In the Journals

BIO-RESORT: Three DES equal in TVF, stent thrombosis at 3 years

Adnan Kastrati

In the overall cohort of a randomized trial, three drug-eluting stents were associated with similar rates of target vessel failure and stent thrombosis at 3 years.

The researchers of the BIO-RESORT (TWENTE III) trial assigned 3,514 all-comers (mean age, 64 years; 73% men) requiring PCI at four centers to an ultrathin-strut biodegradable polymer sirolimus-eluting stent (Orsiro, Biotronik), a thin-strut durable polymer zotarolimus-eluting stent (Resolute Integrity, Medtronic) or a very thin-strut biodegradable polymer everolimus-eluting stent (Synergy, Boston Scientific).

Outcomes of interest included TVF — a composite of cardiac death, target vessel MI and target vessel revascularization — and stent thrombosis. Three-year data were available in 3,393 patients.

Rosaly A. Buiten, MD, from the department of cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands, and colleagues wrote that the 3-year rate of TVF was 8.5% in the SES group, 10% in the ZES group and 8.8% in the EES group (log-rank P for SES vs. ZES = .22; log-rank P for EES vs. ZES = .32).

There were no differences between the groups in cardiac death, target vessel MI or target lesion revascularization, nor any between-stent differences in repeat revascularization between 1 and 3 years.

Stent thrombosis at 3 years occurred in 1.1% of the SES group, 0.9% of the ZES group and 1.1% of the EES group (log-rank P for SES vs. ZES = .67; log-rank P for EES vs. ZES = .67), according to the researchers.

“The present 3-year results are of interest because it is the first year during which the Orsiro SES is entirely free from its biodegradable polymer coating,” Buiten and colleagues wrote. “During this third year of follow-up, the potential advantage of the two biodegradable polymer-coated DES of leaving only a bare-metal stent behind did not translate into a lower incidence of ischemic cardiac events as compared to the durable polymer-coated reference DES. Nevertheless, further follow-up is required to definitely answer the question whether contemporary very thin or ultrathin-strut biodegradable polymer DES might improve clinical outcome at an even later stage.”

In a related editorial, Adnan Kastrati, MD, and Sebastian Kufner, MD, professors of cardiology at Deutsches Herzzentrum München, Technische Universität München, Germany, wrote: “Whereas improved control of cardiovascular risk factors is able to reduce the risk of atherosclerosis progression, it is less likely to impact on restenosis. Thus, more effective and durable prevention of restenosis will remain a target of locally applied treatments even in the years to come. This will still require further improvement in drug-eluting device technologies including adequately tailored drug release kinetics, development of new antiproliferative drugs and metal or bioresorbable stent/scaffold backbones.” – by Erik Swain

Disclosures: The study was funded by Biotronik, Boston Scientific and Medtronic. One author reports he received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific and Medtronic. The other authors, Kastrati and Kufner report no relevant financial disclosures.

 

Adnan Kastrati

In the overall cohort of a randomized trial, three drug-eluting stents were associated with similar rates of target vessel failure and stent thrombosis at 3 years.

The researchers of the BIO-RESORT (TWENTE III) trial assigned 3,514 all-comers (mean age, 64 years; 73% men) requiring PCI at four centers to an ultrathin-strut biodegradable polymer sirolimus-eluting stent (Orsiro, Biotronik), a thin-strut durable polymer zotarolimus-eluting stent (Resolute Integrity, Medtronic) or a very thin-strut biodegradable polymer everolimus-eluting stent (Synergy, Boston Scientific).

Outcomes of interest included TVF — a composite of cardiac death, target vessel MI and target vessel revascularization — and stent thrombosis. Three-year data were available in 3,393 patients.

Rosaly A. Buiten, MD, from the department of cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands, and colleagues wrote that the 3-year rate of TVF was 8.5% in the SES group, 10% in the ZES group and 8.8% in the EES group (log-rank P for SES vs. ZES = .22; log-rank P for EES vs. ZES = .32).

There were no differences between the groups in cardiac death, target vessel MI or target lesion revascularization, nor any between-stent differences in repeat revascularization between 1 and 3 years.

Stent thrombosis at 3 years occurred in 1.1% of the SES group, 0.9% of the ZES group and 1.1% of the EES group (log-rank P for SES vs. ZES = .67; log-rank P for EES vs. ZES = .67), according to the researchers.

“The present 3-year results are of interest because it is the first year during which the Orsiro SES is entirely free from its biodegradable polymer coating,” Buiten and colleagues wrote. “During this third year of follow-up, the potential advantage of the two biodegradable polymer-coated DES of leaving only a bare-metal stent behind did not translate into a lower incidence of ischemic cardiac events as compared to the durable polymer-coated reference DES. Nevertheless, further follow-up is required to definitely answer the question whether contemporary very thin or ultrathin-strut biodegradable polymer DES might improve clinical outcome at an even later stage.”

In a related editorial, Adnan Kastrati, MD, and Sebastian Kufner, MD, professors of cardiology at Deutsches Herzzentrum München, Technische Universität München, Germany, wrote: “Whereas improved control of cardiovascular risk factors is able to reduce the risk of atherosclerosis progression, it is less likely to impact on restenosis. Thus, more effective and durable prevention of restenosis will remain a target of locally applied treatments even in the years to come. This will still require further improvement in drug-eluting device technologies including adequately tailored drug release kinetics, development of new antiproliferative drugs and metal or bioresorbable stent/scaffold backbones.” – by Erik Swain

Disclosures: The study was funded by Biotronik, Boston Scientific and Medtronic. One author reports he received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific and Medtronic. The other authors, Kastrati and Kufner report no relevant financial disclosures.