Comparison of drug-eluting stents vs. drug-coated balloon after rotational atherectomy for severely calcified lesions of nonsmall vessels

Abstract

Calcified lesion is a risk factor for adverse events, even in the drug-eluting stent (DES) era. Recently, drug-coated balloon (DCB) has been shown to have favourable results for in-stent restenosis and small vessels, but its results for calcified lesions are unknown. This study aimed to clarify the rotational atherectomy (RA) and DCB results for calcified lesions of nonsmall vessels. A total of 194 consecutive de novo lesions from 165 cases underwent RA for calcified lesions of nonsmall vessels between January 2016 and August 2018 in a single centre. Overall, 8 cases/10 lesions were excluded because of RA followed plain old balloon angioplasty (POBA). Remaining lesions were grouped into the DES (88 cases/104 lesions) and DCB (69 cases/80 lesions) groups and then compared retrospectively. The primary endpoint was post-discharge major adverse cardiovascular events (MACE) at 1 year, and it was defined as cardiac death, noncardiac death, target-vessel-related myocardial infarction, target lesion revascularization (TLR), and major bleeding (BARC ≥ type 3). There was no difference in the clinical follow-up rate between RA + DES (96/104 lesions) and RA + DCB (78/80 lesions). The post-discharge MACE values after 1 year of RA + DES and RA + DCB were 8% and 11% (P = 0.30), respectively, in terms of cardiac death (0% vs. 0%, respectively), noncardiac death (4% vs. 3%, respectively, P = 0.36), target-vessel-related myocardial infarction (0% vs. 0%, respectively), TLR (4% vs. 8%, respectively, P = 0.30), and major bleeding (1% vs. 0%, respectively). For calcified lesions of nonsmall vessels, RA + DCB showed good results as well as RA + DES. RA + DCB is a potential new strategy for these lesions.

Efficacy and safety of drug-coated balloon in the treatment of acute myocardial infarction: a meta-analysis of randomized controlled trials

“…Data on the treatment of calcified lesions were lacking in the studies included in this meta-analysis. Devices such as cutting and scoring balloons, rotational atherectomy, laser coronary atherectomy are used for the treatment of severe calcified lesions, and study also showed that there was no significant difference in 1-year MACEs between DCB and DES after rotational atherectomy 29 . However, rotational atherectomy and laser coronary atherectomy may lead to increased operative time.…”

Drug-Coated Balloon vs. Stent for de novo Non-small Coronary Artery Disease: A Systematic Review and Meta-Analysis

“…However, it remains potential complications including suboptimal dilatation, dissections, plaque shift, elastic recoil, and vessel perforation with high-pressure balloon inflation (24). Iwasaki et al (21) chose rotational atherectomy which has been demonstrated a preferred choice in calcified lesions in both DCB and stent group for balloon or stent delivery and expansion, as it could reduce calcified plaque. For DCB, lesion preparation might be more important without stent implantations due to elastic recoil and dissections.…”

“…Besides, those results included BMS as a control, which has been rarely applied and not recommended for PCI by the recent guidelines. With the development and advance of DCB, there were several studies that used DCB for treating with de novo non-small vessels (17)(18)(19)(20)(21). Lin et al (22) did a meta-analysis in de novo large vessels, though remained some limitations.…”

Clinical expert consensus document on rotational atherectomy from the Japanese association of cardiovascular intervention and therapeutics: update 2023

“…Moreover, RA might prevent the polymer damage, when DES was delivered to the calcified lesions [30]. Although the initial results of debulking using RA was not satisfactory, the debulking might have developed with the aid of imaging devices and drug-coated balloon in Japan [31][32][33][34][35]. Furthermore, the long-term outcomes following RA with plain old balloon angiography was acceptable when the target lesions were limited to large coronary arteries (diameter ≥ 3 mm) [36].…”