Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque

Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild. This study sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques. Three-ve...

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Veröffentlicht in:	Journal of the American College of Cardiology Jg. 76; H. 20; S. 2289
Hauptverfasser:	Stone, Gregg W, Maehara, Akiko, Ali, Ziad A, Held, Claes, Matsumura, Mitsuaki, Kjøller-Hansen, Lars, Bøtker, Hans Erik, Maeng, Michael, Engstrøm, Thomas, Wiseth, Rune, Persson, Jonas, Trovik, Thor, Jensen, Ulf, James, Stefan K, Mintz, Gary S, Dressler, Ovidiu, Crowley, Aaron, Ben-Yehuda, Ori, Erlinge, David
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 17.11.2020
Schlagworte:	Absorbable Implants Aged Blood Vessel Prosthesis Implantation Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - drug therapy Coronary Artery Disease - surgery Coronary Stenosis - drug therapy Coronary Stenosis - surgery Dual Anti-Platelet Therapy Female Humans Male Middle Aged Percutaneous Coronary Intervention - statistics & numerical data Pilot Projects Plaque, Atherosclerotic - diagnostic imaging Plaque, Atherosclerotic - drug therapy Plaque, Atherosclerotic - surgery Stents Ultrasonography, Interventional coronary artery disease stent bioresorbable scaffold vulnerable plaque prognosis
ISSN:	1558-3597, 1558-3597
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Abstract	Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild. This study sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques. Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically nonobstructive stenosis not intended for PCI but with IVUS plaque burden of ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) versus GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (nonpowered) safety endpoint was randomized target lesion failure (cardiac death, target vessel-related MI, or clinically driven target lesion revascularization) at 24 months. The secondary (nonpowered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (cardiac death, MI, unstable angina, or progressive angina) at latest follow-up. A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by near-infrared spectroscopy-IVUS, the median plaque burden was 73.7%, the median MLA was 2.9 mm , and the median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and the median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9 ± 2.6 mm compared with 3.0 ± 1.0 mm in GDMT alone-treated lesions (least square means difference: 3.9 mm ; 95% confidence interval: 3.3 to 4.5; p < 0.0001). Target lesion failure at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; p = 0.96). Randomized lesion-related major adverse cardiac events occurred in 4.3% of BVS-treated patients versus 10.7% of GDMT alone-treated patients (odds ratio: 0.38; 95% confidence interval: 0.11 to 1.28; p = 0.12). PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA, and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial. (PROSPECT ABSORB [Providing Regional Observations to Study Predictors of Events in the Coronary Tree II Combined with a Randomized, Controlled, Intervention Trial]; NCT02171065).
AbstractList	Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild.BACKGROUNDAcute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild.This study sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques.OBJECTIVESThis study sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques.Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically nonobstructive stenosis not intended for PCI but with IVUS plaque burden of ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) versus GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (nonpowered) safety endpoint was randomized target lesion failure (cardiac death, target vessel-related MI, or clinically driven target lesion revascularization) at 24 months. The secondary (nonpowered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (cardiac death, MI, unstable angina, or progressive angina) at latest follow-up.METHODSThree-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically nonobstructive stenosis not intended for PCI but with IVUS plaque burden of ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) versus GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (nonpowered) safety endpoint was randomized target lesion failure (cardiac death, target vessel-related MI, or clinically driven target lesion revascularization) at 24 months. The secondary (nonpowered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (cardiac death, MI, unstable angina, or progressive angina) at latest follow-up.A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by near-infrared spectroscopy-IVUS, the median plaque burden was 73.7%, the median MLA was 2.9 mm2, and the median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and the median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9 ± 2.6 mm2 compared with 3.0 ± 1.0 mm2 in GDMT alone-treated lesions (least square means difference: 3.9 mm2; 95% confidence interval: 3.3 to 4.5; p < 0.0001). Target lesion failure at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; p = 0.96). Randomized lesion-related major adverse cardiac events occurred in 4.3% of BVS-treated patients versus 10.7% of GDMT alone-treated patients (odds ratio: 0.38; 95% confidence interval: 0.11 to 1.28; p = 0.12).RESULTSA total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by near-infrared spectroscopy-IVUS, the median plaque burden was 73.7%, the median MLA was 2.9 mm2, and the median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and the median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9 ± 2.6 mm2 compared with 3.0 ± 1.0 mm2 in GDMT alone-treated lesions (least square means difference: 3.9 mm2; 95% confidence interval: 3.3 to 4.5; p < 0.0001). Target lesion failure at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; p = 0.96). Randomized lesion-related major adverse cardiac events occurred in 4.3% of BVS-treated patients versus 10.7% of GDMT alone-treated patients (odds ratio: 0.38; 95% confidence interval: 0.11 to 1.28; p = 0.12).PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA, and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial. (PROSPECT ABSORB [Providing Regional Observations to Study Predictors of Events in the Coronary Tree II Combined with a Randomized, Controlled, Intervention Trial]; NCT02171065).CONCLUSIONSPCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA, and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial. (PROSPECT ABSORB [Providing Regional Observations to Study Predictors of Events in the Coronary Tree II Combined with a Randomized, Controlled, Intervention Trial]; NCT02171065). Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild. This study sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques. Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically nonobstructive stenosis not intended for PCI but with IVUS plaque burden of ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) versus GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (nonpowered) safety endpoint was randomized target lesion failure (cardiac death, target vessel-related MI, or clinically driven target lesion revascularization) at 24 months. The secondary (nonpowered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (cardiac death, MI, unstable angina, or progressive angina) at latest follow-up. A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by near-infrared spectroscopy-IVUS, the median plaque burden was 73.7%, the median MLA was 2.9 mm , and the median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and the median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9 ± 2.6 mm compared with 3.0 ± 1.0 mm in GDMT alone-treated lesions (least square means difference: 3.9 mm ; 95% confidence interval: 3.3 to 4.5; p < 0.0001). Target lesion failure at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; p = 0.96). Randomized lesion-related major adverse cardiac events occurred in 4.3% of BVS-treated patients versus 10.7% of GDMT alone-treated patients (odds ratio: 0.38; 95% confidence interval: 0.11 to 1.28; p = 0.12). PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA, and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial. (PROSPECT ABSORB [Providing Regional Observations to Study Predictors of Events in the Coronary Tree II Combined with a Randomized, Controlled, Intervention Trial]; NCT02171065).
Author	Bøtker, Hans Erik Dressler, Ovidiu Ali, Ziad A Matsumura, Mitsuaki Ben-Yehuda, Ori Crowley, Aaron Trovik, Thor James, Stefan K Held, Claes Stone, Gregg W Engstrøm, Thomas Maeng, Michael Jensen, Ulf Erlinge, David Maehara, Akiko Kjøller-Hansen, Lars Persson, Jonas Mintz, Gary S Wiseth, Rune
Author_xml	– sequence: 1 givenname: Gregg W surname: Stone fullname: Stone, Gregg W email: Gregg.Stone@mountsinai.org organization: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: Gregg.Stone@mountsinai.org – sequence: 2 givenname: Akiko surname: Maehara fullname: Maehara, Akiko organization: Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York – sequence: 3 givenname: Ziad A surname: Ali fullname: Ali, Ziad A organization: Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York – sequence: 4 givenname: Claes surname: Held fullname: Held, Claes organization: Uppsala University and Uppsala Clinical Research, Uppsala, Sweden – sequence: 5 givenname: Mitsuaki surname: Matsumura fullname: Matsumura, Mitsuaki organization: Cardiovascular Research Foundation, New York, New York – sequence: 6 givenname: Lars surname: Kjøller-Hansen fullname: Kjøller-Hansen, Lars organization: Zealand University Hospital, Roskilde, Denmark – sequence: 7 givenname: Hans Erik surname: Bøtker fullname: Bøtker, Hans Erik organization: Aarhus University Hospital, Aarhus, Denmark – sequence: 8 givenname: Michael surname: Maeng fullname: Maeng, Michael organization: Aarhus University Hospital, Aarhus, Denmark – sequence: 9 givenname: Thomas surname: Engstrøm fullname: Engstrøm, Thomas organization: University of Copenhagen, Copenhagen, Denmark – sequence: 10 givenname: Rune surname: Wiseth fullname: Wiseth, Rune organization: St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway – sequence: 11 givenname: Jonas surname: Persson fullname: Persson, Jonas organization: Danderyd Hospital, Karolinska Institute, Stockholm, Sweden – sequence: 12 givenname: Thor surname: Trovik fullname: Trovik, Thor organization: University Hospital of North Norway, Tromsö, Norway – sequence: 13 givenname: Ulf surname: Jensen fullname: Jensen, Ulf organization: Södersjukhuset AB, Stockholm, Sweden – sequence: 14 givenname: Stefan K surname: James fullname: James, Stefan K organization: Uppsala University and Uppsala Clinical Research, Uppsala, Sweden – sequence: 15 givenname: Gary S surname: Mintz fullname: Mintz, Gary S organization: Cardiovascular Research Foundation, New York, New York – sequence: 16 givenname: Ovidiu surname: Dressler fullname: Dressler, Ovidiu organization: Cardiovascular Research Foundation, New York, New York – sequence: 17 givenname: Aaron surname: Crowley fullname: Crowley, Aaron organization: Cardiovascular Research Foundation, New York, New York – sequence: 18 givenname: Ori surname: Ben-Yehuda fullname: Ben-Yehuda, Ori organization: Cardiovascular Research Foundation, New York, New York; University of California San Diego, San Diego, California – sequence: 19 givenname: David surname: Erlinge fullname: Erlinge, David organization: Clinical Sciences, Lund University, Lund, Sweden
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/33069847$$D View this record in MEDLINE/PubMed
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ContentType	Journal Article
Copyright	Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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Keywords	coronary artery disease stent bioresorbable scaffold vulnerable plaque prognosis
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PublicationTitle	Journal of the American College of Cardiology
PublicationTitleAlternate	J Am Coll Cardiol
PublicationYear	2020
References	33183503 - J Am Coll Cardiol. 2020 Nov 17;76(20):2302-2304
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Snippet	Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing...
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SubjectTerms	Absorbable Implants Aged Blood Vessel Prosthesis Implantation Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - drug therapy Coronary Artery Disease - surgery Coronary Stenosis - drug therapy Coronary Stenosis - surgery Dual Anti-Platelet Therapy Female Humans Male Middle Aged Percutaneous Coronary Intervention - statistics & numerical data Pilot Projects Plaque, Atherosclerotic - diagnostic imaging Plaque, Atherosclerotic - drug therapy Plaque, Atherosclerotic - surgery Stents Ultrasonography, Interventional
Title	Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque
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Volume	76
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