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Optical Coherence Tomography-Guided versus Angiography-Guided PCI.
Ali, Ziad A; Landmesser, Ulf; Maehara, Akiko; Matsumura, Mitsuaki; Shlofmitz, Richard A; Guagliumi, Giulio; Price, Matthew J; Hill, Jonathan M; Akasaka, Takashi; Prati, Francesco; Bezerra, Hiram G; Wijns, William; Leistner, David; Canova, Paolo; Alfonso, Fernando; Fabbiocchi, Franco; Dogan, Ozgen; McGreevy, Robert J; McNutt, Robert W; Nie, Hong; Buccola, Jana; West, Nick E J; Stone, Gregg W.
Affiliation
  • Ali ZA; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Landmesser U; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Maehara A; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Matsumura M; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Shlofmitz RA; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Guagliumi G; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Price MJ; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Hill JM; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Akasaka T; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Prati F; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Bezerra HG; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Wijns W; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Leistner D; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Canova P; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Alfonso F; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Fabbiocchi F; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Dogan O; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • McGreevy RJ; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • McNutt RW; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Nie H; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Buccola J; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • West NEJ; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
  • Stone GW; From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn Schoo
N Engl J Med ; 389(16): 1466-1476, 2023 Oct 19.
Article in En | MEDLINE | ID: mdl-37634188
ABSTRACT

BACKGROUND:

Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited.

METHODS:

In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed.

RESULTS:

The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group.

CONCLUSIONS:

Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.).
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Coronary Artery Disease / Coronary Angiography / Tomography, Optical Coherence / Percutaneous Coronary Intervention Type of study: Clinical_trials / Guideline Limits: Humans Language: En Journal: N Engl J Med Year: 2023 Type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Coronary Artery Disease / Coronary Angiography / Tomography, Optical Coherence / Percutaneous Coronary Intervention Type of study: Clinical_trials / Guideline Limits: Humans Language: En Journal: N Engl J Med Year: 2023 Type: Article