Abstract Body (Do not enter title and authors here): Background: Drug-coated balloons (DCB) have emerged as an effective treatment for in-stent restenosis and small vessel disease. DCB angioplasty might improve outcomes in heavily calcified lesions, a challenge in the current era of drug-eluting stents (DES). Calcified nodules (CN) also remain problematic due to high incidences of target lesion revascularization (TLR). However, there is limited evidence comparing the efficacy of DCB and DES angioplasty in heavily calcified lesions requiring rotational atherectomy (RA), including those with CN.
Methods: From January 2020 to July 2022, 471 patients underwent percutaneous coronary intervention (PCI) for calcified de novo coronary lesions using either DCB or DES (≤ 3 mm) following RA. Among these, 102 cases (21.7%) received DCB angioplasty, while 369 cases (78.3%) received DES angioplasty. The primary endpoint was the cumulative incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, clinically driven target lesion revascularization (CDTLR), and target vessel-related myocardial infarction (TVMI). We also compared the cumulative one-year incidence of TLR between the DCB and DES groups based on the presence of CN. CN was defined by intravascular ultrasound or optical coherence tomography as a convex shape of the luminal side of calcium.
Results: The cumulative one-year incidence of MACE was higher in the ROTA+DCB group compared to the ROTA+DES group (12.7% vs. 6.2%, Log-rank P=0.039). ROTA+DCB angioplasty was associated with an increased risk of MACE (inverse probability weighted hazard ratio [IPWHR], 3.02 [95% confidence interval {CI}, 1.063-8.583]; p=0.038) and CDTLR (IPWHR, 6.423 [95% CI, 1.825-22.60]; p=0.004) compared to ROTA+DES angioplasty.
In the CN subgroup (n=185), the one-year incidence of TLR was comparable between the DCB and DES groups (10.6% vs. 5.8%, IPWHR, 1.909 [95% CI, 0.414-8.804]; p=0.41). Conversely, in non-CN lesions (n=248), the one-year TLR rate was higher in the DCB group (7.8% vs. 1.0%, IPWHR, 12.42 [95% CI, 1.780-86.59]; p=0.011).
Conclusion: In patients with calcified coronary artery disease, the DCB strategy following RA was associated with a higher rate of MACE at one year compared to the DES strategy following RA. However, for calcified nodules in heavily calcified coronary arteries, the DCB strategy alone was comparable to DES following RA. In contrast, non-CN calcified lesions had a higher TLR rate with DCB compared to DES.