Drug‐Coated balloons vs drug‐eluting stents for the treatment of small coronary artery disease: A meta‐analysis of randomized trials

Abstract

Objectives and background There is conflicting evidence about the effects of drug‐coated balloons (DCB) compared with drug‐eluting stents (DES) in patients with native small vessel coronary artery disease (CAD). Methods The PubMed, Embase, Cochrane Central Register of Controlled Trials, and http://ClinicalTrials.gov databases and main international conference proceedings were searched for randomized controlled trials (RCT) comparing DCB versus DES in patients with native small vessel CAD. Data were pooled by meta‐analysis using a random‐effects model. The primary endpoint was target vessel revascularization (TVR). Secondary clinical endpoints were: myocardial infarction (MI), target lesion revascularization (TLR), all‐cause death, cardiac death, and stent thrombosis or target vessel thrombosis. Secondary angiographic outcomes were: in‐segment restenosis, in‐segment percentage‐diameter stenosis, in‐segment late lumen loss, in‐segment net luminal gain, and in‐segment minimal lumen diameter. Results Five trials enrolling 1,459 patients were included. Mean clinical follow‐up was 10.2 months. The use of DCB, compared with DES, was associated with similar risk of TVR (odds ratio [OR]: 0.97; 95% confidence interval [CI] 0.56 to 1.68; p = .92), TLR (OR: 1.74; 95% CI: 0.57 to 5.28; p = .33), all‐cause death (OR: 1.03; 95% CI: 0.14 to 7.48; p = .98), with a trend toward a lower risk of MI (OR: 0.49; 95% CI: 0.23 to 1.03; p = .06), and with significant lower risk of vessel thrombosis (OR: 0.12; 95% CI: 0.01 to 0.94; p = .04). DCB use was associated with similar risk of angiographic restenosis (OR: 1.12; 95% CI 0.69 to 1.84; p = .64), comparable late luminal loss (standardized mean difference (SMD): –0.18; 95% CI: −0.39 to 0.03; p = .09), while leading to significant higher percentage diameter stenosis (SMD: 0.27; 95% CI 0.12 to 0.41; p < .01) and smaller minimal luminal diameter (SMD: ‐0.52; 95% CI: −0.86 to −0.18; p = .003). Conclusion Compared with DES, the use of DCB for the treatment of native small vessel CAD is associated with similar TVR and restenosis and reduces the risk of vessel thrombosis, although DES implantation yields slightly better angiographic surrogate endpoints.

Small Vessel Coronary Artery Disease: Rationale for Standardized Definition and Critical Appraisal of the Literature

“…In fact, the use of DCBs in anatomic settings adverse for treatment with DESs was not only shown to be similarly efficacious but also safer, as shown by the reduced risk of vessel thrombosis with DCBs than with DESs in patients with small vessel CAD. 47,48 Two early randomized clinical trials have reported conflicting results about the effects of DCBs compared with early-generation DESs on angiographic outcomes in patients with native small vessel CAD. 12,49 More recently, larger randomized trials with the use of second-generation DESs and novel DCB devices provided new evidence about the clinical and angiographic effects of these treatments.…”

“…11,12,36 A recent meta-analysis has shown that the use of paclitaxel-releasing DCB is associated with risks of target vessel revascularization and restenosis that are similar to DES (odds ratio [OR], 0.97; 95% CI, 0.56-1.68; P ¼ .92 and OR, 1.12; 95% CI, 0.69-1.84; P ¼ .64, respectively), whereas DCB yielded to a significant reduction in the risk of vessel thrombosis (OR, 0.12; 95% CI, 0.01-0.94; P ¼ .04) and DES implantation resulted in slightly better angiographic surrogate end points at the mid-term follow-up. 47 However, a recent observational study that included a nationwide cohort of 14,788 patients who underwent PCI with DCBs or DESs for small vessel CAD (defined as 2.5 mm, but inferred by the size of the implanted device) showed that treatment with DCBs compared with DESs was associated with a significantly higher risk for restenosis (hazard ratio, 2.02; 95% CI, 1.54-2.67; P < .001) and a similar risk of target lesion thrombosis, MI, and all-cause death. 50…”

Drug-Coated Balloon-Only Angioplasty Outcomes in Diabetic and Nondiabetic Patients with De Novo Small Coronary Vessels Disease

“…Contrary to our findings, Jalaluddin reported a significantly higher MACE events (4.3% vs. 0.6%; P =0.000), MI (2.6% vs. 0.4%; P =0.002) in the diabetic group [ 37 ]. A meta-analysis by Sánchez et al reported that diabetes did not affect the effect of DCB on the TVR [ 44 ]. These conflicting results might be related on the one hand to the differences in the inclusion criteria; only patients with ≤2.75 mm vessel diameter were enrolled, and all bailout stenting were excluded from our study.…”

“…However, Jalaluddin included all patients regardless of the vessel size [ 37 ]. Concerning the meta-analysis by Sánchez et al, the heterogeneity of the included trials in terms of the vessel size (<3 mm, <2.8 mm, and ≤2.75 mm) is significant to consider, knowing that the risk of restenosis after PCI is inversely correlated to the treated vessel's size [ 12 , 44 , 45 ]. The enrolled trials included the bailout BMS implantation cases, besides, procedural limitations such as the absence of routine lesion pre dilatation in the PICCOLETO trial, and heterogeneity in the duration of the follow-up among the included trials [ 44 ].…”

Efficacy and safety of drug-coated balloons in the treatment of de novo coronary lesions in very small vessels: a prospective, multicenter, single-arm trial

“…The rate of late lumen loss (LLL) and instent restenosis (ISR) is reduced. Substantial evidence has accumulated over the past years in ISR and de novo large or small coronary lesions (8)(9)(10). Very small vessels (VSV; lumen diameter <2 mm) lesions are common in coronary arteries especially in the Asia-Pacific region.…”