ACC 2019 Day 3: SAFARI-STEMI, STOPDAPT-2, SMART-CHOICE and more
Reported from the ACC 2019 (ACC.19) Scientific Sessions in New Orleans
Mirvat Al Asnag reported live on major late-breaking trials presented at ACC 2019 in New Orleans: SAFARI-STEMI, STOPDAPT-2, SMART-CHOICE, TREAT and more
On the last day of ACC.19, the excitement continued. Much of the discussion revolved around the #SAFARI-STEMI trial. This was an investigator driven, multicenter prospective randomized open-label trial with blinded evaluation. All patients referred for primary PCI with symptoms of less than 12 hours were included. The main exclusion criteria were fibrinolytic therapy, oral anticoagulants, and prior CABG. Per design, patients were given aspirin 160mg and loaded with a P2Y12 in addition to unfractionated heparin 60 units/kg. Patients were then randomized to radial or femoral access.
The outcomes were as follows:
- Primary: All-cause mortality at 1 year
- Secondary: Stroke, reinfarction, stent thrombosis and bleeding (TIMI definition) at 30 days
A total of 2,292 patients were randomized (1,136 radial and 1,156 arm respectively). Bivalirudin use was 88.1% in the radial and 92.4% in the femoral arm. Ticagrelor use was 91.5% in both arms. The cardiac catheterization results were, for the most part, similar in both arms. However, the crossover rate was 8.1% in the radial and only 2.3% in the femoral arm. Use of an IABP was higher in the femoral arm (1.8 vs 2.5%). Closure devices were used in 5.5% of the radial and 68.2% of the femoral arm. Key time intervals revealed a statistically significant difference favouring femoral access (Arrival to Catheterization laboratory to first balloon inflation, Lidocaine to first balloon inflation, and Fluoroscopy time).
As a result of a continued lower than expected rate of the primary outcome, the DSMB requested a futility analysis. A futility index of 0.83 was calculated. The trial was terminated early after enrolling 2,292 patients with 99.6% having completed the 30-day follow-up. With regards to the primary outcome of mortality at 30 days, there was no difference. Similarly, the secondary outcomes of stroke, reinfarction and a composite of death, stroke, thrombosis and reinfarction, no difference was detected. No advantage to radial access was detected with regards to bleeding (using the TIMI and BARC) either.
After the MATRIX trial, the ESC guidelines recommended radial access for PCI in STEMIs. This trial presents unexpectedly different conclusions including equivalent bleeding rates. Reconciling the results of this trial with previously published data may be in part due to the lower use of GPIIbIIIa inhibitors and a safer and more refined femoral access technique. It remains unknown how many were performed with ultrasound guidance and a micropuncture kit. The use of bivalirudin and closure devices was notably high in this study and may contribute to the results. In addition, the studied population was of lower risk. The mean age was 61-62 years, BMI 28.2, male 78%, systolic BP 141 mmHg, previous MI in 10-11% and previous PCI in 9% (both arms).
The radial access advocates would argue that real-world practice may not mirror that of experienced operators in a controlled trial. The early termination of the trial does not appear to have impacted the results. However, the power of the study to report a mortality benefit is questioned particularly when considering the metanalysis published in 2016 (Ando G, Capodanno D. JACC Interv. 2016;9:660-70).
#ACC19@PCRonline#ACCIC#SAFARISTEMI#LBCT#RadialFirst has no advantage over TFA in STEMI pic.twitter.com/m4km2EDpmI
— mirvat (مرفت عبدالله الأصنج) (@mirvatalasnag) March 18, 2019
Two other trials presented today showed promise with regards to a short DAPT regimen.
- STOPDAPT-2: This is a randomized controlled trial to determine whether a short DAPT regimen (one month followed by clopidogrel monotherapy) was non-inferior to the standard 12-month DAPT regimen. 3,009 were participants and 3,287 non-participants. Cobalt Crommium-Everolimus Euting Stents were used. The primary endpoint was net benefit (cardiovascular death, stroke, MI, bleeding and stent thrombosis). The secondary endpoint was death, MI, stent thrombosis and stroke. Both primary and secondary endpoints ascertained that the abbreviated one-month regimen was non-inferior. The benefit was driven by a significant reduction in bleeding without an increase in ischemic events. It is noteworthy that intracoronary imaging was used in almost 100% of the patients for optimization. This may account for the lower stent thrombosis.
- SMART-CHOICE: This was another randomized trial examining an abbreviated DAPT regimen (3 months of DAPT followed by monotherapy) compared to a standard 12-month regimen of DAPT. The primary endpoint of MACCE demonstrated non-inferiority. BARC type 2-5 bleeding was higher in the extended regimen. Whether the newer P2Y12 inhibitors account for these results cannot be answered by this study.
Finally, the TREAT Trial was also presented today. This study concluded that in patients under the age of 75 years with a STEMI, administration of ticagrelor after fibrinolytic therapy did not increase the risk of major bleeding at 12 months when compared to clopidogrel. It suggests ticagrelor may not reduce MACE. However, a pooled analysis of Treat and PLATO Trials demonstrated a reduction in MACE.
Aside from late breaking trials, at the conclusion of ACC19 heated rapid fire debates were blazing in the breakout rooms up until the end of the day. These debates revisited ORBITA (PCI for stable angina), role of hemodynamic support in high risk PCI and shock, and indications for CTO PCI. The debates generated valuable discussion points about shared decision making, appropriateness criteria and the importance of randomized trials to guide the patient care.
Read more about Late Breaking Trials presented at the ACC.19
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