MASTER: Biodegradable-Polymer DES Tested Against BMS in STEMI
PARIS, France—A biodegradable-polymer sirolimus-eluting stent is as safe and more effective than BMS over the short-term in STEMI patients, according to findings presented May 19, 2015, in a late-break trial session at EuroPCR.
“When the MASTER study was designed, BMS still had an important place in STEMI treatment,” emphasized presenter Goran Stankovic, MD, PhD, of the Clinical Center of Serbia (Belgrade, Serbia). Two randomized trials—EXAMINATION and COMFORTABLE AMI—had demonstrated “slightly discrepant results,” he said.
For MASTER, the researchers randomized 500 patients with acute STEMI to receive the Ultimaster DES (Terumo; n = 375 patients, 759 lesions) or Kaname BMS (Terumo; n = 125 patients, 237 lesions).
Ultimaster releases sirolimus from an abluminal gradient coating and has a polymer that bioresorbs in 3 to 4 months. According to Dr. Stankovic, it has optimal drug-release kinetics that match the biological response.
Safety, Less Late Loss Demonstrated
Baseline characteristics were well matched between the 2 treatment arms. The DES group had a higher number of stents per lesion (mean 1.5 vs 1.3; P = .03) and longer total stent length per patient (mean 29.8 mm vs 26.0 mm; P = .007), and patients receiving DES were more likely to undergo staged procedures (24.1%) than were those receiving BMS (12.8%; P = .008). Importantly, Dr. Stankovic said, the “study population was representative of daily practice.
At 1 month, the primary safety endpoint (composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularization, stroke, definite stent thrombosis, or major bleeding) occurred with similar frequency in the DES and BMS groups. However, there were more unplanned revascularization of the infarct-related artery with BMS and a trend toward more definite stent thrombosis (table 1).
At 6 months, late loss was less evident in DES-treated lesions (0.09 ± 0.43 mm) compared with BMS-treated lesions (0.79 ± 0.67 mm; P < .001).
“The superior efficacy and favorable short-term safety of Ultimaster DES” has been demonstrated, Dr. Stankovic concluded. “We believe that bioresorbable polymer is a potentially valuable feature in the STEMI setting.” He predicted that the study’s primary endpoint of target vessel failure at 1 year will confirm this hypothesis.
Why Compare With BMS?
Several panel members questioned why MASTER used BMS as the comparator, given that DES appear to be superior in this setting.
The current study is useful in supplementing earlier findings on biolimus- and everolimus-eluting devices, Dr. Sankovic explained, noting that now sirolimus with bioresorbable polymer can be added to the list. “I think it’s better to have more choices and CE Mark approval for use in STEMI patients,” he said.
Guglio G. Stefanini, MD, of Bern University Hospital (Bern, Switzerland), went a step further. “To be provocative,” he countered, “is it ethical to use a bare-metal stent [as comparator]?”
Dr. Stankovic emphasized that “the study was designed in 2012, [when] BMS were still a viable option. Nowadays, new studies should [use] a DES vs another DES.”
Stankovic G. Safety and efficacy of biodegradable polymer DES in Management of patients with Acute ST-Elevation myocardial InfaRction: MASTER study. Presented at: EuroPCR; May 19, 2015; Paris, France.
- Dr. Stankovic reports no relevant conflicts of interest.