Bare Metal Stents Group Research Articles

Efficacy and safety of drug-eluting stents versus bare-metal stents in symptomatic intracranial and vertebral artery stenosis: a meta-analysis

ObjectivesThis study aims to present the first comprehensive meta-analysis assessing the effectiveness and safety of drug-eluting stents (DES) versus bare-metal stents (BMS) in treating intracranial and vertebral artery stenosis.MethodsA comprehensive examination was undertaken to compare the effectiveness and safety of DES and BMS in individuals experiencing symptomatic stenosis in the intracranial and vertebral arteries through an in-depth analysis of clinical research. We conducted an extensive search across multiple databases including PubMed, Embase, Web of Science, and the Cochrane Library up to September 2024. The emphasis of our investigation was on various outcomes including rates of in-stent restenosis, symptomatic occurrences of in-stent restenosis, incidence of stroke, procedural success, mortality rates, complications associated with the procedure, and any adverse events.ResultsOur analysis included 12 studies with a total of 1,243 patients (562 in the DES group and 681 in the BMS group). The findings demonstrated a significantly lower rate of in-stent restenosis in the DES group for both intracranial [odds ratio (OR): 0.23; 95% confidence interval (CI): 0.13 to 0.41; p < 0.00001] and vertebral artery stenosis (OR: 0.38; 95% CI: 0.20 to 0.72; p = 0.003) compared to the BMS group. Additionally, the DES group showed a significantly reduced rate of postoperative strokes in vertebral artery stenosis cases (OR: 0.38; 95% CI: 0.16 to 0.90; p = 0.03), with no significant differences noted in the intracranial artery stenosis comparison (OR: 0.63; 95% CI: 0.20 to 1.95; p = 0.42). The study also revealed no significant disparities in symptomatic in-stent restenosis, procedural success, mortality, adverse effects, and perioperative complications between the two groups across the conditions studied.ConclusionThe comparison indicates that DES significantly reduces the risk of in-stent restenosis and postoperative strokes in patients with vertebral artery stenosis, compared to BMS. For both intracranial and vertebral artery stenosis, DES and BMS exhibit comparable safety profiles.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=439967.

Stent Placement After Percutaneous Recanalization of Superior Vena Cava Stenosis in Maintenance Hemodialysis Patients.

This study aimed to evaluate the efficacy and safety of stent placement after percutaneous recanalization of superior vena cava (SVC) stenosis in maintenance hemodialysis patients. Adult maintenance hemodialysis patients hospitalized at a university-affiliated tertiary hospital due to SVC stenosis from January 2016 to June 2023 were prospectively included. The efficacy and safety of percutaneous blunt/sharp SVC recanalization combined with SVC stent placement were observed. The patients' demographic information and laboratory examination data, stent placement success rate, surgery-related complications, and long-term vascular access patency rate were also recorded and analyzed. The study was approved by the institutional ethics committee (2015-201) and registered at http://www.chictr.org.cn (registry number: ChiCTR-ONN-16007790). A total of 58 patients were included in the study with an average age of 54.79±13.42 years. Percutaneous SVC recanalization was successful in 53 cases, with a success rate of 91.38%, including 37 cases of traditional recanalization and 16 cases of sharp recanalization. Among 53 hemodialysis patients who underwent SVC recanalization, 14 patients successfully received covered stents and 38 patients received bare metal stents, achieving a stent placement success rate of 98.1%. One patient encountered stent displacement into the heart immediately after implantation, causing intra-operative cardiac tamponade, who was successfully rescued by thoracotomy. Fifty-two patients were followed-up for median period of 26 months (cuffed catheter: 25 patients, arteriovenous fistula [AVF]: 27 patients). The overall 2-year vascular access patency rate was 33.2% (cuffed catheter: 22.2%, AVF: 41.7%, p=0.414). There was no statistically significant difference in the 2-year vascular access patency rate between the traditional recanalization group and the sharp recanalization group (34.1% vs 31.1%, p=0.731) and between bare metal stent group and covered stent group (38.1% vs 21.4%, p=0.248). Percutaneous SVC recanalization with stent placement is an effective treatment strategy that can provide viable vascular access for maintenance hemodialysis patients with SVC stenosis. Cautions should be paid to potential life-threatening complications such as stent displacement and cardiac tamponade. Superior vena cava (SVC) stenosis is a common central venous occlusive lesion in maintenance hemodialysis patients. Whether stent should be implanted simultaneously following SVC recanalization is still lacking research. This pilot cohort study suggested that percutaneous SVC recanalization with stent placement was an effective treatment strategy which provides satisfactory vascular access for hemodialysis. We further found that SVC sharp recanalization with subsequent stent implantation was a feasible treatment, with the 2-year vascular access patency comparable to the traditional SVC recanalization group. This study also highlighted endovascular SVC recanalization should be performed with caution, and appropriate balloon sizes should be selected to avoid SVC rupture or stent displacement.

The Midterm Outcomes of Endovascular Therapy for Femoropopliteal Lesions via Drug-Coated Balloon, Directional Atherectomy and Bare Metal Stent Angioplasty.

This study investigated the midterm primary patency of drug-coated balloons (DCBs), directional atherectomy plus balloon angioplasty (DA), and bare metal stent (BMS) angioplasty for the treatment of femoropopliteal lesions. This two-center retrospective cohort study included 105 patients (110 limbs) undergoing DCB, DA, and BMS angioplasty-32 patients (34 limbs), 31 patients (32 limbs), and 42 patients (44 limbs), respectively. The demographic, baseline, and procedure data were collected, and the complications and midterm outcomes (patency, amputation-free survival, and clinically driven target lesion revascularization rates) were analyzed. All three procedures achieved a 100% success rate. Significant improvements were noted in ankle brachial index, walking distance, and Rutherford classification at 30 days post-procedure (p < 0.001), with no differences or severe complications among the groups. The all-cause mortality rate during the follow-up period, was 5.5%, and amputation-free survival rates at 24 months were 97.0%, 90.6% and 90.9% in the DCB, DA, and BMS angioplasty groups, respectively. The primary patency rate for the DCB group (79.4%) exceeded those of the DA (56.2%) and BMS (52.2%) groups (p < 0.05), with no significant difference between the DA and BMS groups at 24 months. The secondary patency and clinically driven target lesion revascularization rates were similar among the three groups. A runoff number ≤1, Trans-Atlantic Intersociety Consensus (TASC) D, and severe calcification were found to be independent risk factors for primary patency. The DCB procedure demonstrated superior primary patency, compared to both BMS and DA procedures, in the treatment of femoropopliteal lesions.

Long-term outcomes of percutaneous coronary intervention in patients with prior coronary artery bypass graft - A retrospective experience

ObjectiveTo evaluate the long-term clinical outcomes of percutaneous coronary intervention (PCI) in patients who had previously undergone coronary artery bypass grafting (CABG). MethodA total of 219 patients who had a history of CABG and underwent PCI at tertiary care centre were retrospectively enrolled in this study. Clinical endpoints such as major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction [MI], and target vessel revascularization), any death, cardiac death, MI, target vessel revascularization (TVR), and target lesion revascularisation (TLR) were reported at long-term follow-up. ResultsAbout 66.6 % patients were treated on the native vessel, and 24.2 % on grafts vessel. In all, 360 stents [83.3 % drug-eluting stent (DES) and 16.6 % bare metal stent (BMS)] were implanted. Diabetes mellitus (p = 0.03), LVEF<55 % for PCI (p = 0.04), stent type [BMS (p < 0.001) and DES (p < 0.001)] and chronic kidney disease [(CKD) p < 0.01] were appeared to be the significant predictors of mortality. Age at CABG>50 years (p = 0.04), stent type [BMS (p = 0.03) and DES (p < 0.01)] and CKD (p < 0.01) as independent predictors for MACE. Higher event rate was reported in graft-vessel PCI group as compared to native-vessel PCI group: ISR (p < 0.01), TLR (p = 0.01), mortality (p = 0.04), MACE (p < 0.01) and MI (p = 0.05). Mortality (p < 0.001), MACE (p < 0.001) and MI (p < 0.001) were significantly lower in DES vs. BMS groups. ConclusionNative-vessel PCI was associated with better clinical outcomes than graft-vessel PCI that also with the use of DES as the first choice in patients with a history of CABG.

Rescue Stenting of Isolated Middle Cerebral Artery (MCA) Dissections (MCAD) with Antithrombogenic Coated Stents and Mono-Antiplatelet Therapy (MAPT).

Objective: Acute ischemic stroke (AIS) is a leading cause of death, but isolated middle cerebral artery dissection (MCAD) is rarely reported. The aim of this article is to sum up the current information on this pathology and to explore the technical aspects of its endovascular treatment with emphasis on novel coated, antithrombogenic stents and antiplatelet management. Another part of this article offers our experience with the problematics represented by a small sample group of patients with an MCAD diagnosis who were treated in our center. Methods: We conducted literature research and a retrospective review of patients treated for anterior circulation AIS at our comprehensive stroke center from January 2022 to March 2024. The cohort included 16 patients diagnosed with isolated MCAD, 9 received antithrombogenic coated stents, while 7 received bare metal stents. Pharmacological management of coated stents involved the use of Cangrelor for acute antiplatelet therapy, transitioning to oral Ticagrelor. Results: Among the 16 patients treated, those with antithrombogenic coated stents showed no major complications and had a lower incidence of intracranial hemorrhage compared to the bare metal stent group. The average National Institutes of Health Stroke Scale (NIHSS) score at discharge improved in both groups. Functional outcomes and mortality rates were slightly better in the coated stent group, but no statistical significance was proven. Conclusions: Antithrombogenic coated stents, in conjunction with MAPT, demonstrated a safe and effective option for treating isolated MCAD. These stents offer promising potential for improved outcomes and reduced complications compared to traditional treatments. Further multicentric studies with larger cohorts are recommended to validate these findings.

Efficacy and Safety Evaluation of Tacrolimus-Eluting Stent in a Porcine Coronary Artery Model.

A drug-eluting stent (DES) is a highly beneficial medical device used to widen or unblock narrowed blood vessels. However, the drugs released by the implantation of DES may hinder the re-endothelialization process, increasing the risk of late thrombosis. We have developed a tacrolimus-eluting stent (TES) that as acts as a potent antiproliferative and immunosuppressive agent, enhancing endothelial regeneration. In addition, we assessed the safety and efficacy of TES through both in vitro and in vivo tests. Tacrolimus and Poly(lactic-co-glycolic acid) (PLGA) were applied to the metal stent using electrospinning equipment. The surface morphology of the stent was examined before and after coating using a scanning electron microscope (SEM) and energy dispersive X-rays (EDX). The drug release test was conducted through high-performance liquid chromatography (HPLC). Cell proliferation and migration assays were performed using smooth muscle cells (SMC). The stent was then inserted into the porcine coronary artery and monitored for a duration of 4weeks. SEM analysis confirmed that the coating surface was uniform. Furthermore, EDX analysis showed that the surface was coated with both polymer and drug components. The HPCL analysis of TCL at a wavelength of 215nm revealed that the drug was continuously released over a period of 4weeks. Smooth muscle cell migration was significantly decreased in the tacrolimus group (54.1% ± 11.90%) compared to the non-treated group (90.1% ± 4.86%). In animal experiments, the stenosis rate was significantly reduced in the TES group (29.6% ± 7.93%) compared to the bare metal stent group (41.3% ± 10.18%). Additionally, the fibrin score was found to be lower in the TES group compared to the group treated with a sirolimus-eluting stent (SES). Similar to SES, TES reduces neointimal proliferation in a porcine coronary artery model, specifically decreasing the fibrins score. Therefore, tacrolimus could be considered a promising drug for reducing restenosis and thrombosis.

Comparing Endovascular Approaches in Lower Extremity Artery Disease: Insights from a Network Meta-Analysis.

Endovascular therapy offers an alternative for treating femoropopliteal (FP) and infrapopliteal (IP) lesions related to occlusive lower extremity artery disease. Despite numerous trials, the effectiveness of restenosis prevention using local drug delivery devices remains a topic of debate. An updated systematic review and network meta-analysis was conducted. Our overall aim was to summarize the most recent clinical evidence regarding endovascular approaches for FP and IP atherosclerotic lesions. We conducted a search for randomized trials in the MEDLINE database, and extracted data related to clinical endpoints. Our primary focus was on the rate of major adverse events (MAEs), including mortality, amputation, and target lesion revascularization (TLR). A multiple treatment network meta-analysis supplemented with component network analyses was performed to examine the impact of combined treatment. Our search yielded 33 randomized controlled trials encompassing 5766 patients. This included 19 studies focused on femoropopliteal and 14 on IP lesions, accounting for 3565 and 2201 patients, respectively. Drug-coated balloons (DCBs) and drug-eluting stents (DESs) displayed a reduced MAE risk in comparison to plain old balloon angioplasty (POBA)-RR for DCB: 0.64 (95% CI: 0.52-0.77) and for DES: 0.71 (95% CI: 0.51-0.99). The bare-metal stent (BMS) group manifested the most substantial MAE risk, being 59% higher relative to the DCB cohort (BMS vs. DCB RR: 1.59; 95% CI: 1.03-2.47). For FP lesions, DES was the standout performer, curtailing MAE risk by 55% relative to POBA. Within IP lesions, DES mitigated the MAE risk by 25% versus POBA. DCB did not exhibit any notable MAE reduction when pitted against POBA. In FP arteries, both DESs and DCBs yielded significantly diminished MAEs, thus outpacing other techniques. Regarding IP arteries, only DESs resulted in significantly fewer MAEs. In alignment with contemporary research, our findings revealed no signs of elevated mortality in patients undergoing treatment with drug-eluting apparatuses.

Covered versus bare-metal stenting of the mesenteric arteries in patients with chronic mesenteric ischaemia (CoBaGI): a multicentre, patient-blinded and investigator-blinded, randomised controlled trial

Mesenteric artery stenting with a bare-metal stent is the current treatment for atherosclerotic chronic mesenteric ischaemia. Long-term patency of bare-metal stents is unsatisfactory due to in-stent intimal hyperplasia. Use of covered stents might improve long-term patency. We aimed to compare the patency of covered stents and bare-metal stents in patients with chronic mesenteric ischaemia. We conducted a multicentre, patient-blinded and investigator-blinded, randomised controlled trial including patients with chronic mesenteric ischaemia undergoing mesenteric artery stenting. Six centres in the Netherlands participated in this study, including two national chronic mesenteric ischaemia expert centres. Patients aged 18 years or older were eligible for inclusion when an endovascular mesenteric artery revascularisation was scheduled and a consensus diagnosis of chronic mesenteric ischaemia was made by a multidisciplinary team of gastroenterologists, interventional radiologists, and vascular surgeons. Exclusion criteria were stenosis length of 25 mm or greater, stenosis caused by median arcuate ligament syndrome or vasculitis, contraindication for CT angiography, or previous target vessel revascularisation. Digital 1:1 block randomisation with block sizes of four or six and stratification by inclusion centre was used to allocate patients to undergo stenting with bare-metal stents or covered stents at the start of the procedure. Patients, physicians performing follow-up, investigators, and radiologists were masked to treatment allocation. Interventionalists performing the procedure were not masked. The primary study outcome was the primary patency of covered stents and bare-metal stents at 24 months of follow-up, evaluated in the modified intention-to-treat population, in which stents with missing data for the outcome were excluded. Loss of primary patency was defined as the performance of a re-intervention to preserve patency, or 75% or greater luminal surface area reduction of the target vessel. CT angiography was performed at 6 months, 12 months, and 24 months post intervention to assess patency. The study is registered with ClinicalTrials.gov (NCT02428582) and is complete. Between April 6, 2015, and March 11, 2019, 158 eligible patients underwent mesenteric artery stenting procedures, of whom 94 patients (with 128 stents) provided consent and were included in the study. 47 patients (62 stents) were assigned to the covered stents group (median age 69·0 years [IQR 63·0-76·5], 28 [60%] female) and 47 patients (66 stents) were assigned to the bare-metal stents group (median age 70·0 years [63·5-76·5], 33 [70%] female). At 24 months, the primary patency of covered stents (42 [81%] of 52 stents) was superior to that of bare-metal stents (26 [49%] of 53; odds ratio [OR] 4·4 [95% CI 1·8-10·5]; p<0·0001). A procedure-related adverse event occurred in 17 (36%) of 47 patients in the covered stents group versus nine (19%) of 47 in the bare-metal stent group (OR 2·4 [95% CI 0·9-6·3]; p=0·065). Most adverse events were related to the access site, including haematoma (five [11%] in the covered stents group vs six [13%] in the bare-metal stents group), pseudoaneurysm (five [11%] vs two [4%]), radial artery thrombosis (one [2%] vs none), and intravascular closure device (none vs one [2%]). Six (13%) patients in the covered stent group versus one (2%) in the bare-metal stent group had procedure-related adverse events not related to the access site, including stent luxation (three [6%] vs none), major bleeding (two (4%) vs none), mesenteric artery perforation (one [2%] vs one [2%]), mesenteric artery dissection (one [2%] vs one [2%]), and death (one [2%] vs none). The findings of this trial support the use of covered stents for mesenteric artery stenting in patients with chronic mesenteric ischaemia. Atrium Maquet Getinge Group.

Midterm Results of Drug-Coated Balloon and Bare Metal Stent in the Treatment of TASCII C/D Femoropopliteal Artery Occlusive Disease: A Retrospective Multicenter Study.

This study aimed to compare midterm efficacy between drug-coated balloon (DCB) and bare metal stent (BMS) in the treatment of TASCII C/D femoropopliteal artery lesions. The clinical data of patients with TASCII C/D femoropopliteal artery disease admitted to 3 vascular surgery centers from January 2018 to January 2021 were retrospectively analyzed. Patients were divided into DCB group and BMS group. The DCB group was further subdivided into DCB alone subgroup and DCB+BMS subgroup. Study primary outcomes were freedom from clinical-driven target lesion reintervention (FCD-TLR) at 24 months postprocedure. Secondary outcomes included ankle brachial index (ABI), Rutherford classification, major amputation rate, and mortality. A total of 410 consecutive patients were enrolled. At 24 months follow-up, in DCB group (114 patients) relative to BMS group (296 patients), FCD-TLR (86.00% vs 71.91%, p=0.039), and ABI (0.53±0.11 vs 0.47±0.19, p=0.007) were higher; mean Rutherford class was lower (1.57±0.68 vs 3.31±1.39, p=0.000); and major amputation rate (0.87% vs 4.05%, p>0.05) and all-cause mortality (8.92% vs 6.41%, p>0.05) were statistically similar. In DCB alone, subgroup relative to DCB+BMS subgroup, FCD-TLR (90.00% vs 85.00%, p>0.05), major amputation rate (0 vs 1.08%, p>0.05), and all-cause mortality rate (9.09% vs 8.69%, p>0.05) were statistically similar, while FCD-TLR was higher in the DCB+BMS subgroup (90.00% vs 71.91%, p=0.045). At midterm follow-up of patients treated for TASCII C/D femoropopliteal artery disease, use of DCB or of DCB combined with rescue BMS appeared similarly efficacious, and yielded more favorable outcomes than use of BMS. The efficacy of drug-coated balloons relative to that of bare metal stents for the treatment of complex femoropopliteal artery lesions, particularly TASCII grade D lesions, remains uncertain. There is a scarcity of multicenter comparative studies, and in this multicenter retrospective study with up to 24-month follow-up, use of drug-coated balloon alone or combined with rescue bare metal stent appeared similarly efficacious while yielding more favorable outcomes than use of bare metal stent alone in the treatment of TASCII grade C/D femoropopliteal artery lesions. Randomized studies are warranted.

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.

Outcomes of covered vs bare metal stents for the treatment of aortoiliac occlusive disease

ObjectiveWe retrospectively compared the clinical outcomes of self-expanding covered stents (CSs) and bare metal stents (BMSs) in the treatment of aortoiliac occlusive disease (AIOD) at a single center between 2016 and 2022. MethodsAll patients with AIOD receiving endovascular therapy at a single center from January 2016 to October 2022 were continuously analyzed, including patients with lesions of all classes according to the Trans-Atlantic Inter-Society Consensus II (TASC-II). Relevant clinical and baseline data were collected, and propensity score matching was performed to compare CSs and BMSs in terms of baseline characteristics, surgical factors, 30-day outcomes, 5-year primary patency, and limb salvage. The follow-up results were analyzed by Kaplan-Meier curves. Cox proportional hazard models were used to identify predictors of primary patency. ResultsA total of 209 patients with AIOD were enrolled in the study, including 135 patients (64.6%) in the CS group and 74 patients (35.4%) in the BMS group. Surgical success rates (100% vs 100%; P = 1.00), early (<30-day) mortality rates (0% vs 0%; P = 1.00), cumulative surgical complication rate (12.0% vs 8.0%; P = .891), 5-year primary patency rate (83.4% vs 86.9%; P = .330), secondary patency rate (96% vs 100%; P = .570), and limb salvage rate (100% vs 100%; P = 1.00) did not exhibit significant differences between the two groups. Patients in the CS group had a lower preoperative ankle-brachial index (0.48 ± 0.26 vs 0.52 ± 0.19; P = .032), more cases of complex AIOD (especially TASC D) (47.4% vs 9.5%; P < .001), more chronic total occlusive lesions (77.0% vs 31.1%; P < .001), and more severe calcification (20.7% vs 14.9%; P < .036). After propensity score matching, 50 patients (25 with CS and 25 with BMS) were selected. The results showed that only severe calcification (32.0% vs 8.0%; P = .034) and ankle-brachial index increase (0.45 ± 0.15 vs 0.41 ± 0.22; P = .038) were significantly different between the groups. In terms of surgical factors, patients in the CS group had more use of bilateral femoral or combined brachial artery percutaneous access (60.0% vs 12.0%; P < .001), more number of stents used (2.3 ± 1.2 vs 1.3 ± 0.7; P < .001), longer mean stent length (9.3 ± 3.3 vs 5.8 ± 2.6 cm; P < .001), and more catheter-directed thrombolysis treatment (32.0% vs 4.0%; P = .009). Multivariate Cox survival analysis showed that severe calcification (hazard ratio, 1.32; 95% confidence interval, 1.04-1.85; P = .048) was the only independent predictor of the primary patency rate. ConclusionsAll patients with AIOD who underwent endovascular therapy were included and achieved good outcomes with both CSs and BMSs. The influence of confounding factors in the two groups was minimized by propensity score matching, and the 5-year patency rates were generally similar in the unmatched and matched cohorts. Postoperative hemodynamic improvement was more obvious in patients in the CS group. For more complex lesions, CS is recommended to be preferred. Especially for severe calcification lesions, which is the only independent predictor of primary patency, CS showed obvious advantages. Further studies with more samples are needed to investigate the role of stent types in AIOD treatment.

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.

Outcomes of covered stents versus bare-metal stents for subclavian artery occlusive disease.

To compare the clinical efficacy of covered stents and bare-metal stents in the endovascular treatment of subclavian artery occlusive disease. Between January 2014 and December 2020, 161 patients (112 males) underwent stenting of left subclavian arteries; CSs were implanted in 55 patients (34.2%) and BMSs in 106 (65.8%). Thirty-day outcomes, mid-term patency, and follow-up results were analyzed with Kaplan-Meier curves. Relevant clinical, anatomical, and procedural factors were evaluated for their association with patency in the two groups using Cox proportional hazards regression. Mean follow-up was 45 ± 18 months. The primary patency was 93.8% (95% CI, 81.9%-98.0%) in the covered stent group and 73.7% (95% CI, 63.2%-81.6%; P = 0.010) in the bare-metal stent group. The primary patency in the total occlusion subcategory was significant in favor of CS (93.3%, 95% CI, 61.26%-99.0%) compared with BMS (42.3%, 95% CI, 22.9%-60.5%; P = 0.005). Cox proportional hazards regression indicated that the use of BMSs [hazard ratio (HR), 4.90; 95% CI, 1.47-16.31; P = 0.010] and total occlusive lesions (HR, 7.03; 95% CI, 3.02-16.34; P < 0.001) were negative predictors of patency, and the vessel diameter (HR, 3.17; 95% CI, 1.04-9.71; P = 0.043)) was a positive predictor of patency. Compared with bare stents, covered stents have a higher midterm primary patency in the treatment of subclavian artery occlusive disease.

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.

Editor's Choice – Two Year Results of the Randomised DISCOVER Trial Comparing Covered Versus Bare Metal Stents in the Common Iliac Artery

It has been suggested that covered stents (CS) may lower restenosis rates compared with bare metal stents (BMS) after endovascular treatment of the common iliac artery. This trial aimed to provide additional evidence on the efficacy of CS vs. BMS in the common iliac artery. This multicentre, randomised, single blind controlled superiority trial compared balloon expandable CS and balloon expandable BMS for advanced atherosclerotic lesions in the common iliac artery; this was defined as a stenosis > 3 cm in length or occlusion. The primary end point was freedom from binary restenosis after two years of follow up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and registered with the Dutch Trial register (NTR3381). One hundred and seventy-four limbs were included between 2012 and 2019 with 87 limbs in each group. Six patients crossed over from the BMS group to the CS group but were analysed according to an intention to treat principle. Freedom from binary restenosis after two years of follow up was 84.7% (95% CI 76.7 - 92.7%) in the BMS group and 89.1% (95% CI 82.4 - 95.8%) in the CS group (p= .40). Freedom from occlusion was 95.0% (95% CI 90.3 - 95.7%) in the BMS group and 96.4% (95% CI 92.5 - 100%) in the CS group (p= .66). Freedom from target lesion revascularisation was 91.1% (95% CI 84.8 - 97.3%) and 95.2% (95% CI 90.7 -99.7%), respectively (p= .31). Technical success, complications, haemodynamic success, and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study. No difference was found between balloon expandable CS and BMS for treating advanced atherosclerotic lesions of the common iliac artery.

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.

Risk of Heart Failure in Patients with ST-Elevation Myocardial Infarction Receiving Drug-Eluting Stent Implantation and Undefined Duration of Antiplatelets.

It remains unknown as to whether the use of new-generation drug-eluting stent (NG-DES) in patients with ST-elevation myocardial infarction (STEMI) who receive an undefined duration of dual antiplatelet therapy (DAPT) reduces the risk of hospitalization for heart failure (HHF). In this population-based retrospective cohort study, we applied propensity score matching to select 6831 pairs of patients with STEMI who had similar baseline characteristics and received either NG-DES or bare-metal stent (BMS) implantation between 1 January 2007 and 31 December 2016. The risk of stent-associated HHF was evaluated, wherein death was considered a competing risk. Rates of cumulative incidence competing risk for HHF at the 1, 2, 3, 4, and 5 year follow-up were lower in the NG-DES group (3.79%, 5.21%, 6.15%, 7.01%, and 8.29%, respectively) than in the BMS group (4.51%, 6.21%, 7.32%, 8.33%, and 9.83%, respectively). NG-DES implantation was associated with a lower risk of HHF than BMS implantation after 5 years, with an adjusted subdistribution hazard ratio of 0.82 (95% confidence interval 0.72–0.92, p = 0.001). These results accord with those of patients who received DAPT for >6 months. Our findings highlight that NG-DESs may reduce HHF risk in patients with STEMI receiving an undefined duration of DAPT.

Impact of Stent Types on In-Hospital Outcomes of Patients With Cancer Undergoing Percutaneous Coronary Intervention: A Nationwide Analysis

BackgroundCardiovascular disease and cancer frequently coexist, and patients with cancer are at increased risk of cardiovascular events, including myocardial infarction and stroke. However, the impact of stent types on in-hospital outcomes of patients with malignancy is largely unknown. MethodsPatients with concomitant diagnosis of cancer undergoing PCI between January 2005 and December 2014 were identified in the National Inpatient Sample. They were then categorized into those who have undergone coronary stenting with bare-metal stent (BMS) or drug-eluting stent (DES). Primary outcomes were in-hospital mortality and stent thrombosis. Adjusted and unadjusted analysis was employed on appropriate variables of interest. Results8755 patients were included in the BMS group and 11,611 patients in the DES group. Following propensity matching, 4313 patients were randomly selected in both groups using a 1:1 ratio. There was high use of BMS stent in cancer patient (BMS 43.0%, DES 57.0%) compared to general population (BMS 23.2%, DES 76.8%). When comparing BMS to DES group, there was no statistically significant difference in mortality (4.7% vs. 3.8%, p = 0.097), acute kidney injury (11.3% vs. 10.6%, p = 0.425), bleeding complications (3.50% vs. 3.45%, p = 0.914), and length of hospital stay (5.4% vs. 5.2%, p = 0.119). However, an increased incidence of stent thrombosis was observed in the DES group (4.26% vs. 3.01%, p = 0.002). ConclusionA higher incidence of BMS placement was noted in patients with cancer than in the general population. Paradoxically there was a high incidence of stent thrombosis in the DES group without increasing mortality.

Comparison of Drug-Eluting Stent With Bare-Metal Stent in Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis

In-stent restenosis (ISR) is the primary reason for stroke recurrence after intracranial stenting in patients who were treated with a standard bare-metal stent (BMS). Whether a drug-eluting stent (DES) could reduce the risk of ISR in intracranial atherosclerotic stenosis (ICAS) remains unclear. To investigate whether a DES can reduce the risk of ISR and stroke recurrence in patients with symptomatic high-grade ICAS. A prospective, multicenter, open-label randomized clinical trial with blinded outcome assessment was conducted from April 27, 2015, to November 16, 2018, at 16 medical centers in China with a high volume of intracranial stenting. Patients with symptomatic high-grade ICAS were enrolled, randomized, and followed up for 1 year. Intention-to-treat data analysis was performed from April 1 to May 22, 2021. Patients were randomly assigned to receive DES (NOVA intracranial sirolimus-eluting stent system) or BMS (Apollo intracranial stent system) treatment in a 1:1 ratio. The primary efficacy end point was ISR within 1 year after the procedure, which was defined as stenosis that was greater than 50% of the luminal diameter within or immediately adjacent to (within 5 mm) the implanted stent. The primary safety end point was any stroke or death within 30 days after the procedure. A total of 263 participants (194 men [73.8%]; median [IQR] age, 58 [52-65] years) were included in the analysis, with 132 participants randomly assigned to the DES group and 131 to the BMS group. The 1-year ISR rate was lower in the DES group than in the BMS group (10 [9.5%] vs 32 [30.2%]; odds ratio, 0.24; 95% CI, 0.11-0.52; P < .001). The DES group also had a significantly lower ischemic stroke recurrence rate from day 31 to 1 year (1 [0.8%] vs 9 [6.9%]; hazard ratio, 0.10; 95% CI, 0.01-0.80; P = .03). No significant difference in the rate of any stroke or death within 30 days was observed between the DES and BMS groups (10 [7.6%] vs 7 [5.3%]; odds ratio, 1.45; 95% CI, 0.54-3.94; P = .46). This trial found that, compared with BMSs, DESs reduced the risks of ISR and ischemic stroke recurrence in patients with symptomatic high-grade ICAS. Further investigation into the safety and efficacy of DESs is warranted. ClinicalTrials.gov Identifier: NCT02578069.

Efficacy and Safety Differences between Domestic Paclitaxel Drug-Coated Balloons and Metal Bare Stents in the Treatment of ASO of Femoral-Popliteal Arteries Type IIA-C.

The aim in this study was to investigate the efficacy and safety of domestic paclitaxel-coated balloon (DCB) and bare metal stent (BMS) in the treatment of Transatlantic Cooperative Organization Consensus II (ASC II) types A–C femoral-popliteal arteriosclerosis obliterans (ASO). A total of 103 patients with ASC II A–C femoropopliteal ASO, who received treatment in our hospital from March 2020 to March 2021, were retrospectively selected and divided into the DCB group (n = 56) and BMS group (n = 47), according to treatment methods. The general clinical data and surgical results were compared between the two groups. The patients were followed up, and the primary patency rate, restenosis rate, freedom from target lesion revascularization (f-TLR), and limb preservation rate were recorded. The liver and kidney functions before and after operation and the occurrence of major postoperative adverse events were recorded. The operation was successful in both groups. The minimum diameter of the DCB group was smaller than that of the BMS group after treatment (P < 0.05). At 6 and 12 months after operation, the Rutherford classification decreased and ABI index increased in both groups (P < 0.05), but there was no significant difference (P > 0.05). At 6 and 12 months after surgery, f-TLR was significantly higher in the DCB group than in the BMS group (P < 0.05); at 12 months after surgery, the restenosis rate was lower in the DCB group than in the BMS group (P < 0.05). There was no significant difference in the primary patency rate and limb preservation rate at 6 and 12 months after operation between the two groups (P > 0.05). Before and after operation, there was no significant difference in liver and kidney function between the two groups (P > 0.05). Within 12 months after surgery, 1 patient in the DCB group developed puncture site hematoma 3 days after surgery, and 1 patient in the BMS group developed acute thrombosis 1 day after surgery, and no intervention-related deaths occurred. Domestic paclitaxel DCB can achieve better f-TLR and lower restenosis rate than BMS in the treatment of type II A–C femoral-popliteal artery ASO. Short-term and medium-term efficacy and safety are comparable to BMS.