Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial.

Abstract

BACKGROUND:

Durable polymer coatings have been implicated in mid- and long-term adverse events after drug-eluting stent implantation. A polymer-free dual-drug sirolimus- and probucol-eluting stent and a new generation permanent polymer zotarolimus-eluting stent are recently developed technologies demonstrating encouraging results.

METHODS AND RESULTS:

In a clinical trial with minimal exclusion criteria, we randomly assigned 3002 patients to treatment with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The trial was designed to demonstrate noninferiority of the sirolimus- and probucol-eluting stents. The primary end point was the combined incidence of cardiac death, target-vessel-related myocardial infarction, or target-lesion revascularization at 1-year follow-up. Follow-up angiography was scheduled at 6 to 8 months. The sirolimus- and probucol-eluting stent was noninferior to the zotarolimus-eluting stent in terms of occurrence of the primary end point (13.1% versus 13.5%, respectively, P(noninferiority)=0.006; hazard ratio=0.97, 95% confidence interval, 0.78 to 1.19; P(superiority)=0.74). The incidence of definite/probable stent thrombosis was low in both groups (1.1% versus 1.2%, respectively; hazard ratio=0.91 [95% confidence interval, 0.45 to 1.84], P=0.80). With regard to angiographic efficacy, there were no differences between the sirolimus- and probucol-eluting stent and the zotarolimus-eluting stent in terms of either in-segment binary angiographic restenosis (13.3% versus 13.4% respectively; P=0.95) or in-stent late luminal loss (0.31±0.58 mm versus 0.29±0.56 mm, respectively; P=0.46).

CONCLUSION:

In this large-scale study powered for clinical end points, a polymer-free sirolimus- and probucol-eluting stent was noninferior to a new generation durable polymer-based zotarolimus-eluting stent out to 12 months.

CLINICAL TRIAL REGISTRATION:

http://www.clinicaltrials.gov. Unique identifier NCT 00598533.

• Authors: Steffen Massberg, Robert A Byrne, Adnan Kastrati, Stefanie Schulz, Jürgen Pache, Jörg Hausleiter, Tareq Ibrahim, Massimiliano Fusaro, Ilka Ott, Albert Schömig, Karl-Ludwig Laugwitz, Julinda Mehilli, Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators
• Journal: Circulation (Circulation) Vol. 124 Issue 5 Pg. 624-32 (Aug 02 2011) ISSN: 1524-4539 [Electronic] United States
• PMID: 21768546 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticholesteremic Agents
• Immunosuppressive Agents
• Polymers
• zotarolimus
• Probucol
• Sirolimus

Topics

• Aged
• Angioplasty, Balloon, Coronary (instrumentation, methods, statistics & numerical data)
• Anticholesteremic Agents (therapeutic use)
• Coronary Angiography
• Coronary Artery Disease (diagnostic imaging, mortality, therapy)
• Drug-Eluting Stents (adverse effects, statistics & numerical data)
• Female
• Follow-Up Studies
• Humans
• Immunosuppressive Agents (therapeutic use)
• Male
• Middle Aged
• Myocardial Infarction (mortality)
• Polymers (adverse effects, chemistry)
• Probucol (therapeutic use)
• Prosthesis Design
• Sirolimus (analogs & derivatives, therapeutic use)
• Treatment Outcome