Abbott Vascular's Absorb BVS Demonstrates Noninferiority to Xience DES in STEMI Patients

September 1, 2015—The European Society of Cardiology announced that Prof. Patrick W. Serruys, MD, presented findings from ABSORB STEMI: the TROFI II trial at the ESC Congress 2015, held August 29 to September 2 in London, United Kingdom. 

The study demonstrated that a bioresorbable drug-eluting coronary stent, or vascular scaffold (BVS), performed similarly to the gold-standard metal drug-eluting stent in a noninferiority trial among patients with ST-segment elevation myocardial infarction (STEMI). The study results will be published in the European Heart Journal.

In the ESC press release, Prof. Serruys, who is the trial’s senior investigator, commented, “This is the first randomized controlled trial to compare the stent coverage between these two types of stents in the STEMI setting.”

That BVS eventually biodegrade, thus restoring the natural physiology of coronary vessels, is “a factor which may be more important in STEMI patients, who tend to have delayed arterial healing as compared to patients with stable coronary artery disease,” explained Prof. Serruys. He noted, “This trial provides the basis for further exploration in clinical outcomes trials.”

As summarized by the ESC, the study included 191 STEMI patients (mean age, 58.6 years) undergoing primary percutaneous coronary intervention at eight medical centers. The patients were randomized to receive either an Abbott Vascular Absorb everolimus-eluting BVS (n = 95) or an Abbott Vascular Xience everolimus-eluting metallic stent (n = 96).

The primary endpoint of the study was a 6-month score assessing stent coverage and restenosis of the vessel using coronary optical coherence tomography imaging. The score was similar (1.74 in the BVS arm and 2.8 in the metallic stent arm), indicating almost complete arterial healing in both groups and meeting the criteria for noninferiority (P < .001).

The ESC reported that clinical events measured as a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization were 1.1% in the BVS arm compared to 0.0% in the metallic stent arm (P = ns), with one case of definite subacute thrombosis in the BVS arm.