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CLINICAL STUDIES

Restenosis and clinical outcome in patients treated with amlodipine after angioplasty: results from the coronary AngioPlasty Amlodipine REStenosis Study (CAPARES)

Bjørn Jørgensen, MD^*, Svein Simonsen, MD, PhD^*, Knut Endresen, MD, PhD^*, Kolbjørn Forfang, MD, PhD^*, Karleif Vatne, MD^*, James Hansen, MD, John Webb, MD, Christopher Buller, MD, Gilles Goulet, MD^||, Jan Erikssen, MD, PhD^¶ and Erik Thaulow, MD, PhD, FACC^*

^* Department of Cardiology, Rikshospitalet, University of Oslo, Oslo, Norway
Foothills Hospital, University of Calgary, Calgary, Canada
St. Paul Hospital, Vancouver, Canada
Hospital Saint-Luc, Montreal, Canada
^|| Cardiology Research, Vancouver Hospital, Vancouver, Canada
^¶ Sentralsykehuset i Akershus, Nordbyhagen, Norway

Manuscript received March 12, 1999; revised manuscript received October 5, 1999, accepted November 17, 1999.

Reprint requests and correspondence: Dr. Bjørn Jørgensen, Medisinsk avdeling, Bærum sykehus, Postboks 34, 1355 Bærum Postterminal, Sandvika, Norway

OBJECTIVES

Our intent was to investigate the effect of the dihydropyridine calcium channel blocker amlodipine on restenosis and clinical outcome in patients undergoing percutaneous transluminal coronary angioplasty (PTCA).

BACKGROUND

Amlodipine has sustained vasodilatory effects and relieves coronary spasm, which may reduce luminal loss and clinical complications after PTCA.

METHODS

In a prospective, double-blind design, 635 patients were randomized to 10 mg of amlodipine or placebo. Pretreatment with the study drug started two weeks before PTCA and continued until four months after PTCA. The primary angiographic end point was loss in minimal lumen diameter (MLD) from post-PTCA to follow-up, as assessed by quantitative coronary angiography (QCA). Clinical end points were death, myocardial infarction, coronary artery bypass graft surgery and repeat PTCA (major adverse clinical events).

RESULTS

Angioplasty was performed in 585 patients (92.1%); 91 patients (15.6%) had coronary stents implanted. Follow-up angiography suitable for QCA analysis was done in 236 patients in the amlodipine group and 215 patients in the placebo group (per-protocol group). The mean loss in MLD was 0.30 ± 0.45 mm in the amlodipine group versus 0.29 ± 0.49 mm in the placebo group (p = 0.84). The need for repeat PTCA was significantly lower in the amlodipine versus the placebo group (10 [3.1%] vs. 23 patients [7.3%], p = 0.02, relative risk ratio [RR]: 0.45, 95% confidence interval [CI]: 0.22 to 0.91), and the composite incidence of clinical events (30 [9.4%] vs. 46 patients (14.5%), p = 0.049, RR: 0.65, CI: 0.43 to 0.99) within the four months follow-up period (intention-to-treat analysis).

CONCLUSIONS

Amlodipine therapy starting two weeks before PTCA did not reduce luminal loss, but the incidence of repeat PTCA and the composite major adverse clinical events were significantly reduced during the four-month follow-up period after PTCA with amlodipine as compared with placebo.

Abbreviations and Acronyms   CABG = coronary artery bypass graft surgery   CAPARES = Coronary AngioPlasty Amlodipine REStenosis Study   CCB = calcium channel blockers   CK = creatine kinase   MI = myocardial infarction   MLD = minimal lumen diameter   PTCA = percutaneous transluminal coronary angioplasty   QCA = quantitative coronary angiography   RR = relative risk

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