May 5th, 2010

• Second-Generation DES Superior to First-Generation DES
• 5-Year Outcomes for Left Main Stenting

Second-Generation DES Superior to First-Generation DES: The industry-funded SPIRIT IV investigators randomized 3687 patients to receive either an everolimus-eluting stent (EES) or a paclitaxel-eluting stent (PES). Unlike many previous DES trials, patients did not undergo routine follow-up angiography, thereby avoiding potential bias created by the “oculostenotic reflex.” At 1 year, the primary endpoint — target-lesion failure (defined as cardiac death, target-vessel MI, or ischemia-driven target-lesion revascularization) — was significantly lower in the EES arm compared to PES (4.2% vs. 6.8%, 95% CI 0.46-0.82, p=001). EES was broadly superior to PES in a number of secondary endpoints, according to the report in the New England Journal of Medicine. In particular, the 1-year rates of MI and stent thrombosis were significantly lower in the EES group. The results of the trial also were consistent across a broad spectrum of subgroups, with the notable exception of diabetics, in whom no significant differences were observed.

In an accompanying editorial, Richard Lange and L. David Hillis (who are also moderators of the Interventional Cardiology group on CardioExchange) ask: “Should we abandon paclitaxel-eluting stents in favor of second-generation everolimus-eluting stents” on the basis of SPIRIT IV? For diabetics, they write, first-generation DES may well suffice. “For patients without diabetes, an analysis of cost-effectiveness would help to determine whether the absolute reduction of 1 to 2 percentage points in myocardial infarction (mostly non–ST-segment elevation) and the absolute reduction of 2 to 3 percentage points in target-lesion revascularization associated with the more costly everolimus-eluting stent (which is approximately $300 more expensive than the paclitaxel-eluting stent) warrant its routine use.”

5-Year Outcomes for Left Main Stenting: The 5-year risk of death and the combined risk of death, Q-wave MI, or stroke were similar in patients with left main coronary disease who were treated with CABG or with a stent. In the Journal of the American College of Cardiology, Duk-Woo Park and colleagues from Korea report the 5-year results from the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry. (The 3-year results were previously published in the New England Journal of Medicine.) However, the risk of target vessel revascularization was higher in the stenting group.

In a press statement issued by the European Society of Cardiology, William Wijns said: “This study should be added to the increasing hypothesis-generating signals emerging from various trials and registries that there may be a place for PCI in the treatment of selected patients with unprotected LMCA. The limitation of the study remains that it is a registry, possibly confounded by selection bias for either therapy. Ultimately only a prospective multi-center randomised trial will provide the definitive answer.”

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