Current issues of ACP Journal Club are published in Annals of Internal Medicine


Therapeutics

Laser angioplasty added no benefit to balloon angioplasty in coronary artery disease

ACP J Club. 1996 July-Aug;125:8. doi:10.7326/ACPJC-1996-125-1-008


Source Citation

Appelman YE, Piek JJ, Strikwerda S, et al. Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease. Lancet. 1996 Jan 13;347: 79-84.


Abstract

Objective

To compare the effectiveness of excimer laser coronary angioplasty (ELCA) with balloon angioplasty in patients with long coronary lesions.

Design

Randomized controlled trial with 6-month follow-up.

Setting

The Netherlands and the United States.

Patients

313 consecutive patients (mean age 59 y, 73% men) with stable angina pectoris, coronary lesions longer than 10 mm on visual assessment, and total or functional occlusions and who were suitable for coronary angioplasty were included. Exclusion criteria were myocardial infarction (MI) within the past 2 weeks, a life expectancy < 1 year, factors that made clinical or angiographic follow-up difficult, intended angioplasty of a venous bypass graft, unprotected left main disease, extreme tortuosity of the vessel, highly eccentric lesions, vessels with ostial lesions, angulated lesions of > 45°, bifurcation lesions, aorta-ostial lesions, lesions with a thrombus or dissection, or total occlusions with a low likelihood of passage with a guide wire. Follow-up was 98%.

Intervention

151 patients (158 lesions) were assigned to ELCA, usually followed by balloon angioplasty, and 157 (167 lesions) to balloon angioplasty alone.

Main outcome measures

Cardiac death, MI, coronary bypass surgery, repeat coronary angioplasty of the randomized segment, and minimal lumen diameter in relation to the baseline value (net gain).

Main results

ELCA was followed by balloon angioplasty in 98% of procedures. The angiographic success rate (visual assessment) was 80% in patients treated with ELCA and 79% in patients treated with balloon angioplasty alone. No deaths occurred. MI occurred in 4.6% of patients in the ELCA group compared with 5.7% of patients in the balloon angioplasty group (absolute difference 1.1%, {95% CI 24.2% to 6.5%, P = 0.67}*). Coronary bypass surgery was done in 10.6% of patients in the ELCA group compared with 10.8% of patients in the balloon angioplasty group (P = 0.95). The restenosis rate was 52% in the ELCA group and 41% in the balloon angioplasty group (P = 0.13).

Conclusion

Excimer laser angioplasty followed by balloon angioplasty provided no additional benefit to balloon angioplasty alone in patients with stable angina who had coronary lesions that were > 10 mm in length and with total or functional occlusions.

Source of funding: Dutch Health Insurance Executive Board.

For article reprint: Dr. J.J. Piek, University of Amsterdam, Department of Cardiology, Academic Medical Centre, Meibergdreef 9, 1005 AZ Amsterdam, the Netherlands. FAX 31-20-566-4440.

*Numbers calculated from data in article.


Commentary

In their original article, Grüntzig and colleagues (1) indicated that certain lesions may be less suitable than others for angioplasty. Over subsequent years, it became apparent that the success rates for total occlusions were significantly less than for stenoses, and recurrence rates were higher (2, 3). Various technologies were developed, including the Rotacs catheter and laser catheters, to improve the poor primary success rate associated with occlusions. At the same time, 2 other concepts evolved: The greater the injury inflicted, the greater the response of the vessel to it (4); and less chance of restenosis existed with larger final vessel diameter (5). Meanwhile, changes in wire technology and balloon profile led to improved treatment of chronic total occlusions with angioplasty.

Many of these ideas are borne out in the study of Appelman and colleagues. First, the success rate for balloon angioplasty alone (79%) is higher than previously reported, assuming that patients truly had chronic total occlusion (usually defined as > 3 mo), which is not well defined in this article. Second, 98% of patients treated with ELCA had follow-up balloon angioplasty to achieve a good angiographic result. Third, it would appear that acute gains with ELCA were at the expense of excess damage because these early gains were the same for the balloon (0.82 mm) and ELCA (0.92 mm) groups, whereas late loss for the ELCA group was higher (0.52 mm vs 0.34 mm). ELCA was associated with more complications. Stents are not mentioned at all, which perhaps reflects the historical nature of this study.

This study reconfirms the value of balloon angioplasty. Registry data had suggested that ELCA was better, but such comparisons should always be regarded as suspect until a randomized trial is done.

A. H. Gershlick, MD
University of LeicesterLeicester, England, UK


References

1. Grüntzig AR, Senning A, Siegenthaler WE. N Engl J Med. 1979;301:61-8.

2. Kinoshita I, Katoh O, Nariyama J, et al. J Am Coll Cardiol. 1995;26:409-15.

3. Bell MR, Berger PB, Bresnahan IF, et al. Circulation. 1992;85:1003-11.

4. Schwartz RS. Lab Invest. 1994;71:789-91.

5. Kuntz RE, Baim DS. Circulation. 1993;88:1310-23.