Treatment of Patients With De Novo Small-Vessel Coronary Lesions: Analysis of Six Randomised Controlled Trials Comparing Paclitaxel-Coated Balloons With Drug-Eluting Stents.

Abstract

Both paclitaxel-coated balloons (PCB) and drug-eluting stents (DES) are indicated for the treatment of de novo small-vessel coronary lesions. Since the evidence comparing these two types of devices is limited, we undertook a meta-analysis on this issue. Our meta-analysis compared the efficacy of PCB vs. DES in the treatment of patients with de novo coronary lesions of size ≤ 2.75 mm. Only randomized controlled trials (RCTs) were included. The two treatments under comparison were PCB vs DES; the endpoint was the rate of major adverse cardiovascular events (MACE). Our statistical methods were based on the reconstruction of individual patient data from Kaplan-Meier curves using the IPDfromKM algorithm. After this reconstruction, our statistical calculations included hazard ratio (HR) estimation with a 95% confidence interval (CI), assessment of between-trial heterogeneity, and risk of bias for each RCT. Our literature search identified six RCTs that met our inclusion criteria (PICCOLETO, BELLO, RESTORE SVD, BASKET-SMALL2, PICCOLETO-II, and DISSOLVE). In our main analysis, the six treatment groups using PCB were compared with the six control groups using DES. The results showed an HR of 1.029 (95%CI, 0.7446 to 1.422; P=0.86) over a follow-up of 36 months. Heterogeneity analysis across the six control groups showed worse outcomes in the BELLO trial and better outcomes in the three trials employing a limus-eluting stent. To evaluate trial heterogeneity through the comparison of the six PCB arms, five trials showed similar outcomes while the BELLO trial fared significantly worse. Risk of bias for each RCT was appropriate.  Our results indicate that in de novo small-vessel coronary lesions, PCB and DES showed similar outcomes, despite some cross-study variability. Our results provided meta-analytic confirmation that no recommendations can be made in favor of PCB or DES in the treatment of de novo small-vessel coronary lesions based on current data.