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(Circulation. 1998;97:2017-2024.)
© 1998 American Heart Association, Inc.

Clinical Investigation and Reports

Transdermal Nitroglycerin Patch Therapy Improves Left Ventricular Function and Prevents Remodeling After Acute Myocardial Infarction

Results of a Multicenter Prospective Randomized, Double-Blind, Placebo-Controlled Trial

John J. Mahmarian, MD; Lemuel A. Moyé, MD, PhD; David A. Chinoy, MD; Rafael F. Sequeira, MD; Gabriel B. Habib, MD; W. John Henry, MD; Avanindra Jain, MD; Bernard R. Chaitman, MD; C. S. Wayne Weng, PhD; Hugo Morales-Ballejo, MD; ; Craig M. Pratt, MD

From Baylor College of Medicine, Houston, Tex (J.J.M., C.M.P.); the Center for Controlled Clinical Trials, School of Public Health, University of Texas, Houston (L.A.M.); Jacksonville (Fla) Cardiovascular Clinic (D.A.C.); University of Miami (Fla)/Jackson Memorial Hospital (R.F.S.); Baylor College of Medicine/Veterans Administration Medical Center, Houston, Tex (G.B.H.); Internal Medicine of Greer, SC (J.H.); University of Texas Health Science Center at San Antonio (Tex)/Audie L. Murphy Veterans Hospital (A.J.); St. Louis (Mo) University School of Medicine (B.R.C.); Schering-Plough Corporation, Kenilworth, NJ (W.W.); and Schering-Plough Research Institute, Kenilworth, NJ (H.M.-B.).

Correspondence to John J. Mahmarian, MD, 6550 Fannin St, SM-1246, Houston, TX 77030-2716. E-mail johnj{at}bcm.tmc.edu

Background—Nitrates are widely used in the treatment of angina in patients with acute myocardial infarction (AMI). Short-term administration prevents left ventricular (LV) dilation and infarct expansion. However, little information is available regarding their long-term effects on LV remodeling in patients surviving Q-wave AMI.

Methods and Results—This was a randomized, double-blind, placebo-controlled trial designed to investigate the long-term (6-month) efficacy of intermittent transdermal nitroglycerin (NTG) patches on LV remodeling in 291 survivors of AMI. Patients meeting entry criteria had baseline gated radionuclide angiography (RNA) followed by randomization to placebo or active NTG patches delivering 0.4-, 0.8-, or 1.6-mg/h. RNA was repeated at 6 months and 6.5 days after withdrawal of double-blind medication. The primary study end point was the change in end-systolic volume index (ESVI). Both ESVI and end-diastolic volume index (EDVI) were significantly reduced with 0.4-mg/h NTG patches (-11.4 and -11.6 mL/m², respectively, P<.03). This beneficial effect was observed primarily in patients with a baseline LV ejection fraction 40% (ESVI, -31 mL/m²; EDVI, -33 mL/m²; both P<.05) and only at the 0.4-mg/h dose. After NTG patch withdrawal, ESVI significantly increased but did not reach pretreatment values.

Conclusions—Transdermal NTG patches prevent LV dilation in patients surviving AMI. The beneficial effects are limited to patients with depressed LV function and only at the lowest (0.4-mg/h) dose. Continued administration is necessary to maintain efficacy. Whether these remodeling effects confer a clinical or survival advantage will need to be addressed in an adequately powered cardiac event trial.

Key Words: remodeling • myocardial infarction • nitroglycerin

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