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(Circulation. 2005;111:958-960.)
© 2005 American Heart Association, Inc.

Editorial

Late Follow-Up From RAVEL

Transition From Intention to Observation

Warren K. Laskey, MD

From the Department of Medicine, University of New Mexico, Albuquerque.

Correspondence to Warren K. Laskey, MD, Division of Cardiology, Dept of Medicine, MSC10-5550, University of New Mexico, Albuquerque, NM 87131-0001. E-mail warrenlaskey@earthlink.net

Key Words: Editorials • stents • trials • revascularization • restenosis

An extract of the first 250 words of the full text is provided, because this article has no abstract.

The astonishing, sometimes dismaying, pace with which drug-eluting stents (DES) have made the transition from their bench origins^1,2 to proof of principle,³ hypothesis testing,^4–6 and now routine clinical practice⁷ leaves even the least skeptical among us breathless. With each new advance, however, we should not lose sight of the fundamental elements of evidence-based clinical practice: "Does it work?" and "Is it safe?" It is equally astonishing and dismaying to realize the enormous investments in time, money, and sheer hard work that are required to adequately answer these deceptively simple questions. Using the RAVEL trial (Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions) as a model, I attempt here to outline the essentials for understanding how answers to these questions are provided, or not provided.

See p 1040

As for the first element—"Does it work?"—the following questions must be addressed: What is being measured? With what is it being compared? What is the magnitude of the treatment effect? What is the relationship between time and treatment effect?

In the RAVEL trial,⁴ the primary measure of efficacy was the angiographically assessed late lumen loss at 6 months, and a convincing case was made for the superiority of the sirolimus-eluting stent as compared with the bare metal stent (BMS). A secondary measure of efficacy (the RAVEL study was designed and powered to address the angiographic end point), target lesion revascularization (TLR) rate at 1 year, confirmed the superiority of the . . . [Full Text of this Article]

Related Article:

Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents: Three-Year Results of the RAVEL Trial

Jean Fajadet, Marie-Claude Morice, Christoph Bode, Paul Barragan, Patrick W. Serruys, William Wijns, Constantino R. Constantini, Jean-Léon Guermonprez, Hélène Eltchaninoff, Didier Blanchard, Antonio Bartorelli, Gert-Jan Laarman, MarcoAntonio Perin, J. Eduardo Sousa, Gerhard Schuler, Ferenc Molnar, Giulio Guagliumi, Antonio Colombo, Ernesto Ban Hayashi, and Egon Wülfert
Circulation 2005 111: 1040-1044. [Abstract] [Full Text]