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Longer-term DAPT may reduce ischemic events after complex PCI
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Among patients undergoing complex PCI with drug-eluting stents, a longer duration of dual antiplatelet therapy appears to significantly decrease the risk for ischemic events compared with a shorter treatment course.
Gennaro Giustino, MD, of the Icahn School of Medicine at Mount Sinai, and colleagues performed a post hoc, patient-level pooled analysis to identify six randomized clinical trials comprising 9,577 participants that compared short-duration dual antiplatelet therapy (DAPT; 3-6 months) or longer-duration DAPT (1 year or longer) in patients undergoing complex or noncomplex PCI. DAPT consisted of aspirin and clopidogrel.
The researchers defined complex PCI as a procedure that meets at least one of the following angiographic criteria: three vessels treated, at least three stents implanted, at least three lesions treated, bifurcation with implantation of two stents, total stent length greater than 60 mm or chronic total occlusion as the target lesion.
The primary efficacy endpoint was MACE, defined as the composite of cardiac mortality, MI, or definite or probable stent thrombosis at median follow-up. The primary safety endpoint was major bleeding at median follow-up.
Of the 9,577 patients for whom angiographic characteristics were available, 1,680 (17.5%) underwent PCI procedures defined as complex.
At a median follow-up of 392 days (interquartile range, 366-710 days), patients in the complex PCI category showed higher rates of MACE vs. those with noncomplex PCI (3.61% vs. 2.01%; adjusted HR = 1.98; 95% CI, 1.5-2.6), coronary thrombotic events (2.6% vs. 1.31%; adjusted HR = 2.36; 95% CI, 1.7-3.22), MI (5.4% vs. 2.9%; univariate HR = 2.05; 95% CI, 1.6-2.61), definite/probable stent thrombosis (1.2% vs. 0.5%; univariate HR = 2.51; 95% CI, 1.47-4.3), target vessel revascularization (6.6% vs. 3.6%; univariate HR = 2; 95% CI, 1.6-2.49) and all-cause mortality (3.2% vs. 2.2%; univariate HR = 1.61; 95% CI, 1.18-2.18).
Multivariable Cox regression modeling revealed a persistent and strong association between complex PCI and increased risk for MACE, coronary thrombotic events, definite/probable stent thrombosis, and MI; this association was to a degree comparable to a prior MI or high-risk ACS history, according to the findings. Adjusted analyses did not reveal an association between complex PCI and risk for major bleeding. With the inclusion of complex PCI as a continuous variable within the same multivariable models, the adverse events risk showed an increase proportional to the number of high-risk procedural characteristics (per number of complex PCI variables increase: MACE, adjusted HR = 1.46; 95% CI, 1.27-1.69; P for trend < .0001; coronary thrombotic event, adjusted HR = 1.37; 95% CI, 1.2-1.55; P for trend <.0001; definite/probable stent thrombosis, adjusted HR = 1.35; 95% CI, 1-1.82; P for trend = .05; and MI, adjusted HR = 1.47; 95% CI, 1.25-1.73; P for trend < .0001). Compared with patients who underwent short-term DAPT, those in the complex PCI group who were on a long-term regimen of DAPT had significantly decreased prevalence of MACE (adjusted HR = 0.56; 95% CI, 0.35-0.89) vs. those who did not undergo complex PCI (adjusted HR = 1.01; 95% CI, 0.75-1.35). The extent of this effect increased progressively with each increase in procedural complexity. An increased risk for major bleeding was observed in the long-term DAPT group, and this was similar across PCI complexity groups (P for interaction = .96), according to the researchers.
In a related editorial, Robert C. Welsh, MD, from the Mazankowski Alberta Heart Institute, University of Alberta, and Eric D. Peterson, MD, from the Duke Clinical Research Institute, Duke University Medical Center in Durham, North Carolina, noted that these findings should be considered when tailoring DAPT duration in patients who have undergone complex PCI.
“Among those with high risk on the basis of either patient or procedural risk factors, clinicians will need to assess the patient’s long-term bleeding risks on DAPT,” Welsh and Peterson wrote. “Then, they must determine whether the benefits of longer duration DAPT on MACE are worth the slight, but real increased risk for bleeding.” – by Jennifer Byrne
Disclosure: Giustino reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures. Welsh reports receiving grants and honoraria from AstraZeneca, Bayer, Bristol-Myers Squibb, Janssen and Pfizer. Peterson reports receiving consultant fees and research fees from AstraZeneca and Sanofi.
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