Trials Of Drug-eluting Stents Research Articles

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

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

First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents.

Patients with premature coronary artery disease (CAD) have a higher incidence of myocardial infarction (MI) than patients with non-premature CAD. The aim of the present study is to asess differences in clinical outcome after a first acute MI, percutaneously treated with new-generation drug-eluting stents between patients with premature and non-premature CAD. We pooled and analysed the characteristics and clinical outcome of all patients with a first MI (and no previous coronary revascularization) at time of enrolment, in four large-scale drug-eluting stent trials. Coronary artery disease was classified premature in men aged <50 and women <55 years. Myocardial infarction patients with premature and non-premature CAD were compared. The main endpoint was major adverse cardiac events (MACE): all-cause mortality, any MI, emergent coronary artery bypass surgery, or clinically indicated target lesion revascularization. Of 3323 patients with a first MI, 582 (17.5%) had premature CAD. These patients had lower risk profiles and underwent less complex interventional procedures than patients with non-premature CAD. At 30-day follow-up, the rates of MACE [hazard ratio (HR): 0.22, 95% confidence interval (CI): 0.07-0.71; P = 0.005), MI (HR: 0.22, 95% CI: 0.05-0.89; P = 0.020), and target vessel failure (HR: 0.30, 95% CI: 0.11-0.82; P = 0.012) were lower in patients with premature CAD. At 1 year, premature CAD was independently associated with lower rates of MACE (adjusted HR: 0.50, 95% CI: 0.26-0.96; P = 0.037) and all-cause mortality (adjusted HR: 0.24, 95% CI: 0.06-0.98; P = 0.046). At 2 years, premature CAD was independently associated with lower mortality (adjusted HR: 0.16, 95% CI: 0.05-0.50; P = 0.002). First MI patients with premature CAD, treated with contemporary stents, showed lower rates of MACE and all-cause mortality than patients with non-premature CAD, which is most likely related to differences in cardiovascular risk profile. TWENTE trials: TWENTE I, clinicaltrials.gov: NCT01066650), DUTCH PEERS (TWENTE II, NCT01331707), BIO-RESORT (TWENTE III, NCT01674803), and BIONYX (TWENTE IV, NCT02508714).

Clinical outcome up to 2 years after percutaneous coronary intervention in all-comers with concomitant symptomatic peripheral arterial disease: a pooled analysis in 9,204 randomized trial participants

Abstract Background An increasing number of patients with coronary artery disease, who undergo percutaneous coronary intervention, also have symptomatic peripheral arterial disease. These patients have a worse long-term prognosis, but it is unclear whether the inferior outcome can be seen as early as during the first 2 years from coronary stenting. Purpose The aim of this study in all-comers was to evaluate the impact of symptomatic peripheral arterial disease on 1- and 2-year clinical outcome after coronary stenting. Methods Patient-level data from four large-scale randomised coronary drug-eluting stent trials in all-comers (TWENTE (clinicaltrials.gov: NCT01066650), DUTCH PEERS (NCT01331707), BIO-RESORT (NCT01674803), and BIONYX (NCT02508714)) were pooled to evaluate the impact of symptomatic peripheral arterial disease on clinical outcome after coronary stenting. Peripheral arterial disease was defined as a history (by anamnesis or medical record) of an obstructive arterial lesion, resulting from atherosclerosis in peripheral locations including the lower and upper extremities, carotid or vertebral arteries, and mesenteric or renal arteries. Main clinical endpoint was target vessel failure, a composite of cardiac death, target vessel related myocardial infarction, or clinically indicated target vessel revascularisation. Results Of all 9,204 trial participants, 695 (7.6%) had symptomatic peripheral arterial disease. These patients were older and had a higher cardiovascular risk profile, including a higher prevalence of diabetes, renal failure, hypertension, hypercholesterolemia, and prior stroke. At 1-year follow-up, patients with peripheral arterial disease showed significantly higher event rates of some endpoints. At 2-year follow-up, patients with peripheral arterial disease showed significantly higher rates of various clinical endpoints, including mortality (7.1% vs. 3.0%, p&amp;lt;0.001), myocardial infarction (4.8% vs. 3.4%, p0.04), repeated revascularisation (6.7% vs 4.5%, p&amp;lt;0.04), and major adverse cardiac events (14.6% vs. 8.3%, p&amp;lt;0.001, Figure 1). After multivariate adjustment for confounders, symptomatic peripheral arterial disease was found to be independently associated with the 2-year risks of target vessel and lesion failure, major adverse cardiac events, and all-cause death (p&amp;lt;0.02, for all, Table 1). Conclusion Obstructive coronary artery disease with concomitant symptomatic peripheral arterial disease resulted in higher cardiovascular risk profiles and higher rates of all-cause mortality and various composite clinical endpoints during the first two years of follow-up after coronary stenting. Knowledge of these findings allows to identify patients with an increased short- and medium-term adverse event risk after percutaneous coronary intervention, which is useful for both Heart Team and informed consent discussions. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The original trials were funded by Abbott Vascular, Medtronic, Boston Scientific and Biotronik.

Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial.

In the TALENT study, the sirolimus-eluting ultrathin strut Supraflex stent was non-inferior to the XIENCE stent for a device-oriented composite endpoint (DoCE: defined as cardiac death, target vessel myocardial infarction [TV-MI], or clinically indicated target lesion revascularisation [CI-TLR]) at 12 months. This study investigated the 3-year outcomes of the TALENT trial and long-term impact of ultrathin drug-eluting stents (DES), compared to the XIENCE everolimus-eluting thin stent. The TALENT trial is a prospective, multicentre, randomised all-comers trial comparing the Supraflex sirolimus-eluting stent with the XIENCE everolimus-eluting stent, with planned follow-up for 3 years. The TALENT trial enrolled 1,435 patients (Supraflex n=720, XIENCE n=715) with 3-year follow-up data available in 97.8% in the Supraflex group, and in 98.9% in the XIENCE group. At 3 years, DoCE occurred in 57 patients (8.1%) in the Supraflex group, and in 66 patients (9.4%) in the XIENCE group (p=0.406). There were no significant between-group differences in rates of cardiac death, TV-MI or CI-TLR. The rates of definite or probable stent thrombosis were low and similar between groups (1.1% vs 1.4%; p=0.640). In a meta-analysis of long-term follow-up (3-5 years), ultrathin strut DES tended to reduce DoCE (relative risk 0.89 [0.79-1.01]; p=0.068), compared to thicker strut DES. The risks for cardiac death and definite or probable stent thrombosis were similar between ultrathin strut DES and thicker strut DES. At 3-year follow-up, the use of the Supraflex stent was at least as safe and efficacious as the XIENCE stent in an all-comers population. gov: NCT02870140.

Appropriate Surrogate Endpoint in Drug-Coated Balloon Trials for Coronary Artery Diseases.

BackgroundThe appropriateness of using late lumen loss (LLL) as a surrogate endpoint was established in drug-eluting stent (DES) studies, but it was less supportive for drug-coated balloon (DCB) trials.MethodsStudies published until 23 June 2021 were searched from PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov. The correlation between LLL, MLD (minimal lumen diameter), and %DS (percentage diameter stenosis) and clinical endpoints was evaluated by linear regression. Standardized effect size and its 95% CIs were used to illustrate the difference among LLL, MLD, and %DS.ResultsA total of 24 clinical trials were eligible [16 DCB vs. DES, 7 DCB vs. plain old balloon angioplasty (POBA), and 1 DCB vs. DES vs. POBA]. Thirteen (54.2%) trials used LLL as the primary endpoint. LLL, MLD, and %DS all had significant associations with clinical endpoints. For DCB vs. DES trials, the number of studies that reported inconsistent results between LLL and MLD was 12/16 (75.0%) and between LLL and %DS was 10/15 (66.7%), while in MLD and %DS, it was 1/16 (6.3%). The difference of standardized effect size between LLL and MLD was −0.47 (95% CI, −0.69 to −0.25, p < 0.001) and LLL and %DS was−0.31 (95%CI,−0.43 to−0.20, p < 0.001) while in MLD and %DS, there was no difference, 0.1 (95%CI,−0.02 to 0.22, p = 0.084).ConclusionsFor DCB trials, an appropriate surrogate is associated with the control device. The traditional LLL could be used in the DCB vs. POBA trials. However, MLD/%DS should be considered a more suitable surrogate endpoint when comparing DCB with DES.

Trombosis del stent 10 años después de la intervención coronaria percutánea con stents nuevos frente a stents de la primera generación. Observaciones del metanálisis DECADE

Introduction and objectivesThe DECADE cooperation is a pooled analysis of individual patient data from drug-eluting stent (DES) trials with a 10-year follow-up. This analysis reports the risk of definite stent thrombosis (ST) through to 10 years after percutaneous coronary intervention (PCI) in patients treated with early- and new-generation DES. MethodsIndividual patient data from 5 DES trials with a 10-year follow-up were pooled. The primary endpoint was definite ST up to 10 years after PCI. Patients were divided into 2 groups as per the generation of DES implanted (early and new DES). Individual participant data were analyzed using a 1-stage approach. ResultsWe included 9700 patients, 6866 in the new DES group and 2834 in the early DES group. Through to 10 years, definite ST occurred in 69 of 6866 patients treated with new DES and in 91 of 2834 patients treated with early DES (1.0% vs 3.5%, adjusted hazard ratio, 0.32; 95%CI, 0.23-0.45). The rate of definite ST was lower in the new DES group than in the early DES group from 1 to 5 years (rate ratio, 0.14; 95%CI, 0.08-0.26) and from 5 to 10 years (rate ratio, 0.23; 95%CI, 0.08-0.61) after PCI. ConclusionsThe incidence of definite ST through to 10 years after PCI with new-generation DES was 1%. New-generation DES are associated with a lower 10-year incidence of definite ST than early-generation DES, particularly beyond 1 year after PCI.

Short-term dual antiplatelet therapy in diabetic patients admitted for acute coronary syndrome treated with a new-generation drug-eluting stent.

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug‐eluting stent (DES) remains unclear. This is a prespecified sub‐study from the Randomised Evaluation of short‐term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short‐term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent.MethodsIn this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all‐cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow‐up.ResultsA total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow‐up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all‐cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups.ConclusionsThis sub‐analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high‐risk patients.

Ten-year patterns of stent thrombosis after percutaneous coronary intervention with new- versus early-generation drug-eluting stents: insights from the DECADE cooperation

Introduction and objectivesThe DECADE cooperation is a pooled analysis of individual patient data from drug-eluting stent (DES) trials with a 10-year follow-up. This analysis reports the risk of definite stent thrombosis (ST) through to 10 years after percutaneous coronary intervention (PCI) in patients treated with early- and new-generation DES. MethodsIndividual patient data from 5 DES trials with a 10-year follow-up were pooled. The primary endpoint was definite ST up to 10 years after PCI. Patients were divided into 2 groups as per the generation of DES implanted (early and new DES). Individual participant data were analyzed using a 1-stage approach. ResultsWe included 9700 patients, 6866 in the new DES group and 2834 in the early DES group. Through to 10 years, definite ST occurred in 69 of 6866 patients treated with new DES and in 91 of 2834 patients treated with early DES (1.0% vs 3.5%, adjusted hazard ratio, 0.32; 95%CI, 0.23-0.45). The rate of definite ST was lower in the new DES group than in the early DES group from 1 to 5 years (rate ratio, 0.14; 95%CI, 0.08-0.26) and from 5 to 10 years (rate ratio, 0.23; 95%CI, 0.08-0.61) after PCI. ConclusionsThe incidence of definite ST through to 10 years after PCI with new-generation DES was 1%. New-generation DES are associated with a lower 10-year incidence of definite ST than early-generation DES, particularly beyond 1 year after PCI.

Drug-Eluting or Bare-Metal Stents for Left Anterior Descending or Left Main Coronary Artery Revascularization.

BackgroundNew‐generation drug‐eluting stents (DES) reduce target‐vessel revascularization compared with bare‐metal stents (BMS), and recent data suggest that DES have the potential to decrease the risk of myocardial infarction and cardiovascular mortality. We evaluated the treatment effect of DES versus BMS according to the target artery (left anterior descending [LAD] and/or left main [LM] versus other territories [no‐LAD/LM]).Methods and ResultsThe Coronary Stent Trialist (CST) Collaboration gathered individual patient data of randomized trials of DES versus BMS for the treatment of coronary artery disease. The primary outcome was the composite of cardiac death or myocardial infarction. Hazard ratios (HRs) with 95% CIs were derived from a 1‐stage individual patient data meta‐analysis. We included 26 024 patients across 19 trials: 13 650 (52.4%) in the LAD/LM and 12 373 (47.6%) in the no‐LAD/LM group. At 6‐year follow‐up, there was strong evidence that the treatment effect of DES versus BMS depended on the target vessel (P‐interaction=0.024). Compared with BMS, DES reduced the risk of cardiac death or myocardial infarction to a greater extent in the LAD/LM (HR, 0.76; 95% CI, 0.68–0.85) than in the no‐LAD/LM territories (HR, 0.93; 95% CI, 0.83–1.05). This benefit was driven by a lower risk of cardiac death (HR, 0.83; 95% CI, 0.70–0.98) and myocardial infarction (HR, 0.74; 95% CI, 0.65–0.85) in patients with LAD/LM disease randomized to DES. An interaction (P=0.004) was also found for all‐cause mortality with patients with LAD/LM disease deriving benefit from DES (HR, 0.86; 95% CI, 0.76–0.97).ConclusionsAs compared with BMS, new‐generation DES were associated with sustained reduction in the composite of cardiac death or myocardial infarction if used for the treatment of LAD or left main coronary stenoses.RegistrationURL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42017060520.

In-hospital outcomes of percutaneous coronary intervention with drug-eluting stent in patients with localized and metastatic cancer.

e18631 Background: Patients with localized and advanced malignancy are usually excluded from randomized clinical trials of drug-eluting stents and anti-platelet therapy. We aimed to evaluate short term outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients with localized and metastatic malignancy. Methods: Analysis from the Nationwide inpatient sample January 2016 to December 2018 of patients with localized and advanced malignancy admitted for a percutaneous coronary intervention with drug-eluting stents. Primary outcome was in-hospital mortality. Secondary outcomes were post-procedural complications and healthcare-utilization. Multivariate regression analysis was performed to adjust for confounders. Results: During 2016 – 2018 a total of weighted 1, 244, 550 PCI with DES were performed. 97.9 % in patients without cancer, 1.6% (n=21,125) patients with localized cancer and 0.3 % (n=4,765) with metastatic cancer. During hospitalization patient with cancer were more likely to develop respiratory failure, need for mechanical ventilation, AKI, and to receive blood products. After multivariate regression analysis patients with localized malignancy did not have any difference in-hospital mortality, total charges, cost, cardiac arrest or post procedural bleeding but had less LOS, respiratory failure, AKI requiring HD, post-procedural CVA and higher post-procedural blood transfusion when compared with patients without cancer. Conclusions: Patients with metastatic malignancy have higher in-hospital mortality when compared to patients without cancer. Patients with localized or advanced malignancy do not have higher in hospital complications. Blood transfusion is higher in patients with malignancy but is not related to procedure.[Table: see text]

Similar long-term outcome of dissimilar drug-eluting stents: is it time to change the assessment?

Long-term follow-up of randomised drug-eluting stent (DES) trials provides information that may be of great clinical value. While restenosis in DES generally occurs within the first two years, some safety and efficacy endpoints may only be seen at later stages. Most randomised trials that compared contemporary DES using Kaplan-Meier methods showed no significant difference in long-term outcome despite substantial between-DES differences in strut thickness, polymer type, stent design, and drug1,2,3. However, the inability to prove a difference is not the same as proof of no difference. In case of a negative trial result, in principle, there may be truly ...

Treating diabetic all-comers with contemporary drug-eluting stents: Prespecified comparisons from the BIO-RESORT and the BIONYX randomized trials

BackgroundPatients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES). MethodsWe performed two prespecified secondary analyses of two randomized DES trials, which both stratified for diabetes. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Follow-up was finished before the COVID-19 pandemic. ResultsIn BIO-RESORT, 624/3514 (17.8%) had diabetes: 211 received Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES), and 210 Resolute Integrity zotarolimus-eluting stents (RI-ZES). TVF did not differ between SES (10.2%) and EES (10.0%) versus RI-ZES (12.7%) (SES vs. RI-ZES HR:0.78, 95%-CI [0.44–1.40]; p = 0.40, EES vs. RI-ZES HR:0.79, 95%-CI [0.44–1.40]; p = 0.42). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). There was no difference in TVF between SES (10.7%) versus RO-ZES (12.2%) (HR:0.88, 95%-CI [0.52–1.48]; p = 0.63). ConclusionsThere was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes.

The 2010s in clinical drug-eluting stent and bioresorbable scaffold research: aDutch perspective.

Dutch researchers were among the first to perform clinical studies in bare metal coronary stents, the use of which was initially limited by a high incidence of in-stent restenosis. This problem was greatly solved by the introduction of drug-eluting stents (DES). Nevertheless, enthusiasm about first-generation DES was subdued by discussions about a higher risk of very-late stent thrombosis and mortality, which stimulated the development, refinement, and rapid adoption of new DES with more biocompatible durable polymer coatings, biodegradable polymer coatings, or no coating at all. In terms of clinical DES research, the 2010s were characterised by numerous large-scale randomised trials in all-comers and patients with minimal exclusion criteria. Bioresorbable scaffolds (BRS) were developed and investigated. The Igaki-Tamai scaffold without drug elution was clinically tested in the Netherlands in 1999, followed by an everolimus-eluting BRS (Absorb) which showed favourable imaging and clinical results. Afterwards, multiple clinical trials comparing Absorb and its metallic counterpart were performed, revealing an increased rate of scaffold thrombosis during follow-up. Based on these studies, the commercialisation of the device was subsequently halted. Novel technologies are being developed to overcome shortcomings of first-generation BRS. In this narrative review, we look back on numerous devices and on the DES and BRS trials reported by Dutch researchers.

New-generation drug-eluting coronary stents in octogenarians: Patient-level pooled analysis from the TWENTE I-IV trials

Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients. We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization. The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80 years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, P = .04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, P = .88) and repeat target vessel revascularization (1.9% vs 2.8%, P = .16). In multivariate analyses, age ≥ 80 years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, P < .001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (n = 459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, P < .001). Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.

Proximal LAD Treated With Thin-Strut New-Generation Drug-Eluting Stents: A Patient-Level Pooled Analysis of TWENTE I-III

ObjectivesThis study sought to assess 2-year clinical outcome following percutaneous coronary intervention (PCI) with thin-strut new-generation drug-eluting stents (DES) in patients treated in proximal left anterior descending artery (P-LAD) versus non–P-LAD lesions. BackgroundIn current revascularization guidelines, P-LAD coronary artery stenosis is discussed separately, mainly because of a higher adverse event risk and benefits of bypass surgery. MethodsThe study included 6,037 patients without previous bypass surgery or left main stem involvement from the TWENTE I, II, and III randomized trials. A total of 1,607 (26.6%) patients had at least 1 DES implanted in P-LAD and were compared with 4,430 (73.4%) patients who were exclusively treated in other (non–P-LAD) segments. ResultsTwo-year follow-up was available in 5,995 (99.3%) patients. At baseline, P-LAD patients had more multivessel treatment and longer total stent length. The rate of the patient-oriented composite clinical endpoint (any death, any myocardial infarction, or any revascularization) was similar in P-LAD versus non–P-LAD patients (11.4% vs. 11.6%; p = 0.87). In P-LAD patients, the rate of the device-oriented composite clinical endpoint (cardiac death, target vessel myocardial infarction, or target lesion revascularization) was higher (7.6% vs. 6.0%; p = 0.020), driven by a higher rate of target vessel myocardial infarction (4.1% vs. 2.6%; p = 0.002). However, multivariate analysis showed no independent association between stenting P-LAD lesions and clinical endpoints. ConclusionsIn this patient-level pooled analysis of 3 large-scale contemporary DES trials, treatment of P-LAD lesions was not independently associated with higher 2-year adverse clinical event rates. These results imply that separate consideration in future revascularization guidelines may not be mandatory any longer.

Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up

Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown. To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals. We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies. Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria. Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed. The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years. Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis. The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease. ClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study).

Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited. The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02-1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58-1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71-1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53-1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80-2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments. In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.

Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels

Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce. To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents. This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019. Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods. In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis. Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts. ClinicalTrials.gov identifier: NCT01674803.

Effect of stent diameter in women undergoing percutaneous coronary intervention with early- and new-generation drug-eluting stents: From the WIN-DES collaboration

BackgroundThe risk of stent thrombosis (ST) or target lesion revascularization (TLR) is increased with smaller stent diameters (SD). Whether SD has a deleterious effect in women treated with early- vs. new-generation drug-eluting stents (DES) is unknown. MethodsWe pooled patient-level data from 26 randomized control trials of DES. Only women treated with DES were included. Subjects were stratified according to SD: small, SD ≤ 2.75 mm; intermediate, 2.75 mm < SD ≤ 3.25 mm; and large, SD ≥ 3.25 mm. Endpoints of interest were 3-year definite ST, TLR, major adverse cardiac events (MACE: the composite of death, myocardial infarction or TLR) and death. ResultsOf 6413 women, 2274 (35.0%) had a small SD, 2448 (38.0%) had an intermediate SD, and 1691 (26.0%) had a large SD. By multivariable analysis, stent diameter (per 0.25 mm decrease) was associated with an increased risk of TLR and ST, which was uniform in terms of magnitude and direction between early- and new-generation DES. There were no differences in MACE or death across groups. ConclusionSmall SD in women undergoing PCI is associated with an increased risk of definite ST and TLR, consistently with both early- and new-generation DES.

IMPACT OF GENDER IN HIGH BLEEDING RISK PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION WITH XIENCE EVEROLIMUS ELUTING STENT: A PATIENT-LEVEL POOLED ANALYSIS FROM FOUR XIENCE POST-APPROVAL TRIALS

High bleeding risk patients (HBR) are usually excluded from pre-approval drug-eluting stent trials (DES) and consequently the impact of gender on the long-term outcomes in HBR patients is unclear. We performed a patient-level pooled analysis of 4 all-comer real world post-approval registries (