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

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• 作者：Tomohiro Sakamoto ; MD ; PhD ; FJCC^a ; ^{tom@kumamoto-u.ac.jp" class="auth_mail" title="E-mail the corresponding author} ; Hisao Ogawa ; MD ; PhD ; FJCC^b ; Koichi Nakao ; MD ; PhD ; FJCC^a ; Seiji Hokimoto ; MD ; PhD ; FJCC^b ; Kenichi Tsujita ; MD^b ; Shunichi Koide ; MD ; PhD^c ; Nobuyasu Yamamoto ; MD ; PhD^d ; Hideki Shimomura ; MD ; PhD^e ; Toshiyuki Matsumura ; MD ; PhD^f ; Shuichi Oshima ; MD ; PhD^g ; Koichi Kikuta ; MD ; PhD ; FJCC^h ; Hideki Oka ; MD ; PhDⁱ ; Kazuo Kimura ; MD ; PhD ; FJCC^j ; Kunihiko Matsui ; MD ; PhD^k ; for the 4C (Candesartan for Prevention of Cardiovascular Events after CYPHER&trade ; or TAXUS&trade ; Coronary Stenting) study investigators¹
• 关键词：Percutaneous coronary intervention ; Drug-eluting stent ; Angiotensin II receptor blocker ; Randomized controlled trial
• 刊名：Journal of Cardiology
• 出版年：2016
• 出版时间：April 2016
• 年：2016
• 卷：67
• 期：4
• 页码：371-377
• 全文大小：873 K

文摘

The purpose of this study was to examine the cardiovascular protective effects of candesartan in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs).

Background

Candesartan has been reported to reduce cardiovascular events when therapy was started 6 months after PCI with bare-metal stents in patients who survived restenosis. Candesartan started immediately after PCI with DESs was also effective in preventing cardiovascular events.

Methods

The 4C trial was a multicenter, prospective, randomized, open-label study. A total of 1145 patients at 39 centers in Japan were randomly assigned to receive candesartan plus standard medical treatment or standard medical treatment alone. The primary endpoints were all-cause death, and a composite of non-fatal myocardial infarction (MI), unstable angina pectoris (uAP), congestive heart failure (CHF), and non-fatal cerebrovascular events. The follow-up period was up to 3 years after the index PCI (ClinicalTrials.gov NCT00139386).

Results

The incidence of total death, one of the primary endpoints, was comparable between the two treatment groups (3.8% each, p = 0.9702). Another primary endpoint, non-fatal major cardiovascular events, tended to occur more often in the control group than in the candesartan group (9.2% vs. 12.5%, p = 0.0985). In contrast, candesartan significantly reduced one of the pre-specified secondary endpoints: cardiovascular events that included non-fatal MI, uAP, and CHF (4.4% vs. 6.7%, p = 0.0136). Furthermore, candesartan significantly reduced another secondary endpoint that included cardiovascular events and cardiovascular death (5.0% vs. 7.7%, p = 0.0493).

Conclusions

The 4C trial showed that candesartan administered immediately after PCI with DESs did not improve the prognosis after the index procedure, but did reduce some cardiac-related events for 3 years.