Abstract
Background: Patients with diabetes mellitus (DM) are known to be at high-risk for both ischemic and bleeding complications post-percutaneous coronary intervention (PCI). The ischemic benefit vs. bleeding risk associated with extended dual antiplatelet therapy (DAPT) in high-risk “TWILIGHT-like” patients with diabetes mellitus after PCI has not been established.Methods: All consecutive high-risk patients fulfilling the “TWILIGHT-like” criteria undergoing PCI from January 2013 through December 2013 were identified from the prospective Fuwai PCI Registry. High-risk “TWILIGHT-like” patients were defined by at least one clinical and one angiographic feature based on the TWILIGHT trial selection criteria. The present analysis evaluated 3,425 diabetic patients with concomitant high-risk angiographic features who were event-free at 1 year after PCI. Median follow-up was 2.4 years. The primary effectiveness endpoint was a composite of death, myocardial infarction, or stroke (termed major adverse cardiac and cerebrovascular events), and primary safety endpoint was clinically relevant bleeding according to the Bleeding Academic Research Consortium types 2, 3, or 5.Results: On inverse probability of treatment weighting (IPTW) analysis, prolonged-term (>1-year) DAPT with aspirin and clopidogrel decreased the risk of primary effectiveness endpoint compared with shorter ( ≤ 1-year) DAPT [1.8 vs. 4.3%; hazard ratio (HR)IPTW: 0.381; 95% confidence interval (CI): 0.252–0.576; P < 0.001] and reduced cardiovascular death [0.1% vs. 1.8%; HRIPTW: 0.056 (0.016–0.193)]. Prolonged DAPT was also associated with a reduced risk of definite/probable stent thrombosis [0.2 vs. 0.7%; HRIPTW: 0.258 (0.083–0.802)] and non-significantly lower rate of myocardial infarction [0.5 vs. 0.8%; HRIPTW: 0.676 (0.275–1.661)]. There was no significant difference between groups in clinically relevant bleeding [1.1 vs. 1.1%; HRIPTW: 1.078 (0.519–2.241); P = 0.840). Similar results were observed in multivariable Cox proportional hazards regression model.Conclusion: Among high-risk PCI patients with diabetes mellitus without an adverse event through 1 year, extending DAPT >1-year significantly reduced the risk of major adverse cardiac and cerebrovascular events without an increase in clinically relevant bleeding, suggesting that such high-risk diabetic patients may be good candidates for long-term DAPT.
Highlights
The addition of a P2Y12 inhibitor on a background of aspirin therapy is standard of care after percutaneous coronary intervention (PCI) for the prevention of ischemic complications [1, 2]
For purposes of the present analysis, we included patients who have completed the first year after PCI and were free of all-cause mortality, myocardial infarction (MI), stroke, repeat revascularization, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) major bleeding at the 1 year follow-up
When we examined safety outcomes, extended-term dual antiplatelet therapy (DAPT) did not appear to increase the risk of clinically relevant bleeding
Summary
The addition of a P2Y12 inhibitor on a background of aspirin therapy is standard of care after percutaneous coronary intervention (PCI) for the prevention of ischemic complications [1, 2]. To clarify patients who could potentially benefit from a longer duration of DAPT with adequate thrombotic protection without a trade-off in major bleeding, clinicians are warranted to balance the estimated risks of recurrent ischemic and bleeding events based on a mindful evaluation of patient’s risk profile that include clinical and procedural variables. Under this scenario, the TWILIGHT study enrolled a highrisk population with at least one clinical [e.g., diabetes mellitus (DM)] and one angiographic (e.g., complex coronary artery disease) features who are at high risk of ischemic or bleeding events after PCI [10, 11]. The ischemic benefit vs. bleeding risk associated with extended dual antiplatelet therapy (DAPT) in high-risk “TWILIGHT-like” patients with diabetes mellitus after PCI has not been established
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