The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial.

Abstract

BACKGROUND:

Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients.

METHODS:

In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen.

DISCUSSION:

The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI.

TRIAL REGISTRATION:

ClincalTrials.gov number NCT01267734.

• Authors: Kyung Woo Park, Byoung-Eun Park, Si-Hyuck Kang, Jin-Joo Park, Seung-Pyo Lee, Kwang Soo Cha, Jay Young Rhew, Hui-Kyoung Jeon, Eun Seok Shin, Ju Hyeon Oh, Myung-Ho Jeong, Sanghyun Kim, Kyung-Kuk Hwang, Jung-Han Yoon, Sung Yun Lee, Tae-Ho Park, Keon Woong Moon, Hyuck-Moon Kwon, In-Ho Chae, Hyo-Soo Kim, HOST investigators
• Journal: Trials (Trials) Vol. 13 Pg. 29 (Mar 31 2012) ISSN: 1745-6215 [Electronic] England
• PMID: 22463698 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Chromium Alloys
• Platelet Aggregation Inhibitors
• Chromium
• Platinum
• Everolimus
• zotarolimus
• Sirolimus

Topics

• Angioplasty, Balloon, Coronary (adverse effects, instrumentation)
• Chromium
• Chromium Alloys
• Coronary Stenosis (drug therapy, therapy)
• Drug Therapy, Combination
• Drug-Eluting Stents
• Everolimus
• Humans
• Platelet Aggregation Inhibitors (adverse effects, therapeutic use)
• Platinum
• Prospective Studies
• Prosthesis Design
• Republic of Korea
• Research Design
• Single-Blind Method
• Sirolimus (administration & dosage, analogs & derivatives)
• Time Factors
• Treatment Outcome