New-generation Drug-eluting Stents Research Articles

P2802Second-generation drug-eluting stents versus coronary artery bypass surgery in patients with stable angina and an isolated lesion in the proximal left anterior descending artery

Abstract Background/Introduction Both coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI), especially with the use of new-generation drug-eluting stents (DES), remain the most common therapeutic options of coronary artery disease, especially when the proximal segment of left anterior descending artery (pLAD) is involved. There are only a small number of studies comparing these approaches in patients with isolated lesions in LAD. Purpose We aim to compare the long-term outcomes of PCI with second-generation DES versus CABG surgery with left internal mammary artery, in patients with stable angina and an isolated single vessel pLAD disease. Methods The study population consisted of 1010 consecutive patients with stable angina and an isolated pLAD that were treated either with PCI with second generation (zotarolimus or everolimus) DES (631 patients) or with CABG surgery (379 patients). The primary endpoint was the occurrence of any major adverse cardiac event (MACE) namely cardiac death, non-fatal myocardial infarction and target lesion revascularization (using either percutaneous or surgical technique) as a composite index. Other evaluated main clinical outcomes were the components of MACE, patient-related outcome (PRO-a composite index of all-cause mortality, any myocardial infarction, any revascularization), recurrence of stable angina and arrhythmias occurrence. Results Lower rates of in-hospital complications (0.3% versus 12.1%, p<0.001) and shorter hospitalization [median, 1 (interquartile-range: 1–4) versus 8 (interquartile-range: 7–11), p<0.001] were recorded in the PCI group compared with the surgery arm. During the follow-up period (mean, 4.6±2.5 years), no statistical difference was observed in respect to MACE between the two study groups (10.1% versus 7.4%, p=0.14). Higher rates of repeat revascularization were detected in patients treated with PCI than those treated with CABG (5.5% versus 2.9%, p=0.05). Concerning other secondary endpoints, cardiac death (2.9% versus 3.2%, p=0.78), myocardial infarction (1.7% versus 1.3%, p=0.60), and PRO (18.9% versus 17.7%, p=0.64) did not differ in a statistically significant manner between the two techniques. Recurrence of stable angina was significantly increased in PCI (15.6% versus 8.4%, p=0.001), whereas arrhythmias occurrence was most common in the surgery group (6.3% versus 11.9%, p=0.002). Conclusion PCI with second-generation DES seem to have similar long-term clinical outcomes compared with CABG in patients with isolated LAD disease, highlighting the excellent long-term outcomes of both therapeutic approaches

Impact of Elevated Serum Uric Acid Level on Target Lesion Revascularization After Percutaneous Coronary Intervention for Chronic Total Occlusion

Elevated serum uric acid (SUA) level is reportedly associated with subsequent cardiovascular events including revascularization in patients with coronary artery disease. However, the impact of SUA level on revascularization in patients with chronic total occlusion (CTO), one of the highest risk subsets in coronary artery disease, is unclear. The aim of this study was to evaluate the impact of SUA level on target lesion revascularization (TLR) in contemporary percutaneous coronary intervention (PCI) for CTO. A total of 165 patients who underwent successful PCI with new-generation drug-eluting stent for CTO under intravascular ultrasound guidance were included. Patients were classified into 3 groups according to the tertiles of SUA level at baseline. Coronary angiography was qualitatively and quantitatively assessed, and gray-scale intravascular ultrasound was also analyzed. The primary end point was TLR. The tertiles of SUA level were as follows: low tertile, ≤5.2 mg/dl; intermediate tertile, 5.3 to 6.4 mg/dl; and high tertile, ≥6.5 mg/dl. During a median follow-up of 34 months, TLR was observed in 5 patients (8.8%) in the low tertile, in 5 (9.4%) in the intermediate tertile, and in 14 (25.5%) in the high tertile (p = 0.02). Kaplan-Meier analysis demonstrated a significantly higher incidence of TLR in patients with high tertile than the low and intermediate groups. Multivariable analysis showed SUA ≥6.5 mg/dl, diabetes mellitus, and longer CTO length as independent predictors of TLR. In conclusion, in patients who underwent PCI with drug-eluting stent, elevated SUA level was associated with TLR after successful recanalization of CTO.

Clinical outcomes of long stenting in the drug-eluting stent era: patient-level pooled analysis from the GRAND-DES registry.

We aimed to understand the association between stent length and clinical outcomes after percutaneous coronary intervention (PCI) using newer-generation drug-eluting stents (DES). We analysed 9,217 patients who underwent stenting for a single lesion from the GRAND-DES registry, a patient-level pooled registry including five Korean multicentre DES registries. The median follow-up duration was 730 days (interquartile range 708 to 752 days). A total of 8,035 patients were classified into the short stenting group (≤40 mm), and 1,182 into the long stenting group (>40 mm). The primary endpoint was target lesion failure (TLF). Long stenting (>40 mm) was significantly associated with higher TLF (IPTW adjusted HR 1.88, 95% CI: 1.67-2.13; p<0.001), and definite or probable stent thrombosis (IPTW adjusted HR 2.20, 95% CI: 1.51-3.20; p<0.001). In the landmark analysis, the incidence of TLF was significantly higher with long stenting during the first 30 days after PCI (log-rank p=0.001) and also after 30 days (log-rank p<0.001). Long stenting was associated with a higher risk of early stent thrombosis (log-rank p=0.001), but not with that of late stent thrombosis (log-rank p=0.887). In the contemporary second-generation DES era, stenting longer than 40 mm continues to be associated with less favourable clinical outcomes such as TLF and stent thrombosis.

TCT-55 Incidence, Predictors, and Clinical Implications of Stent Optimization on Intravascular Ultrasound After New-Generation Drug-Eluting Stent Implantation for Diffuse Long Coronary Stenotic Lesions

No data exists regarding clinical implications of intravascular ultrasound (IVUS) optimization for diffuse long lesions in the new-generation drug-eluting stent (DES) era. We investigated the incidence, predictors, and outcomes of stent optimization on IVUS. From 4 randomized trials comparing IVUS

TCT-390 Impact of SYNTAX Score on Long-Term Clinical Outcomes in Patients Treated With New-Generation Drug-Eluting Stents for Unprotected Left Main Disease

Impact of SYNTAX score (SS) on long-term clinical outcomes after new-generation drug-eluting stents implantation for unprotected left main disease remains unclear. Between February 2010 and July 2012, 2,519 consecutive patients with 3,410 lesions were treated only with new-generation drug-eluting

TCT-44 Impact of Stent Edge Hinging on Chronic Neointimal Hyperplasia After Newer-Generation Drug-Eluting Stent Placement in RCA

The longitudinal straightening effect of a stent on a coronary artery can provoke the atherosclerotic process due to increase of mechanical stress around stent edge. New-generation drug-eluting stents (DES) have high flexibility and conformability, possibly moderating these stresses. The aim of this

New-generation drug-eluting stents cost effective in elderly

New-generation drug-eluting stents cost effective in elderly

Contemporary management of stent thrombosis: Predictors of mortality and the role of new‐generation drug‐eluting stents

We sought to evaluate mortality predictors and the role of new-generation drug-eluting stents (NG-DES) in stent thrombosis (ST) management. No data are available regarding the outcome of patients with ST after interventional management that includes exclusively NG-DES. Patients with definite ST of DES or BMS who underwent urgent/emergent angiography between 2015 and 2018 at our institution were considered for the study. After excluding patients who achieved TIMI-flow<2 after intervention or received an old-generation stent, 131 patients were included. Management classification was stent or non-stent treatment (medical management, thromboaspiration, balloon-angioplasty). Follow-up was performed to document all-cause death (ACD) and target-lesion-revascularization (TLR) that was used for censorship. Mode of presentation was STEMI in 88% and UA/NSTEMI in 12%. Type of ST was early, late, and very late in 11, 4, and 85%, respectively. Eighty four patients received stent and 47 non-stent treatment. After 926 ± 34 days, 21 ACDs, 7 TLRs and no cases of definite, recurrent ST were observed. Univariate predictors of in-hospital mortality were LVEF and presentation with shock or cardiac arrest. For patients discharged alive, non-stent treatment (HR 4.2, p = .01), TIMI-2 flow (HR 7.4, p = .002) and GFR < 60 mL/min (HR 3.8, p = .01) were independent predictors of ACD. The stent-treatment group had significantly better ACD-free survival after discharge, both unadjusted (p = .022) and adjusted (p = .018). After ST management, different predictors were observed for in-hospital mortality and mortality in patients discharged alive. The better outcome with NG-DES treatment is a novel observation, warranting further studies to elucidate if it is associated with stent-related or patient-related factors.

Single Long Stents versus Overlapping Multiple Stents in the Management of Very Long Coronary Lesions: Comparisons of Procedures and Clinical Outcomes

Background: Different percutaneous coronary intervention (PCI) strategies, including the use of single long stents (SLSs) and overlapping multiple stents (OMSs), have been introduced to treat very long coronary lesions (VLCLs). The aim of this study was to compare procedural and long-term clinical outcomes between SLSs and OMSs in patients with VLCLs. Methods: In this historical cohort study, 1709 patients who underwent PCI with the new generation of drug-eluting stents (length ≥38 mm) were stratified into the SLS [PROMUS /Resolute/XIENCE (PRX), (=38 mm), n=1121 (65.59%) and BioMime, (≥40 mm), n=124 (7.26%)] and OMS [(59.43±10.80 mm), n=464 (27.2%)] groups and followed up for 440.93±361.32 days. The study endpoints comprised immediate post-PCI outcomes, major adverse cardiovascular events (MACE), the patient-oriented composite endpoint (POCE), and the device-oriented composite endpoint (DOCE) at the long-term follow-up. Results: The mean age of the patients was 59.28±10.60 years, and 69.6% of them were male. Flow grade 3 (P=0.296) and residual stenosis (P=0.533) were statistically similar between all the groups. A lower level of post-PCI troponin was observed in the BioMime group [14.52 (IQR25%-75%:10.44-22.42) ng/L; P=0.031] than in the PRX and OMS groups [18.63 (IQR25%-75%:10.51-34.02) ng/L and 18.96 (IQR25%-75%:11.17-35.34) ng/L; respectively]. Similarly, the PRX and BioMime groups received lower amounts of the contrast agent [206.29±49.15 mL and 208.06±55.23 mL; respectively] than did the OMS group [265.50±74.69 mL; P<0.001]. There were no statistically significant differences in the incidence of MACE [81 (7.2%), 7 (5.6%), and 28 (6.0%); P=0.603], the POCE [141 (12.6%), 13 (10.5%), and 54 (11.6%); P=0.731], and the DOCE [51 (4.5%), 4 (3.2%), and 21 (4.5%); P=0.791] between the PRX, BioMime, and OMS groups, respectively. Conclusion: In the treatment of VLCLs, the SLS and OMSs appear to have similar clinical outcomes. BioMime ultra-long stents may have comparable results to PRX coronary stents.

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial

Newer-generation drug-eluting stents that combine ultrathin strut metallic platforms with biodegradable polymers might facilitate vascular healing and improve clinical outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI) compared with contemporary thin strut second-generation drug-eluting stents. We did a randomised clinical trial to investigate the safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stents versus thin strut durable polymer everolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. The BIOSTEMI trial was an investigator-initiated, multicentre, prospective, single-blind, randomised superiority trial at ten hospitals in Switzerland. Patients aged 18 years or older with acute STEMI who were referred for primary PCI were eligible to participate. Patients were randomly allocated (1:1) to either biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Central randomisation was done based on a computer-generated allocation sequence with variable block sizes of 2, 4, and 6, which was stratified by centre, diabetes status, and presence or absence of multivessel coronary artery disease, and concealed using a secure web-based system. Patients and treating physicians were aware of group allocations, whereas outcome assessors were masked to the allocated stent. The experimental stent (Orsiro; Biotronik; Bülach, Switzerland) consisted of an ultrathin strut cobalt-chromium metallic stent platform releasing sirolimus from a biodegradable polymer. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt-chromium stent platform that releases everolimus from a durable polymer. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction (Q-wave and non-Q-wave), and clinically-indicated target lesion revascularisation, within 12 months of the index procedure. All analyses were done with the individual participant as the unit of analysis and according to the intention-to-treat principle. The trial was registered with ClinicalTrials.gov, number NCT02579031. Between April 26, 2016, and March 9, 2018, we randomly assigned 1300 patients (1623 lesions) with acute myocardial infarction to treatment with biodegradable polymer sirolimus-eluting stents (649 patients and 816 lesions) or durable polymer everolimus-eluting stents (651 patients and 806 lesions). At 12 months, follow-up data were available for 614 (95%) patients treated with biodegradable polymer sirolimus-eluting stents and 626 (96%) patients treated with durable polymer everolimus-eluting stents. The primary composite endpoint of target lesion failure occurred in 25 (4%) of 649 patients treated with biodegradable polymer sirolimus-eluting stents and 36 (6%) of 651 patients treated with durable polymer everolimus-eluting stents (difference -1·6 percentage points; rate ratio 0·59, 95% Bayesian credibility interval 0·37-0·94; posterior probability of superiority 0·986). Cardiac death, target vessel myocardial reinfarction, clinically-indicated target lesion revascularisation, and definite stent thrombosis were similar between the two treatment groups in the 12 months of follow-up. In patients with acute STEMI undergoing primary PCI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 1 year. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents. Biotronik.

Incidence, predictors, and outcomes of distal vessel expansion on follow-up intravascular ultrasound after recanalization of chronic total occlusions using new-generation drug-eluting stents: Data from the CTO-IVUS randomized trial.

To evaluate the incidence, predictors, and outcomes of distal vessel expansion on intravascular ultrasound (IVUS) after recanalization of chronic total occlusion (CTO) particularly using new-generation drug-eluting stent (DES). The luminal changes of narrowed vessels distal to CTO segments after recanalization using new-generation DES have rarely been studied. This substudy of the CTO-IVUS (Chronic Total Occlusion InterVention with drUg-eluting Stents) trial included a total of 69 new-generation DES-treated CTOs with serial matched IVUS analyses at index percutaneous coronary intervention (PCI) and at 1-year follow-up. The predictors of distal vessel expansion, any increase of lumen area at the distal reference (LAdistal ) on 1-year follow-up IVUS, were evaluated by multivariable binary logistic analyses. Distal vessel expansion was identified in 46 (67%). Independent determinants of distal vessel expansion were proximal CTO, a smaller LAdistal at the index PCI, a greater minimal stent area-to-LAdistal (MSA-to-LAdistal ) ratio, and a greater lumen area at the distal stent edge-to-LAdistal (LAedge -to-LAdistal ) ratio. The cut-off values of a MSA-to-LAdistal ratio and a LAedge -to-LAdistal ratio predicting the distal vessel expansion by receiver operating characteristic curve analysis were 1.0 and 1.1, respectively. During the median 5.1 years, rates of target vessel revascularization, cardiac death, and stent thrombosis were similar in the distal vessel-expanded and nonexpanded groups. After opening CTO with new-generation DES, two-thirds of patients exhibited distal vessel expansion on 1-year follow-up IVUS. Expansion determinants were a proximal CTO, lower LAdistal , and larger stent areas relative to the LAdistal (modifiable procedural predictors).

Antithrombotic Therapy in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention.

The objective of this article is to review the contemporary literature on the use of antithrombotic therapy in patients with atrial fibrillation (AF) and coronary artery disease after undergoing percutaneous coronary intervention (PCI). Special consideration was given to the type and duration of therapy, treatment strategies for the elderly (≥65 years of age), and strategies to reduce bleeding. Relevant studies were searched through MEDLINE/PubMed, Web of Science, Cochrane Library, ClinicalTrials.gov, and Google Scholar. Of the 236 publications retrieved, 76 were considered relevant including 35 randomized controlled trials, 17 meta-analyses, 16 observational studies, and 8 published major guidelines. Most trials, meta-analyses, and guidelines support 1 month of triple therapy (TT) with an oral anticoagulant (OAC), dual antiplatelet agents (DAPT) with aspirin (ASA)/clopidogrel, and, afterward, dual therapy (DT) with OAC and single antiplatelet agent for an additional 11 months, or alternatively DT alone for 12 months after PCI. Individual consideration is given to the risk and impact of stent thrombosis (ST), thromboembolism, and bleeding. Several trials and meta-analyses have also suggested that shorter DAPT duration (≤6 months) may be safer than longer therapy (≥6 months) when weighing the risk of bleeding with ischemic outcomes, especially with newer generation drug-eluting stents. The selective use of proton-pump inhibitors in patients prone to gastrointestinal bleeding who are subjected to prolonged exposure with TT or DT may be beneficial. In the elderly, the risk of bleeding from TT, compared with DT, outweighs the benefit of reducing ischemic events. In conclusion, tailoring therapy to the individual patient is recommended considering the ischemic and bleeding risk as well as the risk of thromboembolism. For most patients with AF, 1 month of TT and subsequently DT for additional 11 months are recommended.

Impact of lesion angle on optical coherence tomography findings and clinical outcomes after drug-eluting stent implantation in curved vessels.

Tortuous coronary lesions are associated with adverse outcomes after implantation of bare metal or first-generation drug-eluting stents (DESs). We investigated the impact of lesion angle on vessel wall injuries and stent apposition as assessed by optical coherence tomography (OCT) after second- and newer-generation DES implantation. We investigated 95 de novo lesions treated with a single DES (62 platinum-chromium everolimus-eluting stents and 33 bioresorbable-polymer sirolimus-eluting stents). Post-intervention OCT findings were compared between angled lesions (≥ 45°; n = 33) and non-angled lesions (< 45°; n = 62). The 12-month clinical outcomes were also compared between the groups. Cross-sectional OCT analysis revealed that compared to non-angled lesions, angled ones had a significantly higher incidence of intra-stent dissection around the centre of the angle (19.7% vs. 10.8%, p = 0.01) and incomplete stent apposition (ISA) in the distal and proximal sub-segments (10.0% vs. 4.1%, p = 0.002; 15.3% vs. 7.9%, p < 0.001, respectively). Strut-based analysis also showed that angled lesions demonstrated a higher rate of malapposed strut in the distal and proximal sub-segments (3.0% vs. 0.9%, p < 0.001; 4.3% vs. 1.8%, p < 0.001, respectively). The 12month clinical outcomes were comparable between the groups. Compared to non-angled lesions, angled coronary lesions were associated with a higher incidence of intra-stent dissection and ISA on post-intervention OCT after implantation of second- and newer-generation DESs.

Clinical impact of complex percutaneous coronary intervention in patients with coronary artery disease.

For the revascularization of patients with clinical and anatomical complexities, several technical skills are often required. However, the prognostic effect of complex percutaneous coronary intervention (C-PCI) on the clinical outcomes is not well known. The aim of this study was to investigate the relationship between the C-PCI and mid-term clinical outcomes. We assessed 1062 patients who underwent PCI with newer-generation drug-eluting stent and stratified the patients according to whether they had complex PCI (C-PCI, n = 358) or non-complex PCI (non-C-PCI, n = 704). C-PCI was defined as a procedure with at least 1 of the following features: 3 vessels treated, ≥ 3 stents per vessel implanted, ≥ 3 lesions treated, use of a 2-stent technique, the total stent length per vessel > 60mm, chronic total occlusion, unprotected left main coronary artery stenting, and rotational atherectomy use. All-cause death and major adverse cardiac and cerebrovascular events (MACCE; cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke) were evaluated. The median follow-up period was 1.9 (0.8-3.0) years. The baseline SYNTAX score was significantly higher in the C-PCI group than in the non-C-PCI group [20 (14-27) vs. 10 (6-17), p < 0.001]. Kaplan-Meier analysis showed that the cumulative incidences of all-cause death (log-rank p = 0.12) and MACCE (log-rank p = 0.64) did not differ between the two groups. On multivariable Cox analysis, C-PCI did not adversely affect the clinical outcomes. Despite a high rate of anatomically complex coronary lesions, the patients who underwent C-PCI had comparable "hard" clinical outcomes with those of non-C-PCI.

Drug-eluting coronary stents: insights from preclinical and pathology studies.

Implantation of drug-eluting stents (DES) is the dominant treatment strategy for patients with symptomatic coronary artery disease. However, the first-generation DES had substantial drawbacks, including delayed healing, local hypersensitivity reactions and neoatherosclerosis, which all led to a steady increase in major adverse cardiovascular events over time. Subsequently, newer-generation DES were introduced with thinner struts, different scaffold designs (to improve deliverability while maintaining radial strength), different durable and biodegradable polymers - and in some cases no polymer (to improve vascular biocompatibility) - and new antiproliferative drug types and doses. Currently, >30 different DES are commercially available in Europe, with fewer available in the USA but with many new entrants coming onto the US market in the next few years. Never before have cardiologists been faced with so many choices of stent, each with its own unique design. In this Review, we detail preclinical and pathology studies for each stent design, examining thromboresistance, speed of neointimal coverage and completeness of healing, including endothelialization. We conclude by discussing how these design characteristics might affect the potential for shortening the minimum duration of dual antiplatelet therapy needed after coronary intervention.

Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents.

Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new- versus early-generation DES vary by DM status. We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively ( Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization. The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

Duration of dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent: systematic review and network meta-analysis

ObjectiveTo evaluate the efficacy and safety of standard term (12 months) or long term (>12 months) dual antiplatelet therapy (DAPT) versus short term (<6 months) DAPT after percutaneous coronary intervention...

Percutaneous management of long and diffused coronary lesions using newer generation drug-eluting stents in routine clinical practice: long-term outcomes and complication predictors.

Long and diffuse coronary lesions (LDCLs) are routinely subjected to percutaneous management, but long‑term clinical outcomes and complication predictors with the use of contemporary stents and techniques remain undetermined. The aim of the study was to address long‑term effects of percutaneous management of LDCLs, using contemporary devices and optimization techniques. Long and diffuse coronary lesion was defined as a lesion requiring an implantation of 30 mm or longer total stent(s) length (TSL) into one coronary artery (bailouts excluded). There were 290 LDCL interventions with the use of newer generation drug‑eluting stents (DESs; cobalt chromium everolimus- or zotarolimus-eluting stents) performed between January 2013 and January 2016. The mean (SD) TSL was 55.5 (16.8) mm. The use of intravascular ultrasound / optical coherence tomography was 17.1%, rotablation, 6.9%, and noncompliant balloon, 88.9%. The median (range) follow‑up duration was 831 (390-1373) days. All‑cause mortality and cardiac death rates were 11.7% and 6.9%, respectively. The myocardial infarction (MI) rate was 6.6%, including target‑vessel MI in 4.1%. The rate of clinically‑driven repeat revascularization was 13.8%, and of definite or probable LDCL stent thrombosis, 7.2%. Overall patient‑oriented adverse event rate (any death, MI, or repeat revascularization) was 25.5%, and device‑oriented rate (cardiac death, target vessel‑MI, or target lesion restenosis), 13.4%. Adverse outcome predictors were chronic kidney disease, acute coronary syndrome as an indication for the procedure, chronic heart failure with reduced left ventricular ejection fraction, multivessel disease, and coexisting peripheral artery disease, but not lesion‑related factors, such as bifurcation, calcification, chronic total occlusion, or TSL. Adverse outcomes following contemporary LDCL management using newer generation DESs in routine clinical practice are associated with clinical patient characteristics rather than lesion characteristics or TSL. We identified high‑risk patient cohorts that may benefit from enhanced surveillance.

Drug-eluting balloons versus new generation drug-eluting stents for the management of in-stent restenosis: an updated meta-analysis of randomized studies.

BackgroundNew-generation drug-eluting stents (DES) was more effective in the treatment of in-stent restenosis (ISR) compared with the first-generation DES. Drug-eluting balloons (DEB) and new-generation DES had been available strategies in treatment of bare-metal stents/DES ISR (BMS/DES-ISR). Six new randomized trials have recently examined the angiographic outcomes and one-year clinical outcomes of DEB and new generation DES in BMS/DES-ISR. However, the optimal management for BMS/DES-ISR lesions remains controversial.MethodsWe searched the randomized clinical trials evaluating the angiographic outcomes and one-year clinical outcomes of DEB and new-generation DES in patients with BMS/DES-ISR. The primary endpoints were the angiographic outcomes, including the minimal luminal diameter (MLD), diameter stenosis % (DS%), late lumen loss (LLL), and binary restenosis (BR).ResultsA total of six randomized clinical trials with 1177 BMS/DES-ISR patients were included in our meta-analysis. For angiographic outcomes, there were significantly less MLD and more DS% with DEB compared to new-generation DES (MLD: MD = −0.18, 95% CI: −0.31– −0.04, P < 0.001; DS%: MD = 5.68, 95% CI: 1.00–10.37, P < 0.001). Moreover, for one-year clinical outcomes, DEB was associated with a significant increase risk in target lesion revascularization (TLR) (RR = 2.93, 95% CI: 1.50–5.72, P = 0.002). However, DEB was associated with higher risks of major adverse cardiac event, target vessel revascularization, TLR, BR, and more DS% only in DES-ISR group.ConclusionsDEB and new-generation DES have the similar clinical efficacy for the treatment of BMS-ISR. However, DES showed more MLD, less DS%, and a decreased risk of TLR for the treatment of DES-ISR.

Long-Term Clinical and Angiographic Outcomes After Implantation of New-Generation Drug-Eluting Stents for Patients on Maintenance Hemodialysis.

Prior research has revealed poorer clinical outcomes after drug-eluting stent (DES) implantation for hemodialysis patients. This study aims to investigate the long-term clinical and angiographic outcomes after new-generation DES implantation for hemodialysis patients.We retrospectively enrolled 91 consecutive patients (118 lesions) who underwent successful new-generation DES (everolimus-, zotarolimus-, and biolimus-eluting stents) implantation for the first time. We measured the serum calcium and phosphorus levels in the blood samples obtained just before hemodialysis. The follow-up period of clinical events was, at least, 1.5 years. In this study, major adverse cardiac and cerebrovascular events (MACCE) and clinically driven target lesion revascularization were reported in 36 (39.6%) and 11 (12.1%) patients, respectively. The prevalence of peripheral artery disease was significantly higher in the MACCE group (41.7% versus 14.5%, P = 0.006). The serum calcium level was significantly higher in the MACCE group (9.34 ± 0.92 mg/dL versus 8.77 ± 0.88 mg/dL; P = 0.004). The multivariate Cox proportional hazards model revealed that the serum calcium level (hazard ratio, 1.86; 95% confidence interval [CI]: 1.26-2.77; P = 0.002), suboptimal (over 55 mg2/dL2) calcium-phosphorus product (hazard ratio, 3.27; 95% CI: 1.41-7.61; P = 0.006) and the coexistence of peripheral artery disease (hazard ratio, 3.15; 95% CI: 1.49-6.65; P = 0.003) were independent predictors of MACCE.For hemodialysis patients, MACCE remains a frequent occurrence after new-generation DES implantation and is associated with calcium-phosphate metabolism and peripheral artery disease.