Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial
Selected in The Lancet by S. Brugaletta
Kandzari DE, Mauri L, Koolen JJ, Massaro JM, Doros G, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R
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Why this study – the rationale/objective?
To examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention.
How was it executed – the methodology?
International, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries. Patients were 2:1 randomized to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent.
The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods.
What is the main result?
1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI –6·84 to –0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, di erence in target lesion failure frequency –2·6% [95% credible interval –5·5 to 0·1], non-inferiority margin 3·85%, n=2208).
Critical reading and the relevance for clinical practice
This interesting trial comparing Orsiro vs. Xience in an all-comer population showed the no-inferiority of a bioresorbable-polymer based DES vs. a durable-polymer based DES. In particular a lower TLF, mainly driven by a lower target-lesion myocardial infarction, was seen in the Orsiro group vs. Xience. Two points should be highlighted. First, as the trial was powered for non-inferiority, although p-value was significant, nothing can be said on possible superiority. Future trials should address this point. Second, as previous studies showed that superiority of bioresorbable-polymer DES may need longer than 1-year follow-up to occur vs. durable-polymer DES, longer follow-up should be needed in this kind of trial. The feeling is that in the coming years, we will see many trials on this comparison in many clinical situations, such as STEMI, which maybe represents the most interesting field of comparison.