Bare Metal Stent Implantation Research Articles

Post Percutaneous Transluminal Coronary Angioplasty (PTCA) Coronary Aneurysm- A Case Report

Introduction Coronary aneurysm defined angiographically as luminal dilation 50% larger than that of the adjacent reference segment. (1) Drug-eluting stents (DES), which locally elute antiproliferative drugs, can dramatically inhibit neointimal growth. However, several pathological studies have indicated that DES may delay healing after vascular injury, and DES implantation may be theoretically associated with a risk of coronary artery aneurysm formation. Coronary aneurysms have been reported from 3 days to up to 4 years after DES implantation procedures, with varying clinical presentations. The incidence of coronary artery aneurysms after DES implantation is low within the first 9 months, with a reported incidence of 0.2% to 2.3%, a rate similar to that reported after bare-metal stent (BMS) implantation (0.3% to 3.9%) in the DES versus BMS randomized trials.(2) However, the true incidence of coronary aneurysms in an unselected patient population is still largely unknown. It can be congenital, or secondary to vasculitis (Kawasaki disease) or after percutaneous coronary intervention. Drug-eluting stents (DES), which locally elute antiproliferative drugs, can dramatically inhibit neointimal growth has become standard of care for routine coronary angioplasty. However, several pathological studies have indicated that DES may delay endothelial healing after vascular injury, and DES implantation may be theoretically associated with a risk of coronary artery aneurysm formation (3)

Optimising Percutaneous Coronary Interventions: The Impact of Stent Type and Diameter on Long-Term Clinical Outcomes in Large Coronary Arteries.

Background and Objectives: Our study aimed to reveal the effect of using 4 mm bare-metal stents (BMS), 4 mm drug-eluting stents (DES), or 3 mm DES with 4 mm diameter balloon post-dilation strategies on long-term clinical outcomes and endpoints for large-diameter coronary artery percutaneous coronary intervention (PCI). Materials and Methods: In our study, patients who had undergone PCI were retrospectively screened between January 2014 and July 2020. The study included 350 patients and was divided into three groups; Group I (n = 134) included patients with direct 4.0 mm BMS implantation, Group II (n = 109) included patients with direct 4.0 DES implantation, and Group III (n = 107) included patients with 4mm NC post-dilatation after 3 mm DES implantation. Primary endpoints were determined as target lesion revascularisation, cardiac mortality, and myocardial infarction associated with the target vessel. Our secondary endpoint was all-cause mortality. Results: No differences were observed between the groups in terms of the baseline variables. Stent length was the highest in Group II and the shortest in Group III. There were no significant differences between the groups regarding major adverse cardiovascular events (MACE). Conclusions: Our study suggests that in percutaneous coronary interventions for non-complex lesions, there is no significant difference in MACE outcomes when directly implanting a 4 mm diameter DES, a 4 mm diameter BMS, or a 3 mm diameter DES, followed by post-dilation with an appropriately sized NC balloon when the target vessel diameter is in the range of 4 to 4.4 mm.

The Influence of Myocardial Revascularization on the Condition of the Distal Part of Coronary Arteries in Patients with Type 2 Diabetes Mellitus

The aim. To study the dynamics of the internal lumen of the distal part of coronary arteries after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with type 2 diabetes mellitus
 Materials and methods. This retrospective study included 121 patients with coronary artery disease and type 2 diabetes mellitus after revascularization of coronary arteries through PCI or CABG. In order to evaluate the changes in the condition of the distal sections of the coronary arteries after stenting and CABG, we included patients with type 2 diabetes mellitus in whom repeated coronary angiography was performed 12-60 months after PCI or CABG. The quantitative method (quantitative coronary angiography) and semi-quantitative assessment scales were used to assess the dynamics of the distal part of the coronary arteries.
 Results. The mean age of the patients was 56.2 ± 0.4 years for patients who underwent CABG and 54.3 ± 0.4 years for patients who underwent PCI. There were 64.7% men in the CABG group and 54.0% in the PCI group. The use of drug-eluting stents didn’t affect the internal lumen of the distal part of the arteries. After implantation of bare metal stents, progression of diffuse atherosclerotic lesions was detected. The use of arterial grafts during CABG improved the condition of the inner lumen of the bypassed vessel. However, after venous grafts placement, the patency of the distal coronary arteries may deteriorate in the future.
 Conclusions. In people with type 2 diabetes mellitus and coronary artery disease, after cardiac surgery, the smaller branches of the blood vessels can become narrower over the next 1-5 years if a stent without medication or a vein graft is used. However, when a drug-eluting stent or an artery graft is used, the smaller vessel branches stay about the same or even improve over time.

Safety and efficacy results of percutaneous renal stent implantation in patients with acute coronary syndrome with ectatic and aneurysmatic coronary arteries

ABSTRACT Background For the treatment of stenotic lesions developing in dilated coronary arteries, it is difficult to find an appropriately sized coronary stent given that the vessel diameter is too large. This poses a greater problem, especially in patients who require urgent intervention, such as acute coronary syndrome. Objective We aimed to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries in such patients. Methods In total, 18 patients (renal stent group) who underwent renal stent implantation in ectatic/aneurysmatic coronary arteries requiring percutaneous coronary intervention (PCI) and 45 patients who underwent large-sized bare-metal coronary stent (BMCS) implantation (BMCS group) at our center were included in the study. The primary endpoints were MACE (myocardial infarction and cardiovascular mortality), and the secondary endpoints were restenosis and all-cause mortality. Results In the study patients with a mean follow-up of 25.3 ± 14.6 months (1–48 months), the control coronary angiography duration was 24.6 ± 14.8 months for the renal stent group and 22.8 ± 15.7 months for the BMCS group (p = 0.06). The MACE was observed in 2 (11.1%) patients in the renal stent group and 4 (8.9%) patients in the BMCS group (HR: 1.39 (0.24–7.82), p = 0.70). The secondary composite outcome was identified in 4 (22.2%) patients in the renal stent group and 6 (13.7%) patients in the BMCS group (HR: 1.93 (0.53–6.91), p = 0.31). No significant differences in primary and secondary outcomes were noted between the groups. Conclusion Renal stents used during PCI in patients with acute coronary syndrome with ectatic/aneurysmatic coronary arteries have similar efficacy, and mid-term follow-up results those noted for BMCS. These findings support that renal stents can be used in ectatic and aneurysmatic coronary arteries when necessary. Clinical Trial Registration This study has been registered on ClinicalTrials.gov (NCT05410678).

The effect of antibody-mediated PCSK9 inhibitor on bare-metal stent implantation outcome

Abstract Introduction Percutaneous coronary intervention (PCI) is the gold standard for the management of acute coronary syndrome, and has been benefited from advances in pharmacotherapy and device innovation. Nevertheless, in-stent restenosis and stent thrombosis remain serious complications following PCI procedure with stent implantation. Proprotein convertase subtilisin kexin type 9 (PCSK9) is an enzyme known for its role in plasma cholesterol homeostasis. Efficiently reducing plasma cholesterol, PCSK9 inhibition recently became a pivotal treatment strategy for hypercholesterolemia. However, the effect of PCSK9 inhibition on stent implantation outcomes remains uninvestigated. Methods Carotid artery bare-metal stent (BMS) implantation was performed on C57Bl/6 mice, which then a parallel assessment of various inflammatory mediators was performed. To inhibit PCSK9, alirocumab was administered weekly to antiplatelet-treated mice started before stent implantation. Six weeks after the stent implantation procedure, animals were harvested and histomorphometric analysis was performed on stented arteries. In vitro cell migration and cellular senescence were also assessed on alirocumab-treated primary human aortic endothelial (EC) and vascular smooth muscle cells (VSMC). Results Compared to sham intervention, stent implantation was associated with increased expression of several inflammatory mediators, including PCSK9. Interestingly, the increase in PCSK9 level was confirmed in the stented vascular tissue, but not in plasma (Fig 1A). Following alirocumab treatment, PCSK9 inhibition results in an increased intimal hyperplasia in the stented vascular segment of alirocumab-treated animals compared to controls (Fig 1B). In vitro, alirocumab promoted migration and inhibited the onset of senescence in primary human VSMC, while blunted the migration and increased the senescence of EC. Conclusion The results of this study demonstrated that antibody-based PCSK9 inhibition worsen bare-metal stent implantation outcome in mice. This observed effect is mediated, in part, by the differential effect on VSMC and EC senescence, thus promoting in-stent intimal hyperplasia while blunting vascular healing. The herein-reported data warrant additional investigations concerning the use of PCSK9 inhibitors in patients undergoing PCI with stent implantation.

Abstract 16581: Impact of Drug Eluting Stent Deployment and Calcification on Worsening Target Lesion Failure in Femoropopliteal Lesions

Introduction: Endovascular therapy (EVT) with drug coated balloon (DCB) has been proven superior to balloon angioplasty only in the patency rate. EVT with drug eluting stent (DES) also has shown to be superior to balloon angioplasty only or implantation of bare metal stents. Primary patency of EVT in femoropopliteal lesions (FP-EVT) for DES and DCB is around 80%-90% at 12 months respectively. Therefore, the use of drug technology for FP-EVT is reasonable and generally accepted. However, in daily clinical practice, some target lesion failure (TLF) cases show worse clinical and/or angiographic conditions than the original before the intervention, and many of those cases have bad outcomes. There are no reports on predictors of the worse condition. Methods: A total of 292 consecutive FP lesions of 194 patients who visited our hospital from April 2017 to March 2021 and underwent FP-EVT with drug technologies (DES: 104, DCB: 188) were retrospectively reviewed. "Worsening target lesion failure (WTLF)" was defined as TLF with acute limb ischemia symptom or occlusion of the lesion which had been stenosis at the initial treatment. We investigated the predictor of WTLF. Results: The mean age of all study patients was 72.5±9.3 years and 68% were male. During the follow-up period (median: 568 days), 13 WTLFs were observed. 9 (8.7%) cases were treated with DES and 4 (2.1%) were with DCB at the initial treatment (p=0.01). Cases with WTLF had severer and longer calcification (bilateral calcification: 84.6% vs. 47.7%, p=0.007; calcium length: 162±74mm vs. 85±11mm, p=0.005). Multivariate Cox regression analysis indicated that DES use (Hazard ratio (HR)=4.66, 95% confidence interval [1.28-16.92], p=0.046) and bilateral calcification (HR=7.21, [1.04-50.14], p=0.020) were independently associated with the occurrence of the WTLF. The prevalence of composite outcome, major amputations and all cause deaths, was 54% in the group with WTLF, which was higher than the group without WTLF (p=0.02). Conclusions: Patients with WTLF had bad outcomes. Bilateral calcification and DES deployment were associated with an increased risk for WTLF. For stenotic lesions with bilateral calcification, it may be better to avoid DES deployment.

Natural history of coronary stents: 14 year follow-up of drug eluting stents versus bare metal stents

BackgroundSeveral randomized trials have shown the effectiveness of drug-eluting stents (DES) over bare metal stents (BMS) in terms of repeat revascularization at 1 year; however long term data in this context is conflicting. AimTo assess the long term clinical outcomes after coronary artery stenting with drug-eluting stents and bare metal stents. MethodsThis is a retrospective cohort study, including 100 consecutive patients with Coronary Artery Disease who underwent successful percutaneous intervention (PCI) with implantation of DES and contemporary 100 patients who underwent PCI with implantation of BMS in the years 2005 and 2006 at our center. ResultsOver a median follow-up of 14 years, the primary composite outcome of major adverse cardiovascular and cerebrovascular events (MACCE) was found to be similar in both the groups [DES-37; BMS-36 (p value = 0.88)]. At 1 year of follow-up, the incidence of MACCE was significantly lower with DES group than BMS group [DES-3; BMS-10, P value = 0.04]; but the benefit was not seen at 5 years, 10 years and 14 years follow-up. The incidence of very late stent thrombosis in our study population was similar in either of the groups (p value = 0.13). Obesity and creatinine of >1.4 mg/dl were found to be the predictors of all-cause death. ConclusionIn patients with coronary artery disease, the composite endpoint of MACCE for the first year after stenting was significantly lower in patients receiving DES than those receiving BMS; however, at very long term follow-up, the event rates were similar.

Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction: 8-year results of a randomized clinical trial (PEBSI study).

Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain. An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria. The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis. In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients. ClinicalTrials.gov; identifier: NCT01839890.

Stent Graft vs Drug-Coated Balloon in Endovascular Treatment of Complex Femoropopliteal Artery Lesions: A 2-Center Experience.

Both stent grafts (SG) and drug-coated balloons (DCBs) have shown to be effective treatments for long and complex femoropopliteal (FP) lesions. However, there has not been a clinical trial comparing the 2 treatments directly. This study aims to compare the primary patency (PP) and clinical outcomes of SG and DCB for endovascular treatment of complex FP Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions in patients. From July 2013 to May 2019, a retrospective study was conducted at 2 medical centers to compare the clinical outcomes of Viabahn SG and DCB angioplasty in patients with TASC C/D FP lesions. The study used overlap weighting to adjust for differences in baseline characteristics and to reduce the impact of confounding factors and selection bias between the 2 groups. The primary endpoint was PP through 24 months, and the secondary endpoints included freedom from clinical-driven target lesion revascularization (CD-TLR), all-cause of death rate, and major amputation rate. A total of 161 limbs in 150 patients with TASC C/D FP lesions were treated either with Viabahn SGs (67 limbs, 65 patients) or DCBs (94 limbs, 85 patients). In the DCB group, 22 target vessels (23.4%) underwent directional atherectomy before DCB angioplasty and 37 target vessels (39.4%) underwent bail-out bare-metal stent implantation for early recoil or severe dissection. The SG group had significantly higher PP rates at both the 12 and 24 months than in the DCB group (75.8% vs 39.2%, p=0.02; 64.1% vs 31.9%, p=0.02), respectively. However, there were no significant differences between the 2 groups in terms of CD-TLR, death rate, and major amputation rate. According to the results of multivariate analysis, DCB angioplasty was the only independent predictor associated with restenosis (hazard ratio [HR]=0.264, 95% confidence interval [CI]=0.100-0.696, p=0.007). This study showed that SG was associated with a significantly higher PP rate in complex long FP lesions compared with DCB angioplasty. However, there was no significant difference in the freedom from CD-TLR and major amputation rate. It is important to follow the criteria for using SG strictly to avoid early restenosis, which can lead to acute thrombosis and severe limb ischemia. Closer monitoring is recommended for patients who undergo SG implantation. There has no head-to-head clinical trial that compares DCB and SG in complex long FP lesions. This study showed that SG following the criteria was associated with a significantly higher PP rate compared with DCB angioplasty. Closer monitoring is recommended for patients with SG to avoid acute thrombosis. Randomized controlled trials comparing SG and DCB are necessary.

Antibody-mediated PCSK9 neutralization worsens outcome after bare-metal stent implantation in mice

AimsDespite advances in pharmacotherapy and device innovation, in-stent restenosis (ISR) and stent thrombosis (ST) remain serious complications following percutaneous coronary intervention (PCI) procedure with stent implantation. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is an enzyme involved in plasma cholesterol homeostasis and recently emerged as a therapeutic target for hypercholesterolemia. Antibody-based PCSK9 inhibition is increasingly used in different subsets of patients, including those undergoing PCI. However, whether PCSK9 inhibition affects outcome after stent implantation remains unknown. Methods and results12 to 14 weeks old C57Bl/6 mice underwent carotid artery bare-metal stent implantation. Compared to sham intervention, stent implantation was associated with increased expression of several inflammatory mediators, including PCSK9. The increase in PCSK9 protein expression was confirmed in the stented vascular tissue, but not in plasma. To inhibit PCSK9, alirocumab was administered weekly to mice before stent implantation. After 6 weeks, histological examination revealed increased intimal hyperplasia in the stented segment of alirocumab-treated animals compared to controls. In vitro, alirocumab promoted migration and inhibited the onset of senescence in primary human vascular smooth muscle cells (VSMC). Conversely, it blunted the migration and increased the senescence of endothelial cells (EC). ConclusionAntibody-based PCSK9 inhibition promotes in-stent intimal hyperplasia and blunts vascular healing by increasing VSMC migration, while reducing that of EC. This effect is likely mediated, at least in part, by a differential effect on VSMC and EC senescence. The herein-reported data warrant additional investigations concerning the use of PCSK9 inhibitors in patients undergoing PCI with stent implantation.

Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries.

Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio. To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs. The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model. Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively]. Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.

Bare Stent Fracture After TEVAR With the Modified Restrictive Bare Stent (RBS) Technique in Type B Aortic Dissections.

The aim was to assess the mid-term aortic remodeling and bare-metal stent (BMS) integrity of the restricted bare stent (RBS) technique reconstruction in aortic dissections. This retrospective cohort study included prospectively collected patients treated with the modified RBS technique between 2017 and 2020. The preoperative, postoperative, and last follow-up computed tomographic (CT) scans were analyzed in the centerline at the mid-descending, celiac trunk (CeT), and the mid-abdominal levels for false lumen (FL) patency, aortic diameter, and true lumen (TL) diameter changes. Bare-metal stent integrity was assessed in the 3-dimensional multiplanar reformats. The median follow-up of the cohort (n=17) was 26 (11, 45) months. The procedure was mainly performed with the Relay NBS endograft (15/17; 88%) + E-XL BMS (17/17; 100%). Postoperative mortality, paraplegia, stroke, renovisceral vessel loss, and type I and III endoleaks were not observed. BMS fractured in 6 patients (6/17; 36%), damaged the dissection flap in 4/17 (24%), and led to the reperfusion of the FL and re-interventions with TEVAR (4/17; 24%). Two patients without FL reperfusion showed stable CT follow-ups 13 and 17 months after the fracture diagnosis. The TL expansion was seen at all landmarks and peaked in the thoracic aorta (+10; 6, 15; p<0.001). The FL thrombosis after modified RBS was only relevant in the thoracic aorta (p<0.001) and at CeT (p=0.003). The aortic diameter was stable in the thoracic aorta and increased at distal landmarks (CeT [+5; 1, 10; p=0.001]; mid-abdominal [+3; 1, 5; p=0.004]). The modified RBS technique could not stop aortic growth below the diaphragm and prevent new membrane rupture due to the fractures of the BMS and consecutive flap damage with the reperfusion of the FL. The treatment of complicated type B aortic dissections with TEVAR has become a standard. Particularly, patients with true lumen collapse and malperfusion may benefit from a more aggressive treatment strategy including proximal TEVAR and distal bare-metal stent implantation to re-open the true lumen and to prevent distal stent-induced new entry. However, this study reports the challenges of this approach with a high rate of bare-metal stent fractures during the follow-up. The fractures that occurred at the site of vertical nitinol bridges led to the dissection membrane ruptures and the reperfusion of the false lumen with consecutive dilatation. A close follow-up is mandatory to detect this complication and to treat the patients with TEVAR extension.

Predictors of Lethality, Remodeling, and Aorta-Related Events in Different Types of Proximal Aortic Dissection Surgery.

A retrospective observational comparison of the results of surgical treatment of 213 patients with the diagnosis of "DeBakey type I aortic dissection" has been carried out. The participants were divided into three groups: group 1 underwent classic aortic arch reconstruction using hemiarch technique or total reconstruction of the aortic arch with a multiple-branch prosthesis (n=121); group 2 was subjected to the hemiarch technique and implantation of bare-metal (uncoated) stents (n=55); in group 3, the "frozen elephant trunk" correction technique was used (n=37). The diagnosis of all patients included into the study was preoperatively confirmed by ultrasound and tomographic examination. Predictors of negative events have been identified by building the models of logistic regressions. The multivariate model of logistic regression has revealed multiplicative significant predictors of lethality: postoperative neurological complications increased the probability of lethality by 3.39 (1.24-9.18) times and presence of a patent false lumen by 4.17 (1.49-13.68) times.Among the predictors of aorta-related events, the most important were connective tissue diseases (the probability increased by 6.68 (2.98-15.62) times), presence of partial thrombosis of the false lumen (the probability of event development increased by 2.39 (1.07-5.44) times), and aortic valve repair (the probability aorta-event occurrence increased by 2.84 (1.13-7.17) times).Hybrid prosthesis implantation appeared to be the most significant predictor of false lumen thrombosis increasing its probability by 4.19 (1.90-9.44) times among aortic repair methods, while a bare-metal stent implantation in contrast reduced the likelihood of false lumen thrombosis by 0.17 (0.03-0.62) times. Eventually, the type of repair had not any significant impact on the aorta-related events and lethality in the long-term period.

Peri-Interventional Triple Therapy with Dabigatran Modifies Vasomotion after Bare-Metal Stent Implantation in a Pig Coronary Artery Model

(1) Background: Coronary artery stenting leads to local inflammation, disturbs vasomotion, and slows endothelialization, increasing vascular thrombus risk. We used a pig stenting coronary artery model to assess how peri-interventional triple therapy with dabigatran ameliorates these effects. (2) Methods: In a total of 28 pigs bare-metal stents were implanted. Four days before the percutaneous coronary intervention (PCI), we started 16 of the animals on dabigatran, maintained through 4 days after the procedure. As controls, the remaining 12 pigs received no therapy. In both groups, dual antiplatelet therapy (DAPT) (clopidogrel, 75 mg plus aspirin, 100 mg) was administered until animals were euthanized. Just after the PCI and on day 3 after the procedure, we performed optical coherence tomography (OCT) in eight animals in the dabigatran group and four controls and euthanized them. We followed the eight remaining animals in each group with OCT and angiography for one month before euthanizing them and performed in vitro myometry and histology on harvested coronary arteries from all animals. (3) Results: The dabigatran group showed a significantly increased vasoconstriction at 3 days after PCI (10.97 ± 3.85 mN vs. 7.32 ± 5.41 mN, p = 0.03), but we found no differences between endothelium-dependent and -independent vasodilatation. We also found no group differences in OCT, quantitative angiography, or histomorphometry findings. (4) Conclusions: Starting a short course of dabigatran just before PCI and continuing for a 3-day window along with usual post-PCI DAPT is associated with enhanced vasoconstriction after bare-metal stent implantation without reducing neointimal formation at one month.

Acute Coronary Syndrome after Percutaneous Coronary Intervention: State of the Problem and Clinical Practice Data

Aim. To study the prevalence, clinical and endovascular predictors, causes and timing of the development of acute coronary syndrome (ACS) in patients who had previously undergone percutaneous coronary intervention (PCI), as well as the clinical features of the disease and lipid spectrum parameters.Material and methods. The prospective study included 768 patients successively hospitalized from 01.01.2019 to 01.01.2020 in the Regional cardiovascular center, undergoing to emergency coronary angiography.Results. The main group included 768 patients who underwent emergency coronary angiography for ACS. 90 of them had previously undergone PCI (11.7%). Men prevailed (66.7%), the average age was 62 years. 25.5% of patients underwent ACS within a year after coronary stenting, the mean time from PCI to ACS was 43 months. Most often, there was ACS without ST segment elevation (80%). The results of a retrospective analysis of the first PCI showed that 89.7% of patients underwent urgent PCI, 77.8% of patients received bare metal stents. In 67.1% of patients, 1 stent was implanted, the average diameter was 3.2 mm, the average length was 22 mm. Thromboaspiration was performed in 12% of cases, predilatation in 25%, and NC postdilation in 41.3% of cases. Complications of PCI developed in 9% of patients. Stent thrombosis was diagnosed in 7.8% of cases, significant restenosis in 35.6%. Repeated stenting due to ACS was performed in 64.4% of patients, of which 74.6% received 1 stent; average diameter 3.4 mm, average length 24.0 mm. Predilatation was performed in 52.9% of cases, thromboaspiration – in 41.2%, and NC-postdilation – in 86.7% of cases. Complications of PCI developed in 10%. In addition, 99% of patients had significant dyslipidemia. The average cholesterol level was 4.91 mmol/L, the average low-density lipoprotein level was 2.94 mmol/L.Conclusion. Patients after PCI are 12% of group with ACS in clinical practice of the Regional Vascular Center. The most common predictor of recurrent atherothrombotic events is bare metal stent implantation as well as dyslipidemia.

Histological evaluation of vascular changes after excimer laser angioplasty for neointimal formation after bare-metal stent implantation in rabbit iliac arteries.

Excimer laser is used to treat coronary artery disease, especially in case of lesions with thrombus and in-stent restenosis (ISR). However, there are no in vivo preclinical studies that have evaluated the pathological reactions of the vessel wall after excimer laser ablation. Bare-metal stents were placed in the external iliac arteries of six healthy rabbits. Twenty-eight days later, excimer laser ablation was performed with low-power (45 (fluency)/25 (rate)) in one side, and high-power (60/40) in the opposite side, followed by optical coherence tomography (OCT) evaluation. Rabbits were sacrificed 15min after the procedure, and histological assessment was performed. Morphometry analysis of OCT showed similar stent and lumen size between low-power and high-power group. Histological evaluation suggested endothelial cell loss, fibrin deposition, and tissue loss. The low-power group showed significantly less pathological changes compared with the high-power group: angle of endothelial cell loss, 32.4° vs. 191.7° (interquartile range, 8.8°-131.7° vs. 125.7°-279.5°; p < 0.01); fibrin deposition, 1.1° vs. 59.6° (0.0°-70.4° vs. 31.4°-178.4°; p = 0.03); and tissue loss 0.0° vs. 18.2° (0.0°-8.7° vs. 0.0°-42.7°; p = 0.03). The pathological changes in neointima were more prominent after high-power excimer laser ablation than after low-power excimer laser. To improve safety in clinical practice, understanding the pathological changes of tissues after excimer laser in lesions with ISR is essential.

The Increased Ischemic Risk During the Early Period After Clopidogrel Noncompliance in Patients with Acute Coronary Syndrome: A Meta-Analysis.

Although dual antiplatelet therapy for secondary prevention in acute coronary syndrome (ACS) is highly recommended by current guidelines, P2Y12 inhibitor non-adherence often occurs and devastates prognosis. To evaluate whether the ischemic risk during the early period of clopidogrel noncompliance was increased among ACS patients, a comprehensive search of PubMed, Embase, and Web of Science was conducted to identify studies reporting early ischemic risk after clopidogrel noncompliance in ACS patients. The primary endpoint was a composite of death or myocardial infarction (MI). Effect sizes were synthesized in patients with or without revascularization. A total of 7 observational studies focusing on clopidogrel noncompliance were included in this meta-analysis, whereas no studies involving ticagrelor or prasugrel were retrieved. A significantly increased risk of death or MI 0 to 90 days after clopidogrel noncompliance was found compared with that during 90 to 180 or 90 to 360 days regardless of revascularization (incidence rate ratio [IRR]: 2.01, 95% confidence interval (CI): 1.62-2.49, P < .001, I2 = 9%) or not (IRR: 1.61, 95% CI: 1.05-2.48, P < .001, I2 = 74%). Patients undergoing percutaneous coronary intervention had a higher risk of death or MI 0 to 90 days after clopidogrel noncompliance compared with 90-180 or 90-360 days irrespective of drug-eluting stent or bare metal stent implantation (P < .05 for both). The early ischemic risk after clopidogrel noncompliance is significantly higher than the late risk in ACS patients. Antiplatelet noncompliance remains a serious concern.

29 PROGNOSTIC IMPACT OF TARGET VESSEL FAILURE AS FIRST EVENT AFTER ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: INSIGHT FORM 10-YEAR FOLLOW-UP OF THE EXAMINATION EXTEND TRIAL

Abstract Background Outcome after primary PCI for ST-segment elevation myocardial infarction may be very different. Either it may be free of events during years or it may be characterized by many recurrent events. It is unknown whether to have a target vessel failure (TVF) as first event may impact subsequent outcomes during follow-up. We aim to evaluate very long-term outcomes of STEMI patients according to the occurrence of TVF as the first event during follow-up. Methods EXAMINATION-EXTEND trial randomized STEMI patients to everolimus-eluting stent or bare-metal stent with 10-year follow-up. All the patients were stratified according to their first event (TVF-First vs. NonTVF-First). TVF was defined as the composite of TV cardiac death, TV myocardial infarction, or TV revascularization. The primary endpoint of this study was 10-year POCE, defined as the composite of all-cause death, any myocardial infarction, or any revascularization. Results Out of the 1498 enrolled patients, 161 (10.7%) had a TVF as first clinical event during follow-up. TVF-First patients had higher rates of previous MI or PCI, with less use of manual thrombectomy, and received more BMS with a longer total stent length. On multivariate analysis, manual thrombectomy and bare-metal stent implantation were independent predictors of TVF as first event. Ten-year adjusted POCE was statistically higher in TVF-First patients compared to the NonTVF-First group (31.1% vs 27.5%, adjHR: 1.82; 95%CI: 1.34 - 2.48; p &amp;lt; 0.001). Conclusions In our STEMI population TVF occurred in 10.7% as the first event during follow-up. At 10-year follow-up, patients who experienced a TVF as first event exhibited a high risk for subsequent POCE events as compared to patients who did not.

Long-term clinical outcomes of Chinese diabetic patients after coronary revascularization with drug-eluting stents: a retrospective comparative cohort study

Compared to bare-metal stent implantation, coronary drug-eluting stent (DES) implantation is more likely to reduce restenosis and the need for a subsequent repeat revascularization procedure. Diabetes increases the risk of coronary heart disease and the population of diabetic patients has increased significantly in China in recent years. It's essential to know more about the outcome in these patients underwent DES implantation. To date, the long-term safety and efficacy of coronary DES implantation in Chinese patients with diabetes has rarely been investigated. In this study, according to inclusion and exclusion criteria, 580 patients who underwent DES implantations between July 2014 and January 2016 were included and divided into the diabetic group (n=173) and non-diabetic group (n=407). Clinical baseline characteristics and follow-up outcomes were collected from electronic medical record. Serial clinical follow-up was conducted at 1-, 3-, and 5-year. The primary end point was a composite of major adverse cardiac events (MACEs), including cardiac death, recurrent myocardial infarction (re-MI), and target lesion revascularization (TLR) in 5-year follow-up. The long-term outcomes observed in the 5-year follow-up period were compared between the diabetic and non-diabetic patients. Non-cardiac death was more common in the diabetic than non-diabetic patients in the 5-year follow-up period (8.7% vs. 3.2% P=0.00). Conversely, the risk of occurrence of MACEs, cardiac death, re-MI, and TLR were comparable. The all-cause mortality rate in 5-year follow-up was higher in the diabetic than non-diabetic patients (14.5% vs. 6.1%, P=0.00). The incidence of stent thrombosis was also comparable between the diabetic and non-diabetic patients. Compared to the non-diabetic patients, the diabetic patients were at higher risk for all-cause mortality after coronary DES implantation during the long-term follow-up period.

Stents versus bypass surgery: 3-year mortality risk of patients with coronary interventions aged 50+ in Germany

ObjectivesDue to demographic aging, the prevalence of coronary artery disease (CAD) is expected to increase in the future, resulting in a growing demand for stent and bypass interventions. This study aims to investigate the mortality risk of patients following conventional coronary artery bypass grafting (CABG) or endovascular procedure by the implantation of bare-metal stents (BMS) or drug-eluting stents (DES).MethodsBased on a random sample of 250,000 members of Germany’s largest health insurance ‘Allgemeine Ortskrankenkassen’ (AOK) from 2004 to 2015, incident CAD patients were analyzed by Cox Proportional-Hazard models. Risk adjustment was made for sex, age, other cardiac diseases, non-cardiovascular comorbidities and years since intervention. Due to later admission of DES and thus a shorter observation time, mortality was examined for 3 years since the intervention.ResultsBMS represented the most frequent procedure (48%). We found similar proportions of CABG (19%) and DES interventions (23%). After risk adjustment, the models showed a 21% (p = 0.004) lower mortality risk of patients with DES and also a 21% (p = 0.002) lower mortality risk of CABG patients compared to persons with BMS.ConclusionBased on a large-scale dataset, our study demonstrated survival advantages of CABG and DES interventions over BMS, with no differences between the DES and CABG groups. The results help to assess the risks of coronary interventions. Aspects of quality of life, severity of postoperative physical limitations, duration of rehabilitation, patients’ preferences, and aspects of cost-effectiveness for hospitals and society should be further considered.Graphical abstract