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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.

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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.

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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.

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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.

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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.

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ABSTRACT: Isolated persistent left superior vena cava (PLSVC) is a very rare congenital thoracic venous system anomaly and is commonly an incidental finding, usually detected during central venous access, cardiac catheterization, or cardiothoracic surgeries. This is a rare case report wherein the patient is a known case of ischemic heart disease with s/p percutaneous transluminal coronary angioplasty (PTCA) with a stent to left anterior descending (LAD) artery with in-stent re-stenosis presented with complete heart block and had an unanticipated discovery of isolated PLSVC on facing difficulty during the transvenous approach of permanent pacemaker implantation (PPI). In this case report, we inspect the challenges associated with and various clinical implications of isolated PLSVC.

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Despite the advent of newer stents, in-stent restenosis has been a persistent and formidable challenge. Trials have demonstrated the superiority of drug-coated balloons over plain old balloon angioplasty. A recent AGENT IDE PRESTO (Prevention of REStenosis with Tranilast and its Outcomes) trial highlighted the need for a more comprehensive understanding; therefore, we conducted a meta-analysis to elucidate their respective clinical outcomes. A literature search was conducted by 2 investigators (SS and MH) using MEDLINE (EMBASE and PubMed) using a systematic search strategy by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) until November 1, 2023. CRAN-R software was used for statistical analysis. The quality assessment was performed using the Cochrane Risk of Bias tool (Supplementary Table 5). We included 6 studies with a total of 1,171 patients. Our analysis showed decreased odds of multiple outcomes with statistically significant results, including target vessel revascularization (odds ratio [OR] 0.33, confidence interval [CI] 0.19 to 0.57), target vessel failure (OR 0.30, CI 0.09 to 0.99), target lesion revascularization (OR 0.22, CI 0.10 to 0.46), restenosis (OR 0.1343, CI 0.06 to 0.27), and major adverse cardiac events (OR 0.2 CI 0.12 to 0.37). Although myocardial infraction and all-cause mortality showed decreased odds with all-cause mortality at 0.8 (95% CI 0.363 to 2.09), and myocardial infarction at 0.6 (95% CI 0.0349 to 1.07), the reductions did not reach statistical significance. Our analysis by scrutinizing 6 randomized controlled trials favored drug-coated balloons over plain old balloon angioplasty. However, extensive research for deeper understanding cannot be overemphasized.

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An entrapped undeflatable coronary balloon is a rare complication during percutaneous coronary intervention. It is a complication that can be stressful for the operator, with potentially catastrophic implications for the patient. A fully inflated balloon in the coronaries impedes the blood flow to the distal myocardium and hence causes ischemia, that could jeopardize the hemodynamics of the patients and potentially lead to life-threatening complications. In this article, we go over the bail-out techniques that have been tried while highlighting the pros and cons of each technique.

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An 86-year-old woman was managed for a non-ST-segment elevation myocardial infarction. Coronary angiography revealed significant stenoses at the left anterior descending, left ostial circumflex (LCX), obtuse first marginal, and a Medina 1.0.1 bifurcation lesion at the middle LCX/ second obtuse marginal (OM2). During percutaneous coronary intervention, the rupture of the pre-dilatation balloon was complicated by a type III coronary perforation at the level of the LCX/OM2 bifurcation, leading to cardiac tamponade. Hemodynamics were stabilized by percutaneous pericardial drainage. The placement of a covered stent (BeGraft, Bentley InnoMed), to seal the coronary perforation, was not possible due to its great rigidity and the angulation towards the OM2, even with the use of a guiding catheter extension (Guidezilla, Boston Scientific). To further increase support, we decided to use the flexibility of a regular drug-eluting stent which we implanted from the LCX to the OM2, thereby creating a rail-like path in which the covered stent could then be positioned and deployed successfully, allowing the perforation to be sealed with a good final result. This is what we called the "buddy stent technique".

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Coronary artery anomalies (ANOCOR) are congenital anomalies with various anatomical forms. Percutaneous treatment can be offered in certain situations, most often to address associated atherosclerotic disease or, more rarely, to correct a congenital stenosis. Due to the frequent difficulties of catheterization, percutaneous coronary interventions for ANOCOR are recognized as complex procedures. A thorough anatomical understanding facilitates the identification of the connection site and the initial ectopic course of an ANOCOR during coronary angiography. Selecting an appropriate catheter is a crucial step in the procedure. There is a higher prevalence of atherosclerotic disease along retroaortic courses compared to other ectopic courses. When treating atherosclerotic stenosis downstream of an ectopic course, techniques typically used for complex coronary procedures can be helpful. While angioplasty for congenital stenosis is technically feasible, its role in management algorithms remains to be defined. Currently, this type of percutaneous treatment may be offered to right ANOCOR with interarterial course in adults over 35 years old and with ischemic symptoms or myocardial ischemia.

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