Rationale, Design and Baseline Characteristics of a Study to Evaluate Effects of Candesartan on Cardiovascular Events after Drug-eluting Stent Implantation in Patients with Ischemic Heart Disease

Abstract

Aim: Few multicenter studies have assessed the effects of angiotensin receptor blockers on cardiovascular events after drug-eluting stent implantation in patients with ischemic heart disease.Methods: An open-label multicenter randomized prospective study is in progress to evaluate the effects of candesartan on cardiovascular events in patients with ischemic heart disease after implantation of sirolimus-and/or paclitaxel-eluting stents. Results: A total of 1,145 patients were enrolled at 39 institutes in the Candesartan for prevention of Cardiovascular events after CYPHER or TAXUS Coronary stenting (4C trial). Patients were randomized into a group treated with candesartan (n=602) and a group treated with standard medical therapy without candesartan (n=543). The primary endpoint of the 4C trial is a composite of all-cause death, successful resuscitation after cardiopulmonary arrest and cardiovascular events including non-fatal myocardial infarction, unstable angina requiring emergent hospitalization, congestive heart failure requiring emergent hospitalization and cerebrovascular attacks. All patients will be followed-up for 36 months. Conclusions: The 4C trial will be the first multicenter study to elucidate the effects of candesartan after drug-eluting stent implantation and may provide new information to optimize medical therapy after percutaneous coronary interventions.

Impact of candesartan on cardiovascular events after drug-eluting stent implantation in patients with coronary artery disease: The 4C trial

“…Details have been outlined in the statistical analysis section of the rationale and design paper [12]. In brief, in our previous study, the cardiovascular event rate over 2 years was 14.7% (estimated 20% for 3 years) [13].…”

“…The methodology and protocol of the 4C trial have already been published [12] and registered (ClinicalTrials.gov NCT00139386). In summary, the trial was an open-label, multicenter, randomized, prospective study to evaluate the effects of candesartan on cardiovascular events in patients with ischemic heart disease after implantation of sirolimus-and/or paclitaxel-eluting stents (SESs and/or PESs).…”

“…Inclusion and exclusion criteria are listed elsewhere [12]. Basically, patients with acute or chronic myocardial ischemia who were treated with DES (SESs and/or PESs) and had hypertension or heart failure were eligible for participation.…”

“…Blood pressure of all the study patients was controlled in accordance with the guidelines of the Japanese Society of Hypertension (JSH) 2004 in the first half of the study period and JSH2009 in the latter half. Precise blood pressure control protocol in both groups is described elsewhere [12].…”

“…All endpoint events were judged by consensus of all members of the End-point Committee of the 4C study. Members of the committee are listed elsewhere [12].…”