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EVOLVE II: Bioabsorbable EES safe, effective in long term
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WASHINGTON — At 3 years, the rate of target lesion failure with a novel bioabsorbable polymer-coated everolimus-eluting stent was comparable to that of a durable polymer everolimus-eluting stent, according to new data presented at the American College of Cardiology Scientific Session.
In EVOLVE II, Cardiology Today’s Intervention Editorial Board member Dean J. Kereiakes, MD, medical director at the Christ Hospital Heart and Vascular Center and the Carl and Edyth Lindner Research Center in Cincinnati, and colleagues randomly assigned 1,684 patients to receive a durable polymer everolimus-eluting stent (EES; Promus Element Plus, Boston Scientific; n = 838) or a bioabsorbable polymer EES (Synergy, Boston Scientific; n = 846).
To qualify for inclusion, patients had to have at most three coronary artery lesions in up to two major epicardial vessels. Lesions had to be 34 mm or less in length with reference vessel diameters of 2.25 mm to 4 mm and diameter stenosis between 50% and 100%. The primary endpoint was TLF, which was defined as a composite of cardiac death, target-vessel MI and ischemia-driven target lesion revascularization.
Three-year follow-up data were available for 93% and 96.2% of the study groups, respectively.
Similar to data from 1- and 2-year follow-up, rates of TLF at 3 years did not differ significantly between the durable polymer EES arm and the bioabsorbable polymer EES arm (10% vs. 11%; HR = 1.1; 95% CI, 0.82-1.49). Further, the researchers found comparable rates of cardiac death (2.3% vs. 1.7%; P = .65), target-vessel MI (5.7% vs. 6.5%; P = .55) and TLR (4% vs. 5%; P = .28).
Additionally, results revealed similar rates of all-cause death (3.8% vs. 3.1%; P = .59), target-vessel Q-wave MI (0.4% vs. 0.2%; P = .62), target-vessel non-Q–wave MI (5.3% vs. 6.3%; P = .48), target vessel failure (14.2% vs. 14.4%; P = .95), target vessel revascularization (7.6% vs. 8.1%; P = .72) and non-TLR TVR (4.9% vs. 4.3%; P = .53).
Antiplatelet medication usage was also similar for both treatment arms at 3 years.
Rates of stent thrombosis at 3 years did not differ significantly between patients who received a durable polymer EES and those who received a bioabsorbable polymer EES (0.8% vs. 0.5%; P = .54).
“This is an important observation that we made regarding relative safety of the Synergy stent,” Kereiakes told Cardiology Today’s Intervention.
There were two cases of acute definite stent thrombosis, one case of subacute probable stent thrombosis and one case of very late definite stent thrombosis, which occurred at day 901 after the procedure, in the bioabsorbable polymer EES study arm. Kereiakes noted, however, that issues surrounding this case of very late definite stent thrombosis were complex.
The patient had a distal right coronary artery/posterior descending artery bifurcation lesion with a Medina classification of 1,1,0, and a second lesion in the mid-left anterior descending artery treated during the index procedure. At day 840, he was asymptomatic with no objective evidence of ischemia on a stress test and had an angiogram performed for unclear reasons, which showed a 60% to 70% distal right coronary in-stent restenosis, Kereiakes noted.
“Sixty-one days after treatment with kissing balloon angioplasty using a paclitaxel-coated balloon, the patient developed right coronary thrombosis with occlusion on the angiogram. However, the occlusion was upstream from the stent, even though it’s attributed to the stent,” he said. “The question is whether this was a case of pure stent thrombosis, and I don’t think so [because] the patient had a drug-coated balloon used in the prior complex interventional procedure for benign restenosis.”
Nevertheless, Kereiakes said, even counting this event, the rate of stent thrombosis with the bioabsorbable polymer EES is 0.06% per year after 1 year, and beyond 24 hours the cumulative thrombosis rate is only 0.2% compared with 0.7% with the durable polymer EES.
“The event rate is still less than one-third of that observed with the Promus Element Plus. Right now, 0.06% per year is a high bar,” he said. “We’re dealing with stents that have become much safer than the first-generation drug-eluting stents and bare-metal stents ... and in my opinion, Synergy is still the benchmark for stent safety.” – by Melissa Foster
Reference:
Kereiakes DJ. Abstract 1135-M. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Disclosure: The study was funded by Boston Scientific. Kereiakes reports receiving consultant fees or honoraria from Abbott Vascular, Boston Scientific, HCRI, Micell Technologies, Sanofi Svelte Medical Systems and having other financial relationships with Ablative Solutions.