Stents: Drug-eluting Balloon vs Everolimus-eluting Stent; NCT01239940) and RIBS V (ISR of bare-metal stents) (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent; NCT01239953) randomized trials (including 249 ISR patients treated with DCBs and 249 ISR patients treated with DES). A prespecified comparison of the long-term results obtained with these treatment modalities (ie, DES, DCBs, and BVS) was performed. RESULTS: Clinical follow-up at 3 years was obtained in all (100%) 718 patients. The 3-year target lesion revascularization rate after BVS was 14.1% (vs 12.9% after DCBs [not significant], and 5.2% after DES [HR: 2.80; 95% CI: 1.47-5.36; P = 0.001]). In a landmark analysis (>1 year), the target lesion revascularization rate after BVS was higher than after DES (adjusted HR: 3.41; 95% CI: 1.15-10.08) and DCBs (adjusted HR: 3.33; 95% CI: 1.14-9.70). Very late vessel thrombosis was also more frequent with BVS (BVS: 1.8%, DCBs: 0.4%, DES: 0%; P = 0.03). CONCLUSIONS: In patients with ISR, late clinical results of DES are superior to those obtained with DCBs and BVS. Beyond the first year, DCBs are safer and more effective than BVS.

Drug-coated balloon angioplasty versus drug-eluting stent implantation in ACS patients with different angiographic patterns of in-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) angioplasty and drug-eluting stents (DES) are two widely used treatments for in-stent restenosis (ISR). Focal and non-focal types of ISR affect the clinical outcomes. The present study aims to compare DES reimplantation versus DCB angioplasty in acute coronary syndrome (ACS) patients with focal ISR and non-focal ISR lesions. METHODS: Patients with ISR lesions underwent percutaneous coronary intervention (PCI) were retrospectively evaluated and divided into DES group and DCB group. The primary endpoint was the incidence of target lesion failure (TLF) at 24 months follow up. Propensity score matching (PSM) was conducted to balance the baseline characteristics. RESULTS: For focal ISR, TLF was comparable in the DES and DCB groups at 24 months of follow-up (Before PSM, hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.39-1.27; p = 0.244; After PSM, HR: 0.83; 95% CI: 0.40-1.73; p = 0.625). For non-focal ISR, TLF was significantly decreased in DES compared with DCB group (Before PSM, HR: 0.43; 95% CI: 0.29-0.63; p < 0.001; After PSM, HR: 0.33; 95% CI: 0.19-0.59; p < 0.001), which was mainly attributed to the lower incidence of clinically indicated target lesion revascularization (CD-TLR) (Before PSM, HR: 0.39; 95% CI: 0.26-0.59; p < 0.001; After PSM, HR: 0.28; 95% CI: 0.15-0.54; p < 0.001). CONCLUSIONS: The clinical outcomes for DES and DCB treatment are similar in focal type of ISR lesions. For non-focal ISR, the treatment of DES showed a significant decrease in TLF which was mainly attributed to a lower incidence of CD-TLR.

Sirolimus-coated balloon versus drug-eluting stent for complex coronary lesions. A propensity matched comparison.

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.

[How to solve difficult side branch access: case report and literature review]. / Je n'arrive pas à passer mon guide dans la branche fille ; cas clinique et revue de la littérature.

We present the case of a 53-year-old patient with history of hypertension and dyslipidemia, admitted for effort-induced angina. Coronary angiography revealed two-vessel disease with severe stenosis of the LAD- Diagonal bifurcation (MEDINA 1-1-1). This lesion was considered complex regarding the severe stenosis of the bifurcation core, the angulation <45°, and the severity and length of the diagonal lesion. The procedure was planned according to a TAP technique. The flow in the diagonal was however lost after stenting the main vessel causing an ST elevation with chest pain. It was subsequently recovered using the rescue jailed balloon technique before re-crossing the stent struts of the LAD using a Gaia First® (Asahi) guidewire. The aim of this case report is to illustrate some pitfalls that can be encountered in bifurcation percutaneous interventions and to present technical solutions to solve difficult side branch access issues through a literature review.

[Endocoronary imaging contribution in iatrogenic dissection management]. / Apport de l'imagerie endocoronaire dans la prise en charge d'une dissection iatrogène.

Iatrogenic coronary dissections are rare but potentially serious. Their management is complex, particularly if the dissection occurs without an angioplasty guide in the arterial lumen. In this context, angiography alone is insufficient, and endocoronary imaging is essential (using optical coherence or IVUS) to guide angioplasty when necessary (guide in the true lumen, coverage of the tear). We report here the case of an iatrogenic dissection of the right coronary artery treated with OFDI guiding.

Drug-Coated Balloon Angioplasty vs Plain Balloon Angioplasty in patients with coronary In-Stent Restenosis: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: In-stent restenosis (ISR) remains a significant challenge in interventional cardiology despite advancements in stent technology. Drug-coated balloons (DCBs), which deliver antiproliferative agents directly to the vessel wall, have emerged as a promising alternative to plain balloon angioplasty for ISR treatment. This meta-analysis evaluates the efficacy of DCBs compared to plain balloon angioplasty in patients with coronary ISR. METHODS: A comprehensive search of PubMed and Embase was conducted on June 27, 2024. The search identified randomized controlled trials comparing DCBs and plain balloon angioplasty for ISR treatment. Six trials involving 1,322 patients met the inclusion criteria. Quality was assessed with the Cochrane Risk of Bias tool. Data extraction and statistical analysis were performed using RevMan software, assessing heterogeneity with the I2 statistic and publication bias using funnel plots. RESULTS: The analysis showed that DCBs significantly reduced late in-stent and in-segment luminal loss (P < 0.001) and target lesion revascularization (P = 0.02) compared to plain balloon angioplasty. Major adverse cardiovascular events and the combined endpoint of target lesion revascularization, myocardial infarction, and death also showed highly significant improvements with DCB treatment (P < 0.00001 and P = 0.0002, respectively). However, no significant effect was observed on myocardial infarction and mortality rates. CONCLUSION: DCBs significantly reduce in-stent late luminal loss, target lesion revascularization, and major adverse cardiovascular events compared to plain balloon angioplasty.