Plain Old Balloon Angioplasty Research Articles

Evaluation of the efficacy of combined device strategies for long femoropopliteal artery disease.

One of the major problems associated with bare nitinol stent implantation is stent fracture, particularly in the popliteal artery. The purpose of this study was to determine whether drug coated balloons (DCB), interwoven stents (IWS), or plain old balloon angioplasty (POBA) would be suitable for use in distal femoropopliteal (FP) long lesions when an Eluvia stent was implanted proximal to a lesion. This was a multi-center retrospective study enrolling patients undergoing concomitant use of Eluvia with DCB, IWS or POBA for symptomatic atherosclerotic femoropopliteal disease (lesion length > 15cm) [Rutherford category 2-6] between January 2018 and September 2021. 79 patients with 89 femoropopliteal lesions were enrolled in this study. The mean lesion length and the percentage of the popliteal artery involvement was 24.3 ± 6.4cm vs 24.0 ± 9.0cm vs 26.6 ± 6.2cm and 65.8% vs 89.4% vs 67.8% for the Eluvia + DCB, Eluvia + IWS, and Eluvia + POBA groups, respectively. The 1-year Kaplan-Meier estimates of primary patency and freedom from major adverse limb events (MALEs) were 53.3% vs 44.1% vs 24.2% and 62.4% vs 51.0% vs 28.1%, respectively. Eluvia + POBA was associated with a lower rate for 1-year primary patency (HR 2.49; 95% confidence interval (CI): 1.28-4.87; p = 0.007 and HR 2.38; 95% CI: 1.13-5.77; p = 0.04). In SFA long lesions with proximal Eluvia implantation, distal implantations of either a DCB or IWS were comparable, as opposed to POBA alone which generated worse results.

Use of Rotational Atherectomy-Assisted Balloon Angioplasty in the Treatment of Isolated Below-the-Knee Atherosclerotic Lesions in Patients with Chronic Limb-Threatening Ischemia.

The aim of the study is to evaluate the safety and effectiveness of rotational atherectomy-assisted balloon angioplasty (BTK-RA) for the treatment of isolated below the knee (BTK) atherosclerotic lesions and to compare the outcomes to plain old balloon angioplasty (POBA). Between January 2020 and September 2023, 96 consecutive patients with chronic limb threatening ischemia (CTLI) and isolated BTK-lesions underwent POBA (group A) or BTK-RA (group B). The primary outcome measures were: periprocedural technical success, primary patency, postoperative increase of the ankle branchial index (ABI), target lesion revascularization (TLR), limb salvage, minor amputation and death. Both techniques had similar technical success, operative time, intraprocedural complications and bailout stent implantations, independently of the operator's experience. Group B had significantly higher primary patency rates (93.5% vs. 72.0%, respectively, p = 0.006), TLR (2.1% vs. 24%, p = 0.057), lower in-hospital stay (2.0-3.0 vs. 4.0-6.0 days, respectively, p < 0.001) and higher postoperative ABI (0.8-0.2 vs. 0.7-0.1, respectively, p = 0.008), compared to group A. Significant differences (POBA n: 20, 40%, BTK-RA n = 3, 6.5%) were found in minor amputation rates between the two groups (p < 0.001), while the respective limb salvage rates were similar in both groups (94.0% vs. 97.8%, p = 0.35). The use of BTK-RA for the treatment of BTK-lesions in patients with CTLI showed significant clinical advantages in comparison to POBA.

Comparing Endovascular Approaches in Lower Extremity Artery Disease: Insights from a Network Meta-Analysis.

Endovascular therapy offers an alternative for treating femoropopliteal (FP) and infrapopliteal (IP) lesions related to occlusive lower extremity artery disease. Despite numerous trials, the effectiveness of restenosis prevention using local drug delivery devices remains a topic of debate. An updated systematic review and network meta-analysis was conducted. Our overall aim was to summarize the most recent clinical evidence regarding endovascular approaches for FP and IP atherosclerotic lesions. We conducted a search for randomized trials in the MEDLINE database, and extracted data related to clinical endpoints. Our primary focus was on the rate of major adverse events (MAEs), including mortality, amputation, and target lesion revascularization (TLR). A multiple treatment network meta-analysis supplemented with component network analyses was performed to examine the impact of combined treatment. Our search yielded 33 randomized controlled trials encompassing 5766 patients. This included 19 studies focused on femoropopliteal and 14 on IP lesions, accounting for 3565 and 2201 patients, respectively. Drug-coated balloons (DCBs) and drug-eluting stents (DESs) displayed a reduced MAE risk in comparison to plain old balloon angioplasty (POBA)-RR for DCB: 0.64 (95% CI: 0.52-0.77) and for DES: 0.71 (95% CI: 0.51-0.99). The bare-metal stent (BMS) group manifested the most substantial MAE risk, being 59% higher relative to the DCB cohort (BMS vs. DCB RR: 1.59; 95% CI: 1.03-2.47). For FP lesions, DES was the standout performer, curtailing MAE risk by 55% relative to POBA. Within IP lesions, DES mitigated the MAE risk by 25% versus POBA. DCB did not exhibit any notable MAE reduction when pitted against POBA. In FP arteries, both DESs and DCBs yielded significantly diminished MAEs, thus outpacing other techniques. Regarding IP arteries, only DESs resulted in significantly fewer MAEs. In alignment with contemporary research, our findings revealed no signs of elevated mortality in patients undergoing treatment with drug-eluting apparatuses.

Matched comparison of uncoated and paclitaxel-coated balloon angioplasty for isolated popliteal lesions excluding bail-out stenting

ObjectiveTo evaluate the safety and effectiveness of drug-coated balloon angioplasty (DCB) in isolated popliteal lesions. BackgroundThe benefit of using DCB in femoropopliteal arteries including the proximal popliteal artery has been demonstrated, but has not yet been evaluated for isolated popliteal lesions. MethodsThis retrospective, single-center study includes patients requiring treatment with DCB of isolated popliteal lesions. Two cohorts matched (Plain old balloon angioplasty (POBA) versus DCB) by their baseline and lesion characteristics were compared. Lesions receiving bail-out stents were excluded. Primary endpoint was the 1-year target lesion revascularization (TLR) rate. Secondary endpoints included the procedural success and complication rate, primary patency, changes in Rutherford-Becker class (RBC) and ankle-brachial index (ABI). ResultsOne hundred and seven patients were included in this study. More than one third of the patients had critical limb threatening ischaemia (CLTI) (35 % (POBA) versus 40.4 % (DCB), p = 0.354. The technical success rate of the procedure was 85.1 % (n = 40/47) in the DCB group and 83.3 % (n = 60) in the POBA group (p = 0.510). There were three complications in the POBA group (5.0 %) but none in the DCB group (p = 0.172).After 12 months, in the entire cohort 14 patients (13.1 %) had to undergo a TLR. The TLR-free survival was 81.7 % in the POBA and 93.6 % in the DCB group (p = 0.060). Primary patency rates after POBA and DCB were 65.1 % and 87.5 % at 6 months (p = 0.024), respectively. At 12 months, the patency rates were 71.7 % and 85.1 % (p = 0.076), respectively. For both treatment arms, there was a significant improvement in ABI and RBC compared to baseline.Four patients from the DCB group and two from the POBA group received a minor amputation (p = 0.232). One patient in the DCB group died within 12 months. ConclusionAfter one year the use of DCB is by trend more effective for the treatment of isolated popliteal stenosis compared to POBA. A larger scale prospective study is mandatory.

Ultrasound-Assessed Lesion Morphology and Drug-Coated Balloon Treatment for de novo Dysfunctional Arteriovenous Fistula in Hemodialysis Patients.

This study aimed to evaluate the effect of ultrasound-assessed lesion morphology on the outcomes of drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) treatment for de novo dysfunctional arteriovenous fistulas (AVF) lesions. This single-center retrospective study enrolled 114 consecutive patients (mean age, 73 ± 10 years; male, 69%) with de novo dysfunctional AVF lesions who underwent percutaneous transluminal angioplasty (PTA) using DCB (n = 48) and POBA (n = 66). The morphology of the stenotic lesions, evaluated using ultrasonography, was classified into intimal hyperplasia and shrinking types. The outcome measure was 12-month primary patency. Factors associated with loss of primary patency were evaluated using Cox proportional hazards models. The baseline characteristics were not significantly different between the 2 treatment groups. The 12-month primary patency rate was significantly higher in the DCB group than in the POBA group (66.8 ± 7.1% versus 35.9 ± 6.3%, P = .006). The 12-month primary patency rate in the lesions with intimal hyperplasia type was not significantly different (DCB: 70.3 ± 9.5% versus POBA: 45.9 ± 8.0%; P = .310), whereas that in the shrinking type was significantly higher in the DCB group than in the POBA group (61.9 ± 10.6% versus 15.2 ± 8.1%; P < .001). The interaction analysis demonstrated that lesion morphology had a significantly different hazard ratio (HR) for restenosis between the POBA and DCB groups (P for interaction = .031). The multivariate analysis revealed that DCB usage (adjusted hazard ratio [aHR], 0.49; 95% confidence interval [CI]: [0.28, 0.87]; P = .015), ultrasound-assessed lesion morphology (shrinking type: aHR, 1.77; 95% CI: [1.07, 2.93]; P = .026), and location of stenosis (aHR, 2.26; 95% CI: 1.15, 4.46; P = .018) were significantly associated with AVF patency after PTA. This study revealed that lesion morphology evaluated using ultrasonography had a differential impact on DCB and POBA outcomes. The therapeutic effect of DCB was unexpectedly confirmed in the shrinking type. The effectiveness of DCB in inhibiting smooth muscle cell proliferation in intimal hyperplasia lesions was expected based on the known mechanism of action of paclitaxel. However the therapeutic effect of DCB was unexpectedly confirmed in the shrinking type too. We may not need to hesitate usage of DCB for shrinking type.

Randomized clinical trial to compare the efficacy of self-expanding bare metal nitinol stent and balloon angioplasty alone for below-the-knee lesions following successful balloon angioplasty: 1-year clinical outcomes.

This prospective, multicenter, randomized study aimed to compare the 1-year clinical outcomes after primary stenting with self-expanding bare metal nitinol stent (SENS) and plain old balloon angioplasty (POBA) in patients with critical limb ischemia (CLI) and below-the-knee (BTK) lesions. Overall, 119 patients with CLI and BTK lesions were randomized to POBA alone (POBA group, 61 patients) or primary stenting with SENS (stenting group, 58 patients) after achieving acceptable POBA results in target BTK lesions. Clinical outcomes including amputation and revascularization rates were prospectively compared for 1 year. After 1 year, similar incidence rates of individual clinical endpoints, including cardiac death (6.5% vs. 5.1%, p > 0.999), myocardial infarction (1.6% vs. 0.0%, p > 0.999), repeat revascularization (19.6% vs. 18.9%, p = 0.922), target lesion revascularization (13.1% vs. 17.2%, p = 0.530), and amputation (4.9% vs. 0.0%, p = 0.244), were observed. POBA appeared to have acceptable treatment outcomes compared with primary stenting with SENS after 1 year in CLI patients with BTK lesions undergoing percutaneous transluminal angioplasty (PTA).

In vivo evaluation of intravascular lithotripsy in a healthy porcine coronary model

Abstract Objectives In this study, we aimed to investigate the vascular response to an intravascular lithotripsy (IVL) shockwave balloon in a healthy porcine coronary artery model. Background IVL is a novel clinical technique for modifying heavily calcified atherosclerotic plaques. Methods A total of 24 porcine coronary arteries were treated with IVL or plain old balloon angioplasty (POBA). Histology, histomorphometry, quantitative coronary angiography analysis (QCA), and optical coherence tomography (OCT) were performed post-procedure and at 1-month follow-up (1M-FU). Results There was no significant difference in the late lumen loss and diameter stenosis (determined by QCA) and the minimal lumen area (evaluated by OCT) of the IVL and POBA groups at 1M-FU. Pathological analysis revealed that the lumen and neointima areas were similar between the two groups. However, the medial and adventitial layers were more prominent in the IVL than in the POBA group. The injury score and inflammation of the media and adventitia increased dramatically in the IVL group post-procedure and at 1M-FU. At 1M-FU, media fibrin deposition and adventitial fibrosis were also significantly increased in the IVL group. However, there was no significant difference in neointima fibrin deposition, endothelialization, and thrombosis between both groups. Layered separation of the media and adventitia was observed in the IVL group. Conclusion The findings indicate that the IVL balloon did not cause serious intimal hyperplasia and endothelial damage compared with the effects of POBA in the healthy coronary artery. However, shock waves may cause unique damage to the vascular media and adventitia in the coronary artery, which was not observed in the peripheral artery.Device introductionPathological image at 1M FU

Comparative Analysis of Mortality and Amputation Rates in Patients Undergoing Atherectomy for Infra-Popliteal Peripheral Arterial Disease: Insight From the VQI.

Infra-popliteal peripheral arterial disease (IPPAD) poses challenges due to high restenosis and occlusion rates. The BASIL-2 trial demonstrated the superiority of endovascular treatment compared with surgical bypass in patients with IPPAD. However, the association between different endovascular modalities and clinical outcomes has not been conclusive. Combining plain old balloon angioplasty (POBA) with atherectomy is associated with improved clinical outcomes compared with POBA alone. Patients who underwent POBA vs POBA+atherectomy for IPPAD from the Vascular Quality Initiative database were identified. To mitigate potential selection bias, we employed propensity score matching (PSM) to balance the distribution of confounding variables for mortality identified on multivariable logistic regression. Subsequently, we compared patient characteristics and long-term outcomes between the 2 treatment groups. Among patients who underwent endovascular intervention for IPPAD, 19 979 individuals (80.8%) were treated with POBA alone, while 4747 (19.2%) were treated with both POBA+atherectomy after PSM. Propensity score matching ensured minimal differences in baseline characteristics, such as indication for lower extremity revascularization (LER) and history of LER. After PSM, patients receiving POBA+atherectomy experienced higher rates of technical success and lower perioperative complications, such as renal complications and hematoma, compared with POBA alone. During long-term follow-up, patients who underwent atherectomy had lower rates of major amputation and major adverse limb events (MALE) but slightly lower freedom from reintervention. Nonetheless, there were no differences in mortality. Combining POBA with atherectomy appears to be a safe approach in patients with IPPAD, with lower rates of long-term amputation and MALE at the cost of a higher risk of reintervention. The use of adjunctive atherectomy is associated with improved long-term outcomes in patients with infra-popliteal disease.

Drug-Coated Balloon-Only Strategy for De Novo Coronary Artery Disease: A Meta-analysis of Randomized Clinical Trials.

Many clinical trials have demonstrated the value of drug-coated balloons (DCB) for in-stent restenosis. However, their role in de novo lesions is not well documented. The aim of this study is to evaluate the safety and efficacy of the DCB-only strategy compared to other percutaneous coronary intervention strategies for de novo coronary lesions. The PubMed, Embase, Web of Science, and Cochrane Library Central Register of Controlled Trials (CENTRAL) electronic databases were searched for randomized controlled trials published up to May 6, 2023. The primary outcomes were major adverse cardiac events and late lumen loss. A total of eighteen trials with 3336 participants were included. Compared with drug-eluting stents, the DCB-only strategy was associated with a similar risk of major adverse cardiac events (risk ratio (RR) = 0.90; 95% confidence interval (CI): 0.59 to 1.37, P = 0.631) and a significant decrease in late lumen loss (standardized mean difference (SMD) = -0.29, 95% CI: -0.53 to -0.04, P = 0.021). This effect was consistent in subgroup analysis regardless of indication, follow-up time, drug-eluting stent type, and dual antiplatelet therapy duration. However, DCBs were inferior to DESs for minimum lumen diameter and percentage diameter stenosis. The DCB-only strategy showed significantly better outcomes for most endpoints compared to plain-old balloon angioplasty or bare metal stents. Interventions with a DCB-only strategy are comparable to those of drug-eluting stents and superior to plain-old balloon angioplasty or bare metal stents for the treatment of selected de novo coronary lesions. Additional evidence is still warranted to confirm the value of DCB before widespread clinical utilization can be recommended.

In-Stent Restenosis and Stent Thrombosis: An Elusive Target

SCAI Expert Consensus Statement on Management of In-Stent Restenosis and Stent ThrombosisJournal of the Society for Cardiovascular Angiography & Interventions100971PreviewStent failure remains the major drawback to the use of coronary stents as a revascularization strategy. Recent advances in imaging have substantially improved our understanding of the mechanisms underlying these occurrences, which have in common numerous clinical risk factors and mechanical elements at the time of stent implantation. In-stent restenosis remains a common clinical problem despite numerous improvements in-stent design and polymer coatings over the past 2 decades. It generates significant health care cost and is associated with an increased risk of death and rehospitalization. Full-Text PDF Open Access The dynamics of percutaneous coronary intervention (PCI) have changed significantly since the inception of stents. For the past 3 decades, there has been constant evolution in stent technology, but reducing the incidence of stent thrombosis (ST) and in-stent restenosis (ISR), 2 major Achilles’ heels, has proven elusive. Initially, stents were approved for the treatment of tackling acute dissections and abrupt closure after plain old balloon angioplasty (POBA).1Sigwart U. Puel J. Mirkovitch V. Joffre F. Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty.N Engl J Med. 1987; 316: 701-706Crossref PubMed Scopus (1544) Google Scholar Later, approval was granted for the prevention of restenosis based on the results of randomized clinical trials demonstrating the superiority of bare-metal stents (BMS) over POBA, with lower restenosis rates.2Serruys P.W. de Jaegere P. Kiemeneij F. et al.A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group.N Engl J Med. 1994; 331: 489-495Crossref PubMed Scopus (4396) Google Scholar When they were launched, BMS had high rates of ST and ISR,3Tada T. Byrne R.A. Simunovic I. et al.Risk of stent thrombosis among bare-metal stents, first-generation drug-eluting stents, and second-generation drug-eluting stents: results from a registry of 18,334 patients.J Am Coll Cardiol Intv. 2013; 6: 1267-1274Crossref Scopus (258) Google Scholar,4Moses J.W. Leon M.B. Popma J.J. et al.Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.N Engl J Med. 2003; 349: 1315-1323Crossref PubMed Scopus (4092) Google Scholar which called into question their utility in coronary intervention; however, ST rates were mitigated with the utilization of antiplatelet therapy. The issue of ISR was addressed with the development of drug-eluting stents (DES), utilizing antiproliferative drugs such as paclitaxel and sirolimus that suppressed smooth muscle proliferation, delayed reendothelialization, and reduced neointimal formation.4Moses J.W. Leon M.B. Popma J.J. et al.Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.N Engl J Med. 2003; 349: 1315-1323Crossref PubMed Scopus (4092) Google Scholar,5Stettler C. Wandel S. Allemann S. et al.Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis.Lancet. 2007; 370: 937-948Abstract Full Text Full Text PDF PubMed Scopus (1307) Google Scholar Although first-generation DES markedly reduced the rates of ISR when compared with BMS, they spiked the rates of subacute, late, and very late ST, which were associated with serious cardiac events, including myocardial infarction and death.5Stettler C. Wandel S. Allemann S. et al.Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis.Lancet. 2007; 370: 937-948Abstract Full Text Full Text PDF PubMed Scopus (1307) Google Scholar, 6Hong M.K. Mintz G.S. Lee C.W. et al.Intravascular ultrasound predictors of angiographic restenosis after sirolimus-eluting stent implantation.Eur Heart J. 2006; 27: 1305-1310Crossref PubMed Scopus (226) Google Scholar, 7Jensen L.O. Thayssen P. Christiansen E.H. et al.Safety and efficacy of everolimus- versus sirolimus-eluting stents: 5-year results from SORT OUT IV.J Am Coll Cardiol. 2016; 67: 751-762Crossref PubMed Scopus (101) Google Scholar This led to a recommendation for a minimum of 12 months of dual antiplatelet therapy (DAPT) after PCI.8Fihn S.D. Gardin J.M. Abrams J. et al.2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.Circulation. 2012; 126: 3097-3137Crossref PubMed Scopus (339) Google Scholar Prolonged DAPT mitigates the rates of ST but is associated with patient compliance issues and an increase in the bleeding rate, creating the need for a safer stent. Therefore, the quest for further improvement in the performance of DES continued and led to the development of second- and third-generation DES. Iterations in stent design, reduction in strut thickness, utilizing biocompatible or biodegradable polymers, reduction of drug load, and switching from paclitaxel to limus-based drugs further reduced the rates of ST and restenosis.9Gada H. Kirtane A.J. Newman W. et al.5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions).J Am Coll Cardiol Intv. 2013; 6: 1263-1266Crossref Scopus (179) Google Scholar In addition, the utilization of intravascular imaging and better understanding of concepts such as stent expansion, stent malapposition, and adequate vessel preparation contributed to additional improvement of post-PCI outcomes. The randomized controlled trials comparing second- vs first-generation DES have shown favorable data with considerably lower rates of ST7Jensen L.O. Thayssen P. Christiansen E.H. et al.Safety and efficacy of everolimus- versus sirolimus-eluting stents: 5-year results from SORT OUT IV.J Am Coll Cardiol. 2016; 67: 751-762Crossref PubMed Scopus (101) Google Scholar,10Maeng M. Tilsted H.H. Jensen L.O. et al.Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial.Lancet. 2014; 383: 2047-2056Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar and have allowed for shorter durations of DAPT, from 12 months to 1 month, especially in patients known to have a high bleeding risk.11Mehran R. Cao D. Angiolillo D.J. et al.3- or 1-month DAPT in patients at high bleeding risk undergoing everolimus-eluting stent implantation.J Am Coll Cardiol Intv. 2021; 14: 1870-1883Crossref Scopus (32) Google Scholar On the ISR front, although DES reduced the overall restenosis rates, they are still associated with an increase in late and very late restenosis, with rates of up to 3% per year,7Jensen L.O. Thayssen P. Christiansen E.H. et al.Safety and efficacy of everolimus- versus sirolimus-eluting stents: 5-year results from SORT OUT IV.J Am Coll Cardiol. 2016; 67: 751-762Crossref PubMed Scopus (101) Google Scholar,9Gada H. Kirtane A.J. Newman W. et al.5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions).J Am Coll Cardiol Intv. 2013; 6: 1263-1266Crossref Scopus (179) Google Scholar,12Kastrati A. Mehilli J. Pache J. et al.Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents.N Engl J Med. 2007; 356: 1030-1039Crossref PubMed Scopus (906) Google Scholar accounting for up to 10% of procedures in contemporary practice and remaining a therapeutic challenge. To solve this lingering issue, a look back toward the principle of medical practice focusing on the old saying “prevention is better than treatment” is necessary. Adequate vessel preparation before stent implantation and imaging-guided stent implantation have demonstrated a further reduction in ISR and ST and are essential before stent deployment.6Hong M.K. Mintz G.S. Lee C.W. et al.Intravascular ultrasound predictors of angiographic restenosis after sirolimus-eluting stent implantation.Eur Heart J. 2006; 27: 1305-1310Crossref PubMed Scopus (226) Google Scholar,13Fujii K. Mintz G.S. Kobayashi Y. et al.Contribution of stent underexpansion to recurrence after sirolimus-eluting stent implantation for in-stent restenosis.Circulation. 2004; 109: 1085-1088Crossref PubMed Scopus (271) Google Scholar Currently, we have enough evidence, including randomized trials, demonstrating that the use of intracoronary imaging-guided revascularization is associated with lower rates of major adverse cardiac events and target lesion revascularization compared with angiographic guidance.14Hong S.J. Mintz G.S. Ahn C.M. et al.Effect of intravascular ultrasound–guided drug-eluting stent implantation: 5-year follow-up of the IVUS-XPL randomized trial.J Am Coll Cardiol Intv. 2020; 13: 62-71Crossref Scopus (98) Google Scholar,15Gao X.F. Ge Z. Kong X.Q. et al.3-year outcomes of the ULTIMATE trial comparing intravascular ultrasound versus angiography-guided drug-eluting stent implantation.J Am Coll Cardiol Intv. 2021; 14: 247-257Crossref Scopus (75) Google Scholar Despite this, intracoronary imaging modalities, including intravascular ultrasound (IVUS) and optical coherence tomography (OCT), continue to be underutilized (<25%) during PCI in the United States.16Elgendy I.Y. Ha L.D. Elbadawi A. et al.Temporal trends in inpatient use of intravascular imaging among patients undergoing percutaneous coronary intervention in the United States.J Am Coll Cardiol Intv. 2018; 11: 913-915Crossref Scopus (29) Google Scholar The standardized use of intracoronary imaging during de novo coronary disease intervention with optimal vessel preparation before deploying the stent should be a fundamental step toward the prevention of ISR. For example, calcified lesions should be treated by adjunctive atherectomy or intravascular lithotripsy before stent deployment.17Bhogal S, Garcia-Garcia HM, Klein A, et al. Intravascular lithotripsy for the treatment of severely calcified coronary artery disease: a DISRUPT CAD III intravascular ultrasound substudy. Cardiovasc Revasc Med. Published online March 11, 2023. doi:10.1016/j.carrev.2023.03.003Google Scholar Intracoronary imaging is also essential in understanding the mechanism of ISR and should be the key initial step when approaching the management of stent failure pathologies. Although the use of either IVUS or OCT is interchangeable, ISR is a special clinical scenario where the use of OCT may be preferred due to the limited ability to evaluate neoatherosclerosis by IVUS. The use of intracoronary imaging not only outlines the underlying mechanism of stent failure—mechanical or biological—but also determines the treatment strategy for the target lesion. The underutilization of intracoronary imaging can be improved by training interventional cardiologists and identifying physical barriers obscuring its use. The OCT-ISR app is a free educational tool to understand different types of ISR, with examples of OCT images and their treatment methodology. Mechanical issues, including stent underexpansion and stent undersizing, are most likely mitigated by high-pressure balloons such as the OPN-NC (SIS Medical AG) balloon or off-label use of intravascular lithotripsy. Stent fracture is also best evaluated by OCT and is characterized by the absence of stent struts at the site of the fracture, with a predisposition to nonuniform drug distribution, and will most likely need implantation of another layer of the stent. Well-expanded stents with severe neointimal hyperplasia may be best treated with brachytherapy, drug-coated balloons (DCBs) if available, or an additional layer of DES. The final question remains how to optimally treat ISR of DES. POBA alone is associated with a high recurrence rate, and adding another layer of stent for the treatment of DES-ISR, although the most common therapy today, is not desired. This leaves DCBs as a potential first-line treatment of DES-ISR. Although the DCB is an appealing technology, its future utilization is subjected to the results of well-powered randomized clinical trials testing their noninferiority to DES. With the initial promising results of both paclitaxel- and sirolimus-based DCBs,18Costa R.A. Mandal S.C. Hazra P.K. et al.Sirolimus-coated balloon with a microsphere-based technology for the treatment of de novo or restenotic coronary lesions.Cardiovasc Revasc Med. 2022; 45: 18-25Crossref PubMed Scopus (2) Google Scholar,19Xu B. Gao R. Wang J. et al.A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial.J Am Coll Cardiol Intv. 2014; 7: 204-211Crossref Scopus (125) Google Scholar the randomized studies will assess DCB safety and efficacy against standard-of-care POBA or best-in-class second-generation DES for the treatment of ISR. Meanwhile, vascular brachytherapy remains the most potent option for second and further recurrences of ISR,20Varghese M.J. Bhatheja S. Baber U. et al.Intravascular brachytherapy for the management of repeated multimetal-layered drug-eluting coronary stent restenosis.Circ Cardiovasc Interv. 2018; 11e006832Crossref PubMed Scopus (26) Google Scholar but it is also associated with late recurrences, and unfortunately its availability is limited to only a few centers in the United States. Keeping this in mind, the SCAI Expert Consensus Statement on the Management of In-Stent Restenosis and Stent Thrombosis21Klein L.W. Nathan S. Maehara A. et al.SCAI expert consensus statement on management of in-stent restenosis and stent thrombosis.J Soc Cardiovasc Angiogr Interv. 2023; 2Google Scholar is a commendable step toward standardizing guidelines for treating stent failure pathologies. The expert consensus document discusses risk factors and various classifications and stresses the importance of using intracoronary imaging to determine the cause and choosing effective management strategies for the treatment of both ISR and ST. This document can be used to better understand the modifiable factors that can result in improved outcomes of stenting for coronary intervention and can be used as guidance for the prevention and treatment of both ST and ISR. Over the past 3 decades, investigators have been asking whom to blame for the adverse events related to stents. Are they related to the stent technology, the patient and lesion complexity, or the operator’s technique? The answer is most likely all of the above. Nevertheless, ISR and ST rates are in constant decline (Figure 1)22Cassese S. Byrne R.A. Tada T. et al.Incidence and predictors of restenosis after coronary stenting in 10 004 patients with surveillance angiography.Heart. 2014; 100: 153-159Crossref PubMed Scopus (319) Google Scholar, 23Corbett S.J. Cosgrave J. Melzi G. et al.Patterns of restenosis after drug-eluting stent implantation: insights from a contemporary and comparative analysis of sirolimus- and paclitaxel-eluting stents.Eur Heart J. 2006; 27: 2330-2337Crossref PubMed Scopus (69) Google Scholar, 24Zhang J. Gao X. Kan J. et al.Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE Trial.J Am Coll Cardiol. 2018; 72: 3126-3137Crossref PubMed Scopus (298) Google Scholar and a moving target due to the awareness and improvements that have been implemented over the years. Finally, after 3 decades of stenting every vessel and every lesion, we should ask the questions “Are we placing too many stents?” and “Is it time to consider other emerging technologies such as biodegradable scaffolds or DCBs, which promote the concept of leaving nothing behind?” Although biodegradable scaffolds were removed from marketing in the United States due to mixed results when compared with DES, DCBs are emerging as an alternative to DES for de novo lesions and have the potential to further reduce the rates of ST and ISR by reduction of usage of stents. DCBs may be considered for broadened use if proven to be noninferior to DES in randomized clinical trials, especially in small and distal vessel lesions and in bifurcation lesions. The premise of this technology is simple: do not cage the vessel with metal, and you will not have ST or ISR. Hence, stent technology will continue to be challenged for continued improvements until the abolishment of ST and ISR, or it will be replaced by other emerging technologies in the future. Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems. Sukhdeep Bhogal reported no financial interests.

Treatment effect of medial arterial calcification in below-knee after Auryon laser atherectomy using micro-CT and histologic evaluation

PurposeTo determine the frequency of medial arterial calcification (MAC) fracture following Auryon laser atherectomy using micro-CT and histologic evaluation in an atherosclerotic human cadaveric limb model. MethodsTwo below-the-knee calcified arterial segments from human cadaver limbs underwent treatment with the Auryon laser system with or without plain old balloon angioplasty (POBA). Micro-CT and angiography were performed before and after treatment followed by histological evaluation of regions showing calcium disruption. ResultsAll treatment zones were successfully treated with the Auryon laser (n = 9). Six of 9 treatment zones showed calcium fracture on micro-CT. Each treatment zone was further subdivided using micro-CT analysis (36 evaluated sections) of which 18 sections revealed calcium fracture. Sections with calcium fracture had significantly more confluent and uninterrupted circumferential calcification than sections without calcium fracture (arc of calcification 360.0 [323.7–360.0] vs 312.8 [247.4–314.2] degree, p = 0.007), whereas there were no differences in size of calcium burden (3.4 [2.8–3.9] vs 2.8 [1.3–4.6] mm2, p = 0.46). No arterial dissection or rupture was seen. ConclusionsAuryon laser atherectomy produced fractures of medial arterial calcification in this cadaveric human atherosclerotic peripheral artery model. This effect was observed in arterial segments with a pattern of circumferential uninterrupted calcification (i.e. larger arc of calcification) regardless of calcium burden. Our pilot data suggests Auryon laser may be a promising therapy for calcified lesions.

Cost-Effectiveness of Drug-Coated Balloon Angioplasty versus Plain Old Balloon Angioplasty for Arteriovenous Fistula Stenosis.

To compare the cost-effectiveness of drug-coated balloon angioplasty (DCB) versus plain old balloon angioplasty (POBA) for treatment of arteriovenous fistula (AVF) stenosis. A Markov model was created to compare DCB versus POBA for AVF stenosis over a 2-year time horizon from a United States payer's perspective. Probabilities related to complications, restenosis, retreatment, and all-cause mortality were obtained from published literature. Costs were calculated using Medicare reimbursement rates and data from published cost analyses, inflation-adjusted to 2021. Health outcomes were measured with quality-adjusted life years (QALY). Probabilistic and deterministic sensitivity analyses were performed with a willingness-to-pay threshold of $100,000/QALY. Base case calculation showed better quality-of-life outcomes but increased cost with POBA compared to DCB, with an incremental cost-effectiveness ratio of $27,413/QALY, making POBA the more cost-effective strategy in the base case model. Sensitivity analyses showed that DCB becomes cost-effective if the 24-month mortality rate after DCB is no more than 3.4% higher than that after POBA. In secondary analyses where mortality rates were equalized, DCB was more cost-effective than POBA until its additional cost reached more than $4213 per intervention. When modeled from a payer's perspective over 2years, the cost utility of DCB versus POBA varies with mortality outcomes. POBA is cost-effective if 2-year all-cause mortality after DCB is greater than 3.4% higher than after POBA. If 2-year mortality after DCB is less than 3.4% higher than after POBA, DCB is cost-effective until its additional cost per procedure exceeds $4213 more than POBA. HISTORICALLY CONTROLLED STUDY.: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Combined treatment of dysfunctional dialysis access with cutting balloon and paclitaxel-coated balloon in real world.

Background: Dysfunction in arteriovenous (AV) access is a common reason for subsequent intervention. To evaluate the results of endovascular treatment of AV access lesions using cutting balloon (CB) and drug-coated balloon (DCB) angioplasty compared to standard treatment using plain-old balloon angioplasty (POBA). Patients and methods: Patients who retrospectively were selected from a prospectively maintained database. Primary endpoint was primary patency rate at the target lesion up to 12 months after index procedure. Secondary endpoints were the acute treatment success, the "bail out" stent rate, primary patency at 6 months, freedom from target lesion revascularization (TLR), AV access replacement and surgical revision during a follow-up period up to 12 months, and all-cause mortality rate stratified to patients treated with and without DCB. Results: One hundred and eighty-four patients met the inclusion criteria. POBA as stand alone or combined with DCB angioplasty was performed in 71 patients (38.6%), CB in 54 patients (29.3%), and in 59 patients (32.1%), both CB and DCB were used. Primary patency rate at 12 months was 31.6% for the POBA/DCB-group, 52.3% for the CB-group, and 64.8% for the CB/DCB-group, respectively. In total, 80 patients (51.6%) had a TLR including endovascular or surgical revision, or a shunt replacement. All-cause mortality at 12 months was 7.2% in the DCB group and 9.1% in the group of patients treated without a DCB (p=0.747). Conclusions: The use of CB seems to be crucial for a better outcome. The combination of CB and DCB achieves the best patency results at mid-term.

In vivo evaluation of intravascular lithotripsy in a healthy porcine coronary model

In this study, we aimed to investigate the vascular response to an intravascular lithotripsy (IVL) shockwave balloon in a healthy porcine coronary artery model. IVL is a novel clinical technique for modifying heavily calcified atherosclerotic plaques. A total of 24 porcine coronary arteries were treated with IVL or plain old balloon angioplasty (POBA). Histology, histomorphometry, quantitative coronary angiography analysis (QCA), and optical coherence tomography (OCT) were performed postprocedure and at 1-month follow-up (1M-FU). There was no significant difference in the late lumen loss and diameter stenosis (determined by QCA) and the minimal lumen area (evaluated by OCT) of the IVL and POBA groups at 1M-FU. Pathological analysis revealed that the lumen and neointima areas were similar between the two groups. However, the medial and adventitial layers were more prominent in the IVL than in the POBA group. The injury score and inflammation of the media and adventitia increased dramatically in the IVL group postprocedure and at 1M-FU. At 1M-FU, media fibrin deposition and adventitial fibrosis were also significantly increased in the IVL group. However, there was no significant difference in neointima fibrin deposition, endothelialization, and thrombosis between both groups. Layered separation of the media and adventitia was observed in the IVL group. The findings indicate that the IVL balloon did not cause serious intimal hyperplasia and endothelial damage compared with the effects of POBA in the healthy coronary artery. However, shock waves may cause unique damage to the vascular media and adventitia in the coronary artery, which was not observed in the peripheral artery.

Drug-Eluting Stents: Technical and Clinical Progress.

Drug-eluting stents (DES) demonstrated superior efficacy when compared to bare metal stents and plain-old balloon angioplasty and are nowadays used in almost all percutaneous revascularization procedures. The design of the stent platforms is constantly improving to maximize its efficacy and safety. Constant development of DES includes adoption of new materials used for scaffold production, new design types, improved overexpansion abilities, new polymers coating and, finally, improved antiproliferative agents. Especially nowadays, with the immense number of available DES platforms, it is crucial to understand how different aspects of stents impact the effect of their implantation, as subtle differences between various stent platforms could impact the most important issue-clinical outcomes. This review discusses the current status of coronary stents and the impact of stent material, strut design and coating techniques on cardiovascular outcomes.

Comparison of outcomes for balloon angioplasty, atherectomy, and stenting in the treatment of infrapopliteal disease for chronic limb-threatening ischemia.

We evaluated limb salvage (LS), amputation-free survival (AFS), and target extremity reintervention (TER) after plain old balloon angioplasty (POBA), stenting, and atherectomy for treatment of infrapopliteal disease (IPD) with chronic limb-threatening ischemia (CLTI). All index peripheral vascular interventions for IPD and CLTI were identified from the Vascular Quality Initiative registry. Of the multilevel procedures, the peripheral vascular intervention type was indexed to the infrapopliteal segment. Propensity score matching was used to control for baseline differences between groups. Kaplan-Meier and Cox regression were used to calculate and compare LS and AFS. The 3-year LS for stenting vs POBA was 87.6% vs 81.9% (P= .006) but was not significant on Cox regression analysis (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.56-0.76; P= .08). AFS was superior for stenting vs POBA (78.1% vs 69.5%; P= .001; HR, 0.73; 95% CI, 0.60-0.90; P= .003). LS was similar for POBA and atherectomy (81.9% vs 84.8%; P= .11) and for stenting and atherectomy (87.6% vs 84.8%; P= .23). The LS rate after propensity score matching for POBA vs stenting was 83.4% vs 88.2% (P= .07; HR, 0.71; 95% CI, 0.50-1.017; P= .062). The AFS rate for stenting vs POBA was 78.8% vs 69.4% (P= .005; HR, 0.69; 95% CI, 0.54-0.89; P= .005). No significant differences were found between stenting and atherectomy (P= .21 for atherectomy; and P= .34 for POBA). The need for TER did not differ across the groups but the interval to TER was significantly longer for stenting than for POBA or atherectomy (stenting vs POBA, 12.8months vs 7.7months; P= .001; stenting vs atherectomy, 13.5months vs 6.8months; P< .001). Stenting and atherectomy had comparable LS and AFS for patients with IPD and CLTI. However, stenting conferred significant benefits for AFS compared with POBA but atherectomy did not. Furthermore, the interval to TER was nearly double for stenting compared with POBA or atherectomy. These factors should be considered when determiningthe treatment strategy for this challenging anatomic segment.

EPH96 Risk Factors for Below-the-Knee Amputation in Japanese Patients With Critical Limb Ischemia Who Underwent Plain Old Balloon Angioplasty Therapy: A Claims Database Analysis

Plain old balloon angioplasty (POBA) is a common endovascular therapy for below-the-knee lesions in patients with critical limb ischemia (CLI). However, restenosis often develops, resulting in amputation. This study examined the risk factors for below-the-knee amputation (BKA) in CLI patients that underwent POBA.

Standard Balloon Angioplasty Versus Serranator Serration Balloon Angioplasty for the Treatment of Below-the-Knee Artery Occlusive Disease: A Single-Center Subanalysis From the PRELUDE-BTK Prospective Study.

Endovascular interventions in infrapopliteal occlusive artery disease are becoming more complex, and this frequently tests the standard method of treatment, plain old balloon angioplasty (POBA). The potential that serration angioplasty could produce a more acceptable tibial artery lumen was assessed in this study. The aim of this single-center subgroup analysis was to compare acute angiographic results after endovascular treatment using the Serranator serration balloon catheter in patients participating in the PRELUDE-BTK trial with POBA of the infrapopliteal arteries. A secondary objective was to assess post-treatment hemodynamic improvements. Our center enrolled 15 subjects and treated 17 lesions within the multicenter prospective core laboratory-adjudicated PRELUDE-BTK study. A 25 lesions analyzed separately were treated with POBA and then compared with the Serranator subset. In both cohorts, lesions were treated with either plain angioplasty or Serranator as a stand-alone therapy; subsequent methods, such as drug elution technologies, were not used. Acute angiographic results were analyzed by the SynvaCor angiographic core laboratory. To assess volumetric flow rates, data were analyzed with a fluid flow simulation software and compared against Poiseuille's Law. Final residual stenosis was 17.2%±8.2% in the Serranator group versus 33.7%±15.7% in the POBA group. The mean lumen diameter (MLD) gain for the Serranator group and the POBA group was 1.64±0.41 mm and 1.33±0.63 mm, respectively. The average atmospheric balloon inflation pressure was 5 ATM in the Serranator group versus 9 ATM in the POBA group. Neither group required a bailout stent; however, it was notable that there were significantly more chronic total occlusions (CTOs) treated in the Serranator group at 41.2% versus 12% in the POBA group. Regarding the effectiveness in improving hemodynamic blood flow for non-CTO lesions, the calculated average ratio of post-treatment to pre-treatment flow rates in the Serranator group was 238% than that for the POBA group. For CTO cases where pre-treatment flow rate was zero, final residual stenosis was used as the parameter for comparison. The Serranator group showed a 62% improvement in final residual stenosis over POBA. Endovascular treatment of the infrapopliteal arteries by use of the Serranator serration balloon provides a novel and promising method of action compared with standard balloon angioplasty and, thus, may have a leading role in complex below-the-knee arterial lesions. The Serranator device might help to adequately address issues with conventional routine techniques for the treatment of complex lesions in infrapopliteal arteries in patients with advanced stages of PAD and critical limb ischemia. Integrating modern technologies such as the Serranator balloon catheter into clinical routine is mandatory in order to gain a more favorable outcome in these severely diseased patients and, particularly, to reduce mortality and morbidity.

Endovascular treatment of Buerger's disease in patients with critical limb ischaemia.

Thromboangitis obliteransis (TAO) is a nonatherosclerotic, inflammatory, occlusive arteritis that affects small and medium-sized arteries, veins and nerves. A large proportion of patients with TAO suffer from claudication, and the ultimate condition is gangrene and limb loss if there is no treatment or the cessation of smoking. Endovascular revascularisations are performed frequently and provide acceptable results in patients who are not suitable for surgery. In this study, we aimed to show our clinical experience in patients with TAO who were treated with endovascular revascularisation. Between January 2014 and March 2020, 18 patients with lower-extremity critical limb ischaemia (CLI) underwent endovascular treatment (ET). Technical details and clinical success at follow up were documented. This study included 18 patients with lower-extremity TAO who presented with CLI and were treated with ET. The mean age of the patients was 38.8 ± 7.3 years. Fifty per cent of patients had pain at rest, 33.7% had minor tissue loss and non-healing ulcers, and 16.7% had major tissue loss on admission. The majority of lesions were located in the peroneal and tibial arteries (n = 13, 72.27percnt;). Two (11.1%) patients had distal superficial femoral artery occlusion concomitant with popliteal artery (PA) lesions, and three (16.7%) had PA occlusion concomitant with peroneal and tibial artery lesions. Re-establishment of antegrade flow in at least one vessel was achieved in 15 (83.3%) patients. Balloon angioplasty was performed in all patients. Plain old balloon angioplasty (POBA) was used in nine (60%) patients and drug-eluting balloon (DEB) angioplasty in six (40%). The mean duration of follow up in 15 patient who had undergone successful ET was 21.5 ± 8.1 months. The primary CLI-free rate at 12 and 24 months was 80% (66.7% in all patients). Secondary CLI-free rates at six, 12 and 24 months were 100, 93.3 and 53.3%, respectively. Patients who were active smokers during their follow up had a higher frequency of out-patient clinic consultations (p = 0.03). Controversy has continued on the role of ET in the treatment of TAO. This study shows that ET of TAO had promising primary and secondary patency rates with high technical success and limb-salvage rates.

Effect of Paclitaxel Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions on Mortality

Meta-analyses of randomized controlled trials have suggested an increased long-term mortality risk following femoropopliteal and infrapopliteal angioplasty using paclitaxel-coated devices. This study was conducted to evaluate long-term mortality after paclitaxel drug-coated balloon (DCB) and plain old balloon angioplasty (POBA) of infrapopliteal lesions in real-world practice. A retrospective mortality analysis of patients with at least 3 years of follow-up who underwent balloon-based endovascular therapy of infrapopliteal lesions was performed. Overall, 2,424 patients with infrapopliteal lesions were treated within the study period. Five hundred seventy-six patients fulfilled the study criteria. Of those, 269 patients were treated with uncoated devices without crossover to a paclitaxel-coated device during follow-up and 307 patients with DCB angioplasty. Mean (SD) follow-up was 46.48 (32.77) months. The mortality rate was 66.9% after POBA and 46.9% after DCB (P < .001). In the matched-pair cohort, 164 patients died after uncoated treatment (66.7%), and 119 in the DCB group died (48.4%; P < .001). There was no correlation between DCB length and mortality rate (P = .357). For the entire cohort, multivariate logistic regression analysis showed type of treatment (uncoated device vs DCB; P = .002), age (P < .001), stroke (P = .005), renal insufficiency (P = .014), and critical limb ischemia (P = .001) to be independent predictors of all-cause mortality. There was no significant difference in mortality among the paclitaxel exposure groups. In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of infrapopliteal lesions.