Impact of candesartan on cardiovascular events after drug-eluting stent implantation in patients with coronary artery disease: The 4C trial
Tomohiro Sakamoto, Hisao Ogawa, Koichi Nakao, Seiji Hokimoto, Kenichi Tsujita, Shunichi Koide, Nobuyasu Yamamoto, Hideki Shimomura, Toshiyuki Matsumura, Shuichi Oshima, Koichi Kikuta, Hideki Oka, Kazuo Kimura, Kunihiko Matsui, 4C (Candesartan for Prevention of Cardiovascular Events after CYPHER™ or TAXUS™ Coronary Stenting) study investigators, Koichi Nakao, Shunichi Koide, Nobuyasu Yamamoto, Hideki Shimomura, Toshiyuki Matsumura, Shuichi Oshima, Koichi Kikuta, Hisao Ogawa, Hideki Oka, Kazuo Kimura, Yasuhiro Morikami, Naritsugu Sakaino, Keigo Dote, Yuji Miyao, Yasuharu Nakama, Hiroshi Yamaguchi, Ichiro Kajiwara, Hitoshi Takano, Honin Kanaya, Shuzou Tanimoto, Koshi Matsuyama, Hideaki Yoshino, Akira Yamashina, Yasuhiro Ogata, Nobutaka Hirai, Junji Yajima, Sunao Nakamura, Shozo Sueda, Yoshisato Shibata, Masafumi Yano, Yoshihiko Seino, Takahiko Naruko, Tsuyoshi Enomoto, Atsuyuki Wada, Yoshihiko Saito, Yuji Mizuno, Nobuo Shiode, Ikuo Misumi, Hideki Maruyama, Tomohiro Sakamoto, Hisao Ogawa, Koichi Nakao, Seiji Hokimoto, Kenichi Tsujita, Shunichi Koide, Nobuyasu Yamamoto, Hideki Shimomura, Toshiyuki Matsumura, Shuichi Oshima, Koichi Kikuta, Hideki Oka, Kazuo Kimura, Kunihiko Matsui, 4C (Candesartan for Prevention of Cardiovascular Events after CYPHER™ or TAXUS™ Coronary Stenting) study investigators, Koichi Nakao, Shunichi Koide, Nobuyasu Yamamoto, Hideki Shimomura, Toshiyuki Matsumura, Shuichi Oshima, Koichi Kikuta, Hisao Ogawa, Hideki Oka, Kazuo Kimura, Yasuhiro Morikami, Naritsugu Sakaino, Keigo Dote, Yuji Miyao, Yasuharu Nakama, Hiroshi Yamaguchi, Ichiro Kajiwara, Hitoshi Takano, Honin Kanaya, Shuzou Tanimoto, Koshi Matsuyama, Hideaki Yoshino, Akira Yamashina, Yasuhiro Ogata, Nobutaka Hirai, Junji Yajima, Sunao Nakamura, Shozo Sueda, Yoshisato Shibata, Masafumi Yano, Yoshihiko Seino, Takahiko Naruko, Tsuyoshi Enomoto, Atsuyuki Wada, Yoshihiko Saito, Yuji Mizuno, Nobuo Shiode, Ikuo Misumi, Hideki Maruyama
Abstract
Objective: 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.
Keywords: Angiotensin II receptor blocker; Drug-eluting stent; Percutaneous coronary intervention; Randomized controlled trial.
Copyright © 2015. Published by Elsevier Ltd.
Source: PubMed