Treatment Of Coronary In-stent Restenosis Research Articles

Abstract 4125106: Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis; A Meta-Analysis.

Background: Internationally, drug-coated balloons have emerged as a new treatment approach in In-Stent Restenosis (ISR) offering localized drug delivery to inhibit neointimal growth without the need for additional stent layers. However, their use has not been assessed or approved in the United States. Paclitaxel-coated balloons (PCBs) are gaining traction as alternatives for in-stent restenosis patients. Yet, their safety and effectiveness compared to uncoated balloons remain uncertain. This meta-analysis seeks to systematically assess PCBs' safety and efficacy for ISR treatment by comparing them to uncoated balloons. Research Question: Are paclitaxel-coated balloons (PCBs) superior to uncoated balloons (UCBs) in terms of safety and efficacy for the treatment of coronary in-stent restenosis (ISR)? Aims: Systematically assess the safety and efficacy of paclitaxel-coated balloons (PCBs) compared to uncoated balloons (UCBs) for the treatment of coronary in-stent restenosis (ISR). Methods: A comprehensive literature review was conducted utilizing multiple databases up to May 2024, focusing on randomized controlled trials comparing PCB vs UCB in patients with coronary in-stent restenosis. Six randomized controlled trials with a total of 1,347 patients who completed 1-year follow-up were included. Dichotomous data were calculated as odds ratios (ORs) and 95% confidence intervals (95% CI). P<0.05 was considered to indicate a statistically significant difference. The primary outcomes included Target Lesion Revascularization (TLR), Myocardial Infarction (MI), Stent Thrombosis (ST) and Total Mortality (TM). Results: Compared with patients who underwent UCB angioplasty, those in the PCB group exhibited a clear superiority in TLR [odds ratio (OR), 0.21; 95% CI [ 0.11,0.41]; P<0.00001], and MI [odds ratio (OR), 0.55; 95% CI [0.33,0.91]; P<0.02]. ST was numerically lower in the PCB arm without statistical significance (OR, 0.21; 95% CI [0.03,1.48]; P=0.11). TM was also numerically lower with PCB without reaching statistical significance (OR, 0.60; 95% CI [0.32,1.11]; P=0.10). Conclusion: This meta analysis supports that PCBs are associated with superior outcomes when compared with UCBs in the management of ISR. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis as demonstrated by superior outcomes in target lesion revascularization and recurrent myocardial infarction.

Clinical Significance of Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for In-Stent Restenosis Within Drug-Eluting Stents: Impact on Patient Outcomes.

The evidence for optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) in improving the prognosis of individuals with in-stent restenosis (ISR) is lacking. This retrospective study enrolled 588 consecutive individuals with drug-eluting stent ISR undergoing PCI from March 2010 to March 2022. Two hundred seven (35.2%) underwent OCT guidance, and 381 (64.8%) underwent angiography guidance. Clinical outcomes were analyzed using survival curves. The primary clinical endpoint was 2-year major adverse cardiovascular events (MACEs), a composite of all-cause death, myocardial infarction, and target-vessel revascularization. Compared with angiography guidance, OCT guidance demonstrated a higher frequency of drug-coated balloon use and adjunctive therapeutic modalities, including predilation, postdilation, nonslip element balloons, and noncompliant balloons (P<0.05). Following PCI, the OCT-guided group achieved a significantly larger minimum lumen diameter (2.36 versus 2.15 mm, P<0.001) and a lower percentage diameter stenosis (17% versus 20%, P<0.001) than the angiography-guided group. Survival analysis revealed significantly lower 2-year MACEs in the OCT-guided group compared with the angiography-guided group (7% versus 15%, P=0.007), validated in the propensity matching analysis (7% versus 15%, P=0.001). Multiple sensitivity analyses showed that OCT-guided PCI treatment was an independent protective factor for 2-year MACEs in individuals with drug-eluting stent ISR. Compared with angiography guidance, OCT guidance is associated with a lower 2-year MACE risk among individuals with drug-eluting stent ISR. Therefore, OCT should be actively considered for guiding PCI treatment in individuals with drug-eluting stent ISR. Url: clinicaltrials.gov. Identifier: NCT03809754.

Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis

Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis

TCTAP C-154 Impella Assisted Percutaneous Coronary Intervention for In-Stent Restenosis of Right Coronary Artery Stent Jutting Out Into Aorta for a Patient in Cardiogenic Shock

TCTAP C-154 Impella Assisted Percutaneous Coronary Intervention for In-Stent Restenosis of Right Coronary Artery Stent Jutting Out Into Aorta for a Patient in Cardiogenic Shock

Off-Label Use of Peripheral Paclitaxel Drug-Coated Balloons in Management of Recurrent Coronary In-Stent Restenosis

BackgroundWhile not available for clinical use in the United States, dedicated drug-coated balloons (DCB) are currently under investigation for the management of coronary in-stent restenosis (ISR). Peripheral drug-coated balloons (P-DCB) have been used off-label for coronary ISR. Further data regarding this practice are needed. We aimed to describe outcomes in patients who underwent off-label P-DCB angioplasty for coronary ISR. MethodsWe analyzed data on P-DCB angioplasty for coronary ISR at a single high-volume center between April 1, 2015, and December 30, 2017. Demographic and procedural details were collected, with systematic follow-up as clinically indicated. ResultsData from 31 patients treated with P-DCB angioplasty (mean age 68.0 ± 10.7 years) with coronary ISR (17 recurrent and 14 first time) were analyzed. Most patients presented with high-grade angina (81%) or myocardial infarction (13%). Treated ISR lesions were in native coronary arteries (68%), saphenous vein grafts (SVG, 23%), and the left internal mammary artery (10%). Diffuse intrastent ISR was common (69%) with a mean lesion length of 21.7 ± 12.4 mm. No postprocedural myocardial infarction occurred and 1 nonprocedural mortality occurred during index admission. At follow-up (median: 283, interquartile range [IQR]: 354 days), repeat angiography was performed in 19 patients (median: 212, IQR: 188 days), and 11 patients had target lesion recurrent ISR (Kaplan-Meier event-free survival estimate: 44.7%, 95% CI, 26.1%-76.5%). ConclusionsIn the absence of availability of dedicated coronary DCB, treatment of coronary ISR using P-DCB angioplasty was feasible, although follow-up demonstrated continued risk for recurrent ISR in this high-risk population.

TCT-431 Comparison of the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: The TIS-2 Study.

TCT-431 Comparison of the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: The TIS-2 Study.

Design and rationale of a prospective, randomized, non-inferiority trial to determine the safety and efficacy of the Biolimus A9™ drug coated balloon for the treatment of in-stent restenosis: First-in-man trial (REFORM)

BackgroundDrug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Biolimus A9™ (BA9), a sirolimus analogue with enhanced lipophilicity, may facilitate enhanced local drug delivery into vascular tissue. A novel DCB coated with Biolimus A9™ represents an alternative to traditional paclitaxel- and sirolimus-coated devices. Hence, we sought to investigate the safety and efficacy of this novel DCB in the treatment of coronary ISR. Methods and designREFORM (NCT04079192) is a prospective, multicenter, single blind, randomized controlled trial comparing the BA9-DCB (Biosensors Europe SA, Morges, Switzerland) to the paclitaxel-coated SeQuent® Please DCB (Braun Melsungen AG, Germany) in the treatment of coronary ISR. A total of 201 patients with coronary artery disease and an indication for interventional treatment of ISR in a bare-metal stent (BMS) or drug-eluting stent (DES) have been randomized 2:1 to receive treatment with the BA9- or the paclitaxel-DCB comparator. Patients were enrolled across 24 investigational centers in Europe and Asia. The primary endpoint is percent diameter stenosis (%DS) of the target segment as assessed by quantitative coronary angiography (QCA) at 6 months. Key secondary endpoints are in-stent late lumen loss, binary restenosis, target lesion failure, target vessel failure, myocardial infarction and death at 6 months. Subjects will be followed for 24 months from enrolment. ImplicationsThe REFORM trial will seek to prove that the BA9-DCB is non-inferior to the standard paclitaxel-DCB comparator in the treatment of coronary ISR with respect to %DS at 6 months and has similar safety characteristics.

Prevalence, predictors, and management for balloon uncrossable or undilatable lesions in patients undergoing percutaneous coronary intervention with in-stent restenosis chronic total occlusion.

Percutaneous coronary intervention for in-stent restenosis (ISR) chronic total occlusion (CTO) has been a great challenge. There are occasions when the balloon is uncrossable or undilatable (BUs) even though the guidewire has passed, leading to failure of the procedure. Few studies have focused on the incidence, predictors, and management of BUs during ISR-CTO intervention. Patients with ISR-CTO were recruited consecutively between January 2017 and January 2022 and divided into two groups based on the presence of BUs. The clinical data of the two groups (BUs group and non-BUs group) were retrospectively analyzed and compared to explore the predictors and clinical management strategies of BUs. A total of 218 patients with ISR-CTO were included in this study, 23.9% (52/218) of whom had BUs. The percentage of ostial stents, stent length, CTO length, the presence of proximal cap ambiguity, moderate to severe calcification, moderate to severe tortuosity, and J-CTO score were higher in the BUs group than in the non-BUs group (p < 0.05). The technical success rate and the procedural success rate were lower in the BUs group than in the non-BUs group (p < 0.05). Multivariable logistic regression analysis showed that ostial stents (OR: 2.011, 95% CI: 1.112-3.921, p = 0.031), the presence of moderate to severe calcification (OR: 3.383, 95% CI: 1.628-5.921, p = 0.024) and moderate to severe tortuosity (OR: 4.816, 95% CI: 2.038-7.772, p = 0.033) were independent predictors of BUs. The initial rate of BUs in ISR-CTO was 23.9%. Ostial stents, presence of moderate to severe calcification, and moderate to severe tortuosity were independent predictors of BUs.

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)

Impact of body mass index on outcomes in patients undergoing percutaneous coronary intervention for in-stent restenosis

Abstract Background Recent advances in drug eluting stents (DES) design have significantly decreased the rates of in-stent restenosis (ISR). Nonetheless, ISR remains a major problem, affecting 5–10% of patients undergoing percutaneous coronary intervention (PCI). Furthermore, PCI for ISR is often a poor prognostic factor for outcomes after the procedure. Historically, obese patients tended to have better outcomes when undergoing PCI, however it is unclear if this trend continues for the same population undergoing PCI for ISR. Purpose Investigate the outcomes of patients undergoing PCI for ISR in the overweight and normal weight population. Methods All patients undergoing PCI with DES implantation at a tertiary care center from January 2012 to December 2019 were included. Normal weight was defined as a body mass index (BMI) greater than or equal to 18.5 kg/m2 and less than 25 kg/m2, while overweight was defined as a BMI greater than or equal to 25 kg/m2. Patients with BMI &amp;lt;18.5 kg/m2, underwent PCI for acute myocardial infarction (MI), or received a bare metal stent (BMS) were excluded. The primary outcome was major events (MACE), a composite of all-cause mortality, myocardial infarction (MI), and target vessel revascularization (TVR) up to one year after PCI. Secondary outcomes included individual components of the primary endpoint. Results Out of 16,234 patients with available data on BMI, 12,444 (76.7%) were overweight and 3,790 (23.3%) were normal weight. Among overweight patients, 2,879 (23.1%) underwent PCI for ISR versus 815 (21.5%) of normal weight patients. Regardless of BMI status, patients undergoing PCI for ISR had higher rates of co-morbidities such as hypertension, hyperlipidemia, and diabetes mellitus than non-ISR counterparts. At one year post PCI, both overweight and normal weight patients undergoing PCI for ISR had increased risk of MACE (overweight: 18.4% vs. 6.7%; HR 2.83; 95% CI 2.50–3.20; normal weight: 18.8% vs. 7.8%, HR 2.43, 95% CI 1.95–3.04) when compared to non-ISR counterparts, mostly driven by TVR (overweight: 16% vs. 4.6%; HR 3.58; 95% CI 3.11–4.13; normal weight: 15.2% vs. 4.1%; HR 3.69; 95% CI 2.80–4.86). However, only overweight patients undergoing PCI for ISR had higher risk of all cause mortality (2.2% vs. 1.5%; HR 1.42; 95% CI 1.03–1.95) and MI (3.0% vs. 1.3%, HR 2.22; 95% CI 1.64–2.99) when compared to non-ISR counterparts (Figure 1). Conclusions PCI for ISR was associated with increased risk of MACE, irrespective of body weight. The risks of all-cause mortality and MI in ISR vs non-ISR patients only reached statistical significance in overweight patients. Funding Acknowledgement Type of funding sources: None.

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

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

Healed neointima of in-stent restenosis lesions in patients with stable angina pectoris: an intracoronary optical coherence tomography study.

The phenomenon to heal neointimal rupture or thrombus after coronary stenting occurs as well as in native coronary artery. We investigated clinical characteristics and neointimal vulnerability of healed neointima by optical coherence tomography (OCT). We treated 67 lesions by percutaneous coronary intervention for in-stent restenosis (ISR) and conducted OCT examinations. Healed neointima was defined as neointima having one or more layers with different optical densities and a clear demarcation from underlying components. ISR with healed neointima was found in 49% (33/67) of the lesions. Compared to ISR without healed neointima, ISR with healed neointima showed significantly longer stent age (102 ± 72 vs. 31 ± 39months, P < 0.001), lower frequency of dual antiplatelet therapy [42% (14/33) vs. 74% (25/34), P = 0.017], lower use of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker (ACE-I or ARB) [61% (20/33) vs. 91% (31/34), P = 0.028], lower usage of second-generation drug-eluting stents (DESs) [36% (12/33) vs. 63% (22/34), P = 0.029], higher usage of thick-strut stents [42% (14/33) vs. 15% (5/34), P = 0.012], larger neointimal area (6.8 ± 2.6 vs. 5.2 ± 1.8mm2, P = 0.005), higher incidence of thin-cap fibroatheroma [58% (19/33) vs. 21% (7/34), P = 0.002], neointimal rupture [45% (15/33) vs. 9% (3/34), P = 0.001], and lower incidence of stent underexpansion [15% (5/33) vs. 44% (15/34), P = 0.010]. In conclusions, ISR with healed neointima was associated with neointimal vulnerability, stent age, stent type, stent strut thickness, stent expansion, antiplatelet therapy, and use of ACE-I or ARB.

Paclitexel versus sirolimus-coated balloon in the treatment of coronary instent restenosis.

Few studies compared paclitaxel-coated balloon (PCB) versus sirolimus-coated balloon (SCB) in the treatment of drug-eluting stent (DES) instent restenosis (ISR). Between November 5, 2009, and October 14, 2020, in our center 212 patients with first DES-ISR were treated with PCB (Restore®; Cardionovum GmbH, Bonn, Germany), whereas 230 patients were treated with SCB (Devoir®; MINVASYS SAS, Gennevilliers, France). Following a propensity matching, 186 patients were included into PCB group (PCB group), and in the SCB group (SCB group). The primary purpose of the study was the 1-year target lesion failure (TLF) rate, including cardiac death, target vessel-related myocardial infarction, and repeated target lesion or target vessel revascularization. Procedural success occurred in all cases. Fully optimal predilation (that is, balloon-to-stent ratio >0.91, time of DCB inflation >60 sec, and residual percent diameter stenosis after lesion preparation <20%) was observed more often in the SCB group (126 [68%] patients versus 106 [57%] patients; P=0.042). One-year TLF occurred in 29 (15.5%) patients in the SCB group and in 32 (17%) patients in the PCB group (OR=1.12 [0.65-1.95]; P=0.78). By logistic Cox regression analysis fully optimal predilation (OR=0.06; 95% CI: 0.01-0.21; P<0.001) but not DCB type (OR=0.74; 95% CI: 0.41-1.31; P=0.29) was independent predictor of 1-year TLF. The current study suggests that 1-year TLF is not statistically and clinically different in patients with DES ISR treated with a PCB and a SCB.

Impact of intravascular ultrasound on Outcomes following PErcutaneous coronary interventioN for In-stent Restenosis (iOPEN-ISR study)

BackgroundPercutaneous coronary intervention (PCI) for in-stent restenosis (ISR) remains common. Intravascular imaging allows for the determination of the mechanism of ISR, potentially guiding appropriate therapy. Intravascular ultrasound (IVUS)-guided stent implantation is associated with a reduction in adverse events after PCI, but its impact on treatment of ISR is not clear. MethodsAll patients with 1-year follow-up after ISR treatment from 2003 through 2016 were included and stratified by IVUS use. The primary endpoint was the rate of major adverse cardiac events (MACE) at 1 year, defined as the composite of all-cause mortality, Q-wave myocardial infarction, and target vessel revascularization (TVR). ResultsThe final analysis included 1522 ISR patients, 65.9% of whom were treated with IVUS guidance. The primary endpoint occurred in 18.0% of patients treated with IVUS guidance vs. 24.5% of patients treated with angiography guidance (p = 0.0014). Post-dilatation was used more often with IVUS (18.6% vs. 14.1%, p < 0.001), with a larger diameter of new stents (3.04 ± 0.35 mm vs. 2.94 ± 0.47 mm, p = 0.001). At 1 year, TVR occurred in 14.5% with IVUS guidance and 19.2% with angiography guidance (p = 0.021). ConclusionsThe use of IVUS is associated with decreased MACE at 1 year following PCI for ISR. These results support routine IVUS for the treatment of ISR lesions.

Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries.

In-stent restenosis (ISR) is highly prevalent and leads to repeat revascularisation. Long-term implications of ISR are poorly understood. This study aimed to evaluate the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR. National Cardiovascular Data Registry CathPCI records for individuals aged ≥65 years undergoing PCI from July 2009 to December 2014 were linked to Medicare claims. Baseline characteristics and long-term rates of death, myocardial infarction (MI), repeat revascularisation including target vessel revascularisation (TVR), and major adverse cardiovascular and cerebrovascular events (MACCE) were compared between ISR PCI versus de novo lesion PCI. Of 653,304 individuals, 10.2% underwent ISR PCI and 89.8% underwent de novo lesion PCI. The median duration of follow-up was 825 days (quartile 1: 352 days-quartile 3: 1,379 days). The frequency of MACCE (55.6% vs 45.0%; p<0.001), all-cause mortality (27.8% vs 25.5%; p<0.001), MI (19.0% vs 12.3%; p<0.001), repeat revascularisation (31.9% vs 18.6%; p<0.001), TVR (22.4% vs 8.0%; p<0.001), and stroke (8.8% vs 8.3%; p=0.005) was higher after ISR PCI. After multivariable adjustment, ISR PCI remained associated with worse long-term outcomes than after de novo lesion PCI (hazard ratio [HR] for MACCE 1.24 [95% CI: 1.22, 1.26], mortality 1.07 [95% CI: 1.05, 1.09], MI 1.44 [95% CI: 1.40, 1.48], repeat revascularisation 1.55 [95% CI: 1.51, 1.59], and TVR 2.50 [95% CI: 2.42, 2.58]). ISR PCI was common and was associated with a significantly higher risk of recurrent long-term major ischaemic events compared to patients undergoing de novo lesion PCI. There remains a need for new strategies to minimise ISR.

Characteristics and Outcomes of Patients Undergoing Coronary Intervention for In-Stent Restenosis

Takotsubo's syndrome (TTS) is a form of stress cardiomyopathy with a relatively benign long-term course, but may lead to arrhythmias and cardiogenic shock in the acute setting. Despite a recent rise in suspected stress-induced cardiomyopathy, the relationship between the novel coronavirus disease 19 (COVID-19) and TTS is not fully understood. Early recognition of TTS in these patients is important to guide management and treatment. We present 2 cases of TTS arising in the setting of COVID-19 with rapid progression to biventricular heart failure and cardiogenic shock.

Bioresorbable scaffold versus drug coated balloon for treatment of in-stent-restenosis – long-term outcomes of the randomized ABSORB-ISR trial

Abstract Background Observational studies showed promising results after treatment of coronary instent-restenosis (ISR) using the everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb®. Purpose We compared long-term outcomes after treatment of ISR with BVS versus the paclitaxel-eluting drug coated balloon (PE-DCB) SeQuent® Please, which is commonly used for treatment of ISR. Methods This was randomized-controlled trial of Absorb® BVS versus SeQuent® Please PE-DCB in an all-comers population with clinically relevant ISR. The patients were randomized in a 1:1 fashion. The angiographic primary endpoint was late lumen loss (LLL) at 9 months. Clinical follow-ups (FU) up to 48 months were conducted. Results Totally, 53 patients and lesions were enrolled. The mean age was 66.7±9.8 years, 23 (43.4%) had an acute coronary syndrome (ACS) and 16 (30.2%) were diabetic. PCI was successful in all patients. After 9 months, the mean LLL did not significantly differ between patients treated with BVS versus PE-DCB (median 0.41 (interquartile range (IQR) 0.15; 1.23)mm versus 0.27 (IQR 0.13; 0.66)mm, p=0.86). Moreover, mean lumen area on optical coherence tomography (OCT) did not significantly differ (median 5.47 (IQR 4.44; 7.69)mm2 versus 6.70 (IQR 5.00; 7.82)mm2, p=0.24). Rates of significant ISR (angiographic stenosis &amp;gt;70%) were similar with BVS versus PE-DCB (7 (30.4%) versus 6 (27.3%), p=0.81). The target vessel revascularization rates were 9 (33.3%) versus 9 (34.6%) using the BVS versus PE-DCB (p=0.72), also highlighted in the Figure below). No stent/ scaffold thrombosis occurred during FU. The study was prematurely stopped due to withdrawal of the Absorb® BVS in September 2017. Conclusions In this randomized pilot study, we found no significant difference in angiographic, OCT and clinical endpoints after treatment of ISR lesions using the Absorb BVS versus SeQuent® Please PE-DCB during long-term follow-up (≥48months). However, rates of target vessel revascularization were very high in both groups (&amp;gt;30%). TVR and TLF with BVS or PE-DCB for ISR Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott Vascular

Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint.

In 2013, a drug-coated balloon catheter (DCB) (SeQuent Please) for the treatment of coronary in-stent restenosis (ISR) was approved in Japan. The pre-marketing Japan domestic NP001 study demonstrated better outcomes of the DCB (n = 138) compared to plain balloon angioplasty (n = 72). After the introduction to marketing, a post-marketing surveillance (PMS) (n = 396) was conducted to evaluate the safety and efficacy of the DCB in Japanese routine clinical practice. The aim of this paper was to assess differences between the pre-marketing NP001 study and the PMS. Compared to the NP001 study, more complex lesions were treated in the PMS (type B2/C: 69.0% vs 20.4%, total occlusion: 11.2% vs 0%, p < 0.001, respectively) and target lesion was more frequently ISR related to drug-eluting stent (DES) (79.5% vs 39.4%, p < 0.001). Regarding clinical outcomes, the rate of target lesion revascularization (TLR) was higher in the PMS than in the NP001 study (TLR: 12.9% at 7months and 17.6% at 12months vs 2.8% at 6months, p = 0.001, p < 0.001, respectively). Multivariable logistic regression analysis revealed that DES-ISR was a risk factor of TLR after DCB treatment for ISR (odds ratio: 5.77, 95% CI 1.75-18.95, p = 0.004). Among representative published trials using DCB for ISR, clinical outcomes are often worse in DES-ISR trials than those in bare metal stent-ISR trials. The rates of TLR in previous DES-ISR trials are similar to that in the current PMS (TLR at 12months: 22.1% for ISAR-DESIRE 3, 15.3% for PEPCAD-DES, and 13.0% for RIBS IV). The effectiveness and safety of DCB for coronary ISR have been confirmed in the Japanese real-world survey. PMS would be useful to evaluate the safety and effectiveness of medical products throughout their total life cycles.

A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis.

Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please). AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [-0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups. In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months. NCT02151812 (http://clinicaltrials.gov/).

Procedural and 1-year clinical outcomes of orbital atherectomy for treatment of coronary in-stent restenosis: A single-center, retrospective study.

We evaluated the procedural and 1-year clinical outcomes of orbital atherectomy (OA) for treatment of coronary in-stent restenosis (ISR). The optimal treatment for ISR remains uncertain. While rotational and laser atherectomy have been used as neointimal debulking techniques for ISR, there have been few reports on OA for ISR. This is a retrospective observational study of consecutive patients who underwent percutaneous coronary intervention (PCI) for ISR with OA in Mount Sinai catheterization laboratory between November 2013 and January 2018. Procedural success was defined as angiographic success without in-hospital major adverse cardiac events (MACE; the composite of all-cause death, myocardial infarction [MI], or target vessel revascularization). Clinical outcomes were assessed at 1 month and 12 months postprocedure. A total of 87 patients were included in the study. All 87 patients were treated with OA, after which 49 (56.3%) patients also received new drug-eluting stents. Angiographic success was achieved in 87 (100%) patients and procedural success was achieved in 79 (90.8%) patients. In-hospital MACE occurred in 8 (9.2%) patients, all due to periprocedural non-Q-wave MI. Acute lumen gain was 1.19 ± 0.57 mm after OA plus balloon angioplasty and 1.75 ± 0.50 mm after stent placement. MACE within 1 year occurred in 17 (19.5%) patients. OA for ISR was performed with favorable procedural and 1-year clinical outcomes. Randomized trials are warranted to determine whether OA improves the poor prognosis of patients with ISR treated without debulking.