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CLINICAL STUDIES

Final results of the STent versus directional coronary Atherectomy Randomized Trial (START)

^a Department of Cardiology, Osaka Medical Center, Osaka, Japan. There was no financial support for the study

Manuscript received January 5, 1999; revised manuscript received May 4, 1999, accepted June 21, 1999.

Reprint requests and correspondence: Dr. Etsuo Tsuchikane, Department of Cardiology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari, Osaka 537-8511, Japan
oscmed1{at}skyblue.ocn.ne.jp

OBJECTIVES

This study was designed to compare primary stenting with optimal directional coronary atherectomy (DCA).

BACKGROUND

No previous prospective randomized trial comparing stenting and DCA has been performed.

METHODS

One hundred and twenty-two lesions suitable for both Palmaz-Schatz stenting and DCA were randomly assigned to stent (62 lesions) or DCA (60 lesions) arm. Single or multiple stents were implanted with high-pressure dilation in the stent arm. Aggressive debulking using intravascular ultrasound (IVUS) was performed in the DCA arm. Serial quantitative angiography and IVUS were performed preprocedure, postprocedure and at six months. The primary end point was restenosis, defined as 50% diameter stenosis at six months. Clinical event rates at one year were also assessed.

RESULTS

Baseline characteristics were similar. Procedural success was achieved in all lesions. Although the postprocedural lumen diameter was similar (2.79 vs. 2.90 mm, stent vs. DCA), the follow-up lumen diameter was significantly smaller (1.89 vs. 2.18 mm; p = 0.023) in the stent arm. The IVUS revealed that intimal proliferation was significantly larger in the stent arm than in the DCA arm (3.1 vs. 1.1 mm²; p < 0.0001), which accounted for the significantly smaller follow-up lumen area of the stent arm (5.3 vs. 7.0 mm²; p = 0.030). Restenosis was significantly lower (32.8% vs. 15.8%; p = 0.032), and target vessel failure at one year tended to be lower in the DCA arm (33.9% vs. 18.3%; p = 0.056).

CONCLUSIONS

These results suggest that aggressive DCA may provide superior angiographic and clinical outcomes to primary stenting.

Abbreviations and Acronyms   CSA = cross-sectional area   CK = creatine kinase   DCA = directional coronary atherectomy   DS = percent diameter stenosis   IVUS = intravascular ultrasound   LAD = left anterior descending artery   MLD = minimal lumen diameter   NHLBI = National Heart, Lung, Blood Institute   PA = plaque plus media cross-sectional area   QCA = quantitative coronary angiography   TIMI = thrombolysis in myocardial infarction   TLR = target lesion revascularization   TVR = target vessel revascularization

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