Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents

Abstract

Objectives. This study sought to assess the safety and long-term efficacy of drug-coated balloons (DCB) following aggressive intracoronary image-guided rotational atherectomy (iRA) for severe coronary artery calcification (CAC), and to compare this strategy with new generation drug-eluting stents (nDES) following iRA. Background. Ischemic events following the treatment of CAC is still relatively high. Thus, more innovative strategies are required. Methods. We evaluated 123 consecutive patients (166 lesions) with de novo CAC undergoing an iRA (burr size; 0.7 of the mean reference diameter by intracoronary imaging) followed by DCB (DCB-iRA; 54 patients, 68 lesions) or nDES (nDES-iRA; 69 patients, 98 lesions). Follow-up angiography was obtained at > 6 months. Results. The target vessels (right coronary and circumflex), bifurcation (67.6% versus 47.9%), reference diameter (2.28mm versus 2.49mm), and lesion length (11.89mm versus 18.78mm) were significantly different between the two groups. The median follow-up was 732 days. TLR and TVR in DCB-iRA and nDES-iRA at 3 years were similar: 15.6% versus 16.3% (P=0.99) and 15.6% versus 23.3% (P=0.38). In 41 well-matched lesion pairs after propensity score analysis, the cumulative incidence of TLR and TVR in DCB-iRA and nDES-iRA at 3 years was 12.9% versus 16.3% (P=0.70) and 12.9% versus 26.1% (P=0.17), respectively. On QCA analysis, although the acute gain was smaller in DCB-iRA (0.85 mm versus 1.53 mm, P<0.001), the minimum lumen diameter at follow-up was similar (1.69 mm versus 1.87 mm, P=0.29). The late lumen loss was lower (0.09 mm versus 0.52 mm, P=0.009) in DCB-iRA. Conclusions. DCB-iRA is feasible for CAC.

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

“…RA + DCB results reported in 2017 by Rissanen showed an extremely low TLR rate (1.5% at 12 months) [19]. Subsequently, some studies in Japan also showed a TLR of 6-16%, which was similar to this data [14,20,21]. In Japan, high TLR rate was observed using follow-up CAG.…”

Prognostic Impact of Calcified Plaque Morphology After Drug Eluting Stent Implantation ― An Optical Coherence Tomography Study ―

“…A recent study reported that TLR rates after drug-coated balloon angioplasty following rotational atherectomy for heavily calcified lesions was comparable to that of newergeneration DES. 35 Therefore, if appropriate lesion preparation with rotational atherectomy is achieved in heavily calcified lesions with CN, a "stentless" strategy using drugcoated balloons could be an alternative treatment choice. Furthermore, considering the inferior outcomes of target lesions with CN, detection of CNs in multivessel heavily calcified lesions may encourage the referral of patients for coronary artery bypass grafting rather than performing multiple PCI procedures.…”

Stentless Interventional Procedure Using Rotational Atherectomy and Drug-Coated Balloon for Noncalcified De Novo Lesions

“…Additionally, several recent reports have indicated that stentless PCI using RA/DCB could also be a revascularization therapy of choice particularly for calcified lesions. 1 , 2 , 3 , 4 In contrast, the role of RA for noncalcified lesions in the current DES era still remains uncertain. According to previous reports in the pre-stent era, RA effectively debulked even noncalcified lesions on intravascular ultrasound imaging, and the procedural initial success rate of RA did not differ between noncalcified and calcified lesions.…”

“…Recently drug-coated balloon (DCB)-only angioplasty for de novo lesions has attracted greater attention, and pretreatment with rotational atherectomy (RA) followed by DCB treatment (RA/DCB) has been reported to be an option of stentless PCI particularly for calcified de novo lesions. 1 , 2 , 3 , 4 However, even small-sized data regarding the RA/DCB procedure for noncalcified de novo lesions are still lacking. The purpose of the present retrospective study was therefore to compare angiographic results and clinical outcomes in patients with noncalcified de novo lesions who underwent RA/DCB with patients with calcified de novo lesions in a real-world clinical practice.…”