Key result
SAPT reduces post-PCI gastrointestinal mucosal injury by ~5 percentage points vs. continuing DAPT.
Why the study?
Although gastrointestinal bleeding is the most frequent major complication of antiplatelet therapy, clinically overt gastrointestinal bleeding is relatively uncommon in patients at low bleeding risk. This study evaluated the effects of different antiplatelet regimens on gastrointestinal mucosal injury using magnetically-controlled capsule endoscopy in low-bleeding-risk patients.
Does de-escalation to single antiplatelet therapy (aspirin or clopidogrel monotherapy) after 6 months of DAPT reduce gastrointestinal mucosal injury compared with continued DAPT through 12 months in low-bleeding-risk PCI patients?
RCT (n=505)
Placebo-controlled
Randomly assigned
Does de-escalation to single antiplatelet therapy (aspirin or clopidogrel monotherapy) after 6 months of DAPT reduce gastrointestinal mucosal injury compared with continued DAPT through 12 months in low-bleeding-risk PCI patients?
In low-bleeding-risk PCI patients, de-escalating from DAPT to aspirin or clopidogrel monotherapy at 6 months significantly reduces both capsule endoscopy-detected gastrointestinal mucosal injury and overt clinical bleeding through 12 months compared to continuing DAPT.
Answers are grounded in this paper and cite their sources.
Switching to SAPT after 6 months DAPT reduces GI mucosal injury and bleeding; extends randomized evidence favoring de-escalation in low-bleeding-risk post-PCI patients.
BACKGROUND Gastrointestinal bleeding is the most frequent major complication of antiplatelet therapy. In patients at low bleeding risk, however, clinically overt gastrointestinal bleeding is relatively uncommon. OBJECTIVE We sought to assess the effects of different antiplatelet regimens on gastrointestinal mucosal injury using a novel magnetically-controlled capsule endoscopy system in patients at low bleeding risk. METHODS Patients (n=505) undergoing percutaneous coronary intervention in whom capsule endoscopy demonstrated no ulcerations or bleeding (although erosions were permitted) after 6 months of dual antiplatelet therapy (DAPT) were randomly assigned to aspirin plus placebo (n=168), clopidogrel plus placebo (n=169), or aspirin plus clopidogrel (n=168) for an additional 6 months. The primary endpoint was the incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at 6-month or 12-month capsule endoscopy. RESULTS Gastrointestinal mucosal injury through 12 months was less with single antiplatelet therapy (SAPT) compared with DAPT (94.3% vs. 99.2%, P=0.02). Aspirin and clopidogrel monotherapy had similar effects. Among 68 patients without any gastrointestinal injury at randomization (including no erosions), SAPT compared with DAPT caused less gastrointestinal injury (68.1% vs. 95.2%, P=0.006), including fewer new ulcers (8.5% vs. 38.1%, P=0.009). Clinical gastrointestinal bleeding between 6 and 12 months was less with SAPT compared with DAPT (0.6% vs. 5.4%, P=0.001). CONCLUSIONS Despite being at low risk of bleeding, nearly all patients receiving antiplatelet therapy developed gastrointestinal injury, although overt bleeding was infrequent. DAPT for 6 months followed by SAPT with aspirin or clopidogrel between 6 and 12 months resulted in less gastrointestinal mucosal injury and clinical bleeding compared with DAPT through 12 months.
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Han et al. (2021) conducted an RCT in Antiplatelet therapy-induced gastrointestinal mucosal injury after percutaneous coronary intervention (n=505). Single antiplatelet therapy (aspirin plus placebo or clopidogrel plus placebo) vs. Dual antiplatelet therapy (aspirin plus clopidogrel) was evaluated on Incidence of gastrointestinal mucosal injury (erosions, ulceration, or bleeding) at 6-month or 12-month capsule endoscopy (p=0.02). Single antiplatelet therapy from 6 to 12 months post-PCI resulted in less gastrointestinal mucosal injury than dual antiplatelet therapy through 12 months.
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