Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial.

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 stents.

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. The 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 (ClinicalTrials.gov Identifier: NCT01489449).

• Authors: Bruno Scheller, Marc-Alexander Ohlow, Sebastian Ewen, Stephan Kische, Tanja K Rudolph, Yvonne P Clever, Andreas Wagner, Stefan Richter, Mohammad El-Garhy, Michael Böhm, Ralf Degenhardt, Felix Mahfoud, Bernward Lauer
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 15 Issue 17 Pg. 1527-1533 (Apr 17 2020) ISSN: 1969-6213 [Electronic] France
• PMID: 31659986 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Cardiovascular Agents
• Metals
• Paclitaxel
• Sirolimus

Topics

• Aged
• Aged, 80 and over
• Angioplasty, Balloon, Coronary (methods)
• Cardiovascular Agents (administration & dosage)
• Coronary Restenosis (diagnostic imaging, epidemiology, prevention & control)
• Coronary Vessels (diagnostic imaging)
• Drug-Eluting Stents
• Female
• Humans
• Male
• Metals
• Middle Aged
• Non-ST Elevated Myocardial Infarction (surgery)
• Paclitaxel (administration & dosage, therapeutic use)
• Prosthesis Design
• Sirolimus (administration & dosage)
• Stents
• Treatment Outcome
• Ultrasonography, Interventional