Direct coronary stenting versus stenting with balloon pre-dilation: incidence of enzyme release and follow-up results of a multicentre, prospective, randomized study. The CK and Troponin I Estimation in direct STenting (CK TEST) trial.

AIM

The aim of this study was to assess the safety of direct coronary stenting, its influence on costs, duration of the procedure, radiation exposure, clinical outcome and the incidence of periprocedural myocardial damage as assessed by enzyme release determination.

METHODS

We randomized 103 patients (109 lesions) to direct stent implant or stent implant following balloon predilatation. Patients with heavily calcified lesions, bifurcations, total occlusions, left main lesions and very tortuous vessels were excluded. Three samples of blood were drawn; before, 12 and 24 h after the procedure and total CK, CK MB mass and troponin I determination was carried out in a single centralized laboratory.

RESULTS

Direct stenting was successful in 62/62 lesions (100%). No single loss or embolization of the stent occurred. All stents in the group with predilatation were effectively deployed. The immediate post procedure angiographic results were similar with both techniques. Contrast media consumption and procedural time were significantly lower in direct stenting (150+/-82 cc and 30+/-13 min) than in pre-dilated stenting (184+/-85 cc and 36+/-14 min) (P=0.04 and P=0.036 respectively) while fluoroscopy time was similar (9.1+/-12 vs 9.19+/-15 min, P=0.97). The incidence of enzyme release was similar in the groups with only three non Q MI all in the pre-dilated group (P=0.149). Any elevation of CK MB and troponin I occurred in 7% of direct stent vs 12% of pre-dilated group (P=0.66), isolated troponin I elevation in 21% of both groups. Major adverse cardiac events during hospitalization were 0 in direct and 3 in pre-dilated stenting (P=0.66), but there were no significant differences at follow-up at 1, 6 and 12 months between the 2 groups (target lesion revascularization at 12 months 11 vs 14% in the 2 groups respectively).

CONCLUSION

Direct stenting is as safe as pre-dilated stenting in selected coronary lesions. Acute results and myocardial damage as assessed by enzyme release determination are similar, but procedural costs (as measured by resource consumption) and duration of the procedure are lower in direct stenting. Overall success rate and mid-term clinical outcome are similar with both techniques.