COMFORTABLE AMI: How and why this study may change my practice?
How and why this study may change my practice ? Ron Waksman, MD, FACC, FSCAI Professor of Medicine, Georgetown University, Director Cardiovascular Research Medstar Heart Institute Associate Director of Cardiology , Washington Hospital Center, Washington, DC COMFORTABLE AMI
Speaker’s name- Ron Waksman, MD x I have the following potential conflicts of interest to report- x Research contracts- Boston Scientific, Abbott Vascular, Medtronic, Biotronik x Consulting to Biotronik ? Employment in industry ? Stockholder of a healthcare company ? Owner of a healthcare company ? Other(s) ? I do not have any potential conflict of interest
Human pathologic analysis clearly indicate that healing is delayed by DES in the setting of plaque rupture vs. stable angina and that an increased risk of late thrombotic events should be expected in this setting. We believe there is a need for more rigorous larger randomized controlled trials before new technologies are used for unapproved indications such as AMI. Until these data become available, routine implantation of DES for AMI Cannot be recommended.
Testing new bioabsorbable polymer technology of DES for the STEMI indication Prospective, multinational multicenter, two arm, randomized 1-1. Strong study organization- monitoring, steering committee, DSMB, CEC, angio and IVUS/OCT core labs Enrollment completed in 2 years with > 97% available clinical follow-up at one year
Control was a BMS without a track record in clinical trials or in STEMI The study is underpowered to detect specific components of the primary endpoint which combined safety and efficacy endpoints The one year follow-up does not enable to examine the performance of the device after complete degradation (9 M) of the polymer Did not compared with second Gen DES
If you mainly BMS user you should switch to DES The Comfortable AMI is concordant with all the prior DES versus BMS studies for the use of DES for the AMI indication DES are superior to BMS for re intervention across all AMI trials, without safety issues Guidelines should reflect the data and changed
Kastrati et al Euro Heart Journal 2007 28- 2706
RE INTERVENTION STENT THROMBOSIS Kastrati et al Euro Heart Journal 2007 28- 2706
The Question is If you are mainly a DES user should you switch to the BES technology? Unfortunately The Comfortable AMI did not address this question Can we compare across trials? Probably not, but I could not resist!
* Statistically significant as compared to DES
Harmonizing Outcomes with Revascularization and Stents in AMI II Primary PCI with bivalirudin anticoagulation Aspirin Prasugrel (open-label) Follow-up at 30 days All pts- 30 d, 6 mo, 1 yr, 2 yr, 3 yr Pharmacology rand only- 15 mo Stent randomization eligible Pts without MACE or bleeding Double-blind Clinical FU-
Hypothesis 1- Polymer covered stent are less thrombogenic Hypothesis 2- Reducing restenosis is associated with the reduction of late stent thrombosis and re infarction Hypothesis 3- It is possible that high prasugrel use reduce the overall event rate in comfortable AMI Hypothesis 4- Will biodegradable polymer, when compared to durable, result with lower event rate after one year? In LEADERS it was shown only after 3 years
% Months 15.9% 6.8% ?9.1% 0 5 10 15 20 0 6 12 18 24 BES SES 36 30 10.0% 21.3% 3-year HR 0.43 [0.23 to 0.84] P = 0.01* 25 2-year HR 0.40 [0.20 to 0.80] P = 0.01* 1-year HR 0.40 [0.19 to 0.87] P = 0.02*
I am comfortable to switch from BMS to BES I am not comfortable to switch from DES to BES for all patients with AMI yet I am eager to see the results of the next study that will test biodegradable versus durable polymer DES for AMI patients (Leaders-like study). Thank you for the opportunity to comment on this trial