Synergy Stent With Shorter DAPT Compared to BMS in Elderly Patients in SENIOR Trial
November 1, 2017—Elderly patients undergoing PCI often receive bare-metal stents (BMSs) instead of drug-eluting stents (DESs) to shorten the duration of dual antiplatelet therapy (DAPT) and reduce bleeding risk. However, results from the SENIOR trial found that compared with BMSs, shorter DAPT combined with the Synergy bioabsorbable polymer DES (Boston Scientific Corporation) leads to less adverse events without increasing bleeding risk.
The findings were reported at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 30 to November 2 in Denver, Colorado. The study was published simultaneously in The Lancet.
The study methods and results were summarized in the TCT announcement. Before randomization, 1,200 patients aged ≥ 75 years underwent prespecification of a tailored DAPT strategy: 1 month for patients with stable angina or silent ischemia, and 6 months for patients with acute coronary syndrome (including myocardial infarction). Approximately half of the patients were in each category based upon clinical presentation.
After the intended duration of DAPT was recorded, 596 were assigned to DES and 604 were assigned to BMS. The stent procedures were successful in 98.1% and 97.6% (P = .561) leading to a complete revascularization at baseline in 85.7% and 86.1% (P = .86) of DES- and BMS-treated patients, respectively. DAPT utilization was similar in both study arms, with approximately half of patients continuing DAPT beyond 1 month, and only 20% of patients (in both groups) continuing DAPT beyond 6 months.
The investigators found that the primary endpoint of all-cause mortality, myocardial infarction, stroke, or ischemia-driven target lesion revascularization occurred in 68 patients (11.6%) in the DES group (n = 584) and in 98 patients (16.4%) in the BMS group (n = 592; relative risk [RR], 0.71; 95% confidence interval [CI], 0.52-0.94; P = .0160). This was mainly driven by ischemia-driven target lesion revascularization, which was reported in 10 patients (1.7%) in the DES group and in 35 patients (5.9%) in the BMS group (RR, 0.29; 95% CI, 0.09–0.49; P = .0002). Bleeding complications, evaluated using BARC 2–5, (4.5% vs 5.0%; RR 0.90; 95% CI, 0.51–1.54; P = .68) and stent thrombosis (0.5% vs 1.4%; RR, 0.38; 95% CI, 0–1.48; P = .1315) rates were low in both groups.
Principal investigator Olivier Varenne, MD, who is with the Cardiology Department at Cochin Hospital in Paris, France, commented in the TCT announcement, “The elderly represent a fast-growing segment of the population undergoing percutaneous coronary intervention (PCI). They have been poorly represented in prior studies on DESs and DAPT duration, so there is no clear recommended PCI strategy for this group. The SENIOR trial shows that among elderly patients who undergo PCI, a DES, and a short duration of DAPT is superior to BMS with respect to the occurrence of all-cause mortality, myocardial infarction, stroke, and ischemia-driven target lesion revascularization. Therefore, BMSs should no longer be used as a strategy to reduce DAPT duration in these patients.”