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OCTOBER 29-NOVEMBER 2, 2017
COLORADO CONVENTION CENTER
DENVER, COLORADO

Results from the DAPT STEMI Trial Reported at TCT 2017

DENVER – November 1, 2017 – The first trial to evaluate the safety of dual antiplatelet therapy (DAPT) for less than 12 months in ST-elevation myocardial infarction (STEMI) found six months of DAPT was non-inferior to 12 months of DAPT among patients treated with second-generation drug-eluting stents (DES).

Findings were reported today at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

International guidelines recommend 12 months of DAPT for STEMI patients after primary PCI with DES due to ongoing atherothrombotic risk. While longer duration DAPT therapy reduces the risk of ischemic events, it is also associated with a higher risk of major bleeding which can sometimes be fatal. Second-generation DES have a lower stent thrombosis risk than their predecessors, questioning the need for an extended duration of DAPT.

DAPT STEMI was a prospective, randomized trial designed to evaluate whether six months of DAPT was non-inferior to 12 months of DAPT in event free patients at six-month follow-up after primary PCI. The study enrolled 1,100 STEMI patients who underwent primary PCI with a second generation zotarolimus-eluting stent. Those who were event free at six months and agreed to continue with the study (N=870) were randomized to single antiplatelet therapy (SAPT, N=433) or DAPT (N=437). Baseline and procedural characteristics were similar in both arms.

The study’s primary endpoint was a patient-oriented composite of all-cause mortality, any myocardial infarction, any revascularization, stroke, or thrombolysis in myocardial infarction (TIMI) major bleeding at 18-month follow-up after randomization (i.e. two years after primary PCI). The primary endpoint occurred in 4.8% of the SAPT group versus 6.6 % for the DAPT group {HR 0.73; 95% CI (0.41-1.27); P= 0.26; Pnon-inferiority=0.004}. The incidences of the individual components of the primary endpoint were as follows:

  • Mortality: 0.7% in SAPT vs. 1.4% in DAPT {HR 0.51; 95% CI (0.13-2.02); P=0.33}
  • Myocardial infarction: 1.8% vs. 1.8% {HR 1.02; 95% CI (0.38-2.71); P=0.97
  • Revascularization: 3.0% vs. 3.9% {HR 0.87; 95% CI (0.42-1.83); P=0.72
  • Stroke: 0.7% vs. 0.7% {HR 1.02; 95% CI (0.21-5.03); P=0.99
  • TIMI major bleeding: 0.2% vs. 0.5% {HR 0.51; 95% CI (0.05-5.57); P=0.58

“For the first time in the modern DES era, this trial indicates that STEMI patients, similar to stable angina patients, may not benefit from prolonged DAPT therapy beyond six months as currently recommended,” said Elvin Kedhi, MD, PhD, Head of the Interventional Cardiology and Clinical Research and Innovation at Isala Hartcentrum in Zwolle, The Netherlands. “This sets the stage for further dedicated research on this important topic.”

The DAPT STEMI trial was funded by Maasstad Cardiovascular Research. Dr. Kedhi reported receiving consulting fees/honoraria or institutional grants from Medtronic, Abbott, Meril and OrbusNeich.

 

Results from the ABSORB IV Trial Reported at TCT 2017

DENVER – October 31, 2017 – Thirty-day results from ABSORB IV, the largest randomized everolimus-eluting bioresorbable vascular scaffold (BVS) trial to date, found BVS to be noninferior to a cobalt-chromium everolimus-eluting stent (CoCr-EES) for target lesion failure (TLF).

Findings were reported today at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

First generation BVS have been associated with higher rates of TLF and device thrombosis than current metallic drug-eluting stents. It has been thought that this may be in part due to suboptimal implantation technique used in early studies. Therefore, the ABSORB IV trial mandated the avoidance of smaller vessels, and aggressive pre-dilatation and routine high-pressure post-dilatation were emphasized.

ABSORB IV also permitted the enrollment of more complex and higher-risk patients than ABSORB III, with inclusion of troponin-positive acute coronary syndrome (ACS) and up to three lesions in a maximum of two epicardial coronary arteries, including thrombus. Patients were randomized 1:1 to BVS or CoCr-EES after successful pre-dilatation with a 1:1 sized balloon.

Between August 15, 2014 and March 31, 2017, 2,604 patients at 140 sites in five countries were randomized to BVS (N=1,296) versus CoCr-EES (N=1,308). Median age was 63 years; 28.0% of patients were female and 31.7% had diabetes. Among patients receiving BVS, pre-dilatation was performed in 99.8% of lesions, and post-dilatation was performed in 82.6% of lesions. The acute device success (delivery and deployment of the study scaffold/stent with residual stenosis <30%) was 94.6% for BVS compared to 99.0% for CoCr-EES (P<0.0001).

The primary endpoint of 30-day target lesion failure (TLF) was 5.0% for BVS versus 3.7% for CoCr-EES, a difference of 1.29% (Pnoninferiority=0.02; Psuperiority =0.11). As treated 30-day TLF was 4.6% for BVS versus 3.7% for CoCr-EES, a difference of 0.83% (Pnoninferiority=0.006). Patient-oriented major adverse cardiac events (PoCE) were 5.2% for BVS compared to 4.1% for CoCr-EES (P=0.17). However, the rate of 30-day ischemia-driven target vessel revascularization (ID-TVR) was 1.2% versus 0.2% (P=0.003), and the rate of device thrombosis was 0.6% in the BVS group and 0.2% in the CoCr-EES group (P=0.06).

“At 30 days, BVS was non-inferior to CoCr-EES for target lesion failure,” said Gregg W. Stone, MD, Professor of Medicine at Columbia University Medical Center, and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital. “The rates of non-peri-procedural MI and ID-TLR at 30 days were greater with BVS than with CoCr-EES, and a trend toward greater stent thrombosis with BVS was present. Compared to ABSORB III, reducing the number of very small vessels treated in ABSORB IV substantially reduced the device thrombosis rate in both groups. These results are largely consistent with those from earlier ABSORB trials, and highlight the need for continued advancements in device technology and standardized technique to further improve the early safety profile of BVS.”

The ABSORB IV trial was funded by Abbott Vascular. Dr. Stone reported that he is Chairman of the ABSORB global clinical trial program (uncompensated) and a consultant to Reva, Inc.

Results from the SENIOR Trial Reported at TCT 2017 and Published Simultaneously in The Lancet

DENVER – November 1, 2017 – Elderly patients undergoing PCI often receive bare-metal stents (BMS) instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT) and reduce bleeding risk. However, results from the SENIOR trial found that compared with BMS, shorter DAPT combined with the Synergy bioabsorbable polymer DES leads to less adverse events without increasing bleeding risk.

Findings were reported today at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The study was also published simultaneously in The Lancet.

Prior to randomization, 1,200 patients aged 75 and older underwent pre-specification of a tailored DAPT strategy: one month for patients with stable angina or silent ischemia, and six months for patients with acute coronary syndrome (including myocardial infarction). Approximately half of patients were in each category based upon clinical presentation. After the intended duration of DAPT was recorded, 596 were assigned to DES and 604 were assigned to BMS. The stent procedure was successful in 98.1% and 97.6% (P=0.561) leading to a complete revascularization at baseline in 85.7% and 86.1% (P=0.860) of DES and BMS-treated patients, respectively. DAPT utilization was similar in both study arms, with approximately half of patients continuing DAPT beyond one month, and only 20% of patients (in both groups) continuing DAPT beyond six months.

The primary endpoint of all-cause mortality, myocardial infarction, stroke, or ischemia-driven target lesion revascularization occurred in 68 patients (11.6%) in the DES group (N=584) and in 98 patients (16.4%) in the BMS group (N=592) (RR 0.71; 95% CI, 0.52-0.94; P=0.0160). This was mainly driven by ischemia driven target-lesion revascularization which was reported in 10 patients (1.7%) in the DES group and in 35 patients (5.9%) in the BMS group (RR 0.29, 95% CI, 0.09-0.49; P=0.0002). Bleeding complications BARC 2-5 (4.5% vs. 5.0%; RR 0.90; 95% CI, 0.51-1.54; P=0.68) and stent thrombosis (0.5% vs. 1.4%, RR 0.38, 95% CI, 0.00-1.48; P=0.1315) rates were low in both groups.

“The elderly represents a fast-growing segment of the population undergoing PCI. They have been poorly represented in prior studies on DES and DAPT duration, so there is no clear recommended PCI strategy for this group,” said principal investigator Olivier Varenne, MD, PhD, with the Cardiology Department at Cochin Hospital in Paris, France. “The SENIOR trial shows that among elderly patients who undergo PCI, a DES and a short duration of DAPT is superior to BMS with respect to the occurrence of all-cause mortality, myocardial infarction, stroke, and ischemia-driven target lesion revascularization. Therefore, BMS should no longer be used as a strategy to reduce DAPT duration in these patients.”

The SENIOR trial was funded by an unrestricted grant from Boston Scientific. Dr. Varenne reported lecture fees from Boston Scientific, Abbott Vascular, AstraZeneca and Servier

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32713-7/fulltext?elsca1=tlxpr

 

Results from PARTNER 2A and SAPIEN 3 Cost-effectiveness Studies Reported at TCT 2017

DENVER – October 31, 2017 – Analysis of the PARTNER 2A trial and the SAPIEN-3 Intermediate Risk registry found transcatheter aortic valve replacement (TAVR) to be highly cost-effective compared with surgical aortic valve replacement (SAVR) in intermediate surgical risk patients with aortic stenosis.

Findings were reported today at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Researchers led by Dr. David J. Cohen (Saint Luke’s Mid America Heart Institute, Kansas City, MO) used data from the PARTNER 2A randomized trial and the SAPIEN-3 Intermediate Risk registry to perform a formal, patient-level economic analysis comparing TAVR using either the SAPIEN XT valve (XT-TAVR) or the SAPIEN-3 valve (S3-TAVR) with SAVR. The comparison between XT-TAVR and SAVR was based upon randomized assignment within PARTNER 2A; the comparison between S3-TAVR and SAVR was not randomized. Procedural costs were assessed based on measured resource utilization and all other costs were assessed by linking trial data with Medicare claims for the index hospitalization and follow-up period or by piecewise regression models for the remaining patients.

PARTNER 2A

In the trial, XT-TAVR led to significant reductions in procedure duration compared with SAVR (102±46 vs. 236±83, P<0.001) and hospital length of stay (6.4±5.5 vs. 10.9±7.6, P<0.001). Although procedural costs were $22,083 higher with XT-TAVR than SAVR (reflecting the higher cost of the transcatheter valve), most of this higher cost was offset by reduced costs related to length of stay and in-hospital complications such that total costs for the index hospitalization were only ~$2,900 higher with TAVR ($61,433 vs. $58,545; P=0.014). Over the following 24 months, follow-up costs were substantially lower with XT-TAVR (by $9,303 per patient) such that total medical care costs were lower with TAVR than SAVR two-year follow-up ($107,716 vs. $114,132, P=0.014). When the trial results were projected over a lifetime horizon, XT-TAVR was projected to result in both cost savings of $7,949 and greater quality adjusted life expectancy (by 0.15 years).

SAPIEN 3

When performance of S3-TAVR in the S3i registry was compared with SAVR within PARTNER 2A, the reductions in procedure duration (84±38 vs. 236±83, P<0.001) and length of stay (4.6±5.7 vs. 10.9±7.6, P<0.001) were even greater than in the randomized trial. As a result, despite the higher cost of the transcatheter valve, total costs for the index hospitalization were lower with S3-TAVR than SAVR ($54,256 vs. $58,410, P=0.014). Over the first year of follow-up, S3-TAVR resulted in additional cost savings of nearly $11,000/patient.  When these in-trial results (including improved survival at two years) were projected over a lifetime horizon, S3 TAVR was projected to yield lifetime cost savings of $9,692 per patient and a significant gain in quality adjusted life-years (0.27 years)—an economically dominant strategy.

“For patients with severe aortic stenosis and intermediate surgical risk similar to those enrolled in the PARTNER 2 trial, these results demonstrating substantial cost savings and improved quality-adjusted life expectancy, indicate that transcatheter aortic valve replacement should be considered the preferred strategy based on both clinical and economic considerations,” said David J. Cohen, MD, MSc, Director of Cardiovascular Research at Saint Luke's Mid America Heart Institute in Kansas City, MO.

The PARTNER 2A and SAPIEN 3 Cost-effectiveness Trial was funded by Edwards Lifesciences. Dr. Cohen reported receiving research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular as well as consulting income from Edwards Lifesciences and Medtronic.