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• W2790606727 abstract "I read with great interest the results of the BIOFLOW V trial (Oct 21, 2017, p 1843).1Kandzari DE Mauri L Koolen JJ et al.Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.Lancet. 2017; 390: 1843-1852Summary Full Text Full Text PDF PubMed Scopus (180) Google Scholar David Kandzari and colleagues should be congratulated on such an important study. The authors concluded that an ultrathin bioresorbable polymer drug-eluting stent (BRP-DES) outperformed a durable polymer-eluting stent (DP-DES) because the proportion of patients who had target-vessel myocardial infarctions at 12 months was lower in the BRP-DES group than in the DP-DES group. However, the proportion of patients who had myocardial infarction at 12 months was substantially higher in the DP-DES group than in previous trials comparing a BRP-DES with a DP-DES (table). Therefore, the significant difference in myocardial infarction rate between the two types of stents in this trial appears to be a result of increased events in the DP-DES group rather than decreased events in the BRP-DES group.TableProportion of patients who had myocardial infarction after treatment with durable polymer drug-eluting stentsProportion of patients who had myocardial infarction (%)COMPARE-II (2013)2Smits PC Hofma S Togni M et al.Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial.Lancet. 2013; 381: 651-660Summary Full Text Full Text PDF PubMed Scopus (250) Google Scholar2·5%NEXT (2013)3Natsuaki M Kozuma K Morimoto T et al.Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial.J Am Coll Cardiol. 2013; 62: 181-190Crossref PubMed Scopus (186) Google Scholar3·1%TARGET-1 (2013)4Gao RL Xu B Lansky AJ et al.A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial.EuroIntervention. 2013; 9: 75-83Crossref PubMed Scopus (59) Google Scholar2·2%BIOSCIENCE (2014)5Pilgrim T Heg D Roffi M et al.Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial.Lancet. 2014; 384: 2111-2122Summary Full Text Full Text PDF PubMed Scopus (209) Google Scholar4·4%CENTURY-II (2014)6Saito S Valdes-Chavarri M Richardt G et al.A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial.Eur Heart J. 2014; 35: 2021-2031Crossref PubMed Scopus (143) Google Scholar2·7%EVOLVE-II (2015)7Kereiakes DJ Meredith IT Windecker S et al.Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial.Circ Cardiovasc Interv. 2015; 8: e002372Crossref PubMed Scopus (214) Google Scholar5·0%BIOFLOW-II (2015)8Windecker S Haude M Neumann FJ et al.Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial.Circ Cardiovasc Interv. 2015; 8: e001441Crossref PubMed Scopus (161) Google Scholar2·6%BIOFLOW V (2017)1Kandzari DE Mauri L Koolen JJ et al.Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.Lancet. 2017; 390: 1843-1852Summary Full Text Full Text PDF PubMed Scopus (180) Google Scholar7·0% Open table in a new tab Even in a randomised clinical trial, differences in disease severity and baseline characteristics (ie, predictors of outcomes) exist across groups.9Steyerberg EW Bossuyt PM Lee KL Clinical trials in acute myocardial infarction: should we adjust for baseline characteristics?.Am Heart J. 2000; 139: 745-751Summary Full Text PDF PubMed Scopus (88) Google Scholar In the BIOFLOW V trial, the total study stent length was significantly higher in the DP-DES group than in the BRP-DES group. Similarly, the total numbers of stents and overlapping stents were significantly greater in the DP-DES group than in the BRP-DES group. These factors are associated with increased risk of recurrent myocardial infarction.10Stone SG Serrao GW Mehran R et al.Incidence, predictors, and implications of reinfarction after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction: the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Trial.Circ Cardiovasc Interv. 2014; 7: 543-551Crossref PubMed Scopus (58) Google Scholar, 11Räber L Jüni P Löffel L et al.Impact of stent overlap on angiographic and long-term clinical outcome in patients undergoing drug-eluting stent implantation.J Am Coll Cardiol. 2010; 55: 1178-1188Crossref PubMed Scopus (129) Google Scholar Therefore, the difference in recurrent myocardial infarction rates between the two stents in the BIOFLOW V trial might have been the result of an imbalance in risk factors for recurrent myocardial infarction across the two groups rather than a beneficial effect of the ultrathin stents. Thus, additional studies are needed to determine whether ultrathin stents are the most effective drug-eluting stent. I declare no competing interests. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trialThe outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. Full-Text PDF Bioresorbable polymer drug-eluting stentsIn the BIOFLOW V randomised trial,1 ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; BIOTRONIK, Buelach, Switzerland) were found to be superior to durable polymer everolimus-eluting stents (Xience; Abbott Vascular, Santa Clara, CA, USA) in combined composite endpoints of cardiovascular death, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation at 12 months (95% CI −6·84 to −0·29, p=0·0399). The Kaplan-Meier plot for the primary composite endpoints revealed that most events occurred 1–2 days after patients were randomly assigned; however, the curves run parallel throughout the 1 year follow-up. Full-Text PDF Bioresorbable polymer drug-eluting stents – Authors' replyWe thank Rahman Shah and Mohammed Alkhalil for their interest and thoughtful comments regarding the results of the BIOFLOW V trial1 and appreciate the opportunity to respond with further perspective. Full-Text PDF" @default.
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