Postmarket Registry Evaluates B. Braun's Coroflex Isar Sirolimus-Eluting Stent
June 26, 2017—Findings from postmarket surveillance of the Coroflex Isar drug-coated stent (B. Braun Melsungen AG) for the treatment of real-world patients with de novo and restenotic lesions after stand-alone angioplasty in coronary arteries were published online by Florian Krackhardt, MD, et al in Open Heart.
B. Braun announced European CE Mark approval for Coroflex Isar in February 2014. The polymer-free matrix of Coroflex Isar consists of sirolimus and the matrix builder probucol that was initially studied in the Isar-Test 5 trial.
The Coroflex Isar 2000 Registry assessed the safety and efficacy of the ultrathin-strut Coroflex Isar polymer-free sirolimus-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). In addition, the investigators studied stable coronary artery disease (CAD) with short (≤ 6 months) versus long (> 6 months) dual antiplatelet therapy (DAPT).
As summarized in Open Heart, this unselected large-scale international, multicenter, all-comers study evaluated patients who received the PF-SES. The primary endpoint was the 9-month target lesion revascularization (TLR) rate. Secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. The investigators evaluated subgroups defined a priori, such as patients with ACS, diabetes, lesion subsets, and procedural characteristics relative to DAPT.
The investigators reported that a total of 2,877 patients, of whom 1,084 had ACS, were treated with PF-SES (1.31 ± 0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%; P = .389). The overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1% [58/947] vs 3.2% [50/1566]; P < .001).
The study demonstrated that PF-SES angioplasty is safe and effective in daily clinical routine with low rates of TLR and MACE in an unselected patient population. The data are in agreement with previous clinical findings that an extended DAPT duration beyond 6 months does not improve clinical outcomes in patients with stable CAD, stated the investigators in Open Heart.