Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study

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.

Author(s):  
Kazuhiro Dan ◽  
Hector M. Garcia-Garcia ◽  
Paul Kolm ◽  
Stephan Windecker ◽  
Shigeru Saito ◽  
...  

Background: The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis. Methods: From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES. Results: Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%; P <0.01) and target vessel myocardial infarction (4.2% versus 7.6%; P <0.01) were significantly lower in BP-SES than in DP-EES. No difference in the outcome between the stents was shown in patients with non-small vessel lesions. In patients with calcified lesions, target lesion failure (12.2% versus 6.9%; P =0.056), and cardiac death (1.9% versus 0.3%; P =0.081) were numerically higher in DP-EES than in BP-SES. In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES. Stent thrombosis was similar between the stents in both lesion groups. Conclusions: Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year. Registration: URL: https://www.clinicaltrials.gov . Unique identifiers: NCT01356888, NCT01939249, NCT02389946.


Author(s):  
Rayyan Hemetsberger ◽  
Mohammad Abdelghani ◽  
Ralph Toelg ◽  
Nader Mankerious ◽  
Abdelhakim Allali ◽  
...  

Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare‐metal and first‐generation drug‐eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer‐generation drug‐eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable‐polymer sirolimus‐eluting stent or a durable‐polymer everolimus‐eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target‐lesion failure (TLF) (cardiac death, target‐vessel myocardial infarction, or target‐lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P =0.003) and stent thrombosis rates (2.1% versus 0.2%; P <0.0001), whereas target‐lesion revascularization was not different between the groups (5.0% versus 3.9%; P =0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89–2.08; P =0.148) but did for target‐vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03–2.68; P =0.037). TLF rates were similar between bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent (12.6% versus 15.4%, P =0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable‐polymer sirolimus‐eluting stent showed lower TLF (7.5% versus 10.3%, P =0.045). Conclusions With newer‐generation drug‐eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target‐vessel myocardial infarction was higher. The bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
O Muller ◽  
...  

Abstract Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland


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.


Author(s):  
Wojciech Wańha ◽  
Jacek Bil ◽  
Rafał Januszek ◽  
Natasza Gilis-Malinowska ◽  
Tomasz Figatowski ◽  
...  

Background: Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis. Methods: Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%). Results: Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41–0.83], P =0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45–0.84], P =0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50–0.94], P =0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55–1.51], P =0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55–1.36], P =0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58–1.42], P =0.667) between the thin-DES and DEB group, respectively. Conclusions: This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04415216.


2021 ◽  
Author(s):  
mingkun cao ◽  
Yuxia Yin ◽  
Chao Zhou ◽  
Wei Deng ◽  
Jianying Ma ◽  
...  

Abstract Background Drug-eluting stent (DES) with durable polymers have been proven to cause late or very late adverse events. Biodegradable polymer-coated DES was developed to address the risk by avoiding persistent inflammatory irritation from persistent polymers. However, it is unknown whether the benefits of biodegradable polymer DES will occur over longer time. Methods The trial was a prospective, multicenter and randomized non-inferiority clinical trial done in China. Patients with indications for stent implantation were assigned into Cordimax and Xience V group in a 2:1 allocation. The composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularisation (CI-TLR) was the primary endpoint target lesion failure (TLF). The pre-specified endpoint at five years was major adverse cardiac event (MACE) which was defined as a composite of all-cause death, non-fatal myocardial infarction (MI), and CI-TLR. Results 3266 patients (88.3%) completed 5-year follow-up. No difference was observed for TLF between Cordimax (7.5%) and Xience V (8.3%) group (RR: 0.90, 95% CI: 0.70 to 1.15, P = 0.39). MACE occurred in 280 patients (11.4%) in Cordimax group and 162 patients (13.1%) in Xience V group (RR: 0.85, 95% CI: 0.69 to 1.05, P = 0.13). The incidence of definite or probable stent thrombosis did not differ in both groups (Cordimax 0.7%, Xience V 0.9%; RR: 0.78, 95% CI: 0.36 to 1.66; P = 0.51). Conclusion The biodegradable polymer Cordimax stent showed a comparable result to the durable polymer Xience V stent at 5 years, showing its long-term safety and efficacy performance. Trial registration: This study is registered with ClinicalTrials.gov, number NCT03185221 (14/06/2017).


2020 ◽  
Author(s):  
Shu-bin QIAO ◽  
TENG Hao-bo ◽  
GUO Chao ◽  
GUAN Chang-dong ◽  
WANG Xin-yu ◽  
...  

Abstract Objective: To evaluate the impact of smoking status on the long-term prognosis of male patients with left main coronary artery lesions who received percutaneous coronary intervention. Methods: A retrospective analysis was conducted. A total of 3122 male patients with left main lesions who received percutaneous coronary intervention in our hospital were categorized by smoking status at admission: 1207 in the non-smokers group, 1339 in the current smokers group, and 576 in the ex-smokers group. The patients were followed up for 3 years. The main study endpoints were major cardiovascular adverse events (composite endpoints of all-cause death, all myocardial infarctions and revascularization) and target lesion failure (composite endpoints of cardiogenic death, target vessel-related myocardial infarction, target vessel-related blood flow reconstruction). Results: The patients in the current smokers group was younger than the non-smokers group and the ex-smokers group (p<0.0001). In terms of prognosis, no statistical significance observed in the incidence of composite end point of MACE (p=0.9866), target lesion failure (p=0.2522), and stent thrombosis (p=0.2118), all-cause death (p=0.3130), cardiogenic death (p=0.2509), revascularization (p=0.5028), target vessel-related revascularization (p=0.9866), and stroke (p=0.3895), among the three groups. The current smokers group had the lowest incidence of myocardial infarction while ex-smokers group had the highest incidence rate(5.67%vs.5.10%vs.2.97%,p=0.0072), and so is the incidence of myocardial infarction related to target vessels (5.48%vs.5.10%vs.2.89%,p=0.0067). According to Cox regression analysis, history of myocardial infarction(HR=1.339,95%CI:1.042-1.722,p=0.0227), and baseline SYNTAX score(HR=1.0333, 95%CI:1.017-1.049,p<0.0001) are independent risk factors of MACE, while current smoking(HR=0.793,95%CI:0.646-0.974,p=0.0274) proves to be an independent protective factor of target vessel related myocardial infarction. Conclusion: For male patients with the left main coronary artery lesions receiving PCI, smoking has no impact on the long-term MACE or target lesion failure, current smoking is an independent protective factor for target vessel related myocardial infarction.


2020 ◽  
Vol 4 (2) ◽  
pp. 1006-1018
Author(s):  
N.P. Strygo ◽  
◽  
V.I. Stelmashok ◽  
O.L. Polonetsky ◽  
◽  
...  

Aim. To establish efficacy and safety of endovascular correction of long coronary lesion with biodegradable scaffolds in comparison with everolimus-eluting metallic coronary stents. Materials and methods. From 2013 to 2018 in Republican Scientific and Practical Centre «Cardiology», Minsk, endovascular correction of long (more than 25 mm) coronary artery lesions was performed on 80 patients. Randomly patients were divided into 2 groups: group 1 (n=40) – endovascular correction with the biodegradable everolimus-eluting vascular scaffold Absorb BVS, and group 2 (n=40) – endovascular correction with the everolimus-eluting metallic stent Xience V/Xience Pro. Results. In 12-month observational period there were no cases of death or myocardial infarction in both groups. One-year primary endpoint (death + myocardial infarction + target lesion failure) was 10% in group 1 (scaffolds BVS Absorb) and 8.75% in group 2 (Xience stents), 4 and 3 cases of target lesion failure accordingly (p>0.05). As secondary endpoints there were 3 cases of target lesion revascularization registered and 4 cases of target vessel revascularization in each group, 5 cases of target vessel failure in group 1 and 4 cases in group 2 (p>0.05). There was 1 case of confirmed and 1 case of probable scaffold thrombosis in group 1 (cumulative rate 5%), no cases of stent thrombosis in group 2 (p=0.49). Conclusion. Long lesion correction with biodegradable scaffolds shows similar one-year clinical and angiographic results in comparison with everolimus-eluting stents. Combined endpoint risk (all death cases + myocardial infarction + revascularization due to target lesion failure) statistically did not differ in one-year period in both groups.


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.


Sign in / Sign up

Export Citation Format

Share Document