Manifestation of In-Stent Restenosis More Tightly Linked to Patient Than Device Factors

The clinical presentation of patients undergoing target lesion revascularization for in-stent restenosis is similar across all generations of BMS and DES, and it is more closely related to patient risk factors than stent type, according to a retrospective study published online December 2, 2014, ahead of print in Circulation: Cardiovascular Interventions.

“In-stent restenosis is not benign no matter what stent you have, and if you want to reduce the chance of having it you have to use stents that don’t tend to re-clog. Those are second-generation DES,” Ron Waksman, MD, of MedStar Washington Hospital Center (Washington, DC), told TCTMD in a telephone interview.

For the study, Dr. Waksman and colleagues analyzed 909 consecutive patients with 1,077 culprit lesions arising from in-stent restenosis—including 388 with BMS, 425 with first-generation DES, and 96 with second-generation DES—from April 2003 to May 2013.

First-generation DES included Cypher (Cordis/Johnson & Johnson) and Taxus Express/Liberté (Boston Scientific) while second-generation DES were Xience V (Abbott), Promus Element (Boston Scientific), and Endeavor (Medtronic). Patients who had received a combination of stents were excluded from the analysis. Roughly two-thirds of patients presented with ACS, and those with restenosis in second-generation DES tended to present less with MI (5.2%) compared with those whose culprit lesions were in BMS (10.6%) or first-generation DES (10.1%; P = .273).

Smokers With In-Stent Restenosis Have Tripled MI Risk

 The majority of adverse events (83.5%) were reported in those with ACS, and diagnosis severity was linked with worse outcomes. Six-month risk of MACE (death, MI, and re-target lesion revascularization) was higher in patients who presented with MI (adjusted HR 4.06; 95% CI 1.84-8.94; P < .001) or unstable angina (adjusted HR 1.98; 95% CI 1.01-3.87; P = .046) compared with those without ACS.

Complication Not Merely ‘Inconvenient’

In the early years of the BMS era, restenosis following PCI was thought to be a largely benign condition, Deepak L. Bhatt, MD, of Brigham and Women’s Hospital (Boston, MA), told TCTMD in a telephone interview.

“The thinking was that it wasn’t serious and that when chest pain got bad you would send the patient back to the cath lab,” he said. “It was considered to be an inconvenience, but not a huge deal. However, we found in an analysis some years ago that a fair number of patients with restenosis were presenting with acute coronary syndrome.”

According to Dr. Waksman, the clinical presentation of patients with in-BMS restenosis is now well characterized, but less is known about clinical presentations and outcomes among patients with restenosis of first- and second-generation DES.

Study Confirms Need for Vigilance

“These findings reinforce the need for secondary prevention and clinical surveillance after [in-stent restenosis] with ACS presentations and highlight the unmet clinical need for novel technologies to eradicate [in-stent restenosis], which is gaining new momentum in the DES era,” the researchers write.

In a telephone interview with TCTMD, Ajay J. Kirtane, MD, of Columbia University Medical Center/New York Presbyterian Hospital (New York, NY), said the results also emphasize the need to use vigilance in following PCI patients.

“We really need to do a full-court press with these patients to minimize their risk for adverse events,” he said.

Dr. Bhatt agreed that a key message to clinicians is that vigilance is needed regardless of the type of stent a patient receives. “This shows that even in the modern era of DES, restenosis can be very serious and if you can prevent your patient from getting it that is a good thing,” he said. “It isn’t just about preventing inconvenience and repeat procedures.”

Source:

Magalhaes MA, Minha S, Chen F, et al. Clinical presentation and outcomes of coronary in-stent restenosis across 3-stent generations. Circ Cardiovasc Interv. 2014;Epub ahead of print.

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