Drug-eluting balloons for percutaneous coronary interventions.

نویسندگان

  • Marco Zimarino
  • Raffaele De Caterina
چکیده

Thromb Haemost 2009; 101: 9–11 The simple and originally naïve idea of dilating a coronary stenosis to restore unobstructed coronary flow through percutaneous transluminal coronary angioplasty (PTCA) (1) has been a major advance in the treatment of acute coronary syndromes and is currently also commonly used in stable coronary artery disease (2). However, there is no such thing as a “free lunch”, and the vascular injury caused by the balloon-induced barotrauma elicits an initial inflammatory response in the vessel wall that leads to vessel restenosis in 30–40% of cases through two major processes: a) negative vascular remodeling (used to designate late vessel shrinking after the acute dilation) and b) cellular proliferation. While the former is abolished by the use of stents, acting as metal scaffolds, such metal devices themselves actually increase the risk of the latter, leading to neointimal hyperplasia often more severe than when the plain “old” balloon angioplasty was used (3). Interventions with balloon angioplasty and/or the use of stents are now unanimously referred to as percutaneous coronary interventions (PCI). Drug-eluting stents (DES) were seen as the final solution of the problem, since they dramatically reduce in-stent restenosis by inhibiting cellular proliferation (Fig. 1). The initial enthusiasm for DES, however, has been recently tempered by the concern for the occurrence of late stent thrombosis (4), caused by an incomplete endothelization of the stent struts and an inflammatory response to the polymer (5). We have therefore lately witnessed some revival for the use of bare-metal stents (BMS), which will be probably accompanied by a predictable re-increase in the rate of in-stent restenosis. Because of this, there is currently uncertainty on the optimal selection of stents. As dual antiplatelet therapy is recommended for at least 12 months after DES (6), patients at higher risk of bleeding (the elderly, patients with cancer, candidates to oral anticoagulant and to any type of surgery) or subjects with expected lack of adherence or inability to tolerate an extended course of dual antiplatelet therapy are undoubtedly better candidates to receive BMS. On the other hand, most conditions frequently occurring in the “real world” and usually considered “off-label” indications for DES share a higher risk of both, late thrombosis and restenosis: such are diabetes mellitus, chronic total occlusions, small (≤2.5 mm) coronary arteries, very long (>30 mm) stenoses and bifurcation lesions. Therefore, interest in alternative strategies of PCI using “biocompatible” devices and aiming at the reduction of restenosis has recently resumed. From the finding that vascular cells (endothelial and smooth muscle cells mostly) retain antiproliferative drugs for up to one week after contact exposure to the drugs themselves, and that this contact causes a prolonged inhibition of vascular smooth muscle cell proliferation, the concept and later the development of drug-eluting balloons were born (7). As an alternative to DES, where only about 15% of the stented surface is covered by struts, drug-eluting balloons allow a wider and more homogeneous distribution of the antiproliferative compound. Paclitaxel is well suited for this purpose because its lipophilic properties account for satisfactory penetration and persistence in the tissue; moreover, in the coating preparation, its solubility is enhanced by adding a small amount of the hydrophilic X-ray contrast medium iopromide (Ultravist®) (8). In experimental studies Scheller et al. extensively documented that paclitaxel-eluting balloons (PEB) effectively inhibited neointimal proliferation after BMS deployment (9). These positive findings were confirmed in a small pilot study among patients with in-stent restenosis after BMS (10): patients treated with a balloon coated with a paclitaxel dose of 3 μg/mm2 and inflated for 60 seconds featured a significantly lower sixmonth late lumen loss and need for target-lesion revascularization compared with the uncoated balloon group. In the absence of data about the efficacy and tolerability of higher drug dosages and of the optimal inflation times, Cremers et al. went back to a much awaited experimental study, the findings of which are reported in the present issue of Thrombosis and Haemostasis (11). The authors deployed 56 BMS into left anterior descending and circumflex coronary arteries of 28 domestic pigs, and randomized them to five different strategies: i) control, with uncoated balloon; ii) PEB with 10 seconds inflation time; iii) PEB with 60 seconds inflation time; iv) PEB with two consecutive 60 seconds inflations performed with the same balloon; v) PEB with two consecutive 60 seconds inflations performed with two balloons. After four weeks, angiographic and histomorphometric analyses

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عنوان ژورنال:
  • Thrombosis and haemostasis

دوره 101 1  شماره 

صفحات  -

تاریخ انتشار 2009