November 16th, 2010
What Does BASKET PROVE Have to Prove?
Getting a handle on the study…
Previous data suggested that the use of DES in large native coronary arteries confers no benefit and may, in fact, cause late harm due to stent thrombosis.
In BASKET PROVE (BAsel Stent Kosten Effektivitäts Trial – PROspective Validation Examination), 2314 patients needing stents that were 3 to 4 mm in diameter were randomly assigned to receive (a) a first-generation sirolimus-eluting stent (Cypher Select, Cordis), (b) a second-generation everolimus-eluting stent (Xience V, Abbot Vascular), or (c) a bare-metal (Visions, Abbott Vascular) stent. All patients were treated with aspirin and clopidogrel for 1 year.
At 2 years, the rate of nonfatal MI or cardiac death did not differ significantly among the three groups. However, the rate of target-vessel revascularization was significantly lower in patients who received either DES than in those who received a BMS.
|Cardiac Death or MI||TVR|
* p < 0.007 comparing BMS to either DES)
During the first 6 months after stenting, a statistically nonsignificant trend toward a lower rate of cardiac death and MI was seen with both DES, compared with BMS. However, since the clinical event rate was lower than expected, the trial was underpowered to detect small differences.
Is my patient a” basket case”?
One nice thing about BASKET PROVE findings is that they apply to a “real-world,” rather than a highly selected, patient population. One third of the patients had stable angina, one third had acute coronary syndromes, and one third had acute STEMI. No limit to the number of coronary arteries treated or stents used was imposed, and 76% of stents were implanted in subjects with “off-label” indications (e.g., more than one lesion per vessel, lesions in two or more vessels, lesions that were >27 mm in length, bifurcation lesions, chronic total occlusions, or acute coronary syndromes).
How do I weave these findings into my practice?
You can feel comfortable in the knowledge that there’s no harm in using DES rather than BMS in large coronary arteries (keeping in mind that the results of this study only apply to vessels 3 to 4 mm in diameter, not to smaller or larger arteries).
Should I be implanting DES, rather than BMS, in all large coronary arteries?
It’s not a slam dunk. For patients who cannot (or will not) take dual antiplatelet therapy for a year, BMS should be used. In the remainder, although it’s not harmful to use DES rather than BMS, it may not be cost effective. We need an analysis to examine whether the modest reduction in TVR (absolute reduction of 6 to 7%) justifies the increase in cost of DES over BMS.
Readers: What kind of stents do you generally recommend for large-artery stenoses, and will these findings cause you to reconsider your practice?