Bailout Stenting Research Articles

Clinical outcome of low-dose and high-dose drug-coated balloon angioplasty with intraplaque wiring for femoropopliteal chronic total occlusion lesions.

Chronic total occlusion (CTO) lesions of the femoropopliteal artery have been shown to benefit from drug-coated balloon (DCB) angioplasty. However, because bailout stenting is often performed, the outcome of DCB angioplasty alone remains unknown, particularly the differences in outcomes between low-dose DCB (LD-DCB) and high-dose DCB (HD-DCB). To address these issues, we conducted a single-center, retrospective cohort study and enrolled 66 consecutive patients undergoing initial endovascular therapy with DCBs for femoropopliteal CTO lesions from June 2018 to February 2023. Of the 66 patients, 25 underwent LD-DCB angioplasty and 41 underwent HD-DCB angioplasty. In all lesions, no bailout stenting was performed and intraplaque wiring was confirmed by intravascular ultrasound. The primary outcome measure was 1-year primary patency and the secondary outcome measures were 1-year freedom from clinically driven target lesion revascularization (CD-TLR) and reocclusion. There were no significant differences between LD-DCB and HD-DCB angioplasty in patient and lesion characteristics, 1-year primary patency (76.4% vs. 85.9%, log-rank p = 0.51), CD-TLR (95.2% vs. 94.3%, log-rank p = 0.97), and reocclusion (95.0% vs. 94.3%, log-rank p = 0.99). Patients with two of the three risk factors for restenosis, i.e., minimum lumen area < 12.6 mm2, dissection angle > 63°, and calcification angle > 270°, had a significantly lower patency rate (no factor: 100% vs. 1 factor: 90.3% vs. 2 factors: 62.6%; log-rank p = 0.04). In patients undergoing DCB angioplasty for femoropopliteal CTO lesions, 1-year primary patency and freedom from CD-TLR were favorable, with no significant difference between LD-DCB and HD-DCB angioplasty.

Application of Drug-Eluting Stent With Drug-Coated Balloon Strategy for the Endovascular Treatment of Long-Segment Femoropopliteal Artery Disease.

Endovascular therapy (EVT) has emerged as a primary approach for managing femoropopliteal artery (FPA) lesions, leveraging drug-eluting stents (DESs), and drug-coated balloons (DCBs), to enhance clinical outcomes. Although a full DES coverage strategy is effective in treating complex lesions, concerns over long-term complications prompt the exploration of alternative strategies. The aim of this study was to investigate clinical result of combination therapy of DES with DCB and compare them with full DES implantation. This retrospective, single-center study analyzed 131 patients with occlusive FPA lesions treated at our institution between 2019 and 2022. Patients with Rutherford classification stages 2 to 5 who underwent successful EVT were included. The study compared the outcomes of the drug-within-drug (DWD) strategy, ie, combining DES for failed vessel preparation segments and DCB for successful ones, with those of full DES implantation. The primary outcomes were the primary patency rates, and the secondary outcomes included clinically-driven target lesion revascularization (CD-TLR) rates, restenosis patterns, and survival outcomes. Of the 131 patients initially considered, 118 met the inclusion criteria, with 45 in the DWD group and 73 in the full metal jacket (FMJ) stent group. The DWD group demonstrated equivalent 1-year primary patency rates (85.3%) to the FMJ group (87.9%, p=0.239). Similarly, no significant differences in CD-TLR rates were found between the 2 groups. The restenosis patterns and subsequent treatment strategies were not significantly different. The DWD strategy offers a viable alternative to full DES coverage in treating long-segment FPA lesions, with comparable restenosis and target lesion revascularization (TLR) rates. This approach may mitigate risks associated with full-length stenting, such as thrombosis, and challenges in repeat revascularizations by tailoring treatment to lesion characteristics. The DWD strategy represents a promising approach for complex FPA lesions, providing a balanced solution that potentially reduces long-term complications while maintaining effective patency and revascularization rates. The efficacy of drug-eluting stents (DES) in treating femoropopliteal artery (FPA) lesions has been well demonstrated. However, concerns remain regarding complications such as thrombotic occlusion and aneurysmal degeneration, especially when full stemt coverage of whole lesions is performed. The "Drug-with-Drug" (DWD) strategy, which involves implanting DES only at sites with severe dissection or residual stenosis after pre-balloon dilation and using drug coated balloons (DCB) for segments successfully prepared without stenting, has shown comparable outcomes to full stent coverage. Unlike traditional bailout stenting or spot stenting, the DWD approach maximizes the benefits of drug technology and presents a valuable option for treating long-segment FPA lesions.

Clinical Outcomes Following Low-Dose Second-Generation "Ranger" Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease.

To reveal the rate of 1-year freedom from restenosis and to determine the factors associated with the restenosis risk in femoropopliteal (FP) lesions treated with a Ranger drug-coated balloon (DCB) in real-world clinical settings. This multicenter, prospective observational study enrolled 1131 patients and 1453 de novo or restenotic FP lesions (mean age=75±9 years; female=35.3%, mean lesion length=19.2±16.0 cm; chronic total occlusion [CTO]=33.7%; severe calcification=33.7%) that underwent successful Ranger DCB angioplatsy between March 2021 and December 2022. The primary endpoint was 1-year freedom from restenosis and its associated factors. Bail-out stenting was performed in 5.3%. During the follow-up, restenosis was detected in 249 cases. Freedom from restenosis by the Kaplan-Meier analysis was estimated to be 85.2% and 81.0% at 12 and 14 months, whereas freedom from target lesion revascularization (TLR) was 91.7% and 90.0% at 12 and 14 months. The patterns of restenosis were focal (39.2%), tandem (12.3%), diffuse (17.2%), and occlusive (31.3%). Independent risk factors of restenosis were female sex, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO. Our study demonstrated that 1-year freedom from restenosis after Ranger DCB for FP lesions in a real-world clinical setting was acceptable. Independent predictors of restenosis were female gender, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO. Our study demonstrated the true performance of Ranger DCB in real-world practice, with a very low rate of bail-out stenting and no use of atherectomy devices. In addition, it also elucidated morphologies associated with restenosis and the risk factors for restenosis after DCB. Freedom from re-stenosis and TLR at 1-year after Range DCB angioplasty was 84.5% and 91.5%. Two thirds of restenosis had a non-occlusive pattern, and independent predictors of restenosis were female gender, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.

Polymer Everolimus-Eluting Stent as Bailout Stenting for Below-the-Knee Artery Repair in Patients with Critical Limb-Threatening Ischemia: A Real-World National Registry.

Percutaneous old balloon angioplasty is still the preferred treatment for the treatment of below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). In the case of a suboptimal angioplasty result, a bailout stenting is required. So far, few data are available to assess the outcomes of bailout stenting after BTK angioplasty. This study aims to investigate the 1-year efficacy and safety after implantation of a polymer everolimus-eluting stent (PEES) as bailout stenting for BTK repair in patients with CLTI in a real-world setting. This was a national multicenter prospective observational study. Patients with CLTI (Rutherford 4 to 6) BTK lesions (including P3) and requiring a bailout PEES due to dissection, thrombosis, or residual stenosis ≥30% after angioplasty were included. The freedom of a major adverse limb event at 12 months of the target limb was the primary endpoint. XIENCE assessed 106 limbs (CLTI, 96.2%; chronic total occlusion, 2.8%) in 106 patients (mean age 77.1 years; males, 71.7%; diabetes mellitus, 66.9%; chronic kidney failure, 36.8%) with CLTI undergoing PEES stenting as a bailout for BTK lesions. Bailout stenting was required after 75.5% and 26.4% of residual stenosis and dissection, respectively. The mean diameter and length of the PEES were 3 mm and 3.4 ± 0.5 cm, respectively. At 1 year, the freedom of a major adverse limb event was 79.6% (95% CI, 71.5%-88.7%), the major amputation rate was 6.2% (95% CI, 1.3%-11%), and the target revascularization rate was 14.9% (95% CI, 6.5%-22.5%). In CLTI patients with BTK lesions, PEES stenting showed safety and efficacy as bailout stenting for BTK arterial lesions. This confirms the need for PEES stenting in a real-world practice. The XIENCE study introduces the PEES as an effective bailout stenting option for patients with CLTI undergoing BTK revascularization, particularly for lesions under 4 cm. The study focuses on real-world cases where POBA alone is insufficient, demonstrating that PEES significantly improves outcomes by enhancing limb salvage and reducing the need for major amputations. For clinicians, this innovation offers a precise, size-adaptable solution, especially in cases where bailout stenting is required for short, focal lesions, improving both clinical and procedural results.

Jetstream Atherectomy with Paclitaxel-Coated Balloons: 3-Year Outcomes of the Prospective Randomized JET-RANGER Study

AbstractThe JET-RANGER study (NCT03206762) was a multicenter (11 U.S. centers), randomized trial, core-lab adjudicated and designed to demonstrate the superiority of Jetstream + paclitaxel-coated balloon (JET + PCB) versus percutaneous transluminal angioplasty (PTA) + PCB in treating femoropopliteal arterial disease. The 1- and 2-year outcomes have been recently published. The 3-year outcome data are presented in this report. The JET-RANGER trial initially had 47 patients with 48 lesions. Thirty-one in the JET-PCB arm and 16 in the PTA + PCB arm (2:1 randomization). At 3-year follow-ups, there were 20 patients in the JET-PCB arm and 14 patients in the PTA + PCB arm. Kaplan–Meier survival analysis was performed to estimate the freedom from target lesion revascularization (TLR) at 3 years. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value &lt; 0.05. Freedom from TLR was statistically similar between the two groups at 3 years between JET + PCB and PTA + PCB (freedom from TLR was 88.0 vs. 67.8%, respectively, p = 0.1380). There was also no significant difference in the change of ankle-brachial index (ABI) between the PTA + PCB and JET + PCB from baseline at 6 months (p = 0.7890), 1 year (p = 0.4070), 2 years (p = 0.7410), and 3 years (p = 0.8010). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more categories from baseline to 3 years (p = 0.8949). There were no minor or major amputations for either arm throughout the 3-year follow-up. Five JET + PCB patients died before the 3-year specified window and none in the PTA + PCB arm (p = 0.137). Two of the deaths were due to cancer and three due to cardiac causes. None were deemed related to the device or procedure. JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 3-year follow-up with no difference in amputation or mortality between the 2 arms. A trend toward less TLR was seen in the JET + PCB arm.

Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population.

Sirolimus-coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long-term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de-novo lesions from a real-world practice. To report long-term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions. We analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high-volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE). During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty-two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST-segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions ( 20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67). During the median follow-up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure. The results from this long-term follow-up in a real-world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

Drug-coated balloon versus drug-eluting stent for femoropopliteal total occlusions: intraluminal versus subintimal approaches

Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach.Clinical Trial Registration: NCT02748226.

One-year Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon for Femoropopliteal Artery Lesions: BEASTARS Study Results.

Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease. Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently. After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm2 vs 14 mm2, p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014). In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more). The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.

Mean Pressure Gradient and Fractional Flow Reserve at A Superficial Femoral Artery Dissection after Drug-Coated Balloon Angioplasty.

Residual dissection is a concern in endovascular treatment with a DCB, and there is limited knowledge of hemodynamics at a dissection lesion. Therefore, the objective of this study is to evaluate the mean pressure gradient (MPG) and fractional flow reserve (FFR) at a residual dissection after DCB angioplasty for the superficial femoral artery (SFA). A total of 59 cases with residual SFA dissection treated with DCB angioplasty at a single center were analyzed retrospectively. The dissection was classified into 6 types (A-F). The primary endpoints were MPG and FFR at a residual dissection lesion after DCB angioplasty, using evaluation with a pressure wire. The median lesion length was 70 (40-130) mm with 24% popliteal involvement, and 11 cases (18%) had chronic total occlusion. A completion angiogram revealed dissection of types A (n = 33, 56%), B (n = 18, 31%), C (n = 7, 12%), and D (n = 1, 2%). The median MPGs in type A, B, and C cases were 0 (0-2), 0 (0-4), and 3 (0-6) mmHg, with a significant lower in type C cases than in type A cases (A vs C, P = .021). The median FFRs in type A, B, and C cases of 1.0 (.98-1.00), 1.0 (.96-1.00), and .98 (.95-1.00) did not differ significantly among dissection types (A vs B, P = .86; A vs C, P = .055; B vs C, P = .15). This is the first report of hemodynamics at a SFA dissection. The results suggest that low-grade dissection (types A or B) does not affect MPG and FFR at a SFA lesion. This indicates that a bailout stent may be unnecessary for patients with dissection of types A or B. A further investigation is needed to determine whether a scaffold is required for a SFA lesion with type C dissection.

A latent bleeding complication in ipsilateral common femoral puncture involving delayed diagnosis: a case report

BackgroundThe trans femoral ipsilateral approach is often adopted for endovascular treatment (EVT) for better steerability of guidewires or better device deliverability. However, contrary to the trans femoral contralateral approach, ipsilateral antegrade puncture sometimes causes peculiar bleeding complications.Case presentationA 76-year-old female underwent EVT for chronic occlusion of the left superficial femoral artery (SFA) via the ipsilateral antegrade approach. After guidewire passage, we inflated the drug-coated balloons, but angiography showed blood flow stasis at the mid segment of the SFA. We also ensured prolonged balloon inflation, which resulted in favorable blood flow. While trying to ensure hemostasis, the blood pressure remained decreased, but neither bleeding nor superficial hematoma were observed at the puncture site. After hemostasis was achieved, we removed the surgical drape and noticed a swelling in the mid-portion of the thigh, distant from the puncture point. We then approached the left common femoral artery (CFA) contralaterally. Angiography showed continuous bleeding from a little bit distally to the sheath insertion point that was spreading through an intramuscular space. We stopped the bleeding with balloon tamponade inside the CFA. Angiography after hemostasis demonstrated blood flow stasis at the mid-segment of the SFA, similarly as that seen before. We confirmed compression of the SFA by a large hematoma using both intra- and extra- vascular ultrasound. Therefore, we deployed a self-expandable stent at the compressed SFA position. Finally, we achieved favorable blood flow on angiography.ConclusionWe encountered a case that latent bleeding unrecognized in the surgical field persisted while prolonged inflation of DCB was conducted at just proximal SFA. We could have avoided bailout stenting by noticing the bleeding incident in a timely manner. Prediction and prevention are essential for all kinds of procedural complications in EVT.

Directional atherectomy with anti-restenotic therapy versus open repair in patients with restenotic disease after surgical revascularization of the common femoral artery.

This study evaluated the performance of directional atherectomy with anti-restenotic therapy (DAART) compared to surgery in patients with restenosis of the groin arteries after endarterectomy or femoral bypass anastomosis. Consecutive patients with restenotic lesions from two vascular surgery units were retrospectively evaluated. Detailed medical history, type of previous reconstruction, anatomical and perioperative data, 30-day mortality and morbidity as well as data during follow-up were documented. The primary outcome measure was primary patency, whereas technical success, secondary patency, target lesion revascularization (TLR), freedom from major amputation, overall morbidity and mortality were additionally evaluated. The endovascular (25 patients) and surgical (17 patients) groups were comparable regarding the initial surgical reconstruction, demographics, comorbidities and medication. In the DAART group technical success was 100% without any residual stenosis >30%, distal embolization, perforation or bailout stenting. Hospital stay was shorter after DAART (medial 2 vs. 7 days, P<0.001), while more wound complications were documented in the surgical group within the first 30-days (29.4% vs. 0%, P=0.004). Primary patency, secondary patency and TLR were comparable between the groups (66.7% vs. 64.7%, HR 0.95, 95% CI 0.3-2.9, P=0.93, 86.4% vs. 93.8%, HR 0.65, 95% CI 0.65-6.6, P=0.71, 68% vs. 70.6%, HR 0.95, 95% CI 0.3-2.9, P=0.93, respectively). During follow-up no major amputation was observed, the improvement of the Rutherford class was comparable between the two groups and there were two deaths in the surgical group. In this study, DAART for restenotic atherosclerotic disease of the common femoral artery and its branches is a safe alternative to redo surgery and is associated with shorter hospital stay, fewer wound complications, comparable patency and freedom from TLR rates.

Angiographic and clinical impact of balloon inflation time in percutaneous coronary interventions with sirolimus-coated balloon: A subanalysis of the EASTBOURNE study

IntroductionPercutaneous coronary intervention (PCI) with drug-coated balloon (DCB) is an attractive strategy for the treatment of obstructive coronary artery disease (CAD). The implantation technique strongly influences the outcome of DCB PCI: accurate and adequate lesion preparation, short delivery time and sufficient DCB inflation time are deemed crucial to warrant adequate drug transfer and mitigate the risk of immediate vessel recoil and flow-limiting dissections. However, the optimal DCB inflation time is unclear, current consensus documents suggesting 30–60 s based on Experts' opinion. However, clinical studies comparing the prognostic role of different inflation times are scarce and mainly involve paclitaxel-coated balloons. In this study we aimed to assess the impact of different inflation times in patients undergoing PCI with a sirolimus-coated balloon (SCB). MethodsWe conducted a post-hoc analysis of the prospective, multicenter, EASTBOURNE study, classified into two study groups according to balloon inflation time: long (>30 s) versus short (≤30 s). The primary endpoint was target lesion revascularization (TLR) at 24-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, non-fatal myocardial infarction (MI), and BARC 2–5 bleedings. Furthermore, angiographic endpoints (the rate of bailout stenting and post-procedural TIMI flow <3) were also addressed. ResultsA total of 2289 lesions (2092 in the long inflation group, 197 in the short inflation group) were included in the analysis. Median balloon inflation time was 60 s in the long inflation and 30 s in the short inflation group. The two study groups experienced a similar rate of TLR [6.2 % in the short versus 6.3 % in the long inflation group, p = 1.00] as well MACE (p = 0.683), death (p = 0.102), non-fatal MI (p = 0.822), and BARC 2–5 bleedings (p = 0.252). These results were consistent when considering subpopulations with different target lesion phenotypes (in-stent restenosis, de-novo lesions, large and small vessels). Interesting, the rate of bailout stent implantation and post-procedural TIMI flow <3 was higher in the short SCB inflation time, as compared to the standard strategy. ConclusionsShort vs. long SCB inflation time is associated with a higher need of bailout stenting after PCI with SCB, with similar clinical outcomes at 24-month follow-up.

Angiographic patterns after drug-coated balloon angioplasty for de novo coronary lesions.

Drug-coated balloon (DCB) angioplasty has emerged as an effective treatment option for de novo coronary artery lesions; however, the chronic-phase angiographic patterns after DCB angioplasty for de novo lesions have not yet been described. The aim of the present study was to evaluate chronic-phase angiographic classification after DCB angioplasty. This was a single-centre, retrospective, observational study. From June 2016 to August 2022, 708 lesions (670 patients) underwent DCB angioplasty for de novo coronary lesions. Successful DCB angioplasty was defined as a non-flow-limiting dissection, with residual stenosis ≤30% and absence of a bailout stent. A total of 337 lesions (318 patients) were enrolled in this study. Of the 337 lesions analysed, 91.1% (n=307) were in the non-restenosis group, and 8.9% (n=30) were in the restenosis group. The non-restenosis group was classified into non-restenosis (45.1%; n=152) and lumen enlargement (46.0%; n=155). The restenosis group was classified into focal restenosis (5.0%; n=17), diffuse restenosis (3.6%; n=12), and occlusive restenosis (0.3%; n=1). There were no aneurysms, and plaque cavities were often observed (8.0%). During the chronic phase, residual dissection was seen in only one case (0.3%). This report demonstrates for the first time the angiographic classification after DCB angioplasty for de novo coronary lesions. Restenosis patterns were seen in 8.9% of lesions, and half of the restenosis patterns presented a focal restenosis pattern. Late lumen enlargement was observed in 46% of the treated lesions.

Drug-coated balloon angioplasty with provisional stenting versus primary stenting for the treatment of de novo coronary artery lesions: REC-CAGEFREE I trial rationale and design

BackgroundPercutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain.Study designThe REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization.DiscussionThe ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting.Trial registrationRegistered on clinicaltrial.gov (NCT04561739).

Safety and Effectiveness of Debulking for the Treatment of Infrainguinal Peripheral Artery Disease. Data From the Recording Courses of vascular Diseases Registry in 2910 Patients.

We investigated the safety and efficacy of debulking infrainguinal lesions in patients with peripheral artery disease (PAD) undergoing endovascular revascularization (EVR) as part of the RECording Courses of vascular Diseases (RECCORD) registry. Patient and lesion specific characteristics, including the lesion complexity score (LCS) were analyzed. The primary endpoint encompassed: (i) clinical improvement in Rutherford categories, (ii) index limb re-interventions, and (iii) major amputations during follow-up. The secondary endpoint included the need for bail-out stenting. Overall, 2910 patients were analyzed; 2552 without and 358 with debulking-assisted EVR. Patients were 72 (interquartile range (IQR) = 15) years old and 1027 (35.3%) had diabetes. Overall complication rates were similarly low in the debulking vs the non-debulking group (4.7 vs 3.2%, P = .18). However, peripheral embolizations rates were low but more frequent with debulking vs. non-debulking procedures (3.9 vs 1.1%, P < .001). After adjustment for clinical and lesion-specific parameters, including LCS, no differences were noted for the primary endpoint (odds ration (OR) = 0.99, 95%CI = 0.69-1.41, P = .94). Bail-out stenting was less frequently performed in patients with debulking-assisted EVR (OR = 0.5, 95%CI = 0.38-0.65, P < .0001). Debulking-assisted EVR is currently used in ∼12% of EVR with infrainguinal lesions and is associated with lower bail-out stent rates but higher peripheral embolization rates; no differences were found regarding index limb re-intervention and amputation rates.

Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial

Unsuccessful recanalisation or reocclusion after thrombectomy is associated with poor outcomes in patients with large vessel occlusion (LVO) acute ischaemic stroke (LVO-AIS). Bailout angioplasty or stenting (BAOS) could represent a promising treatment for these patients. We conducted a randomised controlled trial with the aim to investigate the safety and efficacy of BAOS following thrombectomy in patients with LVO. ANGEL-REBOOT was an investigator-initiated, multicentre, prospective, randomised, controlled, open-label, blinded-endpoint clinical trial conducted at 36 tertiary hospitals in 19 provinces in China. Participants with LVO-AIS 24 h after symptom onset were eligible if they had unsuccessful recanalisation (expanded Thrombolysis In Cerebral Infarction score of 0-2a) or risk of reocclusion (residual stenosis >70%) after thrombectomy. Eligible patients were randomly assigned by the minimisation method in a 1:1 ratio to undergo BAOS as the intervention treatment, or to receive standard therapy (continue or terminate the thrombectomy procedure) as a control group, both open-label. In both treatment groups, tirofiban could be recommended for use during and after the procedure. The primary outcome was the change in modified Rankin Scale score at 90 days, assessed in the intention-to-treat population. Safety outcomes were compared between groups. This trial was completed and registered at ClinicalTrials.gov (NCT05122286). From Dec 19, 2021, to March 17, 2023, 706 patients were screened, and 348 were enrolled, with 176 assigned to the intervention group and 172 to the control group. No patients withdrew from the trial or were lost to follow-up for the primary outcome. The median age of patients was 63 years (IQR 55-69), 258 patients (74%) were male, and 90 patients (26%) were female; all participants were Chinese. After random allocation, tirofiban was administered either intra-arterially, intravenously, or both in 334 [96%] of 348 participants. No between-group differences were observed in the primary outcome (common odds ratio 0·86 [95% CI 0·59-1·24], p=0·41). Mortality was similar between the two groups (19 [11%] of 176 vs 17 [10%] of 172), but the intervention group showed a higher risk of symptomatic intracranial haemorrhage (eight [5%] of 175 vs one [1%] of 169), parenchymal haemorrhage type 2 (six [3%] of 175 vs none in the control group), and procedure-related arterial dissection (24 [14%] of 176 vs five [3%] of 172). Among Chinese patients with unsuccessful recanalisation or who are at risk of reocclusion after thrombectomy, BAOS did not improve clinical outcome at 90 days, and incurred more complications compared with standard therapy. The off-label use of tirofiban might have affected our results and their generalisability, but our findings do not support the addition of BAOS for such patients with LVO-AIS. Beijing Natural Science Foundation, National Natural Science Foundation of China, National Key R&D Program Beijing Municipal Administration of Hospitals Incubating Program, Shanghai HeartCare Medical Technology, HeMo (China) Bioengineering, Sino Medical Sciences Technology.

Impact of Drug-Coated Balloon-Based Revascularization in Patients with Chronic Total Occlusions.

Background: Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) for chronic total coronary occlusions (CTOs) improves clinical symptoms and quality of life. However, data on drug-coated balloon (DCB)-based PCI in CTO lesions are limited. Methods: A total of 200 patients were successfully treated for CTO lesions, either with DCB alone or in combination with DES (DCB-based PCI). They were compared with 661 patients who underwent second-generation DES implantation for CTO from the PTRG-DES registry (DES-only PCI). The endpoint was major adverse cardiovascular events (MACEs), which included a composite of cardiac death, myocardial infarction, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years. Results: In the DCB-based PCI group, 49.0% of patients were treated with DCB only and 51.0% underwent the hybrid approach combining DCB with DES. Bailout stenting was performed in seven patients (3.5%). The DCB-based PCI group exhibited fewer stents (1.0; IQR: 0.0-1.0 and 2.0; IQR: 1.0-3.0, p < 0.001), shorter stent lengths (6.5 mm; IQR: 0.0-38.0 mm and 42.0 mm; IQR: 28.0-67.0 mm, p < 0.001), and lower usage of small stents with a diameter of 2.5 mm or less (9.8% and 36.5%, p < 0.001). Moreover, the DCB-based PCI group had a lower rate of MACEs than the DES-only PCI group (3.1% and 13.2%, p = 0.001) at 2-year follow-up. Conclusions: The DCB-based PCI approach significantly reduced the stent burden, particularly in the usage of small stent diameters, and resulted in a lower risk of MACEs compared to DES-only PCI in CTO lesions.

Sex-Specific Analysis of Mid-Term Outcomes of Atherectomy-Assisted Endovascular Treatment in Severe Peripheral Arterial Disease.

Background: Endovascular treatment of lower-extremity peripheral disease (PAD) is associated with higher complication rates and suboptimal outcomes in women. Atherectomy has shown favourable outcomes in calcified lesions, minimising the incidence of stent placement caused by recoil or flow-limiting dissection. To date, there are no published mid-term outcomes evaluating the performance of atherectomy differentiated by sex. This study aims to evaluate sex-specific outcomes and prognostic factors affecting the results of atherectomy-assisted endovascular treatment in severe PAD. Methods: A retrospective analysis was conducted at a single centre in Germany, initiated by physicians and not sponsored by industry, on patients presenting with Rutherford categories ranging from III to V and featuring de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries. The intervention involved rotational atherectomy-assisted angioplasty utilising the Jetstream (Boston, US®) device. The point of interest of this study was postinterventional clinical improvement as well as mid-term outcomes, including primary patency, over a targeted 2-year follow-up period. Statistical analysis utilised Cox regression (survival analysis) to calculate hazard ratios according to sex category. Comparative survival analysis was performed using the log-rank test and visually represented through Kaplan-Meier curves. Risk factors associated with absence of clinical improvement were examined across both sex groups utilising the chi-square or Fisher exact test, as appropriate. Results: A total of 98 patients (103 limbs) were initially included, with >75% having moderate-to-severe lesion calcification (>50%). A total of 84 patients (97 limbs, 62 male and 35 female) proceeded to a 2-year follow-up (mean 16.4 months for males and 16.1 for females) after a successful index procedure. Age distribution, Rutherford class, diabetes, chronic kidney disease (CKD), target vessel, lesion type, and length were balanced among both groups. Similar primary patency rates, of 89% among female and 91% among male limbs, were observed (p = 0.471). Female patients exhibited a lower rate of clinical improvement based on the Rutherford scale in comparison to males (80.6% vs. 94.5%, p = 0.048). CDK was the only significant prognostic factor across pooled data (odds ratio for CKD: 15.15, p < 0.001). Conclusions: Rotational atherectomy showed comparably high rates of mid-term primary patency, with low rates of bailout stent placement. These findings highlight the beneficial use of atherectomy in female patients who are per se at risk for higher rates of complications during and after endovascular interventions.

Drug-coated balloon versus drug-eluting stenting coronary angioplasty for ST-elevation myocardial infarction: a systematic review and meta-analysis of real-world studies

Abstract Funding Acknowledgements None. Introduction In the realm of ST-elevation myocardial infarction (STEMI), drug-eluting stent angioplasty (DES) is a well-established strategy for urgent revascularization. However, several challenges arise when selecting stents for these patients. These challenges include dealing with endothelial oedema and vasospasm during acute thrombotic occlusion. Moreover, there are concerns surrounding DES-related complications. These complications include the need for prolonged anti-platelet therapy, which increases the risk of bleeding, late stent thrombosis, and in-stent restenosis (ISR). In light of these issues, drug-coated balloons (DCB) have emerged as a compelling alternative. Purpose: This study aims to explore the safety and efficacy of DCB compared to conventional DES angioplasty in the management of STEMI. Methods A systematic literature search was conducted across electronic databases (PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov, reference lists of relevant publications, and grey literature sources) for studies published from the inception of DCB up to 31st August 2023. Results Nine eligible studies, consisting of four randomised controlled trials and two retrospective propensity-matched studies, were included. These studies, all single-center, involved a total of 2,122 patients (934 in the DCB versus 1,188 in the DES group) over a median follow-up period of 15 months (ranging from 6 to 36 months). The meta-analysis showed no statistically significant differences between DCB and DES angioplasty in terms of technical success (OR: 1.82, 95% CI: 0.22-15.08, p = 0.58), major adverse cardiovascular events (MACE) (OR: 1.24, 95% CI: 0.60–2.56, p = 0.57), all-cause mortality (OR: 1.20, 95% CI: 0.83–1.75, p = 0.33), cardiac death (OR: 1.40, 95% CI: 0.47-4.17, p = 0.54), cardiovascular-related hospitalization (OR: 0.72, 95% CI: 0.32-1.65, p = 0.44), recurrent myocardial infarction (OR: 0.99, 95% CI:0.34-2.90, p = 0.99), target lesion revascularization (OR: 1.15, 95% CI: 0.56–2.34, p = 0.71), late luminal loss (SMD: -0.25mm, 95% CI: -1.05 to 0.54, p = 0.53), postoperative TIMI flow (OR: 1.16, 95% CI: 0.54-2.50, p = 0.71), fractional flow reserve (MD: 0.012, 95% CI -0.018 to 0.032, p = 0.27), and bleeding risk (7.2% in DCB versus 7.5% in DES). It's noteworthy that 8.2% of patients in the DCB group required bailout stenting due to coronary artery dissection type C, a rate 10 times higher than that in the DES group (p &amp;lt; 0.005). Additionally, DCB angioplasty displayed a statistically significant presence of residual stenosis compared to DES angioplasty (OR: 6.48, 95% CI: 1.13-37.2, p = 0.04). Conclusion DCB angioplasty demonstrates promise but presents unique challenges in STEMI management, particularly in complex scenarios requiring bailout stenting and residual stenosis. The study contributes to the ongoing discussion about the role of DCBs in optimizing STEMI treatment, highlighting their potential benefits and areas of concern.

Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.