BASKET-PROVE Substudy: DES Better Than BMS in Elderly Patients With Large Arteries

In older patients with CAD in large native vessels, DES result in better 2-year outcomes compared with BMS, according to a substudy of the BASKET-PROVE trial published online July 17, 2015, ahead of print in the American Heart Journal. In contrast, patients younger than 75 years only stood to benefit from DES in terms of reduced TVR.Take Home: BASKET-PROVE Substudy: DES Better Than BMS in Elderly Patients With Large Arteries

The BASKET-PROVE study enrolled 2,314 European patients with chronic or acute coronary disease between March 2007 and May 2008. All patients required stents at least 3.0 mm in diameter, received 12 months of dual antiplatelet therapy (DAPT), and were randomized to 1 of 3 devices:

  • Cypher Select sirolimus-eluting stent (n = 775; Cordis)
  • Xience V everolimus-eluting stent (n = 774; Abbott Vascular)
  • Vision BMS (n = 765; Abbott Vascular)

The main trial results, published in 2010 in the New England Journal of Medicine, showed lower rates of MACE and TVR for DES compared with BMS, although the rate of cardiac death or nonfatal MI (primary endpoint) was comparable across groups.

For the substudy, researchers led by David J. Kurz, MD, of Triemli Hospital (Zurich, Switzerland), looked specifically at the 405 patients who were at least 75 years old.

At 2 years, the composite of cardiac death or nonfatal MI was observed less often among those who received DES (HR 0.64; 95% CI 0.44-0.91). Rates of nonfatal MI, all-cause death, and TVR also were lower with DES, though stent thrombosis and TIMI major bleeding were similar between groups (table 1).

Table 1. Two-Year Outcomes Among Patients ≥ 75 Years


Subgroup analysis confirmed these results, with the exception of patients with stable angina, who appeared to benefit more from BMS in terms of cardiac death or nonfatal MI.

In contrast, among patients younger than 75 years, the only benefit seen with DES vs BMS was reduced TVR at 2 years (4.0% vs 8.7%; HR 0.66; 95% CI 0.55-0.80).

Pinpointing the Age Effect

In an effort to explain the discrepant findings between younger and older patients, Dr. Kurz and colleagues highlight the fact that the latter had more multivessel disease—though their procedures were not more complex. “One might speculate that the response to restenosis differed,” they write. “If the elderly are more likely to tolerate restenosis without recurrent angina, this may increase the chance of the restenosis presenting as an acute ischemic event. Especially in large-vessel lesions, this may in turn result in increased mortality in the elderly treated with BMS.”

However, they caution against applying these findings widely given the small study population and potential lack of statistical power.

“One of the main rationales for choosing BMS in the elderly is the fear of bleeding complications with prolonged DAPT,” the authors note. But, they add, “the beneficial results found in this study, as well as the safety analysis of the XIMA trial, where no significant differences in major bleeding rates were found despite different DAPT regimes, should at least question this line of thought.”

A Few Caveats

In an email with TCTMD, Ajay J. Kirtane, MD, SM, of NewYork-Presbyterian Hospital/Columbia University Medical Center (New York, NY), said that “while the data do support the superiority of DES over BMS, especially with respect to a reduction in TVR, we have to be circumspect with regard to the observed reductions in MI and… overall mortality in the elderly, given that there were only 405 patients in that subgroup.”

The sizes of the reductions “are really striking and out of proportion to those that have been observed in other randomized trials,” he added.

Notably, all patients received 12 months of dual therapy “and thus were an ideally suited population for DAPT, despite being elderly,” Dr. Kirtane stressed. But many older patients do not fit into this subgroup, he observed, as “we often struggle with a tradeoff between potentially greater bleeding with a longer obligate period of DAPT with DES and lesser efficacy but a shorter obligate DAPT period with BMS.”


Source: 
Kurz DJ, Bernheim AM, Tüller D, et al. Improved outcomes of elderly patients treated with drug-eluting versus bare metal stents in large coronary arteries: results from the BASKET-PROVE randomized trial. Am Heart J. 2015;Epub ahead of print.

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Disclosures
  • The BASKET-PROVE trial was funded by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research.
  • Dr. Kurz makes no statement regarding conflicts of interest.
  • Dr. Kirtane reports receiving institutional research grants from Abbott Vascular, Abiomed, Boston Scientific, Eli Lilly, Medtronic, St. Jude Medical, and Vascular Dynamics.

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