Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial
Abstract Background Even in the current drug-eluting stent era, revascularization for coronary stenosis with fractional flow reserve (FFR) between 0.75 and 0.80, the so-called “gray zone,” is a matter of debate. Previous studies have reported conflicting results regarding outcomes of revascularizati...
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doaj-afd9a8d5c174402286ff71e26d03a3f82020-11-25T02:55:59ZengBMCTrials1745-62152019-01-012011710.1186/s13063-019-3182-1Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trialHironori Kitabata0Takashi Kubo1Yasutsugu Shiono2Kunihiro Shimamura3Yasushi Ino4Takashi Tanimoto5Yasushi Hayashi6Kenichi Komukai7Hiromichi Sougawa8Keizo Kimura9Masahiro Gohda10Toshikazu Hashizume11Masahiro Obana12Kazuisa Maeda13Junichi Yamaguchi14Takashi Akasaka15Department of Cardiovascular Medicine, Wakayama Medical UniversityDepartment of Cardiovascular Medicine, Wakayama Medical UniversityDepartment of Cardiovascular Medicine, Wakayama Medical UniversityDepartment of Cardiovascular Medicine, Wakayama Medical UniversityDepartment of Cardiovascular Medicine, Wakayama Medical UniversityDepartment of Cardiovascular Medicine, Shingu Municipal Medical CenterDepartment of Cardiovascular Medicine, Wakayama Rosai HospitalDepartment of Cardiovascular Medicine, Hidaka General HospitalDepartment of Cardiovascular Medicine, Hashimoto Municipal HospitalDepartment of Cardiovascular Medicine, Kinan HospitalDepartment of Cardiovascular Medicine, Seiyu Memorial HospitalDepartment of Cardiovascular Medicine, Minami Wakayama Medical CenterDepartment of Cardiovascular Medicine, Saiseikai Wakayama HospitalDepartment of Cardiovascular Medicine, Naga Municipal HospitalDepartment of Cardiology, The Heart Institute of Japan, Tokyo Women’s Medical UniversityDepartment of Cardiovascular Medicine, Wakayama Medical UniversityAbstract Background Even in the current drug-eluting stent era, revascularization for coronary stenosis with fractional flow reserve (FFR) between 0.75 and 0.80, the so-called “gray zone,” is a matter of debate. Previous studies have reported conflicting results regarding outcomes of revascularization versus deferral for coronary stenosis when FFR values are in the gray zone, but these studies have had differing designs and populations. We therefore will investigate whether medical therapy plus percutaneous coronary intervention (PCI) is superior to medical therapy alone in reducing major cardiovascular events in patients presenting with coronary stenosis with gray zone FFR values. Methods/design This is a prospective, multicenter, open-label, parallel group, randomized, controlled, superiority study. A total of 410 eligible participants will be recruited and randomized to either the medical therapy plus PCI group or the medical therapy alone group. The primary endpoint is 1-year major adverse cardiac events (MACEs), defined as a combined endpoint of all-cause death, nonfatal myocardial infarction (MI), or unplanned target vessel revascularization (TVR). Secondary endpoints include MACE at 2 and 5 years. Moreover, each individual component of the primary endpoint, cardiovascular death, target vessel-related and non-target vessel-related MI, all MI, clinically driven TVR or non-TVR, all revascularization, stent thrombosis, and angina symptom status will be evaluated at 1, 2, and 5 years. Discussion This is the first prospective, multicenter, randomized, controlled study to investigate the superiority of medical therapy plus PCI over medical therapy by itself in reducing major cardiovascular events in patients presenting with coronary stenosis with “gray zone” FFR values. The results will help interventional cardiologists in making revascularization decisions regarding coronary stenosis with gray zone FFR values. Trial registration University Hospital Medical Information Network Clinical Trials Registry, UMIN000031526. Registered on 1 March 2018.http://link.springer.com/article/10.1186/s13063-019-3182-1Coronary physiologyFractional flow reserveMedical therapyPercutaneous coronary intervention |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Hironori Kitabata Takashi Kubo Yasutsugu Shiono Kunihiro Shimamura Yasushi Ino Takashi Tanimoto Yasushi Hayashi Kenichi Komukai Hiromichi Sougawa Keizo Kimura Masahiro Gohda Toshikazu Hashizume Masahiro Obana Kazuisa Maeda Junichi Yamaguchi Takashi Akasaka |
spellingShingle |
Hironori Kitabata Takashi Kubo Yasutsugu Shiono Kunihiro Shimamura Yasushi Ino Takashi Tanimoto Yasushi Hayashi Kenichi Komukai Hiromichi Sougawa Keizo Kimura Masahiro Gohda Toshikazu Hashizume Masahiro Obana Kazuisa Maeda Junichi Yamaguchi Takashi Akasaka Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial Trials Coronary physiology Fractional flow reserve Medical therapy Percutaneous coronary intervention |
author_facet |
Hironori Kitabata Takashi Kubo Yasutsugu Shiono Kunihiro Shimamura Yasushi Ino Takashi Tanimoto Yasushi Hayashi Kenichi Komukai Hiromichi Sougawa Keizo Kimura Masahiro Gohda Toshikazu Hashizume Masahiro Obana Kazuisa Maeda Junichi Yamaguchi Takashi Akasaka |
author_sort |
Hironori Kitabata |
title |
Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial |
title_short |
Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial |
title_full |
Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial |
title_fullStr |
Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial |
title_full_unstemmed |
Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial |
title_sort |
comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (comfortable prospective study): study protocol for a multicenter randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-01-01 |
description |
Abstract Background Even in the current drug-eluting stent era, revascularization for coronary stenosis with fractional flow reserve (FFR) between 0.75 and 0.80, the so-called “gray zone,” is a matter of debate. Previous studies have reported conflicting results regarding outcomes of revascularization versus deferral for coronary stenosis when FFR values are in the gray zone, but these studies have had differing designs and populations. We therefore will investigate whether medical therapy plus percutaneous coronary intervention (PCI) is superior to medical therapy alone in reducing major cardiovascular events in patients presenting with coronary stenosis with gray zone FFR values. Methods/design This is a prospective, multicenter, open-label, parallel group, randomized, controlled, superiority study. A total of 410 eligible participants will be recruited and randomized to either the medical therapy plus PCI group or the medical therapy alone group. The primary endpoint is 1-year major adverse cardiac events (MACEs), defined as a combined endpoint of all-cause death, nonfatal myocardial infarction (MI), or unplanned target vessel revascularization (TVR). Secondary endpoints include MACE at 2 and 5 years. Moreover, each individual component of the primary endpoint, cardiovascular death, target vessel-related and non-target vessel-related MI, all MI, clinically driven TVR or non-TVR, all revascularization, stent thrombosis, and angina symptom status will be evaluated at 1, 2, and 5 years. Discussion This is the first prospective, multicenter, randomized, controlled study to investigate the superiority of medical therapy plus PCI over medical therapy by itself in reducing major cardiovascular events in patients presenting with coronary stenosis with “gray zone” FFR values. The results will help interventional cardiologists in making revascularization decisions regarding coronary stenosis with gray zone FFR values. Trial registration University Hospital Medical Information Network Clinical Trials Registry, UMIN000031526. Registered on 1 March 2018. |
topic |
Coronary physiology Fractional flow reserve Medical therapy Percutaneous coronary intervention |
url |
http://link.springer.com/article/10.1186/s13063-019-3182-1 |
work_keys_str_mv |
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