Use Of Drug-eluting Stents Research Articles

Timing of Complete Revascularization in Patients with STEMI and Multivessel Disease: A Systematic Review and Meta-Analysis.

About half of patients with ST-segment Elevation Myocardial Infarction (STEMI) have multivessel coronary artery disease (MVD). Our aim was to provide a quantitative comparison of single-stage complete revascularization during the index revascularization versus deferred staged complete revascularization in STEMI patients with MVD. All studies evaluating patients with STEMI and MVD were included. The primary endpoint was a composite of all-cause death, myocardial infarction and repeat revascularization. Secondary endpoints were cardiovascular death, acute kidney injury and trial defined major bleeding. Eight studies and 2256 patients with STEMI and MVD were included. No difference was evident in the rate of the primary composite endpoint among the study group (Risk Ratio 0.95; 95% CI 0.71-1.27, p = 0.74), while meta-regression showed a significant interaction with drug eluting stent (DES) use (Coefficient -0.005; 95% CI -0.01 to -0.001; p = 0.007). Higher rates of cardiovascular (CV) death were found in the immediate complete revascularization group (5.0% vs 2.6%; Risk Ratio 0.39; 95% CI 0.25-0.62; p 0.01). Our analysis documented similar clinical outcomes with either single-stage immediate complete revascularization and delayed staged complete revascularization. Secondary analyses suggest that an increase in cardiovascular death might be expected with single-stage percutaneous coronary intervention (PCI). While new randomized trials on the topic are ongoing, revascularization can be personalized and guided by the acute clinical setting, patients'-related factors and workflow logistics.

Drug-eluting stent use with abbreviated dual antiplatelet therapy after percutaneous coronary intervention for liver transplantation evaluation.

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Abstract WMP82: National Trends In Endovascular Therapy For Intracranial Atherosclerotic Disease 2008-2019

Introduction: Endovascular therapy is a treatment option for patients with severe symptomatic intracranial atherosclerotic disease (ICAD). The utilization of angioplasty and stenting has varied since the development of stents for this disease in 2005. This study assesses the longitudinal trends for endovascular treatment of ICAD in the U.S. Methods: We performed a data search from the National Inpatient Sample (NIS) database using ICD9 and ICD10 procedure codes from 2008 through 2019. Data was collected for patients with stroke from ICAD who underwent stenting or angioplasty alone. We also assessed the utilization of stenting or angioplasty in thrombectomy cases for large vessel occlusion (LVO), the use of drug eluting stents, patient demographics, regional trends, length of stay, and mortality statistics. Results: Between 2008 and 2019, the nadir of ICAD stenting cases in the U.S. was in 2011 (n=242). There was over a 207% increase in stenting cases in 2015 (n=730), and another increase of 47% in ICAD stenting in 2018 and 2019 (2018=965, 2019=1,175). There was a significant increase in stenting for ICAD over the entire study period (p=0.003). The data also shows a significant increase in the use of stenting as adjunctive therapy to thrombectomy for LVO. In 2011, stenting with thrombectomy in LVO represented 17.8% (43/242) of patients stented with stroke from ICAD. In 2019, these cases represented 48.1% (565/1,175) of the patients stented. Over the study period, this increase in stent use during LVO treatment was significant (p<0.001). Angioplasty alone for ICAD in non-occluded vessels has not significantly changed (p=0.289). Angioplasty as an adjunct to thrombectomy for LVO has steadily increased over the past 10 years, with 94 cases in 2008 and 210 cases in 2019, representing a 123% increase. Conclusion: There has been a progressive increase in stenting for ICAD since the nadir of this procedure in 2011 which is statistically significant. This increase was seen in patients with severe symptomatic ICAD, but also in patients undergoing thrombectomy for acute LVO with ICAD. Positive clinical stenting trials such as WEAVE and the post-hoc analysis from SAMMPRIS, and the increase in endovascular therapy for LVO appear temporally related to these changes.

Long-Term Outcomes of Contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry

Introduction: Several large registries have evaluated outcomes after percutaneous coronary intervention (PCI) in the USA, however there are no contemporary data regarding long-term outcomes after PCI, particularly comparing new generation drug-eluting stents (DES) with other stents in Australia. Additionally, approval of new-generation drug-eluting stents (DES) is almost exclusively based on non-inferiority trials comparing outcomes with early generation DES, and there are limited data comparing safety and efficacy outcomes of new-generation DES with bare metal stents (BMS). This study reports in-hospital and long-term outcomes after PCI with the Xience DES from a large national registry, the GenesisCare Outcomes Registry (GCOR). Methods: The first 1500 patients consecutively enrolled from January 2015 to January 2019 and treated exclusively with either Xience DES or BMS and eligible for 1-year follow-up were included. Baseline patient and procedural data, major adverse cardiovascular events (MACE) in-hospital, at 30 days and 1-year, and medications were reported and analysed with respect to Xience DES (n = 1000) or BMS (n = 500) use. Results: In this cohort the mean age was 68.4 ± 10.7 years, 76.9% were male, 24.6% had diabetes mellitus and 45.9% presented with acute coronary syndromes. Of the overall cohort of 4765 patients from this period including all DES types, and patients who received multiple DES or a combination of DES and BMS, DES were exclusively used in 3621 (76.0%) patients, and BMS were exclusively used in 596 (12.5%). In comparison to international cohorts, adverse clinical event rates were low at 30 days in terms of mortality (0.20%), target lesion revascularisation (TLR, 0.27%) and MACE (0.47%), and at 12 months for mortality (1.26%) TLR (1.16%) and MACE (1.78%). Conclusions: Clinical practice and long-term outcomes of PCI with the Xience DES in Australia are consistent with international series. Recent trends indicate DES use has increased in parallel with good outcomes despite an increasingly complex patient and lesion cohort.

Long-term outcomes of drug-eluting balloons for treatment of side branches in patients with true coronary bifurcation lesions

Background: Bifurcation treatments make up ca. 15–20% of coronary interventions. Despite the use of drug-eluting stents, the management of bifurcation lesions, especially with side branches involved, remains a challenge.Objective: To evaluate long-term clinical and angiographic outcomes after using a paclitaxel-coated balloon for the treatment of side branches in patients with true bifurcation lesions.Methods: Eighty patients with coronary artery disease were enrolled after true bifurcation lesion stenting. All patients were randomized at the 1:1 ratio to the group of main branches stenting followed by the dilatation of side branches with drug-eluting balloons and provisional stenting group.Results: Long-term results were analyzed after 12 months. The most common bifurcation lesion involved the left anterior descending artery and diagonal branch (57.5%). Late lumen loss in the side branch (0.51 ± 0.22 vs 0.33 ± 0.24 mm) and in both the bifurcation branches (main branch + side branch) (1.06 ± 0.29 vs 0.79 ± 0.27 mm) was significantly higher in the patients after provisional stenting.Overall postoperative incidence of major adverse cardiovascular events was 17.5% and 7.5% (p = 0.31) in the provisional stenting and drug coated balloon groups, respectively. Patients with drug-eluting balloons for the treatment of side branches had a more pronounced decrease in angina symptoms after 12 months. Multivariate analysis showed that diabetes mellitus (OR: 10.9) and glomerular filtration rate (OR: 0.95) were independent predictors of major adverse cardiovascular events in bifurcation interventions.Conclusion: Drug-eluting balloons for the dilatation of side branches after the stenting of main branches are superior to provisional stenting in terms of the late lumen loss. Received 31 August 2022. Revised 17 November 2022. Accepted 18 November 2022. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovData collection and analysis: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoStatistical analysis: T.K. Eraliev, D.A. Khelimskii, A.G. BadoianDrafting the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoCritical revision of the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovFinal approval of the version to be published: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. Gorgulko

Advantages of DES over BMS in Preventing the Risk of Myocardial Infarction, Ischemic Stroke, and Mortality in Various Populations

Backgrounds: Previous studies have demonstrated that drug-eluting stents (DESs) are more effective than bare metal stents (BMSs) in reducing the risk of myocardial infarction in the short term, but the long-term preventive benefits for myocardial infarction, ischemic stroke, and mortality are not clear. Objective: This study deeply analyzed the long-term (within 3 years) advantages of the use of DESs in preventing the risk of myocardial infarction, ischemic stroke, and mortality in various populations compared with those of using BMSs. Methods: This was a retrospective observational cohort study. We used the 2015-2019 claims data from Taiwan's National Health Insurance Research Database. Patients over the age of 18 who underwent coronary stent placement (both DESs and BMSs) for the first time in 2016 were included in the study population. Propensity-score matching was applied to increase the comparability of the DES and BMS groups. We used a Cox proportional hazard regression analysis to compare the effectiveness of DESs and BMSs in preventing myocardial infarction, ischemic stroke, and all-cause mortality. A subgroup analysis was also performed. Results: In total, 21,608 cases were included in this study. Overall, the risk of myocardial infarction (aHR = 0.82; 95% CI: 0.78-0.85), ischemic stroke (aHR = 0.88; 95% CI: 0.81-0.95), and mortality (aHR = 0.61; 95% CI: 0.57-0.65) in the DES group were significantly lower than those in the BMS group. However, in some special cases, the results were not statistically significant. In particular, in patients with obesity (aHR = 2.61; 95% CI: 1.20-5.69), the DES group appeared to have a significantly higher long-term intermediate ischemic risk than the BMS group. Conclusions and Relevance: In conclusion, although DESs were more effective than BMSs in reducing the risk of long-term myocardial infarction, ischemic stroke, and mortality, this study also found that, in some cases, the advantages of DESs over BMSs were not clearly observed.

Acute Vessel Closure or Major Adverse Cardiac Events of Drug-Coated Balloons and Stents: A Systematic Review and Meta-Analysis

While the use of drug-eluting stents (DES) has become the first-line strategy for treating coronary artery disease, there are still drawbacks with their use. As our understanding of coronary artery anatomy and physiology evolves, growing evidence supports the use of drug-coated balloons (DCB) not only in the treatment of in-stent restenosis but also in de novo lesions. The aim of this systematic review and meta-analysis is to determine if there is a difference in outcomes when DCBs are used versus when stents are used. PubMed, Cochrane and Web of Science databases were systematically searched. The primary outcome of the meta-analysis was acute vessel closure and the secondary outcomes were stent complications including major adverse cardiovascular events (MACE) and all-cause mortality. Eleven studies with a total of 2349 patients were included. No significant difference was found in terms of acute vessel closure between DCBs and all stents (2.6% vs. 1.0%, OR: 2.13 (0.74–6.44), I2: 4%, p = 0.16). Furthermore, there was no difference in MACE (6.8% vs. 10.1%, OR: 0.53 (0.27–1.04), I2: 48%, p = 0.06), all-cause mortality and target lesion revascularisation. This meta-analysis suggests that the use of DCBs is a safe alternative to stents when treating coronary artery disease.

Time Trend in Incidence of Sudden Cardiac Death After Percutaneous Coronary Intervention from 2009 to 2017 (from the Japanese Multicenter Registry)

The advances in the integrated management of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) have reduced subsequent cardiovascular events. Nonetheless, sudden cardiac death (SCD) remains a major concern. Therefore, we aimed to investigate the time trend in SCD incidence after PCI and to identify the clinical factors contributing to SCD. From a prospective, multicenter cohort registry in Japan, 8,723 consecutive patients with coronary artery disease undergoing PCI between 2009 and 2017 were included. We evaluated the SCD incidence 2years after PCI; all death events were adjudicated, and SCD was defined as unexpected death without a noncardiovascular cause in a previously stable patient within 24hours from the onset. The Fine and Gray method was used to identify the factors associated with SCD. Overall, the mean age of the patients was 68.3 ± 11.3years, and 1,173 patients (13.4%) had heart failure (HF). During the study period, the use of second-generation drug-eluting stents increased. The 2-year cumulative incidence of all-cause mortality and SCD was 4.29% and 0.45%, respectively. All-cause mortality remained stable during the study period (p for trend=0.98), whereas the crude incidence of SCD tended to decrease over the study period (p for trend=0.052). HF was the strongest predictor associated with the risk of SCD (crude incidence [vs non-HF] 2.13% vs 0.19%; p <0.001). In conclusion, the incidence of SCD after PCI decreased over the last decade, albeit the high incidence of SCD among patients with HF remains concerning.

Patient-level and external factors in the use of drug-coated balloons and drug-eluting stents in femoropopliteal endovascular interventions.

Drug-coated balloons (DCB) and drug-eluting stents (DES) have been rapidly adopted for femoropopliteal endovascular interventions due to their favorable patency rates. It is unclear whether choice of using drug coated devices versus bare metal stents (BMS) or plain balloon angioplasty (POBA) as primary treatment in femoropopliteal disease is mostly associated with patient-level factors, safety concerns, or by operator preferences. This study sought to evaluate factors associated with their use in a contemporary dataset. All femoropopliteal lesions treated with endovascular interventions between 2016 and 2019 from the Vascular Quality Initiative registry were included. For each procedure, a primary treatment was identified based on the following hierarchy: DES > DCB > BMS > POBA. A hierarchical logistic regression model predicting DCB or DES use included patient-level characteristics, key events (period after Centers for Medicare and Medicaid Services reimbursement change, January 2018 [vs before] and period after Katsanos meta-analysis December 2018 [vs before]), and random effects for site and operator. Operator-level variability for DCB and DES use was summarized with an adjusted median odds ratio (MOR). A total of 57,753 femoropopliteal endovascular procedures were included. Poor functional status (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.90-0.94), prior anticoagulant use (OR, 0.92; 95% CI, 0.87-0.97), higher Rutherford classification (OR, 0.86; 95% CI, 0.84-0.88), chronic kidney disease stage 4 or 5 (OR, 0.92; 95% CI, 0.86-0.98), and the period after the Katsanos meta-analysis publication (OR, 0.3; 95% CI, 0.29-0.32) were associated with a lower odds of DCB or DES use; whereas female sex (OR, 1.12; 95% CI,1.08-1.17), prior lesion treatment (OR, 1.17; 95% CI, 1.11-1.22), diabetes (OR, 1.07; 95% CI, 1.02-1.12), Trans-Atlantic Inter-Society Consensus class B (OR, 1.16; 95% CI, 1.09-1.24) and C (OR, 1.2; 95% CI, 1.12-1.28), and the period after the Centers for Medicare and Medicaid Services reimbursement change (OR, 1.08; 95% CI, 1.03-1.14) were associated with a higher odds of DCB or DES use. Significant variability in use was found across operators (adjusted MOR, 2.70; 95% CI, 2.55-2.85) and centers (adjusted MOR, 2.89; 95% CI, 2.50-3.27). DCB or DES use in femoropopliteal disease demonstrates wide variability across operators and is linked strongly with external factors, followed by anatomic lesion characteristics and a history of previous interventions. Future work needs to focus on tailoring DCB or DES use to patient and lesion characteristics and to develop appropriate use guidelines integrating these factors.

Percutaneous coronary intervention in patients with cancer using bare metal stents compared to drug-eluting stents.

Management of coronary artery disease (CAD) is unique and challenging in cancer patients. However, little is known about the outcomes of using BMS or DES in these patients. This study aimed to compare the outcomes of percutaneous coronary intervention (PCI) in cancer patients who were treated with bare metal stents (BMS) vs. drug-eluting stents (DES). We identified cancer patients who underwent PCI using BMS or DES between 2013 and 2020. Outcomes of interest were overall survival (OS) and the number of revascularizations. The Kaplan-Meier method was used to estimate the survival probability. Multivariate Cox regression models were utilized to compare OS between BMS and DES. We included 346 cancer patients who underwent PCI with a median follow-up of 34.1 months (95% CI, 28.4-38.7). Among these, 42 patients were treated with BMS (12.1%) and 304 with DES (87.9%). Age and gender were similar between the BMS and DES groups (p = 0.09 and 0.93, respectively). DES use was more frequent in the white race, while black patients had more BMS (p = 0.03). The use of DES was more common in patients with NSTEMI (p = 0.03). The median survival was 46 months (95% CI, 34-66). There was no significant difference in the number of revascularizations between the BMS and DES groups (p = 0.43). There was no significant difference in OS between the BMS and DES groups in multivariate analysis (p = 0.26). In addition, independent predictors for worse survival included age > 65 years, BMI ≤ 25 g/m2, hemoglobin level ≤ 12 g/dL, and initial presentation with NSTEMI. In our study, several revascularizations and survival were similar between cancer patients with CAD treated with BMS and DES. This finding suggests that DES use is not associated with an increased risk for stent thrombosis, and as cancer survival improves, there may be a more significant role for DES.

Timing and predictors of definite stent thrombosis in comatose survivors of out-of-hospital cardiac arrest undergoing percutaneous coronary intervention and therapeutic hypothermia (ST-OHCA study).

Incidence of stent thrombosis (ST) in comatose survivors of out-of-hospital cardiac arrest (OHCA) undergoing immediate percutaneous coronary intervention (PCI) and therapeutic hypothermia (TH) varies considerably, from 2.7% to 31.2%, in retrospective studies. We aimed to investigate occurrence, timing and predictors of definite ST. We prospectively investigated consecutive comatose survivors of OHCA with presumed cardiac aetiology undergoing immediate PCI with drug-eluting stents (DES) and TH targeted at 32-34°C admitted between August 2016 and July 2021. Repeat coronary angiography (CAG) was performed if ST was suspected and systematically between day 8-12 in the absence of clinical signs. All deceased patients underwent autopsy and histopathological analysis. Results: Among 362 comatose survivors of OHCA, immediate PCI with stenting was performed in 169 patients (47%). Since 18 patients did not complete follow-up, 151 patients were ultimately enrolled in ST analysis. Definite ST was confirmed in 29 patients (19.2%; 95% confidence interval [CI]: 12.9%-25.6%) either by CAG (n=18) or autopsy (n=11). ST occurred within 3 days in 62% and presented with at least one clinical sign in 79%. Survival with good neurological recovery was observed in 17% of patients with ST and in 60% of patients without ST (p<0.001). Independent predictors of ST were longer prehospital resuscitation, lower arterial pH and increased creatinine on admission. The incidence of definite ST in comatose survivors of OHCA undergoing immediate PCI and TH targeted at 32-34°C is substantial (19.2%) and significantly higher than in other PCI subsets despite systematic use of contemporary DES and anticoagulation/antiplatelet treatment.

Follow the Data: It Is Time to Incentivize the Use of Drug-Eluting Stents and Balloons

Follow the Data: It Is Time to Incentivize the Use of Drug-Eluting Stents and Balloons

Drug-Eluting, Bioresorbable Cardiovascular Stents─Challenges and Perspectives.

Globally, the leading causes of natural death are attributed to coronary heart disease and type 1 and type 2 diabetes. High blood pressure levels, high cholesterol levels, smoking, and poor eating habits lead to the agglomeration of plaque in the arteries, reducing the blood flow. The implantation of devices used to unclog vessels, known as stents, sometimes results in a lack of irrigation due to the excessive proliferation of endothelial tissue within the blood vessels and is known as restenosis. The use of drug-eluting stents (DESs) to deliver antiproliferative drugs has led to the development of different encapsulation techniques. However, due to the potency of the drugs used in the initial stent designs, a chronic inflammatory reaction of the arterial wall known as thrombosis can cause a myocardial infarction (MI). One of the most promising drugs to reduce this risk is everolimus, which can be encapsulated in lipid systems for controlled release directly into the artery. This review aims to discuss the current status of stent design, fabrication, and functionalization. Variables such as the mechanical properties, metals and their alloys, drug encapsulation and controlled elution, and stent degradation are also addressed. Additionally, this review covers the use of polymeric surface coatings on stents and the recent advances in layer-by-layer coating and drug delivery. The advances in nanoencapsulation techniques such as liposomes and micro- and nanoemulsions and their functionalization in bioresorbable, drug-eluting stents are also highlighted.

An intricate interplay between stent drug dose and release rate dictates arterial restenosis.

Since the introduction of percutaneous coronary intervention (PCI) for the treatment of obstructive coronary artery disease (CAD), patient outcomes have progressively improved. Drug eluting stents (DES) that employ anti-proliferative drugs to limit excess tissue growth following stent deployment have proved revolutionary. However, restenosis and a need for repeat revascularisation still occurs after DES use. Over the last few years, computational models have emerged that detail restenosis following the deployment of a bare metal stent (BMS), focusing primarily on contributions from mechanics and fluid dynamics. However, none of the existing models adequately account for spatiotemporal delivery of drug and the influence of this on the cellular processes that drive restenosis. In an attempt to fill this void, a novel continuum restenosis model coupled with spatiotemporal drug delivery is presented. Our results indicate that the severity and time-course of restenosis is critically dependent on the drug delivery strategy. Specifically, we uncover an intricate interplay between initial drug loading, drug release rate and restenosis, indicating that it is not sufficient to simply ramp-up the drug dose or prolong the time course of drug release to improve stent efficacy. Our model also shows that the level of stent over-expansion and stent design features, such as inter-strut spacing and strut thickness, influence restenosis development, in agreement with trends observed in experimental and clinical studies. Moreover, other critical aspects of the model which dictate restenosis, including the drug binding site density are investigated, where comparisons are made between approaches which assume this to be either constant or proportional to the number of smooth muscle cells (SMCs). Taken together, our results highlight the necessity of incorporating these aspects of drug delivery in the pursuit of optimal DES design.

Disparities in Drug-Eluting Stent Utilization in Patients With Acute ST-Elevation Myocardial Infarction: An Analysis of the National Inpatient Sample.

The superiority of drug-eluting stents (DES) compared with bare-metal stents (BMS) is well-established, but data regarding DES use in ST-elevation myocardial infarction (STEMI) as a function of race is limited. Our goal was to examine stent utilization patterns and disparities based on race, sex, and insurance status in patients with STEMI undergoing percutaneous coronary intervention. The National Inpatient Sample database was used to retrospectively compare DES vs BMS use in patients admitted with STEMI from 2009 to 2018. Multivariable logistic regression was performed to assess the independent predictors of DES use. DES utilization increased significantly from 62.8% in 2009 to 94.0% in 2018. However, African Americans were less likely to receive a DES (odds ratio [OR] .82, 95% confidence interval [CI] .77-.87) compared with Caucasians. Women were more likely to undergo DES implantation (OR 1.07, 95% CI 1.05-1.10). Patients insured by Medicaid (OR .84, 95% CI .80-.89) and those classified as Self-pay (OR .63, 95% CI .61-.66) were less likely to undergo DES implantation compared to those with private insurance (OR 1.33, 95% CI 1.29-1.38). Disparities based on race and insurance status continue to persist despite a significant increase in DES utilization in STEMI patients across the identified subgroups.

Association of serum apoA-I with in-stent restenosis in coronary heart disease

BackgroundDespite use of drug-eluting stents (DES), in-stent restenosis (ISR) continues adversely affecting clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Apolipoprotein A-I (apoA-I) has athero-protective effects. However, there is a paucity of clinical data regarding the association between apoA-I and ISR. We sought to investigate whether serum apoA-I is related to ISR after DES-based PCI.MethodsIn this retrospective case control study, 604 consecutive patients who underwent DES implantation before were enrolled. Patients who underwent repeat angiography within 12 months were included in the early ISR study (n = 205), while those beyond 12 months were included in the late ISR study (n = 399). ISR was defined as the presence of > 50% diameter stenosis at the stent site or at its edges. Clinical characteristics were compared between ISR and non-ISR patients in the early and late ISR study, respectively, after adjusting for confounding factors by multivariate logistic regression, stratified analysis, and propensity score matching. The predictive value was assessed by univariate and multivariate logistic regression analysis, receiver operating characteristic (ROC) curve analysis, and quartile analysis.ResultsIn the early ISR study, 8.8% (18 of 205) patients developed ISR. Serum apoA-I in the ISR group was lower than that in the non-ISR group (1.1 ± 0.26 vs. 1.24 ± 0.23, P < 0.05). On multivariate logistic regression analysis, apoA-I was an independent risk factor for early ISR. Incidence of early ISR showed negative correlation with apoA-I and could be predicted by the combined use of apoA-I and glycosylated hemoglobin (HbA1c) level. In the late ISR study, 21.8% (87 of 399) patients developed ISR. On subgroup analysis, late ISR showed negative correlation with apoA-I irrespective of intensive lipid lowering; on multivariate logistic regression analysis, apoA-I was also an independent risk factor for late ISR. In patients with intensive lipid lowering, combined use of apoA-I, stenting time, and diabetes predicted the incidence of late ISR.ConclusionsApoA-I was an independent risk factor for ISR, and showed a negative correlation with ISR after DES-based PCI. Combined use of apoA-I and clinical indicators may better predict the incidence of ISR under certain circumstances.

Drug-Eluting Stents.

Endovascular revascularization strategies have advanced tremendously over the years and are now often considered first line for treatment of peripheral arterial disease. Drug-eluting stents (DESs) have been developed as one of the tools to overcome the limitations of elastic recoil and neointimal hyperplasia observed with balloon angioplasty and bare metal stents. While these stents have been extremely successful in coronary revascularization, they have not translated as effectively to the peripheral arteries which differ in their unique mechanical environments and differences in vessel and lesion composition. DESs, through their embedded pharmaceutical agent, seek to inhibit vascular smooth muscle cell (VSMC) proliferation and migration. Paclitaxel, sirolimus, and its derivatives (-limus family) achieve VSMC inhibition through unique mechanisms. Several clinical trials have been performed to evaluate the use of DES in the femoropopliteal and infrapopliteal territory and have demonstrated overall decrease in revascularization rates and improved clinical outcomes.

A prospective randomized trial of the use of drug-eluting balloon catheters for the treatment of a lateral branch in patients with true bifurcation lesions

Background. Endovascular interventions for bifurcation lesions of the coronary arteries account for approximately 15-20% of all coronary interventions. Despite the use of drug-eluting stents, the management of bifurcation lesions remains challenging, especially in the setting of lateral branch involvement. Although the Provisional stenting strategy is the preferred method for most patients, several studies have shown that dual-stent techniques may be advantageous in this patient population. However, as a general approach, the European Bifurcation Club recommends that percutaneous coronary interventions be performed with a minimum number of stents.Aim. To evaluate the safety and efficacy of using a paclitaxel-coated balloon in the treatment of a lateral branch in patients with true bifurcation coronary disease.Methods. This work was performed as a result of a clinical analysis and evaluation of the results of treatment of 80 patients with coronary artery disease, who underwent stenting of a true bifurcation lesion in the period from 2020 to 2021. All patients were randomized in a 1:1 ratio to main branch stenting followed by lateral branch dilatation with drug-eluting balloons and provisional stenting. A direct angiographic analysis was carried out before and after the intervention, and control coronary angiography was performed 12 months later with an assessment of the results obtained. All patients underwent a comprehensive clinical, laboratory and instrumental examination.Results. Pre-procedure reference main branch diameters were 2.97 ± 0.41 mm and 3.12 ± 0.38 mm in the Provisional and drug-eluting balloons groups, respectively. The degree of stenosis of the main branch before percutaneous coronary interventions was 65.2 ± 14.1% and decreased to 13.3 ± 6.6% after intervention in the Provisional stenting group. This was comparable to the results of percutaneous coronary interventions in the group of patients who used drug-eluting balloons 63.8 ± 12.3% and 12.9 ± 5.8%, respectively. The minimum diameter of the main branch after percutaneous coronary interventions increased from 1.04 ± 0.34 mm to 2.72 ± 0.44 mm in the Provisional stenting group and subsequently decreased to 2.18 ± 0.33 mm, according to control coronary angiography after 12 months. At the same time, patients who underwent intervention using drug-eluting balloons had a smaller loss of the lumen of the main branch 0.41 ± 0.33 mm versus 0.63 ± 0.32 mm (p = 0.003). In addition, late loss of lumen both in the lateral branch (0.51 ± 0.22 mm versus 0.33 ± 0.24 mm) and total in both branches of the bifurcation (1.06 ± 0.29 mm versus 0.79 ± 0.27 mm) was statistically greater with Provisional stenting.Conclusion. Treatment of bifurcation lesions using the Provisional technique with drug-eluting lateral branch dilatation has shown better results than with conventional balloons.

Comparison between drug-coated balloons and drug-eluting stents in very small coronary artery interventions

The optimal management of very small vessel (reference diameter from 2.0 to 2.25 mm) in percutaneous coronary interventions (PCIs) is controversial. We aimed to compare the efficacy and safety of drug-coated balloons (DCBs) and drug-eluting stents (DESs) for de-novo very small vessel interventions. We conducted a retrospective analysis of consecutive patients who received very small vessel PCI with a DCB or DES between January 2018 and March 2021. The outcome measures were the incidence of ischemia-driven target lesion revascularization (TLR) and major adverse cardiac and cerebrovascular events (MACCEs) within 1 year after PCI. MACCEs were defined as the composite of ischemia-driven TLR, all-cause death, non-fatal acute coronary syndrome, stroke, or heart failure requiring hospitalization. A total of 205 patients undergoing PCI with a DCB or DES were enrolled in this study. The procedural complication rate was 2.5% in the DES group and 1.7% in the DCB group (P = 1.000). After 1-year of follow-up, the cumulative incidence of TLR was 7.2% in the DCB group and 4.9% in the DES group (P = 0.530). The cumulative incidence of MACCEs was 10.6% in the DCB group and 12.7% in the DES group (P = 0.769). Only female gender, acute coronary syndrome on presentation, and dual antiplatelet therapy duration < 3 months were significantly associated with MACCEs at 1 year, but the use of DCB or DES was not. The use of DCBs or DESs in de novo very small vessel intervention was not associated with different outcomes at 1 year.

Five-Year Impacts of Antithrombotic Therapy Based on 10-Year Clinical Outcomes of Cypher™ Stent Implantation.

IntroductionFew researchers have investigated the optimal long-term antithrombotic therapy regimen, especially after first-generation drug-eluting stent (DES) use. This study aimed to evaluate the impact of mid-term antithrombotic therapy on long-term outcomes in patients treated with the first sirolimus-eluting coronary stent (Cypher™).MethodsBetween 2004 and 2009, 1021 patients underwent Cypher™ implantation at our institute; among them, 567 patients had available data on antithrombotic therapy at year 5. We assessed patients’ antithrombotic therapy at year 5 post Cypher™ implantation and examined their association with adverse events from year 5 to year 10 post Cypher™ implantation.ResultsPatients with dual-antiplatelet therapy (DAPT) at year 5 had significantly lower risk of stent thrombosis (ST) than those with single-antiplatelet therapy (SAPT) (hazard ratio [HR] 0.24, p = 0.034). The HR of major bleeding in DAPT, compared to SAPT, was high, but the difference was not significant (HR 1.72, p = 0.26). Risk of major bleeding was significantly higher in patients on oral anticoagulants (OAC) than in those in other groups (OAC/SAPT; HR 5.31, p = 0.0048, OAC/DAPT; HR 3.08, p = 0.022), without significant reduction in the risk of cardiovascular events.ConclusionsThe incidence of ST after Cypher™ implantation in patients with DAPT at year 5 was significantly lower than that in SAPT. However, the risk of bleeding was higher with DAPT than with SAPT. Moreover, the risk of major bleeding was significantly higher in patients on anticoagulant therapy than in other patients. New options for the use of antithrombotic drugs after percutaneous coronary intervention warrant further studies on the optimal antithrombotic therapy for first-generation DES.