Results from the PRISON IV Trial Presented at TCT 2016 and Simultaneously Published in JACC: Cardiovascular Interventions

WASHINGTON – November 2, 2016 – Results from a randomized, multicenter trial failed to show non-inferiority of hybrid, ultra-thin strut sirolimus-eluting stents (Osiro SES) with a biodegradable polymer compared to thin-strut everolimus-eluting stents (Xience EES) with a durable polymer in terms of in-segment late lumen loss in successfully treated chronic total occlusions. In addition, although the rate of binary restenosis was low overall in this complex lesion subset, it was higher with the Osirio SES compared with the Xience EES.

Findings from the PRISON IV trial were reported today at the 28th 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 in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

“Treating chronic total occlusions can be challenging due to their long lengths and the presence of greater degrees of calcium. They often require long stents with high radial strength to maintain acute gain and to minimize late vessel recoil after percutaneous coronary intervention,” said lead investigator, Koen Teeuwen, MD from St. Antonius Hospital in Nieuwegein, The Netherlands.  

Between February 2012 and June 2015, a total of 330 consecutive patients with successfully recanalized native total or chronic total coronary occlusions were randomized to the hybrid sirolimus-eluting stent or the everolimus-eluting stent in two Belgian and six Dutch high-volume PCI centers.

Follow-up angiography was performed at nine months after the procedure. In addition, clinical follow-up was obtained during the hospital stay and at one, six, nine and 12 months.

The primary non-inferiority end point was in-segment late lumen loss assessed at nine months by angiography. Secondary angiographic end points included: in-stent late lumen loss, minimal lumen diameter, in-stent and in-segment percentage of diameter stenosis, binary restenosis and reocclusions at nine months. Secondary individual and composite clinical end points were clinically indicated target lesion revascularization/target vessel revascularization, myocardial infarction, death (cardiac and non-cardiac), stent thrombosis, target vessel failure, and major adverse cardiac events. 

At nine months, angiography was available in 281 of 330 (85%) patients. The primary non-inferiority end point of in-segment late lumen loss was not met for SES compared with EES (0.13±0.63 mm vs. 0.02±0.47 mm; P=0.08, 2-sided; difference=0.11 mm; 95% confidence interval, -0.01 to 0.25; Pnon-inferiority=0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12±0.59 versus 0.07±0.46 mm; P=0.52). The incidence of in-stent/in-segment binary restenosis was higher with SES compared to EES (8.0% vs. 2.1%; P=0.028) with comparable rates of reocclusions (2.2% vs. 1.4%; P=0.68). Clinically indicated target lesion and vessel revascularization (9.2% vs. 4.0%; P=0.08 and 9.2% vs. 6.0%; P=0.33), target vessel failure (9.9% vs. 6.6%; P=0.35) and definite or probable stent thrombosis (0.7% vs. 0.7%; P=1.0) were comparable in the SES and EES group.

Clinical follow-up at 12 months was available in 99% of all subjects. Clinically indicated target lesion and vessel revascularization, target vessel failure and MACE were comparable between both groups. Two subjects in the SES group received non-clinical TLR with balloon angioplasty after observing severe stent strut malapposition with optical coherence tomography at nine months. There was only one probable or definite stent thrombosis in each stent group (0.7% vs. 0.7%; P=1.0). 

“The findings of the study show that the non-inferiority of in-segment late lumen loss was not met for SES against EES in successfully recanalized chronic total occlussions,” said Dr. Teeuwen. “In addition, the rate of binary restenosis was significantly higher with SES. Future developments in stent technology should focus on the challenging characteristics of CTOs to improve device efficacy and clinical outcomes.”

The PRISON IV trial was funded by unrestricted research grants from Biotronik and Abbott Vascular. Dr. Teeuwen reported no relevant disclosures.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. 

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit www.crf.org and www.tctconference.com.

Results from the AMULET OBSERVATIONAL STUDY Reported at TCT 2016

WASHINGTON – November 2, 2016 – Initial results from the largest, prospective evaluation of a percutaneous transcatheter left atrial appendage (LAA) closure device (Amplatzer Amulet) for stroke prevention in patients with non-valvular atrial fibrillation show that the device has a high implant success rate and low major adverse events.

Findings from the AMULET OBSERVATIONAL STUDY were reported today at the 28th 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 enrolled 1,073 patients between June 2015 and September 2016 at 64 clinical sites in Europe, the Middle East, Asia, Australia and South America. 1,060 patients had device implantation, giving a technical success rate of 98.8%. Major adverse events (MAEs) within 7 days of implant included ischemic stroke (0.3%, n=3), pericardial effusion requiring intervention (0.5%, n=5), embolization (0.1%, n=1), and bleeding (0.9%, n=10). There were three deaths (0.2%) that occurred within seven days of attempted implant, two of which were adjudicated as procedure or device related, and one as unrelated to the device. At 1-3 month follow-up, the majority of patients were on antiplatelet therapy only and the CoreLab analyzed results of transesophageal echocardiography (TEE) showed a closure rate of 99%.

“These results indicate that the Amplatzer Amulet is safe and associated with low rates of peri-procedural and early adverse events, as well as demonstrating high closure rates,” said David Hildick-Smith, MD, from the Sussex Cardiac Centre, Brighton and Sussex University Hospitals in Brighton, United Kingdom. “In addition, antiplatelet therapy appears to be an effective treatment strategy post-implantation in the short-term. Additional long-term data is necessary to confirm these promising early findings.”

The AMULET trial was funded by St. Jude Medical. Dr. Hildick-Smith reported grant/research support and consulting fees/honoraria from St Jude Medical, Boston Scientific, Medtronic, Gore, Abbott, Occlutech and Edwards.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit www.crf.org and www.tctconference.com.

Results from the TRANFORM-OCT Study Reported at TCT 2016 

WASHINGTON – November 2, 2016 – Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OCT) to evaluate strut coverage and neoatherosclerosis (NA) found that bioresorbable polymer-based drug-eluting stents (BP-EES) are comparable to durable polymer-based drug-eluting stents (DP-ZES).

Findings were reported today at the 28th 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. 

To mitigate the risk related to durable polymer (DP), bioabsorbable polymers (BP) that coat only the abluminal side of the stent, avoiding contact with circulating blood, and render stent surface similar to those of BMS after complete absorption, have been developed. Whether BP abluminal coating may counteract in-vivo delayed healing and NA development in current thin-strut DES is unknown. TRANSFORM-OCT randomized 90 patients with multivessel disease (1:1) to a BP everolimus-eluting stent (BP-EES, Synergy) or a DP zotarolimus-eluting stent (DP-ZES, Resolute Integrity). The primary endpoints were maximum length of consecutive frames with uncovered struts at three months (powered for non-inferiority of BP-EES) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority of BP-EES) as measured by OCT. The three-month median percentage of covered struts was 79.1 (IQR 60.4, 89.8) for BP-EES and 78.4 (IQR 62.1, 87.8) for DP-ZES, P=0.93. The 18-month median percentage of covered struts was 99.4 (IQR 96.6-100) for BP-EES and 98.0 (IQR 94.4-99.8) for DP-ZES, P=0.14. The co-primary endpoint of in-stent NA at 18 months from 98.9% of all eligible patients was 11.6 % for BP-EES versus 15.9% in DP-ZES (P=0.59) with low percentage of frames with NA in both stent types (1.1 ± 3.1 for BP-EES versus 2.5 ± 9.1 for DP-ZES, P=0.33) 

“In this head-to-head in-vivo comparison of early and late healing response, the bioresorbable abluminal polymer Synergy everolimus-eluting stent was non-inferior at 3-month and similar at 18-month follow-up to the durable conformal polymer Resolute zotarolimus-eluting stent,” said Giulio Guagliumi, MD with Ospedale Giovanni XXIII in Bergamo, Italy. “TRANSFORM-OCT adds a novel mechanistic dimension to the assessment of new-generation drug-eluting stents, consolidating the understanding that well designed and biocompatible polymers, regardless of whether they are durable or biodegradable, may favorably impact the long-term vascular response of these stents.”

The TRANSFORM-OCT trial was designed, promoted and implemented by Ospedale Papa Giovanni XXIII, Bergamo (Italy) with unrestricted financial support provided by Boston Scientific International. The company was not involved with any of the study processes, including site selection, data collection, analysis, and drafting of the present abstract. Dr. Guagliumi reported consultant agreements with Boston Scientific and St. Jude Medical and receive research grants through the hospital by Abbott Vascular, St Jude Medical and Boston Scientific.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. 

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit www.crf.org and www.tctconference.com.

Results of the ReACT Trial Presented at TCT 2016 and Published Simultaneously in JACC: Cardiovascular Interventions

WASHINGTON – November 1, 2016 – A randomized evaluation of routine follow-up coronary angiography after percutaneous coronary intervention (PCI) found that there was no long-term clinical benefit compared to clinical follow-up alone among unselected patients following PCI.

Findings from the ReACT trial were reported today at the 28th 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 simultaneously published in JACC: Cardiovascular Interventions.

In this prospective, multicenter, open label, randomized study, patients who underwent successful PCI without planned staged PCI were randomly assigned to the routine angiographic follow-up (AF) group, in which they received coronary angiography at 8-12 months after PCI, or the clinical follow-up (CF) group. The primary endpoint was defined as a composite of death, myocardial infarction, stroke, emergency hospitalization for acute coronary syndrome, or hospitalization for congestive heart failure during a minimum of 1.5 years follow-up.

Between May 2010 and July 2014, a total of 700 patients were enrolled in the trial at 22 centers in Japan and were randomly assigned to the AF group (N=349) or the CF group (N=351). Although there was a greater incidence of repeat revascularization at one year among patients in the AF group, during the median 4.6 (inter-quartile range: 3.1-5.2) years follow-up, the cumulative 5-year incidence of the primary endpoint was no different between groups (22.4% in the AF group vs. 24.7% in the CF group; hazard ratio: 0.94, 95% confidence interval: 0.67-1.31, P=0.70). There were also no significant differences between the AF and CF groups in terms of any other clinical endpoints. Coronary revascularization within the first year was more frequently performed in the AF group than in CF group (12.8% vs. 3.8%, log-rank P<0.001), although the difference between the two groups attenuated over time with similar cumulative five-year incidence (19.6% vs. 18.1%, log-rank P=0.92).

“In this study, routine follow-up coronary angiography after PCI, as compared with clinical follow-up alone, did not bring any significant clinical benefit,” said lead investigator Hiroki Shiomi, MD from Kyoto University Hospital in Kyoto, Japan.

“Thus, routine follow-up coronary angiography after PCI cannot be recommended as a clinical strategy. However, the present study was underpowered to detect modest benefits or harm of routine FUCAG, and larger-scale trials, especially in high-risk patients, are warranted to definitively address this issue.”

The ReACT trial was funded by the Research Institute for Production Development. Dr. Shiomi reported grant/research support from The Research Institute for Production Development.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit www.crf.org and www.tctconference.com.