A head-to-head comparison of Medtronic’s (NYSE:MDT) Resolute stent and Abbott’s (NYSE:ABT) market-leading Xience V DES showed "non-inferiority" between the two, according to results from the Twente study presented last week at the Transcatheter Cardiovascular Therapeutics symposium.
As measured by the trial’s primary endpoint, target vessel failure after one year, the stents were equivalent, according to the event’s sponsor, the Cardiovascular Research Foundation.
The stents also showed low rates of blood clots in the prospective, single-blinded, randomized controlled trial involving 1,391 patients, according to a press release.
Target vessel failure occurred in 8.2 percent of patients for the zotarolimus-eluting Resolute stent and in 8.1 percent of patients treated with the everolimus-eluting Xience V. Rates of other end-point measures were also on a par for the Resolute and Xience V: cardiac death (1.0 percent vs. 1.4 percent, respectively); target vessel-related myocardial infarction (4.6 percent vs. 4.6 percent); and clinically driven target vessel revascularization (3.3 percent vs. 2.7 percent).
Here’s a look at some other results coming out of the TCT 2011 conference:
Abbott’s Absorb trial shows positive long-term results
Abbott touted long-term data from its two-stage Absorb trial evaluating the Absorb drug-eluting bioresorbable vascular scaffold, announcing five-year results from the first stage and two-year and 18-month data from the second stage.
The 30-patient first stage showed no incidents of cardiac death, blood clots or ischemia-driven target lesion revascularization after five years. The major adverse cardiac event (MACE) rate at five years was 3.4 percent, all of which occurred before the six-month mark.
The 44-patient second stage showed no blood clots and a MACE rate of 6.8 percent after two years. And additional, 18-month data from 101 patients in the second stage revealed no cases of cardiac death or blood clots and a MACE rate of 8.0 percent. Read more
Evolve trial: Boston Scientific’s Synergy stent as good as the Promus Element
Boston Scientific (NYSE:BSX) said its Synergy bio-absorbable stent proved its own "non-inferiority" in a head-to-head test against BSX’s Promus Element stent.
Both devices elute everolimus and were studied in the treatment of de novo coronary lesions. The Synergy arm involved two dose levels for the drug, one similar to the Promus Element and the other half that dose. One of the 291-patient trial’s primary endpoint was independently adjudicated mean late loss at six months. The Synergy stent scored 0.10mm and its half-dose counterpart scored 0.13mm, compared with 0.15mm for the Promus device.
"Additional six-month angiographic outcomes for diameter stenosis and binary restenosis showed no statistical differences between the Synergy and Promus Element stents," according to a press release.
All three stents showed similar rates of target lesion failure after 30 days and six months. There were no incidences of cardiac death, myocardial infarction or stent thrombosis after six months. Read more
BSX touts Cobra trial results
Boston Scientific also touted positive outcomes from its Cobra trial evaluating post-dilation of nitinol stents using the CryoPlasty and PolarCath technologies in treating blockages of the superficial femoral artery.
The 76-patient trial compared the CryoPlasty technique, in which the dilation balloon is cooled to -10°C, with conventional balloon angioplasty, with a primary endpoint of binary in-segment restenosis.
After a year, the rate of binary restenosis was 29.3 percent for the CryoPlasty group and 55.8 percent for the control group. The trial also revealed "significant improvement" in ankle-brachial index (the ratio of blood pressure in the lower legs to blood pressure in the arms) for the CryoPlasty cohort. Read more
Biotronik cites all-comers Energy registry results
An all-comers registry investigating the safety and clinical performance of Biotronik’s PRO-Kinetic Energy bare-metal stent in 1,016 patients showed a MACE rate of 4.4 percent after six months.
Rates of cardiac death, myocardial infarction, target lesion revascularization were 0.6 percent, 1.3 percent and 2.5 percent, respectively, with two cases of stent thrombosis.
were seen. Also, in the small vessel (≤2.75 mm) population, the very low number of events was confirmed with a MACE rate of 6.4 percent and a TLR of only 2.8 percent. Read more
Analysts’ take-away: Emerging technologies upstaged stents
Leerink Swann analysts came away from TCT 2011 convinced that a pair of emerging technologies are the future of cardiology, favoring companies with leads in those markets.
"While drug-eluting stents (DES) still play a prominent role at this meeting – with several clinical data updates – this year, new and emerging technologies were clearly garnering the most attention," analysts Rick Wise, Miroslava Minkova and Danielle Antalffy wrote. "Specifically, two new interventional treatments – both with the potential to evolve into multi-billion dollar market opportunities longer term – were the focus of this year’s meeting: (1) transcatheter aortic valves (TAVI), and (2) renal denervation to treat hypertension."
That’s good news for Boston Scientific, Medtronic and Volcano Corp. (NSDQ:VOLC), at least according to the Leerink researchers. Here’s how they broke down each company’s prospects:
- "BSX: Progress with Restructuring and Longer-Term Opportunities. Despite near-term headwinds, we left TCT overall encouraged that BSX’s restructuring and investment initiatives will gradually position the company for better growth and profitability over time. BSX’s fourth-gen SYNERGY DES and second-gen Lotus TAVI – both in development – were prominently featured at TCT. Still, BSX’s near-term sales and EPS outlook will likely remain pressured by difficult cardio market conditions. In a BSX management dinner we hosted, CFO Jeff Capello emphasized that BSX remains in investment and turnaround mode. With ~$0.14 in one-time favorable items that benefited 2011 EPS, and the potential for ongoing market pressures and select investments, we now believe there is some downside risk to our current $0.70 ex-amortization ($0.48 including amortization) 2012E BSX EPS. Our BSX estimates are under review.
- MDT: Well-Positioned In the Emerging Opportunity to Treat Hypertension. Though still very early, MDT is well-positioned in a potential new multi-billion dollar market opportunity to treat chronic resistant hypertension. Via its Ardian technology, MDT is leading the hypertension market. In early-stage EU data, MDT’s Symplicity catheter demonstrated real and meaningful reductions in both systolic and diastolic blood pressure with a solid safety profile.
- VOLC: Ongoing IVUS and FFR Growth Opportunities and a Full New Product Pipeline. We left TCT more comfortable than we had anticipated with VOLC’s near-term growth outlook, given our increased understanding of some unusual factors – including a US sales force transition – that affected 3Q11 US IVUS sales results. At TCT, VOLC also highlighted a broader and deeper than ever new product pipeline – essential for VOLC to sustain its mid- to high-teens growth profile."