Late Follow-Up From RAVEL

he 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 practice 7 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.