DCB only-strategy is recommended by guidelines for the treatment of an ISR while there is also favorable evidence of feasibility and safety for the use of DCB-only angioplasty on both small and large de novo coronary artery disease[9, 12, 15]. In this retrospectively two-center study, our main finding suggested that similar results between the treatment of DCB-only and DES strategy on ostial lesion of LAD were observed during the average median of 10 months. Hence, this study could throw light on the feasibility and safety of the use of DCB in special LAD ostial lesions.
In era of stent implanting, percutaneous procedures of ostial lesion remained challenge due to their complex geographic feature and skilled technical warrant. In case of inaccurate stent localization at the LAD focal ostium, it could undoubtedly contribute to the potential risk for plaque shift into the LM and/or the LCX and for distal LM damages related to balloon dilatation, which in turn may predispose the LM segment adjacent to the stent to stimulate a progressive restenosis lesion[16]. On the other hand, deploying a cross-over stent in ostium of LAD could increase risk of recurrent restenosis or stent thrombosis in setting of normal left main coronary artery. Occasionally, there is the possibility of bail-out two sent technology which is susceptible to higher risk of in-stent stenosis. Prior results from series of studies demonstrated that the lesions and procedural involvement of left main bifurcation have been shown to be an independent risk factor of in-stent restenosis[17, 18]. In the contrast, no progression of LCX stenosis and minimal lumen diameter was observed in DCB arm, similarity to other register studies[19, 20]. On the other hand, the absolute increase in DAP values for patients
receiving DCB-only approach instead of DES was 93 Gy/cm2. This significant difference indicated that DCB-only strategy has an advantage of lowering exposure time and dose of ionizing radiation. As the result presented above, the DCB-only angioplasty not only has an advantage of protection of ostium LCX, but also simplifies the complex of crossover stent technique, involving guidewire or jailed balloon side branch protection, post-procedural rewiring, kissing balloon angioplasty and proximal optimization technique, and further diminishes ionizing radiation exposure time and the amount of radiation dose which is likely to impair cardiologist and patients’ lens and take higher risk of tumors[21, 22] .
Previously, interventional strategy with coronary stenting remained prevalence in part due to elimination of lesion recoil and the reocclusion of the infarct artery related to balloon angioplasty. However, in recent published study of Brodie et al which recruited 2195 consecutive STEMI patients treated with drug-eluting or bare mental stents or balloon angioplasty from 1994 to 2010, patients treated by balloon-only angioplasty had similar trend for one-year cardiovascular mortality and reinfarction rates compared with the ones treated with BMS or DES[23], similarity to results as our paper presented. The efficacy and safety of DCB with SeQuent Please in the treatment of native-vessel coronary artery disease have been extensively reported[13]. As the largest randomized clinical study to date, BASKET-SMALL 2 compared Sequent Please DCB-only approach with everolimus or Taxus DES in the treatment of small de novo coronary artery(< 3mm). It indicated that DCB is non-inferior to DES regarding MACE (7.5% vs. 7.3%) while patients in the DCB arm faced higher risk of cardiac death (3.1% vs. 1.3%) than DES arm without statistically significant during 12 months follow-up[24]. Furthermore, series of clinical studies demonstrated that Sequent Please DCB-only strategy is also safe and as efficient in de novo lesions of large coronary vessels[12, 25, 26]. Regardless of coronary lumen and lesion location, DCB angioplasty presented the similar rates of adverse clinical outcomes from previous results to our data as this study presented. Meanwhile, the recent published study of Kook et al[27] reported the comparable long-term clinical outcomes of DES and Sequent Please DEB in patients with in-stent restenosis involving left main bifurcation. According to incidence of target vessel revascularization from our study, it indicated that the treatment of a drug-coated balloon-only approach to de novo angioplasty could avoid late and very late in-stent thrombosis, reduce early restenosis and neo-atheroma formation, and simplify the procedure.
Despite of the confirmed advantage of DCB on de novo lesions, the limitation of DCB restricted by acute vessel closure due to elastic recoil and flow-limiting dissections should not be underestimated. Signiant notable feature of BASKET-SMALL 2[24] were 14% failed cases due to dissection or residual stenosis following predilatation. This scarce but fatal immediate side effect of DCB-only approach seems to be taken consideration by the majority of inventors. In this present study, only one patient (2%) in DCB arm suffered the acute occlusion and received the bailout stent in ostial LAD. These favorable results partly derived from less calcified lesion selected by experienced operators. In the pathogenesis of ACS, the calcified plaque is the least frequent etiology, but associated with aggressive lesion preparation which entails predilatation with a high-pressure post-balloon, a large-sized balloon, or a cutting balloon [28, 29]. Accordingly, the potential risk of coronary dissection inevitably ramp up due to this approach to achieve sufficient lumen area. In the study of Sugiyama et al[1], superficial calcific sheet, one type of calcified plaque, prefers to dominate in area of LAD and needs debulking or plaque modification such as rotational and orbital atherectomy. Alternatively, similarly to the other registers[12, 30–32], the middle-term TLR rates was as low as 4% in spite of up to 30% residual stenosis of target coronary artery. The uncompact predialation completed prior to the treatment of DCB-only approach could contribute to subsequent addition stenting implantation and increased TLR rates[12, 33]. Hence, it’s worth noting that rigorous lesion preparation to achieve an acceptable angiographic result before use of DCB was mandatory to avoid complications.