Binary Angiographic Restenosis Research Articles

Comparison of Clinical Outcomes Among Various Percutaneous Coronary Intervention Strategies for Small Coronary Artery Disease

It remains unclear which percutaneous coronary intervention (PCI) strategy is the most preferable in small-vessel coronary artery disease (CAD) patients. We sought to evaluate the clinical efficacy of various PCI strategies for patients with small-vessel CAD through a network meta-analysis of randomized controlled trials (RCTs). We searched multiple databases for RCTs investigating the efficacy of the following PCI strategies for small-vessel CAD (<3 mm in diameter): drug-coated balloons (DCB), early-generation paclitaxel-eluting stents and sirolimus-eluting stents (SES), newer-generation drug-eluting stents (DES), bare-metal stents (BMS), cutting balloon angioplasty, and balloon angioplasty (BA). The primary outcome was the trial-defined major adverse cardiovascular events (MACE), mostly defined as a composite of death, myocardial infarction, and revascularization. The secondary outcomes included each component of MACE and angiographic binary restenosis. We performed a sensitivity analysis for RCTs without BMS or 1st-generation DES. Our search identified 29 eligible RCTs including 8,074 patients among the 8 PCI strategies. SES significantly reduced MACE compared with BA (HR: 0.23; 95% CI [0.10 to 0.54]) with significant heterogeneity (I2 = 55.9%), and the rankogram analysis showed that SES was the best. There were no significant differences between DCB and newer-generation DES in any clinical outcomes, which was consistent in the sensitivity analysis. BMS and BA were ranked as the worst two for most clinical outcomes. In conclusion, SES was ranked as the best for reducing MACE. There were no significant differences in clinical outcomes between DCB and newer-generation DESs. BMS and BA were regarded as the worst strategies for small-vessel CAD.

Mid-Term Angiographic and Intracoronary Imaging Results Following Intracoronary Lithotripsy in Calcified Coronary Artery Disease: Results From Two Tertiary Referral Centres

BackgroundIntracoronary lithotripsy (IVL) is a safe and effective treatment for coronary calcification. Angiographic and intracoronary imaging follow-up have not yet been described. We aimed to describe the mid-term angiographic outcomes following IVL. MethodsPatients successfully treated with IVL in two tertiary referral hospitals were included. Repeat angiography and intracoronary imaging was performed. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) analyses were performed using dedicated workstations. ResultsTwenty patients were included; mean age 67.1 years, left anterior descending artery 55 %. Median IVL balloon size was 3.0 mm and a median of 60 pulses were delivered per vessel. Percentage stenosis by QCA was 60 % [IQR 51–70] reducing to 20 % post stenting (p < 0.001). On OCT, 88.9 % had circumferential calcium. IVL resulted in fractures in 88.9 %. Resulting minimum stent expansion was 91.75 % [IQR 81.5–108].Follow-up was at a median of 22.7 months [IQR16.4–25.5]. Percentage stenosis by QCA was 22.5 % [IQR 14–30] and not significantly different from the index procedure (p > 0.05). Minimum stent expansion by OCT was 85 % [IQR 72–97]. Late luminal loss was 0.15 mm [IQR −0.25 to 0.69]. Binary angiographic instent restenosis (ISR) was 10 % (2 of 20 patients). OCT demonstrated a predominantly homogenous neointimal pattern with high backscatter. ConclusionFollowing successful IVL treatment, repeat angiography demonstrated preserved stent parameters in the majority of patients with favorable vascular healing properties by OCT. A binary restenosis rate of 10 % was observed. These results suggest durable results following IVL treatment of severe coronary calcification however larger studies are warranted.

Clinical Safety and Efficacy of New-Generation Single-Layer Polytetrafluorethylene Covered Coronary Stents

BackgroundEarly-generation “sandwich-design” polytetrafluorethylene (PTFE) covered coronary stents (CS) are associated with a high frequency of adverse events. New-generation single layer PTFE-CS offers the potential to enhanced procedural efficacy and improves clinical safety. Data from a dedicated study, concerning outcomes after treatment with single-layer PTFE-CS in patients undergoing percutaneous coronary intervention are scant. MethodsThis is a retrospective multicenter registry including 30 patients undergoing implantation of 39 single-layer PTFE-CS (BeGraft-coronary Stent Graft System, Bentley InnoMed GmbH, Hechingen, Germany) in native coronary arteries or saphenous bypass grafts, in 3 centers in Europe, between May 2013 and May 2019. Endpoints of interest were procedural success (placement of covered stent), binary-angiographic restenosis (BAR), percent diameter stenosis (% DS) and late-lumen loss at 6–8 months follow-up angiography, rates of target lesion revascularization (TLR), myocardial infarction (MI), stent thrombosis (ST) and mortality at 12 months. Results28 patients underwent implantation of 37 CS due to coronary artery perforation 2 patients due to coronary artery aneurysm. Technical success was achieved in all patients (100 %). More than one stent was implanted in 7 patients (25 %) all in the perforation group. Follow-up angiography was available in 23 patients (77 %) showing favorable results: BAR = 21.8 %, %DS = 30.3 ± 27.5; LLL = 0.16 ± 0.81 mm. At 12 months all patients were alive, rates of TLR were low (3 patients, 10.0 %), there was one case of late stent thrombosis (3.3 %) and one MI (3.3 %). ConclusionsIn this dedicated study, implantation of a new single layer PTFE-CS for the treatment of native coronary arteries or saphenous vein grafts after perforation or due to aneurysm showed high technical success rates and favorable angiographic and clinical efficacy. Clinical safety outcomes are encouraging, but larger prospective studies are needed to determine long-term safety of this device.

High on-aspirin treatment platelet reactivity and restenosis after percutaneous coronary intervention: results of the Intracoronary Stenting and Antithrombotic Regimen-ASpirin and Platelet Inhibition (ISAR-ASPI) Registry

ObjectiveThe aim of this study was to assess the association between high on-aspirin treatment platelet reactivity (HAPR) and the subsequent risk of restenosis after percutaneous coronary intervention (PCI) with predominantly drug-eluting stents.BackgroundThe association between HAPR and subsequent risk of restenosis after PCI is unclear.MethodsThis study included 4839 patients undergoing PCI (02/2007–12/2011) in the setting of the Intracoronary Stenting and Antithrombotic Regimen-ASpirin and Platelet Inhibition (ISAR-ASPI) registry. Platelet function was assessed with impedance aggregometry using the multi-plate analyzer immediately before PCI and after intravenous administration of aspirin (500 mg). The primary outcome was clinical restenosis, defined as target lesion revascularization at 1 year. Secondary outcomes included binary angiographic restenosis and late lumen loss at 6- to 8-month angiography.ResultsThe upper quintile cut-off of platelet reactivity measurements (191 AU × min) was used to categorize patients into a group with HAPR (platelet reactivity > 191 AU × min; n = 952) and a group without HAPR (platelet reactivity ≤ 191 AU × min; n = 3887). The primary outcome occurred in 94 patients in the HAPR group and 405 patients without HAPR (cumulative incidence, 9.9% and 10.4%; HR = 0.96, 95% CI 0.77–1.19; P = 0.70). Follow-up angiography was performed in 73.2% of patients. There was no difference in binary restenosis (15.2% vs. 14.9%; P = 0.79) or late lumen loss (0.32 ± 0.57 vs. 0.32 ± 0.59 mm; P = 0.93) between patients with HAPR versus those without HAPR.ConclusionsThis study did not find an association between HAPR, measured at the time of PCI, and clinical restenosis at 1 year after PCI.Graphical abstract

Efficacy and safety of drug-coated balloon combined with cutting balloon for side branch of true coronary bifurcation lesions: Study protocol for a multicenter, prospective, randomized controlled trial.

Coronary bifurcation lesions are common of percutaneous coronary intervention (PCI), and the optimal interventional therapy strategy is still a matter of debate and remains a challenge for interventional cardiologists. The provisional stenting technique is still a preferred method for most bifurcation lesions, but restenosis of the side branch (SB) occurs in approximately 17-19% of cases. Therefore, the dilemma of reducing SB restenosis still exists, and further research on strategies to reduce restenosis for SB is necessary. Drug-coated balloon (DCB) can reduce clinical events in small vessel disease and in-stent restenosis. The efficacy and safety of DCB for SB of true coronary bifurcation lesions have not been fully investigated. A randomized comparison of DCB combined with cutting balloon angioplasty vs. cutting balloon angioplasty for SB has never been published. The purpose of this study is to explore the superiority of DCB combined with cutting balloon vs. cutting balloon angioplasty for SB after main vessel (MV) drug-eluting stent implantation of true coronary bifurcation lesions. This study is a multicenter, prospective, randomized controlled trial including 140 patients with true coronary bifurcation lesions. Patients will be randomized in a 1:1 manner to receive either DCB combined with cutting balloon or cutting balloon angioplasty for SB after MV drug-eluting stent implantation. The primary endpoint is the evaluation of late lumen loss (LLL) of SB at the 9-month follow-up. The secondary endpoints include procedural success during initial hospitalization, LLL of MV at the 9-month follow-up, binary angiographic restenosis in MV and SB at the 9-month follow-up, the proportion of patients with a final post-PCI quantitative flow ratio result ≤ 0.80 for SB at the 9-month follow-up, and major adverse cardiac events during the 24-month follow-up. This clinical trial will provide evidence as to whether DCB combined with cutting balloon for SB of true coronary bifurcation lesions is a superior treatment approach. ChiCTR2000040475. The results of this clinical trial will be published in a peer-reviewed journal.

Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions

BackgroundNon stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. MethodsThis was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. ResultsA total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. ConclusionThe novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.

Long-term clinical outcomes after drug eluting stent implantation with and without stent overlap.

The aim of this study was to investigate the impact of drug eluting stent (DES) overlap on clinical outcomes after percutaneous coronary intervention (PCI). While the use of overlapping bare metal stent has been associated with an increased risk of adverse clinical events, the long-term impact of DES overlap on clinical outcomes is not certain at present. Similarly, the effect of different DES generations and polymer types on DES overlap associated clinical outcomes has not previously been comprehensively elucidated. We analyzed the angiographic and clinical outcomes of 5605 patients treated with DES in the setting of the ISAR-TEST 4 and ISAR-TEST 5 randomized control trials according to the presence or absence of stent overlap. The clinical endpoints assessed in this study were all-cause death, myocardial infarction (MI), target lesion revascularization (TLR), and definite or probable stent thrombosis at 10-years. We also compared rates of binary angiographic restenosis (BAR) at 6-8months. At 10 years, all-cause mortality (Hazard ratios [HR]=1.05 [0.95-1.16]; p=0.348) did not differ between the stent overlap and no stent overlap groups. MI (8.4% vs. 5.2%; HR=1.67 [1.35-2.07], p < 0.001) and TLR (23.7% vs. 16.3%; HR=1.54 [1.36-1.74], p < 0.001) occurred more frequently in the stent overlap group. For MI, landmark analysis demonstrated that this increase in risk was primarily in the first 30 days post PCI. BAR at 6-8months was also more frequent in the stent overlap group (16.0% vs. 10.3%; HR=1.65 [1.41-1.92], p < 0.001). DES overlap is associated with an increased risk of adverse clinical events post PCI.

Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

Background Reliable vascular access is essential for patients receiving haemodialysis. An arteriovenous fistula is the preferred option; however, these are prone to developing stenotic segments. These lesions are treated with angioplasty, but there is a high rate of recurrence. When the PAVE (Paclitaxel-assisted balloon Angioplasty of Venous stenosis in haEmodialysis access) trial was conceived, a number of small studies suggested that restenosis may be reduced by paclitaxel-coated balloons. Objective To test the efficacy of paclitaxel-coated balloons in arteriovenous fistulas. Design A randomised controlled trial. Setting Twenty UK centres. Participants Patients (aged ≥ 18 years) referred with a clinical indication for angioplasty of an arteriovenous fistula (212 patients in total, 106 per group). Interventions High-pressure plain balloon fistuloplasty was performed in all patients. In the intervention arm, the second component was insertion of a paclitaxel-coated balloon. In the control arm, an identical procedure was followed, but using a standard balloon. Main outcome measures The primary end point was time (days) to loss of target lesion primary patency. Secondary patency end points were time to loss of access circuit primary patency and time to loss of access circuit cumulative patency. Other secondary end points included angiographically determined late lumen loss, rate of binary angiographic restenosis, procedural success, number of thrombosis events, fistula interventions, adverse events during follow-up and patient quality of life. Results Primary analysis showed no evidence for a difference in time to end of target lesion primary patency between groups (hazard ratio 1.18, 95% confidence interval 0.78 to 1.79; p = 0.440). An adjusted secondary analysis with prespecified clinical covariates gave similar results (hazard ratio 1.11, 95% confidence interval 0.69 to 1.78; p = 0.664). Prespecified secondary outcomes included the time to intervention anywhere in the access circuit or the time until the fistula was abandoned. There were no differences in these patency-related secondary outcomes or in any other secondary outcomes, such as adverse events. Limitations The PAVE trial was not a fully blinded trial. It was impossible to ensure that treating radiologists were blinded to treatment allocation because of the appearance of the paclitaxel-coated balloon. The extent to which our findings can be generalised to patients with multiple lesions could be questioned, given the proportion randomised. However, if paclitaxel-coated balloons had been effective at a single lesion segment, then there is no plausible reason why they could not be effective in patients with multiple lesions. Conclusions There were no differences in primary or secondary outcomes. Following a plain balloon angioplasty, additional treatment with a paclitaxel-coated balloon does not provide benefit. Future work The reasons for differences between the results of the PAVE trial and of other studies deserve further analysis and consideration. Other interventions to prevent restenosis following a fistuloplasty are needed. Trial registration Current Controlled Trials ISRCTN14284759. Funding This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 13. See the NIHR Journals Library website for further project information.

Paclitaxel Coated Balloon vs. Bare Metal Stent for Endovascular Treatment of Symptomatic Vertebral Artery Origin Stenosis Patients: Protocol for a Randomized Controlled Trial.

Background: Stenting treatment for refractory symptomatic patients with vertebral artery origin stenosis (VAOS) is safe; however, there is a high rate of in-stent restenosis. Although drug-eluting stents can reduce the incidence of restenosis to some extent, there is still a risk caused by stent fracture. Drug-coated balloon (DCB) has been proven to reduce the rate of restenosis in peripheral and coronary artery disease. DCB can prevent inflammation caused by extraneous material stimulation and allow the subsequent treatment that is characteristic of “leave nothing behind.” The purpose of this trial is to compare the efficacy and safety of DCB and bare metal stent (BMS) in the treatment of VAOS.Method/Design: This trial is a 1:1 randomized, controlled, multicenter, non-inferiority trial that compares the DCB to BMS in terms of angiographically assessed target lesion binary restenosis (≥50%) at 12 months in endovascular treatment of symptomatic patients with VAOS.Discussion: A total of 180 patients with symptomatic VAOS who match the trial eligibility criteria will be randomized 1:1 to treatment with DCB (n = 90) or BMS (n = 90). An angiographic core laboratory-adjudicated target lesion binary restenosis (≥50%) at 12 months of follow-up was selected as primary efficacy endpoint to assess the DCB treatment effect. A clinical events committee will assess the safety endpoints of all-cause death, target vessel related transient ischemic attack and ischemic or hemorrhagic stroke events. A data safety monitoring board will periodically review safety data for subject safety, the study conduct, and progress. In this trial, randomization is only allowed after successful pre-dilatation. We anticipate that this trial will provide rigorous data to clarify whether DCBs are beneficial in patients with symptomatic VAOS.Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03910166.

Endovascular Therapy for Arteriogenic Erectile Dysfunction With a Novel Sirolimus-Eluting Stent

BackgroundArteriogenic erectile dysfunction is a common disease oftentimes not satisfactory treatable with medical therapy. AimTo assess the safety and clinical success rate of endovascular revascularization of erection-related arteries with the angiolite BTK stent in patients with arteriogenic erectile dysfunction. MethodsA total of 100 consecutive men (61.8 ± 10 years) with atherosclerotic lesions in erection-related arteries agreed to participate and were included into a single-center all-comers registry. Endovascular therapy with angiolite BTK drug-eluting stents was performed on a total of 211 lesions. Patients received a baseline International Index of Erectile Function (IIEF)-15 questionnaire at first presentation and 3 and 12 months after stenting. An improvement by 4 points in the erectile function domain consisting of 6 questions (IIEF-6) was defined as minimal clinically important difference. A total of 24 patients with 52 stented arterial lesions underwent angiographic follow-up of the initially treated arterial side during secondary revascularization of the contralateral side (angiographic sub-study). OutcomeClinical improvement of erections in 100 patients undergoing endovascular revascularization of erection-related arteries. ResultsNo major adverse events occurred during endovascular revascularization or within 30 days thereafter. Technical success was achieved in all lesions and procedural success in all patients. At 1 year, 55 of 97 patients (56.7%) improved by at least 4 points in IIEF-6 score and thus achieved a clinically relevant improvement of erectile function.In the angiographic sub-study, arterial patency and binary restenosis were observed in 46 of 52 (88.5%) and in 8 of 52 (15.4%), respectively, after a mean follow-up of 9.6 ± 5.8 months. Clinical ImplicationsIn patients with arteriogenic erectile dysfunction, endovascular therapy with a novel thin-strut sirolimus eluting stent is a safe and feasible treatment option. Strengths & LimitationsThis real-world arterial revascularization registry included patients with a multitude of risk factors for ED, thereby representing the heterogeneity in patients in the clinical practice, which is one of its strengths but also one of its weaknesses. Another strength was the focus being laid on analyzing outcomes of patients with arteriogenic ED using only a single endovascular device. Further studies are warranted to better define subgroups of patients with impaired clinical outcomes. ConclusionWithin the present all-comers registry, endovascular therapy of erectile dysfunction with the angiolite BTK stent was shown to be a safe and feasible treatment option resulting in clinical improvement rates comparable to earlier clinical trials although also showing that further research is warranted to define patient subgroups with particular benefits of endovascular therapy.Schönhofen J, Räber L, Knöchel J, et al. Endovascular Therapy for Arteriogenic Erectile Dysfunction With a Novel Sirolimus-Eluting Stent. J Sex Med 2021;18:315–326.

Safety and feasibility of bioabsorbable everolimus-eluting stents for patients with internal pudendal artery-related arteriogenic erectile dysfunction (PERFECT-ABSORB)

Abstract Background Obstructive pelvic arterial lesions are present in ∼70% of patients aged &amp;gt;50 years and having erectile dysfunction. The internal pudendal artery, with an average diameter of 2.5 mm, is the segment where ∼40% of pelvic obstructive lesions are located. Our prior experience showed a 40–50% binary restenosis rate for drug-eluting stents in internal pudendal artery. In this PERFECT-ABSORB study, we would like to assess the feasibility and safety of the bioresorbable everolimus-eluting vascular scaffolds (BVS), facilitated by intravascular optical coherence tomography (OCT), in patients with erectile dysfunction and concomitant internal pudendal artery stenoses. Methods This prospective, unblinded, single-arm, single-center study was a first-in-man proof-of-concept study. Patients with erectile dysfunction and obstructive pelvic arterial lesions (unilateral diameter stenosis ≥70% or bilateral stenoses ≥50%) in the internal pudendal arteries with reference vessel diameter ≥2.5 mm and ≤4.0 mm and a target-lesion length ≤30 mm in the pelvic computed tomographic (CT) angiography were recruited. All subjects underwent pelvic CT angiography, penile Doppler ultrasonography, and invasive pelvic angiography with OCT at baseline and 8 months after intervention. The primary endpoint is CT angiographic binary restenosis (≥50% lumen diameter stenosis) at 8 months. The secondary endpoints include sustained clinical success in erectile function (International Index for Erectile Function-5 [IIEF-5] score ≥22 or change in IIEF-5 ≥4 and without a later decline by ≥4) at 12 months. Results Eighteen patients were enrolled (mean age, 61.8±5.6 years; range, 52–71 years). The IIEF-5 score at baseline was 7.3±3.6, with a median duration of erectile dysfunction of 3 years. A total of 31 BVSs were implanted: seven patients were treated with one BVS, 9 patients with 2 BVSs, and 2 patients with 3 BVSs. All implanted BVSs were of 2.5 mm in diameter. Among the 17 patients undergoing 8-month follow-up pelvic CT angiography and invasive angiography (one not done due to colon cancer diagnosed later), binary CT angiographic restenosis developed in 7 (37%) of 19 lesions and 7 (41%) of 17 patients. After excluding those with lesions &amp;gt;30 mm (per-protocol analysis), binary CT angiographic restenosis developed in 5 (31%) of 16 lesions and 5 (36%) of 14 patients. Binary restenosis assessed by invasive angiography and OCT was the same as assessed by pelvic CT angiography. Among the 17 patients, 9 (53%) achieved sustained clinical success in erectile function 12 months following the procedure. All of them did not develop binary restenosis. Conclusions We for the first time demonstrated that BVS+OCT strategy for internal pudendal artery stenosis was safe and able to achieve 30% restenosis rate in lesions ≤30 mm in length. Compared to our prior experience, BVS+OCT strategy was associated with a numerically lower restenosis rate. Funding Acknowledgement Type of funding source: None

Angiographic Results After Percutaneous Coronary Interventions in Ostial Versus Distal Left Main Lesions

PurposeWe sought to evaluate angiographic outcomes in ostial and distal LM lesions. Methods176 patients with LM disease undergoing PCI were retrospectively included in this study. 9 months of angiographic and 12 months of clinical follow-up was obtained. Quantitative coronary analysis (QCA) was performed for all lesions, using an 11-segment model. Clinical endpoint measure was a composite endpoint of cardiac death, myocardial infarction and target lesion revascularization (TLR). ResultsDuring 12 months follow up after successful PCI, the composite endpoint occurred more frequently in distal LM bifurcation lesions mainly driven by elevated TLR rates (14.1% in distal LM disease vs. 5.6% in ostial/midshaft LM disease, P = 0.20). Concordantly angiographic binary restenosis (8.2% compared to 0.0%) and late lumen loss (LLL, 0.42 ± 0.97 vs. 0.28 ± 0.34 mm) were increased in distal LM bifurcation lesions compared to ostial LM lesions. In distal lesions highest values for LLL were observed in segments adjacent to the bifurcation (0.37 ± 1.13 mm and 0.37 ± 0.73 mm). On cox proportional regression analysis the angiographic parameter LLL in a bifurcation segment (P = 0.03, HR 1.68 [1.1–2.7]) as well as presence of diabetes mellitus as a clinical parameter (P = 0.046, HR 2.77 [1.0–7.5]) were independent correlates for occurrence of MACE in distal LM bifurcations lesions. ConclusionPCI of ostial LM in accomplished with low LLL (0.28 ± 0.34 mm) and binary restenosis rates. In distal left main lesions highest rates for LLL and binary restenosis were observed in segments nearest to the bifurcation and rather focused on the main vessel (0.42 ± 0.97 mm).

Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions

Purpose: To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. Materials and Methods: Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.4 years; 29 men) with symptomatic moderate to severe lower limb ischemia (Rutherford categories 2 or 3) were enrolled at 4 German centers for the SELUTION SLR first-in-human trial (ClinicalTrials.gov NCT02941224). The SELUTION SLR utilizes micro-reservoirs (biodegradable polymer spheres containing sirolimus) embedded within an amphipathic membrane coated onto an angioplasty balloon. The biodegradable reservoirs are transferred to the target vessel lumen during brief balloon inflation. The primary trial objective was comparison of angiographic late lumen loss at 6 months against an objective performance criterion (OPC) value of 1.04 mm for uncoated balloon angioplasty. Secondary endpoints included device, procedural, and clinical success; clinical and imaging assessments of primary patency and restenosis; functional assessments including Rutherford category and ankle-brachial index (ABI); and major adverse events [composite of cardiovascular mortality, index limb amputation, target limb thrombosis, and clinically-driven target lesion revascularization (CD-TLR)]. Results: At 6 months, median angiographic late lumen loss following SELUTION SLR treatment was 0.19 mm (range −1.16 to 3.07). Mean angiographic late lumen loss (n=34) was 0.29±0.84 mm (95% CI −0.01 to 0.58), significantly lower than the 1.04-mm OPC value (p<0.001). The rate of primary patency by duplex ultrasound was 88.4%, and freedom from angiographic binary restenosis was 91.2%. Through 6 months, there was significant improvement over baseline in Rutherford categories (p<0.001) and in ABI measurements (p<0.001). A single case (2%) of CD-TLR occurred at 5 months. There were no other major adverse events. Conclusion: Through 6 months, the SELUTION SLR DEB appears to inhibit restenosis effectively and safely, improving outcomes in subjects with symptomatic femoropopliteal disease.

A randomized feasibility study of the effect of ascorbic acid on post-angioplasty restenosis of hemodialysis vascular access (NCT03524846)

Restenosis remains a significant problem after angioplasty of hemodialysis vascular access. Both experimental and clinical studies have shown a protective effect of antioxidants against post-angioplasty restenosis. A prospective, randomized, feasibility study was conducted to investigate the effect of ascorbic acid to prevent restenosis. Ninety-three hemodialysis patients were randomized into three groups after angioplasty: placebo (n = 31), 300 mg ascorbic acid (n = 31), and 600 mg ascorbic acid (n = 31), treated intravenously 3 times per week for 3 months. Eighty-nine completed the clinical follow-up, and 81 had angiographic follow-up. In the angiographic follow-up, the mean (stand deviation) late loss of luminal diameter for the placebo, 300 mg, and 600 mg groups were 3.15 (1.68) mm, 2.52 (1.70) mm (P = 0.39 vs. placebo group), and 1.59 (1.67) mm (P = 0.006, vs. placebo group), with corresponding angiographic binary restenosis of 79%, 67% (P = 0.38 vs. placebo group), and 54% (P = 0.08 vs. placebo group). The post-interventional primary patency rates at 3 months were 47%, 55% (P = 0.59 vs. placebo group), and 70% (P = 0.18 vs. placebo group) for placebo, 300 mg, and 600 mg groups. Our results demonstrated that intravenous 600 mg ascorbic acid was a feasible therapy and might attenuate restenosis after angioplasty; however, its effect on post-interventional primary patency was modest.

Outcome after new generation single-layer polytetrafluoroethylene-covered stent implantation for the treatment of coronary artery perforation.

Coronary artery perforation (CAP) is a rare but severe complication during percutaneous coronary intervention (PCI). Implantation of covered stents (CS) represents a potentially life-saving treatment. Concerns exist regarding limited efficacy and high stent thrombosis (ST) rates related to early generation CS. The aim of this study was to evaluate angiographic and clinical outcomes of patients with CAP treated with a new generation single-layer polytetrafluoroethylene (PTFE)-CS. Between May 2013 and November 2017, we identified a total of 61 patients who underwent implantation of 71 single layer PTFE-CS after CAP. We analyzed angiographic results at follow up (including binary angiographic restenosis [BAR] and late-lumen-loss [LLL]) and clinical outcomes in hospital and at follow up, including target lesion revascularization (TLR), cardiovascular-, and all-cause mortality, myocardial infarction (MI) and stent thrombosis (ST). Procedural success was achieved in all but two patients (96.7%). Procedure related MI, occurred in 19 cases (31.1%), in hospital death occurred in five cases (8.2%). At follow-up, TLR occurred in 11 cases (18.0%), two patients (3.3%) died from non-cardiovascular cause, there was no case of MI or ST. In this retrospective analysis, implantation of a new generation PTFE-CS, for the treatment of CAP showed high technical success rates. Although, periprocedural MI-and in-hospital-death rates remain not inconsiderable, new generation PTFE-CS showed favorable angiographic and clinical efficacy and high safety profile, especially with regard to thrombotic events.

Culotte stenting for coronary bifurcation lesions with 2nd and 3rd generation everolimus-eluting stents: the CELTIC Bifurcation Study.

The aim of this study was to provide contemporary outcome data for patients with de novo coronary disease and Medina 1,1,1 lesions who were treated with a culotte two-stent technique, and to compare the performance of two modern-generation drug-eluting stent (DES) platforms, the 3-connector XIENCE and the 2-connector SYNERGY. Patients with Medina 1,1,1 bifurcation lesions who had disease that was amenable to culotte stenting were randomised 1:1 to treatment with XIENCE or SYNERGY DES. A total of 170 patients were included. Technical success and final kissing balloon inflation occurred in >96% of cases. Major adverse cardiovascular or cerebrovascular events (MACCE: a composite of death, myocardial infarction [MI], cerebrovascular accident [CVA] and target vessel revascularisation [TVR]) occurred in 5.9% of patients by nine months. The primary endpoint was a composite of death, MI, CVA, target vessel failure (TVF), stent thrombosis and binary angiographic restenosis. At nine months, the primary endpoint occurred in 19% of XIENCE patients and 16% of SYNERGY patients (p=0.003 for non-inferiority for platform performance). MACCE rates for culotte stenting using contemporary everolimus-eluting DES are low at nine months. The XIENCE and SYNERGY stents demonstrated comparable performance for the primary endpoint.

Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial

ObjectivesThe aim of this study was to compare neointimal modification with scoring balloon pre-dilation before drug-coated balloon (DCB) versus DCB standard therapy in patients presenting with drug-eluting stent (DES) restenosis. BackgroundDCB angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results. The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the antiproliferative drug. Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy. MethodsIn this randomized, open-label, active-controlled trial, 252 patients with clinically significant DES restenosis were enrolled at 4 centers in Germany. Patients undergoing DCB angioplasty were randomly assigned to treatment with scoring balloon pre-dilation or standard therapy. The primary endpoint of the study was in-segment percentage diameter stenosis on 6- to 8-month follow-up angiography. The secondary endpoints included binary angiographic restenosis and late lumen loss on follow-up angiography, the combined incidence of death or myocardial infarction, target lesion revascularization, and target lesion thrombosis at 1 year. ResultsFollow-up angiographic data at 6 to 8 months were available for 203 patients (80.6%). Scoring balloon pre-dilation compared with standard therapy showed significantly lower rates with respect to the primary endpoint (35.0 ± 16.8% vs. 40.4 ± 21.4%; p = 0.047) and binary angiographic restenosis (18.5% vs. 32.0%; p = 0.026). Late lumen loss was numerically lower after scoring balloon pre-dilation compared with standard therapy (0.31 ± 59 mm vs. 0.41 ± 0.74 mm; p = 0.27). There was no difference between the groups in the incidence of death or myocardial infarction (4.0% vs. 3.4%; p = 0.73). Scoring balloon versus standard therapy showed comparable rates of target lesion revascularization (16.2% vs. 21.8%; p = 0.26). No target lesion thrombosis occurred out to 1 year. ConclusionsIn patients presenting with drug-eluting stent restenosis, neointimal modification with scoring balloon improves the antirestenotic efficacy of DCB therapy. (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 [ISAR-DESIRE 4]; NCT01632371)

First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study

ObjectivesThis study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease. BackgroundPolymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution. MethodsThe RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data. ResultsFifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non–Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred. ConclusionsAt 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348)

Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt\u2013chromium coronary stent system

The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt–chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION®). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7–19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION® (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION®. All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

Impact of stent size on angiographic and clinical outcomes after implantation of everolimus-eluting bioresorbable scaffolds in daily practice: insights from the ISAR-ABSORB registry.

We sought to evaluate the impact of stent size on angiographic and clinical outcomes after implantation of everolimus-eluting bioresorbable stents (BRS) in routine clinical practice. All consecutive patients undergoing BRS implantation at two centres in Munich, Germany, were included prospectively. The patient population was divided according to the diameter of the implanted BRS. Angiographic surveillance was scheduled at six to eight months after stent implantation and films were analysed in a core laboratory. A BRS with 2.5 mm diameter was implanted in 101 patients and BRS >2.5 mm diameter in 318. Baseline patient characteristics were similar in both groups. Reference vessel diameter was 2.36±0.22 mm in patients with an implanted 2.5 mm BRS and 3.03±0.40 mm in the other group (p<0.001). At angiographic follow-up, in-stent late luminal loss (0.28±0.47 mm vs. 0.25±0.52 mm, p=0.74) was similar in both groups, though binary angiographic restenosis was numerically higher in patients treated with a 2.5 mm BRS (12.5% vs. 6.1%, p=0.05). After 12 months, the rate of the composite of death, myocardial infarction or target lesion revascularisation was 15.7% vs. 12.3% (p=0.49). Definite stent thrombosis was detected in 1.0% vs. 3.1% (p=0.31). In patients treated with BRS in routine clinical practice, angiographic and clinical outcomes were comparable in patients treated with a 2.5 mm stent as compared with those treated with a larger stent size.