Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial

Pilgrim, Thomas; Piccolo, Raffaele; Heg, Dik; Roffi, Marco; Tüller, David; Müller, Olivier; Moarof, Igal; Siontis, George C.M.; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Cuculi, Florim; Hunziker, Lukas; Eberli, Franz R.; Jüni, Peter; Windecker, Stephan

doi:10.1016/s0140-6736(18)31715-x

Cited by 104 publications

(48 citation statements)

References 40 publications

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“…Many clinical studies have shown that the risks of target lesion failure, safety and efficacy outcomes amongst patients undergoing PCI are similar after implantation of third-generation drug eluting stents with biodegradable polymers or second-generation drug eluting stents with durable polymers [41–43]. In addition, patients with and without DM show different performance in terms of safety and effectiveness for the same kind of stent, thus suggesting the existence of differences between groups with and without diabetes [44, 45].…”

Section: Discussionmentioning

confidence: 99%

Baseline plasma fibrinogen is associated with haemoglobin A1c and 2-year major adverse cardiovascular events following percutaneous coronary intervention in patients with acute coronary syndrome: a single-centre, prospective cohort study

Zhang

Liu

et al. 2019

Cardiovasc Diabetol

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Background Despite revascularisation, a large proportion of acute coronary syndrome (ACS) patients continue to experience major adverse cardiovascular events (MACEs), which are worsened by diabetes mellitus (DM). Fibrinogen (FIB) is a risk factor for MACEs in coronary artery disease and often elevated in DM. However, the relationships between FIB, glucose metabolism (haemoglobin A1c [HbA1c] and fasting blood glucose [FBG]) and MACEs following percutaneous coronary intervention (PCI) in DM, non-DM or whole patients with ACS remains unknown. Methods A total of 411 ACS patients undergoing PCI were enrolled in this study. We compared baseline FIB levels between DM ( n = 103) and non-DM ( n = 308) patients and divided participants into three groups according to FIB level, i.e. FIB-L, FIB-M and FIB-H, to compare baseline characteristics and MACEs. Linear regression analysis of the relationship between glucose metabolism and FIB, Cox regression, survival and landmark analyses of MACEs were also performed over a median of 27.55 months of follow-up. Results Patients with DM had higher FIB levels than non-DM patients (3.56 ± 0.99 mg/dL vs. 3.34 ± 0.80 mg/dL, P < 0.05). HbA1c and FBG were significantly positively correlated with FIB in whole and DM patients but not in non-DM patients (all P < 0.05). Compared with the FIB-L group, the FIB-M (hazard ratio [HR] 1.797, 95% CI 1.117–2.892, P = 0.016) and FIB-H (HR 1.664, 95% CI 1.002–2.763, P = 0.049) groups were associated with higher MACEs in whole; the FIB-M (HR 7.783, 95% CI 1.012–59.854, P = 0.049) was associated with higher MACEs in DM patients. FIB was not associated with MACEs in non-DM patients. During landmark analysis, FIB showed better predictive value for MACEs after PCI in the first 30 months of follow up than in the subsequent period. Conclusion In this study from China, FIB was positively associated with glucose metabolism (HbA1c and FBG) in whole and DM populations with ACS. Moreover, elevated baseline FIB levels may be an important and independent predictor of MACEs following PCI, especially amongst those with DM. However, as the follow-up period increased, the baseline FIB levels lost their ability to predict MACEs.

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Section: Discussionmentioning

confidence: 99%

Baseline plasma fibrinogen is associated with haemoglobin A1c and 2-year major adverse cardiovascular events following percutaneous coronary intervention in patients with acute coronary syndrome: a single-centre, prospective cohort study

Zhang

Liu

et al. 2019

Cardiovasc Diabetol

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“…Sirolimus BP‐DES shares the same efficacy and safety as the most widely used second‐generation DP‐DES . The 3‐year TLF risk of EXCROSSAL was similar to CoCr‐EES (7.1%) in the PLATIUM study, and also carried a similar risk of definite and probable ST (0.5%) .…”

Section: Discussionmentioning

confidence: 80%

“…Sirolimus BP-DES shares the same efficacy and safety as the most widely used second-generation DP-DES. [11][12][13][14] The 3-year TLF risk of EXCROSSAL was similar to CoCr-EES (7.1%) in the PLATIUM study, and also carried a similar risk of definite and probable ST (0.5%). 15 For East Asian patients, the 3-year TLF of CoCr-EES in the ABSORB China study was 4.7%, slightly lower than this study, which may be related to shorter lesions and greater RVD.…”

Section: Clinical Outcomesmentioning

confidence: 99%

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Wang

Tao

et al. 2020

Cathet Cardio Intervent

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Objectives To analyze the 3‐year outcomes of the biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in CREDIT II AND III TRIALS. Background Though approved by CFDA, the long‐term safety and efficacy of EXCROSSAL is still unknown. Methods CREDIT II was a randomized trial comparing the EXCROSSAL versus EXCEL stents in patients with up to two de novo coronary lesions, and CREDIT III was a prospective, single‐arm study evaluating the efficacy and safety of EXCROSSAL in broad types of de novo coronary artery lesions. We pooled the 3‐year follow‐up data of the EXCROSSAL arm of the CREDIT II and CREDIT III Trials. The primary outcome was 3‐year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV‐MI), and clinically indicated target lesion revascularization (CI‐TLR). The patient‐oriented composite endpoint (PoCE) (all‐cause death, all MI, or any revascularization) and stent thrombosis (ST) were also analyzed. Results A total of 833 patients were included in this study. The incidence of TLF and PoCE in the 3‐year follow‐up were 7.6% and 12.5%, respectively. ST occurred in 0.6% of patients. In the subgroup analyses, TLF was significantly higher in small target vessels, multi‐lesion PCI, and multi‐vessel disease. Conclusions The 3‐year follow‐up analysis confirmed low rates of TLF and ST in EXCROSSAL, which is similar to the most widely used new generation durable polymer drug‐eluting stent.

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“…34,35 The BIOSCIENCE trial also showed a marginal interaction of higher risk of stent thrombosis within 1 year and a lower risk of very late stent thrombosis between 1 and 5 years with O-SES (interaction p = .080), although the overall cumulative incidence was similar in both O-SES and durable-polymer EES. 33 However, caution is required as the BIONYX (Bioresorbable polymer-coated Orsiro versus durable polymer-coated Resolute Onyx stents) trial showed results contradictory. 36 O-SES was compared with the Resolute Onyx stent, which is the next iteration of Resolute Integrity ZES.…”

Section: Discussionmentioning

confidence: 99%

Three‐year clinical outcome of biodegradable hybrid polymer Orsiro sirolimus‐eluting stent and the durable biocompatible polymer Resolute Integrity zotarolimus‐eluting stent: A randomized controlled trial

Kim

Kang

Lee

et al. 2019

Cathet Cardio Intervent

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Aims: We compared long-term clinical outcomes between patients treated with Orsiro sirolimus-eluting stent (O-SES) and those treated with durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES). Methods and Results: The ORIENT trial was a randomized controlled noninferiority trial to compare angiographic outcomes between O-SES and R-ZES. We performed a post hoc analysis of 3-year clinical outcomes and included 372 patients who were prospectively enrolled and randomly assigned to O-SES (n = 250) and R-ZES (n = 122) groups in a 2:1 ratio. The primary endpoint was target lesion failure defined as a composite of cardiac death, nonfatal myocardial infarction, and target lesion revascularization. At 3 years, target lesion failure occurred in 4.7% and 7.

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Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial

Abstract: Clinical Trials Unit of the University of Bern and Biotronik.

Cited by 104 publications

References 40 publications

Baseline plasma fibrinogen is associated with haemoglobin A1c and 2-year major adverse cardiovascular events following percutaneous coronary intervention in patients with acute coronary syndrome: a single-centre, prospective cohort study

Baseline plasma fibrinogen is associated with haemoglobin A1c and 2-year major adverse cardiovascular events following percutaneous coronary intervention in patients with acute coronary syndrome: a single-centre, prospective cohort study

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Three‐year clinical outcome of biodegradable hybrid polymer Orsiro sirolimus‐eluting stent and the durable biocompatible polymer Resolute Integrity zotarolimus‐eluting stent: A randomized controlled trial

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