A Single-Center Study on the Outcomes of Target Limb Revascularization in Femoropopliteal Lesions Treated With Drug Coated Balloons and Bare Metal Stents

Purpose: Multiple randomized controlled trials have shown that both drug coated balloons (DCBs) and bare metal stents (BMSs) significantly reduce restenosis in femoropopliteal lesions compared with plain balloon angioplasty. However, few studies have directly compared DCB and BMS treatments. Therefore, the goal of our study was to determine if the rate of target lesion revascularization (TLR) differs between DCB and BMS treatment at our center. Materials and methods: We performed a retrospective chart review of femoropopliteal interventions at a single center from 2009 to 2017. The intervention, patient and lesion characteristics, and TLR events were recorded. Exclusion criteria were loss of follow-up, death, bail-out stenting, and amputation within 60 days of treatment. Freedom from TLR was analyzed over a 3 year period with Kaplan-Meier survival curves. Cox hazard ratios were calculated to account for patient and lesion characteristics. Results: A total of 322 lesions (234 patients) treated with DCBs and 225 lesions (194 patients) treated with BMSs were included in this study. There were significant differences in baseline patient and lesion characteristics between groups—a greater proportion of women, patients with dyslipidemia, and lesions with popliteal involvement were treated with DCBs. There was no difference in the freedom from TLR between DCBs and BMSs. Accounting for patient and lesion characteristics, there was still no difference between DCBs and BMSs on the hazard of TLR. While our analysis did not detect a difference in the rate of TLR, there was a significant difference in the type of TLR. Compared with DCBs, a greater proportion of lesions initially treated with BMSs were retreated via surgical bypass rather than endovascular intervention, suggesting that lesions treated with DCBs may be more amenable to future endovascular intervention. Conclusion: Our retrospective analysis showed no difference in the rate of TLR between lesions treated with DCBs and BMSs. However, DCBs were more often used in complicated lesions involving popliteal arteries and may also allow for easier endovascular reintervention.

Drug-eluting versus bare metal stents in saphenous vein grafts compared to native coronary vessels. The NORSTENT study.

Background. Drug-eluting stents (DES) reduce target lesion revascularization (TLR) with no effect on mortality or myocardial infarction (MI) compared to bare metal stents (BMS) in native vessels. Randomized stent studies in saphenous vein grafts (SVG) are few and the reported effects are ambiguous. The NORSTENT study is the first to randomize lesions to percutaneous coronary intervention (PCI) in native vessels and SVG. Aims. To compare rate of mortality, MI and TLR across stent and vessel types. Methods. In this substudy 6087 patients with a single lesion in native vessels and 164 in SVG, were followed for 5 years. Results. MI was more frequent in SVG (subdistributional hazard ratio (SHR) 4.95 (3.75 – 6.54, p<0.001), but not affected by stent type. In the first 500 days DES reduced TLR in native vessels (SHR 0.21 ( 0.15 – 0.30)p<0.001) and SVG (SHR 0.18 (0.04 – 0.80) p=0.02). Thereafter DES and BMS were equivalent in native vessels, but DES had a higher TLR rate than BMS in SVG (SHR 3.31 (1.23 – 8.94) p=0.02). After 5 years the TLR rate was still significantly lower for DES in native vessels (3.2 % versus 7.8 %, p<0.001) but not in SVG (21.4 % vs 18. 4%). Conclusion: In SVG no difference in TLR between DES and BMS was observed after 5 years in contrast to persistent benefit in native vessels. The high rate of TLR and myocardial infarction in SVG makes treatment of native vessels a preference whenever feasible and better treatment options for SVG are warranted.

Bare Metal Stents on Resveratrol-Coated Balloons in Porcine Coronary and Peripheral Arteries

Balloon angioplasty and stent implantation are standard techniques to reopen stenotic vessels. Often, balloons or stents coated with cytostatic drugs are used to prevent re-occlusion of the arteries. Resveratrol, which is known for its numerous beneficial effects on cardiovascular health, is used as an antioxidant additive on paclitaxel-coated balloon catheters. What is still unclear is whether resveratrol-only balloon coating in combination with a bare metal stent (BMS) also has positive effects on vascular healing. Here, we analyzed neointimal thickening, fibrin deposition, inflammation, vasa vasorum density, and reendothelialization after implantation of BMS via a resveratrol coated balloon approach in a porcine model. In general, resveratrol treatment did not result in significantly altered responses compared to the control group in peripheral arteries. In coronary arteries, an increase in vasa vasorum density became evident three days after resveratrol treatment compared to the control group and abolished up to day 7. Significant effects of the resveratrol treatment on the fibrin score or intima-media area were transient and restricted to either peripheral or coronary arteries. In conclusion, local single-dose resveratrol treatment via a resveratrol-only coated balloon and BMS approach did not lead to adverse systemic or local effects, but also no significant beneficial effects on vascular healing were detected in the current study.

Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis

Background and Purpose: Drug-eluting stents generally have superior performance to bare metal stents in the treatment of vertebral artery stenosis (VAS). This prospective, multicenter, and single-arm clinical trial was initiated to assess in-stent restenosis (ISR) and midterm outcome after rapamycin-eluting stent placement in patients with symptomatic extracranial VAS.Methods: The subjects underwent angiographic follow-up at 6 months and final clinical follow-up at 12 months. The primary efficacy endpoint was ISR at 6 months. Secondary endpoints included technical success, target lesion-related transient ischemic attack (TIA), stroke, or death, and all-cause TIA, stroke, or death during the 12-month follow-up period.Results: A total of 104 stents were implanted in the 101 patients and 83 patients (82.2%) completed angiographic follow-up at 6 months. The technical success rate was 86.1% (87/101); mean in-stent stenosis rate was 25.1 ± 17.1% and ISR rate was 5.9% (95% CI: 0.8–10.9%). All the patients with ISR were completely asymptomatic and no stent fractures were observed during angiographic follow-up. At the 12-month clinical follow-up, target lesion-related TIA, stroke, or death had occurred in two (2.0%) patients and all-cause TIA, stroke, or death had occurred in six (6.1%) patients.Conclusion: The placement of rapamycin-eluting stents in patients with symptomatic extracranial VAS yields favorable ISR results and showed a trend of favorable safety outcomes including low rates of perioperative complications and late stroke. However, further study is needed to establish the long-term clinical benefits of this stent in the treatment of VA disease.

Stent Selection for Primary Angioplasty and Outcomes in the Era of Potent Antiplatelets. Data from the Multicenter Randomized Prague-18 Trial

Drug-eluting stents (DES) are the recommended stents for primary percutaneous coronary intervention (PCI). This study aimed to determine why interventional cardiologists used non-DES and how it influenced patient prognoses. The efficacy and safety outcomes of the different stents were also compared in patients treated with either prasugrel or ticagrelor. Of the PRAGUE-18 study patients, 749 (67.4%) were treated with DES, 296 (26.6%) with bare-metal stents (BMS), and 66 (5.9%) with bioabsorbable vascular scaffold/stents (BVS) between 2013 and 2016. Cardiogenic shock at presentation, left main coronary artery disease, especially as the culprit lesion, and right coronary artery stenosis were the reasons for selecting a BMS. The incidence of the primary composite net-clinical endpoint (EP) (death, nonfatal myocardial infarction, stroke, serious bleeding, or revascularization) at seven days was 2.5% vs. 6.3% and 3.0% in the DES, vs. with BMS and BVS, respectively (HR 2.7; 95% CI 1.419–5.15, p = 0.002 for BMS vs. DES and 1.25 (0.29–5.39) p = 0.76 for BVS vs. DES). Patients with BMS were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01–4.76; for BMS vs. DES, p = 0.045) and at one year (HR 2.1; 95% CI 1.19–3.69; p = 0.01); they also had a higher composite of cardiac death, reinfarction, and stroke (HR 1.66; 95% CI 1.0–2.74; p = 0.047) at one year. BMS were associated with a significantly higher rate of primary EP whether treated with prasugrel or ticagrelor. In conclusion, patients with the highest initial risk profile were preferably treated with BMS over BVS. BMS were associated with a significantly higher rate of cardiovascular events whether treated with prasugrel or ticagrelor.

Prognostic Analysis of Patients with Acute Myocardial Infarction Undergoing Implantation of Different Stents for the First Time

For patients with acute myocardial infarction scheduled to undergo percutaneous coronary stent implantation, in most cases a drug-eluting stent is recommended as the first choice for treatment. However, there is a lack of research on the effectiveness of bare-metal stents and drug-eluting stents on patients with different types of myocardial infarction. Our objective was to explore the effects of bare-metal stents and drug-eluting stents on patients with different types of myocardial infarction in terms of major cardiovascular incidents. This retrospective cohort study included 934 patients with myocardial infarction undergoing coronary artery stent implantation for the first time at the cardiac catheter room of the Tri-Service General Hospital in the Neihu District between 2014 and 2018. Patients’ information, including demographic data, laboratory data, cardiac echocardiography results, and angiocardiography results, was collected by reviewing medical records. Cox proportional hazards regression was used to adjust the potential confounding factors, and the adjusted data were then used to compare the correlation between different types of stents and major cardiovascular incidents in patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction. After the confounding factors were adjusted, in patients with ST-elevation myocardial infarction receiving a drug-eluting stent compared with those receiving a bare-metal stent, it was found that the mortality risk was lower in terms of all causes of death (Adj-HR = 0.26, 95% CI = 0.14–0.48, p < 0.001) and cardiogenic death (Adj-HR = 0.20, 95% CI = 0.08–0.55, p = 0.002), the risk of non-fatal myocardial infarction was lower (Adj-HR = 0.17, 95% CI = 0.04–0.73, p = 0.017), and there was no difference in the risk of revascularization at the lesion site (Adj-HR = 0.59, 95% CI = 0.24–1.43, p = 0.243). It terms of the findings in patients with non-ST-elevation myocardial infarction, those receiving a drug-eluting stent had a lower risk of revascularization at the lesion site (Adj-HR = 0.48, 95% CI = 0.24–0.97, p = 0.04); however, there was no difference in the mortality risk in terms of all causes of death (Adj-HR = 0.71, 95% CI = 0.37–1.35, p = 0.296) or cardiogenic death (Adj-HR = 0.59, 95% CI = 0.18–1.90, p = 0.379),or in the risk of non-fatal myocardial infarction (Adj-HR = 0.27, 95% CI = 0.06–1.25, p = 0.093). Compared with bare-metal stents, drug-eluting stents provide better protection against death to receivers with ST-elevation myocardial infarction; however, this protection is decreased in receivers with non-ST-elevation myocardial infarction. It is recommended that for patients with non-ST-elevation myocardial infarction who are indicated to receive a drug-eluting stent, the clinical effectiveness of the treatment must be considered.

Drug-coated Balloons for Small Coronary Disease—A Literature Review

Purpose of Review In the interventional treatment of coronary artery disease, new-generation drug-eluting stents (DES) currently are the standard treatment. In addition, drug-coated balloons (DCB) are a well-established option for the treatment of in-stent restenosis in both bare-metal stents (BMS) and DES, where DCBs deliver an antiproliferative drug without the necessity of re-implanting a stent. Since the field of use for DCB has increasingly been extended to other indications such as de novo lesions in small vessel disease (SVD), a review of literature may be useful. Recent Findings Recent randomized trial data show good efficacy and safety for DCB in de novo lesions, especially in small coronary arteries, and confirm long-term clinical efficacy and safety up to three years. Summary DCB are an attractive and safe option in the treatment of de novo lesions in SVD.

Computational Analysis of Mechanical Performance for Composite Polymer Biodegradable Stents

Bioresorbable stents (BRS) represent the latest generation of vascular scaffolds used for minimally invasive interventions. They aim to overcome the shortcomings of established bare-metal stents (BMS) and drug-eluting stents (DES). Recent advances in the field of bioprinting offer the possibility of combining biodegradable polymers to produce a composite BRS. Evaluation of the mechanical performance of the novel composite BRS is the focus of this study, based on the idea that they are a promising solution to improve the strength and flexibility performance of single material BRS. Finite element analysis of stent crimping and expansion was performed. Polylactic acid (PLA) and polycaprolactone (PCL) formed a composite stent divided into four layers, resulting in sixteen unique combinations. A comparison of the mechanical performance of the different composite configurations was performed. The resulting stresses, strains, elastic recoil, and foreshortening were evaluated and compared to existing experimental results. Similar behaviour was observed for material configurations that included at least one PLA layer. A pure PCL stent showed significant elastic recoil and less shortening compared to PLA and composite structures. The volumetric ratio of the materials was found to have a more significant effect on recoil and foreshortening than the arrangement of the material layers. Composite BRS offer the possibility of customising the mechanical behaviour of scaffolds. They also have the potential to support the fabrication of personalised or plaque-specific stents.

Association between phosphate and long-term outcome in CAD patients underwent coronary intervention

Phosphate has been linked to higher cardiovascular (CV) risk. However, whether phosphate is associated with poor outcomes for patients with coronary artery disease (CAD) after percutaneous coronary interventions (PCIs) remained undetermined. 2,894 CAD patients (2,220 male, aged 71.6 ± 12.2), who received PCI at TVGH from 2006 to 2015, with phosphate measurement, were enrolled. The primary outcome was the composite of major adverse CV events [MACE, comprising of CV death, nonfatal MI, and nonfatal stroke] and heart failure hospitalization (HHF). The key secondary outcome was MACE. There was a J-curve association between phosphate and CV events after adjusted for comorbidities and renal function. Phosphate around 3.2 ± 0.1 mg/dL was associated with the lowest CV risk. In Cox analysis, each 1 mg/dL increases in phosphate was associated with a higher risk of MACE + HHF (HR: 1.12, 95% CI: 1.05–1.21): CV death (HR: 1.37, 95% CI: 1.22–1.55) and HHF (HR: 1.12, 95% CI: 1.02–1.23). Subgroup analyses showed more prominent association between phosphate and MACE + HHF in male, age > 65, bare-metal stents (BMSs), LVEF < 50%, eGFR < 60, LDL > 70 mg/dL, and emergent PCI. Phosphate has a significant association with the risk of CV events in CAD patients undergoing PCI that was independent of comorbidities and renal function.

Drug‐Eluting or Bare‐Metal Stents for Left Anterior Descending or Left Main Coronary Artery Revascularization

Background New‐generation drug‐eluting stents (DES) reduce target‐vessel revascularization compared with bare‐metal stents (BMS), and recent data suggest that DES have the potential to decrease the risk of myocardial infarction and cardiovascular mortality. We evaluated the treatment effect of DES versus BMS according to the target artery (left anterior descending [LAD] and/or left main [LM] versus other territories [no‐LAD/LM]). Methods and Results The Coronary Stent Trialist (CST) Collaboration gathered individual patient data of randomized trials of DES versus BMS for the treatment of coronary artery disease. The primary outcome was the composite of cardiac death or myocardial infarction. Hazard ratios (HRs) with 95% CIs were derived from a 1‐stage individual patient data meta‐analysis. We included 26 024 patients across 19 trials: 13 650 (52.4%) in the LAD/LM and 12 373 (47.6%) in the no‐LAD/LM group. At 6‐year follow‐up, there was strong evidence that the treatment effect of DES versus BMS depended on the target vessel ( P ‐interaction=0.024). Compared with BMS, DES reduced the risk of cardiac death or myocardial infarction to a greater extent in the LAD/LM (HR, 0.76; 95% CI, 0.68–0.85) than in the no‐LAD/LM territories (HR, 0.93; 95% CI, 0.83–1.05). This benefit was driven by a lower risk of cardiac death (HR, 0.83; 95% CI, 0.70–0.98) and myocardial infarction (HR, 0.74; 95% CI, 0.65–0.85) in patients with LAD/LM disease randomized to DES. An interaction ( P =0.004) was also found for all‐cause mortality with patients with LAD/LM disease deriving benefit from DES (HR, 0.86; 95% CI, 0.76–0.97). Conclusions As compared with BMS, new‐generation DES were associated with sustained reduction in the composite of cardiac death or myocardial infarction if used for the treatment of LAD or left main coronary stenoses. Registration URL: https://www.crd.york.ac.uk/PROSPERO ; Unique identifier: CRD42017060520.