P5525A meta-analysis of randomised controlled trials to compare safety and efficacy of everolimus/sirolimus bioabsorbable polymer with second-generation durable-polymer drug eluting stents

Abstract

Background: Progress in the platforms for DES is aimed at improving safety and outcomes. Second-generation DESs have a biocompatible durable polymer (DP), in addition to bioabsorbable polymers (BP). The benefit of BP is to remove the polymer-triggered inflammatory stimulation associated with DP. There is evidence to suggest BP-DESs are non-inferior to the current generation DES at 12 months. The time course for polymer absorption varies between stents and may take from 4 to 15 months. Hence the potential benefits of BP-DES over DP-DES can only be tested over a longer period, to overcome the time taken for polymer absorption. Purpose: The purpose of the meta-analysis was to compare the safety and efficacy outcomes of BP-DES over a long-term follow-up. Methods: A thorough computer-based search using Ovid MEDLINE, EMBASE, Google Scholar, and PubMed databases was conducted up to 11 November 2017. We only included randomised studies (RCT) comparing clinical outcomes between the BP-DESs and DP-DESs. Only studies where data were available for a minimum of 5 years were included. Safety (Stent thrombosis (ST) and reinfarction) and efficacy (target lesion revascularization (TLR), cardiac mortality) were analysed. Results: The literature search yielded 445 citations. After going through the abstracts and full-texts of the articles we included 5 RCTs where 5-year follow-up data was available. The information about the included studies, stent platform, drug and type of polymer is provided in Table 1.There was no difference in the ST (OR 0.71, 95% CI 0.47 –1.09, I2 = 31%, P=0.12), reinfarction (OR 1.01, 95% CI 0.85 –1.21, I2 = 0%, P=0.89), cardiac mortality (OR 1.00, 95% CI 0.81 –1.23, I2 = 0%, P=0.98), all cause mortality (OR 0.95, 95% CI 0.80 –1.14, I2 = 21%, P=0.61) and TLR (OR 0.80, 95% CI 0.58–1.11, I2 = 68%, P=0.18). Furthermore, there was no difference in the very late ST (OR 0.49, 95% CI 0.19 –1.30, I2 = 56%, P=0.15).