TCT Roundup: From Today’s Triumphs to Tomorrow’s Tech

The 2014 Transcatheter Cardiovascular Therapeutics conference held Sept. 13-15 in Washington, D.C., focused on the cutting edge in its late-breaking clinical trials and presentations. Here is a sampling.

Clinical Trials: IVUS-guided PCI beats out angiography for CTOs

For improved outcomes in patients with chronic total occlusion (CTO), intravascular ultrasound (IVUS)-guided PCI appears to win out over conventional angiography in a randomized trial that compared the two approaches when placing zotarolimus-eluting stents or biolimus-eluting stents into CTO patients.

During the 12-month follow-up, patients were found to have fewer combined incidents of MI, target vessel revascularization (TVR) and cardiac death. Irrespective of stent placed, IVUS-CTO patients experienced about one third as many combined MI, target vessel revascularization (TVR) and cardiac deaths as those who had stents placed via angiography (2.6 percent vs. 7.1 percent). At 12 months, angiography-guided CTO stenting had a TVR rate of 5.2 percent while IVUS-guided stents had 2.6 percent.

TAVR extends survival by two years

Transcatheter aortic valve replacement (TAVR) added more than two years to the life of inoperable patients with severe aortic stenosis, according to five-year results of the PARTNER I trial.

PARTNER was a controlled trial that randomized 358 patients with severe symptomatic stenosis to undergo transfemoral TAVR or standard care. At five years, the all-cause mortality rate for patients in the standard care group was 93.6 percent vs. 71.8 percent for the TAVR group, for an absolute difference of 22 percent. Median survival reached 29.7 months with TAVR vs. 11.1 months with standard care.

The five-year rehospitalization rate was lower in the TAVR group, at 47.6 percent vs. 87.3 percent. Stroke incidence remained higher in the TAVR group than in the standard care group but it mostly plateaued at six months and held steady after that period. 

Simpler is better in side branch stenting

Fractional flow reserve (FFR)-guided side branch lesion stenting holds promise of fewer stents placed and more years between retreatment of stenosis in DKCRUSH-VI, a study that compared FFR-guided stenting against an angiography.

The FFR method, while more technically difficult, resulted in fewer stents being placed and a lower long-term restenosis rate. Similar rates of major adverse cardiac events were seen between the two groups.

Side branch treatment occurred in 56.3 percent of FFR cases vs. 63.2 percent of angiography-guided cases. Fewer stents were attempted in the FFR group, but were largely as successful as those in the angiography-guided group.

Six-week therapy fails to beat six months

Six weeks of triple therapy to provide anticoagulation to patients treated with drug-eluting stents was not superior to six months, according to results of the ISAR-TRIPLE trial.

ISAR-TRIPLE investigators set out to define the optimal duration of triple therapy by randomizing patients to six weeks or six months of clopidogrel (Plavix, Bristol Myers-Squibb/Sanofi Aventis) plus concomitant aspirin and oral anticoagulation with vitamin K antagonists after implantation with a drug-eluting stent.

They enrolled 307 patients in each arm. More than a quarter of patients in the six-week group continued clopidogrel after six weeks, though. At nine months, the rate of the composite of death, MI, definite stent thrombosis, stroke or TIMI major bleeding was 9.8 percent in the six-week group and 8.8 percent in the six-month group.

Several panelists questioned if the study was sufficiently powered to draw conclusions and said the crossover may have diluted results.

Scaffolds appear safe at one year

Fewer patients with coronary artery disease who were treated with a bioresorbable scaffold experienced new or worsening angina at one year than similar patients implanted with metal stents in the ABSORB II trial.

ABSORB II is evaluating the efficacy of an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular) compared with an everolimus-eluting metallic stent (Xience, Abbott Vascular). The study included 501 MI patients with one or two de novo lesions.

 At one year, the acute lumen gain was 1.15 mm in the scaffold group vs. 1.46 mm in the stent group based on quantitative coronary angiography and 2.9 mm2 vs. 3.6 mm2 based on quantitative IVUS. The rate of new or worsening angina was 22 percent in the scaffold group vs. 30 percent in the stent group. Angina stages assessed with the Seattle Angina Questionnaire were similar for the two treatments but data on nitrate use favored Absorb. 

Economic studies: TAVR offers good value in CoreValve analysis

TAVR proved cost effective in an analysis of data from the US CoreValve High Risk trial. The study showed that at one year, high-risk patients treated with the CoreValve system (Medtronic) gained an estimated 0.24 life years and 0.2 quality-adjusted life years (QALYs) compared with patients with severe aortic stenosis treated with surgical aortic valve replacement.

Based on that, the projected lifetime incremental cost-effectiveness ratios with TAVR totaled about $67,000 per QALY gained and $57,000 life years gained. According to a sensitivity analysis, cutting cost of initial TAVR hospitalizations by $2,000 to $4,000 per patient would lower the cost-effectiveness ratios to the generally accepted threshold for being of good value.

Periprocedural complications tag $10K onto TAVR costs

Periprocedural complications to TAVR can account for more than $10,000 of costs, an analysis of data from the CoreValve extreme risk cohort demonstrated. The results were based on 506 patients with severe aortic stenosis who had been enrolled in the extreme risk trial with complete hospital and billing data.

They found that 71 percent of patients had at least one complication. The most costly complication was a need for a repeat valve, at more than $116,000, followed by acute kidney injury, at $49,000.

Arrhythmias and the need for a permanent pacemaker had the greatest attributable cost for the entire study group, followed by bleeding complications. The total attributable cost of complications was $10,745.

Practice management: Women interventionalists few but procedurally mighty

Women are a minority in interventional cardiology, but they are taking on more complex procedures in urban settings and experiencing a high level of procedural success, according to Cindy L. Grines, MD, of the Detroit Medical Center Cardiovascular Institute in Detroit. She presented an update on the state of women in interventional cardiology on behalf of the Women in Innovation (WIN) Study Group.

Only 10.8 percent of cardiologists were female, with a majority of those being noninvasive cardiologists. One-third of hospitals employed a female interventionalist, and in many cases she represented the sole female interventionalist on staff. 

Women treated more patients who presented with cardiogenic shock, STEMI or cardiac arrest in the prior 24 hours, more patients with low income or who were uninsured, and more non-white patients. Even with the high-risk population, overall mortality was 1.8 percent for patients of women interventionalists. Mortality in patients with acute coronary syndrome was 2.18 percent and for elective PCI 0.46 percent.

How to minimize conflict in the cath lab

If you want your cath lab to run efficiently and safely, you need a director with clear vision and the ability to take charge, even—make that especially— in times of strife, Ehtisham Mahmud, MD, director of interventional cardiology and the cardiac cath lab at the University of California San Diego Health System, advised colleagues.

“In this very complicated work environment called the cath lab, if you don’t have a clear chain of command and leadership by the cath lab director, the environment is ripe for conflict,” he said.

His tips? Create a healthy work environment that provides high-quality, cost-effective care; motivate staff and educate administrators to achieve common goals; work on physician outliers; and address disruptive behaviors early and judiciously.

Low-dose heparin poised for comeback

The anticoagulant heparin is making a comeback, said Michael S. Lee, MD, of the University of California, Los Angeles Medical Center, predicting that heparin’s cost and safety at low doses will be the key to its success in the near future.

Bivalirudin (The Medicines Company) may be more frequently used in the U.S., but after nine years of working with both, Lee stands behind heparin. “If you think about this era of cost containment, we’ve got to look for different ways to treat patients safely but also under cost constraints,” Lee said.

Lee and colleagues looked at providing low-risk patients with 40 units per kg and found “our bleeding rates were pretty low.” There was one cardiac death, eight MIs and no thrombosis reported. The take home, Lee said, was that the increased risk of bleeding was with higher doses of heparin.

As heparin is generic, its cost is lower. Lee stated as long as it is properly dosed, it provides relief to patients at a fraction of the cost.