A total of 429 consecutive patients treated with paclitaxel DCB and 1088 consecutive patients treated with non-paclitaxel 2nd-generation DES were identified (Fig. 1). Some 94% of patients in the DCB group were treated with iobromide paclitaxel DCB (67.4% SeQuent Please NEO and 26.6% SeQuent Please), 5% with urea paclitaxel DCB (Falcon) and 1% with other paclitaxel DCB. Some 33.5% of patients were treated with Promus Premier and 26.8% with Promus Element DES, 13% with Synergy DES, 7.6% with Xience Prime, 5.7% with Xience Pro, 6.5% with Onyx DES, 2.9% with Ultimaster DES, 1.8% with Combo dual therapy DES and 2.2% with other second-generation DES. The average age was 66.9 ± 10.2 and 66.8 ± 10 years old for the DCB and DES group, respectively. Male patients accounted for 76.2% of the DCB group and 76.6% of the DES. Table 1 demonstrates that the two groups were well balanced for the great majority of baseline patient characteristics. The DES group had a significantly higher incidence of patients with chronic obstructive pulmonary disease and smoking history while the DCB group had a significantly higher incidence of patients with atrial fibrillation. Significantly more patients were on dual antiplatelet therapy (DAPT) in the DES group and as expected the mean duration of DAPT was significantly longer in the DES group.
Table 2 shows the characteristics of the target vessels treated with DCB or DES. The groups were well balanced in terms of prognostically significant lesions targeted with no difference in left main coronary artery, left anterior descending artery or multi-vessel PCI.
The patients were followed up for an average of 31.6 ± 16.3 months (interquartile range 16.8–45.3 months) in the DCB group and 44.4 ± 18.4 months (interquartile range 27.1–60 months) in the DES group. We obtained mortality data for 1515 patients. It was not possible to obtain mortality status of two patients (one in each group) who were censored at the time of last known alive.
There was no evidence of increased late mortality associated with paclitaxel DCB for de novo coronary artery disease compared with non-paclitaxel 2nd-generation DES (Fig. 2). Interestingly, the Kaplan–Meier curves separate early and then continue to diverge; supporting that DCB-only angioplasty is a safe procedure. Analysis following propensity score matching supported these results (Supplementary Fig. 1). The supplementary Table I demonstrated the 30-day, 6, 12, 24, and 36-month mortality in the DCB and DES groups. After 36 months of follow-up, 9 patients died in the DCB group vs 50 patients in the DES group. We specifically investigated a possible late mortality effect by analysing separately those patients who were alive 2 years following the index PCI and there was no evidence of increased late mortality with paclitaxel DCB (Fig. 3).
Univariate Cox regression analysis identified the following adverse prognostic factors: age, hypertension, peripheral vascular disease, previous myocardial infarction, heart failure, smoking, atrial fibrillation and decreasing estimated glomerular filtration rate (eGFR) [and renal failure defined as estimated glomerular filtration rate (eGFR) < 45] (Table 3). Hypercholesterolaemia and family history of ischaemic heart disease were associated with better prognosis on univariate analysis (Table 3). None of the angiographic characteristics were associated with worse outcome. On multivariate Cox regression analysis only age, decreasing eGFR [and renal failure defined as eGFR < 45—not presented in Table 4] and smoking history remained significant poor prognostic factors (Table 4).