P2798Final 5-year outcomes of the TRIAS High Risk of Restenosis; a multi-centre, randomized trial comparing endothelial progenitor cell capturing stent with drug-eluting stents

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L S M Kerkmeijer ◽  
P Woudstra ◽  
M Klomp ◽  
D N Kalkman ◽  
C Varma ◽  
...  
Keyword(s):  
High Risk ◽  
Cardiac Death ◽  
Vessel Wall ◽  
Thrombus Formation ◽  
Stable Coronary Artery Disease ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Endothelial Progenitor ◽  
Drug Eluting

Abstract Background One of the major long-term disadvantages of percutaneous coronary intervention (PCI) remains in-stent restenosis and need for repeat revascularisation. The polymer-regulated delivery of cytotoxic or cytostatic drugs, on drug-eluting stents (DES), impede the natural healing response of the damaged vessel wall. In animals, endothelial progenitor cells (EPCs) beneficially influence the repair of the coronary vessel wall after damage by stent placement. It is hypothesized that after immobilisation the EPCs differentiate into a functional endothelial layer and that this layer will prevent neointimal proliferation and thrombus formation. Anti-CD34+ antibodies are able to capture the EPCs. The Genous stent consist of a bare-metal stent with anti-CD34+ antibody coating. Purpose Demonstrating long-term performance of Genous EPC capturing stent (ECS) relative to DES regarding target lesion failure (TLF); the composite of cardiac death, myocardial infarction (MI) and any target lesion revascularisation (TLR) within 5 years. Methods We undertook an international, clinical trial in 26 centres planning to randomise 1300 patients with stable coronary artery disease and with a high risk of restenosis between treatment with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was substantially higher and treatment of new patients with an ECS would be unreasonable. The trial was terminated for safety reasons. Results A total of 622 were randomly assigned to receive either Genous ECS (304 patients, 367 lesions) or DES (318 patients, 388 lesions). Five year follow-up data was obtained in 95.5% of patients. TLF occurred in 29.1% of the ECS-treated patients and in 16.0% of the DES-treated patients (p<0.001) (Figure 1). This difference was driven by higher rates of TLR (22.9% vs. 10.7%, p<0.001), but not by cardiac death (6.5% vs. 4.5%, p=0.268), or MI (5.8% vs. 3.6%, p=0.175). Definite or probable stent thrombosis was seen in 8 ECS-treated patients (2.7%) and in 3 DES-treated patients (1%), p=0.11. Figure 1. KM curves of TLF at 5year fu. Conclusion The Genous ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. If the addition of a EPCs capturing layer on a DES, like the COMBO stent, provides a lower risk of restenosis compared to DES will be tested in the ongoing SORT-OUT X trial. Acknowledgement/Funding OrbusNeich

EARLY AND INTERMEDIATE-TERM OUTCOMES WITH DRUG-ELUTING STENTS IN HIGH-RISK PATIENTSWITH SYMPTOMATIC INTRACRANIAL STENOSIS

Neurosurgery ◽  
2006 ◽  
Vol 59 (5) ◽  
pp. 1044-1051 ◽  
Author(s):  
Adnan I. Qureshi ◽  
Jawad F. Kirmani ◽  
Haitham M. Hussein ◽  
Pansy Harris-Lane ◽  
Afshin A. Divani ◽  
...  
Keyword(s):  
High Risk ◽  
Target Lesion ◽  
Intracranial Stenosis ◽  
Drug Eluting Stents ◽  
Free Survival ◽  
Angiographic Restenosis ◽  
Drug Eluting ◽  
Ischemic Events ◽  
Major Stroke

Abstract OBJECTIVE To report the 1-month and intermediate-term results of treatment of symptomatic intracranial stenosis using drug-eluting stents. BACKGROUND Patients with intracranial stenosis who are at high risk because of either high-grade stenosis or medication failure may have an annual risk of recurrent ischemic events in excess of 40%. Drug-eluting stents may reduce the rate of ischemic events in patients with a low restenosis rate. METHODS We determined rates of technical success (defined as reduction of target lesion to stenosis &lt;30%) and 1-month major stroke or death in patients with symptomatic intracranial stenosis (≥70% and/or medication failure). Patients' clinical and follow-up information during a mean period of 14.3 ± 7 months were obtained. Kaplan-Meier analysis was performed to determine the rate of major stroke-free survival during 12 months. RESULTS There were 18 patients (mean age, 58 ± 16 yr; 12 were men) treated with either a sirolimus-eluting stent (n = 14) or a paclitaxel-eluting stent (n = 4) for stenosis located in the: intracranial internal carotid artery (n = 6), proximal middle cerebral artery (n = 4), intracranial vertebral artery (n = 4), vertebrobasilar junction (n = 2), or basilar artery (n = 2). There was one major stroke and no death observed in the 1-month follow-up. At the 6-month follow-up examination, no major stroke or death was observed. Major stroke-free survival was 86% (±standard error of 9%) at 12 months after the procedure. One symptomatic angiographic restenosis was observed during the follow-up period. CONCLUSION A low rate of major stroke or death was observed after treatment of symptomatic intracranial stenosis using drug-eluting stents in high-risk patients.

P1966Impact of coronary artery calcification on long-term outcomes after implantation of first and second-generation drug-eluting stents: a patient-level analysis of 18 randomized trials

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Guedeney ◽  
B Claessen ◽  
R Mehran ◽  
G Mintz ◽  
M Liu ◽  
...  
Keyword(s):  
Randomized Trials ◽  
Second Generation ◽  
Composite Endpoint ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Patient Level ◽  
Drug Eluting ◽  
Long Term Impact ◽  
First And Second Generation

Abstract Background Available data on the long-term impact of coronary artery calcification (CAC) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) are limited. Purpose We evaluated the long-term impact of CAC on outcomes after PCI and the respective performance of first- and second-generation DES. Methods We pooled patient-level data from 18 randomized trials evaluating DES categorized according to the presence of angiographic core lab-confirmed moderate or severe CAC in any target lesion. Outcome measures of interest were the patient-oriented composite endpoint (POCE; death, myocardial infarction [MI], or any revascularization), the device-oriented composite endpoint of target lesion failure (TLF; cardiac death, target vessel MI or ischemia-driven target lesion revascularization), and definite or probable stent thrombosis (ST). Multivariable Cox proportional regression with study as a random effect was used to assess 5-year outcomes. Results A total of 19,833 patients were included. Moderate or severe CAC was present in 6211 (31.3%) patients and associated with increased 5-year risk of the POCE (adjHR 1.12, 95% CI 1.05–1.20, p<0.001), TLF (adjHR 1.21, 95% CI 1.09–1.35, p<0.001), and a trend for greater ST (adjHR 1.24, 95% CI 0.99–1.54, p=0.06). In patients with CAC, second-generation DES were associated with a reduction in the 5-year risk of TLF and ST, and a trend for reduced POCE compared with first-generation DES (Table). Conclusion In this large-scale study, target lesion moderate or severe CAC was associated with adverse patient- and device-related outcomes at 5 years, risks that were reduced but not eliminated with second-generation DES. Acknowledgement/Funding This investigator-sponsored study was funded by Abbott Vascular.

scholarly journals Ultrathin-strut biodegradable polymer versus durable polymer drug-eluting stents: a meta-analysis

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001394 ◽  
Author(s):  
Mohammad Riashad Monjur ◽  
Christian F Said ◽  
Paul Bamford ◽  
Michael Parkinson ◽  
Richard Szirt ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Primary Outcome ◽  
Second Generation ◽  
Meta Analysis ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Durable Polymer ◽  
Drug Eluting

ObjectivesDetermine whether an ultrathin biodegradable polymer sirolimus-eluting stent (‘Orsiro’—BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).MethodsWe conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.ResultsNine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.ConclusionThe Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.

Long-term efficacy and safety of newer generation ultrathin strut drug-eluting stents: a systematic review and meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Lattuca ◽  
X Odorico ◽  
B.V Occean ◽  
L Cornillet ◽  
L Schmutz ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Target Vessel ◽  
Efficacy And Safety ◽  
Short Term ◽  
Term Efficacy ◽  
Drug Eluting

Abstract Background Recent trials have demonstrated that short-term efficacy and safety of ultrathin strut drug-eluting stents (DES) were non-inferior to contemporary stents but long-term benefit remains uncertain. Purpose The main objective of this meta-analysis was to evaluate efficacy and safety of ultrathin strut DES with an extended follow-up in comparison to 2nd and 3rd generations DES. Methods A double-blind review of randomized controlled trials (RCT) comparing ultrathin strut DES to contemporary DES was performed from MEDLINE and CENTRAL databases and from cardiological congresses. The primary efficacy endpoint was target vessel failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) and the primary safety endpoint was occurrence of stent thrombosis (ST). Short (1 year) and long term (≥2 years) effects were estimated separately. This analysis was pre-specified in PROSPERO (CRD42019142206). Results The meta-analysis included 13 RCT including 19,490 patients. In short term, we found TLF decrease with ultrathin strut DES (RR 0.85, CI [0.75–0.97], p=0.01), driven by lower TV-MI (RR 0.83, CI [0.66–1.03], p=0.1) and TLR (RR 0.77, CI [0.58–1.01], p=0.1) rates, and a non-significant downward trend in ST (RR 0.85 CI [0.64–1.14]). In long term, from the 5 trials with extended follow-up, there was no significant difference between ultrathin strut DES and thicker strut stents in rate of TLF at the longest available follow-up (RR 0.90, CI [0.76–1.06], p=0.2), despite a numerically reduction of TV-MI (RR 0.81, CI [0.61–1.08], p=0.05) and TLR (RR 0.85, CI [0.69–1.04], p=0.1) in favor of ultrathin strut stents. However, we observed a persistent numerically reduction in ST (RR 0.79, CI [0.61–1.02], p=0.01). Conclusion Ultrathin strut DES was associated with a lower target lesion failure rate at one year but not beyond 2-years follow-up. Nevertheless, the safety of the ultrathin strut stents was sustained over time with a numerically reduction of ST. Funding Acknowledgement Type of funding source: None

scholarly journals Real-World Long-Term Clinical Outcomes of Ultrathin Strut Biodegradable Polymer Drug-Eluting Stents in Korean ST-Segment-Elevation Myocardial Infarction (STEMI) Patients with or without Acute Heart Failure Undergoing Primary Percutaneous Coronary Intervention

2021 ◽  
Vol 10 (24) ◽  
pp. 5898
Author(s):  
Albert Youngwoo Jang ◽  
Jongwook Yu ◽  
Pyung Chun Oh ◽  
Minsu Kim ◽  
Soon Yong Suh ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
St Segment Elevation ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Percutaneous Coronary ◽  
Drug Eluting

Biodegradable polymers (BDPs) and ultrathin struts were recently introduced to drug-eluting stents (DES) to further improve outcomes. In this study, we analyzed and compared the effect of the ultrathin strut BDP-DES (UBDP-DES) with the conventional durable polymer-DES (DP-DES) in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PPCI). A total of 356 STEMI patients (n = 160 in the UBDP-DES group and n = 196 in the DP-DES group) were enrolled. The primary endpoint was target lesion failure (TLF), including cardiac death, target vessel myocardial infarction, and ischemic-driven, target lesion revascularization (ID-TLR). The mean age was 60.3 ± 12.7 years (male 81.7%), and the median follow-up duration was 63.8 months. TLF was numerically more frequent in the UBDP-DES group (8.1% vs. 4.1%; HR 2.14; 95% CI 0.89–5.18; p = 0.091). Propensity score matching (PSM) was performed to balance discrepancies in the baseline characteristics due to patients in the UBDP-DES group initially having more unstable vital signs. However, after PSM (n = 116 in each group), there was no significant difference in TLF (5.3% vs. 5.3%; HR 1.04, 95% CI 0.34-3.22; p = 0.947) or other secondary endpoints including ID-TLR. In the subgroup analysis, subjects with initial acute heart failure (AHF), defined as Killip class ≥ 3, were associated with 13.6% chance of 30-day mortality (9-fold of those without AHF), although chances of repeat revascularization were low (3.0%). Among patients with AHF, the UBDP-DES group was associated with a numerically higher chance of TLF compared with the DP-DES group. There was no difference in TLF between groups in patients without AHF. This study showed that UBDP-DES has long-term clinical outcomes similar to those of conventional DP-DES in real-world Korean STEMI patients receiving PPCI, especially in those without initial AHF.

scholarly journals Real-World Three-Year Clinical Outcomes of Biolimus-Eluting Stents versus Other Contemporary Drug-Eluting Stents in Patients with Acute Myocardial Infarction Patients: Data from the Korea Acute Myocardial Infarction Registry (KAMIR)

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Ji Young Park ◽  
Seung-Woon Rha ◽  
Yung-Kyun Noh ◽  
Byoung Geol Choi ◽  
Ji Yeon Hong ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cardiac Death ◽  
Bare Metal Stents ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Metal Stents ◽  
Cardiac Events ◽  
Total Death ◽  
Drug Eluting

Introduction. Biolimus-eluting stents (BES) are known to be superior to bare-metal stents. This study aims to evaluate the safety and efficacy of BES compared to other drug-eluting stents (DES) based on big data from the Korea Acute Myocardial Infarction Registry (KAMIR). Methods. The study analyzed a total of 9,759 acute myocardial infarction (AMI) patients who underwent percutaneous coronary intervention (PCI) with DES. Total death, cardiac death, recurrent MI, revascularization, stent thrombosis, target lesion failure (TLF, composite of cardiac death, recurrent myocardial infarction (MI), and target lesion revascularization), and major adverse cardiac events (MACE, composite of total death, recurrent MI, and revascularization) were analyzed in patients with AMI up to three years. Study populations were divided into BES (n = 2,020), everolimus-eluting stents (EES, n = 5,293), and zotarolimus-eluting stents (ZES, n = 2,446) groups. Results. To adjust baseline potential confounders, an inverse probability weighting (IPTW) analysis was performed. After IPTW, at three years, total death (7.2%, 8.6%, and 9.5%, P < 0.001 ), cardiac death (4.1%, 5.3%, and 6.6%, P < 0.001 ), recurrent MI (1.6%, 2.6%, and 3.2%, P < 0.001 ), TLF (6.5%, 8.1%, and 9.1%, P < 0.001 ), and MACE (15.8%, 17.5%, and 18.2%, P < 0.001 ) were lowest in the BES group compared with the other DES groups in AMI patients. During the 3-year clinical follow-up, the BES group showed better outcomes of MACE (hazard ratio (HR), 0.773; 95% confidence interval (CI), 0.676–0.884; P < 0.001 ), TLF (HR, 0.659; 95% CI, 0.538–0.808; P < 0.001 ), total death (HR, 0.687; 95% CI, 0.566–0.835; P < 0.001 ), and cardiac death (HR,0.593; 95% CI, 0.462–0.541; P < 0.001 ) than the EES groups. Conclusions. In this study, BES was superior to EES or ZES in reducing total death, cardiac death, TLF, and MACE in AMI patients.

scholarly journals Prognostic implications of 2018 ESC/EACTS guideline-endorsed high ischaemic risk features on clinical outcomes after PCI with drug-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Wang ◽  
B.O Xu ◽  
R Gao ◽  
K Dou
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Clinical Outcomes ◽  
Bleeding Risk ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Funding Source ◽  
Medical Sciences ◽  
Drug Eluting ◽  
Ischemic Events

Abstract Background Recently, the 2018 ESC/EACTS guidelines on myocardial revascularization have been proposed to standardize the definition of high ischemic events risk (HIR) features. However, the prevalence and the expected ischemic event rate of HIR patients defined by ESC/EACTS-endorsed criteria are currently unknown in the real-world percutaneous coronary intervention practice. We sought to investigate the impact of HIR features on clinical outcomes after drug-eluting stents implantation and whether this effect is influenced by high bleeding risk (HBR). Methods Between January 2013 and December 2013, a total of 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. The primary ischemic endpoint was target lesion failure (TLF) (comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization] and the primary bleeding endpoint was clinically relevant bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Guideline-endorsed HIR features were in the present study and definitions were as follows: diffuse (defined as lesion length ≥20 mm) multivessel disease in patients with diabetes, CKD (defined as estimated glomerular filtration rate &lt;60 ml/min/1.73 m2), ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length &gt;60 mm, and treatment of CTO, and history of ST-elevation myocardial infarction. HBR was defined based on the highest quartile of PARIS bleeding score (≥6 or &lt;6). Results Median follow-up was 29 months. 5149 patients had at least 1 HIR feature (50.6%), who experienced significantly increased risks of TLF (adjusted hazard ratio [HR]: 1.59, 95% confidence interval [CI]: 1.32–1.93; P&lt;0.001), compared to those with non-HIR features. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HRadjust: 0.85 [0.66–1.09]; P=0.200). By including ESC/EACTS-endorsed HIR criteria as a continuous variable within the same multivariable models, the risk of adverse ischemic events tended to be greater as the number of high-risk procedural characteristics increased (per number of high-risk features increase: for TLF, HRadjust: 1.15, 95% CI: 1.07–1.23; P trend&lt;0.001; for MACE, HRadjust: 1.33, 95% CI: 1.22–1.46; P trend&lt;0.001). There was no statistical interaction between HBR and HIR features in regard to TLF (adjusted Pinteraction=0.855) and clinically relevant bleeding (adjusted Pinteraction=0.269), suggesting a consistent effect within ESC/EACTS-endorsed HIR features. Results were consistent when categorizing patients into HBR according to PARIS bleeding risk score ≥8 points. Conclusions ESC/EACTS-endorsed HIR criteria were associated with a substantial risk of ischemic events, with no increase in clinically relevant bleeding in routine clinical practice; and theses associations did not seem to be modified by HBR status. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences

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