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Compared with short-term treatment, prolonged use of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is associated with greater risk of major bleeding with no difference in death or myocardial infarction (MI), according to a meta-analysis published online May 5, 2014, ahead of print in The American Journal of Cardiology.

Jacqueline E. Tamis-Holland, MD, of Mount Sinai St. Luke’s Hospital (New York, NY), and colleagues analyzed data from 4 randomized controlled trials (EXCELLENT, PRODIGY, RESET, and OPTIMIZE) amassing 8,157 patients who were prescribed DAPT following implantation with sirolimus-, paclitaxel-, everolimus-, or zotarolimus-eluting stents. Patients were randomized to long-term (12-24 months; n = 4,076) or short-term DAPT (3-6 months; n = 4,081).

Stent Thrombosis May Not be Deal Breaker

At 12 months, MI and cardiac death (composite primary endpoint) occurred in 136 patients (3.3%) in the short-term and 123 patients (3.0%) in the long-term DAPT groups. Patients who received the shorter duration of DAPT were 59% less likely to have major bleeding but had similar rates of the composite endpoint. Occurrence of stent thrombosis was numerically higher in the short-term DAPT group, though this difference was not statistically significant (table 1).

Table 1. Outcomes at 12 or 24 Months^a: Short- vs Long-Duration DAPT

^aFollow-up duration was 12 months in 3 trials and 24 months in 1 trial.

Landmark analysis from the time of DAPT cessation in the short-term DAPT group demonstrated no difference in composite all-cause death or MI between the short- and long-duration DAPT (2.80% and 2.60%, respectively; P = .62) or stent thrombosis (0.35% and 0.20%, respectively; P = .22).

“That there is no change or difference in death or myocardial infarction confirms that probably the numerically higher rate of stent thrombosis is not clinically relevant,” Sorin J. Brener, MD, of Weill Cornell Medical College (New York, NY), told TCTMD in a telephone interview.

The higher bleeding risk, however, was pointed out by both Dr. Brener and the study authors as being a safety risk associated with long-term DAPT. “When instituting long-term DAPT,” the study authors advise, “one needs to consider the importance of balancing safety of prolonged DAPT (in terms of bleeding risk) with the potential for ischemic events.”

Extension of Previous Studies

“This is an extension of previous studies that have been published. It is a larger population, so the results are more robust,” continued Dr. Brener, adding that the there is no “earth-shattering new concept being explored.”

As to current practice, “The utilization of dual antiplatelet therapy in general has been declining lately because there is a perception that newer-generation [DES] do not require such extensive duration of antiplatelet therapy,” Dr. Brener explained. “Recent ACS patients with second-generation [DES] may not need to be on [DAPT] as long as 1 year, and 3-6 months is probably adequate,” he stated.

Moving forward, Dr. Brener said, “I think this is not so much a disease-specific, as it is a device-specific issue. We need a large registry or trial that looks at specific stents and various durations of antiplatelet therapy.”

Study Details:

Oral DAPT consisted of P2Y12 inhibitor clopidogrel and aspirin.

Related Stories:

• Registry: DAPT Discontinuation Less Associated With Second-Gen DES Thrombosis Compared to First-Gen DES
• Bleeding Common but Often Unreported in ACS Patients on Antiplatelet Therapy
• DAPT Interruption At Least 1 Month After ZES Implantation Appears Safe