Stentless Strategy by Drug-Coated Balloon Angioplasty following Directional Coronary Atherectomy for Left Main Bifurcation Lesion

Abstract

Aims. We aimed to evaluate the efficacy of stentless strategy by drug-coated balloon (DCB) angioplasty following directional coronary atherectomy (DCA) for left main (LM) bifurcation lesions. Methods. A total of 38 patients who underwent DCB angioplasty following DCA for LM bifurcation lesions were retrospectively enrolled. The primary endpoint was target vessel failure (TVF) at 12 months. Secondary endpoints included procedure-related major events during the hospitalization, major adverse cardiac events at 12 months, ischemia-driven target lesion revascularization (TLR) at 12 months, and bleeding complications defined as the Bleeding Academic Research Consortium criteria ≥2 at 12 months. Results. Among these 38 lesions, 31 lesions were de novo LM bifurcation lesions and 7 lesions were stent edge restenosis at the left anterior descending (LAD) ostium. The mean % plaque area (%PA) after DCA was 44.0 ± 7.4%. TVF at 12 months occurred in 1 lesion (3.2%) of de novo LM bifurcation lesion and in 3 lesions (42.9%) of stent edge restenosis at the LAD ostium. All events of TVF were ischemia-driven TLR by percutaneous coronary intervention. Among 4 TLR cases, %PA after DCA was high (55.9%) in the de novo LM bifurcation lesions; on the other hand, %PA after DCA was low (42.4%, 38.7%, and 25.7% in the 3 cases) in stent edge restenosis at the LAD ostium. No procedure-related major events were observed during hospitalization. There was no cardiac death, no myocardial infarction, no coronary artery bypass grafting, and no bleeding complications at 12 months. Conclusions. Stentless strategy by DCB angioplasty following DCA for de novo LM bifurcation lesions resulted in acceptable outcomes. On the other hand, its efficacy was limited for stent edge restenosis at the LAD ostium even after aggressive debulking by DCA.

Overview of in‐hospital outcomes in patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy

“…strategy using DCA followed by additional DCB angioplasty in patients with bifurcation lesions provided favorable midterm clinical outcomes with low restenosis and target lesion revascularization rates (2.3% and 3.1%, respectively) at the 12-month follow-up (n = 129). Inhibition of excessive neointimal hyperplasia and late lumen enlargement by additional paclitaxel-coated balloon angioplasty after DCA are important potential mechanisms of these favorable outcomes [4][5][6]. Indeed, this non-stent strategy was dominant in the DCA group of the present study.…”

“…Second, improved stent expandability and larger acute gain due to lesion modification using DCA may result in a reduced risk of in-stent restenosis in the chronic phase after the index PCI. 3,7 Third, stentless PCI using DCA followed by additional DCB angioplasty is a reasonable treatment strategy even in patients with acute coronary syndrome, [4][5][6]11 especially young female patients with menstruation and/or patients at high bleeding risk who cannot tolerate long-term dual antiplatelet therapy or oral anticoagulants. 19 In particular, based on the DCA/DCB registry conducted in 16…”

“…2 Third, DCA is unsuitable for specific lesions, including severely calcified coronary arteries and/or tortuous vessels. [3][4][5] Finally, in addition to the aforementioned limitations regarding DCA, many possible life-threatening complications can occur, such as cardiac tamponade due to coronary perforation, slow flow phenomenon, acute myocardial infarction due to abrupt vessel closure, and aneurysmal changes of the coronary artery. 3,4,[24][25][26][27][28] However, inhospital mortality and procedure-related complications were comparable between the DCA and non-DCA groups in this study.…”

“…Finally, the J‐PCI registry lacks precise procedural data regarding the size of sheaths and catheters, usage rate of intracoronary imaging such as IVUS and/or optical coherence tomography/optical frequency domain imaging, specific data of the percent plaque area detected by IVUS before and after DCA in each case, and frequency of complex stenting such as any two‐stent strategies; all of these are important clinical factors of PCI using DCA 2–5 . However, given the standardization of DCA procedures with IVUS guidance 2–6 and the current medical circumstances in Japan, in which approximately 85% of the patients underwent PCI using IVUS even before the introduction of the revived DCA catheter, 30 we speculate that IVUS was used in most cases in the DCA group. Despite these limitations, we believe that our nationwide registry‐based study includes novel and important clinical implications regarding the utility of DCA during PCI in patients with stable coronary artery disease and unstable angina.…”

“…2 Currently, several clinical experiences of the novel DCA catheter have been reported. 5,6,[9][10][11][12][13][14] Particularly for coronary bifurcation lesions, Japanese multicenter registry-based studies have revealed the safety and efficacy of DCA before second-generation drug-eluting stent (DES) implantation 3 or additional drug-coated balloon (DCB) angioplasty after DCA without stent implantation 4 with low midterm adverse event rates. These recent studies support the utility of DCA with or without a DES and/ or DCB, even in the era of new-generation DESs.…”