PCI with Concomitant Aortic Stenosis May Not Increase Short-term Mortality

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The presence of severe symptomatic aortic stenosis has little impact on rates of short-term mortality and procedural complications in patients undergoing percutaneous coronary intervention (PCI) for coronary artery disease (CAD), according to a study published online January 26, 2012, ahead of print in Circulation. However, sicker aortic stenosis patients are more likely to die within 30 days.

Researchers led by Samir R. Kapadia, MD, of the Cleveland Clinic (Cleveland, OH), identified 254 patients with severe aortic stenosis who underwent PCI between 1998 and 2008. These patients were paired with 508 comparable patients without aortic stenosis who underwent PCI during the same period and served as controls. The groups were well-matched with respect to baseline characteristics as well as lesion and procedural characteristics.

Early PCI Outcomes Similar

Overall, the primary endpoint of 30-day mortality after PCI was similar in patients with and without severe aortic stenosis (4.3% vs. 4.7%; P = 0.2). However, in patients with low ejection fractions (≤ 30%) and severe aortic stenosis, 30-day post-PCI mortality was higher compared with patients with an ejection fraction greater than 30% (5.4% vs. 1.2%; P < 0.001). In addition, aortic stenosis patients with high Society of Thoracic Surgeons (STS) scores (≥ 10) had a higher 30-day post-PCI mortality compared with those with STS scores less than 10 (10.4% vs. 0%; P < 0.001).

Complication rates were similar regardless of the presence of aortic stenosis.

At a mean follow-up of 3.7 years, 29% of patients with severe aortic stenosis had undergone surgical aortic valve replacement after a mean interval of 15.5 ± 15.7 months after intervention. Postoperative mortality in patients undergoing surgical valve replacement was 8% at 30 days and 14% at 3 months. At a mean follow up of 3.7 years, mortality was 42.5% in aortic stenosis patients who underwent surgical aortic valve replacement, 68% in those who could not undergo replacement and 46.7% in the non-aortic stenosis group.

“I think the take-home message is that angioplasty in [aortic stenosis] patients is similar to angioplasty in high-risk patients, but the complications are not trivial,” Dr. Kapadia said in a telephone interview with TCTMD. “Patients with [aortic stenosis] who have high comorbidities do poorly. These patients should be considered among the most high-risk interventions that we do.”

He added that more research is needed to determine the best timing for coronary intervention in these patients—whether it is best performed before or after valve replacement, or in a combined procedure. The heart team should play a particularly important role in this decision, Dr. Kapadia said.

Another big issue, he added, is which patients with both aortic and coronary stenosis actually need treatment for both.

“This question cannot be answered by our study or any other study out there,” he said. “Does the unrevascularized coronary lead to increased morbidity and mortality? This issue is far from settled.”

A Clearer Picture of PCI Risk in Aortic Stenosis Patients

In an editorial accompanying the study, Susheel K. Kodali, MD, and Jeffrey W. Moses, MD, both of Columbia University (New York, NY), say the study “adds significantly to our understanding of the safety and efficacy of PCI in the setting of [aortic stenosis],” and has implications for transcatheter aortic valve replacement (TAVR).

Drs. Kodali and Moses point out that the short-term mortality rate of 4.3% is “sobering” and indicative of the challenges posed by such high-risk patients.

They add that a “significant proportion” of patients in the study with higher STS scores may have had ACS. As for those with low ejection fraction, post-PCI mortality in this group was 15.4% and driven in part by acute complications.

“The latter raises the issue of whether balloon aortic valvuloplasty could be performed in these patients prior to the PCI to reduce risk,” the editorial notes. “Although data are limited, several small series have shown that [this technique] either concomitantly or staged can be performed safely in patients with [aortic stenosis].”

Drs. Kodali and Moses add that the ongoing questions are whether TAVR can be performed safely in the setting of the patient’s coronary anatomy and whether the extent of CAD will impact the patient’s symptoms as well as long-term survival.

Next Step: Who Should Not Get a Valve?

Peter C. Block, MD, of Emory University Hospital (Atlanta, GA), agreed that the study helps at least to begin to identify patients with aortic stenosis who should or should not undergo PCI.

“I think what this paper tells us is that if you have a patient with a low ejection fraction who has bad coronary disease and is in need of [valve replacement], maybe we should not intervene,” he said. “We don’t have all the answers, but we are beginning to get a clearer picture of who these people are who do poorly.”

Dr. Block added that more answers may come from additional analyses of the PARTNER trial, since many patients with CAD were enrolled.

“The next step is going to be really attempting to identify and define patients who should not get a valve,” Dr. Block said. “That’s harsh, but since we know [from the PARTNER data] that approximately 30% of those who are treated die in a year or 6 months, you can get them through a year or 6 months with balloon valvuloplasty at a tenth of the cost. From a public health perspective this is becoming a very important question, but a question for which we do not know the answers, especially in the setting of TAVR.”

Study Details

The mean age was 75 years in both groups. Patients with severe aortic stenosis had a mean STS score of 13, with 38% of patients with an STS score of greater than 10. The mean logistic EuroScore was 32 in aortic stenosis patients, with 61% having a score greater than 20.

 


Sources:
1. Goel SS, Agarwal S, Tuzcu EM, et al. Percutaneous coronary intervention in patients with severe aortic stenosis: Implications for transcatheter aortic valve replacement. Circulation. 2012;Epub ahead of print.

2. Kodali SK, Moses JW. CAD and aortic stenosis in the TAVR era: Old questions, new paradigms. The evolving role of PCI in the treatment of patients with aortic stenosis. Circulation. 2012;Epub ahead of print.

 

 

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Disclosures
  • Dr. Kapadia reports no conflicts of interest.
  • Dr. Kodali reports serving as a case proctor and on the steering committee of the PARTNER trial for Edwards Lifesciences, as a consultant to St. Jude Medical, and on the scientific advisory board of Thubrikar Aortic Valve.
  • Dr. Moses reports serving as a consultant to Abbott Vascular and Boston Scientific and on the executive committee for the PARTNER trial.
  • Dr. Block reports being an investigator for the PARTNER trials sponsored by Edwards Lifesciences, serving as a consultant for DirectFlow Medical and Medtronic, and owning equity in DirectFlow Medical.

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