BIOFLOW V: COMPARISON OF ULTRATHIN SIROLIMUS-ELUTING BIORESORBABLE POLYMER STENTS WITH THIN EVEROLIMUS-ELUTING DURABLE POLYMER STENTS - TARGET VESSEL MYOCARDIAL INFARCTION ANALYSIS

2018 ◽  
Vol 71 (11) ◽  
pp. A1017
Author(s):  
David E. Kandzari ◽  
Laura Mauri ◽  
Jacques Koolen ◽  
Joseph Massaro ◽  
Gheorghe Doros ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Target Vessel ◽  
Durable Polymer ◽  
Bioresorbable Polymer

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

2021 ◽  
Author(s):  
Dean J. Kereiakes ◽  
Robert L. Feldman ◽  
A.J.J. Ijsselmuiden ◽  
Shigeru Saito ◽  
Giovanni Amoroso ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Target Lesion ◽  
Coronary Stent ◽  
Target Vessel ◽  
End Point ◽  
Rapid Exchange ◽  
Direct Stenting ◽  
Durable Polymer ◽  
Bioresorbable Polymer ◽  
Target Lesion Failure

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.

scholarly journals Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer‐Generation Drug‐Eluting Stents

2021 ◽  
Author(s):  
Rayyan Hemetsberger ◽  
Mohammad Abdelghani ◽  
Ralph Toelg ◽  
Nader Mankerious ◽  
Abdelhakim Allali ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Target Vessel ◽  
Durable Polymer ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
Bioresorbable Polymer ◽  
Sirolimus Eluting Stent

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.

scholarly journals Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions

2020 ◽  
Vol 13 (9) ◽  
Author(s):  
Kazuhiro Dan ◽  
Hector M. Garcia-Garcia ◽  
Paul Kolm ◽  
Stephan Windecker ◽  
Shigeru Saito ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Randomized Controlled Trials ◽  
Target Lesion ◽  
Small Vessel ◽  
Controlled Trials ◽  
Target Vessel ◽  
Randomized Controlled ◽  
Durable Polymer ◽  
Bioresorbable Polymer ◽  
Target Lesion Failure

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.

5-year outcomes in patients with acute coronary syndrome treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
O Muller ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Cardiac Death ◽  
Target Lesion ◽  
Funding Source ◽  
Target Vessel ◽  
Coronary Syndrome ◽  
Durable Polymer ◽  
Stable Cad

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

scholarly journals A serial optical frequency-domain imaging study of early and late vascular responses to bioresorbable-polymer sirolimus-eluting stents for the treatment of acute myocardial infarction and stable coronary artery disease patients: results of the MECHANISM-ULTIMASTER study

2021 ◽  
Author(s):  
Tomonori Itoh ◽  
◽  
Hiromasa Otake ◽  
Takumi Kimura ◽  
Yoshiro Tsukiyama ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Frequency Domain ◽  
Stable Coronary Artery Disease ◽  
Imaging Study ◽  
Optical Frequency ◽  
Bioresorbable Polymer ◽  
Artery Disease

AbstractThe purpose of this study was to assess early and late vascular healing in response to bioresorbable-polymer sirolimus-eluting stents (BP-SESs) for the treatment of patients with ST-elevation myocardial infarction (STEMI) and stable coronary artery disease (CAD). A total of 106 patients with STEMI and 101 patients with stable-CAD were enrolled. Optical frequency-domain images were acquired at baseline, at 1- or 3-month follow-up, and at 12-month follow-up. In the STEMI and CAD cohorts, the percentage of uncovered struts (%US) was significantly and remarkably decreased during early two points and at 12-month (the STEMI cohort: 1-month: 18.75 ± 0.78%, 3-month: 10.19 ± 0.77%, 12-month: 1.80 ± 0.72%; p < 0.001, the CAD cohort: 1-month: 9.44 ± 0.78%, 3-month: 7.78 ± 0.78%, 12-month: 1.07 ± 0.73%; p < 0.001 respectively). The average peri-strut low-intensity area (PLIA) score in the STEMI cohort was significantly decreased during follow-up period (1.90 ± 1.14, 1.18 ± 1.25, and 1.01 ± 0.72; p ≤ 0.001), whereas the one in the CAD cohort was not significantly changed (0.89 ± 1.24, 0.67 ± 1.07, and 0.64 ± 0.72; p = 0.59). In comparison with both groups, differences of %US and PLIA score at early two points were almost disappeared or close at 12 months. The strut-coverage and healing processes in the early phase after BP-SES implantation were significantly improved in both cohorts, especially markedly in STEMI patients. At 1 year, qualitatively and quantitatively consistent neointimal coverage was achieved in both pathogenetic groups.

Off-Pump Coronary Artery Bypass Graft Versus Drug-Eluting Stent Implantation in Patients with Multivessel Disease Involving the Right Coronary Artery

2018 ◽  
Vol 67 (06) ◽  
pp. 458-466
Author(s):  
Jun Ho Lee ◽  
Dong Seop Jeong ◽  
Kiick Sung ◽  
Wook Sung Kim ◽  
Pyo Won Park ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
Coronary Artery Bypass ◽  
Artery Bypass ◽  
Graft Patency ◽  
Target Vessel ◽  
Off Pump ◽  
Target Vessel Revascularization ◽  
Coronary Territory ◽  
The Right

Abstract Background Whether percutaneous coronary intervention (PCI) is superior to coronary artery bypass grafting (CABG) for the right coronary territory is unknown. The aim of this study was to compare the outcomes and patency in the right coronary territory after CABG or PCI. Methods We studied 2,467 multivessel coronary artery disease patients from January 2001 to December 2011; 1,672 were off-pump CABG patients and 795 were PCI. The graft patency and the presence of major adverse cardiac and cerebrovascular events (MACCEs) including death, myocardial infarction, target vessel revascularization, and stroke were analyzed. Results After propensity score matching, cardiac-related survival was found to be significantly higher in the CABG group than in the PCI group (hazard ratio (HR) for the PCI group: 2.445, p = 0.006). The PCI group showed higher rates of myocardial infarction (HR: 2.571, p = 0.011) and target vessel revascularization (HR: 3.337, p < 0.001). In the right coronary territory, the right internal thoracic artery patency was not different in the PCI group compared with the CABG group (p = 0.248). In CABG group, low right coronary artery graft patency was associated with cardiac-related death (HR: 0.17, p = 0.003) and the occurrence of MACCEs (HR: 0.22, p < 0.001). Conclusion CABG was superior to PCI in patients with multivessel disease. Low graft patency in the right coronary territory was associated with cardiac-related death and the occurrence of MACCEs.

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