Abstract and Introduction
Abstract
Objectives The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI).
Background Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis.
Methods In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed.
Results Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C.
Conclusions In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765)
Introduction
Primary percutaneous coronary intervention (PCI) for the treatment of patients with ST-segment elevation myocardial infarction (STEMI) is well established. In this setting, drug-eluting stents (DES) reduce the need for repeat revascularization as compared with bare-metal stents (BMS). However, the revascularization benefit of DES is more pronounced in study settings than in routine clinical practice, partly due to protocol-mandated angiographic follow-up. Moreover, in patients without risk factors for restenosis such as diabetes mellitus, reference vessel diameter >3.0 mm, and lesion length <20 mm, DES and BMS result in similar revascularization rates.
Furthermore, with the use of DES in the STEMI setting, safety concerns remain regarding late acquired stent malapposition with consequently a possible increased risk of stent thrombosis. It is known that DES induce local inflammation due to the presence of polymers, drug-induced delayed endothelial healing, and vessel wall toxicity. Besides, in STEMI, the culprit lesions usually show a large necrotic core and high amount of thrombus formation, characteristics that can cause even more local toxicity, inflammation, and delayed vascular healing after DES implantation. These effects are also associated with an impaired vasomotor function in the treated vessel.
The paclitaxel drug-eluting balloon (DEB) is an emerging device that has shown promising results by means of a high-concentration, rapid local release of an antirestenotic drug (paclitaxel) into the coronary vessel without using durable polymers. Therefore, it could provide a valid alternative treatment in STEMI patients by avoiding sustained drug/polymer interaction with the vessel wall.
The aim of the current study was to test the DIOR DEB (Eurocor, Bonn, Germany) combined with a modern cobalt chromium BMS in primary PCI with the goal of obtaining improved angiographic results and comparable vessel healing and preserved endothelial function with respect to BMS alone and less uncovered or malapposed stent struts than a paclitaxel-eluting DES.