Treatment Of In-stent Restenosis Research Articles

Abstract 4125106: Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis; A Meta-Analysis.

Background: Internationally, drug-coated balloons have emerged as a new treatment approach in In-Stent Restenosis (ISR) offering localized drug delivery to inhibit neointimal growth without the need for additional stent layers. However, their use has not been assessed or approved in the United States. Paclitaxel-coated balloons (PCBs) are gaining traction as alternatives for in-stent restenosis patients. Yet, their safety and effectiveness compared to uncoated balloons remain uncertain. This meta-analysis seeks to systematically assess PCBs' safety and efficacy for ISR treatment by comparing them to uncoated balloons. Research Question: Are paclitaxel-coated balloons (PCBs) superior to uncoated balloons (UCBs) in terms of safety and efficacy for the treatment of coronary in-stent restenosis (ISR)? Aims: Systematically assess the safety and efficacy of paclitaxel-coated balloons (PCBs) compared to uncoated balloons (UCBs) for the treatment of coronary in-stent restenosis (ISR). Methods: A comprehensive literature review was conducted utilizing multiple databases up to May 2024, focusing on randomized controlled trials comparing PCB vs UCB in patients with coronary in-stent restenosis. Six randomized controlled trials with a total of 1,347 patients who completed 1-year follow-up were included. Dichotomous data were calculated as odds ratios (ORs) and 95% confidence intervals (95% CI). P<0.05 was considered to indicate a statistically significant difference. The primary outcomes included Target Lesion Revascularization (TLR), Myocardial Infarction (MI), Stent Thrombosis (ST) and Total Mortality (TM). Results: Compared with patients who underwent UCB angioplasty, those in the PCB group exhibited a clear superiority in TLR [odds ratio (OR), 0.21; 95% CI [ 0.11,0.41]; P<0.00001], and MI [odds ratio (OR), 0.55; 95% CI [0.33,0.91]; P<0.02]. ST was numerically lower in the PCB arm without statistical significance (OR, 0.21; 95% CI [0.03,1.48]; P=0.11). TM was also numerically lower with PCB without reaching statistical significance (OR, 0.60; 95% CI [0.32,1.11]; P=0.10). Conclusion: This meta analysis supports that PCBs are associated with superior outcomes when compared with UCBs in the management of ISR. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis as demonstrated by superior outcomes in target lesion revascularization and recurrent myocardial infarction.

Abstract 4120966: Outcomes Following Balloon Angioplasty with Drug Coated Versus Uncoated Balloons in Patients with Coronary In-Stent Restenosis: A Systematic Review and Meta-Analysis

Background <div> </div> <div>The development of in-stent restenosis (ISR) has emerged as a substantial barrier to interventional treatment for coronary heart disease. Drug-coated balloon (DCB) is an efficacious interventional technique for the management of ISR. This meta-analysis compares the efficacy of DCB in the treatment of ISR with that of an uncoated balloon (UCB).</div> <div> </div> <div>Methods</div> <div> </div> <div>We comprehensively searched literature on MEDLINE, Embase, Cochrane, and clinicaltrials.gov using MeSH terms and relevant keywords for “Balloon Angioplasty” and “in-stent Restenosis” from inception to June 1, 2024, followed by a meta-analysis of all randomized controlled trials (RCTs) to assess both strategies for treatment of ISR. Random effects model was used to aggregate the risk ratios (RR) for dichotomous and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI).</div> <div> </div> <div>Results</div> <div> </div> <div>The search strategy retrieved 2330 studies. Duplicates and irrelevant articles were removed and data from seven RCTs (1,408 patients) was extracted. The mean age ranged from 64 to 74 years. The mean clinical follow-up ranged from 1 to 10 years. DCB was found to be superior to UCB at latest follow up in terms of target lesion revascularization (TLR) (RR 0.34, 95% CI 0.19-0.58; p 0.0001; I2 79%), major adverse cardiovascular events (MACE) (RR 0.41, 95% CI 0.23-0.73; p 0.003; I2 84%), late lumen loss (LLL) (MD -0.46 mm, 95% CI -0.64- -0.28]; p <0.00001; I2 64%), and target vessel revascularization (TVR) (RR 0.45, 95% CI 0.29-0.70; p 0.0003; I2 67%). The two groups were comparable at latest follow up in terms of mortality (RR 0.87, 95% CI 0.65-1.16; p 0.35; I2 0%), cardiac death (RR 0.89, 95% CI 0.66-1.19; p 0.43; I2 0%), myocardial infarction (MI) (RR 0.70, 95% CI 0.39-1.24; p 0.22; I2 28%) and stent thrombosis (RR 0.22, 95% CI 0.04-1.10; p 0.06; I2 46%).</div> <div> </div> <div> </div> <div> </div> <div>Conclusion</div> <div> </div> <div>DCB showed promising results in the treatment of patients with coronary ISR. DCB outperformed UCB in significantly reducing TLR, MACE, LLL and TVR risks. The risk of mortality, cardiac death, MI, and stent thrombosis was similar between DCB and UCB.</div> <div> </div> <div> </div>

Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry.

Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR). We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR. Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR). A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES. Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.

Comparative outcomes of drug-coated balloon angioplasty versus second-generation drug-eluting stent for in-stent restenosis: a real-world data analysis

Abstract Background Coronary in-stent restenosis (ISR) poses a significant challenge in interventional cardiology, with optimal treatment strategies being the subject of ongoing debate. Current clinical guidelines offer a choice between drug-coated balloon angioplasty (DCB) and repeat stenting with second-generation drug-eluting stents (DES), each with distinct implications for long-term patient outcomes. Purpose The aim of this study is to compare 1-year outcomes between DCB angioplasty and second-generation DES in the treatment of ISR. Longitudinal real-world data are used from the OBSERVABLE database, which comprises German health claims data between 2012 and 2021. Methods A total of 10,440 ISR individuals undergoing DCB or DES intervention were identified. After exclusion of bare-metal stents, first generation stents and non-DCBs, 3,810 propensity score-matched individuals remained. The primary outcome was the composite of all-cause mortality and myocardial infraction (MI). Secondary outcomes included all-cause death, MI, and bleeding as a safety outcome. Results At 1-year follow-up, the primary outcome of all-cause mortality and MI was observed in 246 individuals (12.9%) in the DES group, compared with 201 individuals (10.6%) in the DCB group (HR, 1.27; 95% CI, 1.06-1.53). Sensitivity analysis confirmed the robustness of these findings. Secondary outcomes revealed higher all-cause mortality in the DES group (7.9%) compared to the DCB group (6.3%) (HR, 1.31; 95% CI, 1.03-1.66), with no difference in MI. Bleeding events were comparable between the two treatments, with 244 individuals (12.8%) in the DES group and 206 individuals (10.8%) in the DCB group (HR, 1.17; 95% CI, 0.89-1.53). Conclusion This real-world data analysis demonstrated a higher incidence of the primary composite endpoint of all-cause mortality and MI within one year, after treatment with DES compared to DCB. Our results support prior findings about the safety profile of repeated DES implantation and strengthen DCB as a potential superior alternative to DES in ISR management.

Biolimus A9 DEB for the Treatment of In-Stent Restenosis. 1-year outcomes of the REFORM trial

Abstract Background In recent years, drug-coated balloons (DCB) have established themselves as another tool in the arsenal of interventional cardiology devices for the treatment of in-stent restenosis (ISR) lesion. Aims The study was designed to compare the biolimus DCB to the paclitaxel-coated SeQuent PleaseTM DCB. Method This was a prospective, non-inferiority, randomized, multicenter, study conducted at 20 centers in 6 countries. The primary endpoint was in-segment % diameter stenosis (%DS) at six months. The study was powered to enrol 201 patients in at 2:1 randomization to either the biolimus DCB (BCB) or the SeQuent PleaseTM DCB (SQP). Key secondary endpoints included, late-lumen loss, binary restenosis, and target lesion failure (TLF) and myocardial infarction at 1 year. Results A total of 202 patients were randomised with 135 in the BCB group and 67 in the SQP group. Mean patient age was 68.9 ± 9.9 years in the BCB group compared to 68.2 ± 10.5 years in the SQP group. At 6 months, %DS was 41.8 ± 21.3 in the BCB group compared to 31.4 ± 17.7 in the SQP group (95% confidence for the difference: 3.5-16.9, p-value for non-inferiority 0.32). At 12 months, TLF was 23.74%, in the BCB group vs 17.07% in the control group, hazard ratio (HR) of 1.44 [95% CI: 0.72-2.88], p=0.28. There were more clinically driven revascularization in the BCB group (21.61%) compared to SQP (15.61%) [HR: 1.46, 95% CI: 0.71-3.01], p=0.29. More myocardial infarction were observed in the SQP group (BCB: 7.59% vs SQP: 3.77%, [HR: 0.48, 95% CI: 0.14-1.68], p=0.24)(see Figure). Conclusions In ISR patients, the REFORM study was not able to demonstrate non-inferioirity of the biolimus DCB compared to the SeQuent Please DCB.

Long-term outcomes following DCB vs. DES for ISR treatment

Abstract Background The-long term outcomes of patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. Purpose This study aims to investigate the outcomes of patients with drug-eluting stents (DES)-ISR presenting with CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES. Methods Consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin-DES or paclitaxel-DCB for DES-ISR were enrolled. Primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint [DOCE: cardiac death, TLR or target vessel myocardial infarction (TV-MI)]. Propensity-score matching was used to adjust for baseline differences. Results A total of 846 patients were included in the pooled analysis, of whom 381 (45%) were treated with a thin-DES and 465 (55%) with paclitaxel-DCB. Patients who received thin-DES compared with those who received paclitaxel-DCB had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74], P&amp;lt;0.001) TVR (HR, 0.56 [95% CI, 0.39-0.86], P&amp;lt;0.001) and DOCE (HR, 0.63 [95% CI, 0.45-0.88], P=0.007).The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33–0.88], P=0.013), TVR (HR, 0.57 [95% CI, 0.41–0.80], P=0.009), and DOCE (HR, 0.65 [95% CI, 0.42–0.99], P=0.046) between the thin-DES and DCB group, respectively. Conclusions In long term observation in patients with CCS undergoing PCI of ISR, the use of thin-DES is associated with reduced rates of TLR, TVR and DOCE compared with patients treated with DCB.

Contemporary Use of Drug-Coated Balloons for Coronary Angioplasty: A Comprehensive Review.

The interventional treatment of coronary artery disease (CAD) has undergone significant improvements thanks to technological innovations. Nowadays, percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is the standard of care for the treatment of CAD. Nevertheless, the non-negligible incidence of in-stent restenosis (ISR) and suboptimal results in various anatomical settings has led to the development of drug-coated balloons (DCBs). DCBs are catheter-based balloons whose surface is coated with an anti-proliferative drug (mainly Paclitaxel or Sirolimus) loaded onto the balloon surface with different technologies and dose concentrations. In the beginning, these devices were used for the treatment of ISR showing an excellent efficacy profile in the inhibition of intimal hyperplasia. Subsequently, several studies evaluated their use in other angiographical and clinical contexts such as de novo lesions, small vessel disease, diffuse coronary disease, bifurcation lesions, acute coronary syndromes, high-bleeding risk and diabetic patients. This comprehensive review aims to describe the main DCB platforms on the market, their fields of application with the main supporting studies and their future perspectives.

Drug-Coated Balloon Angioplasty for In-Stent Restenosis in the Vertebral Artery Ostium: Experiences From a Single Center.

Background and purpose: Stenting appears to be a safe treatment for vertebral artery ostial stenosis (VAOS) with low complication rates and positive long-term effects. However, in-stent restenosis (ISR) after stenting is common. Drug-coated balloons (DCBs) are an effective management strategy for ISR in patients with coronary or carotid disease. In this study, we investigated the feasibility, safety, and effectiveness of DCB-assisted angioplasty for the treatment of ISR after treatment of VAOS. Research Design: The study included patients in the Department of Neurology at Beijing Tsinghua Changgung Hospital who underwent DCB-assisted angioplasty for ISR after previously undergoing stenting for VAOS. We retrospectively analyzed the clinical and functional outcomes in these patients. Results: Fourteen patients were enrolled in the study between January 2018 and April 2022. Five of the patients were female, and the mean age was 69.4 ± 7.5 years. The technical success rate was 100% and the mean operation time was 57.1 ± 29.2 minutes. No perioperative complications were reported. There were no new cases of cerebral infarction or transient ischemic attacks in hospital or during 6 months of follow-up. There were only 2 reports of ISR in the vertebral artery ostium in the 6 months following DCB-assisted angioplasty. The median modified Rankin scale score was 0. Conclusion: DCB-assisted angioplasty may be feasible for treatment of ISR after stenting of the vertebral artery ostium. However, more research is needed to confirm our findings.

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.

TCT-497 Sex-Specific Clinical Outcomes After Treatment of In-Stent Restenosis With the AGENT Paclitaxel-Coated Balloon: A Subgroup Analysis of the AGENT IDE Randomized Trial

TCT-497 Sex-Specific Clinical Outcomes After Treatment of In-Stent Restenosis With the AGENT Paclitaxel-Coated Balloon: A Subgroup Analysis of the AGENT IDE Randomized Trial

Successful treatment of chronic venous in-stent restenosis using a Phoenix atherectomy device.

Although endovascular treatment of venous obstruction with percutaneous transluminal angioplasty (PTA) and stenting is a safe and effective alternative to conservative treatment, the overall prevalence of in-stent restenosis (ISR) remains high in this patient population. This study reports a novel treatment option for patients with chronic ISR (C-ISR). At our center, all patients with ISR were treated based on the time since the initial intervention. Acute in-stent restenosis (A-ISR) was preferably treated with catheter-directed thrombolysis or a pharmacomechanical peripheral thrombectomy device and PTA. Selected patients with chronic ISR (C-ISR) (greater than 30 days) were treated with a catheter- guided unidirectional atherectomy in addition to PTA, under the assumption of a non-thrombotic mechanism in the development of C-ISR. We demonstrate a safe and practical treatment option for chronic ISR using a catheter- guided technical approach with the Phoenix atherectomy device in four patients. Technical success was achieved in every case, and mid-term patency was restored in three out of four patients. Restenosis following venous stenting is highly complex. Patients must be treated individually, with a focus on anticoagulation and antiplatelet therapy regimens, as well as the appropriate interventional treatment. Catheter- guided atherectomy is a viable option for this heterogeneous group of patients. Further studies are required to understand the etiology of chronic ISR.

TCT-495 The Impact of Cutting Balloon Predilation on the Outcomes of Paclitaxel Drug-Coated Balloon Treatment for Coronary In-Stent Restenosis

TCT-495 The Impact of Cutting Balloon Predilation on the Outcomes of Paclitaxel Drug-Coated Balloon Treatment for Coronary In-Stent Restenosis

TCT-315 Acute and Long-Term Safety and Efficacy of IVUS-Guided Drug Coated Balloon Treatment for Carotid In-Stent Restenosis

TCT-315 Acute and Long-Term Safety and Efficacy of IVUS-Guided Drug Coated Balloon Treatment for Carotid In-Stent Restenosis

TCT-491 AGENT Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis in Small Vessel Coronary Lesions: A Subgroup Analysis of the AGENT IDE Randomized Trial

TCT-491 AGENT Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis in Small Vessel Coronary Lesions: A Subgroup Analysis of the AGENT IDE Randomized Trial

Drug-eluting stent and drug-coated balloon for in-stent restenosis: A meta-analysis

&lt;p&gt;The optimal strategy for patients with in-stent restenosis (ISR) is controversial. We aimed to compare the effects of a drug-coating balloon (DCB) and drug-eluting stent (DES) in ISR treatment.&lt;strong&gt; &lt;/strong&gt;Clinical trials were extensively collected, and retrieved items were screened for inclusion. Both clinical (major adverse cardiac event (MACE); myocardial infarction (MI); and target lesion revascularization (TLR) and angiographic (minimal lumen diameter (MLD), and stenosis relative to reference lumen diameter (SRLD) endpoints were extracted and compared. MACE and MI were not significantly different between the groups. Pooled results of TLR showed a marginal effect that DES was superior to DCB (13.50% for DCB vs&lt;em&gt;.&lt;/em&gt; 11.17% for DES, RR = 1.256, 95% CI: 0.997 to 1.583, &lt;em&gt;P&lt;/em&gt; = 0.053), with heterogeneity across studies (&lt;em&gt;I&lt;/em&gt;&lt;sup&gt;2&lt;/sup&gt; = 42.0%, Cochrane &lt;em&gt;Q&lt;/em&gt;-test = 0.069). Meta-regression identified bare metal stent (BMS) or drug eluting stents (DES) implanted in the previous intervention and proportions of diabetes in the DCB group as sources of heterogeneity. DES implantation also significantly improved angiographic outcomes (WMD for MLD: −0.318, 95% CI: −0.424 to −0.213, &lt;em&gt;P&lt;/em&gt;&lt;em&gt; &lt;/em&gt;&amp;lt; 0.001; WMD for SRLD: 6.164%, 95% CI: 4.915% to 7.412%, &lt;em&gt;P&lt;/em&gt;&lt;em&gt; &lt;/em&gt;&amp;lt; 0.001). All DES, including everolimus-eluting ones, did not benefit BMS-ISR patients compared with DCB treatment.&lt;strong&gt; &lt;/strong&gt;DES implantation, which is superior to DCB angioplasty only in DES-ISR patients, should be preferred in the DES-ISR population to reduce TLR. DCB may be preferred in BMS-ISR to avoid increasing stent layers.&lt;/p&gt;

Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.

Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Coronary In-Stent Restenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

In-stent restenosis (ISR) accounts for 10% of percutaneous coronary intervention (PCI) in the Unites States. Paclitaxel coated balloons (PCBs) have been evaluated as a therapy for coronary ISR in multiple randomized controlled trials (RCTs). We searched PubMed/MEDLINE, Cochrane library, and ClinicalTrials.gov (from inception to April 1, 2024) for RCTs evaluating PCBs versus uncoated balloon angioplasty (BA) in patients with coronary ISR. The outcomes of interest were target lesion revascularization (TLR), major adverse cardiovascular events (MACE), all-cause mortality, cardiovascular mortality, myocardial infarction (MI), and stent thrombosis. We pooled the estimates using inverse variance random-effects model. The effect sizes were reported as risk ratio (RR) with 95% confidence interval (CI). A total of 6 RCTs with 1,343 patients were included. At a follow-up ranging from 6-12 months from randomization, use of PCBs was associated with a statistically significant decrease in TLR (RR 0.28; 95% CI 0.11 to 0.68), and MACE (RR 0.35; 95% CI 0.20 to 0.64) when compared with BA for coronary ISR. However, there was no significant difference in risk between PCBs and BA in terms of all-cause mortality (RR 0.56; 95% CI 0.14 to 2.31), cardiovascular mortality (RR 0.61; 95% CI 0.02 to 16.85), MI (RR 0.60; 95% CI 0.27 to 1.31), and stent thrombosis (RR 0.13; 95% CI 0.00 to 5.06). In conclusion, this meta-analysis suggests that PCBs compared with uncoated BA for treatment of coronary ISR at intermediate term follow-up of one-year was associated with significant decrease in TLR, and MACE without any difference in mortality, MI, or stent thrombosis.

Drug-coated balloon angioplasty versus drug-eluting stent implantation in ACS patients with different angiographic patterns of in-stent restenosis

BackgroundDrug-coated balloon (DCB) angioplasty and drug-eluting stents (DES) are two widely used treatments for in-stent restenosis (ISR). Focal and non-focal types of ISR affect the clinical outcomes. The present study aims to compare DES reimplantation versus DCB angioplasty in acute coronary syndrome (ACS) patients with focal ISR and non-focal ISR lesions. MethodsPatients with ISR lesions underwent percutaneous coronary intervention (PCI) were retrospectively evaluated and divided into DES group and DCB group. The primary endpoint was the incidence of target lesion failure (TLF) at 24 months follow up. Propensity score matching (PSM) was conducted to balance the baseline characteristics. ResultsFor focal ISR, TLF was comparable in the DES and DCB groups at 24 months of follow-up (Before PSM, hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.39–1.27; p = 0.244; After PSM, HR: 0.83; 95% CI: 0.40–1.73; p = 0.625). For non-focal ISR, TLF was significantly decreased in DES compared with DCB group (Before PSM, HR: 0.43; 95% CI: 0.29–0.63; p < 0.001; After PSM, HR: 0.33; 95% CI: 0.19–0.59; p < 0.001), which was mainly attributed to the lower incidence of clinically indicated target lesion revascularization (CD-TLR) (Before PSM, HR: 0.39; 95% CI: 0.26–0.59; p < 0.001; After PSM, HR: 0.28; 95% CI: 0.15–0.54; p < 0.001). ConclusionsThe clinical outcomes for DES and DCB treatment are similar in focal type of ISR lesions. For non-focal ISR, the treatment of DES showed a significant decrease in TLF which was mainly attributed to a lower incidence of CD-TLR.

Comparative Study between Mechanical Rotational Atherectomy Combined with Drug-Coated Balloon versus Drug-Coated Balloon Alone for Treatment of In-Stent Restenosis during Peripheral Endovascular Interventions: A Multicentric Trial

Purpose: To compare the efficacy and safety of percutaneous mechanical debulking (PMD) using mechanical rotational atherectomy combined with paclitaxel drug-coated balloon (DCB) versus using paclitaxel DCB alone in the treatment of in-stent restenosis. Material and Methods: This is a multicentric retrospective observational study conducted over a period of 2 years from 2020 to 2022. The study included 49 patients presented with chronic limb-threatening ischemia (CLTI) associated with in-stent restenosis, either acute (&lt;14 days), subacute (&lt;3 months) or chronic (&gt;3 months). The enrolled patients underwent endovascular revascularization using either PMD combined with paclitaxel DCB or paclitaxel DCB only. They were followed up for 6 months after the intervention clinically and by duplex evaluation. Results: The lesion length was about 14.2 mm in the group treated by PMD+ DCB and 9.3 mm in the group treated by DCB alone. The technical success rate was the same between the two groups. However, the follow-up after 6 months showed that patencies for PMD + DCB and DCB alone were 15 (68.2%) patients and 15 (55.6%) patients, respectively (significant p value = 0.028). Procedural-related complications for PMD + DCB are distal embolization (9%) of cases and no vessel perforation. Regarding the candidates who were treated by DCB alone, there were minor groin hematomas (11.1%), distal arterial thrombosis (11.1%) and contrast-induced nephropathy (CIN) (11.1%) cases. Conclusion: The endovascular management of in-stent restenosis using percutaneous mechanical debulking (PMD) in conjunction with paclitaxel drug-coated balloon (DCB) showed that PMD combined with DCB is a safe and effective modality for achieving recanalization. It gives a satisfactory outcome in terms of technical success, freedom from clinically driven target lesion revascularization rate (CD-TLR) and mortality. Despite these promising results, further research with a large enrolled population may be required to determine the cost/benefit.

Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis

Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis