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The Take Home: AHA
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The American Heart Association Scientific Sessions, held Nov. 11-15, 2017, in Anaheim, California, saw the presentation of much groundbreaking research across all subspecialties of cardiology. Cardiology Today’s Intervention covered the meeting live and caught up with experts to get their thoughts on some of the most relevant studies for interventionalists, including Kirk N. Garratt, MD, MSc, from Christiana Care Health System; C. Michael Valentine, MD, from Stroobants Cardiovascular Center, Centra Health; and B. Hadley Wilson, MD, from Sanger Heart & Vascular Institute, Carolinas HealthCare System and UNC School of Medicine.
STEMI ACCELERATOR-2
Garratt: This is a nice study that is an extension of work that was done earlier under the Mission: Lifeline initiative. The earlier work showed that improvements in processes of care around patients with STEMI could be made if a package of best-care plans were brought forward to individual hospitals and practitioners. However, the earlier work was not as successful as expected in terms of moving the needle on patient care.
As a result, the researchers and those behind that earlier initiative looked at the work that had been done, tried to identify where barriers existed to improvements and process, and then focused on overcoming those barriers. It appears that they focused on a couple of key barriers. One potentially very important area was the identification of a dedicated coordinator who would be assigned to a region and would then coordinate activities at the various participating hospitals. One question I have for the authors pertains to the specific work of the coordinator. The manuscript provides some information, but not much detail about how that person operated. Nevertheless, it does seem that the presence of that regional coordinator was a key difference between the earlier and later experiences for Mission: Lifeline.
In this newer study of 21,160 patients with STEMI presenting to 132 hospitals with 971 EMS agencies in 12 major U.S. metropolitan regions, significant improvements were made in process measures, including first-medical-contact-to-intervention time — the proportion of patients with a first-medical-contact-to-device time of 90 minutes or less improved from 67% to 74% (P < .002) — and dwell time in the ED — there was an increase in the proportion of patients with an ED dwell time of less than 20 minutes (33% to 43%; P < .0001) in the final quarter. Importantly, although it was not a primary objective of the study, there was improvement in in-hospital mortality (4.4% to 2.3%; P = .008), which was not observed in hospitals that did not participate in this second phase of the Accelerator program. This is good evidence showing that these process improvements impacted clinical outcomes.
The main takeaway point from this study is that systematic approaches to improving care processes work. Patients with STEMI are obviously a high-risk population for whom we know delays in treatment carry clinical consequences. Therefore, any standardized care plan that we can put in place that helps reduce variability in care and delays in care should provide clinical benefit. This is one more important study that aims us in that direction.
PRESERVE
Valentine: PRESERVE has great relevance to interventional cardiologists who have been searching for the holy grail of renal preservation in patients at high risk for angiography- and contrast-induced renal failure. For many years, we have tried sodium bicarbonate and acetylcysteine but did not know whether our results were effective and whether patients were benefiting. This study finally closes the door on that question of whether sodium bicarbonate or acetylcysteine will improve outcomes for our patients.
Among patients with chronic kidney disease undergoing angiography, a strategy of IV sodium bicarbonate or oral acetylcysteine yielded no additional benefit for the prevention of death, dialysis or persistent kidney impairment at 90 days. Using a 2-by-2 factorial design, patients with impaired kidney function undergoing coronary or noncoronary angiography were randomly assigned to receive IV 1.26% sodium bicarbonate (n = 2,511), IV 0.9% sodium chloride (n = 2,482), 5 days of oral acetylcysteine (n = 2,495) or placebo (n = 2,498). For the primary endpoint of death, the need for dialysis and a persistent increase in serum creatinine of at least 50% at 90 days, there were no significant differences between the sodium bicarbonate group compared with the sodium chloride group (4.4% vs. 4.7%; OR = 0.93; 95% CI, 0.72-1.22). Similar results were seen in comparison of the acetylcysteine group with the placebo group (4.6% vs. 4.5%; OR = 1.02; 95% CI, 0.78-1.33).
This is the definitive paper. It will change therapy and behavior immediately.
RE-DUAL PCI
Wilson: New data from the RE-DUAL PCI study of dual therapy with dabigatran (Pradaxa, Boehringer Ingelheim) plus a P2Y12 inhibitor vs. triple therapy with warfarin, a P2Y12 inhibitor and aspirin in 2,725 patients with atrial fibrillation who underwent PCI showed that the reduced risk for major and clinically relevant nonmajor bleeding conferred by dual therapy was consistent across various subgroups.
The conclusions were essentially the same, as the dual therapy and either dose of the dabigatran with the antiplatelet P2Y12 inhibitor — either clopidogrel or ticagrelor (Brilinta, AstraZeneca) — were better for both avoidance of thromboembolic events as well as bleeding events and stent thrombosis than the triple therapy.
Importantly, this was the case in people who had or did not have ACS, and in people who had DES or BMS. Those factors did not make a difference.
The choice of P2Y12 inhibitor, ticagrelor or clopidogrel, did not make a difference either, although some think one may cause more bleeding than another. Though the bleeding risk was lower for patients treated with clopidogrel vs. those with ticagrelor, there were no significant interactions by P2Y12 inhibitor choice. There was also no interaction by P2Y12 inhibitor choice for death or thromboembolic events.
These results look very strong. At least three major trials have now shown that dual therapy of an anticoagulant plus an antiplatelet agent without aspirin is superior to triple therapy. This analysis makes that conclusion even stronger, because it shows consistency across subgroups, more like the real-world experience.
This really solidifies that dual therapy is the way to go with patients with AF and PCI that require an anticoagulant, either warfarin or one of the novel oral anticoagulants. In this case, the novel oral anticoagulant was dabigatran. The results suggest that we should not be using triple therapy anymore for anybody, except in select cases.
PRAGUE-18
Valentine: In a follow-up study of the PRAGUE-18 trial, 1,230 patients who underwent PCI for STEMI had similar outcomes at 1 year regardless of assignment to prasugrel (Effient, Daiichi Sankyo/Eli Lilly) or ticagrelor (HR for CV death, MI or stroke = 1.167; 95% CI, 0.742-1.835).
Most interesting, however, was that between one-third and one-half of all patients changed to clopidogrel later in the course of their recovery from STEMI, purely because of cost, with no significant impact on their outcomes at 1 year. In fact, those who switched medications for economic reasons had lower risk for CV death, MI and stroke (HR = 0.433; 95% CI, 0.21–0.894) and bleeding (HR = 0.514; 95% CI, 0.35-0.7455) compared with those who did not switch. That makes this become much more of a real-world study, because so many of our patients end up changing drugs or becoming noncompliant because of cost issues. This suggests that after the acute phase of prasugrel or ticagrelor, changing to clopidogrel, a generic drug, later in the course does not significantly affect 1-year outcomes.
This could change clinical practice, and also may validate current clinical practice, in that many clinicians are forced to change drugs to maintain patient compliance, because our patients tell us that they can’t afford the brand-name medicines and want to stop them. This issue affects me every day, when my patients walk in and say they can’t afford their drug anymore, so I tell them I will change them to generic clopidogrel, but I have no idea if that is a good strategy. This gives me confidence that I may not be impacting long-term outcomes by changing to clopidogrel later in the course.
POISE-2 PCI SUBSTUDY
Wilson: The researchers evaluated whether there would be increased bleeding events in those taking aspirin or increased CV events in those assigned placebo among patients with prior PCI undergoing noncardiac surgery. In this cohort of 470 patients, a subgroup of the 10,010-person POISE-2 study, there was a slight increase in bleeding in the aspirin group, but the reduction in death and MI (HR = 0.5; 95% CI, 0.26-0.95) far outweighed the bleeding risk of initiating aspirin before noncardiac surgery or continuing patients on it. For every 1,000 patients, administering aspirin will prevent nearly 60 MIs, but cause eight major bleeds. Simple math tells us that overall, unless a patient has known high bleeding risk, patients fitting this profile will do better with aspirin. The risk is higher to stop aspirin than to continue it.
This may help change practice somewhat. Some doctors are very worried about bleeding and want to stop aspirin in this scenario. These findings give strong credence to the idea that stopping aspirin is harmful in this population. This solidifies the guidelines and gives doctors taking care of a patient with prior PCI the ammunition to tell the surgeon that if at all possible, aspirin should be continued.
Disclosures: Garratt, Valentine and Wilson report no relevant financial disclosures.