Stent In-stent Restenosis Research Articles

Clinical Significance of Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for In-Stent Restenosis Within Drug-Eluting Stents: Impact on Patient Outcomes.

The evidence for optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) in improving the prognosis of individuals with in-stent restenosis (ISR) is lacking. This retrospective study enrolled 588 consecutive individuals with drug-eluting stent ISR undergoing PCI from March 2010 to March 2022. Two hundred seven (35.2%) underwent OCT guidance, and 381 (64.8%) underwent angiography guidance. Clinical outcomes were analyzed using survival curves. The primary clinical endpoint was 2-year major adverse cardiovascular events (MACEs), a composite of all-cause death, myocardial infarction, and target-vessel revascularization. Compared with angiography guidance, OCT guidance demonstrated a higher frequency of drug-coated balloon use and adjunctive therapeutic modalities, including predilation, postdilation, nonslip element balloons, and noncompliant balloons (P<0.05). Following PCI, the OCT-guided group achieved a significantly larger minimum lumen diameter (2.36 versus 2.15 mm, P<0.001) and a lower percentage diameter stenosis (17% versus 20%, P<0.001) than the angiography-guided group. Survival analysis revealed significantly lower 2-year MACEs in the OCT-guided group compared with the angiography-guided group (7% versus 15%, P=0.007), validated in the propensity matching analysis (7% versus 15%, P=0.001). Multiple sensitivity analyses showed that OCT-guided PCI treatment was an independent protective factor for 2-year MACEs in individuals with drug-eluting stent ISR. Compared with angiography guidance, OCT guidance is associated with a lower 2-year MACE risk among individuals with drug-eluting stent ISR. Therefore, OCT should be actively considered for guiding PCI treatment in individuals with drug-eluting stent ISR. Url: clinicaltrials.gov. Identifier: NCT03809754.

Recurrent Revascularization at 10 Years After Percutaneous Treatment of Drug-Eluting Stent Restenosis

BackgroundTreatment of patients with recurrence of in-stent restenosis (ISR) remains particularly challenging, with data and guideline recommendations for repeat percutaneous coronary intervention being scant. ObjectivesThe aim of this study was to investigate the long-term incidence of recurrent revascularization events after percutaneous treatment of drug-eluting stent (DES) ISR. MethodsIn this post hoc analysis, 402 patients (500 lesions) assigned to plain balloon (PB), drug-coated balloon (DCB), or DES treatment in the randomized ISAR-DESIRE 3 (Efficacy Study of Paclitaxel-Eluting Balloon, -Stent vs. Plain Angioplasty for Drug-Eluting Stent Restenosis) trial were followed up over a median of 10.3 years. The primary endpoint was total repeat target lesion revascularization (R-TLR) including all, first and recurrent, events. ResultsAt the end of follow-up, first R-TLR was required in 204 lesions, 82 in the PB group, 70 in the DCB group, and 52 in the DES group. The total number of R-TLRs was 373: 162 in the PB group, 124 in the DCB group, and 87 in the DES group. During the first year of follow-up, the risk for total R-TLR was reduced by DCB (HR: 0.36; 95% CI: 0.24-0.54) and DES (HR: 0.23; 95% CI: 0.14-0.38) treatment compared with PB treatment. After 1 year, the risk for total R-TLR was nonsignificantly reduced by DCB treatment (HR: 0.77; 95% CI: 0.51-1.16) and significantly reduced by DES treatment (HR: 0.61; 95% CI: 0.39-0.95) compared with PB treatment. Risk in the DCB and DES groups was similar during (HR: 1.54; 95% CI: 0.89-2.69) and after (HR: 1.26; 95% CI: 0.82-1.92) 1 year. ConclusionsThe total number of R-TLRs over 10 years after treatment of patients with DES ISR was high. DCBs and particularly DES were able to reduce the need for both first and recurrent revascularization compared with PB treatment.

Association of LDL-C level with neoatherosclerosis and plaque vulnerability in patients with late restenosis: an optical coherence tomography study

Neoatherosclerosis (NA) is a significant contributor to late stent failure; however, predictors of late in-stent restenosis (ISR) with NA have not been systematically reported. This study aimed to identify predictors of NA incidence and plaque vulnerability in patients with late ISR and the role of low-density lipoprotein cholesterol (LDL-C) levels in this process. A total of 216 patients with 216 lesions who underwent optical coherence tomography (OCT) before interventional procedure for late drug-eluting stent ISR were enrolled and divided into NA and non-NA groups based on OCT findings. Results showed that higher LDL-C levels were associated with NA, thin-cap fibroatheroma (TCFA), intimal disruption, plaque erosion, and thrombosis. Multivariate regression analysis revealed that the LDL-C level was an independent risk factor for NA and TCFA. The LDL-C levels exhibited a significant predictive value for NA and TCFA, surpassing other factors such as stent age and other lipid types. In conclusion, a high LDL-C level is an independent predictor of NA incidence and plaque vulnerability in patients with late ISR.

B-28 | Management of Clinical Stent-In-Stent Restenosis (SISR) in High Risk Coronary Artery Disease Patients With Percutaneous Coronary Intervention (PCI) Followed by Coronary Intravascular Brachytherapy (IVBT)

In-stent-restenosis (ISR) is seen in 10% of patients with DES and is often treated with a repeat DES placement. Recurrent ISR or SISR has a high repeat failure rates, requiring target vessel revascularization (TVR). A combination of the presence of multiple layers of stents, previous restenosis, and other additional comorbidities make this patient population complex and higher risk. Angioplasty followed by IVBT is one possible treatment option in the high-risk patients. This study reviewed the efficacy and safety of PCI followed by IVBT for coronary artery disease in high-risk patients experiencing SISR. A retrospective study was performed which reviewed 78 patients treated between 2016-2021 with SISR involving a total of 91 vessels. All patients underwent PCI with balloon angioplasty followed by IVBT. These patients received localized IVBT radiation using the Novoste Beta-Cath System using a strontium-90 isotope. Radiation dose was delivered based on the vessel diameter, with vessels ≥ 3.5mm in diameter receiving 23 Gy, while vessels of <3.5mm in diameter received 18.4 Gy. Major adverse cardiac events (MACE) were defined as all-cause death, myocardial infarction (MI), and stroke. All patients in the cohort had 2 previously placed DESs in the target lesion. Of total 91 treatments, 67% and 33% treatments were delivered to the LAD or the RCA and circumflex vessel or the marginal arteries, respectively. One patient had intraprocedural cardiac arrest due to suspected intracoronary thrombosis. All patients were symptomatic pre-IVBT and 44% experienced symptomatic reduction after treatment. MACE after IVBT includes MI in 18%, stroke in 5%, and all-cause death occurred in 16% of patients at a median time of 9.3 months post treatment with median follow-up being 22.8 months. Of total, 77% retained patency of the irradiated lesion, while 23% percent experienced restenosis requiring TVR. Coronary restenosis post-deployment of multiple layers of DES remains an ongoing challenge in current times. PCI followed by balloon angioplasty with IVBT is a safe and efficacious treatment option for high-risk coronary artery disease patients with SISR, who have very few treatment options otherwise.

Prevalence, Management and Outcomes of Percutaneous Coronary Intervention for Coronary In-Stent Restenosis: Insights From the France PCI Registry

BackgroundDespite the evolution of stent technology, there is a non-negligible risk of in-stent restenosis (ISR) after Percutaneous coronary intervention (PCI). Large-scale registry data on the prevalence and clinical management of ISR is lacking. MethodsThe aim was to describe the epidemiology and management of patients with ≥1 ISR lesions treated with PCI (ISR PCI). Data on characteristics, management and clinical outcomes were analyzed for patients undergoing ISR PCI in the France-PCI all-comers registry. ResultsBetween January 2014 and December 2018, 31,892 lesions were treated in 22,592 patients, 7.3 % of whom underwent ISR PCI. Patients undergoing ISR PCI were older (68.5 vs 67.8; p < 0.001), and more likely to have diabetes (32.7 % vs 25.4 %, p < 0.001), chronic coronary syndrome or multivessel disease. ISR PCI concerned drug eluting stents (DES) ISR in 48.8 % of cases. Patients with ISR lesions were more frequently treated with DES than drug eluting balloon or balloon angioplasty (74.2 %, 11.6 % and 12.9 %, respectively). Intravascular imaging was rarely used. At 1 year, patients with ISR had higher target lesion revascularization rates (4.3 % vs. 1.6 %; HR 2.24 [1.64–3.06]; p < 0.001). ConclusionsIn a large all-comers registry, ISR PCI was not infrequent and associated with worse prognosis than non-ISR PCI. Further studies and technical improvements are warranted to improve the outcomes of ISR PCI.

Lipoprotein (a) is related to In-Stent neoatherosclerosis incidence rate and plaque vulnerability: Optical Coherence Tomography Study

BackgroundIn-stent neoatherosclerosis (ISNA) is an important reason for stent failure. High lipoprotein (a) [Lp (a)] level is an independent predictor of in-stent restenosis (ISR). To date, the relationship between the level of serum Lp (a) and the incidence rate and vulnerability of ISNA has never been verified.MethodsA total of 119 patients with 125 drug-eluting stent ISR lesions who underwent percutaneous coronary intervention guided by optical coherence tomography were enrolled in this study. According to their Lp (a) level, the patients were divided into two groups [high Lp (a) group ≥ 30 mg/dL, n = 47; or low Lp (a) group < 30 mg/dL, n = 72]. The clinical baseline, angiographic characteristics, and optical coherence tomography data of both groups were recorded and analyzed.ResultsNo significant differences in clinical and angiographic characteristics were found between the two groups (P > 0.05). The incidence rate of ISNA in the high Lp (a) group was significantly higher than that in the low Lp (a) group (94.0% [n = 47] vs. 52.0% [n = 39], P < 0.001). The incidence rate of thin-cap fibroatheroma in ISR lesions was significantly higher in the high Lp (a) group than in the low Lp (a) group (42% [n = 21] vs. 5.3% [n = 4], P < 0.001).ConclusionA high Lp (a) level is associated with the high incidence rate and plaque vulnerability of ISNA.

Percutaneous Coronary Intervention (PCI) Followed by Intravascular Brachytherapy (IVBT) for Management of Stent-in-Stent Restenosis (SISR) in Patients with High-Risk Coronary Artery Disease

<h3>Purpose/Objective(s)</h3> Coronary artery disease (CAD) is the leading cause of death for both men and women in the United States. Percutaneous coronary intervention (PCI) with drug eluting stents (DES) has been a major advance in treatment with over 600,000 stents deployed annually. In-stent restenosis occurs in up to 10% of patients and is often managed with repeat DES placement. However, when stent-in-stent restenosis (SISR) occurs, options remain limited, and one technique includes angioplasty followed by intravascular brachytherapy (IVBT). We undertook this study to review efficacy and safety of PCI followed by IVBT for patients experiencing SISR. <h3>Materials/Methods</h3> We retrospectively reviewed 78 patients from 2016-2021 with SISR involving 91 vessels who received PCI with balloon angioplasty followed by IVBT. IVBT with a strontium-90 source was delivered via The Beta Cath® system (Novoste; Bes Vascular, Norcross, Ga, USA). The radiation dose delivered was 23Gy to vessels of ≥ 3.5mm in diameter, while 18.4 Gy was delivered to vessels of < 3.5 mm diameter. Radiation was prescribed to an area encompassing the angioplasty injury length with a 10mm longitudinal margin on each side. Major adverse cardiac events (MACE) include myocardial infarction (MI), stroke and all-cause death. Target vessel revascularization (TVR) was defined as percutaneous or surgical revascularization of the previously treated vessel. <h3>Results</h3> Median age was 67 years. All patients had at least 2 drug-eluting stents previously placed in the affected vessel. Sixty-one treatments were delivered to the left anterior descending artery or the right coronary artery with the remaining 30 delivered to either to a circumflex vessel or marginal artery. Sixty-three percent received 23Gy while 37% received 18.4Gy. One patient experienced cardiac arrest while receiving intervention, but no other procedure-related toxicities were reported. Median follow up was 22.8 months (range 0.9-60.6). All patients were symptomatic prior to IVBT and 44% experienced symptomatic reduction after treatment. The most common persistent symptom was angina in 71% of those patients. MACE after IVBT include MI in 18%, stroke in 5% and all-cause death occurring in 16% at a median time of 9.3 months after treatment (range 0.9-29.6). Seventy-seven percent had patency of the irradiated lesion, while 23% percent experienced restenosis requiring TVR. <h3>Conclusion</h3> PCI followed by IVBT is a safe and effective paradigm for patients with high-risk coronary artery disease experiencing SISR, who have few other treatment options.

Predictive Value Analysis of in-Stent Restenosis Within Three Years in Older Acute Coronary Syndrome Patients: A Two-Center Retrospective Study.

We aimed to investigate prognostic factors of in-stent restenosis (ISR) within 3 years in older acute coronary syndrome (ACS) patients after drug-eluting stent (DES) implantation and establish a clinical model for predicting ISR. We retrospectively collected 215 older ACS patients who followed coronary angiography (CAG) after DES implantation, divided into ISR group and non in-stent restenosis (non-ISR) group according to the results of reviewed CAG. Logistic regression analysis was performed to screen independent predictors related to ISR and build the clinical predictive model, which clinical application was assessed by decision curve analysis (DCA) and clinical impact curve (CIC). Kaplan-Meier survival curves for ISR by independent predictors. In multivariate logistic regression analysis showed that the red cell distribution width (RDW) was higher in ISR group compared with non-ISR (odds ratio (OR) = 1.54, 95% confidence interval (CI): 1.14–2.08, p < 0.01). Instead, a negative correlation was observed between minimum stent diameter and ISR (OR = 0.28, 95%CI:0.09-0.86, p = 0.03). A novel nomogram composed of these significant features presented a concordance index (C-index) of 0.710, DCA and CIC suggested that the predictive nomogram had clinical utility. Schoenfeld residuals showed the model RDW ≥ 12.6% with minimum stent diameter <3 mm was consistent with the proportional risk assumption. The Kaplan-Meier estimate for ISR showed statistical significance. Higher levels of RDW and lower minimum stent diameter were associated with incidence of ISR within 3 years in older ACS patients after DES implantation.

The effect of stent compression on in-stent restenosis and clinical outcomes in iliac vein compression syndrome.

To evaluate the effect of stent compression on in-stent restenosis (ISR) and clinical outcomes in patients with iliac vein compression syndrome (IVCS) after iliac vein stenting. Fifty patients with IVCS treated with iliac vein stenting (Smart Control, Cordis, USA) between March 2017 and October 2018 were consecutively enrolled in this study. Computed tomography venography (CTV) was performed to assess stent compression and ISR. Based on the degree of stent compression, patients were allocated to a significant stent compression (SSC) group and an insignificant stent compression (ISC) group. The incidence of ISR was analyzed between the SSC and ISC groups. Patients' venous clinical severity scores (VCSSs) and responses to the chronic venous insufficiency questionnaire (CIVIQ) one year after stenting were compared between the two groups to evaluate the clinical improvement of venous insufficiency. In total, 34% of patients had SSC. There were significant differences in the incidence of ISR (52.9% vs. 21.2%, P=0.023), and in each group, there was one case of stent occlusion (5.88% vs. 3.03%, P=0.999). Patients in the SSC group had a higher VCSS score (8.41±5.92 vs. 3.15±2.87, P=0.04) and a lower CIVIQ score (83.35±8.86 vs. 92.21±4.32, P=0.001). SSC has a significant effect on the incidence of ISR and the clinical outcomes of venous insufficiency. Thus, a dedicated iliac venous stent with sufficient radial resistive force, crush resistance, and outward radial force is needed to prevent the occurrence of stent compression.

Potential Mechanisms of In-stent Neointimal Atherosclerotic Plaque Formation.

Percutaneous coronary intervention has become the main revascularization strategy for coronary artery disease. Compared with early percutaneous coronary angioplasty and the extensive clinical application of bare metal stents, drug-eluting stents can significantly reduce the stenosis caused by the elastic retraction of plaque and neoatherosclerosis (NA), but there is still a high incidence of in-stent restenosis (ISR), which restricts the clinical efficacy of stent implantation. In-stent neoatherosclerosis (ISNA), defined as atherosclerotic lesions in the neointima, is one of the main causes of late stent failure. ISNA plays an important role in stent thrombosis and ISR. The rate of target lesion revascularization and in-stent thrombosis is high when NA arises. Therefore, it is of great clinical significance to explore the occurrence of NA and its development mechanism after stent implantation to prevent ISR and improve stent implantation efficacy and associated clinical prognosis. In this article, we systematically reviewed the existing clinical research on ISNA and the role of optical coherence tomography in its evaluation.

Clinical implication of quantitative flow ratio to predict clinical events after drug-coated balloon angioplasty in patients with in-stent restenosis.

BackgroundThe association between the quantitative flow ratio (QFR) and adverse events after drug‐coated balloon (DCB) angioplasty for in‐stent restenosis (ISR) lesions has not been investigated.HypothesisPost‐procedural QFR is related to adverse events in patients undergoing DCB angioplasty for ISR lesions.MethodsThis retrospective study included data from patients undergoing DCB angioplasty for drug‐eluting stent (DES) ISR between January 2016 and February 2019. The QFR was measured at baseline and after DCB angioplasty. The endpoint was the vessel‐oriented composite endpoint (VOCE), defined as a composite of cardiac death, vessel‐related myocardial infarction, and ischemia‐driven target vessel revascularization.ResultsOverall, 177 patients with 185 DES‐ISR lesions were included. During 1‐year follow‐up, 27 VOCEs occurred in 26 patients. The area under curve (AUC) of the post‐procedural QFR was statistically greater than that of the in‐stent percent diameter stenosis (0.77, 95% confidence interval [CI] 0.67–0.87 vs. 0.64, 95% CI 0.53–0.75; p = .032). Final QFR cutoff of 0.94 has the best predictive accuracy for VOCE. A QFR > 0.94 was associated with a lower risk of VOCE compared to a QFR ≤ 0.94 (log‐rank test, p < .0001). Survival analysis using the multivariable Cox model showed that a post‐procedural QFR ≤ 0.94 was an independent predictor of 1‐year VOCE (hazard ratio 6.53, 95% CI 2.70–15.8, p < .001).ConclusionsA lower QFR value was associated with worse clinical outcomes at 1 year after DCB angioplasty for DES‐ISR.

When 7 times angioplasty on Saphenous Vein graft would not compete the Native vessel Percutaneous Coronary intervention

Coronary artery bypass graft (CABG) has been the first option for revascularization in multiple vessel coronary artery disease. One of the most major obstacles after CABGs is atherosclerotic changes of SVGand more than 50 percent ofSVGare occluded at 10 years and 25 percent show severe stenosis at angiographic follow-up. Whether native vessel percutaneous coronary intervention (PCI) on native vessel or saphenous vein graft intervention is of benefit in these patients is still a debate. In this case report we want to clarify a common clinical scenario in a patient with prior CABG seven years ago which a proper decision in the right time could save many futile efforts. The patient underwent 7 PCI on the diseased SVG on OM with frequent occlusion due to stent thrombosis and in-stent restenosis which finally native vessel antegrade CTO PCI alleviated the problem and patient followed up 2 months after the procedure without any chest pain in his ordinary activities.

Doppler ultrasound and contrast-enhanced ultrasound in detection of stent stenosis after iliac vein stenting

BackgroundTo compare the diagnostic accuracy of Doppler ultrasound (DUS) with contrast-enhanced ultrasound (CEUS) for detection of iliac vein stent stenosis using multidetector computed tomography venography (MDCTV) as the reference method.MethodsPatients with iliac vein obstructive disease treated with nitinol stents (Smart Control, Cordis, USA) between January 2016 and December 2017 were consecutively included in this study. DUS, CEUS, and MDCTV were carried out in all patients within one week of each other at 1 year post stenting to investigate the presence of stent compression and in-stent restenosis (ISR).ResultsThe study included 139 patients (87 females; mean age 58 ± 15 years). For detecting stent compression, the kappa coefficient between the ultrasound modality of gray-scale imaging and MDCTV was 0.901, indicating very good agreement between these two modalities. ISR was detected in 50, 61, and 65 patients by DUS, CEUS, and MDCTV, respectively. DUS and CEUS (kappa = 0.449) and DUS and MDCTV (kappa = 0.516) had moderate agreement for ISR diagnosis, while for which CEUS and MDCTV (kappa 0.884) had very good agreement. The sensitivity and specificity of DUS and CEUS for diagnosing ISR were 63.1% and 90.8%, 87.8% and 97.3%, respectively.ConclusionsCEUS is probably superior to DUS in terms of diagnostic accuracy for the follow-up of patients with iliac vein stent stenosis.

Abstract 15603: Discovery of Plasminogen Activator Inhibitor-1 Platelet-derived Extracellular Vesicles to Predict Major Adverse Cardiac Events

Objective: To evaluate the utility of plasminogen activator inhibitor-1 positive platelet-derived extracellular vesicles (PAI-1 + PEV) as a biomarker for major adverse cardiac events (MACE) following angiography. Background: The stented coronary artery is at high-risk for complications, predominantly in the form of stent thrombosis and in-stent restenosis. Clinical risk scores have been attempted but no current models nor biomarkers yet accurately identifies the high-risk cohort following revascularization. Methods: PAI-1 + PEV was measured by flow cytometry in 172 patients undergoing coronary angiography. Biological characteristics and utility of PAI-1 + PEV as a biomarker were evaluated. The primary outcome was the incidence of MACE (composite of death, myocardial infarction, cerebrovascular accident, and unplanned revascularization) at 12 months. Results: During a median follow-up period of 377 days (IQR, 269.5 to 442.5 days), 38 patients (20.9%) experienced MACE. In this study, the existence of PAI-1 + PEV complex was validated by flow cytometry (Figure 1A). Furthermore, low log-transformed PAI-1 + PEV levels were associated with MACE (4.17 0.40 vs. 4.33 0.59 logPAI-1 + PEV, p=0.02). After adjustment for known clinical risk factors, low PAI-1 + PEV levels were independently associated with MACE with a hazard ratio of 7.79 (95% CI, 1.87 to 32.4, p=0.005). Finally, low plasma PAI-1 + PEV levels was predictive of MACE in both the discovery and validation cohort (Figure 1B-C). Conclusion: Our results demonstrate the existence of a PAI-1 + PEV and its potential utility as a biomarker to predict MACE. Low plasma PAI-1 + PEV levels was predictive of MACE in both the discovery and validation cohort.

Trends and Outcomes of Restenosis After Coronary Stent Implantation in the United States

BackgroundThere is a paucity of data on the burden of in-stent restenosis (ISR) in the United States as well as on its presentation and appropriate treatment strategies. ObjectivesThis study aims to provide an analysis of the temporal trends, clinical presentation, treatment strategies, and in-hospital outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR in the United States. MethodsThis study is a retrospective analysis of data collected in the Diagnostic Catheterization and Percutaneous Coronary Intervention (CathPCI) registry of the National Cardiovascular Data Registry (NCDR) between 2009 and 2017. Of the total patients undergoing PCI, we identified those undergoing PCI for ISR lesions. For comparison of in-hospital outcomes, propensity-score matching was employed. ResultsAmong the 5,100,394 patients undergoing PCI, 10.6% of patients underwent PCI for ISR lesions. Patients with bare-metal stent ISR declined from 2.6% in 2009 Q3 to 0.9% in 2017 Q2 (p < 0.001), and drug-eluting stent ISR rose from 5.4% in 2009 Q3 to 6.3% in 2017 Q2 (p < 0.001). Patients with ISR PCI were less likely to present with non–ST-segment elevation myocardial infarction (MI) (18.7% vs. 22.5%; p < 0.001) or ST-segment elevation MI (8.5% vs. 15.7%; p < 0.001). In the propensity-matched population of patients, there were no significant differences between patients with ISR and non-ISR PCI for in-hospital complications and hospital length of stay. ConclusionsISR represents approximately 10% of all PCI and is treated most commonly with another stent. Approximately 25% of patients present with acute MI. In-hospital outcomes of patients with ISR PCI are comparable with those undergoing non-ISR PCI.

Angiographic performance of everolimus-eluting stents for the treatment of coronary in-stent restenosis in daily practice.

The present study aims to analyze the angiographic anti-restenotic performance of durable polymer everolimus-eluting stents (EES) for the treatment of in-stent restenosis (ISR) in daily practice. Randomized data is available supporting the use of drug-coated balloons and drug-eluting stents for the treatment of ISR; however, additional real-world data including angiographic follow-up is needed. Patients who underwent EES-implantation for the treatment of drug-eluting stent ISR and attended for a 6-8months angiographic surveillance were analyzed. Off-line assessment of the angiograms was conducted at a central quantitative coronary angiographic core laboratory. A total of 426 patients with ISR were treated with EES and had undergone angiographic follow-up. The mean age was 66.8 ± 9.9 years and 27.5% suffered from diabetes. A total of 459 lesions were treated. The diameter stenosis decreased from 64.3 ± 19.1% (preprocedural) to 12.0 ± 6.4% (postprocedural). At 6-8months angiographic follow-up, the in-segment diameter stenosis was 38.3 ± 21.7% and the in-stent late luminal loss was 0.54 ± 0.74 mm in the treated area analysis. The rate of recurrent binary restenosis was 25.7%. In the setting of ISR, the angiographic anti-restenotic efficacy of stenting with EES is comparable to that observed in randomized clinical trials and less favorable than its performance in patients undergoing stenting for de novo disease.

EXPERIENCE OF PACLITAXEL-COATED BALLOON FOR THE TREATMENT OF SIDE BRANCHES IN THE LEFT MAIN CORONARY ARTERY BIFURCATION LESIONS

The management of the coronary bifurcation lesions using drug eluting stents (DES) is still challenging because of some issues including stent thrombosis and in-stent restenosis. Recently, several studies evaluated the efficacy of treatments using DES for the main branches, drug-coated balloons for

A computational study on vascular damage caused by shape memory alloy self-expandable and balloon-expandable stents in a stenosed artery

Atherosclerosis is one of the major types of cardiovascular diseases. Stent deployment into the stenosed artery is the most common treatment for atherosclerosis. Two common stent models based on two different expansion principles are balloon-expandable and self-expandable stents. Depending on the modality of the expansion, the material used for these two stents varies. Despite the extensive progress made in the field of stent construction, plaque fragmentation and in-stent restenosis are two of the problems that still cause complications in stenting. Computational modeling and finite element method help us predict the damage effects to the artery and plaque in the stenting process. In this article, we simulate the insertion of two stents (the stainless steel stent and the shape memory alloy stent) in a diseased artery with real geometry. Results are compared to account for the effects of these stents on the artery, especially, the maximum stress in the plaque and arterial layers and surgically induced damage as the main cause of plaque fracture during the stent deployment and in-stent restenosis. It is found that arising from superelasticity, the shape memory alloy stent induces less damage to the artery. In addition, the stress created in the artery by the shape memory alloy stent is smaller. Therefore, the risk of plaque fragmentation and in-stent restenosis is reduced in shape memory alloy stents.

Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon

ObjectivesThe aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). BackgroundTreatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR. MethodsFifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm2) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm2) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. ResultsQuantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups. ConclusionsThis first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318)

Leave nothing behind: Promising results for coronary drug‐coated balloons in clinical practice

1,025 patients with de novo coronary artery disease (66.9%) or in-stent restenosis (ISR) (33.1%) underwent treatment with paclitaxel drug-coated balloons in a multinational single-arm registry. Bail-out stenting rate was only 4.8%. One-year target lesion revascularization was 2.3% for de novo lesions, 2.9% for bare metal stent ISR, and 5.8% for drug-eluting stent ISR. Short-term results with coronary drug-coated balloons are promising. Nonetheless, long-term data, preferably from randomized trials are necessary to confirm their safety and efficacy.