Coronary Drug-eluting Stent Research Articles

Symptomatic Severe Stenosis of Cavernous Internal Carotid Artery Stenting: A Case Report with Short Literature Review

AbstractIntracranial internal carotid artery (ICA) stenosis is rarely reported as compared with extracranial ICA stenosis. Atherosclerosis is one of the major beginnings of stenosis of vasculatures, which may lead to ischemic stroke causing morbidity and mortality. We report the case of a 60 -year-old man presented to us with complaints of multiple episodes of dizziness, mild headache, and transient left arm weakness for 3 months and had history of smoking, hypercholesterolemia (high level of low-density lipoprotein level = 220 mg/dL), diabetes mellitus, and hypertension under medication. No neurological deficits were observed at the time of admission. Patient underwent angioplasty and stenting with drug-eluting balloon-expandable coronary stent. Patient was discharged well at the 3rd day of procedure. No recurrence of stroke and restenosis were noted till 3 months of follow-up period. Stenting following angioplasty for treatment of symptomatic severe cavernous ICA stenosis with everolimus-eluting coronary balloon-expandable stent, Xience Xpedition, is safe and effective.

Abstract 393: Rescue Intra‐arterial Therapy for Emergent Large Vessel Occlusion Secondary to Intracerebral Atherosclerotic Disease In the Philippines: A Single Center Study

Introduction Large vessel occlusions (LVO) secondary to intracranial atherosclerotic disease (ICAD) has an estimated prevalence of 10‐30% of all LVO cases, and the usual risk factors associated with it are hypertension, diabetes, ethnicity, and age. To date, the gold standard of treatment for strokes from LVO are intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT). ICAD‐LVO results in increased morbidity and mortality, as well as early re‐occlusion after revascularization therapy. ICAD‐LVO results in re‐occlusion at 30‐50% compared to 5% rate in cardioembolic strokes. Rescue therapy (RT) for re‐stenosis or re‐occlusion includes intra‐arterial (IA) administration of antiplatelets, angioplasty, and emergency stenting. Despite advancements in endovascular therapy and medical management, the optimal approach for rescuing patients who fail initial reperfusion attempts remains a challenging and underexplored area. By documenting RT strategies, we can identify which are effective in such scenarios and ultimately its impact on clinical outcomes. Of note, this is the first study on RT in ICAD‐LVO in the Philippines. Methods A retrospective chart review of all emergent LVO who underwent cerebral angiogram for the purpose of endovascular thrombectomy from September 2018 to July 2024 was performed. Those included were patients who underwent rescue therapy for ICAD‐LVO. The following were collected, demographic data (age and sex), admitting MRS, NIHSS score upon admission, underlying co‐morbidities (hypertension, diabetes, history of previous stroke), use of anti‐thrombotics/anti‐coagulants as maintenance medications, ASPECTS or MR ASPECTS, history of IV thrombolysis administration, rescue therapy instituted (IA thrombolytics, stenting, or angioplasty), in‐hospital mortality, and discharge MRS. Results Among the 101 LVO patients reviewed, 10 of which were due to ICAD‐LVO and underwent rescue therapy. The mean age was 65 where 80% are male. The demographic data showed that all patients included were hypertensive and half are diabetic and dyslipidemic. 80% (n=8) of patients received IA tirofiban as RT with a mean dose of 960mcg, 1 underwent emergency stenting using a drug eluting coronary stent, and 1 received IA alteplase. No early neurological improvement was seen in those who received RT. For the immediate outcomes, 80% (n=8) of patients had an MRS of 3‐5 upon discharge. Regarding its safety, only 20% (n=2) had hemorrhagic transformation but were asymptomatic. Only 1 patient (10%) with a basilar ICAD‐LVO who received IA tirofiban died, but not as a direct result of the RT, but due to withdrawal of care. CONCLUSIONS ICAD‐LVO remains to be a challenging feat to overcome in revascularization therapy and results in worse outcomes. Rescue therapy with IA tirofiban seems to be safe but does not offer added benefit in terms of acute clinical outcomes. A study on long‐term outcomes of patients who received RT for ICAD‐LVO is recommended to better determine its safety and efficacy.

Comparative long-term efficacy and safety of two paclitaxel-coated balloons with different coating strategies for the treatment of drug-eluting coronary stent restenosis.

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

Atlas Drug-Eluting Coronary Stents Inhibit Neointimal Hyperplasia in Sheep Modeling.

Coronary artery disease (CAD) is one of the leading causes of mortality and morbidity worldwide. Many patients with CAD require mechanical revascularization. However, restenosis after minimally invasive interventions is a major problem for these patients. Fortunately, the controlled drug delivery properties of drug-eluting stents seem to be able to overcome this problem. In this study, the pharmacodynamic and pharmacokinetic properties of Atlas Drug-eluting Coronary Stents coated with poly (lactic acid-coglycolic acid) (PLGA) were evaluated. This study included 20 non-atherosclerotic female sheep divided into 4 groups that included 4 study and 1 control animal randomly assigned to each group. Animals in the study groups were stented with Atlas Drug-eluting Coronary Stents, and the pharmacodynamic and pharmacokinetic properties were evaluated. Sirolimus was shown to have a statistically important effect on the vascular endothelium. With time, the decrease in sirolimus in blood samples was statistically significant. Two animals died after implantation; however no clinically significant side effects were observed in the others. The results in this study showed a significant reduction in neointimal hyperplasia after experimental implantation of Atlas Drug-eluting Coronary Stents coated with PLGA polymer. Pharmacokinetic studies also showed that the stent did not release a significant amount of sirolimus after 28 days.

Coronary artery bypass grafting vs. drug-eluting stent implantation: the probabilities of reintervention, transition to severe care-need, nursing home, and death in patients with coronary artery disease within the first three years: evaluations based on health claims data in Germany.

Coronary artery bypass grafting (CABG) and drug-eluting stent implantation (DES) are established as central methods of revascularization for patients with coronary artery disease. This study aims to analyse the health trajectories of patients after first CABG or first, second or third DES within the first three years, with a focus on follow-up interventions, severe care need, transition into a nursing home, and death. Based on health claims data (n=11,581), we estimated age-and sex standardized probabilities of reintervention, and of transition to severe care need, nursing home and death following initial CABG (n=2,008) or DES (n=9,573) for patients aged 50 years and older using logistic regression models and direct standardization. Up to three follow-up DES interventions and one follow-up CABG were considered. There was a fairly high probability of reintervention, particularly after a DES and within the first year. Follow-up interventions were more likely to involve DES than CABG. The probability of death was notably higher for CABG patients. The probabilities of severe care need and moving to a nursing home were slightly lower and similar across the revascularization methods and over time. DES and CABG are often associated with a need for follow-up interventions. Depending on the procedure, however, the risk of repeat surgery or adverse health outcomes varies. DES is associated with a relatively high probability of follow-up revascularization and a nearly constant probability of negative health outcomes in the short and medium term. In contrast, within three years after a CABG, follow-up reinterventions are rather rare. However, this procedure is particularly associated with an increased risk of mortality and short-term transition into a nursing home.

Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery

BackgroundCurrent guidelines recommend the perioperative continuation of aspirin in patients with coronary drug-eluting stents (DES) undergoing noncardiac surgery. However, supporting evidence is limited. ObjectivesThis study aimed to compare continuing aspirin monotherapy vs temporarily holding all antiplatelet therapy before noncardiac surgery in patients with previous DES implantation. MethodsWe randomly assigned patients who had received a DES >1 year previously and were undergoing elective noncardiac surgery either to continue aspirin or to discontinue all antiplatelet agents 5 days before noncardiac surgery. Antiplatelet therapy was recommended to be resumed no later than 48 hours after surgery, unless contraindicated. The primary outcome was a composite of death from any cause, myocardial infarction, stent thrombosis, or stroke between 5 days before and 30 days after noncardiac surgery. ResultsA total of 1,010 patients underwent randomization. Among 926 patients in the modified intention-to-treat population (462 patients in aspirin monotherapy group and 464 patients in the no-antiplatelet therapy group), the primary composite outcome occurred in 3 patients (0.6%) in the aspirin monotherapy group and 4 patients (0.9%) in the no antiplatelet group (difference, −0.2 percentage points; 95% CI: −1.3 to 0.9; P > 0.99). There was no stent thrombosis in either group. The incidence of major bleeding did not differ significantly between groups (6.5% vs 5.2%; P = 0.39), whereas minor bleeding was significantly more frequent in the aspirin group (14.9% vs 10.1%; P = 0.027). ConclusionsAmong patients undergoing low-to-intermediate risk noncardiac surgery >1 year after stent implantation primarily with a DES, in the setting of lower-than-expected event rates, we failed to identify a significant difference between perioperative aspirin monotherapy and no antiplatelet therapy with respect to ischemic outcomes or major bleeding. (Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery [ASSURE-DES]; NCT02797548)

De-escalation to ticagrelor monotherapy versus 12 months of dual antiplatelet therapy in patients with and without acute coronary syndromes: a systematic review and individual patient-level meta-analysis of randomised trials

Dual antiplatelet therapy (DAPT) for 12 months is the standard of care after coronary stenting in patients with acute coronary syndrome (ACS). The aim of this individual patient-level meta-analysis was to summarise the evidence comparing DAPT de-escalation to ticagrelor monotherapy versus continuing DAPT for 12 months after coronary drug-eluting stent implantation. A systematic review and individual patient data (IPD)-level meta-analysis of randomised trials with centrally adjudicated endpoints was performed to evaluate the comparative efficacy and safety of ticagrelor monotherapy (90 mg twice a day) after short-term DAPT (from 2 weeks to 3 months) versus 12-month DAPT in patients undergoing percutaneous coronary intervention with a coronary drug-eluting stent. Randomised trials comparing P2Y12 inhibitor monotherapy with DAPT after coronary revascularisation were searched in Ovid MEDLINE, Embase, and two websites (www.tctmd.com and www.escardio.org) from database inception up to May 20, 2024. Trials that included patients with an indication for long-term oral anticoagulants were excluded. The risk of bias was assessed using the revised Cochrane risk-of-bias tool. The principal investigators of the eligible trials provided IPD by means of an anonymised electronic dataset. The three ranked coprimary endpoints were major adverse cardiovascular or cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction, or stroke) tested for non-inferiority in the per-protocol population; and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding and all-cause death tested for superiority in the intention-to-treat population. All outcomes are reported as Kaplan-Meier estimates. The non-inferiority was tested using a one-sided α of 0·025 with the prespecified non-inferiority margin of 1·15 (hazard ratio [HR] scale), followed by the ranked superiority testing at a two-sided α of 0·05. This study is registered with PROSPERO (CRD42024506083). A total of 8361 unique citations were screened, of which 610 records were considered potentially eligible during the screening of titles and abstracts. Of these, six trials that randomly assigned patients to ticagrelor monotherapy or DAPT were identified. De-escalation took place a median of 78 days (IQR 31-92) after intervention, with a median duration of treatment of 334 days (329-365). Among 23 256 patients in the per-protocol population, MACCE occurred in 297 (Kaplan-Meier estimate 2·8%) with ticagrelor monotherapy and 332 (Kaplan-Meier estimate 3·2%) with DAPT (HR 0·91 [95% CI 0·78-1·07]; p=0·0039 for non-inferiority; τ2<0·0001). Among 24 407 patients in the intention-to-treat population, the risks of BARC 3 or 5 bleeding (Kaplan-Meier estimate 0·9% vs 2·1%; HR 0·43 [95% CI 0·34-0·54]; p<0·0001 for superiority; τ2=0·079) and all-cause death (Kaplan-Meier estimate 0·9% vs 1·2%; 0·76 [0·59-0·98]; p=0·034 for superiority; τ2<0·0001) were lower with ticagrelor monotherapy. Trial sequential analysis showed strong evidence of non-inferiority for MACCE and superiority for bleeding among the overall and ACS populations (the z-curve crossed the monitoring boundaries or the required information size without crossing the futility boundaries or approaching the null). The treatment effects were heterogeneous by sex for MACCE (p interaction=0·041) and all-cause death (p interaction=0·050), indicating a possible benefit in women with ticagrelor monotherapy, and by clinical presentation for bleeding (p interaction=0·022), indicating a benefit in ACS with ticagrelor monotherapy. Our study found robust evidence that, compared with 12 months of DAPT, de-escalation to ticagrelor monotherapy does not increase ischaemic risk and reduces the risk of major bleeding, especially in patients with ACS. Ticagrelor monotherapy might also be associated with a mortality benefit, particularly among women, which warrants further investigation. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale.

Advantages and disadvantages of coronary drug-eluting stent: a 23-year journey of randomized clinical trials

Advantages and disadvantages of coronary drug-eluting stent: a 23-year journey of randomized clinical trials

Endovascular intervention using combined percutaneous access in a patient with recurrence of critical ischemia after repeated bypass operations on arteries of the lower extremities (clinical case)

Unsatisfactory long-term results of shunting operations on the arteries of the lower extremities are most often caused by a stenotic process followed by thrombosis in the anastomotic zone, especially in combination with the progression of the underlying disease and the spread of obstructive atherosclerotic lesions on the inflow and outflow arteries. A clinical case of endovascular treatment of a patient with peripheral arterial disease is presented, who previously underwent 3 reconstructive bypass operations on the arteries of the lower extremities within 15 months before hospitalization, but again sought medical help due to the recurrence of critical ischemia of the left lower extremity. Considering the high risk of repeated open surgery due to the patient’s comorbidity (diabetes mellitus and extensive Q-myocardial infarction, suffered after the first bypass surgery), as well as gross scar changes after previous vascular operations, it was decided to perform endovascular intervention using a non-standard combined percutaneous approach. Iliac artery stenosis and post-thrombotic occlusion of the popliteal artery in the area of the distal anastomosis of the femoral-popliteal bypass graft on the left side were detected on the preoperative MSCT with intravenous contrast enhancement. Because of the gross postoperative scars, we could not use standard percutaneous approaches through any of the femoral arteries. Access through the arteries of the upper limbs also did not ensure the operation on all affected segments due to the long distance to the intervention zone and absence of instruments of the required length. Therefore, in order to maximally solve the tasks of the operation, we simultaneously used an antegrade left transaxillary access and a transpedal retrograde access through the left foot artery. Thus, the patient underwent simultaneous balloon angioplasty of stenoses of the common and external iliac arteries on the left side by transaxillary access, as well as balloon angioplasty and implantation of a coronary drug-eluting stent in the popliteal artery in the area of the distal anastomosis of the femoral-popliteal bypass graft by retrograde transpedal access on the left. As a result, the magistral arterial blood flow of the limb and the function of the shunt were completely restored with a good angiographic and clinical result.The applied methods of endovascular treatment have shown high efficiency and can be recommended as an alternative to traditional vascular surgery.

Ethnic minorities treated with new-generation drug-eluting coronary stents in two European randomised clinical trials.

Several ethnic minorities have an increased risk of cardiovascular events, but previous European trials that investigated clinical outcome after coronary stenting did not assess the patients' ethnic background. To compare ethnic minority and Western European trial participants in terms of both cardiovascular risk profile and 1‑year clinical outcome after percutaneous coronary intervention. In the BIO-RESORT and BIONYX randomised trials, which assessed new-generation drug-eluting stents, information on patients' self-reported ethnic background was prospectively collected. Pooled patient-level data of 5803 patients, enrolled in the Netherlands and Belgium, were analysed in this prespecified analysis. The main endpoint was target vessel failure after 1year. Patients were classified as belonging to an ethnic minority (n = 293, 5%) or of Western European origin (n = 5510, 95%). Follow-up data were available in 5772 of 5803 (99.5%) patients. Ethnic minority patients were younger, less often female, more often current smokers, more often medically treated for diabetes, and more often had apositive family history of coronary artery disease. The main endpoint target vessel failure did not differ between ethnic minority and Western European patients (3.5% vs 4.9%, hazard ratio 0.71, 95% confidence interval 0.38-1.33; p = 0.28). There was also no difference in mortality, myocardial infarction, and repeat revascularisation rates. Despite the unfavourable cardiovascular risk profile of ethnic minority patients, short-term clinical outcome after treatment with contemporary drug-eluting stents was highly similar to that in Western European patients. Further efforts should be made to ensure the enrolment of more ethnic minority patients in future coronary stent trials.

One-Year Outcomes of Long Coronary Drug-Eluting Stents (≥40 MM) in Patients With Diffuse Coronary Artery Disease: Findings From a Tertiary Care Hospital in North India.

Background and objective Diffuse coronary artery disease (CAD) is associated with extensive involvement of coronary arteries, necessitating the useof long (≥40 mm) drug-elutingstents (DES) based on the lesion length. However, these long DES can lead to complications such as in-stent restenosis (ISR) and stent thrombosis. This study aimed to assess the safety, efficacy, and one-year clinical outcomes of using long DESin patients with diffuse CAD undergoing PCI at a tertiary care hospital in north India. Methodology Patients with diffuse CAD undergoingPCI with longDESbetween January 2017 and June 2022 were included in the study. Baseline characteristics were recorded, and patients were followed up telephonically or in the outpatient department (OPD) at one, three, six, and 12 months following the PCI. The primary endpointwas the target lesion failure (TLF) rate, with secondary endpoints constituting all-cause mortality, major adverse cardiovascular events (MACE), subacute stent thrombosis, and ISR. Results A total of 200 patients were recruited and followed up for one year. The median age of the patients was 58 years (range: 48.25-63 years), and 82% were men. The most frequently stented artery was the left anterior descending (LAD, 48%), followed by the right coronary artery (RCA, 36%). A total of 388 stents (mean: 1.94 ±0.79) were implanted, including both long and short stents. The mean length and diameter of long stents were 43.64 ±3.58 mm and 3 ±0.37 mm, respectively. At the one-year follow-up, patients undergoing PCI with long DES ≥40 mm had an overall TLF rate of 5%, all-cause mortality of 6% (12 patients), MACE of 6% (12 patients), subacute stent thrombosis of 4% (eight patients), and ISR of 1% (two patients).A large proportion of patients (90%) had an uneventful follow-up of up to a year. At the one-year follow-up, all 10 (5%)patients with a primary outcomehad a smallerstent diameterthan those without a primary outcome (2.5 ±0.25 mm vs. 3.03 ±0.35 mm, p=0.015). Conclusions Our results suggest that using extremely long stents (>40 mm) for diffuse coronary lesions is safe, efficacious, and associated with relatively low event rates. In addition, the stent diameter has a substantial correlation with the primary outcome. Further studies with larger sample sizes as well as longer follow-up periods are required to validate our findings.

One- versus three-month dual antiplatelet therapy in high bleeding risk patients undergoing percutaneous coronary intervention for non-ST-segment elevation acute coronary syndromes.

A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains uncertain. We aimed to compare the impact of 1-month versus 3-month DAPT on clinical outcomes after DES implantation among HBR patients with or without NSTE-ACS. This is a prespecified analysis from the XIENCE Short DAPT programme involving three prospective, international, single-arm studies evaluating the safety and efficacy of 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT among HBR patients after implantation of a cobalt-chromium everolimus-eluting stent. Ischaemic and bleeding outcomes associated with 1- versus 3-month DAPT were assessed according to clinical presentation using propensity score stratification. Of 3,364 HBR patients (1,392 on 1-month DAPT and 1,972 on 3-month DAPT), 1,164 (34.6%) underwent DES implantation for NSTE-ACS. At 12 months, the risk of the primary endpoint of death or myocardial infarction was similar between 1- and 3-month DAPT in patients with (hazard ratio [HR] 1.09, 95% confidence interval [CI]: 0.71-1.65) and without NSTE-ACS (HR 0.88, 95% CI: 0.63-1.23; p-interaction=0.34). The key secondary endpoint of Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding was consistently reduced in both NSTE-ACS (HR 0.57, 95% CI: 0.37-0.88) and stable patients (HR 0.84, 95% CI: 0.61-1.15; p-interaction=0.15) with 1-month DAPT. Among HBR patients undergoing implantation of an everolimus-eluting stent, 1-month, compared to 3-month DAPT, was associated with similar ischaemic risk and reduced bleeding at 1 year, irrespective of clinical presentation.

Adjunctive Cilostazol in Patients With High Residual Platelet Reactivity After Drug-Eluting Stent Implantation: A Randomized, Open-Label, Single-Center, Prospective Study (ADJUST-HPR).

Cilostazol as an adjunct to dual antiplatelet therapy (DAPT) postcoronary stenting may further reduce vascular occlusion risks. The aim of this study was to assess the impact of cilostazol on high residual platelet reactivity (HRPR) in patients undergoing drug-eluting coronary stent implantation. In a randomized, open-label, single-center, prospective study, the degree of platelet inhibition by cilostazol 100 mg twice daily was assessed on top of conventional DAPT compared with standard clopidogrel and low-dose aspirin combination in poststent patients with HRPR. HRPR was defined as P2Y12 units (PRU) > 240 as measured by the VerifyNow P2Y12 assay. In addition, the platelet activity was assessed by light transmittance aggregometry (LTA) and Multiplate electrode analyzer (MEA). The total of 148 patients were screened, and HRPR was observed in 64 (43.2%). Those were randomized for DAPT versus triple therapy (TAPT). After 30 days, TAPT group exhibited significantly lower rate of HRPR when assessed by all 3 devices (VerifyNow: 40.0 vs. 66.7% P = 0.04, LTA: 6.7 vs. 30.0% P = 0.02, MEA: 10.0 vs. 30.0% P = 0.05 L all vs. DAPT). Also, higher absolute mean difference in TAPT versus DAPT group after 30 days (VerifyNow: 71.3 ± 38.2 vs. 24.6 ± 40.2 P < 0.001, LTA: 23.9 ± 15.1 vs. 9.4 ± 11.8 P < 0.001, MEA: 9.3 ± 12.9 vs. 2.4 ± 17.3 P = 0.08) was observed. Cilostazol in addition to standard DAPT reduces the incidence of HRPR and diminishes further platelet activity in poststent patients. Whether this favorable laboratory finding will affect clinical outcomes requires an adequately powered randomized trial.

Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries.

Background: Chronic limb-threatening ischaemia can be a debilitating disease and may result in limb amputation if untreated. Atherosclerotic disease of the infra-popliteal arteries is particularly challenging to treat due to the small caliber of the vessels and the heavy burden of atherosclerotic plaque. Percutaneous transluminal angioplasty is the conventional first-line approach and is advantageous due to its minimal invasiveness, repeatability, and cost-effectiveness but is limited by high rates of elastic recoil, dissection, and short- to mid-term re-stenosis. Methods: This review analyses the growing body of published and presented clinical data from multiple randomised controlled trials that have investigated the role of coronary drug-eluting stents in the treatment of infrapopliteal disease. Results: Coronary drug-eluting stents demonstrate superior primary patency compared with angioplasty and/or bare metal stenting alone but are limited to application in short-segment disease and have not been widely adopted due to the nature of the permanent implant. Conclusions: Newer devices like drug-eluting resorbable scaffolds are promising as they allow the restoration of vessel wall vasomotion without a residual foreign body and can be used to treat longer, complex lesions.

Evaluation of post-dilatation on longitudinal stent deformation and postprocedural stent malapposition in the left main artery by optical coherence tomography (OCT): an in vitro study

BackgroundThe diameter of the ostial and proximal left main coronary artery can be greater than 5.0 mm. However, the diameters of the mostly available coronary drug-eluting stents (DESs) are ≤ 4.0 mm. Whether high-pressure dilatation can increase the diameter of stents from 4.0 to 5.0 mm and whether post-dilatation leads to longitudinal stent deformation (LSD) of 4.0-mm-diameter stents have rarely been studied. Therefore, this study aims to evaluate LSD and stent malapposition of six types of commercially available 4.0-mm-diameter stents in China in a 5.0-mm-diameter artificial blood vessel model by optical coherence tomography (OCT) in vitro.MethodsThe left main coronary artery was simulated by a truncated cone-shaped silicone tube. The internal diameters were 4.0 mm at one end of the silicone tube and 5.0 mm at the other end. Six different types of coronary stents widely used in China were selected for this study. Each stent was respectively implanted into the simulated blood vessel and dilated to a diameter of 4.2 mm according to the stent-balloon pressure compliance table. The stents were subjected to post-dilatation with a 5.0 × 15-mm noncompliant balloon. The LSD ratio of the longitudinal axis of each stent and stent malapposition were measured through OCT, and any fractures of the stents were determined.ResultsNone of the six types of stents fractured following post-dilatation. The longitudinal axes of the BuMA and Excrossal stents were slightly shortened, while the other stents were elongated after high-pressure post-dilatation. All stents expanded to a diameter of 5.0 mm without incomplete stent apposition, except for the Nano Plus stent, which remained malapposed after high-pressure post-dilatation.ConclusionAll 4.0-mm-diameter stents can be expanded to a diameter of 5.0 mm by noncompliant balloon post-dilatation without stent strut fracture. Most stents were found to be well apposed after high-pressure post-dilatation. However, LSD was observed after post-balloon dilatation. Stent malapposition might be positively correlated with the percentage change in stent length.

Endovascular treatment of symptomatic severe intracranial atherosclerotic stenosis with a novel intracranial dedicated drug-eluting stent: a more effective treatment approach.

Endovascular treatment of severe intracranial atherosclerotic stenosis (ICAS) using coronary drug-eluting stents (DESs) significantly reduces the risk of in-stent restenosis (ISR) and stroke recurrence. However, there are few reports regarding the treatment of ICAS with intracranial dedicated DES. Herein, we present our experience with the feasibility, safety, and medium-term follow-up outcomes of a novel intracranial DES, named NOVA stent, in patients with symptomatic severe ICAS (≥70%). From December 2021 to May 2022, patients with symptomatic severe ICAS who underwent implantation of the NOVA stent in our institution were retrospectively analyzed for procedural results, perioperative complications, imaging and clinical follow-up outcomes. Twenty-four patients, 16 (66.7%) with anterior circulation lesions and 8 (33.3%) with posterior circulation lesions, were enrolled. All patients with intracranial ICA (n = 6), middle cerebral artery (n = 10), basilar artery (n = 3), intracranial vertebral artery (n = 3), and the vertebrobasilar junction (n = 2) stenosis were treated successfully using NOVA stents. The severity of stenosis ranged from 75 to 96% (mean 85.9%) before treatment and this was reduced to 0 to 20% (mean 8.6%) immediately after stent placement. Symptomatic distal embolism occurred in one case; however, there were no other perioperative complications. The mean follow-up duration was 12.2 ± 1.06 months. No symptomatic ischemic events occurred during follow-up. Follow-up cerebral angiography was performed in 22 of 24 patients (91.7%), and significant ISR occurred in one patient (4.2%). Our results demonstrate that implantation of the novel intracranial DES NOVA in severe ICAS is feasible, safe, and effective in selected cases, reducing the incidence of ISR, and showing excellent midterm clinical outcomes, providing a promising option for ICAS treatment.

Design and Fabrication of Environmentally Responsive Nanoparticles for the Diagnosis and Treatment of Atherosclerosis.

Cardiovascular disease poses a significant threat to human health in today's society. A major contributor to cardiovascular disease is atherosclerosis (AS). The development of plaque in the affected areas involves a complex pathological environment, and the disease progresses rapidly. Nanotechnology, combined with emerging diagnostic and treatment methods, offers the potential for the management of this condition. This paper presents the latest advancements in environment-intelligent responsive controlled-release nanoparticles designed specifically for the pathological environment of AS, which includes characteristics such as low pH, high reactive oxygen species levels, high shear stress, and multienzymes. Additionally, the paper summarizes the applications and features of nanotechnology in interventional therapy for AS, including percutaneous transluminal coronary angioplasty and drug-eluting stents. Furthermore, the application of nanotechnology in the diagnosis of AS shows promising real-time, accurate, and continuous effects. Lastly, the paper explores the future prospects of nanotechnology, highlighting the tremendous potential in the diagnosis and treatment of atherosclerotic diseases, especially with the ongoing development in nano gas, quantum dots, and Metal-Organic Frameworks materials.

Comparison of the Effects of Indobufen and Aspirin in Older Patients with Coronary Artery Disease After Coronary Drug-Eluting Stent Implantation: A Prospective Randomized Single-Center Study.

After coronary drug-eluting stent (DES) implantation, dual antiplatelet therapy (DAPT, usually aspirin in combination with a P2Y12 inhibitor) is necessary. However, older patients are prone to aspirin intolerance or resistance. Indobufen has been reported as an ideal alternative to aspirin. To evaluate the clinical efficacy and safety of indobufen-based DAPT in this population, a total of 251 older patients (aged ≥65 years) undergoing coronary DES implantation in a tertiary healthcare facility in Quzhou, China, were enrolled, of which 110 received indobufen-based DAPT and 141 received aspirin-based DAPT. Baseline data, adverse reactions, adverse events, angina attacks, and repeated revascularization during 1-year follow-up were collected. At 1-year follow-up, creatinine, and left ventricular ejection fraction levels in the indobufen group were higher than those in the aspirin group, whereas estimated glomerular filtration rate levels were lower than those in the aspirin group. No significant difference in the incidence of adverse reactions or adverse events was found between the two groups. At 1-year follow-up, the incidence of angina in the indobufen group was significantly lower than that in the aspirin group, and the repeated revascularization rate was lower than that in the aspirin group. Indobufen-based DAPT was beneficial in avoiding repeated revascularizations (odds ratio 0.433, 95% CI 0.229-0.821, P = 0.010). These findings highlight that, for older patients who underwent coronary DES implantation, indobufen-based DAPT may be a better choice, which can effectively improve patients' symptoms and prognosis. However, application to older patients with potential renal insufficiency requires caution.

Testing a Cloud-Based Model for Active Surveillance of Medical Devices with Analyses of Coronary Stent Safety Using the Data Extraction and Longitudinal Trend Analysis (DELTA) System.

To demonstrate the use of the Data Extraction and Longitudinal Trend Analysis (DELTA) system in the National Evaluation System for health Technology's (NEST) medical device surveillance cloud environment by analyzing coronary stent safety using real world clinical data and comparing results to clinical trial findings. Electronic health record (EHR) data from two health systems, the Social Security Death Master File, and device databases were ingested into the NEST cloud, and safety analyses of two stents were performed using DELTA. This is an observational study of patients receiving zotarolimus drug-eluting coronary stents (ZES) or everolimus eluting coronary stents (EES) between July 1, 2015 and December 31, 2017. After exclusions, 3334 patients receiving EES and 1002 receiving ZES were available for study. Analysis using inverse probability weighting showed no significant difference in one-year mortality or major adverse cardiac events (MACE) for EES compared to ZES [Mortality Odds Ratio 0.94 (95% CI 0.81-1.175); p = 0.780] [MACE Odds Ratio 1.04 (95% CI 0.92-1.16; p = 0.551]). Analysis using propensity matching showed no significant difference in EES one-year mortality (547 of 992 alive and available after censoring) compared to ZES (546 of 992) [Log-Rank statistic 0.3348 (p = 0.563)]. Automated cloud-based medical device safety surveillance using EHR data is feasible and was efficiently performed using DELTA. No statistically significant differences in 1-year safety outcomes between ZES and EES were identified using two statistical approaches, consistent with randomized trial findings.

After placement of a newer-generation drug-eluting coronary artery stent in a patient with a high bleeding risk, does one month of dual antiplatelet therapy effectively reduce the incidence of major bleeding while also maintaining stent effectiveness?

After placement of a newer-generation drug-eluting coronary artery stent in a patient with a high bleeding risk, does one month of dual antiplatelet therapy effectively reduce the incidence of major bleeding while also maintaining stent effectiveness?