Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial

Kandzari, David E.; Mauri, Laura; Koolen, Jacques; Massaro, Joseph M.; Doros, Gheorghe; García‐García, Héctor M.; Bennett, Johan; Roguin, Ariel; Gharib, Elie; Cutlip, Donald E.; Waksman, Ron

doi:10.1016/s0140-6736(17)32249-3

Cited by 230 publications

(158 citation statements)

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“…Six percent of patients in the Orsiro group and 10% of patients in the Xience group met the 12-month primary endpoint of TLF (P = 0.0399). 21 It is noteworthy that the Xience stent in the BIOFLOW V had higher TLF rate in selected lower-risk patients at 12-month follow-up than in an 'allcomers' population at 2-year follow-up in the previous SORT OUT IV trial (5%). 22 The difference in TLF was primarily driven by a difference in target-vessel MI (4.7% vs. 8.3%), which was not explained by differences in definite stent thrombosis (0.5% vs. 0.7%).…”

Section: Devices Drug-eluting Stentsmentioning

confidence: 88%

“…22 The difference in TLF was primarily driven by a difference in target-vessel MI (4.7% vs. 8.3%), which was not explained by differences in definite stent thrombosis (0.5% vs. 0.7%). 21 The SENIOR trial randomized elderly patients undergoing PCI to DES or bare metal stent (BMS) with use of a short duration of dual antiplatelet therapy [DAPT for 1 month in elective patients, 6 months in patients with acute coronary syndromes (ACS)]. The study found a significant reduction in the composite endpoint including all-cause mortality, MI, stroke, and ischaemia-driven target lesion revascularization in the DES group.…”

Section: Devices Drug-eluting Stentsmentioning

confidence: 99%

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The year in cardiology 2017: coronary interventions

Kristensen

Mæng

Capodanno

et al. 2018

European Heart Journal

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PreambleThe first balloon coronary angioplasty was performed in Zurich by Andreas Grüntzig in 1977. The patient, a 38-year-old man with severe angina and a tight stenosis on the left anterior descending artery, is still alive, is doing well, and he celebrated the 40-year anniversary of his percutaneous coronary interventions (PCI) in 2017 ( Figure 1). During the last decades, PCI techniques have undergone major improvements with the first real game changer being the introduction of bare metal stents, which made PCI safer and improved longer-term outcomes. Later on, drug-eluting stents (DESs) were introduced, which resulted in a major reduction in restenosis and also-with the newer generation DES-a low rate of stent thrombosis. Further, the introduction of intracoronary pressure measurements for assessment of severity of coronary stenoses [fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR)] and intracoronary imaging [intravascular ultrasound (IVUS) and optical coherence tomography (OCT)] for lesion assessment has refined lesion and procedure assessment. Improved outcomes were also fostered by development of better and safer adjunctive antithrombotic drugs and secondary prevention, optimizing drug-device synergy. Still, 40 years later the research in the coronary interventional field is very intense, and we aim here to summarize major developments in PCI published in 2017. Myocardial revascularization Percutaneous coronary intervention techniqueThe SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) II study investigated the impact of a contemporary PCI strategy on clinical outcomes of 454 patients with three-vessel disease. 1Characteristics of the SYNTAX II strategy that captures all components of today's 'best of PCI practice' are summarized in Figure 2. Following this approach systematically, the authors demonstrated major adverse cardiac and cerebrovascular events (MACCE) at 1 year to be much improved with respect to a matched historical PCI cohort from the SYNTAX I trial (10.6% vs. 17.4%; P = 0.006). The better result of the contemporary PCI strategy compared with the procedural technique followed at the time of the SYNTAX I trial was driven by a lower risk of myocardial infarction (MI) and revascularization, with a parallel reduction in stent thrombosis. Overall, the SYNTAX II study suggests that the combination of best practice components in PCI technique portends improved patient outcomes beyond what can be achieved by introducing one single new element. Because these results outperform PCI results obtained in the earlier SYNTAX I trial, the hypothesis was generated that a new randomized study of modern best PCI practice in patients with three-vessel disease might show non-inferiority vs. coronary artery bypass grafting (CABG). 1Glimpsing to the future, the feasibility and technical success of robotically-assisted PCI for complex coronary lesions were investigated in 334 procedures from 315 patients included in the Complex Robotically Assisted Percutaneous Coronary Intervention (...

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Section: Devices Drug-eluting Stentsmentioning

confidence: 88%

Section: Devices Drug-eluting Stentsmentioning

confidence: 99%

The year in cardiology 2017: coronary interventions

Kristensen

Mæng

Capodanno

et al. 2018

European Heart Journal

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“…In light of these considerations, the results of the 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-V (BIOFLOW V) trial published in Lancet in October 2017 (8) have to be highlighted. The BIOFLOW V study was a multicentre trial which randomly assigned 1,334 patients with a 2:1 ratio to either the ultrathin strut biodegradable-polymer sirolimus-eluting stent (SES, Orsiro, Biotronik, Bülach, Switzerland) or the thin strut fluoropolymer-based everolimus-eluting stent (EES, Xience, Abbott Vascular, Santa Clara, CA, USA).…”

mentioning

confidence: 99%

Ultrathin strut biodegradable-polymer sirolimus-eluting stents: being wary or going with the flow?

2018

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“…These DES have shown excellent safety and efficacy profiles for the treatment of coronary artery disease (CAD) (1)(2)(3)(4)(5), with a consequent widespread diffusion in the daily clinical practice. The biomechanical characteristics of cobalt-and platinumchromium alloys has allowed the production of even thinner stent struts, with further improvement of DES mechanical performances (6).…”

mentioning

confidence: 99%

“…In a recent report in The Lancet (15) the Orsiro™ stent (Biotronik, Buelach, Switzerland), a second generation DES with an ultrathin cobalt-chromium platform (60 µm strut thickness) and a bioresorbable carrier made of poly-L-lactic acid loaded with sirolimus (1.4 µg/mm 2 ), demonstrated better clinical outcomes in comparison with the Xience™ stent (Abbott Vascular, Santa Clara, CA, USA), an everolimus-eluting stent with a non-resorbable Editorial Should ultrathin strut drug eluting stents be considered the new benchmark for novel coronary stents approval? The complex interplay between stent strut thickness, polymeric carriers and antiproliferative drugs Alessandro Lupi 1 , Alon Schaffer 1 , Angelo Sante Bongo polymer carrier and a thin cobalt-chromium platform (80 µm strut thickness), currently considered the benchmark for DES comparisons due to the huge number of patients included in its study programme and the excellent clinical results reported (16).…”

mentioning

confidence: 99%