Practice Update: Cardiology

ACC 2017 9

primary endpoint of symptomatic recur- rent fatal or nonfatal VTE was reduced by approximately 70% in both rivaroxaban groups (1.2% VTE occurrence with 10 mg and 1.5% with 20 mg vs aspirin at 4.4% VTE occurrence; HR = 0.26 for 10 mg rivarox- aban vs aspirin and HR = 0.34 for 20 mg vs aspirin; P < 0.001 for both comparisons). 1 There was no difference among prespeci- fied subgroups, including type of prior VTE event (provoked vs unprovoked) and dura- tion of prior anticoagulation therapy. There was a trend toward a higher rate of major or clinically relevant non-major bleeding in the rivaroxaban 20 mg per day group compared with the aspirin group (3.3% vs 2.0%; HR, 1.59; P = 0.08); however, the rates in individual safety endpoints did not dif- fer, and the incidence of adverse events was similar among the groups. While not reaching statistical significance, there was a signal for the elderly (>75 years of age) and fragile in particular to do better with rivaroxaban 10 mg per day than aspirin in terms of bleeding. Thus, in summary, the EINSTEIN-CHOICE trial showed that patients with VTE ben- efit from extended anticoagulation, and rivaroxaban 10 mg per day seems to strike the best balance in terms of efficacy and safety compared with aspirin. These results are also in line with the AMPLIFY-EXT trial published 4 years ago, which showed that extended (12-month) anticoagulation with apixaban 2.5 mg per day or 5 mg per day is safe and efficacious compared with placebo for the prevention of recurrent VTE. 2 Obvi- ously, an open question now is in regard to the timing of stopping the therapy. Both, EINSTEIN-CHOICE and AMPLIFY-EXT do not show a solid plateau in the comparator groups, suggesting that anticoagulationmay need to continue beyond the time frame specified in these trials. References 1. Weitz JI, Lensing AWA, Prins MH, et al. N Eng J Med DOI:10.1056/NEJMoa1700518. 2. Agnelli G, Buller HR, Cohen A, et al. N Engl J Med 2013;368(8):699-708. Both, EINSTEIN-CHOICE and AMPLIFY-EXT do not show a solid plateau in the comparator groups, suggesting that anticoagulation may need to continue beyond the time frame specified in these trials.

was again 75%. Similar to what was found in PRAMI and any other study that had been done in between, the main reduction is by a lower number of future revascularizations, which is intuitive. However, one may want to consider the trend of a 50% lower MI rate with the complete versus the culprit-only approach. The effect size on this endpoint was much stronger in PRAMI. Overall, COMPARE-ACUTE is building momentum for a complete revascularization approach in STEMI patients, confirming the PRAMI trial data. In an era of cost- confinement, this seems most certainly a very cost-effective approach. The risks of multivessel intervention should still not be forgotten; in this trial, more than two-thirds of patients had just one more vessel to be taken care of at the time of STEMI. References 1. Wald DS, Morris JK, Wald NJ, et al. N Engl J Med 2013; 369 (12):1115-1123. 2. Smits PC, Abdel-Wahab M, Neumann F-J, et al. N Engl J Med DOI: 10.1056/NEJMoa1701067. EINSTEIN-CHOICE The EINSTEIN-CHOICE trial compared two doses of rivaroxaban, 10 mg per day and rivaroxaban 20 mg per day, and aspirin 100 mg per day for the duration of 12 months in patients with a venous thromboembolic event (VTE; 50% isolated deep-vein thrombosis, 40% unprovoked) who had completed recommended 6 to 12 months of treatment and were in equipoise in regard to extended anticoagulation. The

to the aortic valve. One has to point out, though, that the average age in this trial was nearly 80 years and that the long-term use over decades in younger patients is not as defined. Also, the complication profile var- ies by type of valve and is to be outlined and considered by patients when deciding which type of procedure to undergo. Reference 1. Reardon MJ, Van Mieghem NM, Popma JJ, et al. N Engl J Med DOI:10.1056/NEJMoa1700456. COMPARE-ACUTE Some 3.5 years ago, the PRAMI trial re-rev- olutionized our views of non-culprit lesion intervention in the setting of a STEMI. 1 The mantra had been “culprit only,” but the PRAMI trial indicated a 75% reduction in major adverse cardiovascular events (MACE) with “preventive” stenting of any lesion greater than 50% in addition to the culprit lesion. Several other trials revis- ited this question, but here is another that stands out: the COMPARE-ACUTE trial. 2 Unique about the trial is that all patients underwent FFR of any lesion with at least a 50% diameter stenosis, and about half of these were significant in both groups; that is, those who would be allowed to have additional PCI based on the informa- tion provided and those who would have culprit-only intervention despite the infor- mation provided. Strikingly, even though no longer based on angiography findings alone, the MACE reduction with this strategy

VOL. 2 • NO. 1 • 2017