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CLINICAL RESEARCH: CLINICAL TRIAL

Evaluation of the effect of oral verapamil on clinical outcome and angiographic restenosis after percutaneous coronary intervention

The randomized, double-blind, placebo-controlled, multicenter verapamil slow-release for prevention of cardiovascular events after angioplasty (VESPA) trial

Hans-Peter Bestehorn, MD^*,*, Franz-Josef Neumann, MD^*, Heinz Joachim Büttner, MD^*, Peter Betz, MD, PhD^*, Peter Stürzenhofecker, MD, Eberhard von Hodenberg, MD, Antoine Verdun, MD, Laszlo Levai, MD, Jean Pierre Monassier, MD^|| and Helmut Roskamm, MD^*

^* Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany
Herz-und Gefäßklinik Bad Neustadt, Bad Neustadt, Germany
Herz-Zentrum Lahr, Lahr, Germany
Clinic St. Joseph Colmar, Colmar, France
^|| Hospital Emil Müller, Mulhouse, France

Manuscript received May 7, 2003; revised manuscript received January 2, 2004, accepted February 10, 2004.

^* Reprint requests and correspondence: Dr. Hans-Peter Bestehorn, Herz-Zentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany.
hans-peter.bestehorn{at}herzzentrum.de

OBJECTIVES: We investigated the effect of oral verapamil on clinical outcome and angiographic restenosis after percutaneous coronary intervention (PCI).

BACKGROUND: Thus far, there is no established systemic pharmacologic approach for the prevention of restenosis after PCIs. Five small studies reported encouraging results for calcium channel blockers.

METHODS: Our randomized double-blind trial included 700 consecutive patients with successful PCI of a native coronary artery. Patients received the calcium channel blocker verapamil, 240 mg twice daily for six months, or placebo. Primary clinical end point was the composite rate of death, myocardial infarction, and target vessel revascularization (TVR) during one-year follow-up; the angiographic end point was late lumen loss at the six-month follow-up angiography.

RESULTS: We obtained complete clinical follow-up in 95% of the patients, and scheduled angiography was performed in 94%. The proportion of patients treated with stents was 83%. The primary clinical end point was reached in 67 (19.3%) patients on verapamil and in 103 (29.3%) patients on placebo (relative risk [RR] 0.66 [95% confidence interval (CI) 0.48 to 0.89]; p = 0.002). This difference between the groups was driven by TVR (17.5% with verapamil vs. 26.2% with placebo; RR 0.67 [95% CI 0.49 to 0.93]; p = 0.006). Late lumen loss was 0.74 ± 0.70 mm with verapamil and 0.81 ± 0.75 mm with placebo (p = 0.11). Compared with placebo, verapamil reduced the rate of restenosis 75% (7.8% vs. 13.7%; RR 0.57 [95% CI 0.35 to 0.92]; p = 0.014).

CONCLUSIONS: Verapamil compared with placebo improves long-term clinical outcome after PCI of native coronary arteries by reducing the need for TVR. This was caused by a reduction in the rate of high-grade restenosis.

Abbreviations and Acronyms   CABG = coronary artery bypass grafting   CAD = coronary artery disease   CI = confidence interval   MI = myocardial infarction   MLD = minimal lumen diameter   PCI = percutaneous coronary intervention   PTCA = percutaneous transluminal coronary angioplasty   RR = relative risk   TVR = target vessel revascularization   VESPA = Verapamil Slow-Release for Prevention of Cardiovascular Events After Angioplasty trial

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