Response to Letters Regarding Article, “Two-Year Clinical Outcomes With Drug-Eluting Stents for Diabetic Patients With De Novo Coronary Lesions: Results From a Real-World Multicenter Registry”

Long-term clinical outcomes after drug eluting stent implantation in women with de novo coronary lesions

“…DES use in women with diabetes was not associated with any significant improvement in long-term risk of cardiac death, MACE or TVR. These unexpected findings contrast with previous data reported in non gender related diabetic analyses [11] and need to be validated in dedicated larger studies.…”

“…Of note, the extent of the MACE and TVR reduction at the 3-year was lower when compared with the results recorded in the first year in the above reported randomized data. We cannot exclude that this discrepancy could be, at least partially, attributed to the well known clinical trial overestimates of the benefits that DES can offer in routine clinical practice for several reasons including mandatory angiographic follow-up [16], frequent use in control groups of thickstrut BMS [17], and exclusion of "off-label indications" (indications at increased risk of adverse outcomes in which the advantage of DES vs BMS in terms of repeat PCI reduction seems to be less evident [18]) that are, conversely, quite common in clinical practice [5,11]. In our study population, DES treatment was associated with a reduction of TVR and MACE solely during the first 6 months of follow-up, while thereafter (from six months to 3 years) DESs and BMSs showed similar effects.…”

“…Launched in July 2002, REAL (REgistro regionale AngiopLastiche dell'EmiliaRomagna) is a large, prospective, web-based registry designed to collect clinical and angiographic data for all consecutive PCIs performed in the Emilia-Romagna region (∼4 million inhabitants) of central-northern Italy [10,11]. All fifteen public/private interventional cardiology centers in Emilia-Romagna participate in data collection.…”

Differences in Restenosis Rate With Different Drug-Eluting Stents in Patients With and Without Diabetes Mellitus

“…It is also a possible confounder, although unlikely a systematic one, that patients with more than 1 type of DES in the coronary arteries were included. Ideally we would like to have included information on insulin treatment because this group of patients with DM may have a more rapid progression of atherosclerosis (3,5). However, this information was not available for the entire time period we studied.…”

“…Randomized trials (3,4) and results from registries (5) seem to favor the use of drug-eluting stents (DES) over bare-metal stents (BMS) for better clinical and angiographic outcome. Most data on patients with DM and DES are available for the sirolimus-eluting Cypher stent (Cordis, Johnson & Johnson, Miami, Florida) and the paclitaxel-eluting Taxus stent (Boston Scientific, Natick, Massachusetts) (3,(5)(6)(7)(8)(9). However, with more players on the market for DES, other stent platforms, drugs, and polymers are introduced.…”