Less GI injury and bleeding after six months of SAPT compared to DAPT: OPT-PEACE

Key Points:

• In the OPT-PEACE trial, patients undergoing complete revascularization with current generation stents received 6 months of DAPT with aspirin and clopidogrel and were subsequently randomized to either a) ongoing DAPT, b) aspirin alone, or c) clopidogrel alone for the remaining 6 months.
• The primary outcome was gastrointestinal mucosal injury (erosion, ulceration or bleeding) at 6 or 12 months. Important secondary outcomes included clinically relevant bleeding and ischemic events. GI mucosal injury was evaluated via a novel non-invasive capsule monitoring system (AMCE).
• Treatment with SAPT resulted in lower GI mucosal injury as well as clinically relevant bleeding at 6 or 12 months. No ischemic events were observed by 12 months.

Dual antiplatelet therapy (DAPT) is used for up to a year after drug-eluting stent placement in order to decrease the risk of subsequent ischemia; however, the prolonged period of DAPT poses a challenge for patients at high-risk of bleeding, especially those at risk for gastrointestinal injury. The OPT-PEACE (NCT03198741) trial (COmparison of Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation for Prevention of Gastrointestinal Injury Evaluated by Ankon Magnetically Controlled Capsule Endoscopy) evaluated the impact of three different antiplatelet regimens on rates of GI mucosal injury and bleeding via a novel system known as ANKON® magnetically controlled capsule endoscopy (AMCE), a non-invasive system involving swallowing a capsule which is actively magnetically controlled through the stomach and small intestine before passive excretion. In a breaking presentation at the 2021 Transcatheter Cardiovascular Therapeutics Conference today, Dr. Yaling Han and her team presented the results of the OPT-PEACE trial.

The OPT-PEACE study was a randomized, double-blinded clinical trial. All patients were treated with 6 months of DAPT with aspirin and clopidogrel; they were then divided into three arms: ongoing DAPT, aspirin monotherapy, or clopidogrel monotherapy for the remaining 6 months. All patients then underwent AMCE at the time of screening, randomization, and 6 months afterward. Adults with silent ischemia, stable angina, or NSTEMI who underwent complete revascularization with current-generation drug-eluting stents were eligible for inclusion. Relevant exclusion criteria included: patients with STEMI, stenting within 1 year, previous stent thrombosis, active GI bleeding, previous GI surgery, or contraindications to the AMCE procedure.

A total of 505 patients were randomized, of whom, 168 received aspirin only, 169 received clopidogrel only, and 168 received ongoing DAPT. At baseline capsule screening, rates of gastric mucosal injury were similar between the aspirin (82%), clopidogrel (83%) and DAPT (84%) arms.

The primary endpoint was gastrointestinal mucosal injury (erosion, ulceration or bleeding) at 6 or 12 months. Outcomes were compared between a single antiplatelet strategy (SAPT) vs DAPT as well as in the aspirin vs clopidogrel groups. The SAPT group had significantly reduced GI erosion (94.3% vs 99.2%, p=0.02) and no differences in erosion or ulceration compared to the DAPT group. There were no differences between the aspirin and clopidogrel groups in any of these endpoints. Clinically evident bleeding and ischemic events were included as secondary outcomes. SAPT resulted in less GI bleeding (0.6% vs 5.4%, p=0.001). Once again, there were no differences observed between the aspirin and clopidogrel groups. There were no observed ischemic events at 1 year, including MI, revascularization, or stent thrombosis.

The limitations of this study included a) the inclusion of only low-risk bleeding patients, b) lack of endoscopic findings at time of GI bleeds, and c) small sample size limiting the aspirin vs clopidogrel comparison.  When discussing the implications of the study at TCT, Dr. Han stated: “In patients at low risk of bleeding, nearly all patients receiving antiplatelet therapy developed GI injury. At 6 or 12 months, patients on SAPT developed less GI mucosal injury and clinical bleeding. Further studies will be needed in high-risk patients.”