Author + information
- Received August 17, 2020
- Revision received September 14, 2020
- Accepted September 14, 2020
- Published online October 14, 2020.
- Gregg W. Stone, MD1,2,∗∗ (, )@GreggWStone@DavidErlinge,
- Akiko Maehara, MD2,3,
- Ziad A. Ali, MD, DPhil2,3,
- Claes Held, MD, PhD4,
- Mitsuaki Matsumura, BS2,
- Lars Kjøller-Hansen, MD, DMSc5,
- Hans Erik Bøtker, MD, PhD, DMSc6,
- Michael Maeng, MD, PhD6,
- Thomas Engstrøm, MD, PhD7,
- Rune Wiseth, MD, PhD8,
- Jonas Persson, MD, PhD9,
- Thor Trovik, MD, PhD10,
- Ulf Jensen, MD, PhD11,
- Stefan K. James, MD, PhD4,
- Gary S. Mintz, MD2,
- Ovidiu Dressler, MD2,
- Aaron Crowley, MA2,
- Ori Ben-Yehuda, MD2,12,
- David Erlinge, MD, PhD13,
- for the PROSPECT ABSORB Investigators∗
- 1The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
- 2The Cardiovascular Research Foundation, New York, NY, USA
- 3New York-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA
- 4Uppsala University and Uppsala Clinical Research, Uppsala, Sweden
- 5Zealand University Hospital, Roskilde, Denmark
- 6Aarhus University Hospital, Aarhus, Denmark
- 7University of Copenhagen, Copenhagen, Denmark
- 8St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
- 9Danderyd Hospital, Karolinska Institute, Stockholm, Sweden
- 10University Hospital of North Norway, Tromsö, Norway
- 11Södersjukhuset AB, Stockholm, Sweden
- 12University of California San Diego, San Diego, CA, USA
- 13Clinical Sciences, Lund University, Lund, Sweden
- ↵∗∗Address for correspondence: Gregg W. Stone MD, Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, 1 Gustave L. Levy Place, New York, NY 10029, Tel/fax: 646-434-4134
Background Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild.
Objectives We sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques.
Methods 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 non-obstructive stenosis not intended for PCI but with IVUS plaque burden ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) vs. GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (non-powered) safety endpoint was randomized target lesion failure (TLF; cardiac death, target vessel-related MI or clinically-driven target lesion revascularization) at 24 months. The secondary (non-powered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (MACE; cardiac death, MI, unstable angina, or progressive angina) at latest follow-up.
Results 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 NIRS-IVUS median plaque burden was 73.7%, median MLA was 2.9 mm2, and median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and 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% CI 3.3-4.5, P<0.0001). TLF 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 MACE occurred in 4.3% BVS-treated patients vs. 10.7% GDMT alone-treated patients (OR 0.38, 95% CI 0.11-1.28, P=0.12).
Conclusions 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.
↵∗ The investigators, institutions and research organizations participating in the Providing Regional Observations to Study Predictors of Events in the Coronary Tree II study combined with a randomized, controlled, intervention trial (PROSPECT ABSORB) are listed in the Supplementary Appendix.
Disclosures: Gregg W. Stone: Grants to the Cardiovascular Research Foundation from Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden for core laboratory and data center analyses; speaker honorarium – Terumo, Cook; consultant – TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Matrizyme, Miracor, Neovasc, V-wave, Abiomed, Shockwave, MAIA Pharmaceuticals, Vectorious, Spectrawave, Valfix, Ancora, Cardiomech; equity/options – Applied Therapeutics, Biostar family of funds, MedFocus family of funds, Aria, Cardiac Success, Cagent, SpectraWave, Valfix, Ancora, Orchestra Biomed, Qool Therapeutics; honoraria – Orchestra Biomed, Qool Therapeutics. Akiko Maehara: Institutional research grant and consultant – Boston Scientific, Abbott Vascular. Ziad A. Ali: Speakers bureau – AstraZeneca; institutional grant – Abbott, Cardiovascular Systems Inc; lecture fees – Amgen; scientific advisory/educational lectures – Boston Scientific; equity – Shockwave Medical. Claes Held: Grants from Uppsala Clinical Research Center for clinical endpoint adjudication committee. Mitsuaki Matsumura: Consultant – Terumo. Lars Kjøller-Hansen: None. Hans Erik Bøtker: None. Michael Maeng: Personal fees – AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Boston Scientific, Novo Nordisk. Thomas Engstrøm: Speakers fee/advisory board – Novo Nordisk, Bayer, Abbott. Rune Wiseth: None. Jonas Persson: Unrestricted research grant and personal fee for lecturing – Abbott Vascular. Thor Trovik: Proctor on CTO procedures – Boston Scientific. Ulf Jensen: None. Stefan K. James: None. Gary S. Mintz: Honoraria – Boston Scientific, Medtronic, Philips/Volcano, Terumo. Ovidiu Dressler: None. Aaron Crowley: None. Ori Ben-Yehuda: Grants to the Cardiovascular Research Foundation from Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden for core laboratory and data center analyses. David Erlinge: Speakers fees – Amgen, AstraZeneca, Bayer, Chiesi; advisory board – Bayer, Boehringer-Ingelheim, Sanofi.
Funding: Supported by Abbott Vascular, Santa Clara, CA, USA; Infraredx, Bedford, MA, USA; and The Medicines Company, Parsippany, NJ, USA.
Tweet: “In the first randomized trial of non-flow-limiting vulnerable plaques, PCI was safe, substantially enlarged the follow-up lumen areas and was associated with favorable long-term clinical outcomes.”
Registration: Clinicaltrails.gov identifier NCT0217065
- Received August 17, 2020.
- Revision received September 14, 2020.
- Accepted September 14, 2020.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.