Long-Term Follow-Up of Percutaneous Coronary Intervention With Paclitaxel-Eluting Balloon Catheter.

Drug-eluting balloons currently constitute a therapeutic tool used in percutaneous coronary interventions (PCI). Long-term results remain unknown. We evaluated the prognosis of PCI using a second generation paclitaxel-eluting balloon (PEB) in real-world patients. We included all PCI with PEB in de novo or in-stent restenosis coronary lesions performed in our unit from March 2009 to March 2019. We assessed the composite of major adverse cardiovascular events (MACE) rate after a median follow-up of 42 months. Consecutive patients (n = 320) with 386 lesions were included; 46.9% presented with stable angina and 53.1% acute coronary syndromes; 52.6% of the lesions were in-stent restenosis and 47.3% de novo lesions with a mean diameter of 2.4 ± 0.5 mm. A bare metal stent was implanted in 6.7% and a drug-eluting stent in 8.5% of patients. The MACE rate was 8%: 10 (2.6%) cardiovascular deaths, 13 (3.4%) myocardial infarctions, and 16 (4.1%) target lesion revascularization. The all-cause death rate was 5.2%. No cases of thrombosis were recorded. In conclusion, PEB was a safe and effective tool to treat in-stent restenosis and de novo coronary lesions, especially small vessel disease, during long-term follow-up.

Safety of 3-Month Dual Antiplatelet Therapy After Implantation of Ultrathin Sirolimus-Eluting Stents With Biodegradable Polymer (Orsiro): Results From the SMART-CHOICE Trial.

Background This study sought to investigate the safety of 3-month dual antiplatelet therapy (DAPT) in patients receiving ultrathin sirolimus-eluting stents with biodegradable polymer (Orsiro). Methods and Results The SMART-CHOICE (Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Anti- platelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents) randomized trial compared 3-month DAPT followed by P2Y12 inhibitor monotherapy with 12-month DAPT in 2993 patients undergoing percutaneous coronary intervention. The present analysis was a prespecified subgroup analysis for patients receiving Orsiro stents. As a post hoc analysis, comparisons between Orsiro and everolimus-eluting stents were also done among patients receiving 3-month DAPT. Of 972 patients receiving Orsiro stents, 481 patients were randomly assigned to 3-month DAPT and 491 to 12-month DAPT. At 12 months, the target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization, occurred in 8 patients (1.7%) in the 3-month DAPT group and in 14 patients (2.9%) in the 12-month DAPT group (hazard ratio [HR], 0.58; 95% CI, 0.24-1.39; P=0.22). In whole population who were randomly assigned to receive 3-month DAPT (n=1495), there was no significant difference in the target vessel failure between the Orsiro group and the everolimus-eluting stent group (n=1014) (1.7% versus 1.8%; HR, 0.96; 95% CI, 0.41-2.22; P=0.92). Conclusions In patients receiving Orsiro stents, clinical outcomes at 1 year were similar between the 3-month DAPT followed by P2Y12 inhibitor monotherapy and 12-month DAPT strategies. With 3-month DAPT, there was no significant difference in target vessel failure between Orsiro and everolimus-eluting stents. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02079194.

One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: a propensity-matched analysis of two international all-comers registries.

OBJECTIVES: Recent improvements in coronary stent design have focussed on thinner struts, different alloys and architecture, more biocompatible polymers, and shorter drug absorption times. This study evaluates safety and efficacy of a newer generation thin-strut cobalt chromium sirolimus-eluting coronary stent (SES, Ultimaster) in comparison with a second-generation thicker strut stainless steel biolimus-eluting stent (BES, Nobori) in percutaneous coronary intervention (PCI) practice. METHODS: A propensity score analysis was performed to adjust for differences in baseline characteristics of 8137 SES patients and 2738 BES patients of two PCI registries (e-Ultimaster and NOBORI 2). An independent clinical event committee adjudicated all endpoint-related adverse events. RESULTS: The use of SES, as compared with BES was associated with a significantly lower rate of myocardial infarction (MI) (1.2% vs 2.2%; P = 0.0006) and target vessel-related MI (1.1% vs 1.8%; P = 0.002) at 1 year. One-year composite endpoints of all predefined endpoints were lower in patients undergoing SES implantation (target lesion failure: 3.2% vs 4.1%; P = 0.03, target vessel failure: 3.7% vs 5.0%; P = 0.003, patient-oriented composite endpoint 5.7% vs 6.8%; P = 0.03). No significant differences between SES and BES were observed in all-cause death (2.0% vs 1.6%; P = 0.19), cardiac death (1.2% vs 1.2%; P = 0.76) or stent thrombosis (0.6% vs 0.8%; P = 0.43). CONCLUSIONS: These findings suggest an improved clinical safety and efficacy of a newer generation thin-strut SES as compared with a second-generation thicker strut BES.

Long-term follow-up after sirolimus-coated balloon use for coronary artery disease. Final results of the Nanolutè study.

OBJECTIVES: To test the long-term efficacy of a sirolimus-coated balloon (SCB). BACKGROUND: Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data. METHODS: All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI). RESULTS: A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%). CONCLUSION: The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.

Resultado del tratamiento percutáneo de la reestenosis de stents farmacoactivos: ¿depende de si el stent tenía o no recubrimiento polimérico? / Do outcomes following intervention for drug-eluting stent restenosis depend on whether the restenosed stent was polymer-free or polymer-coated?

INTRODUCCIÓN Y OBJETIVOS: Los resultados de los pacientes con reestenosis de stents farmacoactivos (SFA) son peores que los de pacientes con reestenosis de stents metálicos. No se sabe si está relacionado o no con la presencia de recubrimiento de polímero. Se compararon los resultados tras la intervención sobre la reestenosis del stent (RS) de SFA sin polímero y SFA recubiertos de polímero duradero. MÉTODOS: Se incluyó a los pacientes del estudio aleatorizado ISAR-TEST 5 sometidos a un nuevo intervencionismo percutáneo por RS durante el seguimiento. Se analizaron los resultados angiográficos a los 6 y a los 8 meses y los eventos clínicos a los 2 años, y se compararon los 2 grupos en función del tipo de stent. Las diferencias entre uno y otro grupo se ajustaron mediante análisis multivariable. RESULTADOS: Se incluyó a 326 pacientes con RS: 220 de SFA sin polímero y 106 de SFA con polímero. Se dispuso de angiografía de control del 83,4% de los pacientes. No se observaron diferencias entre los grupos en cuanto a reestenosis binaria recurrente (el 31,7 y el 27,0%; p = 0,38; pajustada=0,29). A los 2 años, el objetivo compuesto de muerte, infarto de miocardio o nueva revascularización de la lesión diana fue similar en los 2 grupos (el 35,7 frente al 34,0%; HR=1,04; IC95%, 0,70-1,55; p = 0,83; pajustada=0,79). Las tasas de nueva revascularización de la lesión diana de ambos grupos también fueron comparables (el 29,8 y el 31,5%; HR=0,91; IC95%, 0,60-1,39; p = 0,68; pajustada=0,62). CONCLUSIONES: No se encontraron diferencias entre los pacientes sometidos a reintervención por RS de SFA en cuanto a eventos clínicos o angiográficos en función del tipo de stent, con o sin polímero

INTRODUCTION AND OBJECTIVES: Outcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES. METHODS: Patients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups. RESULTS: A total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P=.38; Padjusted=.29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; Padjusted=.79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR=0.91, 95%CI, 0.60-1.39; P=.68; Padjusted=.62). CONCLUSIONS: In patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES

Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data.

Background More than 600 000 coronary stents are implanted during percutaneous coronary interventions (PCIs) annually in the United States. Because no real-world surveillance system exists to monitor their long-term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain. Methods and Results We used deterministic matching to link the NCDR (National Cardiovascular Data Registry) CathPCI Registry to Medicare fee-for-service claims for patients aged ≥65 years who underwent PCI with drug-eluting stents (DESs) between July 1, 2009 and December 31, 2013. We identified subsequent PCIs within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415 306 DES placements in 368 194 patients, 33 174 repeat PCIs were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR CathPCI Registry; 16 942 (51.1% of repeat PCIs) were target vessel revascularizations. Of these, 8544 (50.4%) were within a previously placed DES: 7652 for in-stent restenosis and 1341 for stent thrombosis. Of 16 176 patients with a claim for acute myocardial infarction in the follow-up period, 4446 (27.5%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24 288 patients whose death was identified in claims data, 278 (1.1%) were attributed to the same coronary artery in which the DES was implanted during the index PCI. Conclusions Most repeat PCIs following DES stent implantation identified in longitudinal claims data could be linked to real-world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in-depth examination to accurately assess stent safety.

A comparison between drug-eluting stent implantation and drug-coated balloon angioplasty in patients with left main bifurcation in-stent restenotic lesions.

BACKGROUND: The current guidelines recommend both repeat stenting and drug-coated balloons (DCB) for in-stent restenosis (ISR) lesions, if technically feasible. However, real-world clinical data on the interventional strategies in patients with left main bifurcation (LMB)-ISR have not been elucidated. METHODS: Seventy-five patients with LMB-ISR, who underwent percutaneous coronary intervention (PCI) between January 2009 and July 2015, were retrospectively reviewed for the present study (repeat drug eluting stent [DES] implantation [n = 51], DCB angioplasty [n = 24]). RESULTS: Analysis of the baseline characteristics showed that the patients in the DCB group had a lower incidence of non-ST segment elevation myocardial infarction/ST segment elevation myocardial infarction at the index PCI (8.3% vs. 25.5%; p = 0.12), higher low-density lipoprotein-cholesterol level (92.9 mg/dL vs. 81.7 mg/dL; p = 0.09), and more "stent-in-stent" lesions (25% vs. 7.8%; p = 0.07) than those in the DES group. A smaller post-procedural minimal target lesion lumen diameter was also noted in the DCB group than in the DES group (2.71 mm vs. 2.85 mm; p = 0.03). The cumulative incidence rates of major adverse cardiac events (MACEs) were similar between both groups (median follow-up duration, 868 days; MACE rate, 25% in the DCB group vs. 25.5% in the DES group; p = 0.96). The multivariate Cox regression analysis indicated that the true bifurcation of ISR was an independent risk predictor of MACEs (hazard ratio, 4.62; 95% confidence interval, 1.572-13.561; p < 0.01). CONCLUSIONS: DES and DCB showed comparable long-term clinical results in patients with LMB-ISR lesions.

Do outcomes following intervention for drug-eluting stent restenosis depend on whether the restenosed stent was polymer-free or polymer-coated?

INTRODUCTION AND OBJECTIVES: Outcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES. METHODS: Patients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups. RESULTS: A total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P=.38; Padjusted=.29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; Padjusted=.79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR=0.91, 95%CI, 0.60-1.39; P=.68; Padjusted=.62). CONCLUSIONS: In patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES.

Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of In-Stent Restenosis.

OBJECTIVES: This study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR). BACKGROUND: DCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies. METHODS: This is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24 months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization. RESULTS: A total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6 months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4 ±â€¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, these parameters were 52.6 ±â€¯10% and 55.2% (IQR 49.3-58.5), respectively. In-segment LLL was 0.25 ±â€¯0.43 mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6 months, 13.3% at 12 months, and 13.3% at 24 months. CONCLUSIONS: In this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR. SUMMARY: We sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4 ±â€¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, corresponding values were 52.6 ±â€¯10% and 55.2% (IQR 49.3-58.5), respectively. The observed in-segment LLL was 0.25 ±â€¯0.43 mm and binary restenosis rate was 7.7%. TLF was 10% at 6 months and 13.3% at 12 and 24 months.

Long-term clinical safety and efficacy of drug-coated balloon in the treatment of in-stent restenosis: A meta-analysis and systematic review.

OBJECTIVES: The aim of this study was to evaluate the long-term clinical safety and efficacy of drug-coated balloon (DCB) in the treatment of in-stent restenosis (ISR). BACKGROUND: There is a long-term safety issue in peripheral arterial disease patients treated with paclitaxel-coated balloon, this has also raised concerns on DCB in coronary intervention. METHODS: Nine randomized controlled trials (RCTs) and nine observational studies (OSs) were included with a total of 3,782 patients (1,827 in the DCB group, 1,955 in the drug-eluting stent [DES] group) being analyzed. The primary outcome measure-major adverse cardiovascular events (MACEs), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), cardiac death (CD), stent thrombosis (ST), all-cause death (AD), and coronary angiography outcomes included late lumen loss (LLL), minimum luminal diameter (MLD), diameter stenosis (DS) were analyzed. RESULTS: DCB treatment significantly reduced the LLL (MD: -0.13; [CI -0.23 to -0.03], p = .01). No difference was found for MLD (MD: -0.1; [CI -0.24 to 0.04], p = .17) and DS% (RR = 0.98 [CI 0.80-1.20], p = .86). There was no significant difference in TLR, TVR, MI, CD, ST, AD, and the overall incidence of MACEs between the two groups up to 3 years follow-up. Subgroup analysis for different type of ISR and DES showed no significant difference in the incidence of endpoints, and there is no difference when considering RCTs or OSs only. CONCLUSIONS: The safety and efficacy of the DCB and DES in the treatment of ISR is comparable at up to 3 years follow-up.

Two decades after coronary radiation therapy: A single center longitudinal clinical study.

OBJECTIVES: The aim of this study was to evaluate the very long-term clinical outcome after radioactive stent (RS) implantation and intracoronary ß radiation brachytherapy (IRBT). BACKGROUND: Radioactive stents (RS) and intracoronary ß radiation brachytherapy (IRBT) were introduced to prevent restenosis after percutaneous coronary intervention (PCI). Both techniques were associated with a higher incidence of major adverse cardiac events (MACE) in the short and intermediate-term follow up as compared to conventional PCI. METHODS: One hundred and thirty-three patients received radioactive stents (32 P) and 301 patients were treated with IRBT adjunctive to PCI. These groups were propensity matched to respectively 266 and 602 control patients who were treated with routine PCI during the same inclusion period. Endpoints were all-cause mortality and MACE, defined as all-cause death, any myocardial infarction or any revascularization. RESULTS: Median follow-up duration was 17 years. All-cause mortality rates were similar in all groups. Adjusted hazard ratios for MACE and mortality in the RS cohort were 1.55 (95% CI 1.20-2.00) and 0.92 (95% CI 0.63-1.34), respectively. Adjusted hazard ratios for MACE and all-cause mortality in the IRBT cohort were 1.41 (95% CI 1.18-1.67) and 0.95 (95% CI 0.74-1.21), respectively. The difference in MACE rates was predominantly driven by coronary revascularizations in both groups, with a higher MI rate in the IRBT group as well. CONCLUSIONS: Coronary radiation therapy was associated with early increased MACE rates, but the difference in MACE rates decreased beyond 2 years, resulting in a comparable long-term clinical outcome. Importantly, no excess in mortality was observed.

Efficacy of drug-coated balloon angioplasty in early versus late occurring drug-eluting stent restenosis: A pooled analysis from the randomized ISAR DESIRE 3 and DESIRE 4 trials.

BACKGROUND: Whether there exist differences concerning clinical outcomes between patients presenting with early versus late DES-ISR undergoing treatment with drug-coated balloons (DCB) remains a scientific knowledge gap. METHODS: This is a pooled analysis including patients with DES-ISR assigned to treatment with DCB in the setting of the ISAR DESIRE 3 and 4 trials. Clinical outcomes were evaluated according to time of occurrence of ISR after DES implantation, in patients presenting with early (≤12 months) versus late DES-ISR (>12 months) undergoing treatment with DCB. The primary endpoint of this analysis was major adverse cardiac event (MACE), defined as the combined incidence of death, myocardial infarction and target lesion revascularization (TLR) at 12 months after DCB treatment. Secondary endpoints included the incidence of death, myocardial infarction, TLR and target lesion thrombosis at 12 months after DCB treatment. RESULTS: This analysis included 352 patients, 199 patients presented with early-ISR, 153 patients with late-ISR. Concerning the primary endpoint, patients with early-DES-ISR as compared those with late-DES-ISR showed significant higher risk (25.9% vs. 17.0%; p = .04). In a multivariate analysis including diabetic status, clinical presentation, previous coronary bypass graft and diameter stenosis after DCB-treatment, the adjusted hazard ratio showed significant higher risk for MACE of early-DES-ISR as compared to late-DES-ISR (HRadj = 1.8, [95% CI = 1.1-3.0], p = .02). CONCLUSION: Clinical outcome at 12 months after treatment of DES-ISR with DCB, showed significant higher clinical event rates in patients presenting with early DES restenosis, as compared with patients presenting with late DES restenosis.

Do ultrathin strut bare-metal stents with passive coating improve efficacy in large coronary arteries? Insights from the randomized, multicenter BASKET-PROVE trials.

BACKGROUND: The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest higher rates of symptomatic restenosis in patients receiving the newer generation BMS. We investigated the efficacy of a newer generation ultrathin strut silicon-carbide coated cobalt-chromium (CoCr) BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0 mm). METHODS: All patients randomized to SCC- (n = 761) or UC-BMS (n = 765) in the two BASKET-PROVE trials were included. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis (ST) were also assessed. We used inverse probability weighted proportional hazards Cox regressions adjusting for known confounders. RESULTS: Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. The risk for clinically driven TVR was increased om the SCC-BMS group compared to the UC-BMS group (cumulative incidence, 10.6% vs. 8.4%; adjusted relative hazard [HR], 1.49 [95% CI, 1.05-2.10]). No differences in safety endpoints were detected, cardiac death (1.6% vs. 2.8%; HR, 0.62 [CI, 0.30-1.27]), non-fatal MI (3.2% vs. 2.5%; HR, 1.56 [CI, 0.83-2.91]), and definite/probable ST (0.8% vs. 1.1%; HR, 1.17 [CI, 0.39-3.50]). Differences in strut thickness between the two stents did not explain the association between stent type and clinically driven TVR. CONCLUSIONS: In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of clinically driven repeat revascularization compared to the UC-BMS with no signs of an offsetting safety benefit.

A Novel Rabbit Model for In-Stent Neoatherosclerosis.

In-stent neoatherosclerosis is an important problem after percutaneous coronary intervention. To explore the mechanisms and treatment of in-stent neoatherosclerosis, an animal model is needed. To avoid the disadvantages of current animal models, such as excessive use of X-rays and a high mortality rate, we attempted to develop an improved animal model. We explored a method that uses a short time interval to establish a rabbit model of in-stent neoatherosclerosis with a high survival rate and to evaluate its indicators. Sixty rabbits were divided into three equal groups: group A, the traditional method; group B, the standard intervention method; and group C, the improved method. In group C, we made two small incisions in each rabbit's neck, separated the common carotid, punctured it, and implanted a stent. The incision was then sutured. Four weeks later, we used optical coherence tomography (OCT) to scan all rabbits for neoatherosclerosis. We found no significant differences in OCT data between our new animal model and the traditional and interventional groups (P > 0.05). The technological success rate was higher in the new animal model (P < 0.001). We developed a new method to establish an animal model of neoatherosclerosis, which had similar results to the traditional and interventional methods.

Short-Term and Long-Term Efficacy of Drug-Coated Balloon for In-Stent Restenosis in Hemodialysis Patients with Coronary Artery Disease.

The efficacy of drug-coated balloons (DCB) for in-stent restenosis (ISR) in hemodialysis (HD) patients remains unclear.We retrospectively evaluated 153 consecutive patients who underwent DCB for ISR with follow-ups for up to 3 years after the procedure between February 2014 and June 2017. Patients were divided into an HD group (n = 39) and a non-HD group (n = 114). The primary endpoint was target lesion revascularization (TLR). The secondary endpoints were all revascularizations and major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction and cerebral infarction. Kaplan-Meier curves of survival free from TLR were compared between the two groups. We also performed propensity score matching and then compared the two matched groups (n = 27 in each group). The acute procedure success rate was similar for the two groups (100% versus 99.1%, P = 0.56). The incidence of TLR was higher in the HD group than in the non-HD group (41.0% versus 9.6%, P < 0.0001). The rate of revascularizations and MACE combined was significantly higher in the HD group than in the non-HD group (64.1% versus 17.5%, P < 0.0001). Kaplan-Meier analyses showed that survival free from TLR was significantly lower in the HD group than in the non-HD group both before and after propensity score matching (P < 0.0001 and P = 0.005, respectively; log-rank test).Contrary to the similar acute procedure success, recurrent ISR and MACE occurred more frequently in HD patients than in non-HD patients after DCB, which indicates poorer long-term efficacy of DCB in HD patients.

Comparison of drug-eluting balloon with repeat drug-eluting stent for recurrent drug-eluting stent in-stent restenosis.

OBJECTIVE: Approximately, 10-20% of patients with drug eluting stent (DES) in-stent restenosis (ISR) will develop recurrent ISR; yet, the optimal management of recurrent DES-ISR is unknown. We sought to compare the outcomes of recurrent DES-ISR treated with drug eluting balloons (DEB) to those with repeated implantation of new-generation DES. METHODS: A total of 172 patients with recurrent DES-ISR were enrolled and stratified into two cohorts: the repeated DES implantation (Re-DES) group and the DEB group. The primary endpoint was the 1-year incidence of major adverse cardiovascular events (MACE). RESULTS: Ninety-three patients treated with DEB and 79 patients with Re-DES implantation were analyzed. Both groups had comparable baseline characteristics. Lesser residual stenosis was achieved in the Re-DES group (11.3 ± 3.2% vs. 22.4 ± 4.3%; P = 0.00) than in the DEB group. However, the incidence of MACE and target lesion revascularization (TLR) were less in the DEB group (17.2% vs. 32.9%; P = 0.02 and 15.1% vs. 27.8%; P = 0.04, respectively). For the ≥3 metal-layered DES-ISR subgroup, DEB drastically reduced the incidences of MACE and TLR compared with Re-DES (20.0% vs. 57.9%; P = 0.02 and 16.0% vs. 47.4%; P = 0.04, respectively). Survival analysis demonstrated that MACE-free survival was significantly higher in the DEB group compared with the Re-DES group, whether the metal layers were ≥3 or 2. Multivariate analysis revealed that the risk factors of MACE were diabetes mellitus, ≥3 metal-layered DES ISR, and repeat DES deployment. CONCLUSIONS: For recurrent DES-ISR, DEB may improve clinical outcomes compared with Re-DES implantation, especially for ≥3 metal-layered DES-ISR.

Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial.

BACKGROUND: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. DESIGN: COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. CONCLUSIONS: The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.

Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis.

Drug-coated balloon (DCB) angioplasty has been shown to be a promising option for the treatment of coronary in-stent restenosis (ISR). We compared the clinical outcomes of patients with ISR who were treated with two commonly used paclitaxel-containing DCBs, the Pantera Lux (PL) and SeQuent Please (SP). A total of 491 patients with 507 ISR lesions [PL-DCB in 127 (26%) patients and SP-DCB in 364 (74%) patients] underwent DCB angioplasty for ISR lesions. The major adverse cardiac events (MACEs), including cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, were assessed. There were no significant differences in each occurrence of MACE and cardiac death: 16 MACEs (61 per 1000 person-years) in the PL-DCB group and 55 (60 per 1000 person-years) MACEs in the SP-DCB group, log-rank p = 0.895, and three cardiac deaths (11 per 1000 person-years) in the PL-DCB group and ten cardiac deaths (11 per 1000 person-years) in the SP-DCB group, log-rank p = 0.849. Diabetes mellitus under insulin treatment [hazard ratio (HR) 2.71; 95% confidence interval (CI) 1.31-5.60; p = 0.007], chronic kidney disease (HR 1.99; 95% CI 1.01-3.92; p = 0.045), early-onset ISR (HR 1.99; 95% CI 1.18-3.36; p = 0.010), and recurrent ISR (HR 1.89; 95% CI 1.08-3.32; p = 0.026) were associated with the occurrence of MACE after DCB angioplasty. There was no significant difference of MACE between PL-DCB and SP-DCB treatment in patients with ISR. Patients with insulin-treated diabetes, chronic kidney disease, early-onset ISR, and recurrent ISR were at a higher risk of MACE after DCB angioplasty.

Association of Elevated Plasma Homocysteine Level with Restenosis and Clinical Outcomes After Percutaneous Coronary Interventions: a Systemic Review and Meta-analysis.

PURPOSE: We conducted this systemic review and meta-analysis to investigate the association between elevated plasma homocysteine (Hcy) levels and recurrent restenosis and clinical outcomes after percutaneous coronary intervention (PCI). METHODS: PubMed, EMBASE, and Web of Science were systematically searched prior to May 2018. Studies evaluating the association between plasma Hcy levels and the occurrence of restenosis, major adverse cardiac events (MACE), all-cause mortality, cardiac death, non-fatal myocardial infarction (MI), and target lesion revascularization were identified. RESULTS: A total of 19 articles with 4340 participants were identified. Higher Hcy levels were not associated with an increased risk of restenosis (relative risk (RR) = 1.10, 95% CI 0.90-1.33). Hcy levels in the restenosis group were not significantly higher than in the non-restenosis group (weighted mean difference = 0.70, 95% CI - 0.23-1.63). Subgroup analysis revealed that higher Hcy levels were not associated with restenosis after stenting but appeared to increase the risk of restenosis after angioplasty. Elevated Hcy levels increased the risk of all-cause mortality by an average of 3.19-fold (RR = 3.19, 95% CI 1.90-5.34, P = 0.000), the risk of MACE by 1.51-fold (RR = 1.51, 95% CI 1.23-1.85, P = 0.000), and the risk of cardiac death by 2.76-fold (RR = 2.76, 95% CI 1.44-5.32, P = 0.000) but appeared not to increase the risk of non-fatal MI (RR = 1.36, 95% CI 0.89-2.09). CONCLUSIONS: Our meta-analysis suggests that although there is no clear association between higher Hcy levels and restenosis following stent implantation, higher Hcy levels appeared to increase the risk of restenosis after coronary angioplasty and also increased the risk of all-cause mortality, MACE, and cardiac death after PCI. REGISTRATION DETAILS: The protocol of this meta-analysis was registered on PROSPERO (CRD42018096466). ( http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018096466 ).