BIOFLOW-V: Orsiro Bests Workhorse Xience at 12 Months

Patrice Wendling

August 31, 2017

BARCELONA, SPAIN —The biodegradable-polymer Orsiro sirolimus-eluting stent (Biotronik) proved superior to the durable-polymer Xience everolimus-eluting stent (Abbott Vascular) for 12-month target lesion failure and MI in patients with up to three native de novo or restenotic coronary artery lesions in a new study[1].

Dr David Kandzari

"To our knowledge this is the first trial that has demonstrated superior outcomes compared with the Xience stent, which has served as a benchmark or standard for drug-eluting stents," study author Dr David Kandzari (Piedmont Atlanta Hospital, GA) said in an interview.

The findings of BIOFLOW-V, presented here at the European Society of Cardiology (ESC) 2017 and simultaneously published online in the Lancet, will be used to support an upcoming Food and Drug Administration submission for the device, which is already available in more than 100 countries.

Researchers previously reported that the ultrathin Orsiro stent had angiographic results comparable to Xience Prime in simple de novo lesions in BIOFLOW II and similar outcomes to two other stents in an all-comers population in BIORESORT.

Though not quite all-comers, BIOFLOW-V enrolled a complex patient population representative of those treated in clinical practice, Kandzari said during the late-breaking PCI Science session.

Patients were included if they had ischemic heart disease and an indication for PCI of up to three de novo target lesions in at least two target vessels, with a reference vessel diameter between 2.25 mm and 4.0 mm and a visually estimated lesion length of <36 mm.

Among the 1334 randomized patients (mean age 64.5 years, ~75% male), half presented with an acute coronary syndrome, 36% had diabetes, more than a quarter had experienced a prior MI, and about 74% of lesions were ACC/AHA class B2/C.

Important exclusion criteria were patients with acute ST-segment-elevation MI, hemodynamic instability, chronic total occlusion (CTO), or bypass graft disease. As reported recently by theheart.org | Medscape Cardiology, the Orsiro stent failed to achieve parity with Xience in the PRISON-IV study in patients with successfully recanalized CTOs.

In the present study, procedural success—defined by <30% residual stenosis of the target lesion using the assigned stent only without an in-hospital major adverse event—was significantly higher with Orsiro than with Xience (93.9% vs 90.1%; P=0.019). This was driven largely by a higher rate of in-hospital MI in the Xience group (3.9% vs 6.7%; P=0.029).

At 30 days, however, rates of all-cause mortality, target lesion revascularization, and stent thrombosis were low and similar in both groups.

At 12 months, the primary end point of target lesion failure was 6.2% with Orsiro and 9.6% with Xience (P=0.04).

The Orsiro group had numerically but nonsignificantly lower rates of cardiac death (0.1% vs 0.7%; P=0.115) and clinically driven target lesion revascularization (2.0% vs 2.4%; P=0.686), but target vessel MI persisted as a significant difference through 12 months (4.7% vs. 8.3%; P=0.016).

In multivariable analysis, the findings remained significant and were independent of any baseline characteristics, Kandzari said.

The investigators also conducted a Bayesian analysis of patients pooled from BIOFLOW II and BIOFLOW IV who met all inclusion criteria for BIOFLOW V.

Among these 2208 patients, the observed 12-month target lesion failure rates were 6.3% with Orsiro and 8.9% with Xience, resulting in a difference of -2.6% (95% CI 6.7–11.4), with a probability of noninferiority of 100%. A post hoc superiority analysis showed a 96.9% probability Orsiro was superior to Xience, he said.

Commenting for theheart.org | Medscape Cardiology, session cochair Prof Michael Haude (Lukas Hospital, Neuss, Germany) said, "For the first time, we have a clear superiority with the new-generation drug-eluting stent against the gold standard, which is Xience."

He added, "It is remarkable because the real benefit of the bioabsorption of the polymer of the Orsiro hasn't still completely happened at 1 year, so we can imagine probably when we look at the longer-time run, the curves would separate even more, but they separate already at 1 year on a significant basis. So that is really remarkable."

The study was funded by Biotronik. Kandzari reported consulting, royalties, and stock ownership with Boston Scientific, Medtronic, and Micell Technologies; and research contracts with Abbott/St Jude, Biotronik, Boston Scientific, Medtronic, Medinol, Micell Technologies, and Orbus Neich. Disclosures for the coauthors are listed in the paper.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

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