Binary Restenosis Rate Research Articles

Difference in one-year late lumen loss between high- and low-dose paclitaxel-coated balloons for femoropopliteal disease

The objective of the study is to investigate the difference in 1-year late lumen loss (LLL) between the high- (IN.PACT Admiral) and low-dose (Lutonix) paclitaxel-coated balloon (PCB). Although a recent randomized clinical trial demonstrated no difference in efficacy endpoint between high- and low-dose PCB, it remains unclear whether high-dose PCB was superior to low-dose PCB in actual clinical practice. We enrolled 64 patients with 67 de novo femoropopliteal lesions who underwent PCB angioplasty at Kokura Memorial Hospital from May 2014 to March 2020 and subsequent follow-up angiography after 1 year. The primary endpoint was 1-year LLL, whereas the secondary endpoints were binary restenosis and clinically driven target lesion revascularization (CD-TLR) after 1 year. The high- and low-dose PCB groups had 45 and 22 lesions, respectively. Although the low-dose PCB group had higher rates of coronary artery disease, hemodialysis, and chronic limb-threatening ischemia than the high-dose PCB group, the latter had a longer lesion length and more lesions with a TASC classification C or D than the former. The high-dose PCB group had a significantly lower LLL than the low-dose PCB group (0.40 ± 1.05 vs. 1.19 ± 1.03 mm; P = 0.003, respectively). Moreover, the high-dose PCB group had significantly lower rates of binary restenosis at 1 year than the low-dose PCB group (22.2% vs. 50.0%; P = 0.02, respectively). Moreover, negative LLL was only observed in the high-dose PCB group (33.3% vs. 0%, P = 0.005). The high-dose PCB group had a significantly lower LLL than the low-dose PCB group.

The Efficacy of Drug-Coated Balloons and Drug-Eluting Stents in Infrapopliteal Revascularization: A Meta-analysis.

The study aimed to compare the effectiveness of drug-coated balloon (DCB) and drug-eluting stents (DESs) to standard endovascular techniques like percutaneous transluminal angioplasty (PTA) and bare metal stent (BMS) for treating infrapopliteal artery disease. Including 8 DCB trials and 4 DES trials, this meta-analysis of 12 recent randomized controlled trials (RCTs) is comprehensive. We searched MEDLINE, EMBASE, Science of Web, Cochrane, and PubMed for this meta-analysis. We searched these databases for papers from their inception to February 2023. We also analyzed the references given in the listed studies and any future study that cited them. No language or publication date restrictions were applied to the 12 RCTs. The experimental group includes 8 DCB studies and 4 DES investigations, the DCB group is primarily concerned with the paclitaxel devices, whereas the DES group is preoccupied with the "-limus" devices. Key clinical outcomes in this study were primary patency and binary restenosis rates. This study's secondary outcomes are late lumen loss (LLL), clinically-driven target lesion revascularization (CD-TLR), limb amputation, and all-cause mortality. The evidence quality was assessed using Cochrane risk-of-bias. The PROSPERO registration number for this study is CRD42023462038. Only 108 of 1152 publications found satisfied qualifying criteria and contained data. All 13 RCTs have low to moderate bias. Drug-coated balloons and DESs were compared in the excluded study. The analysis comprised 2055 participants from 12 RCTs that met the inclusion criteria, including 1417 DCB patients and 638 DES patients. Drug-coated balloons outperform traditional methods in short-term monitoring of primary patency, binary restenosis, and CD-TLR. The benefits fade over time, and the 2 techniques had similar major amputation rates, mortality rates, and LLL. Drug-eluting stents outperform conventional procedures in primary patency, binary restenosis, and CD-TLR during medium-term to short-term follow-up. Comparing the 2 methods, major and minor amputations, death rate, and LLL were similar. Comparison of DES and DCB with PTA or BMS shows that DES had better follow-up results. DCB has positive short-term results, but long-term effects differ, however, more research is needed to determine when DES and DCB should be used in medical procedures. The provision of additional evidence to substantiate the advancement of drug-coated balloon (DCB) therapy in the treatment of lower limb arteriosclerosis obliterans, particularly in the below-the-knee area characterized by high calcium load and significant occlusion, is comparable in efficacy to conventional procedures. This finding is advantageous for the progress of interventional revascularization. The advancement and efficacy of DCB have resulted in improved treatment outcomes for medical practitioners in clinical settings. Our research incorporates the most recent randomized experiments.

Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-analysis of Primary Patency and Binary Restenosis Rates.

Percutaneous transluminal angioplasty (PTA) remains the mainstay of endovascular therapy for infrapopliteal chronic limb-threatening ischemia (CLTI), but outcomes have not been well characterized using high-quality data. The aim of this meta-analysis was to provide an updated benchmark for rates of primary patency and binary restenosis after PTA using prospectively collected, predominantly core-lab adjudicated randomized controlled trial (RCT) data. MEDLINE, EMBASE, Cochrane Central, and ClinicalTrials.gov were queried for RCTs published through November 2022 using PTA as a control arm and including patients with infrapopliteal CLTI. Studies were excluded if >25% of patients had intermittent claudication, other vessels were included, or primary patency or binary restenosis were not outcomes. Outcomes were analyzed using random effects models. This analysis was publicly registered (PROSPERO ID#394543). No funding was utilized. Seventeen RCTs were included (1048 patients, 1279 lesions). Pooled primary patency rates using data from 6 RCTs were 68% at 6 months (95% confidence interval [CI]=45%-84%) and 66% at 12 months (95% CI=51%-79%). Pooled binary restenosis rates using data from 11 RCTs were 54% at 6 months (95% CI=33%-73%) and 60% at 9 to 12 months (95% CI=39%-78%). Significant heterogeneity was present in all outcomes (I2>50%, p<0.0001). Publication bias was not observed (Egger's p>0.1). This meta-analysis provides estimates for binary restenosis and primary patency following PTA utilizing prospectively collected, predominantly core-lab adjudicated data. Results demonstrate 1-year primary patency rates that are 10% to 20% higher than what has been historically used in power calculations. These new estimates will help facilitate more accurate power analysis for future RCTs. Rates of primary patency and binary restenosis after percutaneous transluminal angioplasty (PTA) have not been well-described using high-quality data, and investigators have been utilizing estimates of 40% to 50% and 45% to 65%, respectively, when performing power calculations for trials. This meta-analysis demonstrates using high-quality, prospectively collected, and predominantly core-lab adjudicated randomized controlled trial data that actual rates of primary patency are closer to 60% up to 1 year following PTA and provides the first meta-analysis estimate of binary restenosis rates up to 1 year after PTA. These estimates will help facilitate more accurate power calculations for future RCTs in this space.

A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small Vessels

BackgroundThere are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de novo small vessel disease (SVD). ObjectivesThis study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB. MethodsThis prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to treatment with an SCB or PCB, with balloon sizing determined using optical coherence tomography. The primary endpoint was noninferiority for the 6-month angiographic net lumen gain. ResultsAngiographic follow-up was completed in 109 (90.1%) patients in the per-protocol analysis. The mean ± SD angiographic net gains were 0.25 ± 0.40 mm with SCBs vs 0.48 ± 0.37 mm with PCBs, resulting in SCBs failing to meet the 0.30 mm criterion for noninferiority (Pnoninferiority = 0.173), with an absolute difference of −0.23 mm (95% CI: −0.37 to −0.09) secondary to a smaller late loss (0.00 ± 0.32 mm vs 0.32 ± 0.47 mm; P < 0.001) and more frequent late lumen enlargement (53.7% vs 30.0%; OR: 2.60; 95% CI: 1.22-5.67; P = 0.014) with PCBs. Binary restenosis rates were 32.8% and 12.5% following treatment with SCBs and PCBs, respectively (OR: 3.41; 95% CI: 1.36-9.44; P = 0.012). The mean angiography-derived fractional flow ratio at follow-up was 0.86 ± 0.15 following treatment with SCBs and 0.91 ± 0.09 following PCBs (P = 0.026); a fractional flow ratio ≤0.80 occurred in 13 and 5 vessels after treatment with SCBs and PCBs, respectively. ConclusionsThe SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo.

TCT-627 Binary Restenosis Rates Following Percutaneous Transluminal Angioplasty for Below-the-Knee Chronic Limb-Threatening Ischemia: A Meta-Analysis of Randomized Controlled Trial Data

TCT-627 Binary Restenosis Rates Following Percutaneous Transluminal Angioplasty for Below-the-Knee Chronic Limb-Threatening Ischemia: A Meta-Analysis of Randomized Controlled Trial Data

A Randomized Comparison of 2 Different Drug-Coated Balloons for In-Stent Restenosis

BackgroundAlthough use of drug-coated balloons (DCB) is a promising technique, little is known about the clinical efficacy of the Dissolve DCB in drug-eluting stent (DES) in-stent restenosis (ISR). ObjectivesThis study sought to evaluate the efficacy and safety of the Dissolve DCB in patients with DES ISR. MethodsThis was a prospective, multicenter, randomized, noninferiority trial comparing Dissolve DCB with SeQuent Please DCB in patients with DES ISR. Angiographic and clinical follow-up was planned at 9 months in all patients. The primary endpoint was 9-month in-segment late loss. ResultsA total of 260 patients with ISR from 10 Chinese sites were included (Dissolve DCB, n = 128; SeQuent Please DCB, n = 132). Nine-month in-segment late loss was 0.50 ± 0.06 mm with Dissolve DCB vs 0.47 ± 0.07 mm with SeQuent Please DCB; the 1-sided 97.5% upper confidence limit of the difference was 0.18 mm (P for noninferiority = 0.03). Rates of target lesion failure and binary restenosis were numerical higher in the Dissolve DCB cohort compared with the SeQuent Please DCB cohort at 9 months (17.5% vs 10.7%; P = 0.12; 23.4% vs 16.4%; P = 0.19, respectively). At 9 months, major adverse cardiac and cerebrovascular events occurred in 36 patients (28.3%) vs 30 patients (22.9%) in the Dissolve DCB and SeQuent Please DCB groups, respectively. ConclusionsIn this head-to-head randomized trial, the Dissolve DCB was noninferior to the SeQuent Please DCB for 9-month in-segment late loss. However, Dissolve DCB with its numerical increase in target lesion failure and binary restenosis warrants assessment in larger clinical trials (A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-Stent Restenosis; NCT03373695)

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.

Drug-coated balloons versus drug-eluting stents for coronary de novo lesions in dialysis patients

BackgroundThe aim of this study was to compare the efficacy of drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) angioplasty in the treatment of de novo coronary artery lesions in dialysis patients.MethodWe retrospectively enrolled 400 consecutive dialysis patients with 464 coronary de novo lesions treated by DCB or DES from five participating institutions in Japan. The primary endpoint was target lesion revascularization (TLR) at 12 months. We performed serial coronary angiographic analysis.ResultsThere were no significant differences in the rate of TLR between the groups in either crude or propensity score-matched analysis (DES 14.1% vs. DCB 14.7%, P = 0.864, DES 12.1% vs. 12.1%, P = 1.00). Target lesion thrombosis was not observed in the DCB group; however, stent thrombosis was observed in 7 patients (2.2%) in the DES group. The rate of binary restenosis was similar in both groups (DES, 20.9% vs. DCB, 22.8%; P = 0.749). The late lumen loss at follow-up was significantly greater in the DES group than in the DCB group (0.61 ± 0.76 mm vs 0.22 ± 0.48 mm; P < 0.001). Late lumen enlargement was observed in 38.6% of patients in the DCB group.ConclusionThe efficacy of DCB angioplasty for de novo coronary artery lesions in dialysis patients was similar to that of DES angioplasty in the real world. Drug-coated balloon angioplasty can be an acceptable treatment for de novo coronary artery lesions in dialysis patients.

The Impact of Intravascular Ultrasound onFemoropopliteal Artery EndovascularInterventions: A Randomized Controlled Trial.

The aim of this study was to investigate whether the addition of intravascular ultrasound (IVUS) guidance during femoropopliteal artery interventions reduced the rate of binary restenosis within 12months compared with angiographic guidance alone. IVUS is more accurate than angiography for assessment of vessel size and disease severity. Low-level studies suggest that the use of IVUS in femoropopliteal endovascular interventions improves outcomes, but currently, no level 1 evidence exists. This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to guidance by angiography or angiography and IVUS. The primary outcome measure was freedom from binary restenosis, on duplex ultrasound, within 12months. Secondary outcomes included clinically driven target lesion revascularization, disagreements in imaging findings between modalities, and changes in treatment caused by IVUS. Freedom from binary restenosis at 12months was significantly higher in the IVUS group (72.4% vs 55.4%; P = 0.008). There was no significant difference between groups for clinically directed target lesion revascularization (84.2% and 82.4%; P = 0.776). Mean vessel diameter was significantly larger with IVUS (5.60mm vs 5.10mm; P< 0.001). A change in treatment occurred caused by IVUS in 79% of cases. Binary restenosis was lower in the IVUS group for cases treated with drug-coated balloons (9.1% vs 37.5%; P = 0.001). The use of IVUS resulted in a significant reduction in the rate of restenosis after endovascular intervention. This is the first randomized controlled trial to demonstrate that IVUS improves outcomes in femoropopliteal interventions. This benefit may primarily relate to cases treated with drug-coated balloons. (Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?; ACTRN12614000006640).

Impact of Late Lumen Loss on Clinical Outcomes of Side-Branch Bifurcation Lesions Treated by Drug-Coated Balloon Angioplasty With Main-Branch Stenting

BackgroundDrug-coated balloon (DCB) angioplasty for side branches with main branch stenting is effective for bifurcation lesions and reduces late lumen loss (LLL) in side branches. However, the predictors and clinical implications of LLL after DCB angioplasty are largely unexplored. MethodsAmong 181 patients undergoing DCB angioplasty for side branches with drug-eluting stent implantation for main branches between 2016 and 2018, we enrolled 138 patients (138 lesions) undergoing follow-up coronary angiography within 1 year. The 1-year cumulative rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE: defined as a composite of all-cause death, myocardial infarction, and TLR) were compared between patients with late lumen gain (LLG) (LLG group) and those with LLL (LLL group). ResultsThe binary restenosis rate of the side branch was 8.0% (11 lesions), mean LLL was −0.14 ± 0.43 mm, and LLG was observed in 99 lesions (71.7%). The DCB size/reference vessel diameter ratio showed mild discrimination (area under the curve, 0.60; 95% confidence interval, 1.2–65.0; p = 0.03) for predicting the side branch progression. The 1-year cumulative rates of MACE and TLR were not significantly different but numerically lower in the LLG group than in the LLL group (2.0% vs. 7.8%, p = 0.11 and 2.0% vs. 7.7%, p = 0.11, respectively). Lumen regression after DCB angioplasty for side branches are associated with improved clinical outcomes. Conclusions: The DCB size relative to the reference vessel diameter is a predictor of late lumen enlargement in side branches.

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.

Predictors of long-term outcomes of coronary bifurcation stenting: 6-year results from international, randomized POLBOS I and POLBOS II clinical trials

Abstract Introduction Bifurcation lesions pose a therapeutic challenge during percutaneous coronary intervention (PCI). Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. Purpose The aim of this study was to analyze the 6-year follow-up of BiOSS (Balton, Poland) stents in patients enrolled into two randomized clinical trials POLBOS I (NCT02192840) and POLBOS II NCT02198300). Methods The BiOSS stent is a coronary dedicated bifurcation balloon expandable stent made of 316L stainless steel and coated with a biodegradable polymer as well as the drug. The stent consists of two parts with different diameters connected with two struts of 1.9 - 2.5 mm length each. The aim of randomized POLBOS trials was to compare the BiOSS stents with regular drug eluting stents (rDES) in patients with stable CAD or NSTE-ACS (POLBOS I: paclitaxel eluting BiOSS Expert vs rDES; POLBOS II: sirolimus eluting BiOSS LIM vs rDES). Provisional T-stenting was the default strategy. Angiographic control was performed at 12 months in all patients. The primary end-point was composed MACE defined as cardiac death, myocardial infarction or target lesion revascularization (TLR). Clinical assessment was performed every year after index procedure. Results In POLBOS I trial BiOSS Expert was implanted in 120 patients (49.4%), and rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In rDES group, 38.2% of patients received paclitaxel-eluting stents. Side branch treatment with rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% (P=0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with rDES group (11.5% vs 7.3%; P=0.02). Significantly lower rates of restenosis were observed in final kissing balloon (FKB) subgroups of both the BiOSS Expert (8.1% vs 13.2%; P&amp;lt;0.05) and rDES groups (4.9% vs 9.5%; P&amp;lt;0.05). In POLBOS II 202 patients were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with rDES (n=100). The target vessel was the LAD (44% vs 43%) followed by the LMS (35.3% vs 38%). Side branch treatment was required in 8.8% (rDES) and 7% (BiOSS). At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [BiOSS] vs. 15% [rDES, p=0.08]), as was the TLR rate (9.8% vs. 9% [p=0.8]). The binary restenosis rates were significantly lower in the FKBI subgroup of the BiOSS group (5.9% vs. 11.8%, p&amp;lt;0.05). At the time of ESC Congress 2020 we will present data from 6-year follow-up from POLBOS I trial and POLBOS II trial focusing on LM stenting and patients with diabetes. Conclusions BiOSS® stents provided satisfactory 1-year results which seemed comparable with rDES. Long-term data are pending. Funding Acknowledgement Type of funding source: None

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

Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment.

Hemodialysis (HD) is associated with a high in-stent restenosis (ISR) rate even in the second-generation era. Drug-coated balloons (DCB) generally provide excellent clinical outcomes in patients with ISR lesions. Nonetheless, safety and efficacy of DCB for ISR lesions in HD patients are largely unknown. A total of 17 centers across Japan participated in this study. Patients were eligible for the study if ISR lesions were treated with DCB. Enrolled patients were divided into 2 groups (HD and non-HD groups). Angiographic, OCT, and clinical outcomes were compared between the HD and the non-HD groups. A total of 210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group). At 8months, the binary restenosis rate was significantly higher (26.3% versus 11.3%, p = 0.02) and in-segment late loss was significantly higher (0.49 ± 0.61mm versus 0.23 ± 0.33mm, p = 0.02) in the HD group than the non-HD group. In the OCT analyses, change of minimum stent area between post- and pre-procedure was significantly smaller in the HD group compared to the non-HD group (0.08 ± 0.95mm2 versus 0.68 ± 1.07mm2, p = 0.004). Target vessel failure (TVF) rate at 2years was significantly different between the 2 groups (25.0% in the HD group and 12.1% in the non-HD group, p = 0.04). In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28-26.4, p = 0.02). Clinical and angiographic outcomes following OCT-guided DCB treatment in ISR lesions were significantly worse in HD patients compared to non-HD patients.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT02300454.

Clinical Outcomes and Angiographic Results of Bailout Stenting for Guide Catheter-Induced Iatrogenic Coronary Artery Dissection - Impact of Stent Type.

Guide catheter-induced iatrogenic coronary artery dissection is a rare but feared complication. When it occurs, bailout stenting is widely performed; however, its prognosis and the impact of stent type remains unclear. The study population consisted of 77,257 consecutive patients (coronary angiography, 55,864; percutaneous coronary intervention, 21,393) between 2000 and 2015. We investigated the incidence, clinical outcomes, and angiographic results after bailout stenting and compared by stent type: bare-metal stent (BMS) and drug-eluting stent (DES). Iatrogenic coronary artery dissection occurred in 105 patients (incidence rate, 0.14%). All cases of iatrogenic coronary artery dissection that were recognized as requiring bailout procedure could be managed by stent implantation, and no patients died during bailout procedure. The 5-year cumulative incidences of cardiac death, target lesion revascularization, and major adverse cardiac events were 11.3%, 10.3%, and 21.0%, respectively. The binary restenosis rate was 10.4%, and it was not significantly different between BMS and DES implantation. In lesions with preprocedural stenosis, however, it was significantly lower in the DES group than in the BMS group. On the other hand, coronary artery dissection recurred in 8 patients, which was observed only after DES implantation. The immediate and long-term outcomes of bailout stenting for iatrogenic coronary artery dissection were acceptable. Although DES may be favorable for stenotic lesions, coronary artery dissection can recur after DES implantation.

Angiographic performance of everolimus-eluting stents for the treatment of coronary in-stent restenosis in daily practice.

The present study aims to analyze the angiographic anti-restenotic performance of durable polymer everolimus-eluting stents (EES) for the treatment of in-stent restenosis (ISR) in daily practice. Randomized data is available supporting the use of drug-coated balloons and drug-eluting stents for the treatment of ISR; however, additional real-world data including angiographic follow-up is needed. Patients who underwent EES-implantation for the treatment of drug-eluting stent ISR and attended for a 6-8months angiographic surveillance were analyzed. Off-line assessment of the angiograms was conducted at a central quantitative coronary angiographic core laboratory. A total of 426 patients with ISR were treated with EES and had undergone angiographic follow-up. The mean age was 66.8 ± 9.9 years and 27.5% suffered from diabetes. A total of 459 lesions were treated. The diameter stenosis decreased from 64.3 ± 19.1% (preprocedural) to 12.0 ± 6.4% (postprocedural). At 6-8months angiographic follow-up, the in-segment diameter stenosis was 38.3 ± 21.7% and the in-stent late luminal loss was 0.54 ± 0.74 mm in the treated area analysis. The rate of recurrent binary restenosis was 25.7%. In the setting of ISR, the angiographic anti-restenotic efficacy of stenting with EES is comparable to that observed in randomized clinical trials and less favorable than its performance in patients undergoing stenting for de novo disease.

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).

Scoring balloon predilation before bioresorbable vascular scaffold implantation in patients with in-stent restenosis: the RIBS VI ‘scoring’ study

Currently drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. RIBS VI (NCT02672878) and RIBS VI 'Scoring' (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 ± 0.5 vs. 1.90 ± 0.4 mm, P = 0.81), % diameter stenosis (28 ± 17 vs. 29 ± 15%), late lumen loss (0.23 ± 0.4 vs. 0.22 ± 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ClinicalTrials.gov ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI 'Scoring').

Outcomes of Patients With Coronary Arterial Bifurcation Narrowings Undergoing Provisional 1-Stent Treatment (from the BIONICS Trial)

Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (pinteraction = 0.61). In conclusion, patients with bifurcation lesions treated and a provisional strategy experienced similar outcomes as those with nonbifurcation lesions. RES performed as well as ZES in bifurcation and nonbifurcation lesions.