Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

Conditions

Coronary Heart Disease

Brief summary

The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

Detailed description

This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.

J J Coughlan, Alp Aytekin, Erion Xhepa, Salvatore Cassese, Michael Joner et al. (16 authors)

Clinical Research in Cardiology2022-02-1117 citations

10.1007/s00392-022-01986-4

Ten-year clinical outcomes of polymer-free versus durable polymer new-generation drug-eluting stent in patients with coronary artery disease with and without diabetes mellitus : Results of the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents (ISAR-TEST 5) trial.

Koch T, Lenz T, Joner M, Xhepa E, Koppara T, Wiebe J, Coughlan JJ, Aytekin A, Ibrahim T, Kessler T, Cassese S, Laugwitz KL, Schunkert H, Kastrati A, Kufner S, Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators.

2021-06-2214 citations

10.1007/s00392-021-01854-7

10-Year Outcomes From a Randomized Trial of Polymer-Free Versus Durable Polymer Drug-Eluting Coronary Stents.

Kufner S, Ernst M, Cassese S, Joner M, Mayer K, Colleran R, Koppara T, Xhepa E, Koch T, Wiebe J, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Byrne RA, ISAR-TEST-5 Investigators.

2020-07-0181 citations

10.1016/j.jacc.2020.05.026

Five-year clinical outcomes in patients with diabetes mellitus treated with polymer-free sirolimus- and probucol-eluting stents versus second-generation zotarolimus-eluting stents: a subgroup analysis of a randomized controlled trial.

Harada Y, Colleran R, Kufner S, Giacoppo D, Rheude T, Michel J, Cassese S, Ibrahim T, Laugwitz KL, Kastrati A, Byrne RA, Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators.

2016-09-019 citations

10.1186/s12933-016-0429-y

Randomized Trial of Polymer-Free Sirolimus- and Probucol-Eluting Stents Versus Durable Polymer Zotarolimus-Eluting Stents: 5-Year Results of the ISAR-TEST-5 Trial.

Kufner S, Sorges J, Mehilli J, Cassese S, Repp J, Wiebe J, Lohaus R, Lahmann A, Rheude T, Ibrahim T, Massberg S, Laugwitz KL, Kastrati A, Byrne RA, ISAR-TEST-5 Investigators.

2016-03-2346 citations

10.1016/j.jcin.2016.01.009

Interventions

DEVICERapamycin + Probucol-eluting stent (ISAR stent)

due to randomization, Rapamycin- + Probucol-eluting stent will be implanted

DEVICEpolymer based Zotarolimus-eluting stent (Endeavor Resolute)

due to randomization, Zotarolimus-eluting stent with polymer will be implanted

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels * Written, informed consent by the patient or her/his legally-authorized representative for participation in the study * In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion criteria

* Target lesion located in the left main trunk. * Target lesion located in the bypass graft. * In-stent restenosis. * Cardiogenic shock. * Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. * Known allergy to the study medications: Clopidogrel, Rapamycin, Probucol, Zotarolimus, stainless steel or cobalt chrome. * Inability to take clopidogrel for at least 6 months. * Pregnancy (present, suspected or planned) or positive pregnancy test. * Previous enrollment in this trial. * Patient's inability to fully cooperate with the study protocol.

Design outcomes

Primary

Measure	Time frame
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation	at one year

Secondary

Measure	Time frame
Late luminal loss	at 6-8 months follow-up angiography
stent thrombosis	at one year

Countries

Germany

Outcome results

None listed