Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): Rationale and study design of the randomized TWENTE III multicenter trial

Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; Houwelingen, K. Gert van; Vries, Arie G. de; Danse, Peter W.; Schotborgh, Carl E.; Scholte, Martijn; Löwik, Marije M.; Linssen, Gerard C.M.; IJzerman, Maarten J.; Palen, Job van der; Doggen, Carine J.M.; Birgelen, Clemens von

doi:10.1016/j.ahj.2013.11.014

Cited by 26 publications

(26 citation statements)

References 34 publications

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“…In our study, the ongoing major bleeding risk during follow-up was substantially lower than that previously reported and was not significantly different among groups [26]. These results are similar to those of other recent DES registries in diabetics and do reassure regarding the ongoing bleeding risk in these patients treated with DAPT up to 1 year after PCI [4,14].…”

Section: Discussionsupporting

confidence: 76%

“…This report presents the findings in the diabetic patient group enrolled in the e-SELECT registry, evaluating the interaction between baseline DM treatment (insulin use vs. no insulin) and outcome. Although first-generation SES have been replaced by newer stent designs eluting different antiproliferative drugs, a relatively large number of second-generation DES are still coated with sirolimus and are currently used in patients with DM [4]. Accordingly, the e-SELECT registry data may serve as a clinical benchmark for future comparative effectiveness analyses and may improve our clinical understanding of PCI long-term results in the DM population.…”

Section: Introductionmentioning

confidence: 99%

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One‐year clinical outcomes after sirolimus‐eluting coronary stent implantation in diabetics enrolled in the worldwide e‐SELECT registry

Bartorelli

Assenza

Abizaid

et al. 2015

Cathet Cardio Intervent

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BackgroundDiabetes mellitus has worse outcome after percutaneous coronary intervention.AimWe assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year after implantation of sirolimus‐eluting stents (SES) in patients with diabetes mellitus in a large multicenter registry.MethodsFrom May 2006 to April 2008, 15,147 unselected consecutive patients were enrolled at 320 centers in 56 countries in a prospective, observational registry after implantation of ≥ 1 SES. Source data were verified in 20% randomly chosen patients at > 100 sites. Adverse events were adjudicated by an independent Clinical Event Committee.ResultsComplete follow‐up at 1 year was obtained in 13,693 (92%) patients, 4,577 (30%) of whom were diabetics. Within diabetics, 1,238 (9%) were insulin‐treated diabetics (ITD). Diabetics were older (64 vs. 62 years, P < 0.001), with higher incidence of major coronary risk factors, co‐morbidities, and triple‐vessel coronary artery disease. Coronary lesions had smaller reference vessel diameter (2.88 ± 0.46 vs. 2.93 ± 0.45 mm, P < 0.001) and were more often heavily calcified (26.1% vs. 22.6%, P < 0.001). At 1 year, diabetics had higher MACE rate (6.8% vs. 3.9%, P < 0.001) driven by ITD (10.6% vs. 5.5%, P < 0.001). Finally, diabetics had significant increase in ST (1.7% vs. 0.7%, P < 0.001), principally owing to ITD (3.4% vs. 1.1%, P < 0.001). There was an overall low risk of major bleeding during follow‐up, without significant difference among subgroups.ConclusionsIn the e‐SELECT registry, diabetics represented 30% of patients undergoing SES implantation and had significantly more co‐morbidities and complex coronary lesions. Although 1‐year follow‐up documented good overall outcome in diabetics, higher ST and MACE rates were observed, mainly driven by ITD. © 2015 Wiley Periodicals, Inc.

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Section: Discussionsupporting

confidence: 76%

Section: Introductionmentioning

confidence: 99%

One‐year clinical outcomes after sirolimus‐eluting coronary stent implantation in diabetics enrolled in the worldwide e‐SELECT registry

Bartorelli

Assenza

Abizaid

et al. 2015

Cathet Cardio Intervent

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“…Five-year follow-up data comparing biodegradable polymer-based DES with durable polymer DES showed a safety benefit and a significant reduction in very late stent thrombosis [13]. The currently ongoing BIORESORT prospective randomized-controlled multicenter trial comparing biodegradable coating DES with permanent coating DES will also address long-term clinical follow-up [14]. In our randomized trial with 3 months of DAPT after BMS plus DCB, we found no definite stent thrombosis up to 5 years.…”

Section: Discussionmentioning

confidence: 79%

Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease

Seeger

Markovic

Birkemeyer

et al. 2016

Coronary Artery Disease

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“…69, 71, 72 . Other strategies that are utilized in tissue engineering could also be helpful, including the patterning of scaffolds to induce and direct cell invasion 73 .…”

Section: Engineering Techniques For Harnessing Endogenous Mesenchymalmentioning

confidence: 99%

Strategies to Direct the Enrichment, Expansion, and Recruitment of Regulatory Cells for the Treatment of Disease

et al. 2014

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Disease and injury perturb the balance of processes associated with inflammation and tissue remodeling, resulting in positive feedback loops, exacerbation of disease and compromised tissue repair. Conversely, under homeostatic healthy conditions, these processes are tightly regulated through the expansion and/or recruitment of specific cell populations, promoting a balanced steady-state. Better understanding of these regulatory processes and recent advances in biomaterials and biotechnology have prompted strategies to utilize cells for the treatment and prevention of disease through regulation of inflammation and promotion of tissue repair. Herein, we describe how cells that regulate these processes can be increased in prevalence at a site of disease or injury. We review several relevant cell therapy approaches as well as new strategies for directing endogenous regulatory cells capable of promoting environmental homeostasis and even the establishment of a pro-regenerative micro-environment. Collectively, these examples may provide a blueprint for next-generation “medicine” that spurs the body’s own cells to action and replaces conventional drugs.

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Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): Rationale and study design of the randomized TWENTE III multicenter trial

Cited by 26 publications

References 34 publications

One‐year clinical outcomes after sirolimus‐eluting coronary stent implantation in diabetics enrolled in the worldwide e‐SELECT registry

One‐year clinical outcomes after sirolimus‐eluting coronary stent implantation in diabetics enrolled in the worldwide e‐SELECT registry

Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease

Strategies to Direct the Enrichment, Expansion, and Recruitment of Regulatory Cells for the Treatment of Disease

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