The use of coronary stents vs plain old balloon angioplasty (POBA), has allowed to reduce recoil and limiting flow dissection which were major limitation in the earlier coronary artery treatments. With the evolution of drug eluting stents (DES), a favorable safety and efficacy profile was achieved, reducing target vessel related adverse events. However, the presence of a metal mesh in DES entails the need for prolonged dual antiplatelet therapy.
Drug coated balloons (DCB), a stent-free strategy, could be beneficial in certain scenarios, such as small vessel disease. In fact, the use of DES in small vessels has been associated with twice as many target lesion failure (TLF) events vs larger vessels.
Paclitaxel drug coated balloon angioplasty has been shown comparable to DES in small vessels. However, prior studies included a limited number of patients and provided little information on long term followup.
Fezzi et al. presented the ANDROMEDA, a meta-analysis of individual data from patients in randomized studies comparing paclitaxel coated balloons vs DES. Patients with denovo small vessel disease were included, considering a maximum diameter of 3.0 mm, followed up at mean 36 months.
The primary outcome was a composite of major adverse cardiovascular (MACE), including all-cause mortality, acute MI, vessel thrombosis or target vessel revascularization. Co-primary outcome was TLF, while secondary outcomes were individual components of primary end point.
Four studies meeting inclusion criteria were selected:
- BELLO (Balloon Elution and Late Loss Optimization).
- BASKET-SMALL 2.
- PICCOLETO II (Drug-Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment).
- RESTORE SVD China (the latter only assessed TLF).
A total 1,154 patients were randomized to PCB or DES. Among DCB patients, there was higher predilation rate (98.9% vs. 93.4%; P<0.001), larger diameter balloons were used [2.0–2.5 mm vs. 2.2 (2.0–2.5) mm; P= .030], and coverage was longer [20.0 (15.0–26.0) mm vs. 18.0 (15.0–23.0) mm; P < .001], with less inflation pressure.
At three years, the PCB patients saw lower incidence of MACE vs DES patients (18.5% vs. 24.5%; HR 0.67, CI 95%: 0.47–0.96, P = .027). This differences were consistent even after adjusting for multivariables (HR 0.75, CI 95%: 0.58–0.96, P = .022). there was mid to high heterogeneity between the included studies (I² = 57.5%; P = 0.047), with the highest impact coming from the BASKET-SMALL 2.
As regards the secondary outcomes of TLF, there were no significant differences between the strategies (14.7% vs. 17.6%; HR 0.78, CI 95%: 0.55–1.12, P = 0.185), with medium heterogeneity.
Prespecified subgroup analysis showed younger patients (<67) obtained greater benefits from PCB (MACE: HR 0.55, CI 95%: 0.38–0.81, P = .002; TLF: HR 0.62, CI 95%: 0.40–0.96, P = .031). However, this difference lost significance after adjusting for repeated statistical tests.
Conclusions
The authors concluded the use of paclitaxel coated balloons in small vessels was associated with significant MACE reduction vs DES (33% relative reduction), mainly due to lower incidence of AMI and revascularization. There were no differences in TLF at three years.
These findings suggest that PCBs might position as a reference strategy in the treatment of small vessel disease.
Reference: Simone Fezzi, Daniele Giacoppo, Gregor Fahrni, Azeem Latib, Fernando Alfonso, Antonio Colombo, Felix Mahfoud, Bruno Scheller, Raban Jeger, Bernardo Cortese, Individual patient data meta-analysis of paclitaxel-coated balloons vs. drug-eluting stents for small-vessel coronary artery disease: the ANDROMEDA study, European Heart Journal, 2025;, ehaf002, https://doi.org/10.1093/eurheartj/ehaf002.
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