Universität zu Köln

Scheller, Bruno, Ohlow, Marc-Alexander ORCID: 0000-0001-9674-2129, Ewen, Sebastian, Kische, Stephan, Rudolph, Tanja K., Clever, Yvonne P., Wagner, Andreas, Richter, Stefan, El-Garhy, Mohammad, Boehm, Michael, Degenhardt, Ralf, Mahfoud, Felix and Lauer, Bernward (2020). Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention, 15 (17). S. 1527 - 1545. TOULOUSE CEDEX 6: EUROPA EDITION. ISSN 1969-6213

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Abstract

Aims: Drug-coated balloons (DCB) may avoid stent-associated long-term complications. This trial compared the clinical outcomes of patients with non-ST-elevation myocardial infarction (NSTEMI) treated with either DCB or stems. Methods and results: A total of 210 patients with NSTEMI were enrolled in a randomised, controlled, non-inferiority multicentre trial comparing a paclitaxel iopromide-coated DCB with primary stent treatment. Ile main inclusion criterion was an identifiable culprit lesion without angiographic evidence of large thrombus. The primary endpoint was target lesion failure (TLF; combined clinical endpoint consisting of cardiac or unknown death, reinfarction, and target lesion revascularisation) after nine months. Secondary endpoints included total major adverse cardiovascular events (MACE) and individual clinical endpoints. Mean age was 67 +/- 12 years, 67% were male, 62% had multivessel disease, and 31% were diabetics. One hundred and four patients were randomised to DCB, 106 to stent treatment. In the stent group, 56% of patients were treated with BMS, 44% with current-generation DES. In the DCB group, 85% of patients were treated with DCB only whereas 15% underwent additional stent implantation. During a follow-up of 9.2 +/- 0.7 months, DCB treatment was non-inferior to stent treatment with a TLF rate of 3.8% versus 6.6% (intention-to-treat, p=0.53). There was no significant difference between BMS and current-generation DES. The total MACE rate was 6.7% for DCB versus 14.2% for stent treatment (p=0.11), and 5.9% versus 14.4% in the per protocol analysis (p=0.056), respectively. Conclusions: In patients with NSTEMI, treatment of coronary de novo lesions with DCB was non-inferior to stenting with BMS or DES. These data warrant further investigation of DCB in this setting, in larger trials with DES as comparator.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Scheller, Bruno UNSPECIFIED UNSPECIFIED UNSPECIFIED Ohlow, Marc-Alexander UNSPECIFIED orcid.org/0000-0001-9674-2129 UNSPECIFIED Ewen, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Kische, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Rudolph, Tanja K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Clever, Yvonne P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wagner, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Richter, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED El-Garhy, Mohammad UNSPECIFIED UNSPECIFIED UNSPECIFIED Boehm, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Degenhardt, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Mahfoud, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Lauer, Bernward UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-337770
DOI:	10.4244/EIJ-D-19-00723
Journal or Publication Title:	EuroIntervention
Volume:	15
Number:	17
Page Range:	S. 1527 - 1545
Date:	2020
Publisher:	EUROPA EDITION
Place of Publication:	TOULOUSE CEDEX 6
ISSN:	1969-6213
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CORONARY; ANGIOPLASTY; RESTENOSIS Multiple languages Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/33777