Long-term clinical outcomes of excimer laser coronary atherectomy for the management of recurrent in-stent restenosis.

BACKGROUND: Recurrent in-stent restenosis (ISR) remains a serious problem. Optimal modification of the underlying mechanism during index percutaneous coronary intervention (PCI) is key to prevent ISR. Excimer laser coronary atherectomy (ELCA) has its own indications and is among others used in recurrent ISR in case of stent underexpansion and/or diffuse neointimal hyperplasia. We aimed to assess the long-term clinical outcomes of ELCA for the management of recurrent ISR. METHODS: A multicenter, retrospective observational study was conducted. Patients with recurrent ISR who were additionally treated with ELCA were included. The primary outcome was major adverse cardiac events (MACE) defined as a composite of cardiovascular death, myocardial infarction, stroke, target lesion revascularization at 12 months, and longer term. RESULTS: Between 2014 and 2022, 51 patients underwent PCI with the additional use ELCA for recurrent ISR. Primary outcome occurred in 6 patients (11.8%) at 12 months and in 12 patients (23.5%) at a median follow-up of 4 (1-6) years. Technical and procedural success were achieved in 92% and 90% of cases, respectively. Coronary perforation occurred in 2 patients as a result of distal wire perforation, but was not ELCA-related. There were no in-hospital MACE. CONCLUSIONS: ELCA appears to be a safe method with acceptable long-term results for the management of recurrent ISR.

Comparison of Recurrent With First-Time In-Stent Restenosis.

Recurrent in-stent restenosis (Re-ISR) remains a therapeutic challenge. We aimed to investigate the clinical characteristics, treatment, and long-term outcomes in patients with Re-ISR compared with those with first-time ISR (First-ISR). This retrospective study consecutively enrolled patients who underwent percutaneous coronary intervention (PCI) for ISR in Fuwai Hospital between January 2017 and December 2018. Re-ISR was defined as a second event of ISR after a previous successful treatment of the ISR lesion. The primary outcome was defined as a composite of all-cause death, spontaneous myocardial infarction, and repeat revascularization. A total of 2,006 patients (2,154 lesions) with ISR underwent successful PCI were enrolled and categorized into 2 groups: the Re-ISR group (246 patients/259 lesions) and the First-ISR group (1,760 patients/1,895 lesions). During a mean follow-up of 36 months, the primary outcomes occurred in 80 patients (32.5%) in the Re-ISR group and 349 patients (19.3%) in the First-ISR group (p <0.001 by log-rank test), major driven by spontaneous myocardial infarction (4.9% vs 2.7%, p = 0.049) and repeat revascularization (30.1% vs 16.5%, p <0.001). The multivariable Cox regression analysis revealed that Re-ISR was independently associated with a higher rate of major adverse cardiovascular events (adjusted hazard ratio 1.88, 95% confidence interval 1.39 to 2.53, p <0.001) and repeated revascularization (adjusted hazard ratio 2.09, 95% confidence interval 1.53 to 2.84, p <0.001). The relation remained consistent after the propensity score analysis. In conclusion, in the present cohort of patients who underwent PCI for ISR, Re-ISR was significantly associated with a higher risk of long-term outcomes than First-ISR.

Prevention of in-stent restenosis with drug-eluting balloons in patients with postirradiated carotid stenosis accepting percutaneous angioplasty and stenting.

OBJECTIVE: To investigate the technical safety and outcome of in-stent restenosis (ISR) prevention with drug-eluting balloon (DEB) in patients with postirradiated carotid stenosis (PIRCS) undergoing percutaneous angioplasty and stenting (PTAS). METHODS: Between 2017 and 2021, we prospectively recruited patients with severe PIRCS for PTAS. They were randomly separated into two groups based on endovascular techniques performed with and without DEB. Preprocedural and early postprocedural (within 24 hours) MRI, short-term ultrasonography (6 months after PTAS), and long-term CT angiography (CTA)/MR angiography (MRA), 12 months after PTAS, were performed. Technical safety was evaluated based on periprocedural neurological complications and the number of recent embolic ischemic lesions (REIL) in the treated brain territory on diffusion-weighted imaging of early postprocedural MRI. RESULTS: Sixty-six (30 with and 36 without DEB) subjects were enrolled, with one failure in techniques. For 65 patients in the DEB versus conventional groups, technical neurological symptoms within 1 month (1/29 (3.4%) vs 0/36; P=0.197) and REIL numbers within 24 hours (1.0±2.1 vs 1.3±1.5; P=0.592) after PTAS showed no differences. Peak systolic velocity (PSVs) on short-term ultrasonography was significantly higher in the conventional group (104.13±42.76 vs .81.95±31.35; P=0.023). The degree of in-stent stenosis (45.93±20.86 vs 26.58±8.75; P<0.001) was higher, and there were more subjects (n=8, 38.9% vs 1, 3.4%; P=0.029) with significant ISR (≥ 50%) in the conventional group than in the DEB group on long-term CTA/MRA. CONCLUSIONS: We observed similar technical safety of carotid PTAS with and without DEBs. The number of cases of significant ISR were fewer and the degree of stenosis of ISR was less in primary DEB-PTAS of PIRCS than for conventional PTAS in the 12-month follow-up.

Intravascular Lithotripsy for Acute Stent Under-Expansion and In-Stent Restenosis: A Case Series.

Coronary in-stent restenosis (ISR) has an incidence of about 10% of percutaneous coronary interventions (PCIs) performed in the United States. Traditional management strategies for ISR include balloon angioplasty with non-compliant or use of cutting/scoring balloons or atheroablative therapies (like laser and rotational atherectomy), all of which are inherently limited in their ability to treat stent under-expansion or calcification around the stent. Shockwave intravascular lithotripsy (IVL) has recently demonstrated safe and efficacious treatment of severely calcified coronary stenoses with reported cases of treating ISR as an off-label use. In this case series, we describe the successful use of IVL for 6 cases of ISR and 1 case of stent under-expansion using 40-80 IVL pulses per lesion. Angiographic success was obtained in all seven patients, and there were no intra-procedural complications or adverse cardiac events at a mean follow-up of 200 days. Our report indicates that IVL can be safely and effectively used to treat ISR and stent under-expansion.

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.

BACKGROUND: This 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). METHODS: A 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. RESULTS: Patient, lesion, and procedural characteristics in both treatment groups were similar. Nine-month in-segment LL was 0.38 ±â€¯0.50 mm with Restore vs. 0.35 ±â€¯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. CONCLUSIONS: The two-year follow-up indicated sustained long-term clinical safety and efficacy for both devices on the basis of QFR value.

In-Stent Restenosis.

In-stent restenosis (ISR) remains a potential complication after percutaneous coronary intervention, even in the era of drug-eluting stents, and its treatment remains suboptimal. Neoatherosclerosis is an important component of the pathology of ISR and is accelerated in drug-eluting stents compared with bare-metal stents. Coronary angiography is the gold standard for evaluating the morphology of ISR, although computed tomography angiography is emerging as an alternative noninvasive modality to evaluate the presence of ISR. Drug-coated balloons and stent reimplantation are the current mainstays of treatment for ISR, and the choice of treatment should be based on clinical background and lesion morphology.

Long-term outcomes following drug-eluting balloons vs. thin-strut drug-eluting stents for treatment of recurrent restenosis in drug-eluting stents.

BACKGROUND: There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR). AIMS: To compare the long-term outcomes of patients treated with either a thin-strut drug-eluting stent (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES). METHODS: A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. The primary outcome was target lesion revascularization (TLR). RESULTS: Out of 311 patients (mean age, 67 years; 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3%, respectively; HR, 0.38; 95% CI, 0.17-0.86; P = 0.01). The risks of device-oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model, the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13-0.84; P = 0.02). CONCLUSIONS: In patients with R-ISR implantation of a thin-DES is associated with a lower risk of repeated revascularization compared with angioplasty with a DEB.

In-hospital and 1-Year Outcomes of Repeated Percutaneous Coronary Intervention for In-stent Restenosis With Acute Coronary Syndrome Presentation.

BACKGROUND: In-stent restenosis (ISR) is the Achilles' heel of percutaneous coronary intervention (PCI). There have been controversial data about outcomes of repeated PCI (redo-PCI) for ISR. This study aims to determine the predictors of major adverse cardiac events (MACE) in patients underwent redo-PCI for ISR. METHODS: In this retrospective study, all patients with acute coronary syndrome who were underwent successful PCI for ISR at Tehran Herat Center (between 2004 and 2019) were eligible for inclusion. Patients with moderate to severe valvular heart disease and/or hematological disorders were excluded. Participants were divided into 2 groups based on the occurrence of the MACE [composite of cardiovascular death, myocardial infarction (MI), coronary artery bypass grafting, target vessel revascularization, and target lesion revascularization]; then, the study variables were compared between the 2 groups. Finally, the predictors of MACE were identified using Cox regression analysis. RESULTS: Of 748 redo-PCI patients (mean age: 65.2 ± 10.1; 71.0% males), 631 patients had met the inclusion criteria. Fifty-four patients (9.8%) developed MACE within a 1-year follow-up period. Multivessel disease, primary PCI, Ad-hoc PCI, history of non-ST-segment elevation MI, and diabetes mellitus were independent predictors for MACE. In a subgroup analysis, 30 patients who experienced third PCI (target lesion revascularization/target vessel revascularization) were followed more as 1-year MACE. Among these patients, 14 MACEs were observed during the last follow-up (till June 2020). CONCLUSIONS: Multivessel disease, primary PCI, and history of non-ST-segment elevation MI were the predictors of higher 1-year MACE, whereas Ad-hoc PCI and diabetes mellitus had a protective effect on MACE.

Procedural Results and One-Year Clinical Outcomes of Treatment of Bioresorbable Vascular Scaffolds Restenosis (from the RIBS VII Prospective Study).

Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, n = 309) and RIBS V (BMS - ISR, n = 189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, p = 0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, p = 0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).

The Relationship Between APOE Gene Polymorphism and In-stent Restenosis After Stenting at the Beginning of the Vertebral Artery.

OBJECTIVE: To retrospectively investigate the relationship between apolipoprotein E (APOE) gene polymorphism and in-stent restenosis (ISR) after stenting at the beginning of the vertebral artery. METHODS: The study included 155 patients who successfully underwent stenting at the beginning of the vertebral artery and had postoperative digital subtraction angiography or computed tomography angiography. Based on the follow-up results, they were divided into the restenosis (ISR) group and non-restenosis (non-ISR) group. The clinical information and APOE genotypes of both groups were analyzed. A binary logistic regression model was used to analyze independent risk factors for ISR. RESULTS: After 1 year of follow-up, 49 (31.6%) patients had ISR and 106 (68.4%) did not. Binary logistic regression analysis showed that serum low-density lipoprotein cholesterol (LDL-C), serum lipoprotein-related phospholipase A2 (Lp-PLA2), and E3/E4 genotype were independent risk factors for ISR after stenting at the beginning of the vertebral artery. In addition, the LDL-C level of patients with the E3/E4 genotype was higher compared with the E3/E3 genotype group (P < 0.05). CONCLUSIONS: APOE gene polymorphism is associated with ISR, and the E3/E4 genotype is an independent risk factor for ISR after stenting at the beginning of the vertebral artery. Further genetic studies can identify risk genotypes to facilitate the early prediction and identification of high-risk patients with ISR.

Endoscopic Internal Thoracic Artery Harvesting with Changes in Scope Position.

Although minimally invasive direct coronary artery bypass (MIDCAB) is a less invasive procedure, internal thoracic artery (ITA) harvesting is difficult. A 65-year-old woman was advised to undergo MIDCAB for recurrent in-stent restenosis. We harvested the ITA using three-dimensional endoscopy without robotics and determined the scope position using enhanced computed tomography. We changed the camera installation between the wound and the camera port, according to the harvesting site with a harmonic scalpel using the skeletonized technique. We harvested the ITA from the subclavian vein level superiorly to the xyphoid process level inferiorly.

Stentectomy for LAD "full metal jacket" with in-stent restenosis: How to do it.

We report our technique for the surgical revascularization of symptomatic severe in-stent restenosis of a "full metal jacket" (≥60 mm overlapping stents) of the left anterior descending coronary artery without suitable distal targets: on-pump cardioplegic-arrest stent removal (stentectomy) with endarterectomy and skeletonized left internal mammary artery onlay patch reconstruction. We also describe our follow-up protocol, including antiplatelet/anticoagulation and angiography. With proper patient selection, multidisciplinary collaboration, and surgical expertise, this advanced coronary procedure can be beneficial to a growing population of patients otherwise deemed to be untreatable.

Long-term outcomes after treatment of in-stent restenosis using the Absorb everolimus-eluting bioresorbable scaffold.

BACKGROUND: Early studies evaluating the performance of bioresorbable scaffold (BRS) Absorb in in-stent restenosis (ISR) lesions indicated promising short-term to mid-term outcomes. AIMS: To evaluate long-term outcomes (up to 5 years) of patients with ISR treated with the Absorb BRS. METHODS: We did an observational analysis of long-term outcomes of patients treated for ISR using the Absorb BRS (Abbott Vascular, Santa Clara, California, USA) between 2013 and 2016 at the Heart Centre Luzern. The main outcomes included a device-oriented composite endpoint (DOCE), defined as composite of cardiac death, target vessel (TV) myocardial infarction and TV revascularisation, target lesion revascularisation and scaffold thrombosis (ScT). RESULTS: Overall, 118 ISR lesions were treated using totally 131 BRS among 89 patients and 31 (35%) presented with an acute coronary syndrome. The median follow-up time was 66.3 (IQR 52.3-77) months. A DOCE had occurred in 17% at 1 year, 27% at 2 years and 40% at 5 years of all patients treated for ISR using Absorb. ScTs were observed in six (8.4%) of the cohort at 5 years. CONCLUSIONS: Treatment of ISR using the everolimus-eluting BRS Absorb resulted in high rates of DOCE at 5 years. Interestingly, while event rates were low in the first year, there was a massive increase of DOCE between 1 and 5 years after scaffold implantation. With respect to its complexity, involving also a more unpredictable vascular healing process, current and future BRS should be used very restrictively for the treatment of ISR.

Effect of umbilical cord blood stem cell transplantation on restenosis after endovascular interventional therapy for diabetic hindlimb vascular disease.

This study aimed to investigate the mechanism of human umbilical cord blood stem cell (HUCBSC) transplantation on restenosis after percutaneous transluminal angioplasty (PTA) for diabetic hindlimb vascular disease in rabbits. After successfully preparing a rabbit model of diabetic hindlimb vascular disease, 16 rabbits were randomly assigned to two groups. Of these, 8 rabbits received PTA surgery alone (PTA group), and the other 8 rabbits received PTA and HUCBSC (PTA+HUCBSC group) treatments. Five more healthy rabbits were set as healthy control (HC group). Samples were collected after 4 weeks of treatment. The expressions of regulator of calcineurin 1 (RCAN1) and calcineurin A (CnA) in the diseased artery were detected by immunofluorescence staining. The distribution of HUCBSCs was observed by pathological examination in transplanted artery, distal artery, and liver. Cytology experiments were applied to assess the levels of JAK and STAT3, and the migration and proliferation of human aortic vascular smooth muscle cells (HA-VSMC). In the rabbit model of diabetic vascular lesions in the hindlimbs, we found the stenosis of the femoral artery became more and more serious with time, and the expression level of PCNA positive cells was also gradually increased. The expression levels of RCAN1 and CnA in the PTA+HUCBSC group were significantly lower than those in PTA group. HUCBSC inhibited the migration and proliferation of HA-VSMC via JAK/STAT3 pathway. After HUCBSC local transplantation, HUCBSC had no distal tissue distribution. HUCBSC transplantation may prevent restenosis after PTA of diabetic hindlimb vascular disease through JAK/STAT3 pathway.

Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. STUDY DESIGN: AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. CONCLUSION: This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Successful Retrieval of Entrapped Guide Extension Catheter in the Right Coronary Artery with Heavy Calcifications.

Usage of an optimal guide extension catheter often helps successful outcomes in complex percutaneous coronary intervention. Here, we report a case of successfully retrieving a guide extension catheter entrapped by a coronary stent in the middle RCA. The guide extension catheter was retrieved by anchoring with the stent delivery balloon. Also, our in vitro experiment demonstrated that a "deep seating method" and an "anchoring guide extension catheter method" could be effective in bailing out guide extension catheter entrapment.

Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study.

AIMS: Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. METHODS: One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. RESULTS: A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. CONCLUSION: Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).

Drug-coated balloon angioplasty versus balloon angioplasty for treating patients with in-stent restenosis in the femoropopliteal artery: A meta-analysis.

BACKGROUND: The introduction of endovascular surgery has led to frequent stent use, although in-stent restenosis (ISR) remains a challenging issue. Drug-coated balloon (DCB) and conventional balloon angioplasty (BA) are common endovascular procedures for addressing ISR in the femoropopliteal artery. However, there is controversy regarding which procedure provides the greatest benefit to patients. METHODS: The PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched for prospective controlled trials that compared DCB and BA for patients with ISR in the femoropopliteal artery. The study has been approved by Ethics Committee of Wuhan Central Hospital. RESULTS: The meta-analysis included 6 prospective trials with 541 patients. We found that DCB use was associated with significant reductions in binary restenosis at 6 months (relative risk [RR]: 0.45, 95% confidence interval [CI]: 0.33-0.63; P < .00001), binary restenosis at 1 year (RR: 0.44, 95% CI: 0.34-0.57; P < .00001), target lesion revascularization (TLR) at 6 months (RR: 0.36, 95% CI: 0.20-0.65; P = .0006), and TLR at 1 year (RR: 0.38, 95% CI: 0.27-0.54; P < .00001). The DCB group also had significantly better clinical improvement (RR: 1.39, 95% CI: 1.13-1.71; P = .002), although we did not detect inter-group differences in terms of death, target vessel thrombosis, or ipsilateral amputation. The brand of DCB may a cause of heterogeneity. CONCLUSION: Relative to BA, DCB use increases the durability of treatment for ISR in the femoropopliteal artery, based on significant reductions in binary restenosis and TLR at 6-12 months after the procedure. Furthermore, DCB use was associated with better clinical improvement. However, additional randomized controlled trials are needed to validate these findings.