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.

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.

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

Intracoronary Thrombolysis in Patients With ST-Segment Elevation Myocardial Infarction: A Meta-Analysis of Randomized Controlled Trials

Angiology ◽  
2021 ◽  
pp. 000331972199503
Author(s):  
Ling Chen ◽  
Liye Shi ◽  
Wen Tian ◽  
Shijie Zhao
Keyword(s):  
Myocardial Infarction ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
St Segment Elevation ◽  
Myocardial Microcirculation ◽  
Segment Elevation Myocardial Infarction ◽  
Randomized Controlled ◽  
St Segment ◽  
Intracoronary Thrombolysis

Background: The effects of intracoronary (IC) thrombolysis therapy in patients with ST-segment elevation myocardial infarction (STEMI) receiving primary percutaneous coronary intervention (PPCI) remain unclear. Methods: The meta-analysis was conducted according to the PRISMA statement. All relevant studies were identified by searching the PubMed, EMBASE, Cochrane Library, and Web of Science, with no time or language limitation. The pooled risk ratio (RR) and weighted mean difference (WMD) with a 95% CI were calculated. Results: Nine randomized controlled trials involving a total of 1341 patients were included. Compared with the control group, IC thrombolysis in patients with STEMI could reduce the incidence of major adverse cardiac events (MACE; RR 0.632, 95% CI, 0.474-0.843, P = .002) and improve left ventricular ejection fraction (RR 0.343, 95% CI, 0.178-0.509, P < .001) and myocardial microcirculation. However, there was no difference noted in the mortality (RR 0.759, 95% CI, 0.347-1.661, P = .490). The incidence rate of major bleeding and minor bleeding was comparable between the 2 groups. Conclusions: Intracoronary thrombolysis was associated with improved MACE and myocardial microcirculation in patients with STEMI having PPCI, though it failed to improve mortality.

scholarly journals A meta-analysis of everolimus-eluting stents versus sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Hang Ouyang ◽  
Xuehui Zeng ◽  
Chunlei Zhang ◽  
Linli Song ◽  
Jiarui Xu ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Diabetic Patients ◽  
Controlled Trials ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Late Luminal Loss

Abstract Objective We performed this meta-analysis to determine which stent among everolimus eluting stents (EES), sirolimus eluting stents (SES) and paclitaxel eluting stents (PES) should be preferred for the treatment of DM patients. Methods A systematic search of publications about randomized controlled trials (RCTs) focused on diabetic patients received EES, SES or PES was conducted. We evaluated the following indicators: target vessel revascularization (TVR), target lesion revascularization (TLR), late luminal loss (LLL), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality and cardiac mortality. Results EES showed obvious advantages over SES for DM patients, as it induced the lowest rate of target vessel revascularization and target lesion revascularization (TLR) (p = 0.04). In addition, EES induced lower in-segment LLL than PSE and SES and lower in-stent LLL than PES in DM patients (all p < 0.05). Moreover, EES effectively reduced all-cause mortality compared to SES (RR = 0.71, 95% CI: 0.52–0.99, p = 0.04) and MI rates compared to PES (RR = 0.44, 95% CI: 0.26–0.73, p = 0.0002). Furthermore, EES could reduce the ST rate compared with both SES (RR = 0.53, 95% CI: 0.28–0.98, p = 0.04) and PES (RR = 0.18, 95% CI: 0.07–0.51, p = 0.001). Conclusion Among those three types of stents, EES should be the first recommended stent for DM patients.

Complete versus culprit-only PCI in patients with STEMI and multivessel disease: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.Y Levett ◽  
S.B Windle ◽  
K.B Filion ◽  
J Cabaussel ◽  
M.J Eisenberg
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Complete Revascularization ◽  
Funding Source ◽  
Randomized Controlled ◽  
Mcgill University ◽  
Scholar Award

Abstract Background Approximately half of patients with ST-segment elevation myocardial infarction (STEMI) present with multivessel coronary artery disease (CAD) during primary percutaneous coronary intervention (PCI). Purpose To compare the risks of major cardiovascular outcomes and procedural complications in patients with STEMI and multivessel CAD randomized to complete revascularization versus culprit-only PCI. Methods We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing complete to culprit-only PCI, identified via a systematic search of MEDLINE, Embase, and the Cochrane Libraries. Count data were pooled using DerSimonian and Laird random-effects models with inverse variance weighting to obtain relative risks (RRs) and corresponding 95% confidence intervals (CIs). Results A total of 8 RCTs (n=6,632) were included, with mean/median follow-up times ranging from 6 to 36 months. Compared to culprit-only PCI, complete PCI was associated with a substantial reduction in MACE (12.6% vs. 22.0%), repeat myocardial infarction (4.5% vs. 6.9%), and repeat revascularization (3.3% vs. 12.1%) (Table 1). Complete PCI may also improve all-cause and cardiovascular mortality, but estimates were accompanied by wide 95% CIs. Findings for stroke, major bleeding, and contrast-induced AKI were inconclusive. Conclusion Complete revascularization appears to confer benefit over culprit-only PCI in patients with STEMI and multivessel CAD, and should be considered a first-line strategy in these patients. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Mr. Levett is supported by a Dr. Clarke K. McLeod Memorial Scholarship, funded through the McGill University Faculty of Medicine Research Bursary Program. Dr. Filion is supported by a Junior 2 Research Scholar award from the Fonds de recherche du Québec – Santé and a William Dawson Scholar award from McGill University.

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