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Outcome of percutaneous coronary intervention with the Absorb bioresorbable scaffold: data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Department of Cardiology, Västerås Hospital, Västerås, Sweden.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.ORCID iD: 0000-0003-4413-9736
Danderyd Hospital, Department of Cardiology, Stockholm, Sweden.
Sahlgrenska University Hospital, Department of Cardiology, Gothenburg, Sweden.
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2017 (English)In: EuroIntervention, ISSN 1774-024X, E-ISSN 1969-6213, Vol. 13, no 11, p. 1304-1311, article id EIJ-D-17-00458Article in journal (Refereed) Published
Abstract [en]

Aims: Randomised trials indicate higher rates of stent thrombosis (ST) and target lesion failure (TLF) after percutaneous coronary intervention (PCI) with the Absorb bioresorbable scaffold (BRS) compared with modern drug-eluting stents (DES). We aimed to investigate the outcome of all Swedish patients treated with the Absorb BRS.

Methods and results: The Absorb BRS (n=810) was compared with commonly used modern DES (n=67,909). The main outcome measure was definite ST; mean follow-up was two years. Despite being implanted in a younger, lower-risk population compared with modern DES, the Absorb BRS was associated with a higher crude incidence of definite ST at stent level: 1.5 vs. 0.6%, hazard ratio (HR) 2.38 (95% confidence interval [CI]: 1.34-4.23), adjusted HR 4.34 (95% CI: 2.37-7.94); p<0.001. The patient level adjusted HR was 4.44 (95% CI: 2.25-8.77). Rates of in-stent restenosis were similar for BRS and DES. Non-compliance with dual antiplatelet therapy (DAPT) guidelines was noted in six out of 12 BRS ST events. Three very late ST events occurred with the Absorb BRS.

Conclusions: In this real-world observational study, the Absorb BRS was associated with a significantly higher risk of definite ST compared with modern DES. Non-compliance with DAPT guideline recommendations was common among Absorb definite ST events.

Place, publisher, year, edition, pages
2017. Vol. 13, no 11, p. 1304-1311, article id EIJ-D-17-00458
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-342850DOI: 10.4244/EIJ-D-17-00458ISI: 000424327500013PubMedID: 28781242OAI: oai:DiVA.org:uu-342850DiVA, id: diva2:1185259
Funder
Swedish Heart Lung FoundationSwedish Research CouncilAvailable from: 2018-02-23 Created: 2018-02-23 Last updated: 2020-02-06Bibliographically approved
In thesis
1. Invasive treatment of coronary artery disease: Aspects on antithrombotic and percutaneous treatment options
Open this publication in new window or tab >>Invasive treatment of coronary artery disease: Aspects on antithrombotic and percutaneous treatment options
2020 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The outcome after percutaneous coronary intervention (PCI) has improved considerably thanks to more effective antithrombotic treatment strategies and improved coronary stents. Stent thrombosis (ST) is a rare complication to PCI associated with considerable mortality and morbidity.

The general aim of this thesis was to add real-world evidence for antithrombotic and technical strategies in invasive treatment of coronary artery disease. Five observational studies were performed on a large, unselected, real-world population undergoing PCI. All studies were based on data from the national registry SWEDEHEART.

In 31,258 patients undergoing PCI for ST-elevation myocardial infarction (STEMI), the rate of definite early ST was low (0.84%, n=265) but ST was associated with very high mortality (21%, n=51) at one year.

Among 20,600 patients with STEMI, we compared the outcomes for those treated with heparin and those treated with bivalirudin during PCI. Rates of ST were low and similar with heparin and bivalirudin but all-cause mortality at 30 days and one year was significantly higher with heparin. We found no differences in rates of major bleeding, re-infarction and stroke.

A novel bioresorbable scaffold (Absorb), used in patients undergoing PCI for all indications, was associated with a four- to eightfold higher adjusted rate of definite ST over two years, compared with conventional modern drug-eluting stents (DES). One in four ST events occurred later than one year after PCI. Rates of in-stent restenosis were comparable with Absorb and DES. Suboptimal implantation technique and non-adherence to antiplatelet therapy guidelines was common among patients with bioresorbable scaffold thrombosis.

The novel parenteral and potent platelet inhibitor cangrelor was used nearly exclusively in STEMI (n=899), in early presenters with high-risk, often with cardiac arrest (18%) but was associated with low ST rates and no major bleeding events.

In an unselected population of 65,000 patients undergoing PCI for all indications, the Xience permanent polymer everolimus eluting stent (n=36,600) appears to be safe and effective with low event rates of ST and in-stent restenosis. Compared with a control group of other modern DES (n=167,000) including a high proportion of thinner struts and absorbable polymers, Xience exhibits similar results in all important endpoints.

All studies of this thesis provided important real-world evidence on antithrombotic and technical treatment strategies in invasive management of coronary artery disease.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2020. p. 87
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1638
Keywords
PCI, STEMI, stent thrombosis, bivalirudin, heparin, bioresorbable scaffold, cangrelor, drug eluting stent, DES
National Category
Medical and Health Sciences
Research subject
Cardiology
Identifiers
urn:nbn:se:uu:diva-403926 (URN)978-91-513-0871-5 (ISBN)
Public defence
2020-03-27, H:son-Holmdahlsalen, Ing 100, Akademiska Sjukhuset, Uppsala, 13:00 (English)
Opponent
Supervisors
Available from: 2020-03-05 Created: 2020-02-06 Last updated: 2020-03-05

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Grimfjärd, PerJames, StefanVarenhorst, ChristophLagerqvist, Bo

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