Poly (l‐lactic acid) bioresorbable scaffolds versus metallic drug‐eluting stents for the treatment of coronary artery disease: A meta‐analysis of 11 randomized trials

Abstract

Background: Bioresorbable vascular scaffolds (BVS) have been proposed for overcoming the long-term limitations of permanent metallic stents, while theoretically warranting similar advantages in plaque stabilization and anti-restenotic drug delivery in the early postrevascularization phase. However, increased rates of malapposition, restenosis, or thrombosis have emerged from initial trials with BVS, that were nevertheless underpowered for the evaluation of the real outcome benefits of these coronary devices. The recent completion of newer randomized clinical trials paves the way to the present meta-analysis, aiming at the comparison of Poly (L-Lactic acid) BVS (PLLA-BVS) versus metallic drug-eluting stents (DES) in the treatment of coronary stenoses. Methods: Literature and main scientific session abstracts were searched for randomized clinical trials (RCTs) comparing drug-eluting BVS versus metallic DES for the treatment of coronary artery disease (CAD). The primary efficacy endpoint was mortality, secondary endpoints were cardiovascular death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis and the composite of device-oriented target lesion failure (TLF). Results: We included 11 randomized trials, for a total population of 10,707 patients, 54.5% treated with BVS. The major indication for PCI was stable CAD, whereas acute coronary syndrome represented 30% of the patients. At a mean follow-up of 2.64 years (1-5 years), mortality occurred in 2.71% of the patients, with no difference according to the type of implanted stent (OR[95%CI] = 0.94 [0.74, 1.20], p = .62). No interaction was observed according to patients' risk profile or the rate of diabetes and ACS. However, a significant increase in myocardial infarction, stent thrombosis, TLR and TLF was observed with BVS as compared to DES. Conclusions: The present meta-analysis provides the most updated data on the use of PLLA-BVS for the treatment of CAD. We documented a poorer performance of these new coronary devices, as compared to new generation metallic DES, being associated with an increased rate of recurrent cardiovascular events. However, such ischemic complications did not impact on mortality, with a comparable survival independently from the type of stent.

Stent Selection for Primary Angioplasty and Outcomes in the Era of Potent Antiplatelets. Data from the Multicenter Randomized Prague-18 Trial

“…We did not find significant differences in cardiovascular outcomes between DES and BVS at 7, 30, and 365 days despite the fact that BVS patients were less morbid. Former and recent RTCs and meta-analyses have shown worse or equal mid or long term outcomes of BVS compared to 2nd generation DES, especially if implanted in the context of an AMI [25][26][27][28][29][30][31][32]. The rate of early scaffold/stent thrombosis in our study (BVS 1.5% vs. DES 0.8%) was comparable to that seen in other published reports [27,30,33].…”

Review of the Protective Mechanism of Curcumin on Cardiovascular Disease

“…59 PLLA is a candidate material for biodegradable vascular scaffolds. 131 In one study, there was a significant increase in inflammatory cytokines around PLLA stents after they were implanted into porcine coronary arteries. In vitro studies, curcumin (20 μM) can reduce foam cell inflammation caused by PLLA degradation through PPAR γ signaling pathway.…”

Cambios estructurales y funcionales de las arterias coronarias tratadas con plataformas coronarias bioabsorbibles Absorb BVS

“…Verdoia M, et al (70) 10707 En comparación con DES, BVS presenta mayor riesgo de eventos cardiovasculares durante el seguimiento, pero sin aumento de la mortalidad.…”

“…Varones, n (%) 71 (77,2) Hipertensión Arterial, n (%) 44 (47,8) Diabetes mellitus, n (%) 14 (15,2) Fumador activo, n (%) 65 (70,7) Insuficiencia renal (TFG < 60 ml/min), n (%) 3 (3,3) Dislipemia, n (%) 57 ( 62)…”