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Below, Gregg W. Stone, MD, director of cardiovascular research and education and professor of medicine, division of cardiology with Columbia University Medical Center/New York-Presbyterian Hospital, New York, and Cardiology Today Intervention Editorial Board member, shared his thoughts about the clinical impact of some of the hottest trials in intervention and beyond presented at this year's European Society of Cardiology Congress in Paris.
 Image: Brian Ellis |
To start, PRODIGY was a very interesting and potentially important study. In PRODIGY, patients receiving a drug-eluting stent were randomly assigned to either 6 or 24 months of dual antiplatelet therapy. The results in terms of efficacy were very similar to a prior study that was published out of Korea, the REAL-LATE/ZEST-LATE study, which showed no benefit in the rate of adverse CV events with prolonged DAPT.
The PRODIGY study was unique, however, in that it included a detailed analysis of bleeding complications. A persistent and significant increase in hemorrhagic complications was noted in patients on prolonged dual antiplatelet therapy (DAPT). Not only did DAPT provide no additional benefit, but it was also harmful. Of course, there is also additional cost ascribed to daily DAPT beyond aspirin alone, although there was no formal cost analysis in this study.
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| Gregg W. Stone |
Many physicians use DAPT indefinitely based on the paucity of clinical trial data and the concerns of late stent thrombosis. Collectively, REAL-LATE/ZEST-LATE and PRODIGY bring into question the current recommendations for 1 year or longer use of DAPT for all patients after a drug-eluting stent (DES); the PRODIGY study in particular suggests that this practice may not only not be beneficial but may, in fact, be harmful.
EXAMINATION
EXAMINATION was a very interesting trial that examined outcomes with the fluoropolymer-coated everolimus-eluting stent (EES; XIENCE V, Abbott) vs. an otherwise identical bare metal stent (BMS; Multi-Link Vision, Abbott) in patients with STEMI as part of a primary angioplasty strategy. The study basically confirmed what other studies in DES in primary percutaneous coronary intervention have shown in that there were lower rates of target lesion and target vessel revascularization with the DES. However, where this study was unique is that it also showed statistically significant lower rates of stent thrombosis with the EES compared with the BMS. The fluoropolymer-coated EES is emerging as the next generation DES with the lowest rates of stent thrombosis, perhaps due to the polymer, which has shown very low rates of platelet and thrombus deposition in blood contact applications. Since patients with STEMI are at the highest risk for stent thrombosis, the results of EXAMINATION suggest that the EES may not only be as safe as the BMS but perhaps even safer.
Although EXAMINATION was a fairly large study, it still was not powered for a reduction in stent thrombosis, so it remains possible that this was a false-positive finding. A larger, adequately powered trial would be required to confirm this observation before we can be convinced that this DES is safer than a BMS. Nonetheless the outcomes are very intriguing and consistent with what has been seen in other clinical trials.
CRISP AMI
In CRISP AMI, researchers examined whether the use of intra-aortic balloon pump counterpulsation in patients with an acute MI involving the anterior wall, mostly due to proximal or mid-left anterior descending artery occlusion, but without cardiogenic shock, would show benefit in terms of infarct size reduction when placed before primary angioplasty. Only approximately 10 minutes was required to insert and activate the intra-aortic balloon pump before angioplasty was done, a very small amount of time. However, there was no benefit with the routine use of intra-aortic balloon pump, and, in fact, there was a fairly strong trend toward an increase in infarct size in the balloon pump arm. There were also non-significant trends present for increased vascular/bleeding complications and stroke, which has also been seen in other studies of balloon pump therapy.
As a result, CRISP AMI was a negative trial and suggests that in most patients with large anterior MI there is no role for routine intra-aortic balloon pump therapy prior to angioplasty (or afterwards, on the basis of earlier studies), unless cardiogenic shock develops.
ARISTOTLE
But the one study I thought was most impressive of all was ARISTOTLE, a very large, prospective, randomized trial of warfarin (Coumadin, Bristol-Myers Squibb) vs. apixaban (Eliquis, Bristol-Myers Squibb & Pfizer), a new factor Xa inhibitor in patients with nonvalvular atrial fibrillation. ARISTOTLE demonstrated that apixaban was actually safer and more effective than warfarin in reducing the risk of stroke and major hemorrhage. The main driver for this benefit was that apixaban reduced major hemorrhagic complications, including hemorrhagic stroke, with a non-significant trend toward reduction of non-hemorrhagic stroke. As a result, all-cause mortality was reduced with apixaban compared with warfarin.
Despite being taken twice daily, apixaban is substantially easier to take than warfarin: it doesn’t interfere with foods and most other medications; it doesn’t require monitoring; and the outcomes for patients, including survival, were significantly improved. So I expect this to have a major role to play in patients with nonvalvular AF.
Disclosure: Dr. Stone has consulted for Abbott Vascular, Boston Scientific, Medtronic, Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly-Daiichi Sankyo and AztraZeneca.