P269 Mid-term clinical outcomes of biodegradable polymer everolimus-eluting stents compared with durable polymer everolimus-eluting stents: a propensity-matched study

2020 ◽  
Vol 41 (Supplement_1) ◽  
Author(s):  
H Matsuda ◽  
A Kagase ◽  
T Tokuda ◽  
Y Ochiumi ◽  
M Takeya ◽  
...  

Abstract Background Introduction: Several studies have reported that durable polymer drug-eluting stents could cause delayed healing and late catch-up. Although biodegradable polymer everolimus-eluting stents (BP-EES) might solve these problems, there is few data about mid-term clinical outcomes of BP-EES compared with durable polymer everolimus-eluting stents (DP-EES). Purpose This study aimed to compare mid-term clinical outcomes between BP-EES and DP-EES. Methods Between January to December 2016, 206 consecutive patients were treated with BP-EES and 177 consecutive patients were treated with DP-EES in our Heart Center. The primary endpoint was 3-year cumulative incidence of target lesion failure (TLF) defined as cardiac death, target vessel-related myocardial infarction and clinical-driven target lesion revascularization. Moreover, clinical-driven target vessel revascularization (TVR) and definite stent thrombosis (ST) were also evaluated.  Results After propensity score matching, 160 patients were selected in each group. At 3 years, the cumulative incidences of TLF were 4.1% in BP-EES group vs. 7.9% in DP-EES (p = 0.12). Similarly, those of clinical-driven TVR were not different between the 2 groups (10.9% vs. 8.0%, p = 0.39). The incidence of definite ST in BP-EES tended to be higher than in that of DP-EES (BP-EES vs. DP-EES; 0% vs. 1.8%, p = 0.06). Conclusions There were no significant differences of TLF between BP-EES and DP-EES within 3 years. In this study, BP-EES seems to prevent definite ST and be safer than DP-EES in mid-term. Abstract P269 Figure.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Matsuda ◽  
A Kagase ◽  
T Tokuda ◽  
Y Ochiumi ◽  
M Takeya ◽  
...  

Abstract Background and introduction Diabetic patients are at high risk of adverse cardiovascular events after percutaneous coronary intervention (PCI) even with durable polymer drug-eluting stents. A biodegradable polymer everolimus-eluting stents (BP-EES) might improve clinical outcomes in patients with diabetes mellitus. Purpose This study aimed to compare the mid-term clinical outcomes between BP-EES and durable polymer everolimus-eluting stents (DP-EES) in diabetic patients. Methods We investigated consecutive 383 patients treated with BP-EES or DP-EES at our Heart Center between January and December 2016. Among these patients, 155 (40.5%) patients had diabetes mellitus. The primary endpoint was 3-year cumulative incidence of target lesion failure (TLF) defined as target vessel-related myocardial infarction (MI) and clinical-driven target lesion revascularization (TLR). Moreover, the incidence of definite stent thrombosis (ST) was also evaluated. Results After propensity score matching, 148 patients were divided into 2 groups (BP-EES; N=74, DP-EES; N=74). The 3-year cumulative incidences of TLF were significantly lower in BP-EES group than in DP-EES group (BP-EES vs. DP-EES; 1.4% vs. 11.4%, p=0.01). The incidence of cardiac death, target vessel-related MI, and definite ST were none in the both group. Figure 1 Conclusions In diabetic patients, the incidence of TLR within 3 years was significantly lower in BP-EES than in DP-EES. In PCI for diabetic patients, BP-EES might improve clinical outcomes compared to DP-EES.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Hiroaki Matsuda ◽  
Ai Kagase ◽  
Takahiro Tokuda ◽  
Yusuke Ochiumi ◽  
Akira Murata ◽  
...  

Objectives. Our aim was to evaluate the safety and efficacy of biodegradable polymer everolimus-eluting stents (BP-EES) compared with durable polymer everolimus-eluting stents (DP-EES) in midterm. Background. There are few data about midterm clinical outcomes of BP-EES compared with DP-EES. Methods and Results. Between January 2016 and December 2017, 395 consecutive patients were treated with BP-EES and 391 consecutive patients were treated with DP-EES in Nagoya Heart Center. The primary endpoint was a 3-year cumulative incidence of target lesion failure (TLF) defined as cardiac death, target vessel myocardial infarction (MI), and clinical indicated target lesion revascularization (TLR). Moreover, clinical indicated target vessel revascularization (TVR) and definite stent thrombosis (ST) were also evaluated as the secondary endpoints. After propensity score matching, 327 patients were selected in each group. At 3 years, the cumulative incidence of TLF was 4.5% in the BP-EES group versus 6.5% in DP-EES (adjusted HR 0.67 (95% CI 0.33–1.30), log-rank P=0.23). Regarding the individual components of the TLF at 3 years, the cumulative incidence of target vessel MI was significantly lower in BP-EES than in DP-EES (0% versus 1.9%: adjusted HR 0.83 (95% CI 0.71–0.97), log-rank P=0.01), but there was no difference between BP-EES and DP-EES in the incidence of cardiac death and clinically indicated TLR. The cumulative 3-year incidence of definite ST was significantly lower in BP-EES than in DP-EES (0% versus 1.6%, log-rank P=0.02). Conclusions. There were no significant differences of TLF between BP-EES and DP-EES within 3 years. In this study, BP-EES seems to prevent definite ST and be safer than DP-EES in midterm.


Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001394 ◽  
Author(s):  
Mohammad Riashad Monjur ◽  
Christian F Said ◽  
Paul Bamford ◽  
Michael Parkinson ◽  
Richard Szirt ◽  
...  

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.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
J Lanz ◽  
...  

Abstract Background Patients with diabetes mellitus (DM) remain at higher risk for adverse events after percutaneous coronary intervention (PCI) compared with non-diabetic individuals. Among available drug-eluting stents (DES), thin-strut durable polymer everolimus-eluting stents (DP-EES) were shown to provide the best safety and efficacy profile in diabetics. Whether biodegradable polymer DES provide additional long-term clinical benefit compared with DP-EES among diabetic patients remains uncertain. Purpose To compare the long-term performance of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus DP-EES for PCI in patients with insulin-requiring and non-insulin-requiring DM. Methods We performed a prespecified subgroup analysis of the randomized, multicenter, non-inferiority BIOSCIENCE trial (NCT01443104). Patients with stable coronary artery disease or acute coronary syndrome were randomly assigned to treatment with ultrathin-strut BP-SES or thin-strut DP-EES. Patients were further divided according to diabetic status. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (MI) and clinically-indicated target lesion revascularization (TLR), within 12 months. Results Among 2'119 patients enrolled between March 2012 and May 2013, 486 (22.9%) presented with DM (insulin-requiring, 33.1%). Compared with non-diabetics, patients with DM were older and had a greater baseline cardiac risk profile, including higher prevalence of hypertension, hypercholesterolaemia, peripheral artery disease, chronic renal failure and prior PCI, coronary artery bypass graft surgery, or stroke. At 5 years, TLF occurred similarly in 74 patients (cumulative incidence, 31.0%) treated with BP-SES and 57 patients (25.8%) treated with DP-EES (RR 1.23; 95% CI 0.87–1.73; p=0.24) in diabetics, and in 124 patients (16.8%) treated with BP-SES and 132 patients (16.8%) treated with DP-EES (RR 0.98; 95% CI 0.77–1.26; p=0.90) in non-diabetics (p for interaction=0.31). Cumulative incidences of cardiac death (14.9% vs. 9.5%; p=0.10), target-vessel MI (11.4% vs. 11.0%; p=0.81), clinically-indicated TLR (16.9% vs. 15.8%; p=0.68), and definite thrombosis (3.0% vs. 2.5%; p=0.63) at 5 years were similar among diabetic patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between diabetic status and treatment effect of BP-SES versus DP-EES. Conclusion In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout five years between diabetic patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Acknowledgement/Funding BIOSCIENCE was an investigator-initiated trial supported by a dedicated research grant from Biotronik, Bülach, Switzerland


Author(s):  
Dean J. Kereiakes ◽  
Robert L. Feldman ◽  
A.J.J. Ijsselmuiden ◽  
Shigeru Saito ◽  
Giovanni Amoroso ◽  
...  

Background: The SVELTE fixed-wire and rapid exchange bioresorbable-polymer sirolimus-eluting coronary stent systems (SVELTE sirolimus-eluting stent [SES]) are novel, low-profile devices designed to facilitate direct stenting, transradial access, and enhance procedural efficiencies. Methods: Eligible subjects (N=1639) scheduled to undergo percutaneous coronary intervention for non–ST-segment–elevation myocardial infarction or stable coronary artery disease were randomly assigned (1:1) to treatment with either SVELTE SES or a control durable polymer everolimus-eluting coronary stent. The primary end point was 12-month target lesion failure and a noninferiority margin was specified as 3.58% with an expected event rate of 6.5%. Results: Target lesion failure was observed in 10.3% of SVELTE SES and 9.5% of control everolimus-eluting stent subjects under intention to treat analysis (difference=0.8%; P NI =0.034). Clinically indicated target lesion revascularization and stent thrombosis were observed in 1.5% versus 1.9% ( P =0.57) and 0.38% versus 0.51% ( P =0.72) of SVELTE SES versus control everolimus-eluting stent–treated subjects, respectively. Protocol-defined target vessel myocardial infarction (9.4% versus 8.2%) was higher than anticipated and more frequent at sites that utilized troponin versus creatine kinase myocardial band assays. Conclusion: The SVELTE SES did not meet the prespecified threshold for noninferiority. Unexpectedly, high rates of target vessel myocardial infarction in both treatment groups contributed to higher than expected rates of target lesion failure, effectively underpowering the study. No differences between the SVELTE SES and control everolimus-eluting stent were observed for primary clinical or angiographic end point events. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03190473.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Okuno ◽  
T Ishihara ◽  
O Iida ◽  
M Asai ◽  
M Masuda ◽  
...  

Abstract Background Biodegradable polymer drug-eluting stent (BP-DES) has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) for patients presenting coronary artery disease (CAD). Although BP-DES showed non-inferior safety and efficacy to durable polymer DES (DP-DES) in several randomized clinical trials, hemodialysis (HD) patients, who have been well known as high risk population for adverse events, were excluded in the most of trials. Therefore, there are limited data comparing the clinical outcomes between BP-DES and DP-DES in HD patients with CAD after PCI. Purpose The purpose of this study was to investigate clinical outcomes in HD patients after BP-DES implantation compared with those after DP-DES implantation. Methods We retrospectively analyzed 234 HD patients (male 74%, mean age 71±10 years) undergoing PCI for 404 lesions with 472 DESs (71 patients for 138 lesions with 170 BP-DESs [91 Ultimaster and 79 Synergy] and 163 HD patients for 266 lesions with 302 DP-DESs [219 Xience, 53 Promus and 30 Resolute]) from 2011 to 2017. Two-year clinical outcomes were compared between BP-DES group and DP-DES group. The primary outcome measure was the incidence of target lesion revascularization (TLR), while the secondary outcome measures were the occurrence of cardiac death (CD), stent thrombosis (ST), myocardial infraction (MI), target vessel revascularization (TVR), non-TVR and major adverse cardiac event (MACE) defined as a composite of CD, MI, and TVR. Outcome measures were estimated by the Kaplan-Meier method and the differences between BP-DES group and DP-DES group were assessed by the log-rank test. We also conducted Cox's proportional hazard model to identify predictors for TLR occurrence. Results Baseline patient and lesion characteristics were similar between the two groups. The two-year incidence of TLR was not significantly different between BP-DES group and DP-DES group (14.1% vs. 22.2%, p=0.391). The two-year incidences of CD (17.3% vs. 17.5%, p=0.381), ST (0% vs. 3.9%, p=0.133), MI (4.2% vs. 5.8%, p=0.965), TVR (21.3% vs. 27.5%, p=0.586), non-TVR (26.1% vs. 31.3%, p=0.439) and MACE (41.1% vs. 42.6%, p=0.526) were also not different between the two groups. After multivariate analysis, diabetes mellitus (hazard ratio 1.97; 95% confidence interval 1.03–3.78, p=0.004) was independently associated with TLR occurrence in HD patients. Two-year clinical outcomes of HD patient Conclusions At two-year follow-up after PCI, BP-DES had comparable safety and efficacy profiles to DP-DES in HD patients presenting CAD. Acknowledgement/Funding None


2021 ◽  
Vol 11 (2) ◽  
pp. 99-108
Author(s):  
Yusuke Watanabe ◽  
Satoru Mitomo ◽  
Ozan M. Demir ◽  
Kuan-Liang Liu ◽  
Ying-Chang Tung ◽  
...  

<b><i>Aims:</i></b> We assessed clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) distal bifurcation lesions using drug-eluting stents (DES) in hemodialysis (HD) patients compared to non-HD patients. <b><i>Methods and Results:</i></b> We identified 1,858 consecutive patients who underwent PCI for ULMCA distal bifurcation lesions at 4 high-volume centers in Japan, Italy, and Taiwan between January 2005 and December 2015. Of them, 1,416 patients were treated with DES including 113 HD patients and 1,303 non-HD patients. The primary end point was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. HD patients were more likely to be younger and have diabetes mellitus, dyslipidemia, peripheral artery disease, lower ejection fraction, and higher EuroSCORE. TLF rate at 3 years was significantly higher in HD group than in non-HD group (adjusted hazard ratio [HR] 2.43 [1.75–3.38], <i>p</i> &#x3c; 0.001). Cardiac mortality and TLR rate were also significantly higher in HD group than in non-HD group (adjusted HR 3.85 [2.34–6.34], <i>p</i> &#x3c; 0.001, and HR 2.10 [1.41–3.14], <i>p</i> &#x3c; 0.001, respectively). <b><i>Conclusions:</i></b> HD was strongly associated with adverse cardiac events after PCI for ULMCA distal bifurcation lesions with DES.


2021 ◽  
Author(s):  
Akito Kawamura ◽  
Yasuyuki Egami ◽  
Shodai Kawanami ◽  
Hiroki Sugae ◽  
Kohei Ukita ◽  
...  

Abstract This study aimed to compare the strut coverage between Orsiro ultrathin struts biodegradable polymer sirolimus-eluting stents (O-SES) and Xience thin struts durable polymer everolimus-eluting stents (X-EES) in acute coronary syndrome (ACS) patients using optical coherence tomography (OCT). In BIOSTEMI trial, O-SESs were superior to X-EESs with respect to target lesion failure (TLF) in ACS patients. However, there were few reports comparing intravascular imaging between the two stents in ACS. Between August 2016 and February 2020, 50 lesions from 50 ACS patients who underwent OCT-guided percutaneous coronary intervention (PCI) were enrolled. We compared mid-term vascular healing using OCT between O-SESs and X-EESs at 8-month after stenting. The protocol was approved by the Osaka Rosai Hospiral ethics committee. Among 50 lesions, the X-EES group consisted of 25 lesions and the O-SES of 25 lesions. The percentage of covered strut, the percentage of malapposed strut and mean neointimal thickness at 8-month were evaluated. In the 8-month OCT analysis, the proportion of covered strut was significantly higher in the O-SES group than in in the X-EES group (97.3% vs. 86.0%; p = 0.001). On the other hand, there were no significant differences in the frequency of malapposed strut (0.4% vs 1.0%, p = 0.238). The O-SES group had the tendency of thinner neointima compared to the X-EES group (60µm vs 76µm, p = 0.089). Compared to X-EESs, O-SESs showed better mid-term vascular healing and tended to have thinner neointima in ACS patients. Ultra-thin strut may play a key role in better vascular healing.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Jonghanne Park ◽  
Joo Myung Lee ◽  
Kyung Woo Park ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  

Background: Long term outcomes are imperative to confirm safety of drug-eluting stents. There have been two randomized controlled trials comparing everolimus-eluting stents (EES) and Resolute zotarolimus-eluting stents (ZES-R). To date, long-term clinical outcomes of these stents were limited to only one report which has recently reported 4-year comparisons of these stents. Therefore, more evidences are needed regarding long-term clinical outcomes of the second generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in “all-comer” cohorts up to 3-year follow-up. Methods: The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R. Target lesion failure and patient-related composite events were compared in crude and propensity score matched analyses. Results: Of 5054 patients, 3830 patients (75.8%) had off label indication (2217 with EES and 1613 with ZES-R). The stent-related outcome (189 [6.2%] vs. 127 [6.4%], p=0.812) and the patient-related outcome (420 [13.7%] vs. 250 [12.5%], p=0.581) did not differ between EES and ZES-R respectively at 3 year, which was corroborated by similar results from the propensity score-matched cohort (HR 0.92, 95% CI 0.70-1.20, p=0.523 and 0.85, 95% CI 0.70-1.02, p=0.081, for stent and patient related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs. 10 [0.5%], p=0.370) was also similar. The rate of stent thrombosis was very low and comparable between the two stents (3 [0.1%] vs. 1 [0.1%], p=0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440-5.354, p<0.001) and off label indication (adjusted HR 1.782, 95% CI 1.169-2.718, p=0.007) were the strongest predictors of target lesion failure. Conclusion: In this robust real world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 3-year follow-up. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off label indications, suggesting excellent long term safety and sustained efficacy of both types of second generation drug-eluting stents.


Sign in / Sign up

Export Citation Format

Share Document