乌鸦传媒

Nearly all people taking antiplatelets after percutaneous coronary intervention (PCI) developed some form of gastrointestinal (GI) injury within a year, although being on one instead of two antiplatelets helped somewhat, the OPT-PEACE trialists found.

Patients at low bleeding risk who were on 6 months of dual antiplatelet therapy (DAPT) before switching to aspirin or clopidogrel (Plavix) alone had a lesser incidence of gastric or small intestinal mucosal injury after another 6 months compared with peers randomized to DAPT throughout all 12 months (94.3% vs 99.2%, P=0.02), reported Zhaoshen Li, MD, of Changhai Hospital of the Navy Military Medical University in Shanghai, in a presentation at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held in Orlando and broadcast online.

The findings were published simultaneously in the (JACC).

GI injuries at 12 months were assessed using a novel noninvasive endoscopy system and categorized into three types:

• Erosion: 93.6% with DAPT vs 96.9% with aspirin or clopidogrel monotherapy (P=0.16)
• Ulceration: 14.4% vs 18.5% (P=0.30)
• Bleeding: zero in both groups

On the basis of these findings, cardiologists should start thinking like gastroenterologists, urged John Bittl, MD, of AdventHealth Ocala, Florida, and Loren Laine, MD, of Yale School of Medicine in New Haven, and the VA Connecticut Healthcare System, in an .

"It is known that a history of GI bleeding in a patient undergoing PCI is the strongest risk factor for bleeding after hospital discharge, which in itself is a stronger predictor of mortality than is myocardial infarction," according to Bittl and Laine.

"Patients at high bleeding risk undergoing PCI should thus be considered for SAPT [single antiplatelet therapy] after 1-3 months of DAPT after PCI, so long as they remain at low risk of ischemic events. They should also receive proton pump inhibitors [PPIs]," the editorialists said.

PPI use is not without downsides, however, as they have been linked with kidney disease, bone fractures, dementia, and other adverse events.

Current guidelines recommend that people undergoing PCI with drug-eluting stents (DES) get DAPT for at least 6 months in stable ischemic heart disease and 12 months in acute coronary syndrome.

Yet newer evidence suggests a shorter course of DAPT followed by SAPT can reduce bleeding without raising ischemic risk.

Results from OPT-PEACE are "incredibly important" as they help clinicians to optimize long-term antiplatelet therapies with an eventual goal of personalized therapy for each individual undergoing a coronary procedure, said TCT press conference panelist Rajiv Tayal, MD, MPH, of Valley Health System in Ridgewood, New Jersey.

In left atrial appendage occlusion, patients are also headed toward SAPT instead of longstanding DAPT, according to fellow panelist Mintu Turakhia, MD, MAS, of Stanford University and the VA Palo Alto Health Care System in California.

"We need to do more studies like this" and "fundamentally challenge" all the assumptions held about antiplatelet regimens in heart patients, Turakhia said.

Li reported that in OPT-PEACE, neither aspirin nor clopidogrel in particular were associated with significantly more clinical bleeds or GI injury. However, in the subset of patients lacking GI lesions after the initial 6 months of DAPT, those randomized to clopidogrel monotherapy trended toward more GI mucosal injuries (96.2% vs 92.4% with aspirin alone, P=0.18).

This "challenges the conventional wisdom that aspirin is the culprit in DAPT responsible for GI injury and raises the possibility that clopidogrel, which does not inhibit COX-1 but targets the P2Y12 receptor, may be ulcerogenic or impair the healing of mucosal injury due to other causes," according to Bittl and Laine.

The Ankon endoscopy system used in OPT-PEACE has the patient swallow a capsule containing an endoscope that is tracked as it passes through the GI tract, magnetically controlled. This device is of comparable accuracy as standard invasive upper GI endoscopy, according to Li.

No retained devices or major device-related complications occurred over the 2,050 Ankon procedures in the study.

was a double-blind randomized trial conducted at 28 Chinese centers, and included patients who underwent successful PCI with DES.

Of 1,028 patients at low bleeding risk who underwent capsule endoscopy, 783 showing no GI injuries other than erosions were enrolled and given clopidogrel (Plavix) plus aspirin for the first 6 months. After 6 months, another endoscopy was performed and 505 were randomized to one of three arms: one continuing DAPT, one getting aspirin only, and one clopidogrel only.

Patient and procedural characteristics were well-balanced among the three groups. Mean age was 57, and roughly three in four were men.

There were no adverse ischemic events or deaths at 12 months. Patient-reported GI symptoms were similar across antiplatelet regimens after PCI.

DAPT users who had no GI injuries at 6 months developed these injuries more frequently by 12 months after staying on DAPT instead of switching to a single antiplatelet (95.2% vs 68.1%, P=0.01).

Ultimately, DAPT was associated with more GI bleeding at 12 months (5.4% vs 0.6%, P=0.001), counting both overt bleeds and a positive fecal occult blood test result.

Among the study limitations were the lack of endoscopic examination of people with clinical GI bleeds and the wholly East Asian patient population.

Trial results also cannot be extrapolated to high-risk patients, though clinical use of capsule endoscopy is promising for this group, Li said.

"A finding in the present study that has investigational implications was the discovery of GI erosions in nearly all patients. It is possible some erosions were due to other causes or constitute a finding that is too sensitive, too nonspecific and prone to being over-read," Bittl and Laine noted.

"This supports the clinical impression that patients and doctors should be more concerned with symptomatic ulceration or overt bleeding than with incidental endoscopic erosions," they suggested.