Drug-eluting Stent In-stent Restenosis Research Articles

Long-term outcomes of DCB and DES for the treatment of in-stent restenosis in relation to the vessel size.

Percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or drug-eluting stents (DES) are well-established treatments for in-stent restenosis, however little is known about the impact of vessel size on the outcomes. The study aimed to evaluate the efficacy and safety profile of DCB versus DES in DES in-stent restenosis depending on the vessel size. Consecutive patients with DES in-stent restenosis who underwent PCI between January 2010 and February 2018 entered the registry with a long-term follow-up. Patients who received DCB at the index procedure were compared with those who received DES in three subgroups depending on the vessel size (≤2.5 mm; 2.5-3.5 mm; >3.5 mm). Data were analyzed using propensity score matching and Kaplan-Meier estimator plots. Among 1,374 patients with DES in-stent restenosis, 615 were treated with DES and 759 with DCB. After propensity score matching, we analyzed 752 patients in the DES and DCB groups at a long-term follow-up. The risk of DOCE did not differ significantly between the DES and DCB groups, both in the overall population (HR 0.85; 95%CI [0.58; 1.26], log-rank p = 0.41) and when divided into small (HR 0.84; 95%CI [0.36; 1.95], log-rank p = 0.70), medium-sized (HR 0.90; 95%CI [0.49; 1.65], log-rank p = 0.73), and large-sized (HR 0.81; 95%CI [0.42; 1.53], log-rank p = 0.50) coronary arteries. The incidence of all-cause death was significantly higher in the overall DES population (HR 4.03; 95%CI [2.40; 6.79], log-rank p < 0.001) and subgroup of small (HR 5.54; 95%CI [1.80; 17.02], log-rank p = 0.003), medium-sized (HR 4.37; 95%CI [1.92; 9.94], log-rank p = 0.009) and large-sized coronary arteries (HR 3.26; 95%CI [1.35; 7.86], log-rank p = 0.02). DES and DCB strategies are comparable methods of treating ISR regardless of the diameter of the treated vessel in a long-term follow-up.

Comparison of Neoatherosclerosis and Neovascularization of Restenosis after Drug-Eluting Stent Implantation: An Optical Coherence Tomography Study.

Neoatherosclerosis (NA) is associated with stent failure. However, systematic studies on the manifestations of NA and neovascularization (NV) at different stages after drug-eluting stent (DES) implantation are lacking. Moreover, the relationship between NA and NV in in-stent restenosis (ISR) has not been reported. This study aimed to characterize NA and NV in patients with ISR at different post-DES stages and compare the association between NA and NV in ISR lesions. A total of 227 patients with 227 lesions who underwent follow-up optical coherence tomography before percutaneous coronary intervention for DES ISR were enrolled and divided into early (E-ISR: 1 year), late (L-ISR: 1-5 years), and very-late (VL-ISR: 5 years) ISR groups. Furthermore, ISR lesions were divided into NV and non-NV groups according to the presence of NV. The prevalence of NA and NV was 52.9% and 41.0%, respectively. The prevalence of lipidic NA (E-ISR, 32.7%; L-ISR, 50.0%; VL-ISR, 58.5%) and intimal NV (E-ISR, 14.5%; L-ISR, 30.8%; VL-ISR, 38.3%) increased with time after stenting. NA was higher in ISR patients with NV lesions than in those without (p 0.001). Patients with both ISR and NV had a higher incidence of macrophage infiltration, thin-cap fibroatheroma, intimal rupture, and thrombosis (p 0.01). Progression of lipidic NA was associated with L-ISR and VL-ISR but may not be related to calcified NA. NA was more common in ISR lesions with NV; its formation may substantially promote NA progression and plaque instability.

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.

The effect of sex differences on neointimal characteristics of in-stent restenosis in drug-eluting stents: An optical coherence tomography study

BackgroundPrevious studies have demonstrated that there are sex-related differences in atherosclerosis. However, in terms of the nature of in-stent restenosis (ISR) neointima, the effect of gender on the results is unclear. MethodsPatients with ISR of drug-eluting stents (DES) who underwent OCT examination in Senior Department of Cardiology of the Chinese People's Liberation Army General Hospital from March 2010 to March 2022 were included. The patients were divided into male and female groups. ResultsIn this study, a total of 230 DES-ISR patients and 249 DES-ISR target lesions were analyzed. OCT data showed that compared to females, males have a higher incidence of thin-cap fibrous atherosclerosis (TCFA) (37.4% [n = 77] vs. 9.3% [n = 4], p < 0.001) and in-stent neoatherosclerosis (ISNA) (82.0% [n = 169] vs. 62.8% [n = 27]). p = 0.005). In addition, a multivariate logistic regression analysis demonstrated that male was independently associated with a higher incidence of ISNA (OR: 2.659, 95% CI: 1.239–5.707; p = 0.012) and TCFA (OR: 4.216, 95% CI: 1.370–12.976; p = 0.012). ConclusionFor DES-ISR patients, the incidence of ISNA in female was significantly lower than that in male and vulnerability of neointimal pattern is lower in female than in male.

Application of genetic risk score for in-stent restenosis of second- and third-generation drug-eluting stents in geriatric patients

BackgroundThe second-and third-generation drug-eluting stents (DESs) in-stent restenosis (ISR) genetic risk score (GRS) model has been previously validated. However, the model has not been validated in geriatric patients. Therefore, we conducted this study to test the feasibility of the DES-ISR GRS model in geriatric patients with coronary artery disease (CAD) in Taiwan.MethodsWe conducted a retrospective, single-center cohort study and included geriatric patients (age ≥ 65 years) with CAD and second-or third-generation DES(s) deployment. Patients undergoing maintenance dialysis were excluded. ISR was defined as ≥ 50% luminal narrowing on the follow-up coronary arteriography. The DES-ISR GRS model included five selected exonic single-nucleotide polymorphisms (SNPs): CAMLG, GALNT2, C11orf84, THOC5, and SAMD11. The GRS was defined as the sum of the five selected SNPs for the risk allele.ResultsWe enrolled 298 geriatric patients from January 2010 and December 2019 in this study. After propensity score matching, there were 192 geriatric patients with CAD in the final analysis, of which 32 patients had ISR. Patients were divided into two groups based on their GRS values: low (0–2) and high (≥ 3) GRS. A high GRS was significantly associated with DES-ISR in geriatric patients.ConclusionThose geriatric patients with a high GRS had significantly higher second-or third-generation DES ISR rates. The five SNP-derived DES-ISR GRS model could provide genetic information for interventional cardiologists to treat geriatric patients with CAD.Trial registrationThe primary study protocol was registered with clinicaltrials.org. with registration number: NCT03877614; on March 15, 2019. (http://clinicaltrials.gov/ct2/show/NCT03877614)

Evaluation and management of drug-eluting stent in-stent restenosis.

In-stent restenosis (ISR) is the most common cause of stent failure. Although the rate of ISR is significantly lower with contemporary drug-eluting stents (DES), it remains a challenging clinical entity to treat. In this review, we focus on a practical approach to management of DES ISR with intravascular imaging at its core, as supported by several recently published articles. This facilitates assessment of the underlying mechanism(s) essential to the successful treatment of ISR allowing for a tailored selection of treatment modalities. The successful treatment of DES ISR requires identification of the causative mechanism(s). Individualized treatment may include high-pressure balloon angioplasty alone, cutting or scoring balloons, intravascular lithotripsy, atheroablative therapies and a selection of either repeat DES implantation or drug-coated balloon treatment.

Comparison of 7-Year, Real-World Clinical Outcomes between Drug-Coated Balloon Angioplasty versus Drug-Eluting Stent Implantation in Patients with Drug-Eluting Stent In-Stent Restenosis.

There are no data available comparing the real-world, long-term clinical outcomes of drug-eluting balloon (DEB) angioplasty and drug-eluting stent (DES) implantation in DES in-stent restenosis (ISR) lesions. We aimed to compare the real-world, long-term data available between DEBs and DESs in DES-ISR lesions. We analyzed consecutive DES-ISR lesions (225 lesions from 205 patients; male: 66.3%; mean age: 62.4 years) treated with either DEB or DES. The primary endpoint was target lesion revascularization (TLR), and the primary safety endpoint was the lesion-oriented composite outcome (LOCO). The LOCO is composed of cardiac death, myocardial infarction, and target lesion thrombosis during follow-up. During the 7-year follow-up period, TLR did not differ significantly between the DEB (n = 108) and the DES groups (n = 117) (HR: 1.07; 95% CI: 0.59-1.93, p = 0.83). The LOCO was significantly lower in the DEB group compared to the DES group (HR: 0.40; 95% CI: 0.16-0.98, p = 0.04), which was mainly driven by the lower levels of myocardial infarction (HR: 0.24; 95% CI: 0.06-0.94, p = 0.04) and the absence of target lesion thrombosis in the DEB group (vs. DES group 6%, p = 0.02). Additionally, cardiac death was found to be similar between the DEB and DES groups (HR: 0.56; 95% CI: 0.18-1.75, p = 0.32). DEB angioplasty showed favorable safety with a similar efficacy to that of DES implantation in DES-ISR lesions during the long-term follow-up period.

Drug-coated balloon therapy is more effective in treating late drug-eluting stent in-stent restenosis than the early occurring one-a systematic review and meta-analysis.

Drug-eluting stent in-stent restenosis (DES-ISR) remains one of the important assignments to be resolved in interventional cardiology, as it is present in 5%-10% of total percutaneous coronary intervention cases. Drug-coated balloon (DCB) utilization is promising, as it comes with long-term protection from recurrent restenosis in optimal conditions without the hazard of higher risk for stent thrombosis and in-stent restenosis. We aim to reduce the need for recurrent revascularization in DES-ISR, specifying the population in which the DCB therapy should be used. In this meta-analysis, the results of studies containing data on the time frame between drug-eluting stent implantation and the clinical presentation of in-stent restenosis and concomitant drug-coated balloon treatment were summarized. A systematic search was performed in Medline, Central, Web of Science, Scopus and Embase databases on November 11th, 2021. The QUIPS tool was used to assess the risk of bias in the included studies. The occurrence of a major cardiac adverse events (MACE) composite endpoint, containing target lesion revascularization (TLR), myocardial infarction, and cardiac death, and each of these separately, was assessed at 12 months after the balloon treatment. Random effects meta-analysis models were used for statistical analysis. Data of 882 patients from four studies were analyzed. Across the included studies, a 1.68 OR (CI 1.57-1.80, p < 0.01) for MACE and a 1.69 OR (CI 1.18-2.42 p < 0.01) for TLR were observed, both in favor of late DES-ISR. The main limitation of the study is the relatively low patient number. Nevertheless, this analysis shows the first statistically significant results for the effect of DCB treatment in the early or late presentation of DES-ISR. As to date, intravascular imaging (IVI) remains limitedly accessible, other landmarks as the time frame of in-stent restenosis development are to be pursued to advance therapeutic outcomes. In consideration of other biological, technical and mechanical factors, time frame of occurrence as a prognostic factor could reduce the burden of recurrent revascularization in patients at an already high risk. Systematic Review Registration: identifier [CRD42021286262].

A Randomized Comparison of 2 Different Drug-Coated Balloons for In-Stent Restenosis

BackgroundAlthough use of drug-coated balloons (DCB) is a promising technique, little is known about the clinical efficacy of the Dissolve DCB in drug-eluting stent (DES) in-stent restenosis (ISR). ObjectivesThis study sought to evaluate the efficacy and safety of the Dissolve DCB in patients with DES ISR. MethodsThis was a prospective, multicenter, randomized, noninferiority trial comparing Dissolve DCB with SeQuent Please DCB in patients with DES ISR. Angiographic and clinical follow-up was planned at 9 months in all patients. The primary endpoint was 9-month in-segment late loss. ResultsA total of 260 patients with ISR from 10 Chinese sites were included (Dissolve DCB, n = 128; SeQuent Please DCB, n = 132). Nine-month in-segment late loss was 0.50 ± 0.06 mm with Dissolve DCB vs 0.47 ± 0.07 mm with SeQuent Please DCB; the 1-sided 97.5% upper confidence limit of the difference was 0.18 mm (P for noninferiority = 0.03). Rates of target lesion failure and binary restenosis were numerical higher in the Dissolve DCB cohort compared with the SeQuent Please DCB cohort at 9 months (17.5% vs 10.7%; P = 0.12; 23.4% vs 16.4%; P = 0.19, respectively). At 9 months, major adverse cardiac and cerebrovascular events occurred in 36 patients (28.3%) vs 30 patients (22.9%) in the Dissolve DCB and SeQuent Please DCB groups, respectively. ConclusionsIn this head-to-head randomized trial, the Dissolve DCB was noninferior to the SeQuent Please DCB for 9-month in-segment late loss. However, Dissolve DCB with its numerical increase in target lesion failure and binary restenosis warrants assessment in larger clinical trials (A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-Stent Restenosis; NCT03373695)

Management of In-stent Restenosis

Despite recent improvements in percutaneous coronary intervention (PCI), in-stent restenosis (ISR) — which accounts for 5–10% of all PCI procedures in contemporary clinical practice remains a substantial problem and the most frequent reason for stent failure. While the absolute number of ISR-PCI operations performed in contemporary practice has increased as a result of rising procedural volume and complexity, the relative rate of ISR has decreased with newer-generation drug eluting stents (DESs) in comparison to the bare metal stent (BMS) period. While BMS ISR is usually early and characterized by neointimal hyperplasia, DES ISR tends to be late with neoatherosclerosis as a characteristic feature. According to recent research, drug-coated balloons or DESs are the most effective therapy options for the majority of ISR cases. Future ISR interventional paradigms may be influenced by intravascular imaging (IVI) ISR tissue patterns. IVI can provide useful information to guide treatment options in ISR-PCI.

A retrospective study from a single center to compare outcomes in 79 patients with in-stent restenosis treated with paclitaxel-coated balloon angioplasty or drug-eluting stent implantation

BackgroundDespite the recent progress made in drug-eluting stents (DESs), in-stent restenosis (ISR) is still a common complication of percutaneous coronary interventions. This retrospective study from a single center aimed to compare outcomes in 79 patients with ISR treated with paclitaxel-coated balloon (PCB) angioplasty or DES implantation.ResultsFrom January 2017 to December 2021, 83 ISR lesions from 79 patients were included. Thirty-two were treated with PCB and 51 treated with available DES in the catheterization laboratory. Baseline characteristics were similar in both groups. Mean time between index angioplasty and restenosis was 27 months with a minimum of 4 months and a maximum of 70 months. Concerning Mehran ISR angiographic classification, classes II and III were more likely treated with DES. Stenosis diameter and minimal lumen diameter (MLD) were similar in both groups. PCB used was significantly shorter than DES: Mean length was 19.75 ± 5.7 versus 22.1 ± 16.5 (p < 0.001), respectively. Angiographic results immediately after intervention were similar in both groups: In-segment MLD after the procedure was 2.5 ± 0.4 in the DES group and 2.26 ± 0.55 in the PCB group. A median follow-up of 20 months was achieved for 68 patients, and 11 were lost to follow-up. There was also no difference in both groups regarding free from events survival.ConclusionsThe findings from this study support recent international studies that have shown no significant differences between DES and PCB and in-stent restenosis. This suggests that PCB use is an option to consider in our local daily practice.

Intracoronary Brachytherapy for Drug-Eluting Stent Restenosis: Outcomes and Clinical Correlates.

This study aimed to report outcomes of intracoronary brachytherapy (ICBT) in treating drug-eluting stent (DES) in-stent restenosis (ISR) and identify correlated factors. Patients who underwent ICBT for DES ISR from 2010 to 2021 were included in this single-institution retrospective PCI registry. Patients were treated with balloon angioplasty, laser atherectomy, and/or rotational atherectomy, followed by ICBT at a dose of 18.4-25 Gy delivered at the site of ISR with dose determined by the reference vessel size. The primary outcome was 3-year target lesion failure rate (TLF). Secondary end points were 1-year TLF, target lesion revascularization (TLR), all-cause mortality, and cardiac mortality. In total, 330 consecutive patients presented with 345 treated lesions; 70% were male, age was 66 ± 11 years, 55% were diabetic patients, 62% underwent previous bypass surgery, and 89% were placed with at least 2 stent layers at the treated site. The rate of TLF was 18% at 1 year and 46% at 3 years. All-cause mortality and cardiac mortality rates were 19.8% and 12.3% at 3 years. The number of stent layers was associated with 3-year TLF (1 layer, 33.3%; 2 layers, 47.0%, >3 layers, 60.2%; P = .045). Diabetes, repeat ICBT, final percent stenosis, lesion length, and intravascular imaging use were not correlated with the primary outcome. Lower ICBT dose (P = .035) and restenosis <1 year from previous percutaneous coronary intervention (P = .044) were correlated with early (1-year) TLF. ICBT for recurrent DES ISR provided low recurrence rates at 1 year, which increased substantially by 3 years. Outcomes were most closely correlated with the number of stent layers, but early restenosis and lower ICBT dose adversely affected early TLF.

Retracted: Efficacy and Prediction Model Construction of Drug-Coated Balloon Combined with Cutting Balloon Angioplasty in the Treatment of Drug-Eluting Stent In-Stent Restenosis.

[This retracts the article DOI: 10.1155/2022/9832622.].

Frequency of In-Stent Restenosis among Different 2nd/3rd Drug Eluting Stents in Patients Presenting with ACS/Angina at Trtiary Cradiac Care Centre

Objective: Primary objective was to determine the frequency of in-stent restenosis (ISR) among second/third generation drug eluting stents (DES), diagnosed angiographically in cardiac catheterization laboratory either in emergency settings or elective stage procedure and to determine the risk factors precipitating ISR.&#x0D; Study Design: Analytical Cross-sectional study.&#x0D; Place and Duration of the study: Tertiary Cardiac Care Center of Rawalpindi Pakistan, from Nov 2021 to Apr 2022.&#x0D; Methodology: After hospital ethical committee approval, medical data of consecutive patients were analyzed. Clinical and bio data were obtained followed by admission. Risk factors for atherosclerosis obtained along with baseline investigations and echocardiogram obtained to calculate ejection fraction. Classified interventional cardiologists analyzed angiographic images and confirmed the presence of ISR. Details of previous angioplasty and type of stent were documented.&#x0D; Results: Out of total 137 patients, 98(72%) were males and 39(28%) females. 94(68%) patients were diabetic, 102(72%) were hypertensive, 72(52%) had dyslipidemia, 56(40%) were smokers, and 32(23.35%) strong family history of CHD. After coronary angiography we found that frequency of ISR was 32(23%) in patients who had Xlimus sirolimus stent, 34(24.8%) patients had Xience (everolimus eluting stent), 33(24%) had Ultimaster (sirolimus eluting stent), 38(27%) had Biomatrix stent with p-value=0.25.&#x0D; Conclusion: The clinical presentation of ISR is usually with angina in all new generation DES. There was no statistically significant difference in terms of ISR among second/3rd generation DES. DES ISR not only depends upon the type of DES used but also depends upon multiple patient ...

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.

Intracoronary Brachytherapy for Recurrent DES Restenosis

<h3>Purpose/Objective(s)</h3> This study aims to report outcomes of intracoronary brachytherapy (ICBT) in treating drug-eluting stent (DES) in-stent restenosis (ISR) and to identify correlated, patient and treatment factors. <h3>Materials/Methods</h3> Patients undergoing ICBT for recurrent DES ISR from 2010 to 2021 were included in this single-institution retrospective PCI registry. Most lesions had ≥2 layers of pre-existing DES and were treated with balloon angioplasty, excimer laser coronary atherectomy (ELCA), or rotablator followed by ICBT at a dose of 18.4 Gy (vessel diameter ≤ 3.35mm) or 23 Gy (vessel diameter >3.35mm) delivered 2 mm from source center at the site of ISR. After March 2015, the standard dose was changed to 23 Gy or 25 Gy. All patients had operator-determined final target lesion stenosis <50%, and there were no in-hospital deaths. The primary outcome was 3-year target lesion failure rate (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Secondary endpoints where target lesion failure (TLF) rate at one year, any cause mortality, and cardiac mortality. Cox regression analyses were used to determine covariates, correlated with TLF rate, with p<0.05 considered significant and 0.05<p<0.10 considered a trend. The covariates were pre-specified based on previous studies and limited in number to avoid over-modelling. Analysis was performed using IBM statistical software and SYSTAT version 13. <h3>Results</h3> There was a total of 330 patients with 345 treated lesions. The mean age was 66 years, and 70.3% were men. At 3 years, all-cause mortality was 22.6% and cardiac mortality was 13.5%. The mean time to ISR from last failed DES implantation was 284 days. 255 of the 285 patients with known number of stent layers had at least 2 stents at the target lesion. Most of the patients had advanced coronary disease; 62% had prior bypass surgery. Rate of TLF was 18% at 1 year and 46% at 3 years. More stent layers were found to be correlated with 3-yr TLF (p=0.045). Lower radiation dose was negatively correlated with 1-yr TLF (p=0.039) but not at 3 years. TLF was trended higher if the target lesion was a vein graft (p=0.097). Final diameter of stenosis of the target lesion was not correlated with TLF at 1 year or at 3 years. <h3>Conclusion</h3> ICBT for recurrent DES-ISR provided low recurrence rates at 1 year, which increased substantially by 3 years. Outcomes were significantly better with lower numbers of stent layers at the target lesion but not with greater final diameter of target lesion stenosis.

Comparing the efficacy and safety of two different drug-coated balloons in in-stent restenosis: Two-year clinical outcomes of the RESTORE ISR China randomized trial

BackgroundThis head-to-head, multicenter, randomized trial investigated the safety and efficacy of Restore (Cardionovum, Bonn, Germany) drug-coated balloon (DCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR). MethodsA total of 240 patients with coronary DES-ISR were treated with Restore DCB or with SeQuent® Please (Braun, Melsungen, Germany) DCB. This trial used nine-month in-segment late lumen loss (LL) as the primary endpoint. Secondary endpoints included two-year clinical event rates. ResultsPatient, lesion, and procedural characteristics in both treatment groups were similar. Nine-month in-segment LL was 0.38 ± 0.50 mm with Restore vs. 0.35 ± 0.47 mm with SeQuent® Please (p for non-inferiority = 0.02). The two-year follow-up rates were 95.8 % (115/120) in the Restore group and 94.2 % (113/120) in the SeQuent® Please group. Both groups had similar one- and two-year target lesion failure (TLF) rates (13.3 % vs. 12.6 %; p = 0.87 at one year, 14.8 % vs. 15.0 %; p = 1.0 at two years). Moreover, the all-cause mortality and myocardial infarction rates were 0 and 3.5 % (4/120) in the Restore group and 0.9 % (1/120) and 3.5 % (4/120) in the SeQuent® Please group, respectively. Additional analyzing of vessel quantitative flow ratio (QFR) did also show noninferior outcomes for one explicit treatment bunch. ConclusionsThe two-year follow-up indicated sustained long-term clinical safety and efficacy for both devices on the basis of QFR value.

Efficacy and Prediction Model Construction of Drug-Coated Balloon Combined with Cutting Balloon Angioplasty in the Treatment of Drug-Eluting Stent In-Stent Restenosis.

Objective To investigate the efficacy of drug-coated balloon (DCB) combined with cutting balloon angioplasty (CBA) in the treatment of drug-eluting stent in-stent restenosis (DES-ISR) and to construct a predictive model for the occurrence of DES-ISR. MethodsAccording to the criteria of diagnosis, inclusion, and exclusion, DES-ISR patients who were treated in the outpatient and inpatient departments of cardiovascular medicine of Second People's Hospital of Guangdong Province from July 2021 to December 2021 were included. A total of 72 cases were planned to be enrolled, including 36 cases in the control group and 36 cases in the experimental group. The control group was treated with DCB, and the experimental group was combined with CBA. The treatment success rate, coronary angiography results before and after surgery, and the incidence of major adverse cardiovascular events during the follow-up period were compared between the two groups. Seventy-two DES-ISR patients were divided into ISR group and 59 non-ISR patients were divided into non-ISR group. The clinical data of the two groups were compared to analyze the risk factors affecting the occurrence of DES-ISR, and the prediction model was established. Results The surgical success rate of the experimental group was 94.44% (34/36), which was higher than the 77.78% (28/36) of the control group (P < 0.05). The minimum lumen diameter (MLD) of the experimental group 6 months after operation was greater than that of the control group, the late lumen loss (LL) and lumen stenosis rate were higher than those in the control group, and the incidence of major adverse cardiovascular events was lower than that in the control group (P < 0.05). In the ISR group, the proportion of patients with abnormal BMI, smoking, hypertension, diabetes, and family history of coronary heart disease and multivessel coronary artery disease was higher than that in the non-ISR group, the degree of stenosis target lesion was higher than that in the non-ISR group, the diameter of target lesion and stent diameter were smaller than those in the non-ISR group, and the length of target lesion and stent length were longer than those in the non-ISR group; the number of stents was more than that in the non-ISR group (P < 0.05). Combined hypertension, multiple coronary artery lesions, stenosis target lesion degree ≥85.05%, and target lesion length ≥36.88 mm were risk factors for DES-ISR, and target lesion diameter ≥3.15 mm and stent diameter ≥3.15 mm were protective factors (P < 0.05). The prediction model of DES-ISR was obtained by multiple logistic regression analysis, P = 1[1 + e(2.281 + 3.321Xhypertension + 3.427Xumber of arterial lesions + 3.359Xstenosis target lesion degree − 3.143Xtarget lesion diameter + 0.650Xtarget lesion length − 10.159Xstent diameter)]. The Hosmer-Lemeshow test showed that Hosmer-Lemeshow χ2 = 0.925, P =0.413; the ROC curve analysis showed that the AUC of the prediction model for the occurrence of DES-ISR was 0.924, the SE value was 0.022, and the 95% CI was 0.880-0.967. Conclusion DCB combined with CBA has good clinical efficacy in the treatment of DES-ISR, which can reduce the rate of lumen stenosis and the incidence of adverse cardiovascular events. The prediction model established according to risk factors has high predictive value for the occurrence of DES-ISR.

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions.

Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. URL: https://www. gov; Unique identifier: NCT02996318, NCT03242096.