Incidence Of Target Lesion Revascularization Research Articles

Efficacy and safety of drug-coated balloons in chronic total coronary occlusion recanalization: a systematic review and meta-analysis

BackgroundWith advancements in chronic total coronary occlusion (CTO) recanalization techniques and concepts, the success rate of recanalization has been steadily increasing. However, the current data are too limited to draw any reliable conclusions about the efficacy and safety of drug-coated balloons (DCBs) in CTO percutaneous coronary intervention (PCI). Herein, we conducted a meta-analysis to confirm the efficacy of DCB in CTO PCI.MethodsWe systematically searched PubMed, Web of Science and Embase from inception to July 25, 2023. The primary outcome was major advent cardiovascular events (MACE), including cardiac death, nonfatal myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). The follow-up angiographic endpoints were late lumen enlargement (LLE), reocclusion and restenosis.ResultsFive studies with a total of 511 patients were included in the meta-analysis. Across studies, patients were predominantly male (72.9-85.7%) and over fifty years old. The summary estimate rate of MACE was 13.0% (95% CI 10.1%-15.9%, I2 = 0%, p = 0.428). The summary estimate rates of cardiac death and MI were 2.2% (95% CI 0.7%-3.7%, I2 = 0%, p = 0.873) and 1.2% (95% CI -0.2-2.6%, I2 = 13.7%, p = 0.314), respectively. Finally, the pooled incidences of TLR and TVR were 10.1% (95% CI 5.7%-14.5%, I2 = 51.7%, p = 0.082) and 7.1% (95% CI 3.0%-11.2%, I2 = 57.6%, p = 0.070), respectively. Finally, the summary estimate rates of LLE, reocclusion and restenosis were 59.4% (95% CI 53.5–65.3%, I2 = 0%, p = 0.742), 3.3% (95% CI 1.1–5.4%, I2 = 0%, p = 0.865) and 17.5% (95% CI 12.9–22.0%, I2 = 0%, p = 0.623), respectively.ConclusionAccordingly, DCB has the potential to be used as a treatment for CTO in suitable patients.

Factors influencing coronary artery target lesion revascularization after drug-coated balloon angioplasty.

Concerns regarding restenosis after treatment with drug-coated balloons (DCB) remain. We aimed to identify the incidence of target lesion revascularization (TLR) and explore clinical, procedural, and other factors influencing it. Single-center retrospective analysis of a prospective cohort PCI registry study included 80 patients (100 lesions) who underwent successful DCB angioplasty between January 2020 and October 2023 and follow-up angiography within 2 years of either planned or unplanned reason. Incidence and factors associated with TLR were analyzed. Angiographic evaluation was conducted within a median of 151 days (interquartile range: 109 days). During index procedure, 54% were complex lesions. Intravascular imaging (IVI) was performed in 80% of lesions. TLR occurred in 11% of the lesions and was less frequent in the IVI group compared to the angiography-alone group [6.3 vs. 54.5%; odds ratio: 0.156, 95% confidence interval (CI): 0.042-0.580; p = 0.002]. No association was found between baseline and lesion characteristics, lesion complexity, plaque morphology, pre-dilatation procedure balloon type, maximal inflation pressure, or length of DCB between the groups (p > 0.05). Multivariate analysis revealed that IVI utilization was independently associated with a lower TLR rate (adjusted odds ratio: 0.116, 95% CI: 0.020-0.669; p = 0.016). In DCB angioplasty, only IVI use exhibited a significant difference in the TLR rate among baseline lesion characteristics and lesion preparation and was independently associated with a lower TLR rate.

ASSESSMENT OF SAFETY AND FEASIBILITY OF ROTATIONAL ATHERECTOMY (RA) VERSUS CONVENTIONAL STENTING IN PATIENTS WITH CHRONIC TOTAL OCCLUSION (CTO) LESIONS

Chronic total occlusion (CTO) sores in coronary arteries present a challenge in percutaneous coronary intervention (PCI) because of their complex anatomy and high rates of procedural failure. Objectives: In this comparative study, we aim to investigate the safety and feasibility of rotational atherectomy (RA) versus conventional stenting in patients with chronic total occlusion (CTO) lesions. Methods: This comparative study was conducted at Ayub teaching hospital from September 2023 to December 2023. Data was collected from 110 patients from both genders. Patients aged > 18 years and diagnosed with chronic total occlusion (CTO) lesions in coronary arteries confirmed by coronary angiography were included in the study. Baseline demographic and clinical data, including age, gender, comorbidities, and angiographic characteristics, were collected for each participant. Additionally, procedural details such as the type of intervention, rotational atherectomy, conventional stenting, procedural time, fluoroscopy time, contrast volume, and any adverse events encountered during the procedure were recorded. Results: Data were collected from 110 patients from both genders. The mean age of participants in the Rotational Atherectomy (RA) group was 62.4 ± 7.3 years, while in the Conventional Stenting group, it was 61.8 ± 6.9 years. There were 40 males and 15 females in the RA group, compared to 38 males and 17 females in the Conventional Stenting group. The prevalence of diabetes mellitus was 42.0% in the RA group and 45.5% in the Conventional Stenting group. Left ventricular ejection fraction (LVEF) was 53.7 ± 4.2% in the RA group and 54.1 ± 4.5% in the Conventional Stenting group. The RA group showed a success rate of 81.8%, and the conventional stenting group achieved a success rate of 90.9%. However, the RA group experienced slightly higher rates of major procedural complications (9.1% vs. 5.5%) and minor procedural complications (12.7% vs. 10.9%) than the conventional stenting group. Conventional stenting group, the mean change was -1.2 ± 0.7. Additionally, the incidence of target lesion revascularisation (TLR) was observed in 8 patients (14.5%) in the RA group and 12 patients (21.8%) in the conventional stenting group. Furthermore, major adverse cardiovascular events (MACE) occurred in 9 patients (16.4%) in the RA group and 11 patients (20.0%) in the conventional stenting group. Conclusion: It is concluded that both rotational atherectomy (RA) and conventional stenting are effective and safe treatment options for patients with chronic total occlusion (CTO) lesions. Our findings suggest that both strategies yield comparable procedural success rates, complication rates, and efficacy outcomes, including myocardial infarction frequency, troponin levels, and left ventricular ejection fraction changes.

Current Management of In-Stent Restenosis.

In-stent restenosis (ISR) remains the primary cause of target lesion failure following percutaneous coronary intervention (PCI), resulting in 10-year incidences of target lesion revascularization at a rate of approximately 20%. The treatment of ISR is challenging due to its inherent propensity for recurrence and varying susceptibility to available strategies, influenced by a complex interplay between clinical and lesion-specific conditions. Given the multiple mechanisms contributing to the development of ISR, proper identification of the underlying substrate, especially by using intravascular imaging, becomes pivotal as it can indicate distinct therapeutic requirements. Among standalone treatments, drug-coated balloon (DCB) angioplasty and drug-eluting stent (DES) implantation have been the most effective. The main advantage of a DCB-based approach is the avoidance of an additional metallic layer, which may otherwise enhance neointimal hyperplasia, provide the substratum for developing neoatherosclerosis, and expose the patient to a persistently higher risk of coronary ischemic events. On the other hand, target vessel scaffolding by DES implantation confers relevant mechanical advantages over DCB angioplasty, generally resulting in larger luminal gain, while drug elution from the stent surface ensures the inhibition of neointimal hyperplasia. Nevertheless, repeat stenting with DES also implies an additional permanent metallic layer that may reiterate and promote the mechanisms leading to ISR. Against this background, the selection of either DCB or DES on a patient- and lesion-specific basis as well as the implementation of adjuvant treatments, including cutting/scoring balloons, intravascular lithotripsy, and rotational atherectomy, hold the potential to improve the effectiveness of ISR treatment over time. In this review, we comprehensively assessed the available evidence from randomized trials to define contemporary interventional treatment of ISR and provide insights for future directions.

Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty. To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries. A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years. Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs. In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results. German Clinical Trials Register: DRKS00031245. The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.

Balón liberador de sirolimus en el tratamiento del síndrome coronario agudo y crónico: el estudio PEACE, un subanálisis del registro EASTBOURNE

Introduction and objectivesThe PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS). MethodsThis was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events. ResultsBaseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P=.007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P=.820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P=.258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P=.009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure. ConclusionsThis SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.

Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry

BackgroundThe outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons.AimsTo evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India).MethodsWe conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2–5 bleedings.ResultsAmong 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91–2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95–3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92–1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09–4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status.ConclusionsIn the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease

BackgroundAlthough target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) disease is not rare, its timing of occurrence and prognostic impact on long-term mortality is uncertain. ObjectivesThis study sought to investigate TLR incidence over time and its impact on mortality after PCI with drug-eluting stents (DES) for LMCA disease. MethodsUsing a pooled data from 4 multicenter observational registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents], IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization], MAIN-COMPARE [Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization], and PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease]), we evaluated 1,397 patients with LMCA disease treated with DES and available long-term mortality data. The association between TLR and the 10-year risk of mortality was examined by multivariable Cox proportional hazards regression, with TLR as a time-varying covariate. ResultsDuring maximum follow-up of 10 years (median 6.8 years), TLR occurred in 118 patients and its 10-year cumulative incidence was 10.8%. TLR mostly occurred within 2 years after initial PCI and decreased over time: early-stage TLR (within 2 years) in 73 (61.9%) patients and late-stage TLR (beyond 2 years) in 45 (38.1%) patients. Among all TLR patients, 23 patients underwent coronary artery bypass grafting and 95 underwent repeat PCI. In the time-varying multivariable Cox model, the presence of TLR was not significantly associated with an increased risk of mortality (adjusted HR: 0.90; 95% CI: 0.50-1.63; P = 0.73). ConclusionsAlthough the incidence of ischemia-driven TLR was mostly common within 2 years after left main PCI, TLR occurred steadily during the 10-year follow-up period. However, given that such patients were optimally revascularized, the prognostic impact of TLR on mortality was not substantial. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133; Observational Study for Left Main Disease Treatment [IRIS-MAIN]; NCT01341327; Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease [MAIN COMPARE]; NCT02791412; Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968)

Two-year real world clinical outcomes after intravascular imaging device guided percutaneous coronary intervention with ultrathin-strut biodegradable-polymer sirolimus-eluting stent

BackgroundThere are little clinical data on imaging-guided percutaneous coronary intervention (PCI) 1 year after the biodegradable-polymer sirolimus-eluting stents (BP-SES) implantation, when the polymer disappears. MethodsWe retrospectively analyzed 2455 patients who underwent successful PCI with BP-SES or durable-polymer everolimus-eluting stents (DP-EES) between September 2011 and March 2021, and compared 2-year clinical outcomes of BP-SES (n = 459) with DP-EES (n = 1996). The outcome measures were target lesion revascularization (TLR) and major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. Multivariate analysis using the Cox proportional hazard model and inverse probability weighting (IPW) analysis based on the propensity score were used to evaluate the clinical outcomes. ResultsThe 2-year cumulative incidences of TLR (BP-SES: 4.9% vs. DP-SES: 6.1%, p = 0.304) and MACE (10.3% vs. 12.5%, p = 0.159) were similar between the two groups. Multivariable and IPW analysis revealed the risks of TLR (p = 0.388 and p = 0.500) and MACE (p = 0.139 and p = 0.083) also had no significant difference. There was a significant interaction between none/mild and moderate/severe calcification with respect to MACE and TLR (adjusted p for interaction = 0.036 and 0.047, respectively). The risk of MACE was significantly lower in BP-SES than in DP-EES in lesions with none/mild calcification (adjusted hazard ratio [aHR]: 0.53; 95% confidence interval [CI]: 0.30–0.91), while it was similar in those with moderate/severe calcification (aHR: 0.95; 95% CI: 0.58–1.55). ConclusionsCompared with DP-EES, BP-SES demonstrated durable 2-year clinical outcomes. However, BP-SES showed better clinical performance than DP-EES for lesions with none/mild calcification.

Drug coated balloons-based approach versus conventional percutaneous coronary intervention with drug eluting stents for left anterior descending revascularization

Abstract Introduction While representing the gold standard for percutaneous coronary interventions (PCI), drug eluting stents (DES) are associated with a progressively increasing risk of stent-related adverse events over time. (1) Left anterior descending (LAD) disease is a critical area for coronary stenting, due to the wide distribution with several side branches at risk of occlusion after stent implantation. Thus, the development of novel approaches for LAD PCI is warranted. Drug-coated balloons (DCB) used alone or in combination with DES as part of a hybrid procedure could allow to minimize stent burden and reduce the occurrence of stent-related events, but the evidence on their use for de novo lesions in large vessels is limited. (2-4) Methods Consecutive patients undergoing DCB implantation on the LAD in two Italian centers from 2018 to 2021 were retrospectively enrolled and compared to a historical cohort of LAD PCI with DES. Patients with in-stent restenosis were excluded. The primary endpoint was target lesion revascularization (TLR), while secondary endpoints included target vessel revascularization (TVR) and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, TLR and TVR. Results 175 patients undergoing a DCB-based treatment on the LAD were included and compared to 1503 patients who received conventional PCI with DES. 83.9% of patients were male and 28.3% were diabetics, with no differences between the two groups. Total treated length was higher in the DCB group (54.9±20 for DES vs.66.2±35.2 mm for DCB, p&amp;lt;0.001); conversely, a greater mean DES length (54.9±20 vs.42.5±27.1 mm, p&amp;lt;0.001) was observed in the DES cohort. In the DCB group, mean DCB length was 36.8±20.2 mm; 32% of patients underwent DCB-only PCI and, in those who had hybrid PCI, DCB length was higher than stent length in 61.1% of cases. Large vessels (device diameter ≥3 mm) were treated in 81.6% and 77.1% of patients in the DES and DCB groups respectively, with no significant differences, while DCB with diameter ≥3 mm were used in 41.7% of patients in the DCB cohort. Mean follow-up duration was 2024 and 495 days in the DES and DCB groups respectively. At two years, the cumulative incidence of TLR was 9.1% (95% CI:7.6-10.9%) in the DES group vs. 4.8% (95% CI: 1.8-12.3%) in the DCB group (Log-rank p =0.225). After covariate adjustment through stepwise multivariable Cox regression analysis, DCB use was independently associated with lower TLR occurrence (HR 0.23, 95% CI: 0.06-0.98), alongside with large vessels involvement, while diabetes, dyslipidemia, and prior CABG correlated with greater TLR risk. No differences between DES and DCB were detected for secondary endpoints. Conclusions A DCB-based treatment approach allowed a significantly reduced stent burden for LAD PCI and led to a lower risk of target lesion failure at two years. Future randomized studies are warranted to demonstrate the effect of DCB-based LAD PCI on long term outcomes.Major adverse cardiovascular eventsTLR predictors at Cox regression

Abstract 18850: Impact of Intravascular Imaging-Guided versus Coronary Angiography-Guided Percutaneous Coronary Intervention on Adverse Cardiovascular Events: A Systematic Review and Meta-Analysis of Randomized Control Trials

Background: Intravascular imaging (IVI) namely intravascular ultrasound (IVUS) and optical coherence tomography (OCT), presents as a promising imaging modality for drug-eluting stent (DES) implantation compared to the gold-standard conventional two-dimensional angiography. IVI provides detailed information on vessel lumen, lesion length, and degree of calcification. For this purpose, we conducted a meta-analysis by pooling recently conducted randomized control trials (RCTs) to compare IVI with angiography for DES implantation. Hypothesis: IVI is associated with a significant reduction in CV events for DES implantation. Methods: Fourteen RCTs reporting CV outcomes with IVI versus angiography-guided stent implantation in CAD patients undergoing PCI were included in MEDLINE, and Scopus databases (Inception till May 2023). The primary outcome of interest was target-lesion revascularization (TLR). The outcome measures were summary random effects risk ratio (RR) with 95% confidence intervals. Results: A total of 8,946 patients (IVI 4,751 vs. angiography 4,195; mean age 61.7 years) were included. Over a median follow-up of 15 months (12-24.3), IVI was associated with significantly reduced TLR (RR 0.63 [0.49, 0.79]; Figure 1), target vessel revascularization (RR 0.66 [0.53, 0.83]), and major adverse cardiovascular events (MACE) (RR 0.69 [0.58, 0.78]) vs. conventional angiography for PCI. However, no significant difference was observed in all-cause mortality between the two imaging modalities (RR 0.85 [0.63, 1.15]). Meta-regression analysis showed no significant impact of follow-up duration, baseline comorbidities such as hypertension, smoking status, previous myocardial infarction, and stent length on TLR incidence. Conclusion: IVI was associated with improved CV outcomes in terms of reduced TLR, TVR, and MACE incidence when compared with traditional angiography in CAD patients for stent implantation.

Bioresorbable Vascular Scaffolds: Should We use Them Again?

Context: An important development in the percutaneous management of coronary artery disease was the creation of the drug-eluting stent (DES). The DES reduces the high incidence of target lesion revascularization associated with balloon angioplasty and bare metal stents by overcoming vessel recoil and restenosis. Despite these advantages, DES carries a persistent risk of stent-related problems due to the permanent implantation of a foreign body and the limitation of arterial vasomotion. Similar to DES, bioresorbable vascular scaffolds (BRS) are intended to distribute drugs and offer mechanical support before completely degrading over the years. Evidence Acquisition: This study was a review article. The data were acquired from PubMed and Google Scholar. Medical Subject Headings (MeSH) terms were used when available, and only English articles were included in the review. Results: Recent studies have shown that the BRS is not inferior to modern DES clinically, although some clinical results are worrying, particularly the greater rates of scaffold thrombosis. Early studies showed that BRS was superior to DES; nevertheless, larger-scale applications and longer observations revealed serious problems with their use, such as reduced radial strength and a higher risk of thrombosis, which led to a higher rate of serious adverse cardiac events. Conclusions: The position of DES was not directly challenged by additional attention to procedural details and research on the second generation of BRS with innovative features. Bioresorbable vascular scaffolds still have an opportunity to demonstrate their supremacy in standout indicators.

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial.

Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing. We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention. The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR). A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups. At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years. gov: NCT03216733.

Long-term clinical outcomes of drug-coated balloon for the management of chronic total occlusions.

This study aims to compare the clinical outcomes of patients with de novo chronic total occlusion (CTO) lesions treated by hybrid strategy and drug-coated balloons (DCB)-only strategy. DCBs have been used as an alternative to or in combination with drug-eluting stents in CTO lesions. However, the clinical impact of DCB treatment on CTO lesion remains uncertain. We retrospectively enrolled 154 patients with de novo CTO lesions treated by DCB, including 57 cases in hybrid group and 97 cases in DCB-only group. The lesions in hybrid group were more complicated than those in DCB-only group as shown by higher J-CTO score, and therefore higher percentage of retrograde approach, more IVUS guidance, more CTO guidewires, and longer procedural time were demonstrated. Although the percentage of non-flow-limiting dissection and residual stenosis of more than 30% were lower in hybrid group, TIMI flow grade, satisfactory and acceptable recanalization rate were not significantly different between two groups. During a median follow-up was 470 days, the incidence of target lesion revascularization (TLR), myocardial infarction and cardiac death was 11.0%, 1.3% and 1.9%, respectively. The long-term TLR-free survival was comparable between hybrid and DCB-only groups. By multivariate analysis, DCB length and age were predictors of TLR. DCB treatment appears effective and safe in selected de novo CTO lesions during long-term follow up. The recanalization results and long-term outcomes are comparable between hybrid and DCB-only group despite more complicated lesions in hybrid group.

Ten-year clinical outcomes from a randomized trial comparing new-generation everolimus-eluting stent versus first-generation Sirolimus-eluting stent: Results from the RESET extended study.

New-generation drug-eluting stents (DES) achieved technological innovations and reported clinical advantages as compared with first-generation DES in clinical trials with 3-5 years follow-up. However, detailed clinical outcome data in very long-term follow-up is still scarce. To evaluate 10-year clinical outcomes after first- and new-generation DES implantation. In this extende follow-up study of the RESET, which is a largest randomized trial comparing everolimus-eluting stent (EES) with Sirolimus-eluting stent (SES), the study population consisted of 2892 patients from 84 centers. The primary efficacy and safety endpoints were target lesion revascularization (TLR) and a composite of death or myocardial infarction (MI), respectively. Complete 10-year follow-up was achieved in 87.9% of patients. Cumulative 10-year incidences of TLR and non-TLR were not significantly different between EES and SES (13.9% vs. 15.7%, Log-rank p = 0.20, and 33.4% vs. 31.3%, Log-rank p = 0.30). The cumulative 10-year incidence of death/MI was also not significantly different between the groups (32.5% vs. 34.4%, Log-rank p = 0.18). Cumulative 10-year incidence of definite stent thrombosis was numerically lower in EES than in SES (1.0% vs. 1.7%, Log-rank p = 0.16). The lower risk of EES relative to SES was significant for a composite endpoint of target lesion failure (TLF: 19.6% vs. 24.9%, Log-rank p = 0.001) and target vessel failure (TVF: 26.7% vs. 31.4%, Log-rank p = 0.006). During 10-yearof follow-up, the risks for primary efficacy and safety endpoints were not significantly different between new-generation EES and first-generation SES, although EES compared with SES was associated with a lower risk for composite endpoints such as TLF and TVF.

Device Effectiveness for Femoropopliteal Artery Disease Treatment: An Analysis of K-VIS ELLA Registry

BackgroundAlthough drug-coated balloons (DCBs) and drug-eluting stents (DES) are frequently used for the treatment of femoropopliteal artery (FPA) disease, their mid- or long-term clinical efficacy in real-world practice is still limited. ObjectivesFrom the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) multicenter registry cohort, clinical outcomes of drug-eluting devices for FPA lesions in comparison with bare-metal stents (BMS) were evaluated. MethodsLimbs that underwent percutaneous transluminal angioplasty for FPA lesions with plain old balloon angioplasty (POBA, n = 826), BMS (n = 943), DCBs (n = 778), or DES (n = 227) between 2012 and 2020 were included. The primary outcome was target lesion revascularization (TLR) at 2 years. Inverse probability of treatment weighting was used to account for confounding. ResultsAfter inverse probability of treatment weighting, baseline characteristics were well-balanced among groups. Compared with the 2-year cumulative incidence of TLR with BMS (26.5%), the incidence of TLR was significantly lower in limbs treated with DCBs (15.9%; HR: 0.44; 95% CI: 0.30-0.64; P < 0.001) or DES (15.9%; HR: 0.51; 95% CI: 0.29-0.87; P = 0.014). No significant differences were observed in the risk of TLR between DCBs vs DES (HR: 0.87; 95% CI: 0.51-1.49; P = 0.613) and POBA vs BMS (HR: 0.94; 95% CI: 0.73-1.21; P = 0.626). All-cause mortality was comparable in the 4 groups. Treatment with DCBs showed a more pronounced favorable outcome in limbs with Trans-Atlantic Inter-Society Consensus II type C/D lesions or long lesions (≥150 mm) compared with POBA, BMS, or DES (Pinteraction< 0.05). ConclusionsIn real-world practice, DCBs and DES demonstrated comparably superior midterm outcomes over POBA or BMS in the treatment of FPA lesions.

How I do it: optimizing angioplasty using the Tack endovascular system in the management of chronic limb threatening ischemia

Dissection occurring after percutaneous transluminal angioplasty (PTA) is associated with decreased vessel patency and an increased incidence of target lesion revascularization. Management of post-PTA dissection with the Tack Endovascular System (Philips, N.V., Amsterdam, Netherlands) has created an effective and durable treatment strategy for infrainguinal dissections. In this report, we discuss the indications and optimal methods for using Tack devices in post-PTA dissections.

Drug-Coated Balloons for De Novo Coronary Artery Lesions: A Meta-Analysis of Randomized Clinical Trials.

Through meta-analysis, we aimed to assess the efficacy and safety of drug-coated balloons (DCB), compared with drug-eluting stents (DES) or uncoated devices, in the treatment of de novo coronary lesions. Only randomized controlled trials were included. The primary outcomes were late lumen loss (LLL), target lesion revascularization (TLR), and major adverse cardiac events (MACEs). Subgroup analyses were conducted based on clinical indications, whether DCBs were used with a systematic or bailout stent, and types of DESs. The present meta-analysis demonstrated that DCBs elicit significantly lower incidences of TLR, MACE, and LLL, compared with uncoated devices, and similar incidences, compared with DESs, in the treatment of de novo coronary lesions. Subgroup analysis indicated that DCBs used with a bailout stent achieved lower incidences of binary restenosis and myocardial infarction, compared with uncoated devices, and provided less LLL than DESs. DCBs showed similar rates of TLR and MACE, with significantly less LLL, than DESs in treating de novo small-vessel diseases. The clinical efficacy of DCBs was similar to that of second-generation DES. Overall, DCB is favored over bare metal stent alone in treating de novo coronary lesions. DCBs appear to be a promising alternative to DESs in the treatment of de novo coronary lesions.

Prevalence and outcomes of stent thrombosis with in-stent calcified nodules: substudy from the REAL-ST registry.

The relationship between in-stent calcified nodules (IS-CN) and second-generation drug-eluting stent (G2-DES) stent thrombosis (ST) remains uncertain. We aimed to evaluate the prevalence, clinical demographic and long-term clinical outcomes after G2-DES ST with IS-CN. The prespecified substudy of the REAL-ST registry (a retrospective, multicentre registry of patients with definite ST after first- and G2-DES implantation) enrolled patients who experienced definite G2-DES ST and who underwent pre-intervention intravascular ultrasound imaging at index ST events. IS-CN was observed in 15 out of 118 (13%) definite G2-DES ST cases. The multiple logistic regression model demonstrated that haemodialysis (odds ratio [OR] 12.27, 95% confidence interval [CI]: 1.56-94.54; p=0.02), proximal or mid-right coronary artery lesions (OR 12.79, 95% CI: 1.78-92.13; p=0.01) and severe calcification (OR 13.01, 95% CI: 1.18-142.94; p=0.04) were independently associated with ST with IS-CN. The cumulative 5-year incidence of target lesion revascularisation (TLR) after ST was significantly higher in the IS-CN group than in the non-IS-CN group (p=0.02). Independent predictors of TLR after the index ST events were female sex (hazard ratio [HR] 3.05, 95% CI: 1.20-7.74; p=0.02), diabetes mellitus (HR 3.26, 95% CI: 1.26-8.41; p=0.01) and IS-CN (HR 3.07, 95% CI: 1.16-8.14; p=0.02). IS-CN may be one of the underlying mechanisms of G2-DES ST. Notably, IS-CN was associated with a higher TLR rate after the index ST events, suggesting the need for careful clinical follow-up of ST patients with IS-CN.

Long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions.

BackgroundDrug-coated balloons (DCB), alone or in combination with drug-eluting stents (DES), may be used to treat diffuse coronary lesions. We aimed to explore the efficacy and safety of DCB in patients with diffuse coronary lesions.MethodsConsecutive patients with diffuse coronary lesions (lesion length > 25 mm) who underwent DCB and/or DES between January 2015 and December 2019 were included in this prospective, observational, multicenter study. The DCB group included 355 patients (360 lesions), of which 142 patients (143 lesions, 39.7%) received the DCB-only strategy and 213 patients (217 lesions, 60.3%) received the hybrid strategy (DCB combined with DES). The DES group included 672 patients (831 lesions) treated with DES alone. Target lesion revascularization (TLR) during 3-year follow-up was the primary outcome of interest. The secondary outcome was major adverse cardiac events (MACE), defined as a composite of all-cause death, non-fatal myocardial infarction, and target vessel revascularization.ResultsThe two groups had comparable baseline clinical and lesion characteristics. Lesion length was similar (43.52 ± 16.46 mm vs. 44.87 ± 15.80 mm, P = 0.181), but the stent length in the DCB group was significantly shorter (24.02 ± 23.62 mm vs. 51.89 ± 15.81 mm, P < 0.001). Ten lesions (2.8%) in the DCB group received bailout stents. Over 3 years of follow-up, no significant difference in TLR incidence between the groups (7.3 vs. 8.3%, log-rank P = 0.636) was observed. Incidence of MACE also did not differ significantly (11.3 vs. 13.7%, log-rank P = 0.324). No thrombosis events occurred in the DCB group, while four patients (0.6%) in the DES group experienced stent thrombosis (log-rank P = 0.193). Moreover, similar TLR and MACE rates were observed between DCB-only and hybrid strategies (TLR: 6.4 vs. 8.0%, log-rank P = 0.651; MACE: 11.4 vs. 11.2%, log-rank P = 0.884).ConclusionLong-term outcomes show that the efficacy and safety of the DCB strategy (DCB alone or combined with DES) are similar to those of DES alone in diffuse coronary lesions. These findings suggest that this strategy is a promising alternative for select patients with diffuse coronary lesions.